Francis Medical has received FDA clearance for its Vanquish water vapor ablation system for prostate tissue ablation.
Maple Grove, Minnesota–based Francis Medical, a privately-held company, announced the 510(k) clearance on Dec. 2, describing it as a critical milestone that enables the commercial launch of the system as a prostate cancer treatment option. It’s the latest good news for the company, which raised $80 million in an oversubscribed Series C in January 2025.
The Vanquish system is a transurethral, ultrasound and electromagnetically guided, thermal water vapor device. It can convectively ablate cancerous prostate tissue
Min-Vasive Medtech: Download our free 72-page special report featuring interviews with minimally invasive device development experts and engineers at major OEMs and groundbreaking startups
The FDA clearance came after the company reported positive 12-month follow-up data on the first 110 patients enrolled in the ongoing VAPOR 2 clinical study. Overall, VAPOR 2 is a prospective, multicenter, single-arm study to treat 235 patients with intermediate-risk, localized prostate cancer across 26 U.S. clinical sites, with initial treatments completed in February 2025.
Six-month biopsy data from 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, which can be side effects of traditional surgical or radiation treatments.
In addition, the Vanquish System demonstrated the ability to effectively treat cancerous lesions in all prostate locations, addressing a significant limitation of existing ablative options, according to Francis Medical.
“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.”
Patients reported 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.”
Said Francis Medical CEO Mike Kujak: “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. 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.”
Read more at Medical Design & Outsourcing: Francis Medical’s Vanquish system offers new features for prostate cancer ablation
