Boston-based startup Sano LLC seeks $1 million in seed funding to commercialize its chronic wound diagnostic in 2015. The recent winner of M2D2 aims to bring the diagnostic to market at a price point as low as a home pregnancy test.
While Woundchek has a CE Mark, American physicians are left with a pretty basic tool kit for wound treatment: sniffing for foul odor, looking at the color and how much liquid the wound is producing and considering the amount of granulation in the tissue. Sano LLC CEO Paul Hayre said Sano wants to “bring in a little bit of science to the art of wound care.”
These more subjective measures will likely continue to help physicians determine treatment on a first pass, and a diagnostic would help determine (or reroute) treatment for persistent wounds.
Sano’s bedside diagnostic measures the amount of MMPs, a naturally occurring enzyme in wound healing. Hayre said the body secretes a high concentration of MMPs about three days after a wound is created. They should digest and “clean the slate” so around day five or six the wound can build a matrix over which cells migrate to heal the wound, he said.
But, in more than 30 percent of wounds, this concentration remains high, and the wound can’t heal.
“These enzymes are constantly destroying that process,” he said.
The clinician would swab the wound, then insert the swab into the company’s device and proprietary cherry-pink liquid and shake it up. The device offers a color metric read-out. The higher the concentration of MMPs, the darker the color.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Allowing doctors to offer more accurate treatment would cut some cost from care. But making a diagnostic intended to be used throughout the treatment process — perhaps several times per patient, Hayre said the company wants to shoot for a point-of-care price on par with a home pregnancy test. That way, there’s no reason clinicians wouldn’t use the test multiple times to monitor the wound’s progress and adjust treatment, he said.
“We need to make money, of course. But at the same time, if a diagnostic is priced too high it won’t find its way into a cycle of care today,” Hayre said.
The company has a prototype in hand and will work on human trials during the next three to five months. The company was built with the exit strategy in mind — creating a diagnostic after interviewing wound care strategics’ M&A teams, Hayre said. He said the startup is in talks with at least four such strategics about licensing or partnership.
Though Hayre said all the company’s eggs are currently in the wound-care basket, the MMP technology could provide a platform for the company to reach into cancer and other disease diagnostics, and even equine medicine.
If all goes according to plan, the company would take the 510(k) de novo pathway, aiming for commercialization of this product by Q2 or Q3 in 2015.
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