mdxg-20231231


Item	Description	Page
Part I
Item 1.	Business	7
Item 1A.	Risk Factors	21
Item 1B.	Unresolved Staff Comments	37
Item 1C.	Cybersecurity	37
Item 2.	Properties	37
Item 3.	Legal Proceedings	37
Item 4.	Mine Safety Disclosures	37
Part II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	38
Item 6.	[Reserved]	40
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	40
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	48
Item 8.	Financial Statements and Supplementary Data	F- 1
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	79
Item 9A.	Controls and Procedures	79
Item 9B.	Other Information	80
Item 9C.	Disclosures Regarding Foreign Jurisdictions that Prevent Inspections	80
Part III
Item 10.	Directors, Executive Officers and Corporate Governance	80
Item 11.	Executive Compensation	81
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	81
Item 13.	Certain Relationships and Related Transactions, and Director Independence	81
Item 14.	Principal Accounting Fees and Services	81
Part IV
Item 15.	Exhibits, Financial Statement Schedules	82
Item 16.	Form 10-K Summary	85
	Signatures	86

This discussion includes certain estimates, projections and other statistical data. These estimates and projections reflect management’s best estimates based upon currently available information and certain assumptions we believe to be reasonable. These estimates are inherently uncertain, subject to risks and uncertainties, many of which are not within our control, have not been reviewed by our independent auditors and may be revised as a result of management’s further review. In addition, these estimates and projections are not a comprehensive statement of our financial results, and our actual results may differ materially from these estimates and projections due to developments that may arise between now and the time the results are final. There can be no assurance that the estimates will be realized, and our results may vary significantly from the estimates, including as a result of unexpected issues in our business and operations. Accordingly, you should not place undue reliance on such information. Projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. See Item 1A, Risk Factors for further information.

The manufacturing of our product offering begins with donated birth tissue, namely the placenta, umbilical cord and placental disc, which we source through a large donor network developed over multiple years with leading hospitals and clinician groups. In partnership with these facilities, we are able to obtain donated birth tissue from consenting mothers, which then are shipped to our manufacturing facilities in Marietta, Georgia, and undergo a series of testing followed by our proprietary tissue manufacturing workflow, which we refer to as the PURION® process. We employ Current Good Tissue Practices (“CGTP”) and terminal sterilization to produce our allografts. MIMEDX provides products primarily for use in the wound care, burn, and surgical sectors of healthcare. All of our products sold in the United States are regulated by the U.S. Food & Drug Administration (“FDA”), and to the extent we sell our products outside the United States, by other regulatory agencies in such international markets.

Patients present with chronic wounds in a variety of care settings and these wounds vary in severity and complexity to treat. Our products can be found in many of these sites of service, including the private physician office (e.g., podiatry clinics), wound care centers, hospital inpatient and outpatient settings, nursing homes and federal facilities, such as those operated by the Department of Veterans Affairs (“VA”). The most common types of chronic and hard-to-heal wounds appear in the lower extremities, presenting as diabetic foot ulcers (“DFUs”), venous leg ulcers (“VLUs”), and pressure ulcers, among others. Taken together, nearly 60% of the chronic wounds in the U.S. are categorized as chronic leg ulcers (which include DFUs and VLUs), with 47% treated with Advanced Wound Care dressings such as skin substitutes2. These wounds require intervention and active management by clinicians and are treated in a variety of sites-of-service, with numerous products aimed at achieving healing for the patie

Traditional dressings such as bandages, gauzes and ointments, along with treatment of active infection and debridement, currently represent the “standard of care” for treating chronic wounds such as DFUs and VLUs. If, after four weeks of standard of care therapy, the wound has not responded appropriately or improved, clinical research has shown that advanced therapy such as a skin substitute can be beneficial as part of the patient’s treatment plan. However, oftentimes advanced therapies are not employed due to current treatment guidelines, product access, or medical education around the clinical and economic benefits of AWC products, including skin substitutes. We believe this represents a large opportunity for us to expand the market and drive initiatives resulting in market growth. According to recent data, MIMEDX’s EPIFIX is the current product of choice for physicians choosing to use an amniotic skin substitute product as a barrier or cover. Our EPIFIX, EPICORD® and EPIEFFECT® products can be stored at room temperature for up to five years, in contrast to certain other skin substitutes currently on the market that have performance, storage or handling limitations. In addition, we market multiple sizes of EPIFIX, EPICORD and EPIEFFECT sheets for use as protective barriers, which enables a healthcare provider to select an appropriate size graft based on the size of the wound to reduce product waste. Our EPICORD, EPICORD Expandable and EPIEFFECT product lines also offer an alternative treatment option to address larger, deeper wounds in a cost-effective way at a point earlier in the treatment algorithm.

The FDA initiated inspections covering our Marietta, Georgia, and Kennesaw, Georgia, processing facilities from February 22, 2023, through March 2, 2023. During the inspections, the FDA communicated that our product, AXIOFILL, appeared to be regulated under Section 351 of the Public Health Service Act (the “PHS Act”). Based on this position, the FDA inspected the facilities related to AXIOFILL production using regulations 21 CFR 210 and 211, relating to finished pharmaceutical products in addition to 21 CFR 1271, relating to HCT/Ps (as defined below). The FDA issued a Form 483, which is a list of inspectional observations, at the conclusion of each inspection. Specifically, the FDA issued a Form 483 consisting of one (1) observation at our Marietta, Georgia, processing facility, and a Form 483 consisting of six (6) observations at our Kennesaw, Georgia, processing facility. All observations were related to our AXIOFILL product and 21 CFR 211. There were no observations relating to noncompliance with 21 CFR 1271.

With the exception of government accounts, most purchasers of our products include physicians, hospitals, or ambulatory surgery centers (“ASCs”) that rely on reimbursement by third-party payers. Accordingly, our growth substantially depends on adequate levels of third-party reimbursement for our products from these payers. Third-party payers are sensitive to the cost of products and services and are increasingly seeking to implement cost containment measures to control, restrict access to, or influence the purchase of health care products and services. In the U.S., such payers include U.S. federal healthcare programs (e.g., Medicare and Medicaid), private insurance plans, managed care programs, and workers’ compensation plans. Federal healthcare programs have prescribed coverage criteria and reimbursement rates for medical products, services, and procedures. Similarly, private, third-party payers have their own coverage criteria and negotiate reimbursement amounts for medical products, services, and procedures with providers. In addition, in the U.S., an increasing percentage of insured individuals are receiving their medical care through managed care programs (including managed federal healthcare programs) which monitor and may require pre-approval of the products and services that a member receives. Ultimately, however, each third-party payer determines whether and on what conditions they will provide coverage for our products, and such decisions often include each payer’s assessment of the science and efficacy of the applicable product.

The largest third-party payer in the United States is the Medicare program, which is a federally-funded program that provides healthcare coverage for senior citizens and certain disabled individuals. The Medicare program is administered by the Centers for Medicare and Medicaid Services (“CMS”), an agency within the U.S. Department of Health and Human Services (“HHS”). Medicare Administrative Contractors (“MACs”) are private insurance companies that serve as agents of CMS in the administration of the Medicare program and are responsible for making coverage decisions and paying claims for the designated Medicare jurisdiction. There are seven Part A/B MACs in the U.S., which cover 12 unique geographical jurisdictions. Each MAC also has its own standards and process for determining coverage and reimbursement for a procedure or product. Private payers often follow the lead of governmental payers in making coverage and reimbursement determinations. Therefore, achieving favorable Medicare coverage and reimbursement is usually a significant gating factor for successful adoption of a new product or clinical application by private payers.

The coverage and reimbursement framework for products under Medicare is determined in accordance with the Social Security Act and pursuant to regulations promulgated by CMS, as well as the agency’s coverage and reimbursement guidance. In some cases, CMS does not specify coverage, leaving each of the MACs to determine whether and on what conditions they will provide coverage for the product. Such decisions are based on each MAC’s assessments of the science and efficacy of the applicable product. As noted below under the heading “Research and Development,” we have devoted significant resources to clinical studies to provide data to the MACs, as well as other payers, in order to demonstrate the clinical efficacy and economic effectiveness of our tissue technologies. As of the date of this report, both EPIFIX and EPICORD allografts are eligible for coverage by all MACs. In January 2019, EPIFIX and EPICORD received separate CMS HCPCS Codes, Q4186 and Q4187, distinguishing each product in coverage and reimbursement policies. On July 1, 2023, EPIEFFECT received a CMS Code Q4278, also.

For Medicare reimbursement purposes, our EPIFIX and EPICORD allografts are classified as “skin substitutes.” Current reimbursement methodology varies between the hospital outpatient department (“HOPD”) and ASC setting versus the physician office. Currently, within the HOPD and ASC places of service, skin substitutes are reimbursed under a “packaged” or “bundled” methodology that provides a single payment for both the application of the product as well as the product itself. CMS classifies skin substitutes into low cost or high cost groups, based on a geometric mean unit cost and per day cost. For 2022, the geometric mean unit cost threshold applicable to both our EPIFIX and EPICORD allograft products was $48 per square centimeter, and the per day cost threshold was $949. For 2023, the geometric mean unit cost threshold applicable to both our EPIFIX and EPICORD allograft products was $47 per square centimeter, and the per day cost threshold was $949. For 2024, the geometric mean unit cost threshold applicable to our EPIFIX, EPICORD and EPIEFFECT allograft products is $47 per square centimeter, and the per day cost threshold was $807. The national HOPD average packaged (“bundled”) rate for our EPIFIX and EPICORD allograft products was $1,549 in 2019, $1,623 in 2020, $1,715 in 2021, $1,749.26 in 2022, and $1,725 in 2023. The national HOPD average packaged (“bundled”) rate for our EPIFIX, EPICORD and EPIEFFECT products in 2024 is $1,738. CMS assigns lower national rates to the ASC to reflect a less resource-intensive place of service. Revenue in the ASC setting constitutes less than 1% of the Company’s annual net sales. Medicare payments for most items and services, including EPIFIX and EPICORD sheet products, have been subject to sequestration reductions of approximately 2% periodically from 2013.

