EX1A-13 TST WTRS 20 a69629_exhibit13-1.htm TESTING THE WATER MATERIALS
Exhibit 13.1
 
 *  Corporate Presentation  Daniel LeeChief Executive OfficerDavid CockeChief Financial OfficerKevin Stone, M.D.Founder & ChairmanAugust 2015 
 

 *  DISCLAIMERTHE INFORMATION CONTAINED HEREIN IS PROVIDED SOLELY FOR THE PURPOSE OF ACQUAINTING THE READER WITH APERION BIOLOGICS, INC. (THE “COMPANY” OR “WE”) AND ITS EXECUTIVE PERSONNEL, AND TO SOLICIT ANY INDICATION OF INTEREST IN A POTENTIAL OFFERING OF SECURITIES BY THE COMPANY. IT IS NOT AN OFFER TO SELL NOR IS IT A SOLICITATION OF ANY OFFER TO BUY ANY SECURITIES AND CONVEYS NO RIGHT, TITLE OR INTEREST IN THE COMPANY OR THE PRODUCTS OF ITS BUSINESS ACTIVITIES. NO MONEY OR OTHER CONSIDERATION IS BEING SOLICITED IN CONNECTION THIS MEETING AND PRESENTATION, AND IF SENT IN RESPONSE, WILL NOT BE ACCEPTED. NO OFFER TO BUY THE SECURITIES CAN BE ACCEPTED AND NO PART OF THE PURCHASE PRICE CAN BE RECEIVED UNTIL AN OFFERING STATEMENT ON FORM 1-A IS QUALIFIED PURSUANT TO REGULATION A OF THE SECURITIES ACT OF 1933, AS AMENDED, AND ANY SUCH OFFER MAY BE WITHDRAWN OR REVOKED, WITHOUT OBLIGATION OR COMMITMENT OF ANY KIND, AT ANY TIME BEFORE NOTICE OF ITS ACCEPTANCE GIVEN AFTER THE QUALIFICATION DATE. ANY PERSON'S INDICATION OF INTEREST IN THE MEETING INVOLVES NO OBLIGATION OR COMMITMENT OF ANY KIND. THE INFORMATION CONTAINED HEREIN IS CONFIDENTIAL AND STRICTLY PROPRIETARY. BY ACCEPTING THIS DOCUMENT, THE RECIPIENT AGREES NOT TO REPRODUCE ITS CONTENTS NOR DISCLOSE OR DISTRIBUTE SAME TO ANY PERSON OR ENTITY WITHOUT THE EXPRESSED PRIOR CONSENT OF THE COMPANY. THIS PRESENTATION DOES NOT PURPORT TO BE ALL-INCLUSIVE OR TO CONTAIN ALL OF THE INFORMATION YOU OR ANY PROSPECTIVE INVESTOR MAY DESIRE. YOU SHOULD MAKE YOUR OWN DECISION ON WHETHER THIS INVESTMENT OPPORTUNITY MEETS YOUR INVESTMENT OBJECTIVES AND RISK TOLERANCE LEVEL. ANY PERSON CONSIDERING ENTERING INTO A PROPOSED TRANSACTION SHOULD SEEK ITS OWN INDEPENDENT FINANCIAL AND LEGAL ADVICE.   FORWARD LOOKING STATEMENTSTHIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT ARE BASED ON OUR MANAGEMENT’S BELIEF AND ASSUMPTIONS AND ON INFORMATION CURRENTLY AVAILABLE TO OUR MANAGEMENT. ALTHOUGH WE BELIEVE THAT THE EXPECTATIONS REFLECTED IN THESE FORWARD-LOOKING STATEMENTS ARE REASONABLE, THESE STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS THAT MAY CAUSE OUR ACTUAL RESULTS, LEVELS OR PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY THESE FORWARD-LOOKING STATEMENTS. ACCORDINGLY, YOU SHOULD NOT PLACE UNDUE RELIANCE ON THESE STATEMENTS. FORWARD-LOOKING STATEMENTS IN THIS PRESENTATION INCLUDE, BUT ARE NOT LIMITED TO, STATEMENTS RELATING TO THE PROJECTED GROWTH OF ACL MARKETS; THE ANTICIPATED COMMERCIALIZATION OF OUR Z-LIG PRODUCTS; THE POTENTIAL APPLICATIONS OF OUR Z-PROCESS AND TECHNOLOGY; OUR STRATEGIES TO REALIZE DEVELOPMENT OPPORTUNITIES; THE TIMING AND STATUS OF CLINICAL TRIALS FOR OUR PRODUCT CANDIDATES; AND OUR ABILITY TO SUCCESSFULLY LAUNCH AND MARKET OUR PRODUCTS. THESE FORWARD LOOKING STATEMENTS ARE SUBJECT TO VARIOUS RISK FACTORS THAT MAY CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM OUR CURRENT EXPECTATIONS. WE HAVE NO CURRENT INTENTION OF UPDATING THE FORWARD-LOOKING STATEMENTS CONTAINED IN THIS PRESENTATION EXCEPT TO THE EXTENT REQUIRED BY LAW. YOU SHOULD THEREFORE NOT RELY ON THESE FORWARD-LOOKING STATEMENTS AS REPRESENTING OUR VIEWS AS OF ANY DATE SUBSEQUENT TO THE DATE OF THIS PRESENTATION. 
 

