Imagine a prostate cancer treatment that’s as effective as traditional methods but without the life-altering side effects. That’s the promise of Francis Medical’s groundbreaking Vanquish® Water Vapor System, which has just received FDA 510(k) clearance for treating intermediate-risk prostate cancer. This is a game-changer for the millions of men facing this diagnosis, offering a minimally invasive option that prioritizes both cancer control and quality of life. But here’s where it gets even more exciting: early results from the VAPOR 2 clinical study show that this innovative technology eliminates targeted cancerous tissue in 91% of patients after just one procedure, with minimal pain and remarkably low rates of urinary incontinence and erectile dysfunction—side effects that often accompany surgery or radiation. And this is the part most people miss: the Vanquish System can effectively treat cancerous lesions in all areas of the prostate, addressing a major limitation of current ablative treatments.
Francis Medical, a privately-held medical device company based in Minneapolis, announced this milestone on December 2, 2025. The FDA clearance was supported by 12-month follow-up data from the first 110 patients in the VAPOR 2 study, a prospective, multicenter trial treating 235 patients with intermediate-risk, localized prostate cancer across 26 U.S. sites. Initial treatments were completed in February 2025, and long-term follow-up will continue to support a premarket approval (PMA) submission for an expanded indication.
The Vanquish System works by delivering thermal energy via sterile water vapor, precisely targeting and destroying cancerous tissue while respecting the prostate’s natural boundaries. This approach minimizes damage to surrounding structures, a stark contrast to traditional treatments that often leave patients grappling with long-term complications. Six-month biopsy data revealed that 91% of patients had no detectable intermediate-risk disease (≥GGG2) after a single procedure. Equally impressive, 93% of patients reported high satisfaction at 12 months, with 94% believing the treatment was a wise decision.
“This technology represents a significant step forward in prostate cancer care,” said Dr. Samir Taneja, senior vice president of Northwell Health and co-principal investigator of the VAPOR 2 study. “For patients weighing the risks of treatment against their quality of life, water vapor ablation offers a compelling alternative with fewer side effects compared to conventional therapies.”
Dr. Arvin George, director of Prostate Cancer Programs at Johns Hopkins University’s Brady Urological Institute and another VAPOR 2 co-principal investigator, added, “The patient experience has been remarkably positive. Most reported little to no pain, resumed daily activities quickly, and expressed high satisfaction with their decision a year later.”
Prostate cancer is the most common cancer among U.S. men, with the American Cancer Society estimating that one in eight men will be diagnosed in their lifetime. Traditional treatments, while effective, often come with debilitating side effects that impact daily life. Francis Medical’s water vapor technology aims to change this narrative by offering a therapy that’s tough on cancer but gentle on patients.
“FDA clearance allows us to bring a much-needed alternative to patients with localized prostate cancer,” said Mike Kujak, president and CEO of Francis Medical. “The early VAPOR 2 results validate our belief that water vapor technology can effectively manage prostate cancer while minimizing the long-term side effects associated with traditional treatments. We’re committed to making Vanquish a first-line therapy that prioritizes both cancer control and patient well-being.”
The story behind Francis Medical adds a deeply personal layer to this innovation. Founder Michael Hoey created the company in honor of his father, Francis Hoey, who suffered through harsh prostate cancer treatments before passing away in 1991. Decades later, many treatments still carry similar side effects, but water vapor technology offers hope for a gentler approach.
But here’s the controversial part: Will this breakthrough technology disrupt the status quo of prostate cancer treatment? Some may argue that traditional methods, despite their side effects, remain the gold standard. Others will champion Vanquish as a long-overdue advancement. What do you think? Is water vapor ablation the future of prostate cancer care, or is it too early to tell?
For more information on Francis Medical and the Vanquish System, visit www.francismedical.com or call (763) 951-0370.
Call to Action:
Are you or a loved one facing prostate cancer? Learn more about how the Vanquish System could offer a new path forward. Visit Francis Medical’s website today to explore this innovative treatment option and join the conversation about the future of prostate cancer care.