Healthcare Industry News:  bone graft 

Devices Orthopaedic Regenerative Medicine FDA

 News Release - February 9, 2011

RepRegen(TM) seeks US FDA 510(k) clearance for StronBone(TM)

Company has previously received European CE Marking approval for StronBone, the first product of RepRegen’s platform to repair and regenerate hard tissue, such as bone

LONDON--(Healthcare Sales & Marketing Network)-- RepRegen, the ‘smart biomaterials’ company, announced today that RepRegen Inc. in the US has submitted StronBone to the U.S. FDA for 510(k) clearance.

StronBone bioactive glass with Strontium is 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 Marking Approval for StronBone. 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,” added 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.”

About RepRegen™ Ltd

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. A spin-out company from Imperial College London, RepRegen is headquartered within the Imperial College Incubator.

RepRegen’s first product is StronBone(TM) 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.

RepRegen develops products to repair and restore tissue better and faster. The company’s Smart Biomaterials are designed both to support and to improve cellular growth in vivo. The materials comprise innovations in bioactive ceramics or biomimetic polymer scaffolds. One of the most remarkable RepRegen innovations is the use of Strontium which gives the formation of bone tissue an additional boost. Both product lines have significant competitive advantages, on the one hand, by enhancing cellular growth through topography of scaffolds and on the other hand, by the use of specially selected materials.

RepRegen’s Chairman and CEO each have considerable experience in starting, building and growing medtech companies. Dr. Rietiker, MD, is Chairman of RepRegen, Chairman of the Switzerland-based investment platform AurigaVision AG and Senior Advisor to Brown Brothers Harriman. Steve was formerly CEO of Sulzer Medica/Centerpulse. Mr. Ian Brown MBA, CEO of RepRegen, has 25 years of international industry experience, including Chromogenix (Sweden), Instrumentation Laboratory (Italy) and Cordlife (Singapore and Australia) and he is an alumnus of INSEAD (France), Europe’s leading business school. RepRegen’s Chief Scientific Officer is Professor Molly Stevens. Prof. Stevens is Professor of Biomedical Materials and Regenerative Medicine and Research Director for Biomedical Material Sciences at the Institute of Biomedical Engineering, Imperial College London. Molly joined Imperial College London in 2004 after spending several years as a Postdoctoral Associate in the Chemical Engineering Department at the Massachusetts Institute of Technology (MIT).

Note: In the EU, StronBone bone graft Substitute is a medical device product which has CE Marking approval. In the USA, StronBone bone graft Substitute is a medical device product which has not yet been cleared by the FDA and can therefore only be used for investigational use.

Source: RepRegen

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