Our Success So Far
The Foundation for the Future
Originally founded upon a revolutionary cell-based technology discovered at Washington University in St. Louis, ISTO has been a pioneer in the orthobiologics industry since 1997. In 2001, the National Institute of Standards and Technology awarded the company a prestigious three-year Advanced Technology Program award. The $2 million prize helped fund ISTO’s work with chondrocytes (cartilage cells), and in 2007 ISTO patented its groundbreaking juvenile cartilage cell expansion platform. This unique and commercially scalable technology is applicable to a broad range of clinical uses, and is at the core of some of ISTO’s most exciting new advances.
ISTO currently has two revolutionary therapies in the pipeline that utilize its cell-based platform. In 2006, the FDA approved ISTO’s Investigational New Drug application for what is now called RevaFlex™ Regenerative Cartilage Technology. Clinical trials began soon after, and RevaFlex has shown promise as the new standard of care for restoring damaged knee cartilage1.
In 2008, ISTO announced preclinical data on a spinal disc repair product called NuQu® Cell-Based Therapy, which is being developed as a novel treatment for disc degeneration2. Clinical trials were initiated in 2009. For the creation of NuQu, Orthopedics This Week and RRY Publications awarded ISTO the 2012 Spine Technology Award in the category of Biomaterials and Biologics.
Novel Bone Grafts
Additionally, ISTO has developed a novel biosynthetic called InQu® Bone Graft Extender & Substitute. ISTO received 510(k) clearance for InQu in 2007, and in 2010, Tissue Engineering published InQu’s preclinical data demonstrating radiographic and biomechanical equivalence between the InQu extender and autograft groups in a model of posterolateral fusion. In 2011, InQu received Conformité Européenne (CE) approval, allowing its commercial launch in Europe. In 2012, ISTO was issued a patent covering InQu’s unique biosynthetic structure, which utilizes poly(lactide-co-glycolide) (PLGA) with entangled hyaluronic acid. To date, this product has been used in more than 40,000 surgeries in the United States.