ISTO Technologies has received FDA approval to begin a Phase I clinical study for NuQu, an injectable formulation of juvenile cartilage cells designed to treat chronic back pain caused by degenerative disc disease. According to preclinical study data released last year, juvenile chondrocytes have the ability to regenerate damaged cartilage, replacing the nucleus cells lost to degeneration. NuQu is intended as an early intervention treatment for disc-related low back pain, potentially repairing cell biology and restoring disc function.
There is a large unmet clinical need for non-invasive back pain therapies. About four million U.S. patients suffer from disc-related back pain, with around 500,000 of them not responding to conservative treatments such as anti-inflammatory drugs or physical therapy. Nagging back pain causes a significant decrease in a patient’s quality of life. Simple tasks such as driving a car or bending over cause discomfort, and patients may slide into depression. Back pain can also lead to absences from work and decreased productivity. The economic cost of back pain in the U.S. is estimated to be $100 billion annually. There is currently no effective treatment for degenerative disc disease.
Having gained approval for the clinical study, ISTO is now seeking a corporate partner to ensure that the NuQu program reaches its full potential. Other products in the company’s pipeline are DeNovo ET, a knee implant based on the same technology used in NuQu; and InQu, a bone graft extender and substitute.
Related video: Mitchell Seyedin, President and CEO of ISTO Technologies