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ReGen Biologics, Inc. Health Tech Net November 15, 2002 Presented by: Gerald E. Bisbee, Jr., Ph.D. Chairman, President and CEO Brion Umidi, SVP and CFO
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Cautionary Note on Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on the current expectations and beliefs of the managements of Aros and ReGen and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including those discussed in the Risk Factors section of Aros' current report on Form 8-K/A, filed with the Securities and Exchange Commission on September 4, 2002. Aros' filings with the SEC are available to the public from commercial document-retrieval services and at the Web site maintained by the SEC at http://www.sec.gov.
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Today’s Agenda The Orthopedic Marketplace –Hips, knees, spine, sports medicine and more ReGen Biologics –The CMI –The marketplace –The Company
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The Orthopedic Marketplace
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Not Just Hips and Knees Orthopedics - medical devices addressing joint deterioration, trauma, arthritis, spinal problems and related pain/ mobility issues. $12.4 billion market expanded beyond traditional hip and knee replacements to new and developing areas. Segments include: –Reconstructive implants– Spine –Sports medicine – Orthobiologics –Trauma – Other –Dental
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Market Segments - Breakdown
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Market Segments - Growth
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Trends and Innovations Key areas of current and future development: –Spinal disc repair and replacement; –Minimally invasive surgical techniques; and –Tissue regeneration.
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Innovations in the Spine Achieve more normal anatomic function, which is lacking in traditional spinal fusion and cage applications. Developments are focused primarily on: –Artificial discs and disc repair procedures; –Using an array of materials and approaches; –Designs that absorb shock and restore more normal anatomic function.
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Minimally Invasive Surgical Technologies Minimally invasive hip and knee replacements, requiring less surgical impact and quicker recovery. Instrumentation devices in the spinal and orthobiologics areas. Nerve guidance systems to more effectively navigate around nerves during surgery.
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Tissue Regeneration Currently small, but rapidly growing segment, including: –Soft tissue regeneration, such as implants and procedures in the articular cartilage and meniscus of the knee; –Growth factors and gene therapy; and –Bioresorbable fixation devices.
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Orthopedic Valuations Public company valuations reflect large market with reliable earnings/cash flow, and promising high growth segments. Revenue growth of 9% - 13% in 2002. Earnings per share growth of 15% - 20%. Pricing multiples of 2x forward EPS growth rates. Public company pricing multiples of 30x - 40x forward EPS.
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ReGen Biologics, Inc.
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ReGen Biologics Overview ReGen is in the biological remodeling business –Designs and manufactures proprietary biologically active type I collagen scaffold and delivery devices –Strong intellectual property position Current application is orthopedics – Collagen Meniscus Implant (CMI) is first product R&D –Each product engineered with unique mechanical properties –Additional orthopedic applications in articular cartilage, spine, ligament, and hand
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Scaffold Promotes In-situ Regrowth Core technology: Porous Type I bovine collagen scaffold Pore size optimized for cellular infiltration and growth Promotes in-situ use of patient’s own cells to populate and seed the regrowth
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Management Gerald E. Bisbee, Jr., Ph.D. Chairman and CEO; CEO Apache Medical & Sequel Corporation; Director Healthcare Group, Kidder Peabody; Ph.D., Yale; M.B.A., Wharton John Dichiara SVP, Clinical and Regulatory Affairs; 15 years of experience at Howmedica; B.A., Biological Science, Columbia College William G. Rodkey, DVM VP, Scientific Affairs; internationally known knee researcher; DVM, Purdue; board certified Brion D. Umidi SVP and CFO; 16 years of experience assisting corporations with various corporate, financial, development and operational matters; B.A., Accounting and Finance, Loyola College
