Artelon® Tissue Reinforcement receives regulatory clearance for the marketing of new indications in the USA

Västra Frölunda, Sweden, September 21, 2007
The biomaterials company Artimplant 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™.

President and CEO Hans Rosén 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.”