Bone Solutions (BSI) plans to file four additional 510(k) applications with the FDA related to its OsteoCrete platform. The company has previously received FDA 510(k) clearance for the first application in its OsteoCrete pipeline as a bone void filler.
The imminent additional FDA filings empower BSI to explore new strategic partnerships within the orthopedic industry.
OsteoCrete was certified in May 2009 as a bone void filler by the FDA for broad applications in musculoskeletal structure, trauma, bone grafting, and related surgeries. The company has been filing for 510(k) certification for maxillofacial applications, then as a bone anchor, next for cranial applications, and then as a non-load-bearing spine application.
Bone Solutions believes that its recent studies since the initial FDA certification show that OsteoCrete will fit successfully in all these application areas.
FDA-cleared OsteoCrete Bone Void Filler is a biocompatible magnesium-based bone void filler that is both injectable and moldable. It is indicated for bony voids or defects that are not intrinsic to the stability of the bony structure.
OsteoCrete is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). The defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoCrete is designed to provide a bone void filler that resorbs and is replaced with bone during the healing process.
BSI’s magnesium-based technology, including OsteoCrete, is protected by a seminal US patent, ‘Magnesium Phosphate-Based Adhesive for Bone, Ligament and Tendon Repair and Stabilization,’ and a method for applying the composition during surgery. An additional four patents have been filed.
Dr Tony Copp, EVP and COO, said: “This broad strategy for our unique compound, OsteoCrete which is resorbable, osteoconductive, and injectable, has high strength, provides physician-friendly flexibility as to handling and setting time and is designed to set in a wet environment has major competitive advantages over existing bone graft substitutes on the market today, including lower cost.
“But that market segment, bone graft substitutes, is only one of many other market segments for which we believe OsteoCrete will be applicable. Given recent orthopedic industry transactions such as Baxter International’s acquisition of Apatech, we feel now is the perfect time for BSI to be exploring potential strategic partnerships. We certainly believe we can be competitive with the Apatech product.”