 *  Z-Lig is the first non-human biologic device for ACL reconstructionReceived CE Mark approval for initial indication of revision and multiligament reconstruction proceduresProprietary Z-Process immunochemically modifies optimal animal tissue for compatibility with human immune system while retaining scaffold quality and strengthRequires no change in surgical techniqueStabilizes knee and functions as dynamic implant for gradual host cell repopulation and subsequent ligamentizationRe-establishment of original tissue morphology allows natural repair of cumulative wear that limits useful life of non-biologic grafts in mechanically intensive applications  Z-Lig®: Alternative Solution for ACL Replacement  Z-Lig – a novel ACL replacement which provides both structure and immunocompatibility  Patient #4  Patient currently 9 years post-surgery 
 

 *  Product Pipeline   Target all currently used options for ACL reconstructionAll designed and optimized to meet doctor and patient needsDesigned to work with current fixation devices and instrumentsReceived CE Mark (BT+ and BTB) to commercialize in EU and other countries  The Z-Lig® Family of devices  Z-Lig BTB  Z-Lig BT+  Z-Lig ST 
 

 *  Product Pipeline  Z-Patch  Z-Fix  Patch product for soft tissue repair/augmentation sourced from porcine dermisSurgical market opportunity includes orthopaedics, general and reconstructive, plastic and wound healingCritical role of α-Gal removal has been published extensively  Initial application as a biologic fixation device for ACL reconstructionAll biologic ACL reconstructionMarket opportunity includes conductive and inductive bone graft repair and spacer implants  Near-term product opportunities in large global markets with 510 (k) pathway  Product representation  Product representation 
 

       Current Development Status  Current Development Status  Current Development Status  Current Development Status  Current Development Status        ProductName  ProductCategory  InitialRegulatoryPathway  Research  Preclinical  Pilot  Pivotal  Marketed  Clinical Detail  EU Market  U.S. Market  Z-Lig®  ACL  CE Mark            6 & 12 months post implantation in 60 patient EUSA trial100% of remaining subjects met 36 month endpoint in 4/2015  1Q:15$0.7b    Z-Lig®  ACL  PMA            FDA has unconditionally approved U.S. pivotal trial protocol10-patient U.S. pilot safety trial completed    2018-9$0.8b  Z-Patch  ExtracellularMatrix  CE Mark            Completion of developmental testing and validation 1H:17CE Mark approval by 1H:18  2018$1.0b    Z-Patch  ExtracellularMatrix  510 (k)            510(k) approval by 1H:18U.S. post-market tevaluation to follow    2018$1.2b  Z-Fix  Bone  CE Mark            CE Mark approval by 2H:18  2018$4.0b    Z-Fix  Bone  510 (k)            Preclinical testing to be completed in 2H:16    2018$6.8b  Z-Meniscus  Meniscus  CE Mark            Preclinical testing to be conducted 2H:17  2019-20$1.0b    Z-Meniscus  Meniscus  PMA            Preclinical testing to be conducted 2H:17    2020$1.5b  *  Product Pipeline 
 

