16 Feb, 2021, 07:00 ET
DALLAS, Feb. 16, 2021 /PRNewswire/ -- Signature Biologics, LLC., a regenerative medicine company focused on the development, manufacture, and commercialization of cellular and tissued based products (HCT/P's) for unmet human medical needs, today announced that the U.S. Food and Drug Administration (FDA) has approved an IND Application to proceed with the study of Signature Cord Prime™ in patients with symptomatic osteoarthritis (OA) of the knee with our Principal Investigator.
An IND is a request for authorization from the FDA to administer an investigational drug or biological product to humans. Signature Biologics applied for the IND for Signature Cord Prime™ to begin clinical study of the product, working towards a full Biologics Licensing Application (BLA) with FDA's Center for Biologics Evaluation and Research (CBER).
"This represents a push for regenerative medicine as the first hUC [human umbilical cord] product of its kind to receive approval to be studied in osteoarthritis of the knee," said Dr. Neil Riordan Ph.D., CEO of Signature Biologics. "We are pleased that FDA has enabled us to proceed and we are grateful for the partnership." The FDA granted IND approval based on multicenter, retrospective clinical evidence from 135 knees treated with Signature Cord™ that demonstrated both safety and statistically significant reduction in pain and improvement in function.
Osteoarthritis is the most common form of arthritis, affecting more than 32.5 million Americas and more than 500 million worldwide. According to the CDC, OA was the second most costly health condition treated at US hospitals in 2013, at $16.5 billion or 4.3% of the combined costs for all hospitalizations. In 2015, the US financial cost of OA was estimated to reach $200 billion annually or 1.1% of GDP. Knee replacement surgeries required in the U.S. are growing every year and are expected to rise to 1.28 million Americans by 2030.
About Signature Cord Prime™
Signature Cord Prime™ is a cryopreserved, human umbilical cord tissue allograft for the management of symptomatic knee osteoarthritis. Signature Cord Prime consists of micronized umbilical cord tissue and contains naturally occurring cellular growth factor, pro angiogenesis, anti-inflammatory cytokines, and extracellular components. Signature Cord Prime is one of the products in Signature Biologics' regenerative medicine pipeline. For more information on Signature Biologics' Products, visit www.signaturebiologics.com/products/
About Signature Biologics, LLC.
Signature Biologics is a leading regenerative medicine company providing a portfolio of human placental-derived products to support and improve the natural healing process of the body in wound, musculoskeletal, and pain management applications. Signature Biologics' vision is born from decades of biologics leadership, adherence to scientific inquiry, and the highest quality standards. For more information, visit www.signaturebiologics.com
SOURCE Signature Biologics
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