In a groundbreaking development, Rescue Biomedical, a forward-thinking company, has received a Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The grant will enhance its life-saving technology designed to detect opioid overdoses. The technology also administers naloxone, a drug that rapidly reverses opioid overdose effects.
The Opioid Crisis: A Growing Public Health Challenge
The opioid epidemic continues to be a devastating public health crisis. The Centers for Disease Control and Prevention (CDC) reported 91,799 overdose deaths in 2020, marking a 31% increase from 2019. Many of these deaths were caused by opioids, a class of drugs that includes prescription painkillers, heroin, and synthetic opioids like fentanyl. Naloxone, a medication that can reverse the effects of opioid overdose, has been a critical tool in harm reduction efforts. However, many overdose deaths occur because the administration of naloxone is delayed or not available when needed.
Rescue Biomedical’s closed-loop drug delivery system aims to solve this issue. It does this by automatically detecting when an individual is overdosing. It then immediately administers naloxone to prevent serious harm or death.
Rescue Biomedical’s Innovative Approach
The technology being developed by Rescue Biomedical offers a game-changing solution in the fight against opioid overdoses. According to Hyowon “Hugh” Lee, CEO of Rescue Biomedical, the company’s device continuously monitors the user for signs of an overdose. He is also a Purdue University associate professor. When an overdose is detected, the device automatically delivers a dose of naloxone to the patient. It reverses the overdose and potentially saves their life before emergency medical services arrive.
“Our device is designed to protect individuals who are at high risk of opioid overdose. This includes those who have recently undergone treatment for opioid use disorder (OUD),” Lee explained. Patients who complete treatment for OUD are at higher risk of overdose due to reduced tolerance levels, making immediate intervention crucial.
Funding and Development Goals
Rescue Biomedical has been awarded a four-year, $2.82 million NIH grant to accelerate the development of this life-saving technology. The grant is part of the Fast-Track SBIR program. This program allows the company to move swiftly from Phase I to Phase II without the need for additional scientific reviews. This significantly speeds up the approval process.
During Phase I, Rescue Biomedical will focus on:
- Understanding customer needs
- Identifying regulatory pathways for U.S. Food and Drug Administration (FDA) approval
In Phase II, the company plans to:
- Conduct usability evaluations
- Demonstrate the functionality of the device in real-world settings, advancing toward full regulatory approval.
Lee highlighted that these milestones are critical in pushing the device closer to commercialization, after which the company will need to raise additional funds for manufacturing scale-up and clinical trials to achieve full FDA approval.
Collaborations and Expertise
The development of Rescue Biomedical’s opioid overdose detection and naloxone delivery system is a collaborative effort. Key team members include:
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- Craig Goergen, associate professor of biomedical engineering at Purdue University
- Chi Hwan Lee, associate professor of biomedical engineering and mechanical engineering at Purdue University
- Jacqueline Linnes, associate professor of biomedical engineering at Purdue University
In addition, the company works closely with the MED Institute and researchers such as Matthew Aalsma and Allyson Dir from the Indiana University School of Medicine. Dir noted that the rising rates of opioid overdoses make this technology both timely and critical. “The development of the Rescue Biomedical technology is really exciting and comes at a critical time,” Dir remarked. “Harm reduction is meant to save lives, and this potential technology will be a great addition to the toolkit of strategies and interventions.”
Impact and Future Potential
The potential of this technology to revolutionize overdose prevention is immense. The automated naloxone delivery system could become a vital tool in harm reduction strategies, especially for individuals at high risk of overdose. As the opioid crisis continues to claim lives, solutions like this are essential for preventing deaths and reducing the long-term impact of opioid misuse.
This technology’s success could also pave the way for other automated drug delivery systems, where real-time health monitoring is used to deliver critical, life-saving interventions during medical emergencies.
Conclusion: A Lifeline for Opioid Use Disorder Patients
The Rescue Biomedical overdose detection and naloxone delivery system represent a significant advancement in combating the opioid epidemic. As the technology continues to develop and undergo testing, it has the potential to save countless lives by providing immediate intervention during opioid overdoses.
Rescue Biomedical’s innovative approach, supported by partnerships with research institutions like Purdue University, could redefine the landscape of harm reduction and opioid overdose prevention.