 *  In orthopaedics and other surgical categories, human & animal tissue is widely used but has limitationsWe have developed and patented a technique facilitating successful implantation of animal tissuesOur Z-Lig® Anterior Cruciate Ligament Replacement (ACLR) is the first “off-the-shelf” biological ACL replacement device Positioned to address the $2 billion ACL marketCompelling clinical data, with 96% success at 6 months and 92% at 12 months, better than the standard of careOur commercial introduction underway in Europe and other countries Q1 2015CE Mark granted for revision and multi-ligament indicationsUnconditional FDA approval received to commence US pivotal trialOur tissue processing methods represent a technology platform – several anatomies/applications await  Aperion is commercializing an off-the-shelf ACL replacement  Aperion Biologics 
 

 Knee Injuries/ACL Surgeries Growing Globally  ACL injuries are common: estimated 2.6M* ACL injuries annually globally. Not all are treated today.$2b in ACL surgeries: 800K targetable procedures annually@$2,500 per procedureGrowing at 6-10%*Concentrated in EU and US30% in European market (where we have approval to sell) 40% US30% ROW  One of the few remaining high growth markets in orthopedics  European ACL Graft Mark(265k procedures annually)  US ACL Graft Market(300k procedures annually)  Global ACL Graft Market – $2.1b*  *  *Third party research (iData Research) or company estimates 
 

 *  One of the few remaining high growth markets in orthopedics  Number of Procedures (mm)  Global ACL Reconstruction Market Projections (1)  ACL Reconstructions ’12:’21 CAGR: 7%   2012E – 2021E CAGRUS – 8%EU – 5%ROW – 6%  US  EU  ROW  US ACL Graft Market by Type (300k procedures)  European ACL Graft Market by Type (265k procedures)  Global ACL Graft Market – $2.1B (1)  (1) Figures are from third party research and are projected 2012 estimates. ROW includes markets that can be penetrated in the near term via CE Mark approval.Note: These figures include: (i) the sales of allografts and synthetic grafts and (ii) the direct surgical costs of the autograft harvesting and subsequent direct incremental rehabilitation and medication costs related to the second surgical site (assumed to be $2,500 per procedure in total).   Knee Injuries/ACL Surgeries Growing Globally 
 

 The Z-Process™: The Effective Way to Treat Xenografts for Use in SurgeryWhat Makes us Different  
 

 *  Current Treatment Options  Safety  ++  +++  ?  ++  ?  Consistent Quality  ++  +  ?  +++  ++  Ability to Regenerate / Remodel  ++  ++  ++  ?  ?  No Supply Limitation  +++  +  ?  +++  +++  Standard surgical technique        ?  ?  No 2nd Surgical Site Required/Reduces OR time    -        Commentary  Safe, strong, available  Current “gold standard”Disadvantaged by higher operative and rehab time  Variable tissue qualityGlobal availability constrained by legal, cultural and religious issuesPotential for disease transmission  Indicated for high performance athletes quick return to activityRegeneration lacking, high failure rate  Biological / tissue based but does not regeneratePorcine xenografts already well acceptedFixation methods (crosslinking) restrict ability to remodel  Traditional Xenograft  Z-Lig  Allograft  LARS Synthetic  Autograft 
 

 *  Immune Challenge: alpha-galactosidase (α-Gal)  Lower species express specific carbohydrate epitopes called α-GalHumans (and some primates) have evolved to produce antibodies that bind to the α-Gal antigen to initiate a rapid immune rejection process1% of circulating human antibodies are anti-Gal 
 

 *  Aperion is the only company with issued patents to use alpha galactosidase to cleave the gal-antigen from non-primate tissue so that it is compatible with the human immune systemAlpha galactosidase is the only known treatment for cleaving the gal-antigen while preserving the graft’s key biological components and functionalityThe enzyme and its mechanism of action is well characterized and understood  Traditional Xenograft Hyperacute Rejection  Z-Process Prevents Rejection  Gal Antigen  PorcineGraft  Human’s Anti-GalIdentifiers  Human’s Neutrophils & Macrophages  Z-Process’GalactosidaseRemoving Gal  Aperion’s Solution: The Z-Process 
 

