Exhibit 13.1
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* Corporate Presentation Daniel LeeChief Executive OfficerDavid CockeChief Financial OfficerKevin Stone, M.D.Founder & ChairmanAugust 2015
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* 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ON FORM 1-A IS QUALIFIED PURSUANT TO REGULATION A OF THE SECURITIES ACT OF 1933, AS AMENDED, AND ANY SUCH OFFER MAY BE WITHDRAWN OR REVOKED, WITHOUT OBLIGATION OR COMMITMENT OF ANY KIND, AT ANY TIME BEFORE NOTICE OF ITS ACCEPTANCE GIVEN AFTER THE QUALIFICATION DATE.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.
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* 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
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* 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
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* 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
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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
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* 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
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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
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* 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
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The Z-Process™: The Effective Way to Treat Xenografts for Use in SurgeryWhat Makes us Different
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* 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
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* 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
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* 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
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* 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
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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
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Z-Lig Clinical Results: Demonstration of Significant Clinical Outcomes
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* 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
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* 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
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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
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* 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
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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
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* 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
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* 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
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* 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
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Z-Lig European Commercialization
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* 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 +
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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 *
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US Market Regulatory and Commercial
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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
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Summary Remarks
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* 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
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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
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* 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 *
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* 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
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* 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
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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
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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