In 2022, CMS announced plans to potentially change the reimbursement mechanism for skin substitutes in the physician office setting but did not propose or enact any national changes to the rules for these products. In March 2023, the Office of Inspector General published a report entitled, “Some Skin Substitute Manufacturers Did Not Comply with New ASP Reporting Requirements,” which detailed extensive problematic expenditure issues associated with the current Medicare reimbursement landscape in the private physician office setting for some skin substitute products. In alignment with many industry stakeholders, including MIMEDX, the report recommended that all skin substitute products transition to ASP-based payments as soon as possible in an effort to substantially reduce Medicare expenditures for these products. Over the last several quarters, there has been a notable increase in the number of skin substitute products listed on the Medicare ASP list, but non-ASP or WAC-based products still remain available in the marketplace.

In February 2020, the AHRQ published a technology assessment analyzing Skin Substitutes for Treating Chronic Wounds. AHRQ conducted a literature search yielding 164 studies and 81 Supplemental Evidence and Data for Systematic Reviews (“SEADs”) submissions. Only 22 randomized, controlled trials (“RCTs”) met the inclusion criteria to be reviewed in the AHRQ analysis, and out of the 22 RCTs MIMEDX had six RCTs included in the final brief. Of the 22 studies reviewed, only 12 were assessed as low risk of bias, of which five were MIMEDX RCTs. This important government assessment highlights our commitment to providing unbiased level 1 clinical evidence in advanced wound treatment. This dedication to elevating the standard of care is further underscored by the fact that the AHRQ points out in its assessment that MIMEDX was the only entity to provide two studies out of the 22 evaluated that performed a subgroup analysis of patients with DFUs that received adequate debridement. Both studies reported an increase in wounds healed with adequate debridement.

•The federal Anti-Kickback Statute (“AKS”), which is a criminal law that prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward referrals, purchases or orders, or arranging for or recommending the purchase, order or referral of any item or service for which payment may be made in whole or in part by a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The Patient Protection and Affordable Care Act amended the intent requirement of the federal AKS, so that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. A conviction for violation of the AKS results in criminal fines and requires mandatory exclusion from participation in federal health care programs. Although there are a number of statutory exceptions and regulatory safe harbors to the federal AKS that protect certain common industry practices from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor.

•While manufacturers of human cell and tissue products regulated solely under Section 361 are not subject to the federal Physician Payments Sunshine Act and its implementing regulations (together with the Act, the “Sunshine Act”), in the future, if we expand our product portfolio beyond those regulated solely under Section 361, this law will require us (with certain exceptions) to report information to CMS related to certain payments or other transfers of value we make to U.S.-licensed physicians and teaching hospitals, and for reports submitted on or after January 1, 2022, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives. Such information will subsequently be made publicly available by CMS on the Open Payments website. There is a risk that CMS or another government agency may take the position that our products are not human cell and tissue products regulated solely under Section 361, and thereby assert that we are currently subject to the Sunshine Act, which could subject us to civil penalties and the administrative burden of having to comply with the law.

In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of protected health information. Among other things, HITECH made HIPAA’s privacy and security standards directly applicable to “business associates,” independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

In 2021, MIMEDX received regulatory approval from the Japanese Ministry of Health, Labour and Welfare (JMHLW) to market EPIFIX in Japan. Under JMHLW guidelines, EPIFIX is classified as a Class IV Medical Device and “Specified Biological Product” and is approved for the treatment of refractory ulcers, such as DFUs and VLUs that do not respond to conventional therapy. As a condition of the final approval, MIMEDX will conduct post-market surveillance, consisting of a limited study of over 75 participants. The JMHLW has the ultimate responsibility of granting final approval on all Class III and IV Medical Devices and “Specified Biological Products.” All approved products in Japan, including EPIFIX, are regulated by the Pharmaceuticals and Medical Devices Agency (“PMDA”), which acts as the technical arm of the JMHLW. The PMDA serves in a similar function as the FDA in the United States, and is responsible for ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices in Japan. The PMDA provides review and approval of medical devices, QMS/GLP/GCP inspections, and collection and analysis of adverse event reports.

Our business is in a very competitive and evolving field. Competition from other tissue processors, medical device companies, and biotherapeutic companies, and from research and academic institutions, is intense, expected to increase and subject to rapid change and could be significantly affected by new product introductions as well as changes in reimbursement that could favor certain products and competitors over others. Established competitors and newer market entrants are investing in additional clinical research that may allow them to gain further clinician usage, adoption and payer coverage of their products. In addition, consolidation and cost containment measures in the healthcare industry may cause hospitals to consolidate their purchases with suppliers that have a broad portfolio of products. This would continue to give rise to demands for price concessions, which could have an adverse effect on our business, results of operations and financial condition. Further, competitors may introduce placental-based membrane products in the future at lower prices, adding new features or gaining additional reimbursement coverage, or utilize sales and marketing practices that negatively impact the industry. Further, they may copy our products outside the United States. The presence of this competition may lead to pricing pressure, which could have an adverse effect on our business, results of operations and financial condition.

The success of our human tissue products depends upon, among other factors, the availability of tissue from human donors. Any failure to obtain tissue from our sources will interfere with our ability to effectively meet demand for our products incorporating human tissue. The availability of donated tissue could also be adversely impacted by regulatory changes, public opinion of the donor process and our own reputation in the industry. We may not be successful in our ability to scale tissue recovery efforts to meet the potential future demand of our pipeline. Obtaining adequate supplies of human tissue involves several risks, including limited control over availability (due to for example, access to hospital accounts and the number of consenting mothers), quality, delivery schedules, and eligibility requirements. In addition, any interruption in the supply of any human tissue component could harm our ability to manufacture our products until a new source of supply, if any, could be found. We also utilize third-party providers of placental donations on an as-needed basis to mitigate risks but there can be no assurance that these third parties will be able to provide donated tissues at all times. We may be unable to find a sufficient alternative supply channel in a reasonable time period or on commercially reasonable terms, if at all, which would have an adverse effect on our business, results of operations and financial condition.

We may obtain the assistance of additional distributors and independent sales representatives to sell products in certain sales channels, particularly in territories and fields where agents are commonly used. Our success is partially dependent upon our ability to train, retain and motivate our independent sales agencies, distributors, and their representatives to appropriately and compliantly sell our products in certain territories or fields. They may not be successful in implementing our marketing plans or compliance safeguards. Some of our independent sales agencies and distributors do not sell our products exclusively and may offer similar products from other companies. Our independent sales agencies and distributors may terminate their contracts with us, may devote insufficient sales efforts to our products or may focus their sales efforts on other products that produce greater commissions for them, which could have an adverse effect on our business, results of operations and financial condition. We also may not be able to find additional independent sales agencies and distributors who will agree to appropriately and compliantly market or distribute our products on commercially reasonable terms, if at all. If we are unable to establish new independent sales representative and distribution relationships or renew current sales agency and distribution agreements on commercially acceptable terms, our business, financial condition, and results of operations could be materially and adversely affected.

A cyberattack, a disruption in availability, or the unauthorized alteration of systems or data could adversely affect our business, results of operations and financial condition. We rely on technology for day-to-day operations as well as positioning to enhance our stance in the market. We generate intellectual property that is central to the future success of the business and transmit large amounts of confidential information. Additionally, we collect, store and transmit confidential information of customers, patients, employees and third parties. We also have outsourced significant elements of our operations to third parties, including significant elements of our information technology infrastructure, and, as a result, we are managing many independent vendor relationships with third parties who may or could have access to our confidential information. The continually changing threat landscape of cybersecurity today makes our systems potentially vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees, partners, and vendors, and from attacks by malicious third parties, including supply chain attacks originating at our third-party partners. Such attacks are of ever-increasing levels of sophistication. Attacks are made by individuals or groups that have varying levels of expertise, some of which are technologically advanced and well-funded including, without limitation, nation states, organized criminal groups and hacktivists organizations.

To ensure protection of our information, we have invested in cybersecurity and have implemented processes and procedural controls to maintain the confidentiality and integrity of such information. We measure these controls and their success through a cybersecurity framework that is based on industry standards. While we have invested in the protection of our data and technology, there can be no guarantees that our efforts will prevent all service interruptions or security breaches. Any such interruption or breach of our systems could adversely affect our business operations and result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal and reputational harm to our business, including legal claims and proceedings, liability under laws that protect the privacy of personal information, government enforcement actions and regulatory penalties, as well as remediation costs. We also maintain cyber liability insurance. However, this insurance may not be sufficient to cover the financial, legal or reputational losses that may result from an interruption or breach of our systems.

We are pursuing further expansion outside the U.S., including in Japan. Managing a global organization is difficult, time consuming and expensive. Our ability to conduct international operations is affected by many of the same risks we face in our U.S. operations, as well as unique costs and difficulties of managing international operations, including the relationships and operations of distributors we elect to work with in these markets. Adoption of our products in new geographic regions could take longer and cost more than we anticipate. Risks inherent in international operations also include, among others, potential adverse tax consequences, greater difficulty in enforcing intellectual property rights, risks associated with the Foreign Corrupt Practices Act and local anti-bribery law compliance, and other international regulations. These regulations may limit our ability to market, sell, distribute or otherwise transfer our products to prohibited countries or persons. International regulations may also limit what promotional claims we may make for our products.

The process of obtaining an approved BLA, including clinical trial development and execution as well as manufacturing processes, requires the expenditure of substantial time, effort and financial resources and may take years to complete, including costs incurred on top of those fees incurred as part of conducting various clinical studies. The fee for filing a BLA and program fees payable with respect to any establishment that manufactures biologics are substantial. The FDA may not grant approval on a timely basis, or at all, or we may decide not to pursue a BLA for certain products or indications, or need to conduct additional trials for a given indication. Additionally, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. If we do receive approval, some types of changes to the approved product, such as adding new indications or doses, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. Our revenues could be adversely

As a general rule, FDA regulations require that the marketing of 361 HCT/Ps only be for appropriate homologous uses, and that the promotion of pre-approved biological products or devices only be for FDA-approved indications. Generally, unless the products are approved by the FDA for alternative uses, the FDA contends that we may not make claims about the safety or effectiveness of our products, or promote them as safe or effective for uses other than those specifically approved by the FDA. Such limitations present a risk that the FDA or other federal or state law enforcement authorities could determine that the nature and scope of our sales, marketing and support activities, though designed to comply with all FDA requirements, constitute the promotion of our products for an unapproved use in violation of the federal FD&C Act. We also face the risk that the FDA or other governmental authorities might pursue enforcement based on past activities that we have discontinued or changed, including sales activities, prior marketing materials, arrangements with institutions and doctors, educational and training programs and other activities.

