First Patient Treated in VAPOR 2 Pivotal Study for Water Vapor Ablation of Prostate Cancer

Maple Grove, MN (21 July 2023) — Francis Medical, Inc, a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, has announced the first patient has been treated in the company’s VAPOR 2 pivotal clinical study evaluating the safety and efficacy of its Vanquish minimally invasive water vapor ablation therapy for managing prostate cancer.

VAPOR 2 is a prospective, multicenter, single-arm study that will treat 235 patients with intermediate-risk, localized prostate cancer at up to 30 US clinical sites. Arvin George from Johns Hopkins (Baltimore, USA) and Samir Taneja from NYU Langone (New York, USA) are co-principal investigators on the study, and the first patient procedure was successfully completed by Naveen Kella of The Urology Place in San Antonio, USA.

“I am excited to be participating in the VAPOR 2 study and it is a great privilege to treat the first patient,” said Kella. “Currently, prostate cancer patients find themselves in the difficult position of balancing the oncological risks of the disease with the life-altering side effects that can often accompany traditional treatments. Water vapor therapy shows great promise to provide patients with another option to proactively manage their cancer risk while preserving quality of life.”

Francis Medical’s Vanquish water vapor technology applies the thermal energy stored in a few drops of sterile water to deliver targeted treatments to the cancerous tissue through a simple transurethral procedure. The therapy is designed to ablate cancer cells while protecting surrounding structures, lessening the likelihood of life-altering side effects common with other prostate cancer treatments.

“The first patient treated in the VAPOR 2 study is an important milestone for the company,” said Michael Kujak, Francis Medical president and chief executive officer. “We would like to thank our employees, investors, patients, and physician partners for bringing us to this stage. We are more confident than ever that this ground-breaking technology will ultimately become the first-line treatment of choice for men and their doctors.”

The company anticipates using the one-year follow-up data from the VAPOR 2 study in support of a US Food and Drug Administration submission for US market clearance. VAPOR 2 patients will be followed for a period of five years to gather longer-term cancer outcomes. Further information on the VAPOR 2 study can be found at clinicaltrials.gov (NCT05683691).

“The vision that started this company and continues to drive us is to create a better experience for the patient,” said Michael Hoey, Francis Medical founder and chief technology officer. “Water vapor is an ideal tool for accomplishing this goal. It is simple, natural, and gentle, but powerful. The first VAPOR 2 study treatment is an important milestone bringing us one step closer to getting this ground-breaking technology into the hands of urologists and their patients.”