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Organization, Nature of Business, and Liquidity (Policies)
12 Months Ended
Dec. 31, 2023
Organization, Nature of Business, and Liquidity [Abstract]  
Organization and Nature of Business

Organization and Nature of Business


Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products solutions, including a lead revolutionary product candidate and FDA-cleared products. The Company’s mission is to provide women with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics focused on servicing the reproductive health needs for those seeking solutions for infertility issues (FemaSeed®) or permanent birth control (FemBloc®). The Company currently operates as one segment with an initial focus on servicing the reproductive health needs for those seeking solutions for infertility issues or permanent birth control.



Femasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemaSeed, a solution which enables directed intratubal insemination to improve on traditional intrauterine insemination (IUI) and provides a lower cost option to in vitro fertilization methods, received approval to sell FemaSeed in Canada in April 2023. In September 2023 the Company received 510(k) clearance from the FDA for FemaSeed for intratubal insemination. The clinical trial was still ongoing at the time of receiving regulatory clearance, however, enrollment was completed in November 2023. FemVue®, a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S., Japan, and Canada. FemChec®, allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success). FemCerv® is a solution for complete tissue sampling with minimal contamination of the endocervical canal as an alternative to the single biopsy method, and is approved for sale in the U.S. and Canada. FemCath®™, allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter that is undirected, is approved for sale in the U.S. and Canada.  FemBloc, the Company’s solution for permanent birth control, is based on the Company’s non-surgical platform technology and in June 2023 Femasys received FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial. In August 2023 Femasys announced the initiation of enrollment in the FINALE [Prospective Multi-Center Trial for FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control] pivotal trial designed to evaluate the safety and efficacy of FemBloc. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control. In addition, the study is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for permanent birth control for one year. Follow-up will continue annually for five years post-market.
Basis of Presentation

Basis of Presentation



The Company has prepared the accompanying financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC).
Liquidity

Liquidity


The Company had previously disclosed in the financial statements as of and for the year ended December 31, 2022, that substantial doubt regarding the Company’s ability to continue as a going concern existed. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of December 31, 2023 of $108,381,629. For the year ended December 31, 2023, the Company generated a net loss of $14,247,124. The Company expects such losses to increase over the next few years as the Company advances FemBloc through clinical development until FDA approval is received and the product is available to be marketed.


Although the Company has a history of negative cash flows from operations and losses, the Company raised $20,800,182, net during 2023 (see Notes 7 and 9). As of December 31, 2023, the Company has cash and cash equivalents of $21,716,077. Based on the improvement in its cash position during 2023, the Company believes it has sufficient financial resources to fund operations and meet its capital requirements and anticipated obligations as they come due in the next twelve months. Therefore, the Company has concluded that the conditions and events raising substantial doubt no longer exist. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, in the future with additional equity and/or debt financing arrangements, and revenue primarily from the sale of FemVue and FemaSeed to support the Company’s research and development activities, largely in connection with FemBloc. While we believe that our cash will provide sufficient cash to fund operations to meet our capital requirements and anticipated obligations as they become due, uncertainty around the Company’s product acceptance in the market could have a negative impact on our liquidity.


There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted. The Company’s ability to meet its obligations in the ordinary course of business is dependent upon its ability to manage financing and generate sufficient cash flow to meet its obligations and ultimately to attain profitable operations. Although management plans to ensure the Company will continue as a going concern, there is no assurance that viability can be obtained since the availability and amount of such funding is not certain. As such, there can be no assurance that the Company will be able to obtain additional liquidity if needed or under acceptable terms, if at all.