RepRegen™ Seeks US FDA 510(k) Clearance For StronBone™

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 11 Feb 2011 - 0:00 PDT


RepRegen, the 'smart biomaterials' company, announced 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."

Source:
RepRegen™ Ltd

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