Our relationships with physicians, hospitals and other healthcare providers are subject to various federal and state healthcare fraud and abuse laws. Healthcare fraud and abuse laws are complex and, in some instances, even minor or inadvertent violations can give rise to liability. Possible sanctions for violation of the healthcare fraud and abuse laws include, without limitation, monetary fines, civil and criminal penalties, exclusion from participating in the federal and state healthcare programs, including, without limitation, Medicare, Medicaid, the VA health programs and TRICARE (the healthcare program administered by or on behalf of the U.S. Department of Defense for uniformed service members, including both those in active duty and retirees, as well as their dependents), and forfeiture of amounts collected in violation of such prohibitions. Many states have similar fraud and abuse laws, imposing substantial penalties for violations. A finding of a violation of one or more of these laws, or even a government investigation or inquiry into the same, would likely result in a material adverse effect on the market price of our Common Stock, as well as on our business, results of operations, and financial condition.

The federal Anti-Kickback Statute (“AKS”) is a criminal law that prohibits, among other things, any person from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward referrals, purchases or orders or arranging for or recommending the purchase, order or referral of any item or service for which payment may be made in whole or in part by a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The Patient Protection and Affordable Care Act (the “PPACA”) amended the federal AKS to clarify the intent that is required to prove a violation. Under the federal AKS as amended, a person or entity need not have actual knowledge of this statute or specific intent to violate it. The PPACA also amended the federal AKS to provide that any claims for items or services resulting from a violation of the federal AKS are considered false or fraudulent for purposes of the federal FCA. A conviction for violation of the AKS results in criminal fines and requires mandatory exclusion from participation in federal health care programs. Although there are a number of statutory exceptions and regulatory safe harbors to the federal AKS that protect certain common industry practices from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor. We have entered into consulting agreements, speaker agreements, research agreements and product development agreements with physicians, including some who may order or recommend our products or make decisions to use them. In addition, some of these physicians own our stock, which

they purchased in arm’s-length transactions on terms identical to those offered to non-physicians, or received stock awards from us in the past as consideration for services performed by them. While we believe these transactions generally meet the requirements of applicable laws, including the federal AKS and analogous state laws, it is possible that our arrangements with physicians and other providers may be questioned by regulatory or enforcement authorities under such laws, which could lead us to redesign the arrangements and subject us to significant civil or criminal penalties. We have designed our policies and procedures to comply with the federal AKS, FCA, and industry best practices. In addition, we have conducted training sessions on these principles. If, however, regulatory or enforcement authorities were to view these arrangements as non-compliant with applicable laws, there would be risk of government investigations/inquiries or penalties. There is also risk that one or more of our employees or agents will disregard the rules we have established. Because our strategy relies on the involvement of physicians who consult with us on the design of our products, perform clinical research on our behalf or educate other health care professionals about the efficacy and uses of our products, we could be materially impacted if regulatory or enforcement agencies or courts interpret our financial relationships with physicians who refer or order our products to be in violation of applicable laws. This could harm our reputation and the reputations of the physicians we engage to provide services on our behalf. In addition, the cost of noncompliance with these laws could be substantial since we could be subject to monetary fines and civil or criminal penalties, and we could also be excluded from federally-funded healthcare programs, including Medicare, Medicaid, VA and TRICARE.

Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims. The PPACA provides that claims tainted by a violation of the federal AKS are false for purposes of the FCA. The DOJ on behalf of the government has previously alleged that the marketing and promotional practices of pharmaceutical and medical device manufacturers, including the off-label promotion of products or the payment of prohibited kickbacks to doctors, violated the FCA, resulting in the submission of improper claims to federal and state healthcare programs such as Medicare and Medicaid. In certain cases, manufacturers have entered into criminal and civil settlements with the federal government under which they entered into plea agreements, paid substantial monetary amounts and entered into onerous corporate integrity agreements with the government that require, among other things, substantial reporting and remedial actions, as well as oversight and review by an outside entity, an Independent Review Organization (“IRO”), at substantial expense to the Company.

There are federal and state laws requiring detailed reporting of manufacturer interactions with and payments to healthcare providers, such as the federal Physician Payments Sunshine Act (“Sunshine Act”). The Sunshine Act requires, among others, “applicable manufacturers” of drugs, devices, biological products, and medical supplies reimbursed under Medicare, Medicaid or the Children’s Health Insurance Program to annually report to CMS information related to payments and other transfers of value provided to “covered recipients.” The term covered recipients includes U.S.-licensed physicians and teaching hospitals, and, for reports submitted on or after January 1, 2022, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives. There is the risk that CMS or another government agency may take the position that our products are not human cell and tissue products regulated solely under Section 361, and thereby assert that we are currently subject to the Sunshine Act, which could subject us to civil penalties and the administrative burden of having to comply with the law.

In addition to the ACA, the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) repealed the Sustainable Growth Rate formula used to calculate Medicare payment updates for physicians providing services to Medicare beneficiaries. In its place, MACRA introduced the Quality Payment Program (“QPP”), which is a value-based program that focuses on quality and outcomes as a metric for physician reimbursement. The Centers for Medicare and Medicaid Services released its final rules for the QPP in October 2016. The QPP, which impacts more than 600,000 physicians and other practice-based clinicians, represents a fundamental change in physician reimbursement, transitioning from a system that solely rewards volume of care to one that also rewards quality and value of care. The rule may have an impact on our revenue in the future. The program’s increased emphasis on quality and cost of care may encourage physicians to merge practices or seek direct employment with hospitals. In addition, the ACA encourages hospitals and physicians to work collaboratively through shared savings programs as well as other bundled payment initiatives. These shifts could lead to a consolidation of hospital providers into larger delivery networks with increased price negotiation strength resulting in downward pressure on our selling prices. Although we believe that we are well positioned to minimize any such impact on our business, our inability to address the consolidation trend could materially and adversely affect our business and results of operations.

There is uncertainty with respect to the impact the U.S. Administration, the executive order, and the attempted legislation may have, if any, and any changes will likely take time to unfold and could have an impact on coverage and reimbursement for healthcare items and services, including our products. We believe that substantial uncertainty remains regarding the net effect of the PPACA, or its repeal and potential replacement, on our business, including uncertainty over how benefit plans purchased on exchanges will cover our products, how the expansion or contraction of the Medicaid program will affect access to our products, the effect of risk-sharing payment models such as Accountable Care Organizations and other value-based purchasing programs on coverage for our product, and the effect of the general increase or decrease in federal oversight of healthcare payers. The taxes imposed and the expansion in government’s role in the U.S. healthcare industry under the PPACA, if unchanged, may result in decreased revenues, lower reimbursements by payers for our products and reduced medical procedure volumes, all of which could have a material adverse effect on our business, results of operations and financial condition.

We currently market our products in a small number of foreign countries, including in Japan. Foreign jurisdictions require separate regulatory approvals and compliance with numerous and varying regulatory requirements. The approval procedures vary among countries and may involve requirements for additional testing. Certain of our products require clearance or approval by the FDA. However, such clearance or approval does not ensure approval or certification by regulatory authorities in other countries or jurisdictions, and approval or certification by one foreign regulatory authority does not ensure approval or certification by regulatory authorities in other foreign countries or by the FDA. The foreign regulatory approval or certification process may include all of the risks associated with obtaining FDA clearance or approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals or certifications and may not receive necessary approvals to commercialize our products in any foreign jurisdiction. Furthermore, many foreign jurisdictions operate under socialized medical care, and obtaining reimbursement for our products under that construct may also prove difficult. If we fail to receive necessary approvals, certifications, or reimbursements necessary to commercialize our products in foreign jurisdictions on a timely basis, or at all, our business, results of operations and financial condition could be adversely affected. Further, governmental authorities outside the U.S. have become increasingly stringent in their regulation of medical devices, and our products may become subject to more rigorous regulation by non-U.S. governmental authorities in the future. U.S. or non-U.S. government regulations may be imposed in the future that may have a material adverse effect on our business and operations.

Our success depends significantly on our ability to protect our proprietary rights to the technologies used in our products. We rely on patent protection, as well as a combination of copyright, trade secret and trademark laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology, including our licensed technology. These legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. In addition, our pending patent applications include claims to material aspects of our products and procedures that may not be protected by issued patents. The patent application process can be time consuming and expensive. Our pending patent applications might not result in issued patents, and issued patents may later be determined to be invalid or unenforceable as a result of district court litigation or related administrative proceedings. Competitors may be able to design around our patents or develop products that provide outcomes that are comparable or even superior to ours. Although we have taken steps to protect our intellectual property and proprietary technology, including entering into confidentiality agreements and intellectual property assignment agreements with some of our officers, employees, consultants and advisors, such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements.

In the event a competitor infringes upon our licensed patents, issued patents, pending patent applications or other intellectual property rights, enforcing those rights may be costly, uncertain, difficult and time consuming. Even if successful, litigation to enforce or defend our intellectual property rights could be expensive and time consuming and could divert our management’s attention. Further, bringing litigation to enforce our patents subjects us to the potential for counterclaims. Other companies or entities also have commenced, and may again commence, actions seeking to establish the invalidity of our patents and certain related claims. In the event that any of our patent claims are challenged, a court, the United States Patent and Trademark Office (“USPTO”), or the Patent Trial and Appeal Board (“PTAB”) of the USPTO may invalidate one or more challenged patent claims or determine that the patent is unenforceable, which could harm our competitive position. If the USPTO or the PTAB ultimately cancels or narrows the claim scope of any of our patents through these proceedings, it could prevent or hinder us from being able to enforce them against competitors. Such adverse decisions could negatively impact our business, results of operations, and financial condition.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many companies have encountered significant problems in enforcing and defending intellectual property rights in certain foreign jurisdictions. This could make it difficult for us to stop infringement of our foreign patents, if obtained, or the misappropriation of our other intellectual property rights. For example, some foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition, some countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business. Accordingly, our efforts to protect our intellectual property rights in some countries may be inadequate.

