Prescient CleanCision

Prescient’s CleanCision Helps Prevent Surgical Site Infections With Revolutionary Active Cleansing Technology

Prescient’s CleanCision has been shown to reduce Surgical Site Infection risk by 61 percent.

Despite efforts to curb the crisis of surgical site infections (SSI) — particularly common in high-risk abdominal and colorectal surgeries — three out of 20 patients undergoing these procedures will develop an infection, resulting in an increased hospital stay, readmission, and potentially, a higher risk of death*. Prescient Surgical, a graduate of the Fogarty Institute that stemmed from the Stanford Biodesign program, has been working with surgeons and hospitals to achieve a zero rate of infection with a groundbreaking new device.

CleanCision, the first in a new category of irrigating wound protection devices, received FDA 510(k) clearance in late 2017 and is now commercially available in the U.S. The device, which can be used on minimally-invasive and open procedures, is appealing because it seamlessly integrates into current care protocols.

CleanCision combines wound protection and irrigation into an intuitive and easy-to-use retraction system that deploys quickly, immediately beginning to clear harmful bacteria that may invade the incision during surgery.

“Our goal is to diminish the possibility of contamination in high-risk surgeries,” said Jon Coe, co-founder and CEO of Prescient.

The analogy he shares compares these surgeries to the Trans-Pacific Pipeline, where the pipes go through a pristine environment; if one were to be cut, terrible pollution would result from the oil spilling over the land. “Surgeons are actively cutting into these contaminated environments during high-risk procedures like colon surgery. CleanCision offers technology that can keep contamination at bay in these situations,” Jon explains.

The company is focusing its efforts on the top colorectal hospitals in the country, supporting the education of physicians and hospital staff, while continuing to generate clinical evidence on CleanCision’s effectiveness in preventing SSI.

A solution to address the intractable issue

While hospitals have been making concerted efforts to curb the rate of infection, the tools and technologies available have not kept pace.

Besides the hazards to patients, hospitals are incurring high costs, spending $10B annually in the U.S. alone treating SSI*. And anecdotally, SSI issues can damage their reputation, leaving hospitals open to criticism from patient safety advocates.

The problem continues to grow, and hospitals remain vulnerable, despite penalties from the Centers for Medicare and Medicaid Services (CMS) that were initiated five years ago. Healthcare facilities continue to struggle to control infection rates, and even if they have improved, there aren’t any guarantees for patients.

Forward-thinking local hospitals like Stanford and UCSF, are taking advantage of this innovative technology and validating the unique value proposition that CleanCision offers. With the topical therapy delivered by CleanCision, surgeons have expressed confidence closing their incisions, and patients are spending less time at the hospital.

“Our affiliation with universities like Stanford and UCFS are important, as their reputation as strong research institutions underscores this new technology as one that will improve patient care,” Jon says. “And we are also particularly proud that our device is being implemented where we initially devised CleanCision.”

CleanCision has also benefited from validation by several publications, including the World Journal of Surgery, which have published news of its success at reducing contamination rates. Several more pieces are planned that share the methodology behind the device’s 61 percent reduction in SSI, along with several economic analyses supporting the value of the device.

The company is currently raising Series B financing to accelerate CleanCision’s early success and expand its customer base across the U.S. and eventually in Europe, where it anticipates receiving a CE mark in early summer. They are also focused on finding commercial partners to efficiently expand its market access.

Giving back to the medtech community

The Prescient team has been keen to give back to the community even as they focus on bringing the device to market. For example, Jon has participated in several educational workshops at the Institute, and relishes talking to current companies-in-residence to share his experiences and path to market. He is also a mentor of the Ferolyn Fellows, taking Julia Fox under his wing during the first year and Bronwyn Harris the following year.

“I had the good fortune to benefit from several mentors who supported me and had a significant influence on the early formation of our startup. Ferolyn was the crucial ingredient in our early success, and I am deeply honored to now have the opportunity to help the next generation of innovators.”

*Source: Prescient Surgical

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