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6 Jenner Street, Suite 150 Irvine, CA 92618 USA phone:(949) 502-3240 fax:(949) 502-3245 |
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Private |
| Founded |
2003 |
| Employees |
85 |
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| www.pegasusbio.com
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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| Bioimplants for Soft-Tissue Replacement in Orthopedic and Musculoskeletal Applications |
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| Management |
| Michael D. Will, President and CEO; Rob A. Cripe, Vice-President, Marketing and Product Development; Jim L. Goode, Vice-President, Sales; Thomas W. Sander, Vice-President, Research and Business Development; Chandra Nataraj, Ph.d., Vice-President and Chief Scientific Officer: Keith E. Myers, Vice-President, Operations; Pamela L. Misajon, Vice-president, Regulatory, Quality, and Clinical Affairs; James J. Jungwirth, Vice-President, Finance and Administration
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| Keywords |
| orthopedics, spine, ortho joint, reconstruction, ortho joint, reconstruction |
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| Description |
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Pegasus Biologics is developing regenerative medicine and soft tissue repair products based on its stabilized (cross-linked), biocompatible and highly organized collagen scaffolds. |
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| Products / Services |
The OrthADAPT (R) Bioimplant is a highly organized Type I collagen scaffold for surgical implantation designed to reinforce the repair or reconstruction of soft tissues and to facilitate the local management of moderately heavy to heavy exuding wounds. The bioimplant is stabilized and sterilized using proprietary technologies which make it resistant to premature enzyme degradation. Pegasus' other product, the Unite Biomatrix collagen wound dressing, was developed to provide an advanced biologic solution for chronic wounds. A durable, cross-linked, native collagen structure allows Unite Biomatrix to be easily applied to the debrided wound bed and maintain integrity as the wound heals. Pegasus Biologics' Research and Development divisions are also focused on exploring future soft and hard tissue repair mechanisms, including osseous and cartilage regeneration.
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| Technology / Differentiation |
| Pegasus uses proprietary cross-linking (UltiFix) and sterilization (UltiSTER) technologies in the processing of its commercialized bioimplants. Conventional methods of cross-linking (e.g. glutaraldehyde) may lead to calcification and encapsulation of biomaterials. Pegasus' next generation technologies maintain the inherent tissue properties allowing for controlled host remodeling. The sterility of bioimplants is achieved without the involvement of harsh chemicals or gamma irradiation and is assured via stringent USP testing. |
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| Market / Customers |
The company estimates the value of the orthopedic soft tissue augmentation repair market to be approximately $60 million, with a total available market exceeding $1.5 billion. According to the American Diabetes Association, over 21 million Americans have diabetes and nearly 15% will develop diabetic foot ulcers annually. Nearly 600,000 venous stasis ulcers are reported annually.
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| Status |
| The OrthADAPT and Unite BioMatrix have both received CE Mark approval and FDA (510k) clearance. Clinical studies are underway or anticipated in following areas: Achilles tendon repair, rotator cuff repair, diabetic foot ulcer treatment, venous stasis ulcer treatment, ventral hernia repairs, and dura repair.
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