Any infringement claim could cause us to incur significant costs, place significant strain on our financial resources, divert management’s attention from our business and harm our reputation. If the relevant patent claims at issue in such a dispute were upheld as valid and enforceable and we were found to infringe, we could be prohibited from selling any product that is found to infringe those claims through an injunction unless we could obtain licenses to use the technology covered by the asserted patent claims or other intellectual property, or are able to design around the patent claim or claims at issue or other intellectual property. We may be unable to obtain such a license on terms acceptable to us, if at all, and we may not be able to redesign our products to avoid infringement. A court could also order us to pay compensatory damages for such infringement, plus prejudgment interest and could, in addition, treble the compensatory damages and award attorney fees. These damages could be substantial and could harm our reputation, business, financial condition and operating results. A court also could enter orders that temporarily, preliminarily or permanently enjoin us and our customers from making, using, or selling products, and could enter an order mandating that we undertake certain remedial measures. Depending on the nature of the relief ordered by the court, we could become liable for additional damages to third parties. Further, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our trade secrets or other confidential information could be compromised by inadvertent or court-ordered disclosure during this type of litigation.

contractual arrangement with one or more of our competitors. Although no claims are currently pending, we may be subject to claims that we, our employees, or our independent contractors have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of these former employers or competitors. In addition, we have been and may in the future be subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. If we fail to defend such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Any future litigation or the threat thereof may adversely affect our ability to hire additional direct sales representatives. A loss of key personnel or their work product could hamper or prevent our ability to market existing or new products, which could severely harm our business, financial condition and operating results.

We have in the past reported material weaknesses in our internal control over financial reporting which we have since remediated. If material weaknesses or deficiencies in our internal control over financial reporting are discovered or occur in the future, our consolidated financial statements might contain material misstatements and we could be required to restate our financial results. Moreover, because of the inherent limitations of any control system, material misstatements due to error or fraud may not be prevented or detected on a timely basis, or at all. If we are unable to provide reliable and timely financial reports in the future, our business and reputation may be further harmed. Failures in internal controls may also cause us to fail to meet reporting obligations, negatively affect investor confidence in our management and the accuracy of our financial statements and disclosures, or result in adverse publicity and concerns from investors, any of which could have a negative effect on the price of our Common Stock, subject us to regulatory investigations and penalties or shareholder litigation, and adversely impact our business, results of operations and financial condition.

The Citizens Credit Agreement also contains certain customary events of default, including, without limitation, (i) failure to pay interest or principal when due, (i) failure to provide notice of certain material events and (iii) failure to perform or observe certain covenants under the Citizens Credit Agreement or any related loan documents (subject to a 30-day grace period in certain circumstances). If an event of default occurs and is continuing, the agent under the agreement may, and at the direction of the lenders, take one or more of the following actions: (i) terminate the commitments, (ii) declare any amounts outstanding immediately due and payable, and (iii) exercise any other right it has under the Citizens Credit Agreement or at law. Compliance with such covenants may restrict our operating flexibility, and in the event that we were unable to comply with such covenants, leading to default and acceleration, this could adversely affect our business, results of operations and financial condition.

As of December 31, 2023, EW Healthcare Partners and their affiliates owned approximately 19.3% of our Common Stock (calculated on the basis described in Item 12, “Security Ownership Of Certain Beneficial Owners And Management” below). Also, for as long as EW Healthcare Partners and its affiliates collectively hold at least (i) 10% of the outstanding shares of our Common Stock, EW Healthcare Partners has the right to select two individuals that the Company must include among its nominees to serve on our Board and (ii) 5% (but less than 10%) of the outstanding shares of our outstanding Common Stock, EW Healthcare Partners has the right to select one individual that the Company must include among its nominees to serve on our Board. EW Healthcare Partners designated Martin P. Sutter and William A. Hawkins, III, who continue to serve on our board as directors. The interests of EW Healthcare Partners may conflict with those of our other shareholders, and EW Healthcare Partners may seek to influence, and may be able to influence, us through its director nomination rights and its share ownership.

We face significant and persistent cybersecurity risks due primarily to: the substantial level of harm that could occur to us and our customers were we to suffer impacts of a material cybersecurity incident; and our use of third-party products, services and components. We are committed to maintaining robust governance and oversight of these risks and to implementing mechanisms, controls, technologies, and processes designed to help us assess, identify, and manage these risks. While we have not, as of the date of this Annual Report, experienced a cybersecurity threat or incident that resulted in a material adverse impact to our business or operations, there can be no guarantee that we will not experience such an incident in the future. In addition, these threats are constantly evolving, thereby increasing the difficulty of successfully defending against them or implementing adequate preventative measures. We seek to detect and investigate unauthorized attempts and attacks against our network, products, and services, and to prevent their occurrence and recurrence where practicable through changes or updates to our internal processes and tools and changes or updates to our products and services; however, we remain potentially vulnerable to known or unknown threats.

We aim to incorporate industry best practices throughout our cybersecurity program. Our cybersecurity strategy focuses on implementing effective and efficient controls, technologies, and other processes to assess, identify, and manage material cybersecurity risks. Our cybersecurity program is designed to be aligned with applicable industry standards and is assessed periodically by independent third-parties. We have processes in place to assess, identify, manage, and address material cybersecurity threats and incidents. These include, among other things: annual and ongoing security awareness training for employees; mechanisms to detect and monitor unusual network activity; and containment and incident response tools. We monitor issues that are internally discovered or externally reported that may affect our business, and have processes to assess those issues for potential cybersecurity impact or risk. We also have a process in place to manage cybersecurity risks associated with third-party service providers. We impose security requirements upon our suppliers, including: maintaining an effective security management program and abiding by information handling and asset management requirements. Our Board of Directors has ultimate oversight of cybersecurity risk, which it manages as part of our enterprise risk management program. That program is utilized in making decisions with respect to company priorities, resource allocations, and oversight structures. The Board of Directors is assisted by the Audit Committee, which regularly reviews our cybersecurity program with management and reports to the Board of Directors. Cybersecurity reviews by the Audit Committee or the Board of Directors generally occur at least annually, or more frequently as determined to be necessary or advisable. Our cybersecurity program is run by the head of our information security department, who reports to our Chief Financial Officer. Our Chief Financial Officer is informed about and monitors prevention, detection, mitigation, and remediation efforts through regular communication and reporting from professionals in the information security team, who hold cybersecurity certifications such as a Certified Information Systems Security Professional, and through the use of technological tools and software and results from third party audits. We have an escalation process in place to inform senior management and the Board of Directors of material issues.

On December 22, 2023, all 95,000 outstanding shares of the Company’s Series B Convertible Preferred Stock (the “Preferred Stock”), together with accrued dividends, were mandatorily converted into shares of the Company’s Common Stock in accordance with the Preferred Stock terms set forth in the Company’s Articles of Incorporation, as amended. The Preferred Stock conversion, triggered by the Company’s increased Common Stock share price and following the third anniversary of the Preferred Stock financing transaction in July of 2020. As a result of this conversion, 29,761,650 new shares of Common Stock were issued by the Company to an affiliate of EW Healthcare Partners and to certain funds managed by Hayfin Capital Management LLP. The Company received no consideration upon the conversion. The shares of Common Stock issued pursuant to the conversion of the Preferred Stock were issued in reliance upon exemptions pursuant to Section 3(a)(9) under the Securities Act of 1933, as amended, and pursuant to applicable state securities laws and regulations, in that the shares of Common Stock were issued by the Company to its existing security holders and no commission or other remuneration was paid or given directly or indirectly for soliciting such exchange.

Selling, general and administrative (“SG&A”) expense includes costs to execute our sales strategy. These include personnel costs pertaining to our sales force and sales support functions, including salaries, commissions and other incentive compensation, commissions to sales agents, customer support, travel expenses, and bad debt expense. SG&A expense also includes costs related to functions which support our business, such as legal, finance, human resources, and other such functions that include costs such as personnel costs, insurance, and certain professional fees. We expect our SG&A expense to fluctuate based on revenue fluctuations, geographic changes, and any changes to the size of our headcount, particularly that of our sales and marketing forces. Certain of these costs scale with sales, but can fluctuate depending on sales mix. For example, we pay sales agents a greater commission than our internal sales force, meaning that we could incur greater commission expenses if a greater proportion of our sales are through sales agents.

The Citizens Credit Agreement provides for senior secured credit facilities in an aggregate principal amount of up to $95.0 million consisting of: (i) a $75.0 million senior secured revolving credit facility (the “Revolving Credit Facility”) with a $10.0 million letter of credit sublimit and a $10.0 million swingline loan sublimit, and (ii) a $20.0 million senior secured term loan facility (the “Term Loan Facility” and, together with the Revolving Credit Facility, the “Credit Facilities”). All obligations are required to be paid in full on January 19, 2029 (the “Maturity Date”), and are guaranteed by certain of the Company’s subsidiaries, and secured by substantially all of the assets of the Company and the guarantors pursuant to a customary security agreement. Subject to the terms of the Citizens Credit Agreement, the Company has the option to obtain one or more incremental term loan facilities and/or increase the commitments under the Revolving Credit Facility in an aggregate principal amount equal to the greater of (i) $50.0 million and (ii) 1.00 times the Company’s Consolidated EBITDA as defined therein, each subject to the existing or any new lenders’ election to extend additional term loans or revolving commitments.

The Company is required to pay a quarterly commitment fee on any unused portion of the Revolving Credit Facility, letter of credit fees, and other customary fees to the Agent and the Lenders. The Term Loan Facility will amortize on a quarterly basis at 1.25% (for year one and two), 1.875% (for year three and four), and 2.5% (for year five) based on the aggregate principal amount outstanding under the Term Loan Facility, with the remainder due on the Maturity Date. The Company must make mandatory prepayments in connection with certain asset dispositions and casualty events, subject in each case to customary reinvestment rights. The Company may prepay borrowings under the Credit Facilities at any time, without premium or penalty, and may, at its option, reduce the aggregate unused commitments under the Revolving Credit Facility in whole or in part, in each case subject to the terms of the Credit Agreement. The Company must also comply with certain financial covenants, including a maximum total net leverage ratio and a minimum consolidated fixed charge coverage ratio, as well as other customary restrictive covenants.