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Board of Directors Gerald E. Bisbee, Jr., Ph.D., Chairman, President and CEO, ReGen Biologics J. Richard Steadman, Steadman Hawkins Clinic; U.S. Ski Team Hall of Fame; highly published; B.S., Texas A&M; M.D., U. of Texas Southwestern Medical School Robert McNeil, Ph.D., General Partner, Sanderling; active and experienced investor and board member; Ph.D., U.C. Irvine Richard Fritschi, President, Centerpulse Orthopedic Division; former Sulzer Medica CFO; General Manager, Joint & Traumatology, Alan W. Baldwin, CEO, Alcore, Inc.; experienced manager, director and investor; B.S., U.S. Military Academy; M.A., University of Alabama
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ReGen Highlights-to-date Intellectual Property –22 U.S., 29 international & 12 pending patents on products materials and processes U.S. Clinical Trial –U.S. Clinical Trial - 288 enrollment complete; surgeries in Q402 –Feasibility study five year results submitted for publication R&D –Initial product developed, active R&D pipeline Products –Products approved and sales underway
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Product Sales Underway Product Approvals –CMI approved for sale in Europe and Australia; ex-U.S. distribution agreement with Centerpulse (NYSE: CEP) –SharpShooter OK for sale in U.S., Canada, Europe, Australia, and Japan; Linvatec WW agreement (NASDAQ: CNMD) –Marketing to begin in Chile Q402, distribution through Centerpulse Canadian approval underway Q402, distribution through Centerpulse
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The First Application -- CMI The market: 775,000 U.S. partial meniscectomies in 2002; ROW = 310,000 Unmet need: –Surgeons and patients have no current option to regrow meniscus tissue –Result is to prevent or delay long term degenerative arthritis which can cause: »Changed or lost lifestyle »Interrupted or lost employment
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Remodeling is Successful Over Time 38% 62% Gain: double amount of tissue 75% Remaining Meniscus Removed meniscus Post Partial Meniscectomy Post CMI (1 & 5 years)
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100% Tissue Regeneration Surgery One Year Post Surgery Before
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The Patient Clinical Benefit 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 Before InjuryBefore Index Surgery 12 Months24 Months36 Months48 Months5+ years MCT CMI MCT Control 30% increase from Control to CMI groups Tegner Activity Level
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The Patient Clinical Benefit Tegner Activity Level 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 Before InjuryBefore Index Surgery 12 Months24 Months36 Months48 Months5+ years MCT CMI Feasibility Patients MCT Control
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U.S. Multicenter Clinical Trial Results Prior surgery patients double amount of tissue CMI patients achieve a significantly higher activity level at two years than controls –Activity levels for feasibility study patients have steadily grown Safety (adverse events) – no apparent safety issues Histology – no immune reactions or infections Ratio of pain, function, and self assessment per unit of activity higher for CMI patients
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Disease Progression - 775,000 P.M. in 2002 $9,500+ $9,500 Meniscus Tear Preserve Meniscus Regenerate Meniscus CMI Collagen Meniscus Implant Remove Meniscus Repair Meniscus Meniscus Repair Partial Meniscectomy Cost: $16,000 Cost: up to $49,500+ Cost: $12,500 Add’l Surgeries Allograft Joint Replacement $15,000 $40,000
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Meniscal Repair – 140,000 in 2002 $9,500+ $9,500 Meniscus Tear Preserve Meniscus Regenerate Meniscus CMI Collagen Meniscus Implant Remove Meniscus Repair Meniscus Meniscus Repair Partial Meniscectomy Cost: $16,000 Cost: up to $49,500+ Cost: $12,500 Add’l Surgeries Allograft Joint Replacement $15,000 $40,000
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CMI – Clinical and Financial Benefits $9,500+ $9,500 Meniscus Tear Preserve Meniscus Regenerate Meniscus CMI Collagen Meniscus Implant Remove Meniscus Repair Meniscus Meniscus Repair Partial Meniscectomy Cost: $16,000 Cost: up to $49,500+ Cost: $12,500 Add’l Surgeries Allograft Joint Replacement $15,000 $40,000
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CMI Advantage – Affects Lifestyle and Costs $9,500+ $9,500 Meniscus Tear Preserve Meniscus Regenerate Meniscus CMI Collagen Meniscus Implant Remove Meniscus Repair Meniscus Meniscus Repair Partial Meniscectomy Cost: $16,000 Cost: up to $49,500+ Cost: $12,500 Add’l Surgeries Allograft Joint Replacement $15,000 $40,000
