Y. Mark Hong, M.D., a key opinion leader (KOL) and world recognized urologist, suggests that if physicians aren’t offering or at least talking to their prostate cancer patients about Profound Medical’s (NASDAQ:PROF; TSX:PRN) TULSA-PRO medical device, they aren’t doing their job as a urologist with respect to informed consent.
Raymond James analyst Rahul Sarugaser, Ph.D., hosted a call with Dr. Hong to discuss TULSA for the treatment of localized prostate cancer.
In a research report, Dr. Sarugaser writes that Dr. Hong reiterated, multiple times that, given TULSA’s strong safety outcomes, it should be presented as an option to every patient as part of informed consent.
Dr. Hong said he has a list of patients deliberately wishing to remain on active surveillance until TULSA is covered by insurance. “Even with [the cost of TULSA] being a major ask, people are ‘literally’ out-the-door wanting this technology,” he said.
The American Medical Association has agreed to consider full CPT-1 reimbursement for TULSA when its CPT Editorial Panel meets in early May.
In Dr. Hong’s view, the cost-effectiveness of TULSA would be favorable because it is an outpatient surgery with no overnight stay; it reduces the number of complications from surgery; patients don’t have to come back every day for radiation treatment; and, importantly, it removes the necessity for active surveillance over 10-to-15 years.
Pointing to Profound’s CAPTAIN head-to-head study of TULSA, compared with radical prostatectomy, Dr. Hong said a positive outcome of non-inferiority to radical prostatectomy would not be surprising, particularly given the strength and durability of TULSA’s four-year TACT pivotal clinical trial data.
“If TULSA shows a non-inferior/superior safety profile, this should prove to amplify adoption through the median ‘meat-and-potatoes’ urologist,” he added.
Dr. Sarugaser said Dr. Hong was an early adopter of TULSA, and has executed one of the highest volumes of procedures in the U.S. to date. His own experience with TULSA is showing better outcomes than the TACT trial.
“We do not underestimate the importance of this, because, the final mile of adoption will come down to physicians’ own (positive) experiences with TULSA.,” Dr. Sarugaser said.
The procedure is proving to be a very popular part of Dr. Hong’s practice, and he is seeing colleagues referring family members to his clinic. In his view, the results of these procedures are “quite phenomenal,” and the learning curve will shorten for the average urologist if they are given the right support by Profound.
In addition, Dr. Hong highlighted that even a perfectly-done robotic surgery carries much more risk than any TULSA procedure, as “the range of things that can go wrong with TULSA are nowhere near the range of things than can go bad with surgery.”
Dr. Sarugaser rates Profound as a “strong buy” with a $17 price target. The stock closed at $9.40 on April 10.