 *  Tissue cleaning processα-Galactosidase enzyme treatmentSolves α-Gal rejection issue by cleaving the terminal galactose of the α-Gal antigenStabilizationWhile alpha-galactosidase enzyme treatment solves the gal rejection issue, it has no effect on the non-α-Gal immune responseCrosslinking provides additional ability to tailor implant with desired remodeling propertiesSterilization and packagingTerminally sterilized by irradiationPackaged in a ready-to-use graft configuration minimizing operating room time  Aperion’s Solution: The Z-Process  A patented, reproducible process that preserves the graft’s ability to remodel, providing long-term functionality  2  3  4  1  Biological and Mechanical Properties maintained 
 

 Z-Process Can Be Used in Numerous Market Opportunities  *  Proprietary product platform has broad applicability to many other tissue needs beyond ACL replacementExtracellular matrixWound healingBone replacementHeart valvesLonger term, Aperion’s technology could be instrumental in:Dynamic scaffold with architectural and mechanical advantagesStem cell deliveryGrowth factor deliveryDrug delivery  Shoulder Rotator cuff repair  Knee ACL/PCL ligament reconstructionsMeniscus  Spine Spacers/bone grafting  HeartHeart valvesVascular grafts  TendonAchilles tendon repair  SkinCosmetic soft tissue augmentation  General Surgery Hernia repair  Wound CareChronic wounds  Urogynecology  Exceptionally solid IP estate providing Aperion with a powerful position in removal of α-Gal in key tissues—broad applicability of Aperion’s technology creates numerous opportunities 
 

 Z-Lig Clinical Results: Demonstration of Significant Clinical Outcomes 
 

 *  Aperion conducted studies in 20 Rhesus monkeys; treated with Z-Lig, allograft and unprocessed porcine xenograftAll Z-Lig results were substantially similar to the allograft-implanted monkey controlSerological studies Support immunocompatibility; transient production of gal and non-gal antibodies substantially decreased at approximately 9 monthsBiomechanical testingDemonstrates graft functional efficacy comparable to the allograft and autograft reconstructionsHistopathologyAdvanced graft remodeling and maturationFunctional host integration of both tendon and boneNo adverse synovial response  Rhesus Allograft(+ control)  Untreated Porcine(- control)  Z-Lig  Preclinical Efficacy Studies  1  2  3 
 

 *  Z-Lig safety pilot was conducted in 10 humans under an IDE with the FDAAs assessed in five of six evaluable subjects:Presented with functional grafts at the 12- and 24-month post- operative time pointsSatisfied all study success criteria including effusion, KT-1000, Pivot Shift, Lachman and Anterior Drawer testsVia MRI, showed significant remodeling and maturation of the functioning graftsFDA subsequently granted unconditional approval of a pivotal non-inferiority trialWe plan to begin this trial in 2016 with funds from this offering  US Pilot Trial Overview  Continued safety and graft function in patients from pilot safety study 12 years post-op  Mean Age 41 Years (range 21-51)7 males / 3 females5 of 10 chronic ACL injury (>3 months post injury)Operative / injured knee previous surgeries:2 ACL revisions1 ACL repair3 Medial meniscal repairsContralateral surgeries:3 ACL reconstructionsExtremely athletic population – Pre-injury Tegner average = 8.0  Patient Demographics 
 

 Z-Lig European/South African Clinical Study for CE Mark approval  *  Study Design  Composite Endpoint  60+ ACL replacement subjects7 sites – Belgium, Denmark, Netherlands, Italy, South Africa, SpainLevel 1 prospective, randomized, controlled trialAllograft-controlledEvaluator- and subject-blinded  6-month performance (non-inferiority) and safetySuccess defined as 2 of 3: KT-1000, Lachman’s, Pivot ShiftUtilization of composite endpoint addresses inherent clinical variability in each of the three individual endpoints 
 

