Like most companies, Francis Medical is facing several unique challenges brought on by the coronavirus pandemic. However, unlike many companies facing the prospect of lost revenues, the real enemy of a pre-revenue startup company, like Francis Medical, is lost time. “Every day of delay to our timeline could mean one day later to market,” says Francis Medical CEO, Mike Kujak. He adds, “It is imperative to our investors, employees, and the millions of men in need of this therapy, that we continue to make as much progress as possible during these challenging times.”
Wrapped Up the Panama Study, Ready for US Clinical Trials
Celebrating successful patient treatments in Panama City: Dr Gustavo Espino and his Panamanian clinical team, Dr Chris Dixon, Dr Randy Beahrs, and the Francis Medical team.
Of particular challenge to Francis Medical is that when the pandemic hit, we were in the initial stages of kicking off our US feasibility study. This study was on the heels of finishing, in early March, the last of a series of 14 patients successfully treated in Panama. The Panama study tested our unique water vapor ablation technology for the treatment of prostate cancer and was designed to mimic the hemi-ablation procedure planned for the US study. “Our results in Panama were extremely encouraging and we are all very excited to get the US study going,” says Francis Medical founder and Chief Technology Officer, Michael Hoey.
Moratorium on Elective Surgeries Delays Clinical Trials
Unfortunately, enrollment in the US trial has been delayed due to the nation-wide moratorium on elective surgeries. Mike Kujak points out that, “until the hold on elective surgeries is lifted, we are working to make sure the foundation is laid for successful patient enrollment when that time comes.” In the meantime, our clinical team and US investigators are using video conferencing technology to conduct clinical site initiations and to identify possible patient candidates, so that once elective surgeries are possible, trial enrollment can begin. The study will treat 15 patients at up to 5 clinical sites across the US. We now expect the first patient to be treated in June or July, but, of course due to the virus, the actual date is difficult to pinpoint.
Equally important is the continued progress on our next generation device. We’re currently developing the next version of the device that will be used in the US Pivotal study scheduled to begin early 2022. “The next generation device will have a number of new features designed to enhance ease of use for the urologist. These features will be key in expanding utilization of our device in the broader urology community,” states Michael Hoey.
End Game Never Changes: Progress Continues in the New Normal
Although we’re discovering that product development can be especially difficult in the age of COVID-19, we’re rising to the challenge. Through countless video conferences, basement R&D labs, and a skeleton crew at the home office we have managed to adjust to the “new normal.” Kujak points out that his team is making the best of a bad situation, “I am very proud of the efforts of our team. They are really making remarkable progress given the situation. I am as confident as ever in our ability to bring this important technology across the finish line.”
Michael Hoey shares Kujak’s confidence and is quick to point out, “Francis Medical is named after my father who suffered and passed away from the horrible effects of prostate cancer. The end game for us will never change. Together we share the vision of bringing this product to market around the world to make a real difference in the lives of millions of men suffering from prostate cancer.”