Discure Technologies, a clinical-stage medical device company pioneering treatments for degenerative disc disease and other orthopedic disorders, today announced its acceptance into the U.S. Food and Drug Administration’s (FDA) Total Product Life Cycle (TPLC) Advisory Program (TAP). Acceptance to TAP will expedite patient access to Discure’s bioelectronic implant, the Discure System, which previously received Breakthrough Device designation from the FDA.
Low back pain is the leading cause of disability globally, the second most common reason for physician visits in the U.S., and accounts for economic losses in excess of $100 billion annually in the U.S. alone. Degenerative disc disease (DDD) is associated with over 35 percent of all low back pain cases. Current treatments, including opioids, injections, and invasive surgery, focus on symptom relief and offer limited long-term efficacy.
The FDA’s TAP program offers an unparalleled opportunity for Discure Technologies by providing early and ongoing access to specialized regulatory guidance, clinical input, and feedback from key stakeholders, including healthcare providers, payers, and patient advocacy groups. These resources and support will facilitate a more efficient path to U.S. marketing authorization and patient access.
“Inclusion in the FDA’s TAP Program underscores the potential of Discure’s bioelectronic therapy, the Discure System, to reverse disc degeneration,” said Yuval Mandelbaum, CEO of Discure Technologies. “By providing important regulatory insights and stakeholder engagement, this program enhances our ability to bring the first curative treatment for degenerative disc disease to patients suffering from chronic back pain. With TAP’s guidance and our positive clinical outcomes, we are optimizing the pathway to efficiently deliver this transformative therapy to those in need.”
Discure Technologies is currently conducting First-in-Human clinical trials of its Discure System in Canada and Italy. Preliminary results have been encouraging, demonstrating a favorable safety profile and efficacy in treating disc degeneration.
