ISTO Technologies Assumes Full Control of DeNovo ET Cartilage Repair Technology Program; Collaboration Agreement with Zimmer Holdings, Inc. Ended; ISTO to Proceed Independently with Phase III Clinical
Apr 29, 2013
St. Louis, MO – April 29, 2013 – ISTO Technologies, Inc. announced today an agreement with Zimmer Holdings, Inc. whereby ISTO has assumed full control of the DeNovo® ET Engineered Tissue program, an engineered cartilage implant intended to repair cartilage defects in the knee. Under the terms of the agreement, any rights and responsibilities previously held by Zimmer related to ISTO and the program have been cancelled. ISTO has renamed the product RevaFlexTM and will proceed independently with further development of the program through a Phase III clinical program.
ISTO Technologies is committed to developing breakthrough products to regenerate and restore function to damaged cartilage and bone. As part of its cell-based orthobiologic platform, the company is currently involved in the development of two unique and potentially ground-breaking cell-based products intended to treat two of the leading causes of disability in the United States. In addition to RevaFlex™, ISTO is developing NuQu®, a minimally-invasive early intervention treatment for discogenic back pain. The Company initiated Phase II clinical trials for NuQu in late December 2012. Both the RevaFlex and NuQu programs address significant unmet medical needs related to chronic pain and disability resulting from cartilage wear and degeneration problems that occur in the knee and lower back, respectively. ISTO’s proprietary cell-expansion process provides the foundation for both programs. Through this process, allogeneic cells are expanded to create products capable of treating thousands of patients from a single donor, thus offering an economy of the scale and “off-the-shelf” therapeutic solution not possible with cartilage programs utilizing autologous cells.
In addition, under the terms of the termination of the collaboration agreement, ISTO will transfer ownership ofDeNovo® NT, a particulated juvenile cartilage allograft tissue implant product, to Zimmer.
ISTO is a leading privately-held regenerative medicine 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.istobiologics.com.