ISTO Technologies, Inc., an orthobiologics company developing innovative cartilage and bone products for spinal therapy and sports medicine indications, today announced that it has received the CE Mark approval for its InQu® product line. InQu is a unique bone graft substitute and extender currently sold through a network of independent distributors in the United States. Receipt of the CE Mark enables ISTO to initiate a commercial launch of the product in Europe.
Mitchell Seyedin Ph.D, President & Chief Executive Officer of ISTO stated, “We are extremely pleased to receive the CE Mark for InQu. The product has proven to be an innovative and cost-effective bone grafting alternative for spinal fusion and other orthopedic surgeries in the United States and we believe that distribution in Europe will augment our domestic revenue growth. We are excited to expand the market for InQu and offer a great alternative for patients in need of bone grafting.”
InQu is a differentiated biomaterial scaffold of synthetic and biologic polymers used mainly in spinal fusion applications. The product is currently manufactured in four different forms (granules, paste, putty and a three-dimensional scaffold). The versatility of the product configurations provides surgeons with more options and allows for broader product applications. The company believes InQu represents a new approach to optimizing bone healing, based on its combination of structural and biological attributes inherent to two uniquely combined biomaterials, polylactide-co-glycolide (PLGA) and unmodified hyaluronic acid (HyA). Both biomaterials have a long history of safe and effective clinical use.
The structural component of InQu, PLGA, creates an osteoconductive scaffold, well-recognized to support new bone formation as it undergoes resorption at the site of implantation. HyA, a ubiquitous component of natural tissue, provides improved handling and is reported to exhibit several unique biophysical and biological properties, which play an important role during embryonic development, tissue regeneration and bone repair. InQu was developed by ISTO and launched in the U.S. in 2008.
ISTO is a privately-held orthobiologics company dedicated to improving patient quality of life through the development of proprietary products for spinal therapies and sport medicine applications. ISTO’s products are intended for the repair and regeneration of damaged or injured cartilage and bone. For additional information on ISTO, please visit our website at www.istotech.com.
Source: ISTO Technologies