ISTO Receives Clearance For Novel Bone Graft Substitute, Bone Graft Extender
FDA has granted 510(k) clearance for ISTO Technologies's InQu for use as a bone graft extender in the spine and as a bone graft substitute in the extremities and pelvis.
InQu represents a new class of synthetic biomaterial scaffold designed to optimize structural and biological properties to support bone cell growth. InQu is a biopolymer composite of hyaluronic acid which is entangled within the three-dimensional backbone created by synthetic polyester. Hyaluronic acid, a ubiquitous component of natural tissue, is known to play a predominant role in tissue morphogenesis, cell migration, adhesion, and cell differentiation. Mitchell Seyedin, President and CEO of ISTO said, "We are very pleased to receive FDA clearance and will focus on demonstrating InQu's clinical benefit to the surgeons and patients."
More than 1 million bone grafting procedures are performed in the United States annually, and more than 3 million procedures are performed worldwide. Synthetic bone graft material represents the fastest growing segment of the orthobiologics market. "We are very excited to participate in this evolving market with our exceptional product," adds Seyedin. ISTO intends to launch InQu at the upcoming annual North American Spine Society conference in Austin, Texas.
In addition to its biomaterial platform technology, ISTO is also developing cartilage regeneration products centered on its patented cell-based technology. Cartilage regeneration is often called the "holy grail" of the orthopedic industry because of its potential to restore function to damaged joints that otherwise have limited healing potential. Cartilage serves as a "shock absorber" protecting all joints, including spinal discs, from the wear and tear experienced during motion. ISTO's first cartilage product is currently in clinical trials.