KitoTech Medical: Creating a device that could revolutionize wound care

Story by Clare LaFond
Photos by Conrado Tapado
UW Center for Commercialization

Closing deep wounds – whether from unintended cuts or surgical incisions – has traditionally meant stitching up the patient with a long line of sutures or very visible, protruding staples. While it can be an unsightly reality, it’s also a necessary step physicians must take to treat and heal deep wounds – a practice that can be scarring, painful and prone to infection.

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But what if doctors could replace those sutures and staples with a device that’s as easy to apply as a bandage and has the strength of sutures? What if this device also resulted in few infections and less scarring? It may sound futuristic, but it’s actually already here – and UW spin-out KitoTech Medical plans to take this new technology to market.

Led by UW researcher Marco Rolandi, assistant professor in the Department of Materials Science and Engineering, and Ron Berenson, a Seattle physician and serial entrepreneur, KitoTech Medical is on the road to revolutionizing wound care. Using suture replacements, the KitoTech team starts with a UW-developed, specially-engineered array of hundreds of tiny microstaples. This array is then put into a bandage which is placed over the wound – a KitoFAST microstaple bandage that is waterproof, breathable and flexible.

“This microstaple technology is painless to apply,” said Berenson, KitoTech’s President and CEO. The microstaples are similar to the tiny microneedles that have been developed from metals and polymers over the past several years, mainly as a way to deliver drugs through the skin. “But we’re doing something different,” Berenson explained. “We’re taking microstaples, putting them into a bandage, and applying them directly to the skin of a wound to close it.”

Rolandi, the lead researcher and scientific founder of KitoTech Medical, describes the microstaples as a novel design that should have stronger holding power than microneedles in closing the wound.

“We have now completed two studies with KitoFAST that have resulted in excellent wound closure,” Rolandi said, “with no evidence of inflammation — and with outstanding cosmetic results.”

It has long been recognized that optimal wound closure requires carefully bringing together the two opposing skin edges of the wound, a procedure known as eversion. Using traditional sutures and staples, it can be challenging to achieve optimal, consistent results since wound edges contract throughout the healing process, often resulting in inflammation and eventual scarring. Outcomes also may vary with the skill level of the doctor closing the wound.

In contrast, KitoFAST – a disposable device – is easy to use via the simple and reproducible procedure of placing the KitoFAST bandage over the wound, and it holds promise for more consistent outcomes.

“Our microstaples are smaller than staples and surgical needles attached to sutures,” Berenson said, “which means smaller holes made in the skin, less inflammation and no permanent puncture marks.”

KitoFAST also uses a larger number of microstaples to close wounds instead of using larger sutures, so less tension is created on each contact point with the skin.

By the end of this year, the KitoTech team plans to complete a limited number of human clinical studies in select surgical procedures, each involving 30 to 40 patients.

Berenson, a medical oncologist who founded biotechnology companies HemaQuest Pharmaceuticals, Xcyte Therapies, and CellPro, first began work with the KitoTech team in his role as a C4C Entrepreneur-in-Residence (EIR). As an EIR, he worked alongside Rolandi and his research team, providing them with real-world insights about the commercialization process and expertise in target markets, product development and fundraising strategies.

KitoTech Medical, which spun out of C4C’s New Ventures Facility business incubator late last year, has so far raised $500,000 and recently opened their second round of financing, which will total $1.5 million. Those funds will support completion of clinical studies, finalization of the manufacturing process, and formulation of a marketing plan.

“We have made significant progress in the development of our device over the last year,” Rolandi said, “and we are very excited about our upcoming clinical trials. This is an innovation that has the potential to revolutionize wound care and to positively impact patients around the world.”