The National Institutes of Health has awarded West Lafayette-based Rescue Biomedical a $2.82 million Fast-Track Small Business Innovation Research grant. The company, led by researchers at Purdue University, will use the funding to develop a technology to detect when a person is overdosing on opioids and deliver naloxone in response.
The technology includes a subcutaneous device that automatically delivers naloxone, a drug that rapidly reverses an opioid overdose.
Rescue Biomedical Hugh Lee, associate professor at the Weldon School of Biomedical Engineering and director of the Center for Implantable Devices at Purdue University, said the company will again target patients with opioid use disorder (OUD) who are at high risk of overdosing. said it is planning to
“Recently treated OUD patients are at increased risk of accidentally overdosing again because of their reduced tolerance,” Lee said in a statement. “Our device provides closed-loop drug delivery.” A system that automatically detects when someone is overdosing and immediately delivers life-saving naloxone to prevent long-term neurological damage and death.”
The four-year grant was given a “Fast Track” designation. This will allow companies to submit applications for both Phase I and Phase II of his SBIR grants to minimize the funding gap between phases.
Purdue said Rescue Biomedical would need regulatory approval at the end of the traditional Phase I period to proceed with Phase II, but no additional scientific review would be required.
Lee said the company aims to achieve certain milestones during the grant period.
“The goal of Phase I is to better understand customer needs and identify a regulatory pathway for approval from the U.S. Food and Drug Administration,” he said. “Phase II aims to conduct more usability evaluations and demonstrate functionality in preparation for regulatory approval. We need to raise additional funding to conduct clinical trials for approval.”
The SBIR program, along with the Small Business Technology Transfer Program, narrowly avoided expiring after Congress reauthorized the program for another three years in late September.
Lee said these kinds of grants are very important for small businesses like his.
“They give us a substantive, non-dilutive starting point to further develop our ideas and bring them to market,” Lee said. “Having passed rigorous review by the Federal Board of Review gives us greater visibility and credibility to other potential investors and stakeholders. We are working to solve real problems, and NIH’s SBIR program makes that possible.”
Purdue University researchers Craig Gogen and Leslie A. Geddes Associate Professor of Biomedical Engineering. Chi Hwan Lee, Leslie A. Geddes Associate Professor of Biomedical Engineering, Associate Professor of Mechanical Engineering. Jacqueline Linnes, Marta E. Gross Associate Professor of Biomedical Engineering, is also part of her Rescue Biomedical team.
The company also works with the MED Institute of West Lafayette, and Ph.D. Matthew Aalsma and Allyson Dir, Indiana University School of Medicine.
