Francis Medical Receives FDA 510(k) Clearance for Use of the Vanquish® Water Vapor System for Prostate Tissue Ablation in Patients with Intermediate Risk Prostate Cancer

Francis Medical, Inc., a privately-held medical device company developing the breakthrough Vanquish® Water Vapor Ablation System for the management of prostate cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the Vanquish System for prostate tissue ablation. FDA clearance was supported by positive 12-month follow-up data on the first 110 patients enrolled in the company’s ongoing VAPOR 2 clinical study. The clearance marks a critical milestone for the company and enables a commercial launch of the Vanquish System.

The Vanquish System is a transurethral, ultrasound and electromagnetically guided, thermal water vapor device used to convectively ablate cancerous prostate tissue. The VAPOR 2 study is a prospective, multicenter, single-arm study to treat 235 patients with intermediate-risk, localized prostate cancer across 26 U.S. clinical sites. Performed on an outpatient basis, initial treatments were completed in February 2025, and patients will continue to be followed to gather longer-term outcomes to support a premarket approval (PMA) submission for an expanded indication for the management of clinically localized prostate cancer.

Six-month biopsy data on the first 110 patients demonstrated elimination of targeted MRI visible intermediate risk (≥GGG2) disease in 91% of patients following a single Vanquish procedure. There were no device-related serious adverse events and low rates of urinary incontinence and erectile dysfunction, two common side effects in traditional prostate cancer treatments, such as surgery or radiation. Additionally, the Vanquish System demonstrated the ability to effectively treat cancerous lesions in all prostate locations, addressing a significant limitation of existing ablative options.

“Patients with intermediate risk prostate cancer currently weigh oncologic risk with quality of life in their treatment decision making,” said Dr. Samir Taneja, senior vice president of Northwell Health and a VAPOR 2 co-principal investigator. “It is exciting to see FDA clearance of this promising technology, with the early results showing that water vapor may provide an efficacious option for prostate cancer management with lower risk of side effects as compared to conventional therapies.”

Patient experience and satisfaction results were also extremely encouraging. Patients indicated minimal to no pain after the Vanquish procedure. At 12 months post procedure, 93% of patients were extremely satisfied or satisfied, and 94% believed that receiving the treatment was a wise decision.

“The patient satisfaction data further supports the exciting potential for Vanquish in the management of prostate cancer,” said Dr. Arvin George, director of Prostate Cancer Programs at the Brady Urological Institute, Johns Hopkins University, and a VAPOR 2 co-principal investigator. “Most patients experienced no pain, quickly resumed daily activities, and indicated high rates of satisfaction with their procedure and decision at 12 months.”

As the most common cancer among U.S. men, the American Cancer Society estimates one in eight American men will be diagnosed with prostate cancer. It is a serious disease often treated with therapies that cause complications, such as urinary incontinence and erectile dysfunction. The Francis Medical Vanquish System’s water vapor energy technology is a breakthrough therapy designed to use the energy stored in sterile water vapor to convectively transfer thermal energy to cancerous tissue, causing cell death. Through this process, damage to surrounding structures can be minimized or eliminated by respecting the prostate’s natural boundaries.

“FDA clearance allows us to offer an alternative to patients with localized prostate cancer that better balances oncologic and quality of life risks. Early VAPOR 2 study results validate the potential for water vapor technology to manage prostate cancer while addressing the long-term side effects typically experienced with traditional treatments,” said Mike Kujak, president and CEO of Francis Medical. “We will continue to follow the VAPOR 2 patients as we strive to fulfill our mission to be a first line therapy in patients with prostate cancer that is tough on cancer and gentle on patients.”

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 treat cancerous tissue via a transurethral procedure, potentially minimizing life-altering side effects. For more information on Francis Medical, visit www.francismedical.com