	December 31,
	2023		2022
ASSETS
Current assets:
Cash and cash equivalents	$	82,000	$	65,950
Accounts receivable, net	53,871		43,084
Inventory	21,021		13,183
Prepaid expenses	5,624		7,315
Current assets of discontinued operations	—		1,331
Other current assets	1,745		3,335
Total current assets	164,261		134,198
Property and equipment, net	6,974		7,856
Right of use assets	2,132		3,400
Deferred tax assets	40,777		—
Goodwill	19,441		19,441
Intangible assets, net	5,257		5,852
Other assets	205		148
Noncurrent assets of discontinued operations	—		535
Total assets	$	239,047	$	171,430
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable	$	9,048	$	8,454
Accrued compensation	22,353		20,856
Accrued expenses	9,361		10,934
Current liabilities of discontinued operations	1,352		1,479
Other current liabilities	3,894		1,834
Total current liabilities	46,008		43,557
Long term debt, net	48,099		48,594
Other liabilities	2,223		4,773

Total liabilities	$	96,330	$	96,924
Commitments and contingencies (Note 16)
Convertible preferred stock Series B; $.001 par value; 100,000 shares authorized, 0 shares issued and outstanding at December 31, 2023 and 100,000 shares issued and outstanding at December 31, 2022	$	—	$	92,494
Stockholders’ equity (deficit)

Common stock; $.001 par value; 250,000,000 shares authorized, 146,227,639 issued and outstanding at December 31, 2023 and 187,500,000 authorized, 113,705,447 issued and outstanding at December 31, 2022	146		114
Additional paid-in capital	276,249		173,804

Accumulated deficit	(133,678)		(191,906)
Total stockholders’ equity (deficit)	142,717		(17,988)
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)	$	239,047	$	171,430


	Year Ended December 31,
	2023		2022		2021
Net sales	$	321,477	$	267,841	$	242,019
Cost of sales	54,634		48,316		39,628
Gross profit	266,843		219,525		202,391

Operating expenses:
Selling, general and administrative	211,124		208,673		194,846
Research and development	12,665		12,701		9,932
Investigation, restatement and related	5,176		12,177		3,791

Amortization of intangible assets	762		701		820
Impairment of intangible assets	—		—		53
Operating income (loss)	37,116		(14,727)		(7,051)

Other expense, net
Interest expense, net	(6,457)		(5,016)		(4,980)
Other expense, net	(26)		(4)		(23)

Income (loss) from continuing operations before income tax provision	30,633		(19,747)		(12,054)
Income tax provision benefit (expense) from continuing operations	36,806		(206)		(247)
Net income (loss) from continuing operations	67,439		(19,953)		(12,301)



(Loss) income from discontinued operations, net of tax	(9,211)		(10,244)		2,016
Net income (loss)	$	58,228	$	(30,197)	$	(10,285)



Net income (loss) from continuing operations available to common stockholders (Note 10)	$	55,796	$	(26,533)	$	(18,437)

Basic net income (loss) per common share:
Continuing operations	$	0.48	$	(0.24)	$	(0.17)
Discontinued operations	(0.08)		(0.09)		0.02
Basic net income (loss) per common share:	$	0.40	$	(0.33)	$	(0.15)

Diluted net income (loss) per common share:
Continuing operations	$	0.43	$	(0.24)	$	(0.17)
Discontinued operations	(0.06)		(0.09)		0.02
Diluted net income (loss) per common share:	$	0.37	$	(0.33)	$	(0.15)

Weighted average common shares outstanding - basic	116,495,810		112,909,266		110,353,406
Weighted average common shares outstanding - diluted	145,962,462		112,909,266		110,353,406

(in thousands, except share data)


	Common Stock			Additional Paid-in		Treasury Stock			Accumulated
	Shares	Amount		Capital		Shares	Amount		Deficit		Total
Balance at December 31, 2020	112,703,926	$	113	$	158,610	1,773,683	$	(7,449)	$	(151,424)	$	(150)

Deemed dividends	—	—		(926)		—	—		—		(926)
Share-based compensation expense	—	—		14,757		—	—		—		14,757
Exercise of stock options	—	—		(1,199)		(487,361)	2,636		—		1,437
Issuance of restricted stock	—	—		(4,053)		(810,405)	4,053		—		—
Restricted stock shares canceled/forfeited	—	—		515		73,056	(515)		—		—
Shares repurchased for tax withholding	—	—		—		469,239	(4,751)		—		(4,751)
Other	—	—		(2,009)		(239,502)	2,009		—		—
Net loss	—	—		—		—	—		(10,285)		(10,285)
Balance at December 31, 2021	112,703,926	$	113	$	165,695	778,710	$	(4,017)	$	(161,709)	$	82



Share-based compensation expense	—	—		12,666		—	—		—		12,666
Issuance of restricted stock	840,759	1		(3,969)		(882,251)	3,968		—		—
Restricted stock shares canceled/forfeited	—	—		30		5,338	(30)		—		—
Exercise of stock options	160,762	—		(618)		(151,239)	1,269		—		651
Shares repurchased for tax withholding	—	—		—		249,442	(1,190)		—		(1,190)
Net loss	—	—		—		—	—		(30,197)		(30,197)
Balance at December 31, 2022	113,705,447	$	114	$	173,804	—	$	—	$	(191,906)	$	(17,988)

Conversion of Series B Preferred Stock	29,761,650	30		87,840		—	—		—		87,870
Repurchase of Series B Preferred Stock	—	—		(4,935)		—	—		—		(4,935)
Employee stock purchase plan	444,809	—		1,367		—	—		—		1,367

Share-based compensation expense	—	—		17,178		—	—		—		17,178
Exercise of stock options	130,129	—		885		(17,032)	112		—		997

Issuance of restricted stock	2,185,604	2		(268)		(73,335)	266		—		—
Restricted stock shares canceled/forfeited	—	—		378		90,367	(378)		—		—

Net income	—	—		—		—	—		58,228		58,228
Balance at December 31, 2023	146,227,639	$	146	$	276,249	—	$	—	$	(133,678)	$	142,717

CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands)


	Year Ended December 31,
	2023		2022		2021
Cash flows from operating activities:
Net income (loss) from continuing operations	$	67,439	$	(19,953)	$	(12,301)
Adjustments to reconcile net income (loss) from continuing operations to net cash flows provided by (used in) operating activities of continuing operations:
Deferred income tax provision	(37,802)		—		—
Share-based compensation	16,959		11,328		14,156
Depreciation	2,665		3,345		4,363

Bad debt expense	1,449		2,820		—
Non-cash lease expenses	1,268		1,259		989


Amortization of intangible assets	762		701		820
Amortization of deferred financing costs	505		467		1,055
Accretion of asset retirement obligation	93		92		81
Loss (gain) on fixed asset disposal	15		(17)		262

Impairment of intangible assets	—		—		53

Increase (decrease) in cash resulting from changes in:


Accounts receivable	(12,237)		(5,937)		(10,620)
Inventory	(7,838)		(1,794)		(1,406)
Prepaid expenses	(283)		(1,371)		(501)


Other assets	1,535		(333)		9,982
Accounts payable	783		839		(159)
Accrued compensation	1,829		(1,859)		5,008
Accrued expenses	(1,708)		2,366		(20,497)

Other liabilities	(497)		75		(1,159)
Net cash flows provided by (used in) operating activities of continuing operations	34,937		(7,972)		(9,874)
Net cash flows (used in) provided by operating activities of discontinued operations	(8,162)		(9,921)		7,892
Net cash flows provided by (used in) operating activities	26,775		(17,893)		(1,982)
Cash flows from investing activities:

Purchases of equipment	(1,987)		(1,514)		(3,218)



Patent application costs	(168)		(170)		(252)
Sales of equipment	—		24		—
Cash paid for licensing agreement	—		(1,000)		—
Principal payments from note receivable	—		—		75
Net cash flows used in investing activities	(2,155)		(2,660)		(3,395)
Cash flows from financing activities:
Proceeds from exercise of stock options	997		651		1,437
Payments under finance lease obligations	(52)		(41)		(38)
Repurchase of Series B Preferred Shares	(9,515)		—		—







Stock repurchased for tax withholdings on vesting of restricted stock	—		(1,190)		(4,751)
Net cash flows used in financing activities	(8,570)		(580)		(3,352)
Net change in cash and cash equivalents	16,050		(21,133)		(8,729)
Cash and cash equivalents, beginning of period	65,950		87,083		95,812
Cash and cash equivalents, end of period	$	82,000	$	65,950	$	87,083

See notes to the consolidated financial statements.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.


Exhibit Number						Description
10.2C						Third Amendment to Lease made as of November 30, 2021 for real property and improvements located at 1775 West Oak Commons Court, Marietta, Georgia between RE Fields, LLC, successor in interest to HUB Properties GA, LLC, and CPVF II West Oak LLC, and MiMedx Group, Inc., dated January 25, 2013, as amended March 7, 2017 (incorporated by reference to Exhibit 10.6 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2022).
10.2D#						Fourth Amendment to Lease made as of January 26 , 202 4 between Georgia RE Fields, LLC, successor in interest to HUB Properties GA, LLC, and CPVF II West Oak LLC, and MiMedx Group, Inc., dated January 2 6 , 20 24.
10.3##						Securities Purchase Agreement, dated as of June 30, 2020, by and between MiMedx Group, Inc., Falcon Fund 2 Holding Company, L.P. and certain other investors (incorporated by reference to Exhibit 10.38 to the Registrant’s Annual Report on Form 10-K filed July 6, 2020).
10.4						Registration Rights Agreement dated as of July 2, 2020, by and between MiMedx Group, Inc. and Falcon Fund 2 Holding Company, L.P. (incorporated by reference to Exhibit 10.39 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
10.5						MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan, as amended and restated effective February 25, 2014 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on March 3, 2014).
10.6*						Form of Incentive Stock Option Agreement under the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K filed on March 4, 2014).
10.7*						Form of Nonqualified Stock Option Agreement under the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s Annual Report on Form 10-K filed on March 4, 2014).
10.8*						Form of Restricted Stock Agreement for Non-Employee Directors under the MiMedx Group, Inc. 2006 Assumed Stock Incentive Plan (incorporated by reference to Exhibit 10.66 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2013).
10.9*						Form of Restricted Stock Agreement under the MiMedx Group, Inc. 2006 Assumed Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Annual Report on Form 10-K filed on March 4, 2014).
10.10*						2016 Equity and Cash Incentive Plan, as amended and restated through May 2, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on June 14, 2023).
10.11*						Form of Incentive Stock Option Agreement under the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on August 2, 2016).
10.12*						Form of Restricted Stock Agreement under the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (for shares not registered under the Securities Act of 1933) (incorporated by reference to Exhibit 10.9 to the Registrant’s Current Report on Form 8-K filed on May 30, 2019).
10.13*						Form of Restricted Stock Agreement under the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed on August 2, 2016).
10.14*						Form of Restricted Stock Agreement for Non-Employee Directors under the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (incorporated by reference to Exhibit 10.11 to the Registrant’s Current Report on Form 8-K filed on May 30, 2019).
10.15*						Form of Nonqualified Stock Option Agreement under the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed on August 2, 2016).
10.16*						Form of Director Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.16 to the Registrant’s Annual Report on Form 10-K filed on March 17, 2020).
10.17						Form of Employee (Time-Vested) Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.33 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
10.18*						Form of Employee (Performance-Vested, uncertain number of shares) Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
10.19*						Form of Employee (Performance-Vested, certain number of shares) Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.35 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
10.20*						Form of Non-Employee Restricted Stock Award Agreement (vest into retirement) (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed on August 4, 2020).
10.21*						Form of Employee (Time-Vested) Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.25 to the Registrant’s Annual Report on Form 10-K filed on March 8, 2021).


