DALLAS–(BUSINESS WIRE)–Bone Solutions Inc. (“BSI”) announced today that it will soon 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 proprietary bone void filler. These imminent additional FDA filings will empower BSI to explore major 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. BSI is next filing for 510(k) certification for maxillofacial applications, then as a bone anchor, next for cranial applications, and then as anon-load-bearing spine application. The Company believes that its recent studies since the initial FDA certification show that OsteoCrete™ will fit successfully in all these application areas.
“BSI is now poised not only to roll out its initial product in the U.S. but also will also pursue CE Mark certification for European Union sales,” said Tom Lally, President.
“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,” added Dr. Tony Copp, EVP and COO. “But that market segment, bone graft substitutes, is only one of many other market segments for which we believe OsteoCrete™ will be applicable,” said Dr. Copp. “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.”
The Company also disclosed that BSI, with Rush Craniofacial Center in Chicago, is pursuing the use of OsteoCrete™ to cast preformed implants. Data from a 3D image derived from a CT or micro CT scan would be converted into a mold with OsteoCrete™ used to fill the mold. “This would create the first anatomically correct personalized implant,” said Lally. First tests will start with craniofacial applications.
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). These 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 U.S. 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.
About Bone Solutions Inc.
Bone Solutions Inc. (“BSI”) intends to establish its magnesium-based OsteoCrete™ platform as the ‘one stop bone-, tendon- and ligament-injectable, biodegradable adhesive technology’ for surgeries at hospitals, clinics and other private surgical centers within the orthopedic industry. The Company believes it is revolutionizing a new solution for orthopedic surgeons with a magnesium-based platform that is designed to attach—for the first time in orthopedic medical history—bone to bone, as well as ligaments and tendons to bone.