 *    Physician  Institution  Leading Opinion Leaders  René Verdonk, MD, PhDPeter Verdonk, MD, PhDFredrik Almqvist, MD, PhD  Gent University Hospital Dept. of Orthopaedic Surgery & TraumatologyGent, Belgium  One of the most highly respected orthopedic/sports medicine research centers in Europe Prof. René Verdonk was inducted into the Hall of Fame for the American Orthopaedic Society for Sports Medicine, one of the highest honors given to a member of this American society  Willem van der Merwe, MDCape Town, South Africa  Sport Science Institute of South AfricaCape Town, South Africa  The Sports Science Institute is a leading center in sports medicine for South AfricaDr. van der Merwe is a member of the ACL Study group, a peer-selected international group focused on advanced ACL treatments  Maurilio Marcacci, MDStefano Zaffagnini, MD  Instituti Ortopedici Rizzoli - Bologna University Sports Traumatology Dept. Bologna, Italy  One of the most highly respected orthopedic/sports medicine research centers in Europe Considered to be the top orthopedic center in Italy  Ramón Cugat, MD, PhDMontserrat García-Balletbó, MD, PhD  Hospital Quirón Artroscopia GCBarcelona, Spain  Dr. Cugat is orthopedic consultant for FC Barcelona and medical assessor for the Catalan Football Federation (130,000 players in the Catalan region)Considered one of the top ACL clinicians in Spain  Martin Lind, MD, PhDPeter Faunoe, MD  Aarhus University HospitalDept. of Orthopaedic Surgery & TraumatologyAarhus, Denmark  Dr. Lind is responsible for the Scandinavian ACL Registry in DenmarkScandinavian ACL Registry is recognized as one of the most comprehensive ACL registries  Kees van Egmond, MDRutger Zuurmond, MD  Isala KliniekenDepartment of Orthopaedic SurgeryZwolle, Netherlands  The Isala Klinieken is the leading training center in the Netherlands for orthopedic surgeons  Pedro Guillen, MD  Clínica CemtroOrthopaedic Surgery & TraumatologyMadrid, Spain  Clinica Cemtro is a private hospital founded by Prof. Guillen which performs over 1,000 ACL reconstructions annuallyConsidered one of the top ACL clinicians in Spain  CE Trial Investigators & Sites 
 

 Outcomes   Tegner  SF-36  Patients return to a high level of activityand demonstrate increased satisfaction with their outcomes over time  *  Percentage achieving > 90% functional performance of operated knee when compared to uninjured knee . . .Z-Lig enables return to normal functional performance 
 

 *  Outcomes - Composite Stability  6 Months  12 Months  85% Success: the “Standard of Care”  24 Months  Demonstrated success better than literature reports with allograft – a clinical “standard of care”  88%   12%   Success  Falure  92%   8%   Success  Falure 
 

 *  Serology Findings – Preclinical & Pilot Safety  Primate  Human  Low antibody titers demonstrate markedly reduced immune recognition  10  100  1,000  10,000  100,000  0  2  4  6  8  10  12  Months Post-Reconstruction  Reciprocal Antibody Titer  Z-Lig: Anti-GAL IgG  Z-Lig: Anti-non-GAL IgG  Untreated: Anti-GAL IgG  10  100  1,000  10,000  100,000  0  20  40  60  80  Months Post-Reconstruction  Anti-GAL IgG  Anti-non-GAL IgG  Reciprocal Antibody Titer  T = 0 represents pre-implant titer  Without Z-technology untreated xenograft is biologically incompatible and non-functional 
 

 *  Key Clinical Takeaways  Key endpoint met for non-inferiority evaluation by Notified BodyCompelling 6, 12 and 24 month safety and performance data versus “standard of care” – study control are performed well above historical resultsObjective measurements - stability, ROMFunctional - one legged hopSubjective - SF-36, TegnerAll of study subjects have met 24 month milestone, most are beyond 36 months  Clinical Analysis  Z-Lig performed extremely well and demonstrated success at 6, 12 and 24 months  Six subjects suffered SAEs deemed related to device—external experts confirm all device-related SAEs caused by infection from water system—remedied by review and improvement of manufacturing process 
 

 Z-Lig European Commercialization 
 

 *  CE Mark Market Launch  The right people, right place and right data to sell in Europe in 2015  Z-Lig will be immediately impactful in Europe  Limited local market allograft supply  +  Compelling Z-Lig European clinical data  +  Support of key clinical opinion leaders  +  Restrictions on allograft importation  Key Market Launch Plan Elements  Key Distributor Terms  Phased launch in select marketsInitial target: multi-ligament and revision ACL reconstruction surgeries- 15% of totalWork with key clinicians and “thought leader” clinical investigatorsRegistries in select markets to collect additional clinical experience  Seeding markets throughout EUWorking with 1 leading distributor in each country: Stocking inventory, invoicingProducts sold at transfer fee; billing managed by distributorReimbursed under DRG codes  Need for immediate alternative to autograft  + 
 

