A staggering 107,000 people in the United States died of a drug overdose in 2021, over 80,000 of them from opioids. Opioid overdose has become the number one killer of Americans under age 50. Yet it doesn’t have to be this way. The drug naloxone is incredibly effective at reversing an opioid overdose if it is administered on time by a bystander or first responder. Unfortunately, up to 75% of opioid overdose deaths occur without a bystander present. This means that there are nearly 60,000 deaths per year that we cannot prevent with existing delivery forms of naloxone.
Resilient Lifescience co-founder Charlie Proctor and I became alarmed by the 22% surge in synthetic opioid deaths during the COVID-19 pandemic and set out to leverage our experience in remote patient monitoring and computer science to develop a solution — a wearable medical device designed to detect and reverse opioid overdoses.
Our patch-based device is worn on the abdomen and monitors the user for signs of an opioid overdose, such as depressed respiration and oxygen saturation. As our algorithms determine that an overdose is occurring, the device administers a subcutaneous dose of lifesaving naloxone. In 2022 we founded our company to develop a prototype and begin the arduous process of bringing a new medical device to market.
As we launched the venture, we were encouraged by the fact that much of the technology required for our product was already proven in the industry. Reflective pulse oximetry and respiratory rate monitoring have become popular on consumer wearables, including many smartwatches. Wearable subcutaneous drug delivery systems have become increasingly popular in recent years, with insulin pumps as the most well-known example. Naloxone itself is off-patent, widely used, and incredibly versatile. It can be administered intranasally, or through intravenous, intramuscular or subcutaneous injection. The drug works by blocking the effects of opioids such as heroin, fentanyl, and prescription medications. According to the Centers for Disease Control, naloxone can restore normal breathing in two to three minutes in a person whose breathing has slowed or even stopped because of an opioid overdose. The frequency and severity of side effects are limited, and naloxone has little impact on individuals without opioids in their system. In October 2022, we tested our first working proof-of-concept device and are now working to develop our technology into a production-ready device suitable for clinical trials.
With our product, we seek to help the 1.7 million Americans who are actively using opioids while receiving treatment for substance use disorder or living with a supportive loved one. On average, it takes nine years from the first treatment to stable long-term recovery for an Opioid Use Disorder (OUD) patient. During that time, many patients with OUD cycle through various phases of treatment and use. Many points in this journey (such as leaving inpatient treatment or incarceration) lead to a significantly increased risk for overdose, as the patient’s tolerance is decreased. We’ve spoken to over 300 patients and their loved ones and found that 85% of patients within this population would be interested in a wearable device to protect against overdose.
We intend to distribute our product to those in need through similar channels as other emergency-use naloxone products. In the U.S., 87% of naloxone is distributed through non-pharmacy means, including state-supported community harm reduction programs that give naloxone out to communities. There was $1.5 billion in State Opioid Response (SOR) grant funding dedicated in 2022, and upward of $54 billion in Opioid Settlement funds to be distributed over the next 18 years. Guardrails around the spending for this money help ensure that at least 70% are dedicated to opioid-related expenses.
Our company is headquartered in Pittsburgh, Pennsylvania, and as a medical device startup, we’ve found this to be a great advantage. Pittsburgh was recently recognized by Colliers in its 2023 life sciences report as among the top emerging life sciences markets in the nation. It’s home to top-tier universities leading in medical device research & development, including Carnegie Mellon University and the University of Pittsburgh — two R1 universities within blocks of each other. The two major healthcare systems, Allegheny Health Network (AHN) and the University of Pittsburgh Medical Center (UPMC) are also heavily involved in the region’s startup ecosystem. With 160 life sciences companies in the region, 90 of whom are medical device companies, we’re fortunate to be in a location with such a concentration of technical expertise and R&D resources.
Resilient Lifescience’s focus in 2023 is to develop the sensing technology and conduct feasibility studies and early trials for the overdose detection component of our technology. Our team raised just over $800,000 to date, including a $500,000 investment from the Richard King Mellon Foundation after being awarded first place in their 2022 Social Impact Venture Competition. We’re proud to have investors from Angels to VC firms, including Tau Ventures, who recognize the potential for our technology to save tens of thousands of lives and achieve commercial success.
We’ve reached our milestones to date with a small founding team. Charlie Proctor is our CTO, a software engineer who holds a computer science degree from Yale and brings experience from Facebook and Google. I started my career as an officer in the United States Marine Corps, where I led troops in combat operations in Afghanistan. I gained medical device experience at GE Healthcare, Edwards Lifesciences, and Spry Health and earned a B.S. from Carnegie Mellon and an MBA from Harvard. We’re excited to scale our research and engineering teams in 2023.
We understand that our device will not singlehandedly solve the opioid epidemic, but it is an important part of the complex solution required to combat this devastating situation. Our technology has the potential to keep people safe during a long and dangerous journey from opioid addiction to recovery.
Editors Note: About Brad Holden, Co-Founder and Chief Executive Officer, Resilient Lifesciences: Brad Holden is the co-founder and CEO of Resilient Lifescience. Brad began his career as an officer in the United States Marine Corps, where he led a team in detecting and eliminating explosive devices in Afghanistan. Prior to founding Resilient Lifescience, he held roles in Product, Strategy, and Operations at Edwards Lifesciences, Spry Health, Autodesk and Infinitus Systems. He and his co-founder Charlie Proctor founded Resilient Lifescience in April 2022 after realizing the potential for wearable devices to replace the need for a bystander to save a life from an opioid overdose. Brad has a B.S. in Biomedical Engineering and Mechanical Engineering from Carnegie Mellon University and an M.B.A from Harvard Business School.