Healthcare Industry News:  Suture Anchor 

Devices Orthopaedic

 News Release - September 21, 2007

Artimplant: Artelon(R) Tissue Reinforcement Receives Regulatory Clearance for the Marketing of New Indications in the USA

VASTRA FROLUNDA, Sweden--(HSMN NewsFeed)--Regulatory News: The biomaterials company Artimplant (STO:ARTIB) has received regulatory clearance for marketing Artelon® Tissue Reinforcement for new indications in the USA. The new clearance offers the opportunity to reach a considerably larger market.

Since 2006 it has been possible to market Artelon® Tissue Reinforcement in the USA as reinforcement of soft tissue tears in the shoulder, limited to the supraspinatus tendon. The present regulatory clearance provides Artimplant and its licensee, Biomet Sports Medicine, with the opportunity to market the product for general soft tissue repair. Examples of new indications that can be marketed are general reinforcement of the rotator cuff in the shoulder and tendon repair around the kneecap, biceps, front thigh muscle (quadriceps) and Achilles tendon.

In addition to using sutures or Suture Anchors for primary repair, patients with severe injury or poor tissue quality will benefit from additional support provided by the Artelon® reinforcement patch. The patch offers additional initial mechanical strength and is at the same time a degradable scaffold for in-growth of the patient's native tissue. The long-term support from the degradable patch should minimize the risk of re-ruptures and the aim is to accelerate rehabilitation and increase long-term strength. With the Artelon® reinforcement patch the risk of tissue reaction or disease transfer related to animal- or human-derived materials is eliminated. Biomet Sports Medicine's current marketing of the product is limited to the rotator cuff of the shoulder under the brand name SportMesh(TM).

President and CEO Hans Rosen says; "The new regulatory clearance is of great importance for Artimplant. We now have the opportunity to market Artelon® Tissue Reinforcement on a considerably larger market than before. Artimplant's experience from Europe in, among other things, the treatment of Achilles tendon ruptures, which can now be marketed in the USA, is very encouraging. Artelon® Tissue Reinforcement has a broad field of use, significant market potential and the scope to becoming substantially bigger than our current best-selling product Artelon® CMC Spacer. The clearance can be regarded as an important step for Artimplant."

About Artimplant

Artimplant is a biomaterials company focused on solutions to problems in orthopedic and oral surgery. We restore health through the development, production, and marketing of degradable implants that regenerate body functions and improve quality of life. Our products, made from Artelon®, meet unmet clinical needs and are marketed in a growing number of therapy areas. Artimplant produces implants for treatment of osteoarthritis in hands and feet, for shoulder and other soft tissue injuries as well as oral applications.

Artimplant is a public company listed on the OMX Nordic Exchange Stockholm in the Small Cap segment and in the healthcare sector.

Forward-looking statements This press release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting the Company's business including increased competition; the ability of the Company to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks detailed from time to time in the Company's filings.


Source: Artimplant

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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