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news.Isto Technologies, an orthobiologics company, has received notification from the FDA allowing the company to proceed with a Phase I clinical study for NuQu, a cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain.
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According to Isto Technologies, NuQu is intended as an early intervention treatment for patients suffering from low back pain by potentially repairing cell biology in a damaged disc, restoring health and improving function. It is anticipated that treatment with NuQu may offer pain relief to those suffering from chronic back pain by repairing and regenerating cartilage in the spine.
In conjunction with the FDA approval to initiate the Phase I trial, Isto also announced that it is seeking a corporate partner for the NuQu program to ensure that the full potential of the program is realized.
Mitchell Seyedin, president and CEO of Isto, said: “Moving the NuQu program into clinical evaluation represents an important achievement for Isto and a notable milestone for those individuals suffering from chronic back pain. We believe that our cell-based therapy utilizing juvenile chondrocytes represents the future of spine care.”