Coagulation Sciences LLC, a medical device startup that is being incubated at the MDI Biological Laboratory in Bar Harbor, Maine, has announced that it has selected Enercon Technologies of Gray, Maine, to be its contract manufacturing partner for its Multiple Coagulation Test SystemTM (MCTS).
The MCTS TM is a desktop device that enables caregivers to quickly analyze the causes of blood clotting disorders at the point of care. The device reduces the costs and risks associated with unnecessary blood transfusions. Because no fast and accurate means exists to determine the cause of bleeding, 40 percent or more of blood and blood product transfusions are later deemed to have been unnecessary.
The major markets for the MCTS TM 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 being incubated 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.
“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, Ph.D., said. “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.”
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, who is 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 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 at the MDI Biological Laboratory. “It is a good match,” Kagan said.
The company is also seeking a Maine manufacturer for the device’s disposable cartridge. The manufacture of the cartridge in Maine would further benefit the Maine economy, Kagan noted. 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.
About the MDI Biological Laboratory
Our scientists are pioneering new approaches to regenerative medicine focused on drugs that activate our natural ability to heal, and that slow age-related degenerative changes. Our unique approach has identified new drugs with the potential to treat major diseases, demonstrating that regeneration could be as simple as taking a pill. As innovators and entrepreneurs, we also teach what we know. Our Maine Center for Biomedical Innovation prepares students for 21st century careers and equips entrepreneurs with the skills and resources to turn great ideas into successful products. For more information, please visit mdibl.org.
About Coagulation Sciences LLC
Coagulation Sciences LLC is a blood testing innovator that seeks to help blood banks and hospitals to significantly decrease blood transfusions. Unlike other coagulation analyzers, Coagulation Sciences’ analytical instruments determine whether a coagulation disorder is truly present and, if so, what is the cause of it. The result is that the Multiple Coagulation Test System TM more rapidly allows doctors to arrest bleeding, improve patient safety and reduce health care costs. For more information, please visit www.coagulationsciences.com.
About Enercon Technologies
Enercon Technologies provides a full range of services, including electronics product development, prototyping, volume manufacturing/assembly, distribution, inventory management and service depot support. At its Design + Build Center, located just outside of Portland, Maine, Enercon provides seamless coordination between engineering and production operations, helping customers streamline the product development cycle, reducing time-to-market and total development costs. For more information, please visit www.enercontechnologies.com.
The full article can be found here:
https://mdibl.org/press-release/coagulation-sciences-selects-enercon-as-its-contract-manufacturer/