Discure’s Degenerative Disc Disease Device Accepted into FDA TAP Program

Discure has been accepted into the U.S. Food and Drug Administration’s (FDA) Total Product Life Cycle (TPLC) Advisory Program (TAP).

Acceptance into TAP means expedited patient access to Discure’s bioelectronic implant for disc degeneration, the Discure system. The technology previously earned breakthrough device status from the FDA.

The FDA’s TAP program provides early and ongoing access to specialized regulatory guidance, clinical input, and feedback from key stakeholders, including healthcare providers, payers, and patient advocacy groups.

Discure’s implantable bioelectronic device is designed to treat and reverse degenerative disc disease (DDD) by actively controlling the reintroduction of fluid, oxygen, and nutrients into the degenerated disc. Unlike current symptom-focused treatments, the Discure system has the potential to be the first disease-modifying solution for DDD, designed to reduce the use of opioids and the need for invasive back surgery.

The company also secured $11 million in an oversubscribed Series A financing round in September 2024, following a SAFE (Simple Agreement for Future Equity) raise of $5 million, bringing the total equity financing raised to $16 million.

The company is currently conducting first-in-human trials of its Discure system in Canada and Italy. The company reported that early results are encouraging, showing a favorable safety profile and efficacy to treat disc degeneration.

“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.”