One of the scariest parts of surgery is also one of the most mundane. After the hard work is done and the patient is in recovery, there is still a risk of surgical site infection (SSI). In fact, three out of 20 patients undergoing high-risk procedures such as abdominal and colorectal surgeries will develop an infection, resulting in an increased hospital stay, readmission, and potentially, a higher risk of death.
That could all change thanks to the continued work of Jon Coe, co-founder and CEO of Prescient Surgical, a Fogarty graduate company that has a technology proven to greatly reduce the incidence of SSIs. CleanCision combines wound protection and irrigation in an intuitive and easy-to-use retraction system that deploys quickly and immediately begins to clear harmful bacteria that may invade the incision.
New studies elicit attention
Previously the company had completed eight studies that demonstrated CleanCision reduced SSIs by 80%. Its most recent research was even more stunning, showing a 91% reduction in SSIs compared with the current standard of care.
Now, another recent study is driving a surge of interest by showing that CleanCision’s infection-fighting technology is applicable to even higher-risk surgical procedures. In the study, CleanCision was used in a urologic oncology procedure for bladder cancer, radical cystectomy with urinary diversion. Once the surgeon removes the bladder, they need to construct a new bladder using a procedure called neobladder reconstruction. During this complex vascular surgery, the risk of surgical-site contamination is high.
A urological oncologist at the City of Hope, an NCI-designed Cancer Center in Duarte, California, was determined to find a way to use CleanCision during this procedure. “He loved the idea from the beginning – was just remarkably enthusiastic,” Jon recalls. “He was telling me how amazing this is, and then he realized he could conduct a study.” The result, which was recently published in the journal, Urology, showed not only a confirmatory reduction in SSI, but also reduced bloodstream and urinary-tract infections (UTI’s).
That’s when the lightbulb went on for Jon. “Those were fantastic results because the top three hospital-acquired infections are typically central line-associated bloodstream infections (CLABSIs), UTIs, and SSIs; they battle for which is number one each year,” he says. “Having that study published sparked interest across the urological oncology community.”
Currently they are waiting for the results of the Cleveland Clinic’s randomized controlled trial (RCT) which should wrap up in late 2022 or early 2023. “For us that will be the definitive proof,” Jon says. “Although we have a trove of evidence to date, people are always going to look to the RCT as the gold standard.”
An exciting future ahead
Recently the product has been purchased and adopted in several new hospitals, which is no small feat given the administrative hurdles that are entailed. But each sale has been followed by repeat purchases from the same account, resulting in recurring revenue, Jon explains. “Once that switch flips and they realize the benefits of using CleanCision, they’re never going to stop.”
In the meantime Prescient continues to forge ahead and Jon remains optimistic. “The thesis when we started the company was to identify an unmet need, build a great product, get our regulatory clearances, and then prove clinically that it works. We’ve done that and we’re profitable so now we’re just supporting the business while we look for the right partner to help accelerate our growth.”