ISTO Gets 501(k) Clearance for Bone-Graft Technology

ISTO Technologies, a St. Louis, MO-based orthobiologics company, has received 501(k) clearance for its InQu bone-grafting technology. FDA has cleared the technology for use as an 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. It’s 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.

More than one million bone-grafting procedures are performed in the U.S. each year, and more than three million worldwide. Synthetic bone-graft material represents the fastest-growing segment of the orthobiologics market.

ISTO plans to launch InQu at the North American Spine Society conference in Austin, TX, happening in late October. In May, the company closed an $8.8 million financing to assist with the launch and to help finance the development of other pipeline products.

In addition to its biomaterial platform technology, ISTO is developing cartilage-regeneration products centered on its patented cell-based technology: DeNovo ET is a tissue engineered cartilage for the repair of damaged or injured cartilage in the knee, and NuQu is an injectable cell-based therapy for the regeneration of the nucleus of the spinal disc.

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.

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