The U.S. Food and Drug Administration is expediting the review process for Francis Medical’s prostate cancer therapy technology, a process that happens when a new treatment could be more effective than current standards of care.
The FDA has granted breakthrough device designation for the Maple Grove-based startup’s Vanquish minimally invasive water vapor ablation therapy, a treatment for prostate cancer that doesn’t come with the debilitating side effects of current therapies like radiation. Francis Medical is currently undergoing a study to test the treatment, and a couple men have already been successful treated in the study.
The designation aims to give patients more timely access to medical devices by speeding up development, assessment and review.
“The goal of Francis Medical is to become the first line therapy of choice for patients with prostate cancer,” Michael Kujak, Francis Medical president and CEO, said in an announcement. “We are excited that the FDA has recognized the potential of our technology to be a breakthrough for patients who today face the difficult choice between addressing their cancer and avoiding the debilitating morbidities often associated with current standards of care.”
In total, more than 40 men have been treated using the technology through early feasibility studies, the current clinical study and international work, according to Business Journal reporting from last week.
The technology works by heating sterile water, injecting it into a needle, putting the needle into the urethra to reach the prostate and creating a small lesion that ablates – or removes – the cancerous cells. It can be completed in under an hour.
The treatment also avoids things like incontinence, impotence or difficulties with bowel control that can be common with other treatments.
The company is currently initiating its Vapor 2 study to support an FDA submission for U.S. market clearance. The study will treat 235 patients across up to 30 centers, three of which are located in Minnesota.
