STOCKHOLM, Sweden, Sept. 23, 2004 (PRIMEZONE) -- Artimplant, a biomaterials and orthobiologics company based in Gothenburg, Sweden, has received FDA clearance through a 510(k) for its Artelon(r) CMC-I Spacer. The decision was announced today, Wednesday.
"This is a major milestone for Artimplant. The North American market represents more than 50 percent of the world market. Hand surgeons in the U.S. are waiting to treat patients with our Spacer. This product has considerable potential, which was clearly shown at the ASSH (American Society for the Surgery of the Hand) meeting two weeks ago in New York," says Tord Lendau, CEO of Artimplant.
"Another 90 days was added to the FDA review process, because further information was requested. Consequently, a factor of uncertainty was added to our discussions with potential partners. This uncertainty is now eliminated," says Tord Lendau. Artelon(r) CMC-I Spacer is developed to treat thumb base arthritis -- a disease with a prevalence in North America and Europe of up to 25 percent among women over 50 years of age. For men the same age, the prevalence is more than 10 percent. For the patient, the Artelon(r) CMC-I Spacer implant means no pain, regained grip strength and a joint that is stable and intact. For the doctor, compared with conventional procedures, operation time is reduced and surgery simplified, with just local anesthesia required.
Clinical data from three years of follow up on patients in a pilot study show excellent clinical results. "We plan to launch the product in the U.S. in partnership with a major orthopedic company through a license agreement or by a network of independent distributors. Which option we will choose depends on the terms we are able to negotiate in current discussions. Sales have just started in Scandinavia, and we estimate that we could sell between 1,000 and 2,000 Spacers in the U.S. during the first year after launch," says Tord Lendau.
Artelon(tm) CMC-I Spacer is made from Artimplant's patented Artelon fiber technology. Development of products for other applications in orthopedics, odontology and plastic surgery, where the company has received inquiries from the market, has begun.
Artimplant is preparing to file additional submissions to FDA and for CE-certification within the next few months, e.g. products indicated for rotator cuff repair and achilles tendon repair.
For additional information, please contact: Tord Lendau, CEO, phone +46 (0)31 746 56 00, +46 (0)708 369 403, tord.lendau@artimplant.se Web site: www.artimplant.com
Artimplant's mission is to develop novel biodegradable materials and implants that meet the needs of patients, physicians and healthcare providers in orthopedics and other therapy areas. The company works together with global partners as a center of excellence in this development.
Artimplant's vision is to become the partner of choice in biomaterials for hard and soft tissue repair in multiple therapy areas. Artimplant is a public company, listed on the Stockholm Exchange, O-list.
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