TissueTech Receives FDA Clearance for TTAX03 Study to Treat Facet Joint Osteoarthritis Pain

Amniox Medical announced its parent company TissueTech had received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a dosing study using its Investigational New Drug (IND) TTAX03 to treat facet joint pain resulting from Osteoarthritis (OA). This Phase 1 randomized, double-blinded, placebo-controlled, dose-finding study will include a one-year follow-up to assess TTAX03's long-term safety and potential lasting benefit.

TissueTech is currently the only human birth tissue manufacturer cleared by the FDA to proceed with an IND study for the treatment of facet OA. FDA clearance of this IND application represents one of the first steps in commercializing TTAX03-FJ as a biologic.

Investigators have already seen positive results from earlier studies using Amniox's commercially available Cryopreserved Amniotic Membrane and Cryopreserved Umbilical Cord (CAM/CUC) particulate CLARIX® FLO to treat joint pain resulting from moderate to severe knee osteoarthritis (OA).

OA is an inflammation-driven disease, and as such, there has been a surge of interest in biologic therapies that might help slow OA disease progression and alleviate associated pain. TissueTech's CAM and CUC products are currently being investigated as biologics for several different indications given their long history of safe use and the known anti-inflammatory, anti-scarring, and pro-regenerative properties of birth tissue.

Research shows that patients seeking pain relief for lower back pain are known to be at risk for higher rates of substance-abuse disorders, with occurrence rates of 5% to 25%. According to the Centers for Disease Control (CDC), in 2017, almost 57 million patients in the U.S. had at least one prescription for opioids filled or refilled. In the context of this opioid epidemic, healthcare providers face the challenge of optimizing pain management solutions that limit opioid use.

"We believe that TTAX03 will prove to be successful as a non-opioid intra-articular treatment for moderate to severe lower back pain resulting from facet joint osteoarthritis," said TissueTech President and Chief Executive Officer Amy Tseng. "We are committed to positively impacting patients' lives and think this product could provide dramatic outcomes for patients who suffer from facet joint OA. Low back pain not only affects one's quality of life but has also been shown to contribute to opioid and other substance abuse disorders. We are hopeful this product will be able to help these patients before they become dependent on such medications."