Francis Medical Announces First Commercial Vanquish® Procedure on the East Coast for Prostate Tissue Ablation

MINNEAPOLIS, March 25, 2026 /PRNewswire/ -- Francis Medical, Inc., a privately held medical device company, announced today the successful completion of the first commercial (non-clinical study) procedure on the East Coast using the Vanquish® Water Vapor Ablation System, a minimally invasive technology designed to ablate targeted prostate tissue while potentially helping to preserve urinary and sexual function.

The procedure was performed by Dr. Robert Given with Urology of Virginia at the Chesapeake Regional Surgery Center in Virginia Beach. This procedure represents the first use of the Vanquish System in routine commercial practice on the East Coast, and in Virginia, outside of a formal clinical study. Dr. Given performed the procedure on a patient diagnosed with localized prostate cancer.

"Introducing Vanquish marks an important milestone for both our practice and patients across the East Coast," said Dr. Robert Given of Urology of Virginia. "This initial case demonstrates how seamlessly this technology can be integrated into clinical care, providing a minimally invasive option for targeted tissue ablation. As the first center on the East Coast to perform these procedures outside of a clinical study, we're excited to expand access to innovative solutions that prioritize both efficacy and preservation of quality of life to patients."

The Vanquish System is a transurethral, ultrasound, and electromagnetically guided thermotherapy device intended to ablate prostate tissue using high-energy sterile water vapor. The Vanquish System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in November 2025 and is supported by positive interim follow-up data in the company's ongoing VAPOR 2 pivotal study. The system represents a novel option for patients as traditional procedures often require surgery or radiation, which can damage surrounding structures important for sexual function and continence.

In the ongoing VAPOR 2 study, 91% of eligible patients showed negative biopsy of targeted prostate tissue at six months following a single Vanquish procedure. The procedure was also well-tolerated, with no device-related serious adverse events and low rates of urinary incontinence and erectile dysfunction whereas traditional procedures are typically associated with side effects that can dramatically impact a patient's quality of life. Patient-reported outcomes were also promising, indicating minimal to no pain following the procedure.

Recently presented data, from the VAPOR 2 pivotal study, at the European Association of Urology international scientific meeting in London reported that 93% of patients indicated that they were satisfied or extremely satisfied, and 94% said that they believed that receiving the treatment was a wise decision. Patients will continue to be followed to gather longer-term outcomes to support a pre-market approval (PMA) submission for an expanded indication for the management of clinically localized prostate cancer.

"We are proud to support Dr. Given and the team at Urology of Virginia as they introduce Vanquish into clinical practice at Chesapeake Regional Surgical Center," said Mike Kujak, CEO of Francis Medical. "These first commercial cases on the East Coast represent an important step in expanding access to our technology and reflect the growing demand for innovative, minimally invasive options. We are committed to partnering with leading physicians to bring differentiated solutions to patients and to advancing the adoption of focal therapy across the U.S."

Disclosure: The Vanquish® Water Vapor Ablation System has been cleared as a tool for the thermal ablation of targeted prostate tissue via a transurethral approach. The FDA has not evaluated the Vanquish System for the treatment of any disease, including prostate cancer, or evaluated the Vanquish System for any long-term prostate cancer treatment outcomes.

About Francis Medical

Francis Medical is committed to developing urological cancer treatments that are tough on cancer and gentle on patients, driven by compassionate belief and clinical data supporting minimally invasive therapies that safely and effectively treat cancerous tissue. The inventor, Michael Hoey, founded Francis Medical as a tribute to and legacy of his father, Francis Hoey, who endured prostate cancer treatments that had harsh implications on his everyday life before he died from the disease in 1991. Unfortunately, current prostate cancer treatments, which typically come with side effects like urinary incontinence and erectile dysfunction, are not much different than what Francis Hoey encountered. In contrast, water vapor technology applies the thermal energy stored in sterile water vapor to ablate targeted prostate tissue via a transurethral procedure, potentially minimizing life-altering side effects. For more information on Francis Medical, visit www.francismedical.com or call (763) 951-0370.

Investor Contacts

Michael Kujak, CEO, Francis Medical

mkujak@francismedical.com

612-910-9790

Brian Johnston, Gilmartin Group

brian@gilmartinir.com

Media Contact

Shelli Lissick, Bellmont Partners

shelli@bellmontpartners.com

651-276-6922

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SOURCE Francis Medical, Inc.

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