Exhibit Number						Description
10.22*						Letter Agreement dated April 10, 2019 between MiMedx Group, Inc. and Timothy R. Wright (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on May 9, 2019).
10.23*						Employment Offer Letter between MiMedx Group, Inc. and Peter M. Carlson, as amended and restated on June 30, 2021 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3, 2021).
10.24*						Employment Offer Letter between MiMedx Group, Inc. and William F. Hulse IV dated November 4, 2019, (incorporated by reference to Exhibit 10.30 to the Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
10.25*						Form of Key Employee Retention and Restrictive Covenant Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on December 21, 2020).
10.26*						Form of Indemnification Agreement (incorporated by reference to Exhibit 10.65 to the Registrant’s Current Report on Form 8-K filed on July 15, 2008).
10.27*						Form of Director Restricted Stock Unit Award Agreement (Type I - Initial Grant, Full Amount) (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3, 2021).
10.28*						Form of Director Restricted Stock Unit Award Agreement (Type II - Initial Grant, Pro Rata Amount) (incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3, 2021).
10.29*						Form of Director Restricted Stock Unit Award Agreement (Type III - Annual Grant) (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed on August 3, 2021).
10.30						Technology License Agreement dated January 29, 2007 between MiMedx, Inc., Shriner's Hospitals for Children and University of South Florida Research Foundation (incorporated by reference to Exhibit 10.32 to the Registrant’s Current Report on Form 8-K filed on February 8, 2008).
10.31						Cooperation Agreement dated as of May 29, 2019 among MiMedx Group, Inc., M. Kathleen Behrens Wilsey, K. Todd Newton, Richard J. Barry, Prescience Partners, LP, Prescience Point Special Opportunity LP, Prescience Capital LLC, Prescience Investment Group, LLC d/b/a Prescience Point Capital Management LLC and Eiad Asbahi (incorporated by reference to Exhibit 10.32 to the Registrant’s Current Report on Form 8-K filed on May 30, 2019).
10.32*						Separation Agreement and General Release between MiMedx Group, Inc. and Timothy R. Wright dated September 15, 2022 (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on September 14, 2022).
10.33*						Interim Executive Employment Agreement between MiMedx Group, Inc. and K. Todd Newton dated September 14, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on September 14, 2022).
10.34*						Restricted Stock Unit Agreement between MiMedx Group, Inc. and K. Todd Newton dated September 15, 2022 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on September 14, 2022).
10.35*						Employment Offer Letter between MiMedx Group, Inc. and Ricci S. Whitlow dated December 27, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 3, 2023).
10.36*						Letter Agreement between MiMedx Group, Inc. and Joseph H. Capper dated January 27, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023).
10.37*						Performance Stock Unit Agreement between MiMedx Group, Inc. and Joseph H. Capper dated January 27, 2023 (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023).
10.38*						Nonqualified Stock Option Agreement between MiMedx Group, Inc. and Joseph H. Capper dated January 27, 2023 (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023).
10.39						Platform Intellectual Property License Agreement by and between MiMedx Group, Inc. and Global Health Solutions, Inc. (d.b.a. Turn Therapeutics) (incorporated by reference to Exhibit 10.44 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2023).
10.40*						Separation Agreement and General Release between MiMedx Group, Inc. and Peter M. Carlson dated July 14, 2023 (incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly Report on Form 10-Q filed on October 30, 2023).
10.41*						Offer Letter dated June 30, 2023, between the Company and Doug Rice (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on July 5, 2023).
10.42*						Key Employee Retention and Restrictive Covenant Agreement dated July 5, 2023, between the Company and Doug Rice (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on July 5, 2023).


☑			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
			For the fiscal year ended December 31, 2023
☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


Florida						26-2792552
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	MDXG	The Nasdaq Stock Market LLC


Large accelerated filer	☑	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
Emerging growth company	☐


Board of Directors			Women and minorities hold one-third of the seats on our Board, including the Chair of the Board.
Employee Gender Diversity			Women represented 56% of our workforce. Women represented 55% of our new hires in 2023.
Employee Ethnic/Racial Diversity			Black or African American: 25% Hispanic or Latino: 9% Other Non-White (including American Indian, Alaskan Native, Asian, Native Hawaiian, or Other Pacific Islander): 9%


	Year Ended December 31,
	(in thousands)
	2023		2022		$ Change		% Change
Net sales	$	321,477	$	267,841	$	53,636	20.0	%
Cost of sales	54,634		48,316		6,318		13.1	%
Gross profit	266,843		219,525		47,318		21.6	%
Selling, general and administrative	211,124		208,673		2,451		1.2	%
Research and development	12,665		12,701		(36)		(0.3)	%
Investigation, restatement and related	5,176		12,177		(7,001)		(57.5)	%
Amortization of intangible assets	762		701		61		8.7	%

Interest expense, net	(6,457)		(5,016)		(1,441)		28.7	%
Other expense, net	(26)		(4)		(22)		nm
Income tax provision benefit (expense)	36,806		(206)		37,012		nm

Net income (loss) from continuing operations	$	67,439	$	(19,953)	$	87,392	nm


	Year Ended December 31,				Change
	2023		2022		$		%
Hospital	$	187,000	$	163,206	$	23,794	14.6	%
Private Office	95,789		77,158		$	18,631	24.1	%
Other	38,688		27,477		$	11,211	40.8	%
Total	$	321,477	$	267,841	$	53,636	20.0	%


	Assumption
Stock price on grant date	$	3.70
Exercise price	$	3.70
Risk-free interest rate	3.58		%
Expected volatility (annualized)	75.00		%
Dividend yield	—		%
Weighted average grant date fair value	$	1.93


Index to Financial Statements

Report of Deloitte & Touche LLP, Independent Registered Public Accounting Firm (PCAOB ID: 34)			F- 2

Consolidated Balance Sheets – As of December 31, 2023 and 2022			F- 4
Consolidated Statements of Operations – For the years ended December 31, 2023, 2022 and 2021			F- 5
Consolidated Statements of Stockholders’ Equity (Deficit) – For the years ended December 31, 2023, 2022 and 2021			F- 6
Consolidated Statements of Cash Flows – For the years ended December 31, 2023, 2022 and 2021			F- 7
Notes to Consolidated Financial Statements			F- 8


	Allowance for Doubtful Accounts
Balance at December 31, 2021	$	1,187
Bad debt expense	2,820
Write-offs	(224)
Balance at December 31, 2022	$	3,783
Bad debt expense	1,449
Write-offs	(2,088)
Balance at December 31, 2023	$	3,144


	Operating Leases						Finance Leases
	December 31,						December 31,
	2023			2022			2023			2022
Assets
Right of use asset	$	2,132		$	3,400		$	—		$	—
Property and equipment, net	—			—			51			98
Total assets	$	2,132		$	3,400		$	51		$	98

Liabilities
Other current liabilities	$	1,495		$	1,391		$	53		$	49
Other liabilities	893			2,381			5			57
Total liabilities	$	2,388		$	3,772		$	58		$	106

Weighted-average remaining lease term (years)	2.0			2.8			1.1			2.1
Weighted-average discount rate	8.3		%	8.3		%	8.3		%	8.3		%


Year Ending December 31,	Operating Leases		Finance Leases		Total
2024	$	1,623	$	55	$	1,678
2025	506		5		511
2026	419		—		419
2027	35		—		35
2028	—		—		—
Thereafter	—		—		—
Total lease payments	2,583		60		2,643
Less: imputed interest	(195)		(2)		(197)
Lease liability	$	2,388	$	58	$	2,446



	Goodwill
Balance as of January 1, 2022	$	19,441
Activity	—
Balance as of December 31, 2022	$	19,441
Activity	—
Balance as of December 31, 2023	$	19,441


	December 31, 2023						December 31, 2022
	Gross Carrying Amount		Accumulated amortization		Net Carrying Amount		Gross Carrying Amount		Accumulated amortization		Net Carrying Amount
Amortized intangible assets
Patents and know-how	$	10,039	$	(7,818)	$	2,221	$	9,923	$	(7,106)	$	2,817
Licenses	1,000		(54)		946		1,000		(4)		996


Total amortized intangible assets	$	11,039	$	(7,872)	$	3,167	$	10,923	$	(7,110)	$	3,813

Unamortized intangible assets
Tradenames and trademarks	$	1,008			$	1,008	$	1,008			$	1,008
Patents in process	1,082				1,082		1,031				1,031
Total intangible assets	$	13,129			$	5,257	$	12,962			$	5,852


	Estimated
	Amortization
Year Ending December 31,	Expense
2024	$	764
2025	369
2026	214
2027	214
2028	211
Thereafter	1,395
Total amortization expense	$	3,167


	December 31,
	2023		2022
Raw materials	$	825	$	810
Work in process	8,521		6,855
Finished goods	11,675		5,518
Inventory	$	21,021	$	13,183


	December 31,
	2023		2022
External commissions	$	4,136	$	2,941
Accrued GPO Fees	1,338		638
Estimated returns	1,096		659
Legal costs	834		4,447
Accrued rebates	745		707
Accrued travel	433		566

