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ISTO Technologies, Inc. Announces Publication of Positive Results From Phase I Clinical Trial of NuQu(R) For Treatment of Low Back Pain

ST. LOUIS, Nov. 27, 2012 (GLOBE NEWSWIRE) -- ISTO Technologies, Inc. announced today the publication of a scientific paper in a leading peer-reviewed neurosurgery journal, the Journal of Neurosurgery: Spine, that highlights promising results with NuQu®, a cell-based biological therapy for the treatment of low back pain. The manuscript, entitled "Prospective study of disc repair with allogeneic chondrocytes" by Domagoj Coric, M.D., Kenneth Petting, M.D., Andrew Sumac, M.D. and Margaret O. Boltes, R.N., is currently available on-line at www.thejns.org (DOI: 10.3171/2012.10.SPINE12512) as a "Publish before Print" article and will soon be available in an upcoming publication.

The paper describes the initial clinical experience with NuQu, which is intended for the treatment of pain and disability associated with degenerative disc disease. The study, conducted by the authors, was designed to evaluate the safety and initial efficacy of NuQu in 15 patients at two clinical sites. In the article, the authors report the 12 month post-treatment results of the single-arm study using MRIs, the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), the 36-Item Short Form Health Survey (SF-36) and other measures. Based on the outcomes at 12 months follow-up, the authors conclude that no serious and unexpected safety concerns have emerged, and that the treatment results "are promising and warrant further investigation in a prospective, randomized, double-blinded, placebo-controlled study design."

Dr. Coric, Lead Clinical Investigator for the project and a practicing neurosurgeon at Carolina Neurosurgery and Spine Associates and Chief of Neurosurgery at Carolinas Medical Center, both in Charlotte, NC, commented, "Given the limited treatment options available today for patients suffering from chronic low back pain, NuQu potentially represents a unique and innovative technology that could eliminate a number of surgical procedures and improve quality of life for a sizable patient population."

There is no biologic treatment currently available for patients who fail traditional nonsurgical management of discogenic back pain. NuQu may offer a solution for these patients and is under clinical investigation as a potential minimally invasive treatment. NuQu is comprised of tissue-expanded juvenile chondrocytes that are supplied frozen to the physician, and then thawed and combined with a fibrin carrier at the time of use. NuQu is delivered percutaneously under 2D-fluoroscopic guidance. Therefore, it is anticipated that patients treated with NuQu will demonstrate faster recovery rates than traditional surgical approaches.

ISTO announced in October that it is initiating a Phase II clinical trial to further evaluate the efficacy and safety of its NuQu cell-based therapy. The company expects to commence enrollment in the randomized, double-blinded, placebo-controlled trial in the fourth quarter of 2012 at multiple U.S. clinical sites.

"We are encouraged that the results from the initial clinical experience with NuQu support our belief that this technology may represent a breakthrough treatment for degenerative disc disease by promoting regeneration and healing of the disc. We believe that the publication of the 12-month data from our Phase I trial in a peer-reviewed journal validates our commitment to NuQu," said Mitchell Seyedin Ph.D. President & CEO of ISTO Technologies. "This technology has the potential to be a cost-effective non-surgical solution to disability from chronic low back pain and we believe that the results from our Phase II study, which includes a placebo control, will support this promise."

NuQu is part of ISTO's proprietary cell-based orthobiologics platform, which harnesses the regenerative capacity of juvenile cartilage cells to create products designed to repair and restore function to damaged cartilage. In addition to NuQu, ISTO is developing DeNovo® ET, a scaffold-free engineered cartilage tissue that is also produced though in vitro expansion of juvenile chondrocytes. This product is intended for the repair of damaged articular cartilage in the knee, and is in Phase III clinical investigation.

ISTO also manufacturers and markets InQu®, a bone graft extender and substitute. InQu is a differentiated product that combines integrated hyaluronic acid and a resorbable polymer for better handling and biology. The primary target market for InQu is spinal fusion applications. For more information, please visit www.istotech.com.

About ISTO

ISTO is a privately-held orthobiologics 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.istotech.com.

CONTACT: ISTO Technologies, Inc. Scott Gill Chief Financial Officer (314) 995-6049 The Ruth Group Nick Laudico (investors) (646) 536-7030 nlaudico@theruthgroup.com Kimberly Muscara (media) (646) 536-7011 kmuscara@theruthgroup.comSource: ISTO