 Go to Market: Phased Seed Strategy at Regional Level  Develop One Key Distributor Relationship per Country - Often Legally Required (Invoicing, etc.)Rationalizing/optimizing based on new personnelChampions and Clinicians in each CountryClinical investigators will continue to use/advocate for Z-LigFor Phase 1, Additional 4 to 10 New Clinicians in Each Country to be identified in conjunction with new distributor  * 
 

 US Market Regulatory and Commercial 
 

 Current team optimizes manufacturing and sourcing operations for long-term commercial viabilityReceives unconditional approval to commence IDE pivotal trial  *  FDA Overview and timeline  2010 - 2013  FDA Communication Timeline  Optimize US pivotal trial protocolPreparation for U.S. pivotal trial     Planned Optimization    Benefit   Randomization   Change subject randomization from 1:1 to 2:1    Reduces N from 326 to 245  Clinical Sites  Increase number of clinical sites from 10 to 20    Reduces recruitment period from 30 months to 15 months  EUSA Trial Data  Consider EUSA trial data in US trial    Potentially reduces N or reduces focus on longer term data  Screw Selection  Company remains screw manufacturer agnostic    Allow multiple manufacturers’ screws to be used 
 

  Summary Remarks 
 

 *  Highlights  Z-Lig will be the first commercialized and clinically tested, “off-the-shelf” biological ACL replacement Addresses shortcomings of existing market alternatives – Z-Lig is Healthy and Strong, Every Time  First & Only Tissue-Based Graft Product  Entered into commercialization in select EU markets in Q12015FDA unconditional approval for US pivotal IDE clinical trial   Commercialization  Disruptive IP protected technology facilitating successful implantation of processed animal tissuesBroad range of additional biologic applications – ligament, matrix, bone, valves, etc.  Proprietary Product Platform  First biologic graft to address >$2 billion global ACL market – a high-growth market in orthopedicsEarly market opportunity in Europe  Large Global Market Opportunity  Strong Management Team  Career-long orthopedic biomaterials focus and extensive commercialization experience  96% success at 6 months and 92% at 12 months in ongoing Level 1 randomized, controlled OUS clinical trialPerformance better than the standard of careClinical results validate 10 year data from US human pilot safety study  Compelling Clinical Data 
 

 Proposed Financing  *   Launch core EU markets Regulatory submissions for non-EU markets   Initiate US IDE study Introduce soft tissue ACL product Introduce dermis product   Expansion EU and non-EU markets Full ACL indication   Expand all Z-Process products in all markets  1H 2016  2H 2015  2H 2016  1H 2017  2H 2017  FINANCING  EVENTS   Scale-up Staffing Expanded indication study Expansion into other OUS markets 
 

 *  Z-Lig’s Time Has Come  The Right Market  ACL reconstruction estimated to outpace hip, knee and spine growthACL market is highly underpenetratedCurrent treatment options for ACL have severe drawbacksAutografts require longer operative and rehab timeAllografts are in short supply and vary greatly in qualitySynthetic grafts lack the ability to regenerate resulting in high failure rateTraditional xenograft fixation methods restrict ability to remodel  The Right Technology  First revolutionary product innovation in over a decadeTechnology platform w/ multiple applications outside ACLExtracellular matrixBone replacementMeniscus replacementProduct that addresses shortcomings of other xenograft products – strength vs. remodeling  At The Right Time  Near-term commercialization in EU and other marketsMinimal allograft availability will drive Z-Lig uptake immediatelyImmediate need for a graft alternative for revision and multiligament proceduresClearly defined US regulatory pathwayStrong EU data supports efficacy and timelineStudy design to address reimbursement Leverage experience and infrastructure to best position Z-Lig for approval510(k) approval path for Z-Patch and Z-Fix minimizes risk  The product the Sports Medicine world has been waiting for… 
 