Other	779		976
Total	$	9,361	$	10,934


	Number of Shares	Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value
Outstanding at January 1, 2023	933,894	$	6.46
Granted	3,694,000	3.77
Exercised	(147,161)	6.78
Unvested options forfeited	—	—
Vested options expired	(438,213)	5.85
Outstanding at December 31, 2023	4,042,520	4.06		5.61	19,086
Exercisable at December 31, 2023	348,520	$	7.09	0.44	$	615


	RSA			RSU			PSU
	Number of Shares	Weighted-Average Grant Date Fair Value		Number of Shares	Weighted-Average Grant Date Fair Value		Number of Shares	Weighted-Average Grant Date Fair Value
Unvested at January 1, 2023	122,755	$	6.13	4,774,971	$	6.28	241,072	$	4.62
Granted	—	—		3,278,244	4.66		3,851,427	3.83
Vested	(32,388)	6.98		(2,258,939)	6.18		—	—
Forfeited	(90,367)	5.83		(1,885,537)	5.46		(365,227)	4.24
Unvested at December 31, 2023	—	$	—	3,908,739	$	5.38	3,727,272	$	3.84


Year ending December 31,	Principal
2024	$	1,000
2025	49,000
2026	—
2027	—
2028	—
Thereafter	—
Outstanding principal	$	50,000


	Series B Preferred Stock
	Shares	Amount
Balance at December 31, 2020	100,000	$	91,568
Deemed dividends	—	926
Balance at December 31, 2021	100,000	$	92,494
Activity	—	—
Balance at December 31, 2022	100,000	$	92,494
Repurchase of Series B Preferred Stock	(5,000)	(4,625)
Conversion of Series B Preferred Stock	(95,000)	(87,869)
Balance at December 31, 2023	—	$	—


	Sales Returns Allowance
Balance at December 31, 2021	$	788
Additions charged to expense or revenue	2,034
Deductions and write-offs	(2,163)
Balance at December 31, 2022	659
Additions charged to expense or revenue	3,899
Deductions and write-offs	(3,462)
Balance at December 31, 2023	$	1,096


Year ending December 31,	Meeting Space Commitments
2024	$	654
2025	237

Total	$	891


*			Indicates a management contract or compensatory plan or arrangement
#			Filed herewith
##			Certain exhibits and schedules have been omitted pursuant to Item 601(b)(10) of Regulation S-K, but a copy will be furnished supplementally to the Securities and Exchange Commission upon request.


Exhibit Number						Description
3.1						Restated Articles of Incorporation, adopted March 4, 2021, effective March 5, 2021 (inco rporated by re ference to Exh ibit 3.1 to the Registrant ’s Annual Report on Form 10-K filed on March 8, 20 21).
3.2						Articles of Amendment to Restated Articles of Incorporation, effective June 3, 2021 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 10, 2021).
3.3						Articles of Amendment to Restated Articles of Incorporation, effective June 3, 2021 (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed on June 10, 2021).
3.4						Articles of Amendment to Restated Articles of Incorporation, effective June 13, 2023 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 14, 2023)
3.5						Amended and Restated Bylaws of MiMedx Group, Inc., as amended and restated as of February 16, 2023 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on February 23, 2023).
4.1						The description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to the Registrant’s Registration Statement on Form 8-A filed on November 2, 2020).
10.1##						Loan Agreement dated as of June 30, 2020 by and among MiMedx Group, Inc., certain subsidiaries of MiMedx Group, Inc. parties thereto, the Lenders from time to time party hereto, Hayfin Services LLP, as administrative agent for the Lenders and as collateral agent for the Secured Parties (incorporated by reference to Exhibit 10.36 to Registrant’s Annual Report on Form 10-K filed on July 6, 2020).
10.2						Lease effective May 1, 2013 between Hub Properties of GA, LLC and MiMedx Group, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on May 10, 2013).
10.2A						First Amendment to Lease dated March 7, 2017 between CPVF II West Oak LLC (as successor in interest to HUB Properties of GA, LLC) and MiMedx Group, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on March 13, 2017).
10.2B#						Second Amendment to Lease for real property and improvements located at 1775 West Oak Commons Court,Marietta, Georgia between RE Fields, LLC, successor in interest to HUB Properties GA, LLC, and CPVF II West Oak LLC, (“Landlord”), and MiMedx Group, Inc., (‘Tenant”) dated January 25, 2013, as amended March 7, 2017 (the “Lease”).


Exhibit Number						Description
10.43*						Inducement Performance Stock Unit Agreement dated June 30, 2023, between the Company and Doug Rice (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on July 5, 2023).
10.44*						Inducement Restricted Stock Unit Agreement dated June 30, 2023, between the Company and Doug Rice (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on July 5, 202 3).
10.45*						Inducement Stock Option Agreement dated June 30, 2023, between the Company and Doug Rice (incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed on July 5, 2023).
10.46#						Management Incentive Plan , as amende d and restated effective June 6, 2023 .
21.1#						Subsidiaries of MiMedx Group, Inc.
23.1#						Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.
24.1#						Power of Attorney (included on the signature page to this Report).
31.1#						Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2#						Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1#						Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2#						Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
97.1#						MiMedx Compensation Recoupment Policy, as amended and restated effective November 29, 2023.
101.INS#						XBRL Instance Document
101.SCH#						XBRL Taxonomy Extension Schema Document
101.CAL#						XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF#						XBRL Taxonomy Extension Definition Linkbase Document
101.LAB#						XBRL Taxonomy Extension Label Linkbase Document
101.PRE#						XBRL Taxonomy Extension Presentation Linkbase Document


	MIMEDX GROUP, INC.

February 28, 2024	By:	/s/ Doug Rice
		Doug Rice
		Chief Financial Officer


Company			Jurisdiction of Organization
MiMedx Tissue Services, LLC			Georgia
MiMedx Processing Services, LLC			Florida
MiMedx Supply, LLC			Delaware
MiMedx Japan, Godo Kaisha			Japan


Date:	February 28, 2024	/s/ Joseph H. Capper
		Joseph H. Capper
		Chief Executive Officer

Cover Page - USD ($) $ in Millions	12 Months Ended
Cover Page - USD ($) $ in Millions	Dec. 31, 2023	Feb. 22, 2024	Jun. 30, 2023
Cover [Abstract]
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2023
Current Fiscal Year End Date	--12-31
Document Transition Report	false
Entity File Number	001-35887
Entity Registrant Name	MIMEDX GROUP, INC.
Entity Incorporation, State or Country Code	FL
Entity Tax Identification Number	26-2792552
Entity Address, Address Line One	1775 West Oak Commons Court, NE
Entity Address, City or Town	Marietta
Entity Address, State or Province	GA
Entity Address, Postal Zip Code	30062
City Area Code	770
Local Phone Number	651-9100
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	MDXG
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	true
Document Financial Statement Error Correction	false
Entity Shell Company	false
Entity Public Float			$ 760.0
Entity Common Stock, Shares Outstanding		146,958,420
Documents Incorporated by Reference	Documents Incorporated By Reference Portions of the proxy statement relating to the 2024 Annual Meeting of Shareholders, to be filed within 120 days after the end of the fiscal year to which this report relates, are incorporated by reference in Part III of this Report.
Entity Central Index Key	0001376339
Document Fiscal Year Focus	2023
Document Fiscal Period Focus (Q1,Q2,Q3,FY)	FY
Amendment Flag	false

Audit Information	12 Months Ended
Audit Information	Dec. 31, 2023
Auditor Information [Abstract]
Auditor Firm ID	34
Auditor Name	Deloitte & Touche LLP
Auditor Location	Atlanta, Georgia

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 82,000	$ 65,950
Accounts receivable, net	53,871	43,084
Inventory	21,021	13,183
Prepaid expenses	5,624	7,315
Current assets of discontinued operations	0	1,331
Other current assets	1,745	3,335
Total current assets	164,261	134,198
Property and equipment, net	6,974	7,856
Right of use assets	2,132	3,400
Deferred tax assets	40,777	0
Goodwill	19,441	19,441
Intangible assets, net	5,257	5,852
Other assets	205	148
Noncurrent assets of discontinued operations	0	535
Total assets	239,047	171,430
Current liabilities:
Accounts payable	9,048	8,454
Accrued compensation	22,353	20,856
Accrued expenses	9,361	10,934
Current liabilities of discontinued operations	1,352	1,479
Other current liabilities	3,894	1,834
Total current liabilities	46,008	43,557
Long term debt, net	48,099	48,594
Other liabilities	2,223	4,773
Total liabilities	96,330	96,924
Commitments and contingencies (Note 16)
Convertible preferred stock Series B; $.001 par value; 100,000 shares authorized, 0 shares issued and outstanding at December 31, 2023 and 100,000 shares issued and outstanding at December 31, 2022	0	92,494
Stockholders’ equity (deficit)
Common stock; $.001 par value; 250,000,000 shares authorized, 146,227,639 issued and outstanding at December 31, 2023 and 187,500,000 authorized, 113,705,447 issued and outstanding at December 31, 2022	146	114
Additional paid-in capital	276,249	173,804
Accumulated deficit	(133,678)	(191,906)
Total stockholders’ equity (deficit)	142,717	(17,988)
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)	$ 239,047	$ 171,430

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2023	Dec. 31, 2022
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY (DEFICIT)
Series B convertible preferred stock par value (in dollars per share)	$ 0.001	$ 0.001
Series B convertible preferred stock, shares authorized (in shares)	100,000	100,000
Series B convertible preferred stock, shares issued (in shares)	0	100,000
Series B convertible preferred stock, shares outstanding (in shares)	0	100,000
Stockholders’ equity (deficit)
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	250,000,000	187,500,000
Common stock, shares issued (in shares)	146,227,639	113,705,447
Common stock, shares outstanding (in shares)	146,227,639	113,705,447

