Francis Medical, a Maple Grove-based medical device company, announced Tuesday that the U.S. Food and Drug Administration has authorized clearance of Vanquish, the company’s prostate cancer treatment technology that has been in development since Francis Medical was founded in 2018.

This means the company’s minimally invasive treatment, which uses the energy stored in water vapor and applies it to the prostate to ablate cancerous tissue, can now be made commercially available. 

A spin-out of NxThera, which was founded in 2008 and purchased by Boston Scientific in 2018, Francis Medical raised $25 million in Series A funding and has come a long way, having raised $160 million in total as of January.

The next steps following the FDA approval involve building a sales organization within Francis Medical in order to launch the technology, says president and CEO Mike Kujak. With a planned, limited release in early 2026—which is set to expand in the United States in the second half of the year—Kujak says the company aims to go overseas by 2027.

Samir Taneja, senior vice president of Northwell Health and a VAPOR 2 co-principal investigator, said in a press release, says early results show that “water vapor may provide an efficacious option for prostate cancer management with lower risk of side effects as compared to conventional therapies.”

“This is going to change the landscape of how prostate cancer is treated,” says Kujak. 

Although Kujak noted it was too early to disclose revenue projections, the company has initiated a sales team by hiring a head of commercial marketing, a vice president of sales and marketing, four sales directors, and two reimbursement personnel.

The FDA approval was substantiated by 12-month follow-up data collected by the company on the first 110 of the 235 patients partaking in an ongoing five-year VAPOR 2 clinical study, which assesses the transurethral, ultrasound, and electromagnetically guided treatment. One year after the procedure, 93% of patients reported satisfaction.

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