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 Appendix  * 
 

 *  Management  Name  Background  Daniel LeeChief Executive Officer  Joined Aperion in 2008; 20+ years experience in medical device industryPrior Experience: Responsible for TruRepair business at Smith & Nephew Endoscopy, responsible for Global Marketing Activities at OsteoBiologics, Director of Marketing at Regeneration Technologies and Director of Sports Medicine R&D group at Surgical DynamicsHolds a Certified Tissue Bank Specialist certification and 13 patents on implants and instruments used in orthopaedic and general surgeryReceived Masters of Science in Biomedical Engineering from University of Alabama at Birmingham and Bachelor of Science degree in Materials Science and Engineering from Johns Hopkins University  David CockeChief Financial Officer  Joined Aperion in 2008Prior Experience: GM at NuPak Medical, CFO at NuTech, managed Corporate Development Department at KCI, employed at Corporate Finance group of GE Capital and Investment Banking group of Salomon BrothersReceived MBA degree from University of Virginia’s Darden Graduate School of Business Administration and BBA degree with High Honors from the University of Texas at Austin   Lance JohnsonVP, Quality Systems  Joined Aperion Biologics in November 2010; 20+ years of experience in FDA Requirements and Quality SystemsPrior Experience: Quality Manager at Zimmer Spine, Quality Engineering Manager at Abbott Spine and 16 years of experience as investigator with FDA; Received Level II Auditor certification in 2003 and Medical Device Level II certification in 1998 Received Bachelor of Science degree in Biotechnology from Oklahoma State University  
 

 *  Board of Directors  Name  Background  Daniel LeeChief Executive Officer  Joined Aperion in 2008; 20+ years experience in medical device industryPrior Experience: Responsible for TruRepair business at Smith & Nephew Endoscopy, responsible for Global Marketing Activities at OsteoBiologics, Director of Marketing at Regeneration Technologies and Director of Sports Medicine R&D group at Surgical DynamicsHolds a Certified Tissue Bank Specialist certification and 13 patents on implants and instruments used in orthopaedic and general surgeryReceived Masters of Science in Biomedical Engineering from University of Alabama at Birmingham and Bachelor of Science degree in Materials Science and Engineering from Johns Hopkins University  David CockeChief Financial Officer  Joined Aperion in 2008Prior Experience: GM at NuPak Medical, CFO at NuTech, managed Corporate Development Department at KCI, employed at Corporate Finance group of GE Capital and Investment Banking group of Salomon BrothersReceived MBA degree from University of Virginia’s Darden Graduate School of Business Administration and BBA degree with High Honors from the University of Texas at Austin   Lance JohnsonVP, Quality Systems  Joined Aperion Biologics in November 2010; 20+ years of experience in FDA Requirements and Quality SystemsPrior Experience: Quality Manager at Zimmer Spine, Quality Engineering Manager at Abbott Spine and 16 years of experience as investigator with FDA; Received Level II Auditor certification in 2003 and Medical Device Level II certification in 1998 Received Bachelor of Science degree in Biotechnology from Oklahoma State University  
 

 Aperion’s Manufacturing Facility  *  Unlike allografts, Aperion’s production process is highly scalableReadily available and consistent raw materialPorcine tissue sourced in accordance with ISO/TR 22442 and FDA regulationsSignificantly higher gross margins than currently commercialized allografts4,000-square foot facility in San Antonio, Texas1,000-square feet of Class 6 to Class 8 clean roomsReceived ISO 13485 certification of its quality systems in January 2010, recertified in June 2011, transferred to new notified body October 2013Supports commercial sales for next 2-4 years   Aperion’s headquarters in San Antonio, Texas has Class 6 to Class 8 manufacturing clean rooms 
 

 Intellectual Property  *  23 issued patents in the U.S. and internationally and 3 patent applications: exclusive rights to use alpha-galactosidase enzyme to remove gal antigens from non-primate animal tissues, including ligaments, cartilage, bone, heart valves, vascular tissue, collagen and many other tissuesMaterial Composition for Z-processed tissuesThe Process used to create the Z-productsAdditional extensive coverage of immunochemical modifications of dermal- and tendon-derived injectable collagen formulations  Exceptionally solid IP estate providing Aperion with a powerful position in removal of α-Gal in key tissues