January 08, 2019
SAN FRANCISCO–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts (HDFs), today announced at the JPMorgan Healthcare Conference the issuance of a new Australian patent. The company’s industry leading intellectual property portfolio in spine treatments for its lead product, CybroCell, now includes 36 U.S. and foreign patents issued with 40 pending. The recent FDA clearance of the company’s Investigational New Drug protocol and positive results from its Phase 1/Phase 2 clinical trial and strong patent position pave the way for continued development and clinical trials into the effectiveness of its fibroblast cell therapy.
“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.”
The technologies described in Australian patent No. 2017206234, “Methods And Compositions For Repair Of Cartilage Using An In Vivo Bioreactor,” are related to differentiating HDF’s into chondrocyte-like cells by exposing them to a specific environment of growth factors, hypoxia, hydrostatic pressure and shear stress.
About Degenerative Disc Disease
Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.
CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients experienced sustained improvement in pain relief and increased back mobility.
Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc replacement using human dermal fibroblasts. Currently, SpinalCyte holds 36 U.S. and international issued patents and has filed for an additional 40 patents pending. SpinalCyte holds 117 U.S. and International Patents pending and issued across a variety of clinical pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.
David Schull or Ned Berkowitz
Russo Partners LLC
Source: BusinessWire, Jan 8, 2019