RepRegen Goes After 510(k) Clearance for Tissue Repair Product

United Kingdom-based RepRegen has submitted its StronBone to the U.S. Food and Drug Adminstration (FDA) for 510(k) clearance.

StronBone bioactive glass with strontium is, according to the company, the first product that is being commercialized from RepRegen’s repair and regeneration platform of “smart” biomaterials for bone and other (hard) tissue. Recently, RepRegen received CE Mark in the European Union for the device. RepRegen has discovered that the addition of strontium “turbocharges” the bioactivity of bioceramic technology; this major materials science discovery enables development of enhanced products to repair and regenerate bone and other (hard) tissue.

“RepRegen’s advanced biomaterials represent a leap forward in designing superior products for tissue repair and regeneration by supporting and enhancing natural cellular growth and tissue regeneration in vivo”, said Ian Brown, RepRegen’s CEO.

The business opportunities ahead of RepRegen are “significant,” according to company Chairman Dr. Stephen Rietiker. “The Company’s ‘smart’ biomaterials related to its hard tissue platform are of great interest to a significant number of orthopaedic companies with whom we are in discussions,” he said.

RepRegen is an emerging medical device company using patent-pending repair and regeneration technology in two platforms designed to mend and regrow tissue in vivo. The first platform is focused on bone and other (hard) tissue, whereas the second platform is focused on muscle and other (soft) tissue. The firms is a a spin-out company from Imperial College London.

RepRegen’s first product is StronBone bone graft substitute bioactive glass with strontium. StronBone and other products in the hard tissue repair and regeneration range are for orthopaedic (trauma and spine) and craniomaxillofacial applications.