ISTO and Zimmer Part Ways on Cartilage Tissue Program

ISTO Technologies Inc. has agreed to take full control of the Denovo ET (engineered tissue) program, which until now was managed by both ISTO and Zimmer Holding Inc. in collaboration. Denovo ET is an engineered cartilage implant designed to repair defects in the knee, and orthobiologics company ISTO’s expertise is in cartilage tissue regeneration. 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 Revaflex and will proceed independently with further development of the program through a Phase III clinical program.

The two companies also worked on Denovo natural tissue (NT), a particulated juvenile cartilage allograft tissue implant product. Under terms of the agreement, Zimmer will gain complete control of that product. ISTO and Zimmer have been collaborating since 2002.

“After working with Zimmer for several years on both Denovo ET and Denovo NT programs, it became apparent to both parties that it made more sense for each of us to take full control of the program that best fit the strategic objectives and time horizons for each company,” Mitchell Seyedin, Ph.D., CEO of ISTO told Orthopedic Design & Technology. “ISTO believes that the patented cell-expansion technology behind the newly name Revaflex program will enable off-the-shelf knee cartilage repair solution not shared by other competing technologies in the market or in the development.”

ISTO Technologies is focused on developing 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 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 using autologous cells.

“We are very excited about having full control of Revaflex and believe that this program and our NuQu program, an early intervention treatment for degenerative disc disease, represent the future of orthopedics and spine,” added Seyedin.