CAPS Medical's PlasmaSure™ Achieves FDA Breakthrough Device Designation for Tumor Ablation

CAPS Medical's PlasmaSure™ Receives FDA Breakthrough Device Designation

CAPS Medical, a progressive MedTech company focused on innovative tumor ablation solutions, recently announced that its PlasmaSure™ system has been granted the prestigious Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation marks a significant milestone in the company’s efforts to provide more effective treatment options for patients with non-muscle invasive bladder cancer (NMIBC).

The PlasmaSure™ technology utilizes non-thermal atmospheric plasma energy to selectively ablate tumors, preserving surrounding healthy tissue. This approach is especially critical in treating NMIBC where minimizing collateral damage is paramount. Traditional treatments often require invasive procedures that can lead to longer recovery times and increased patient risk. By employing its innovative platform, CAPS Medical aims to replace the conventional transurethral resection of bladder tumors (TURBT) with a simpler, in-office procedure.

Clinical Study and Results

CAPS Medical has successfully completed its first-in-human clinical study, where around 70 tumors were treated using the PlasmaSure™ system. This study reported impressive results with durable complete response rates over both short and long-term follow-ups. Notably, the procedure was performed without any adverse events, and there was no damage to healthy tissues surrounding the tumors, highlighting the safety of the PlasmaSure™ technology.

Patients expressed high tolerance towards the procedures, which were conducted without general anesthesia, further underscoring the user-friendly design of the treatment. CEO Ilan Uchitel expressed excitement about the breakthrough designation, emphasizing its importance in validating the clinical need for more effective, accessible solutions for NMIBC patients.

Future Implications of Breakthrough Designation

The FDA’s Breakthrough Device Designation not only signifies the agency's recognition of the PlasmaSure™ system's potential impact but also provides CAPS Medical with a pathway for priority review and improved communication with the FDA. This includes more flexible clinical study designs and potential eligibility for faster reimbursement pathways under CMS’s Transitional Coverage for Emerging Technologies. The ultimate goal is to establish PlasmaSure™ as the new standard of care in NMIBC and beyond.

Expanding Beyond NMIBC

Building on its success with NMIBC, CAPS Medical is looking to extend the application of the PlasmaSure™ technology to treat additional solid tumors, including lung, esophageal, gastric, and prostate cancers. Early data from pre-clinical studies show promise for these indications, indicating that the PlasmaSure™ platform could evolve into a multi-indication solution.

As part of its strategic growth, CAPS Medical is establishing a U.S. headquarters to facilitate closer collaboration with clinical partners, regulatory bodies, and payors in the U.S. market. This step is critical as the company prepares for pivotal trials and subsequent commercialization efforts.

In conclusion, CAPS Medical is on a transformative journey to redefine tumor ablation through its PlasmaSure™ system – a groundbreaking solution designed to enhance patient care while minimizing invasive procedures. The clinical community and patients alike will be eagerly watching as CAPS Medical moves towards implementing this innovative technology across cancer treatment landscapes.