Francis Medical is heating up with a 510(k) clearance from the FDA for its water vapor ablation therapy aimed at cancers of the prostate, kidneys and bladder.
The regulatory go-ahead for its Vanquish system was buoyed by a follow-up clinical study that involved 110 patients, the company said in a Dec. 2 press release.
Vanquish wields water vapor to overcome some of the limitations of traditional thermal ablation. It applies high pressure in 10-second bursts through a catheter that displaces the interstitial fluid surrounding tumor cells. When the vapor condenses back to liquid water, its heat is transferred directly into the cells’ membranes—causing cell death more evenly across the lesion compared to the delivery of conductive heat, which cools as it moves across the tissue.
During clinical trials, the Vanquish System also showed it was able to effectively treat cancerous lesions in all prostate locations, addressing a significant limitation of existing ablative options, according to the company.
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“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,” Mike Kujak, Francis Medical’s president and CEO, said in a statement. “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.”
The trial’s participants reported minimal to no pain after undergoing the Vanquish procedure. In follow-ups a year later, 93% said they were extremely satisfied or satisfied, and 94% believed 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 the study’s co-principal investigator, Arvin George, M.D., director of prostate cancer programs at the Brady Urological Institute of Johns Hopkins University. “Most patients experienced no pain, quickly resumed daily activities, and indicated high rates of satisfaction with their procedure and decision at 12 months.”
Since 2021, St. Francis has hauled in a total of $135 million in venture capital funding to develop the system. Last January, the company brought in $80 million in series C money.