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CMI Market Penetration Comparables Spinal fusion cage = 35% in five years Radiofrequency (RF) Ablation = 40% in five years Meniscal Repair Arrow = 50% in five years CMI = estimated 31% market penetration in five years post approval
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CMI Projected $500 Million Market
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Surgeon and Patient Incentives Match Surgeon’s View –Quality of life: happy patient attracts more patients –Meniscus --“the more the merrier” –CMI delays or prevents osteoarthritis –CMI adds important treatment option »Expand revenue source –New “standard of care” requires surgeon to perform procedure
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Surgeon and Patient Incentives Match Surgeon’s View –Quality of life: happy patients lead to referrals –Literature shows that in terms of the meniscus -- “the more the merrier” –CMI delays or prevents osteoarthritis –CMI adds important treatment option »Expand revenue source –New “standard of care” requires surgeon to perform procedure Patient’s View –Quality of life: increased activity is key –Internet search shows that in terms of meniscus, “the more the merrier,” –CMI delays or prevents osteoarthritis –New treatment option demanded »Decreases total costs –New “standard of care” demanded by patients and defined in literature
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Reimbursement Follows Clinical Benefit Tissue regrowth and activity levels show positive results in the 12-18 month timeframe desired by managed care companies Patients and surgeons will define CMI as new “standard of care” CMI procedure ($16,000) is attractive alternative to very expensive joint replacement procedure ($40,000+) Reimbursement in U.S. will include the following steps: –Obtain CPT code –Develop economic model –Establish Relative Value Units (RVU) –Present economic model and clinical benefits to major insurance and managed care companies
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The SharpShooter ® Application PICTURE
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Selected ReGen Milestones Through 2004 Product Sales –Annual sales goals established - Distribution agreements accelerating sales, for both CMI and SharpShooter FDA Submissions –CMI U.S. submission planned in Q404, when two year follow-up for all patients is complete –U.S. Feasibility study on Grade IV patients in Q103 –Two 510k applications R&D –One significant product development partnership –Four additional patents Financings –One round of financing in next 12 months
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Research & Development Pipeline Approved for sale in Europe and Australia. Clinical trial enrollment currently complete Prototype developed; cadaver testing initiated Patents issued; large animal model testing complete Patent issued; primate testing complete; 510(k) submission expected Prototype development; large animal model testing initiated Prototype developed; animal studies initiated Patent filed; lab testing Prototype development Patents issued; prototype development Research In-Vitro Testing Pre-Clinical ClinicalMarketComments Medial Meniscus Implant: Europe & Australia U.S. Lateral Meniscus Implant Intervertebral Disc Repair Hand Bone Augmentation Device Ligament Augmentation Devices CMI + Growth Factors CMI Improvements Rotator Cuff Repair Device Articular Cartilage Repair September 2002
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Recent Financing Transactions Multi-Stage Financing Completed June 21, 2002: Private Placement of $4 million into ReGen Biologics, Inc., in addition to conversion of approximately $2.6 million bridge financing provided by Sanderling companies and other existing ReGen shareholders Merger with Aros Corporation, resulted in net liquid assets of approximately $3 million, and instant public company status Shareholders of ReGen own approximately 80% of post merged company
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Key Scientific Advisors Kenneth E. DeHaven, M.D., Professor, Department of Orthopedics, University of Rochester Charles P. Ho, M.D., Director, National Orthopedic Imaging Associates Steven Arnoczky, D.V.M., Endowed Professor of Orthopedic Surgery, Michigan State Veterinary School Mininder S. Kocher, M.D., Instructor of Orthopedic Surgery, Harvard Medical School Paolo Bulgheroni, M.D., Clinical Professor, Institute of Orthopedics and Traumatology, Varese, Italy Juan Carlos Monllau, M.D., Clinical Professor, Orthopedic Surgery, Barcelona, Spain Shu-Tung Li, Ph.D., Founder and President, Collagen Matrix, Inc.
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ReGen Biologics, Inc. www.regenbio.com
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