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Income Statement [Abstract]
Net sales	$ 321,477,000	$ 267,841,000	$ 242,019,000
Cost of sales	54,634,000	48,316,000	39,628,000
Gross profit	266,843,000	219,525,000	202,391,000
Operating expenses:
Selling, general and administrative	211,124,000	208,673,000	194,846,000
Research and development	12,665,000	12,701,000	9,932,000
Investigation, restatement and related	5,176,000	12,177,000	3,791,000
Amortization of intangible assets	762,000	701,000	820,000
Impairment of intangible assets	0	0	53,000
Operating income (loss)	37,116,000	(14,727,000)	(7,051,000)
Other expense, net
Interest expense, net	(6,457,000)	(5,016,000)	(4,980,000)
Other expense, net	(26,000)	(4,000)	(23,000)
Income (loss) from continuing operations before income tax provision	30,633,000	(19,747,000)	(12,054,000)
Income tax provision benefit (expense) from continuing operations	36,806,000	(206,000)	(247,000)
Net income (loss) from continuing operations	67,439,000	(19,953,000)	(12,301,000)
Net (loss) income from discontinued operations	(9,211,000)	(10,244,000)	2,016,000
Net income (loss)	58,228,000	(30,197,000)	(10,285,000)
Net income (loss) from continuing operations available to common stockholders (Note 10)	$ 55,796,000	$ (26,533,000)	$ (18,437,000)
Basic net income (loss) per common share:
Discontinued operations - basic (in dollars per share)	$ (0.08)	$ (0.09)	$ 0.02
Basic net income (loss) per common share (in dollars per share)	0.40	(0.33)	(0.15)
Diluted net income (loss) per common share:
Continuing operations - basic (in dollars per share)	0.48	(0.24)	(0.17)
Continuing operations (in dollars per share)	0.43	(0.24)	(0.17)
Discontinued operations (in dollars per share)	(0.06)	(0.09)	0.02
Diluted net income (loss) per common share (in dollars per share)	$ 0.37	$ (0.33)	$ (0.15)
Weighted average shares outstanding - basic (in shares)	116,495,810	112,909,266	110,353,406
Weighted average shares outstanding - diluted (in shares)	145,962,462	112,909,266	110,353,406

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Treasury Stock	Accumulated Deficit
Balance beginning of period (in shares) at Dec. 31, 2020		112,703,926
Balance, beginning of period at Dec. 31, 2020	$ (150)	$ 113	$ 158,610	$ (7,449)	$ (151,424)
Treasury stock, beginning balance (in shares) at Dec. 31, 2020				1,773,683
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Deemed dividends	(926)		(926)
Employee stock purchase plan	0
Share-based compensation expense	14,757		14,757
Exercise of stock options (in shares)				(487,361)
Exercise of stock options	1,437		(1,199)	$ 2,636
Shares repurchased for tax withholding (in shares)				469,239
Shares repurchased for tax withholding	(4,751)			$ (4,751)
Issuance of restricted stock (in shares)				(810,405)
Issuance of restricted stock	0		(4,053)	$ 4,053
Restricted stock shares canceled/forfeited	0		515	$ (515)
Restricted stock cancellation/forfeited (in shares)				73,056
Other	0		(2,009)	$ 2,009
Other (in shares)				(239,502)
Net income (loss)	(10,285)				(10,285)
Balance end of period (in shares) at Dec. 31, 2021		112,703,926
Balance, end of period at Dec. 31, 2021	82	$ 113	165,695	$ (4,017)	(161,709)
Treasury stock, ending balance (in shares) at Dec. 31, 2021				778,710
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Employee stock purchase plan	0
Share-based compensation expense	12,666		12,666
Exercise of stock options (in shares)		(160,762)		151,239
Exercise of stock options	651		(618)	$ 1,269
Shares repurchased for tax withholding (in shares)				249,442
Shares repurchased for tax withholding	(1,190)			$ (1,190)
Issuance of restricted stock (in shares)		(840,759)		882,251
Issuance of restricted stock	0	$ 1	(3,969)	$ 3,968
Restricted stock shares canceled/forfeited	0		30	$ (30)
Restricted stock cancellation/forfeited (in shares)				5,338
Net income (loss)	$ (30,197)				(30,197)
Balance end of period (in shares) at Dec. 31, 2022	113,705,447	113,705,447
Balance, end of period at Dec. 31, 2022	$ (17,988)	$ 114	173,804	$ 0	(191,906)
Treasury stock, ending balance (in shares) at Dec. 31, 2022				0
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Conversion of Series B preferred shares (in shares)		29,761,650
Conversion of Series B Preferred Stock	87,870	$ 30	87,840
Repurchase of Series B Preferred Stock	(4,935)		(4,935)
Employee stock purchase plan (in shares)		444,809
Employee stock purchase plan	1,367		1,367
Share-based compensation expense	$ 17,178		17,178
Exercise of stock options (in shares)	(147,161)	(130,129)		17,032
Exercise of stock options	$ 997		885	$ 112
Shares repurchased for tax withholding	0
Issuance of restricted stock (in shares)		(2,185,604)		73,335
Issuance of restricted stock	0	$ 2	(268)	$ 266
Restricted stock shares canceled/forfeited	0		378	$ (378)
Restricted stock cancellation/forfeited (in shares)				90,367
Net income (loss)	$ 58,228				58,228
Balance end of period (in shares) at Dec. 31, 2023	146,227,639	146,227,639
Balance, end of period at Dec. 31, 2023	$ 142,717	$ 146	$ 276,249	$ 0	$ (133,678)
Treasury stock, ending balance (in shares) at Dec. 31, 2023				0

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Cash flows from operating activities:
Net income (loss) from continuing operations	$ 67,439,000	$ (19,953,000)	$ (12,301,000)
Adjustments to reconcile net income (loss) from continuing operations to net cash flows provided by (used in) operating activities of continuing operations:
Deferred income tax provision	(37,802,000)	0	0
Share-based compensation	16,959,000	11,328,000	14,156,000
Depreciation	2,665,000	3,345,000	4,363,000
Bad debt expense	1,449,000	2,820,000	0
Non-cash lease expenses	1,268,000	1,259,000	989,000
Amortization of intangible assets	762,000	701,000	820,000
Amortization of deferred financing costs	505,000	467,000	1,055,000
Accretion of asset retirement obligation	93,000	92,000	81,000
Loss (gain) on fixed asset disposal	15,000	(17,000)	262,000
Impairment of intangible assets	0	0	53,000
Increase (decrease) in cash resulting from changes in:
Accounts receivable	(12,237,000)	(5,937,000)	(10,620,000)
Inventory	(7,838,000)	(1,794,000)	(1,406,000)
Prepaid expenses	(283,000)	(1,371,000)	(501,000)
Other assets	1,535,000	(333,000)	9,982,000
Accounts payable	783,000	839,000	(159,000)
Accrued compensation	1,829,000	(1,859,000)	5,008,000
Accrued expenses	(1,708,000)	2,366,000	(20,497,000)
Other liabilities	(497,000)	75,000	(1,159,000)
Net cash flows provided by (used in) operating activities of continuing operations	34,937,000	(7,972,000)	(9,874,000)
Net cash flows (used in) provided by operating activities of discontinued operations	(8,162,000)	(9,921,000)	7,892,000
Net cash flows provided by (used in) operating activities	26,775,000	(17,893,000)	(1,982,000)
Cash flows from investing activities:
Purchases of equipment	(1,987,000)	(1,514,000)	(3,218,000)
Patent application costs	(168,000)	(170,000)	(252,000)
Sales of equipment	0	24,000	0
Cash paid for licensing agreement	0	(1,000,000)	0
Principal payments from note receivable	0	0	75,000
Net cash flows used in investing activities	(2,155,000)	(2,660,000)	(3,395,000)
Cash flows from financing activities:
Proceeds from exercise of stock options	997,000	651,000	1,437,000
Payments under finance lease obligations	(52,000)	(41,000)	(38,000)
Repurchase of Series B Preferred Shares	(9,515,000)	0	0
Stock repurchased for tax withholdings on vesting of restricted stock	0	(1,190,000)	(4,751,000)
Net cash flows used in financing activities	(8,570,000)	(580,000)	(3,352,000)
Net change in cash and cash equivalents	16,050,000	(21,133,000)	(8,729,000)
Cash and cash equivalents, beginning of period	65,950,000	87,083,000	95,812,000
Cash and cash equivalents, end of period	$ 82,000,000	$ 65,950,000	$ 87,083,000

Nature of Business	12 Months Ended
Nature of Business	Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Nature of Business	Nature of Business MiMedx Group, Inc. (together with its subsidiaries, except where the context otherwise requires, “MIMEDX,” or the “Company”) is a pioneer and leader in placental biologics focused on helping humans heal. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX is dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. All of our products sold in the United States are regulated by the United States Food and Drug Administration (“FDA”). The Company’s product portfolio and product development focuses on Wound and Surgical markets. The Company’s business is focused primarily on the United States of America but the Company also has a small commercial presence in several international locations, including Japan. Disbanding of Regenerative Medicine Business Unit On June 20, 2023, the Company announced the disbanding of its Regenerative Medicine business unit and the suspension of its Knee Osteoarthritis clinical trial program. During the fourth quarter of 2023, the Company completed the regulatory obligations associated with the clinical trial and concluded that the business unit met the criteria for presentation as a discontinued operation at that time. Refer to Note 13, Discontinued Operations, for further discussion.

401(k) Plan	12 Months Ended
401(k) Plan	Dec. 31, 2023
Retirement Benefits [Abstract]
401(k) Plan	401(k) Plan The Company has a 401(k) plan (the “401(k) Plan”) covering all employees who have completed one month of service. Under the 401(k) Plan, participants could defer up to 90% of their eligible wages to a maximum of $22,500 per year (annual limit for 2023). Employees age 50 or over in 2022 could make additional pre-tax contributions of up to $7,500. In 2023, 2022 and 2021, the Company matched 50% of employee contributions up to 8% of the employee’s eligible compensation. The matching contribution for the years ended December 31, 2023, 2022, and 2021 was $2.7 million, $3.3 million, and $2.7 million, respectively.

Government Assistance	12 Months Ended
Government Assistance	Dec. 31, 2023
Government Assistance [Abstract]
Government Assistance	Government Assistance Employee Retention Credit The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) provided an employee retention credit (“ERC”), which was a refundable tax credit against certain payroll taxes. Upon determination that the Company overcame the barriers required to receive the credit, the Company qualified and filed to claim the ERC. The Company reflected the ERC as a reduction to the respective captions on the consolidated statements of operations associated with the employees to which the payroll tax benefit related. For the year ended December 31, 2021, the Company recorded $1.6 million as a reduction to selling, general and administrative expense. Of this amount, $1.0 million and $1.4 million were reflected as part of other current assets in the consolidated balance sheets as of December 31, 2023 and 2022, respectively. During year ended December 31, 2023, the Company received $0.4 million relating to the ERC.