Wednesday, February 25, 2009

FDA clears Serica’s silk tissue repair tech

By Mass High Tech staff

Serica Technologies Inc., a maker of biomaterials, has received U.S. Food and Drug Administration 510(k) clearance for its SeriScaffold soft tissue repair technology.

The company makes ligament grafts, surgical meshes and gels made from a protein produced by B. mori silkworms. SeriScaffold is a natural, silk biomaterial that acts like a scaffold in supporting weak or damaged tissue. The technology could be used in breast cancer patients recovering from reconstructive surgery, as well as plastic surgery procedures in general. The scaffold will use silk for restructuring, rather than synthetic materials or cadaver tissue from humans or animals. Additionally, the scaffold could find use in rotator cuff and hernia repair surgeries, the company said.

Pre-clinical studies show more time for healing ligaments due to a slow biosorption rate for silk.

Serica officials said the company seeks a partner for aesthetic and reconstructive surgery.

Serica, formerly Tissue Regeneration Inc., was founded in 1998 by Gregory Altman. Altman, CEO of the company, developed the firm’s technology after he ruptured his anterior cruciate ligament, or ACL, while playing varsity football at Tufts University.