[Bellefonte, PA] — Actuated Medical, Inc. is pleased to announce that it has been selected as a Contract Research Organization (CRO) under the National Institutes of Health (NIH) Blueprint MedTech (BPMT) initiative with a potential contract value of $35M over 5 years.
100 million people in the U.S. suffer from neurological diseases like Parkinson’s and Epilepsy. The problem is growing. The U.S. expends $800 billion annually on the treatment of neurological conditions. Recognizing the need for better diagnosis and treatments, the NIH has launched the BPMT program. The BMPT initiative assists innovators, facilitating moving their cutting-edge medical device developments toward Regulatory Approvals and commercialization, with support and resources that small companies and university researchers often lack.
Actuated Medical has been selected to offer extensive support to BPMT awardees that are working with the MedTech Hubs of CIMIT in Boston and NeuroTech Harbor in the Baltimore/DC area. This exciting partnership reinforces Actuated Medical’s commitment to advancing healthcare through groundbreaking research, development, and manufacturing.
“We are thrilled to have been selected as a CRO for the BPMT initiative,” said Maureen L. Mulvihill, Actuated Medical President & CEO. “This program will allow us to support entrepreneurial researchers moving their groundbreaking devices toward first-in-man studies to transform treatment of neurological conditions like stroke, Epilepsy, and Parkinson’s Disease.“
The Actuated Medical BPMT contract provides comprehensive support to multiple BPMT grantees. This assistance encompasses the completion of biocompatibility studies, in vivo preclinical testing with adherence to good laboratory practice (GLP) guidelines, and sterilization and shelf-life testing crucial for advancing medical device development. Actuated Medical’s commitment extends to supporting research protocol development, facilitating in-house staff training, and conducting all necessary tests vital for biocompatibility, sterilization, and preclinical safety studies. These findings will serve as the cornerstone for informing regulatory filings, including Investigational Device Exemptions (IDEs), and eventual marketing approval by the US Food and Drug Administration (FDA).
This project has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N95023D00022.
About NIH Blueprint for Neuroscience Research:
https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech/resources
About Center for Innovative NeuroTech Advancement (CINTA):
https://www.cimit.org/web/center-for-innovative-neurotech-advancement
About and NeuroTech Harbor (NTH):
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