Westborough Firm Seeks FDA Approval
PHOTO/COURTESY
Babs Soller, president and chief scientific officer of Reflectance Medical Inc. of Westborough.
A Westborough medical device startup hopes to use a $500,000 grant from the Massachusetts Life Sciences Center to get its non-invasive heart monitoring system approved by the FDA and commercialized within the next year.
Reflectance Medical Inc. is looking to commercialiaze a product called the CareGuide monitor, which was first developed by researchers at the University of Massachusetts Medical School in Worcester to warn doctors and physicians of patients that are at risk of cardiovascular failure.
The company was founded in 2007 and has since received more than $8 million from the U.S. military to develop the technology, which government officials hope could be used to treat soldiers in combat situations.
The latest grant from the Waltham-based Life Sciences Center will bring the company's product closer to not only government use, but use by doctors and hospitals as well. To help prepare for a market launch, the company expects to hire three or four more workers in the next year.
Early Warning Signs
One of the best ways to predict cardiovascular failure is to measure the amount of oxygen in a patient's tissues, and to track the patient's pH levels. Normally, this process takes time because a blood sample is usually required and has to be analyzed.
Reflectance's product, however, provides a non-invasive and continuous monitoring of those two vital signs, plus others, according to Babs Soller, president and chief scientific officer of the company.
Soller helped pioneer the technology when she was a professor at the medical school.
Military officials think the technology could be used specifically for soldiers that suffer from gunshot wounds to predict how severe their injuries are.
In a commercial setting, Soller said the product could be used to inform doctors when a therapy is needed and monitor how the therapy is working in real time.
The company has taken advantage of a number of grant programs from the state and federal government.
Specifically, it has received more than $8 million through the federal government's small business innovation research (SBIR) and small business technology transfer (STTR) programs. The SBIR program requires that a portion of federal grants be reserved for small businesses while the STTR program provides funding to bring technology from the academic lab setting to commercialization.
Reflectance received the $500,000 grant from the Massachusetts Life Sciences Center through the center's Small Business Matching Grant program, which provides funding to companies that have already received federal support.
Reflectance already has eight employees in Westborough, but during the next year Soller hopes to add a handful of additional staff. She hopes to get word this fall from the FDA about whether or not the technology can advance to market.
"What's really hard is this step, where you're taking great technology being developed in universities all across America and bringing it to market," Soller said. "It's really difficult to get to a point from where it works in the lab to it working in a commercial setting, but these programs help a lot with that."
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