Newswise — MINNEAPOLIS, July 19, 2023 /PRNewswire/ – 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, today 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 U.S. clinical sites. Dr. Arvin George from Johns Hopkins and Dr. Samir Taneja from NYU Langone are co-principal investigators on the study, and the first patient procedure was successfully completed by Dr. Naveen Kella of The Urology Place in San Antonio, Texas.
“I am excited to be participating in the VAPOR 2 study and it is a great privilege to treat the first patient,” said Dr. 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.”
As the second most common cancer in U.S. men, the American Cancer Society estimates one in eight American men will be diagnosed with prostate cancer during their lifetime. Prostate cancer is a serious disease often treated with therapies that cause complications, such as urinary incontinence and erectile dysfunction. 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 groundbreaking 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 an FDA submission for U.S. 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 groundbreaking technology into the hands of urologists and their patients.”
About Francis Medical:
Francis Medical is committed to developing urological cancer treatments that are tough on cancer and gentle on patients, with a compassionate belief that minimally invasive therapies can effectively treat cancerous tissue. The company’s foundation is a tribute to and legacy of the inventor’s father, Francis Hoey, who endured prostate cancer treatments that had harsh implications on his everyday living before the disease took his life in 1991. Unfortunately, current prostate cancer treatments are not much different from what Francis Hoey encountered, with the typical side effects including urinary incontinence and erectile dysfunction. In contrast, water vapor technology applies the thermal energy stored in sterile water vapor to cancerous tissue via a simple transurethral procedure, potentially minimizing life-altering side effects. For more information on Francis Medical, visit www.francismedical.com or call (763) 951-0370.