MINNEAPOLIS, March 5, 2026 /PRNewswire/ -- Francis Medical, Inc., a privately held medical device company, announced today the successful completion of the first commercial (non-clinical trial) procedures in Arizona using the Vanquish^® Water Vapor Ablation System for prostate tissue ablation.

The procedures were performed on patients diagnosed with localized prostate cancer by Dr. Rahul Mehan with East Valley Urology Center of Arizona, at the Verve Surgery Center in Mesa, Ariz. These procedures represent the first use of the Vanquish System in routine commercial practice in the state outside of a formal clinical study.

Vanquish 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 was supported by positive follow-up data on the first 110 patients enrolled in the company's ongoing VAPOR 2 pivotal study.

"Bringing Vanquish into our practice and being the first in Arizona outside of clinical trials to do so, reflects our forward-looking approach to procedural innovation, clinical excellence, and our commitment to continuously enhancing the patient experience," said Dr. Mehan. "We evaluate emerging technologies carefully to ensure they align with our clinical standards, safety, and patient-centered approach to deliver minimally invasive options supported by clinical evidence and responsible adoption."

In VAPOR 2 at 6-months, 91% of eligible patients showed elimination of targeted MRI visible, biopsy confirmed intermediate-risk disease (≥GGG2) 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. Patient-reported outcomes were also promising, indicating minimal to no pain following the procedure.

"These first commercial procedures in Arizona represent an important milestone in our controlled U.S. launch strategy," said Mike Kujak, President and CEO of Francis Medical. "Transitioning from clinical study experience to real-world urological practice underscores the level of dedication, preparation, and operational rigor that has defined our early launch phase. We are optimistic that the technology will deliver upon its early clinical promise and provide a minimally invasive alternative to men concerned by their prostate health."

At 12 months, VAPOR 2 demonstrated 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.

Additionally, the Vanquish System demonstrated the ability to effectively ablate target lesions in all prostate locations, addressing a significant limitation of existing options.

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 a compassionate belief and clinical data supporting that minimally invasive therapies 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 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.