Devices FDA Orthopaedic

 News Release - July 9, 2007

FDA Clears Small Bone Innovations' Implant to Treat Thumb Arthritis

Miami Surgeon Helped Develop Less Invasive Procedure

MIAMI--(HSMN NewsFeed)--Small Bone Innovations, Inc. (SBi), has announced that its Artelon® CMC Spacer Arthro has been cleared by the Food and Drug Administration for marketing in the U.S. This product is an extension of SBi's line of implants to treat a common complaint: osteo-arthritis (OA) in the base of the thumb.

Miami-based hand surgeon Dr. Alejandro Badia has conducted over forty surgeries using Artelon spacers and helped SBi create the Arthro product for arthroscopic implantation ('key-hole' surgery). "The most convincing argument for using the Artelon spacer to treat early to mid-stage thumb arthritis may be rapid recovery and return to normal activities," said Dr. Badia. "This could have a profound economic impact as experience with the technology suggests patients may quickly return to near normal function."

The Artelon® CMC Spacer Arthro was designed to allow minimally invasive, arthroscopic implantation in the joint between the first metacarpal and the trapezium (see graphic). By avoiding violation of the joint capsule, the procedure may offer significant advantages to surgeons and their patients such as joint stability, faster recovery and less pain.

Anthony G. Viscogliosi, Chairman and CEO of SBi, said: "By working closely with surgeons, we are producing more advanced implants for keyhole-type surgery, such as the Artelon® CMC Spacer Arthro, that allow faster and more comfortable restoration of patients' quality-of-life."

According to Mr. Viscogliosi, Artelon spacers have been implanted using more traditional surgery in more than 3,000 patients in the U.S. and Europe since the technology was introduced commercially in 2005. Dr. Badia has become a leading proponent of the technology developed originally in Sweden by Artimplant AB and marketed under license by SBi in the U.S. and elsewhere.

About Dr. Alejandro Badia, M.D, F.A.C.S.

Dr. Alejandro Badia, www.drbadia.com, is an internationally renowned orthopedic surgeon and an innovative leader in the treatment of osteo-arthritis, trauma and other painful or diseased conditions of the hand (expert in thumb-related injuries), wrist, elbow and shoulder. Common conditions treated by Dr. Badia include: arthritis at the base of the thumb; carpal tunnel syndrome; wrist & elbow fractures; tendonitis; rotator cuff tears & shoulder dislocations; nerve compression disorders and tumors.

Dr. Badia studied physiology at Cornell University and obtained his medical degree at NYU, where he also trained in orthopedics. A hand fellowship at Alleghany General Hospital in Pittsburgh was followed by an AO trauma fellowship in Freiburg, Germany.

Dr. Badia can be seen daily on Miami Herald.com's 'Ask the Expert' Column partaking in Q & A sessions. Patients or referring physicians may contact Dr. Badia's office at (305) 661-3000 or on his website, www.drbadia.com.

About Miami Hand Center

Miami Hand Center is an innovative leader in the treatment of the hand, wrist, elbow and shoulder. Our state-of-the-art facility has the sophisticated equipment to perform innovative microscopic and arthroscopic procedures that will not only reduce the recovery time but also the cost to the payer.

The physicians at Miami Hand Center are committed to providing the highest level of cost-effective care and attention to their patients, with a proven track record of quality outcomes.

Source: Small Bone Innovations

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