LONDON--(BUSINESS WIRE)--RepRegen™, the ‘smart biomaterials’ company previously known as BioCeramic Therapeutics, announced today that it has received CE marking approval for StronBone™ bioactive glass with Strontium, the first product that will be commercialized from RepRegen’s repair-and-regeneration platform of ‘smart’ biomaterials for hard tissue, such as bone.
“This European regulatory approval enables us to fast-forward the discussions we are having with several potential strategic partners about our hard tissue platform, in general, and our StronBone product, in particular,” said Ian Brown, RepRegen’s CEO.
“We have previously said that the business opportunities ahead of RepRegen are significant and that some of these opportunities are near-term,” added Chairman Dr. Stephen Rietiker. “The Company’s ‘smart’ biomaterials related to its hard tissue platform represent great new medical device products for the orthopedic biomaterials market sector that will be well-received.”
About RepRegen™ Ltd.
RepRegen™ Ltd. is a medical device company that uses patent-pending repair and regeneration technology platforms designed to mend and regrow hard tissue such as bone and soft tissue such as cartilage. A spin-out from Imperial Innovations plc and headquartered within the Imperial College Incubator, RepRegen is poised to commercialize the initial product of its hard tissue repair and regeneration platform: StronBone™ Bone Graft Substitute. Other products on the hard tissue repair and regeneration runway are targeted for orthopedic (trauma, spine) and craniomaxillofacial applications. The one-of-a-kind properties of RepRegen’s platforms are designed to enable faster and superior tissue repair and regeneration. The Company’s ‘smart’ biomaterials are designed to support and enhance natural cellular growth and tissue regeneration in vivo. These unrivaled materials are comprised of bioactive ceramics or biomimetic fibrous polymer scaffolds. A major RepRegen materials science innovation is the use of Strontium, which boosts performance of bioceramics for bone repair. Both of RepRegen’s platforms — the hard and the soft tissue technologies — include a portfolio of new and unique products with performance characteristics that are designed to yield competitive advantages, including (1) Enhanced cellular growth properties for better and faster healing; and (2) Diversified structures tailored for a variety of porosities and configurations for specific applications.
NOTE: StronBone™ Bone Graft Substitute is an investigational device in the USA and limited by federal law to investigational use only. In the EU, StronBone™ Bone Graft Substitute has received CE marking approval.
