ISTO Biologics

Isto is a unique orthobiologics company, developing breakthrough technologies that are deeply rooted in biology for spine and orthopedics.

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.

Our Mission

HELPING PATIENTS HEAL FASTER

Isto is focused on using cutting-edge science to develop novel orthobiologic products that are safe, efficacious, and cost-effective. Our groundbreaking biologics portfolio has already improved the quality of life for countless patients. Each day brings new discoveries and innovations that will help doctors restore mobility, reduce pain, and improve the quality of life for their patients.

Core Commitments

• Dedicated to Improving Patient Outcomes

We are here to serve medical professionals and in order to improve patient outcomes through the use of our products and services.

• Collaboration and Partnership

Collaboration and partnership are essential to our success. Through collaborating and partnering with world-class researchers and business partners, we are focused on accelerating new product innovation.

• Corporate Citizenship

We are committed to holding the highest ethical standards and providing the best service to our customers, medical professionals and patients.

Cell-Based 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.