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Organogenesis Canton, MA Since 1985 First company to gain FDA approval for a “living skin” product: Apligraf® Approved for treatment of diabetic foot ulcers.

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Presentation on theme: "Organogenesis Canton, MA Since 1985 First company to gain FDA approval for a “living skin” product: Apligraf® Approved for treatment of diabetic foot ulcers."— Presentation transcript:

1 Organogenesis Canton, MA Since 1985 First company to gain FDA approval for a “living skin” product: Apligraf® Approved for treatment of diabetic foot ulcers and venous leg ulcers Corporate partnership with Novartis for sales and marketing of Apligraf®

2 Corporate Woes 9/13/02: Temporary halt to sales of Apligraf®. 110 employees on furlough. 9/25/02: Filed for bankruptcy 12/02: Delisted by AMEX 12/18/02: Shipment of Apligraf® to Novartis resumed Sales and marketing rights being gradually returned to ORG

3 Apligraf® Human keratinocytes and fibroblasts from neonatal foreskin Mothers of donors screened Proprietary cell culturing processes Matrix of bovine Type I collagen BOTH EPIDERMIS AND DERMIS

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6 Approved Uses Partial and full-thickness venous leg ulcers (VLU) - >6 mos. for treatment - Apligraf® saves $7500/patient Full-thickness diabetic foot ulcers (DFU) - 800,000 patients per year in U.S. - 80,000 amputations per year

7 Diabetic Foot Ulcer wk 0wk 1 wk 5wk 16

8 Clinical Studies: VLU 240 patients age 18-89 Non-infected partial or full-thickness skin loss ulcer >1 month duration Not responding to conventional therapy Repeated applications sometimes necessary (no more than 5 allowed) Control: pressure dressing and zinc impregnated gauze

9 Clinical Studies: VLU results 24 weeks - Apligraf®: 55.4% full closure - Control: 49.1% full closure Recurrence - Apligraf®: 8.3% (6/72) @ 6 mos. - Control: 7.4% (4/54) @ 6 mos. - Apligraf®: 18.1% (13/72) @ 12 mos. - Control: 22.2% (12/54) @ 12 mos.

10 Clinical Studies: DFU 208 patients 18-80 years old 112 received Apligraf®, 96 control 0.4 cm 2 – 16.3 cm 2 full-thickness DFU Multiple applications of Apligraf® if <50% take (up to 5X)

11 Clinical Studies: DFU results 12 weeks - Apligraf®: 56% full closure - Control: 38% full closure Recurrence - Apligraf®: 40% (25/63) 80% (20/25) close at 6 mos. - Control: 44% (16/36) 63% (10/16) close at 6 mos.

12 Other Products FortaPerm and FortaGen Highly purified collagen for soft tissue repair/reinforcement - incontinence - hernia repair - breast reconstruction - Biomet: orthopedic and periodontal (rotator cuff repair patch)

13 Pipeline (or former pipeline) Vascular graft (publication by Huynh et al. with an acellular collagen tube) Liver assist device Other uses of Apligraf® (e.g. burns)

14 Advanced Tissue Sciences La Jolla, CA Founded 1987; public offering 1988 Strategic alliance with Smith & Nephew for sales and marketing of Dermagraft® and Transcyte® Filed for bankruptcy 2/7/03

15 Transcyte® Human fibroblast-derived temporary skin substitute FDA approved as temporary wound cover for full thickness burns in March 1997 FDA approved as a temporary wound cover for partial thickness burns in October 1997 Currently available from Smith & Nephew

16 Transcyte® Bilayer graft Outer silicone polymer (epidermis) Inner dermal layer - nylon mesh - human fibroblasts - collagen matrix - growth factors

17 Transcyte® Storage: - Cassette containing two 5” x 7.5” pieces - Stored at -20°C; thawed at 37°C - Are fibroblasts viable? Cost: $1350 per cassette

18 Dermagraft® Cryopreserved human fibroblast-derived dermal substitute Human fibroblasts are seeded onto a bioabsorbable polyglactin (PLGA) mesh scaffold FB secrete human dermal collagen, matrix proteins, growth factors and cytokines, to create a three-dimensional human dermal substitute containing metabolically active, living cells Does not contain macrophages, lymphocytes, blood vessels or hair follicles. FDA approved for diabetic foot ulcers (10/01)

19 Clinical Trial: DFU 12 weeks - Dermagraft®: 38.5% complete healing - Control: 31.7% complete healing 32 weeks - Dermagraft®: 57.5% complete healing - Control: 42.4% complete healing Multiple applications of Dermagraft® often necessary (1/week)

20 Pipeline (or former pipeline) Huge number of patents Orthopedics - cartilage (NeoCyte), ligament, tendon Aesthetic and Reconstructive Surgery - injectable collagen, LaserDerm, NouriCell Cardiovascular - angiogenesis patch, vascular grafts, heart valves, stents


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