Discure Technologies, a clinical-stage medical device company focused on developing treatments for degenerative disc disease and other orthopaedic conditions, has been accepted into the U.S. Food and Drug Administration’s (FDA) Total Product Life Cycle (TPLC) Advisory Programme (TAP).
This acceptance is expected to accelerate patient access to the company's bioelectronic implant, the Discure System, which had previously received Breakthrough Device designation from the FDA.
Low back pain is a leading cause of disability worldwide and is the second most common reason for physician visits in the United States. Degenerative disc disease (DDD) accounts for more than 35 per cent of all low back pain cases.
Existing treatments, such as opioid medications, injections, and invasive surgical procedures, primarily address symptoms rather than providing a long-term solution.
The FDA’s TAP programme aims to support innovative medical technologies by offering early and continuous regulatory guidance. It also facilitates engagement with key stakeholders, including healthcare professionals, insurers, and patient advocacy groups.
This approach helps streamline the process of obtaining U.S. market approval and ensures quicker patient access to novel therapies.
By participating in the programme, Discure Technologies will benefit from regulatory insights and expert feedback, helping to optimise the development and approval process for its bioelectronic therapy.
The Discure System is designed to address the root cause of disc degeneration and could offer a potential solution for individuals suffering from chronic back pain.
Currently, the company is conducting First-in-Human clinical trials of the Discure System in Canada and Italy. Initial results have shown promise, indicating both a positive safety profile and effectiveness in treating disc degeneration.
The support provided through the TAP programme is expected to further aid the advancement of this innovative treatment towards broader clinical use.
