Francis Medical Achieves FDA Clearance for Innovative Prostate Cancer Treatment with Vanquish® System

In a groundbreaking development for prostate cancer treatment, Francis Medical, Inc., a private medical device company, has announced that it has received FDA 510(k) clearance for its Vanquish® Water Vapor Ablation System. This innovative technology is designed specifically for the ablation of prostate tissue in patients diagnosed with intermediate-risk prostate cancer. The FDA's endorsement comes after promising data was gathered from the ongoing VAPOR 2 clinical study showing positive 12-month follow-up results on the initial 110 enrolled patients.

The Vanquish® System employs an advanced transurethral approach, utilizing ultrasound and electromagnetic guidance, enabling precise thermal treatment through the application of water vapor. This non-invasive technique not only minimizes damage to surrounding tissue but also aims to enhance patient outcomes by reducing common side effects associated with traditional treatments like surgery or radiation therapy.

Significance of the FDA Clearance

Achieving FDA clearance represents a pivotal moment for Francis Medical as it opens doors to commercial launch and wider availability of the Vanquish® System. The VAPOR 2 study has been carried out across 26 clinical sites in the U.S., involving a diverse group of 235 patients suffering from localized prostate cancer. Initial treatments began in February 2025, with ongoing follow-ups aimed at providing further insights to support future premarket approval applications for an expanded indication in localized prostate cancer management.

One of the most remarkable findings from the VAPOR 2 study was that 91% of the first 110 patients achieved the elimination of targeted MRI-visible intermediate-risk disease after their first Vanquish treatment. Additionally, the study reported no severe adverse events linked to the device, alongside significantly low instances of urinary incontinence and erectile dysfunction—two prevalent complications in traditional cancer therapies.

Patient-Centric Approach and Promising Results

Dr. Samir Taneja, a key investigator involved in the VAPOR 2 study, emphasized the importance of considering both oncologic risks and quality of life when making treatment decisions for prostate cancer. The early results suggest that water vapor technology not only provides effective treatment options but does so with significantly reduced side effects compared to conventional methods.

Patient experiences post-procedure have also been overwhelmingly positive. Many of the participants reported minimal to no pain, with 93% expressing high levels of satisfaction with their decision to pursue the Vanquish treatment. Furthermore, 94% of patients felt that receiving the treatment was a prudent choice—verifying the therapy's strong acceptance and perceived value.

A Solution for the Common Prostate Cancer Challenge

Prostate cancer remains a pressing health issue, with the American Cancer Society estimating that one in eight U.S. men will face this diagnosis. Traditional treatments often come with adverse side effects such as urinary incontinence and erectile dysfunction, which can drastically affect a patient's quality of life. The Vanquish System’s innovative use of thermal energy from sterile water vapor aims to reduce damage to nearby structures while effectively targeting cancerous cells.

Mike Kujak, President and CEO of Francis Medical, stated that this FDA approval paves the way for delivering a treatment option that better balances oncological efficacy with quality of life. The promising data from the VAPOR 2 study further validates the Vanquish System's potential as a critical first-line therapy for patients grappling with this challenging cancer type.

About Francis Medical

Founded with a mission to pioneer treatments for urological cancers that are effective yet gentle on patients, Francis Medical was established by Michael Hoey. The company aims to revolutionize prostate cancer care through minimally invasive therapies supported by robust clinical evidence. The establishment of Francis Medical serves as a lasting legacy honoring Michael’s father, Francis Hoey, whose struggles with prostate cancer opened the door to exploring better treatment options. For further details about the Vanquish® Water Vapor Ablation System and Francis Medical's mission, interested parties can visit Francis Medical's website or reach out via their contact number.

As Francis Medical embarks on this new chapter with the clinical launch of the Vanquish System, it sets a goal to change the landscape of prostate cancer treatment, providing options that are tough on cancer while being considerate of patient well-being.