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On January 8th, SpinalCyte LLC announced the issuance of a new Australian patent. The intellectual property portfolio for their leading product, CybroCell, now contains 36 international patents with 40 more pending.
“This new Australian patent further expands our robust international intellectual property estate for our fibroblast technology,” said Pete O’Heeron, Chief Executive Officer of SpinalCyte. “SpinalCyte is at the forefront of human dermal fibroblast cell therapy companies, specifically in disc degeneration. We are confident that this promising therapy will greatly reduce the need for potentially addictive opioids for the treatment of back pain, while providing increased function.”
CybroCell is an allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease (DDD). SpinalCyte’s Phase 1/Phase 2 clinical trial demonstrated that DDD patients experienced an increase in pain relief and an improvement in back mobility after 12 months when treated with injections of human dermal fibroblasts. CybroCell is also the first off-the-shelf product of its kind.
Degenerative disc disease is a condition where a patient’s spinal disc begins to deteriorate, and in severe cases, can start to collapse. It is a common ailment, with an approximation of 85% of people over 50 years old having some indication of DDD with over 1.3 million procedures undergone annually to combat it. Most patients treated opt for spinal fusion or discectomy. A spinal fusion consists of the full removal of the affected disc and the fusion of the two adjacent vertebrae, which can increase strain on the adjacent tissues and discs, leading to further deterioration. On the other hand, a discectomy is comprised of a partial or full removal of the affected disk to decompress and relieve the nervous system. While this technique provides relatively quick relief, it can also cause long-term spinal discomfort and pain.
The recent FDA clearance of SpinalCyte’s Investigational New Drug custom, favorable results from its aforementioned Phase 1/Phase 2 clinical trial, and pertinent patent position pave the path for continued development and further trials on the effectiveness of its fibroblast cell therapy.
For Further Information
More on the orthopedic biomaterials market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Biomaterials.