Healthcare Industry News: Healthpoint
News Release - May 19, 2006
Nexa Orthopedics Receives FDA Clearance to Market Pyrolytic Carbon ImplantCarpometacarpal Implant is First in a Series of New Products to be Introduced to the U.S. Market
SAN DIEGO, May 19 (HSMN NewsFeed) -- Nexa Orthopedics Inc. ("Nexa"), the technology leader in products for reconstructive surgery of the extremities, announced today that it has received 510(k) clearance to market from the U.S. Food and Drug Administration for its pyrolytic carbon Carpometacarpal Implant (CMI). The Nexa CMI is designed to relieve basal thumb joint pain associated with arthritis while improving the thumb's range of motion and biomechanical function.
Nexa President and CEO Paul Nichols remarked, "The CMI is the first pyrolytic carbon product cleared to market in the U.S. following our recent acquisition of BioProfile, S.A. BioProfile products have been available in Europe for many years, and with our expertise in regulatory affairs we are now able to provide the U.S. surgeon with this advanced option for extremities arthroplasty."
The CMI is intended to replace the proximal end of the first metacarpal for treatment of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation or bone loss. Nexa will officially launch the CMI in the United States in September 2006 at the American Society for Surgery of the Hand conference in Washington, DC.
"Pyrolytic carbon has been the gold standard in heart valves for more than 35 years due to its biocompatibility, surface characteristics and wear resistance," said Chris Harber, Nexa's Vice President, Marketing and US Sales. "These properties make pyrolytic carbon an excellent material for hemi and interpositional arthroplasty applications. Nexa is the only company that designs, manufactures and distributes pyrolytic carbon orthopedic implants in the world, and American extremities surgeons can expect expanded access to pyrolytic carbon implants in 2006 and beyond."
About Nexa Orthopedics, Inc.
Nexa Orthopedics, Inc. was founded in 2004 by HealthpointCapital to create the pre-eminent company in extremities surgery through a program of business investments, technology in-licensing and internal development. Paul Nichols, Nexa President and CEO, has 15 years experience in extremities orthopedics as both an executive and entrepreneur, including founding both Avanta Orthopaedics Corporation and Futura Biomedical, LLC.
Founded in 2002 and headquartered in New York City, HealthpointCapital has two private equity funds focused exclusively on the $22 billion worldwide orthopedic device industry. The Funds are the premier source for orthopedic companies that require growth capital as well as strategic advice and guidance. HealthpointCapital's execution team has over 50 years of combined experience investing and growing companies and is headed by John Foster who has managed seven previous funds. HealthpointCapital invests in only the most exceptional companies in the orthopedic industry. These are firms that exhibit proven technologies, outstanding management teams and strong growth potential.
Web sites: http://www.nexaortho.com and http://www.HealthpointCapital.com.
Source: Nexa Orthopedics
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