West Lafayette, Indiana received a Fast-Track Small Business Innovation Research, or SBIR, grant from the NIH. The company develops technology that detects when a person is overdosing on an opioid and delivers naloxone to reverse the action.
The minimally invasive, subcutaneous device presents a closed-loop drug delivery system. Hyowon “Hugh” Lee, Rescue Biomedical CEO, said the company seeks to partner with recovery clinics and clinicians. This way, they can identify and work with opioid use disorder (OUD) patients at high risk of overdosing again.
“OUD patients who recently undergo treatment are at a higher risk of accidentally overdosing again due to their lowered tolerance,” said Lee, a Purdue University associate professor from the Weldon School of Biomedical Engineering, director of the Center for Implantable Devices at Purdue, and Purdue Faculty Champion in Mental Health and Substance Misuse. “Our device is a closed-loop drug delivery system that automatically detects when someone is overdosing and immediately provides life-saving naloxone to prevent long-term neurological damage or death.”
The four-year, $2.82 million grant is an expedited award. Rescue said it requires administrative approval at the end of a traditional Phase I period. This allows it to continue to Phase II with no required additional scientific review.
How rescue plans to use the grant
Lee laid out specific milestones penciled in throughout the grant’s lifetime. He noted that the grant offers visibility and credibility to potential investors and stakeholders.
“In Phase I, our goal is to better understand customer needs and identify a regulatory pathway for approval from the FDA,” said Lee. “In Phase II, we aim to perform more usability evaluations and demonstrate functionality as we move toward regulatory approval.
“After the successful conclusion of these milestones, we will need to raise additional funds to scale up our manufacturing and to go through clinical trials to obtain regulatory approval.”
Rescue Biomedical’s team includes Purdue researchers Craig Goergen, the Leslie A. Geddes Associate Professor of Biomedical Engineering; Chi Hwan Lee, the Leslie A. Geddes Associate Professor of Biomedical Engineering and associate professor of mechanical engineering; and Jacqueline Linnes, the Marta E. Gross Associate Professor of Biomedical Engineering. Vy Le is involved with the company while also pursing an MBA from Rice University. The company collaborates with MED Institute and Drs. Matthew Aalsma and Allyson Dir of the Indiana University School of Medicine.
Rescue Biomedical licenses its technology through the Purdue Research Foundation Office of Technology Commercialization.
“The development of the Rescue Biomedical technology is really exciting and comes at a critical time,” Dir said. “Harm reduction is meant to save lives, and this potential technology will be a great addition to that toolkit of strategies and interventions. The more resources that are available, the more opportunities there are to improve outcomes and save lives.”
