ISTO AND ZIMMER PART WAYS (Orthopedics This Week)
ISTO Technologies, Inc. and Zimmer Holdings, Inc. have reached a fork in the road. And they’re taking it.
On April 29, 2013, ISTO announced that the companies have called off their collaboration and will go their own ways to develop products to repair cartilage defects. ISTO is assuming full control of the DeNovo ET engineered tissue program. Zimmer will get ownership of DeNovo NT, a particulated juvenile cartilage allograft tissue implant product. ISTO is renaming DeNovo ET to RevaFlex.
We asked ISTO Chief Financial Officer Scott Gill why the companies were parting ways.
Strategic Objectives and Time Horizons
Gill said after working with Zimmer for several years on both the 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. ISTO believes that the patented cell-expansion technology and manufacturing scalability behind the newly named RevaFlex program will enable us to better deliver an off-the-shelf knee cartilage repair solution capable of meeting the large demand for such a product better than other cartilage programs currently available or in development.”
He added that his team believes that the RevaFlex program and the company’s NuQu program, an early intervention treatment for degenerative disc disease, represent the future of orthopedics and spine. “These innovative biologic products have the ability to regenerate and restore function and address some of the leading causes of disability in the U.S.”
Phase III Clinical Program
RevaFlex is an engineered cartilage implant intended to repair cartilage defects in the knee. ISTO will proceed independently with further development of the program through a Phase III clinical program.
As part of its cell-based orthobiologic platform, ISTO 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 U.S. 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.