ST. LOUIS, Sept. 24 ISTO Technologies Inc., a privatelyheld orthobiologics company, today announced that the United States Food andDrug Administration has granted 510(k) clearance for InQu(TM). InQu isindicated for use as a bone graft extender in the spine and as a bone graftsubstitute in the extremities and pelvis.
InQu represents a new class of synthetic biomaterial scaffold designed tooptimize structural and biological properties to support bone cell growth.InQu is a biopolymer composite of hyaluronic acid which is entangled withinthe three-dimensional backbone created by synthetic polyester. Hyaluronicacid, a ubiquitous component of natural tissue, is known to play a predominantrole in tissue morphogenesis, cell migration, adhesion, and celldifferentiation. Mitchell Seyedin, President and CEO of ISTO said, "We arevery pleased to receive FDA clearance and will focus on demonstrating InQu'sclinical benefit to the surgeons and patients."
More than 1 million bone grafting procedures are performed in the UnitedStates annually, and more than 3 million procedures are performed worldwide.Synthetic bone graft material represents the fastest growing segment of theorthobiologics market. "We are very excited to participate in this evolvingmarket with our exceptional product," adds Seyedin. ISTO intends to launchInQu at the upcoming annual North American Spine Society conference in Austin,Texas.
In addition to its biomaterial platform technology, ISTO is alsodeveloping cartilage regeneration products centered on its patented cell-basedtechnology. Cartilage regeneration is often called the "holy grail" of theorthopedic industry because of its potential to restore function to damagedjoints that otherwise have limited healing potential. Cartilage serves as a"shock absorber" protecting all joints, including spinal discs, from the wearand tear experienced during motion. ISTO's first cartilage product iscurrently in clinical trials.
ISTO Technologies, Inc. is a clinical-stage orthobiologics company focusedon developing differentiated products for sports medicine, spinal therapy, andtrauma. ISTO's products are intended for the repair and regeneration ofdamaged or injured cartilage and bone. For additional information on ISTO,please visit our website at http://www.istotech.com.
SOURCE ISTO Technologies Inc.