Coagulation Sciences LLC, a medical device startup engaged in product development at the MDI Biological Laboratory, has chosen Enercon Technologies Inc. of Gray to manufacture a desktop device that enables caregivers to quickly analyze the causes of blood-clotting disorders.
Enercon Technologies said in a news release the “multiple coagulation test system” reduces costs and risks associated with unnecessary blood transfusions — noting that because no fast and accurate means currently exist to determine the cause of bleeding, 40% or more of blood and blood product transfusions are later deemed to have been unnecessary.
The major markets for the devices are emergency rooms, trauma centers, operating rooms and rural medical centers. Coagulation Sciences expects to perform clinical studies in 2018 and begin manufacturing the device in 2019.
The company is one of four startups at the Maine Center for Biomedical Innovation on the campus of the MDI Biological Laboratory. The incubator, which supports the growth of the science and technology sector of Maine’s economy, was launched in response to the need for laboratory space, expertise and mentoring to help tech and biotech startups take their companies to the next level.
According to its website, the incubator launched in March 2017 and is funded through a $3 million state bond issue to promote the science and technology sector in Maine by facilitating innovation- and entrepreneurial-based learning and by nurturing emerging life science and technology companies. The 6,560-square-foot center doubled the lab’s training capacity.
“Coagulation Sciences’ progress is evidence of the value of an incubator that provides state-of-the-art laboratory facilities and expertise,” MDI Biological Laboratory President Kevin Strange said in the release. “The availability of incubator space on our campus will ultimately lead to the creation of new science and tech jobs, helping Maine transition to a 21st-century economy based on information and knowledge.”
About the manufacturing partners
Coagulation Sciences located its product development operations at the MDI Biological Laboratory after Michael Kagan, product development director, was unable to find suitable laboratory incubator space in the New England region. The arrangement provides Coagulation Sciences with access to scientific and business development resources that were not available elsewhere, Kagan said.
The founder and CEO of Coagulation Sciences, Dr. Sheldon Goldstein, is an internist and cardiac anesthesiologist who practices at Montefiore Medical Center in the Bronx. Goldstein, an expert in the management of bleeding patients, is testing the prototype in the company’s laboratory in New York, where it is based.
The company expects to enter into clinical trials at major medical centers in 2018, Kagan said.
Coagulation Sciences said it chose Enercon Technologies as its contract manufacturing partner because the company had extensive experience in the manufacture of medical devices, offered lower production costs by comparison with larger competitors and was located in the same state as the product development laboratory.
Coagulation Sciences also stated it is seeking a Maine manufacturer for the device’s disposable plastic cartridge.
If a Maine manufacturer cannot be identified, the company is considering other options in New England in addition to possibly establishing its own facility in Maine, Kagan said.
Plans call for expanding the product line to include medical devices for use in other coagulation-related disorders.
In 2016, Mainebiz reported on how Gray-based product design, development and device manufacturer Enercon Technologies is quietly making its mark on many high-tech products sold in Maine and throughout the world.
The company received approval in August 2016 from the town to expand its current 35,000-square-foot headquarters and manufacturing facility with another building that will be 69,000-plus square feet. The company also has 15,000 square feet of manufacturing in Auburn that it may integrate in Gray once the new facility is completed.