Delivering More Than Knowledge: The HEAL Small Business Programs

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Dear HEAL Community,

HEAL now funds more than 1,000 research projects in every U.S. state. As I wrote about last month, this $2.5-billion endeavor has grown substantially this fiscal year – we added 10 new programs and more than 200 new projects that are looking for scientific solutions to prevent overdose and connect people to treatment for pain and addiction.

The nation’s small businesses make up an important part of our research community – through the HEAL Small Business Programs, we are investing directly in the heart of innovation. These entrepreneurs often pour most of their personal resources into making a product with a purpose. HEAL funding offers a make-or-break opportunity to advance a great idea to the marketplace, providing a bridge to venture capital or other larger funding sources needed for commercialization.

Currently, through the federal small business programs, HEAL funds nearly 100 such companies in 20 states with funds from nine NIH Institutes and Centers. While this is a relatively small portion of all HEAL research, it is highly innovative, and these scientists are passionate about what they do.

Two striking examples are novel but relatively simple ways to help the youngest victims of the opioid crisis. Prapela VS is a hospital bassinet pad that applies gentle, soothing vibrations to newborns born dependent on opioids. The device is being tested by HEAL-funded scientists to reduce irritability and improve breathing in these tiny patients. Another is “Roo,” a hearing aid-like device placed around a baby’s ear to mimic the comfort of being in a mother’s pouch. The device can help control withdrawal symptoms by delivering soothing electrical signals that prompt the release of endorphins – the body’s own version of opioids. 

Mobile apps are a big part of our lives. Beyond news, games, and tools like shopping lists, mobile apps can help people stay healthy, and even save lives. Examples of HEAL-funded small business projects developing and testing mobile apps include:

• Sober Grid is the world’s largest recovery app. It gives rapid context-specific peer support and motivational exercises to prevent relapse.
• Re-SET-0+ and imFREE provide personalized support to reinforce the benefits of taking medication to treat opioid use disorder and encourage patients to disregard the opinions of people who do not support their treatment and recovery.
• SecondChance converts a smartphone into a short-range active sonar system capable of monitoring breathing and detecting overdose – an important tool to save the lives of overdose victims who often die because they are alone or among untrained or impaired bystanders.
• Rewire uses a mindfulness-based approach to help adolescents reduce or quit their substance use – toward preventing behavioral health problems and suicide.

HEAL research is following many paths to find new treatments for pain and opioid use disorder. Beyond conventional drug development strategies that develop and test new medications, technology plays an innovative role. Currently being developed and tested include:

• A naturally absorbable film releases controlled amounts of a non-opioid pain medication for several days following surgery. This material could be combined with local anesthesia for up to 4 days after surgery to reduce or potentially eliminate opioid use.
• A unique bone glue delivers non-addictive, locally acting pain medication directly to the site of a wisdom-tooth extraction over a period of hours to weeks, forming a stable covering and filling in the wound. After that, it is replaced by actual bone during the body’s normal recycling processes.
• A nerve-blocking device and self-administered nasal spray for migraine hope to make it easier for people in severe pain to find relief with fewer side effects typical of current treatments.
• EMPOWER is a portable, non-invasive transcutaneous electrical nerve stimulation device for opioid use disorder that helps control withdrawal- and craving-related responses.
• Future Selves is a personalized, immersive virtual reality experience that helps people with opioid use disorder visualize the consequences of certain choices, toward avoiding harm.
• RelieVRx is a home-based virtual reality device that manages post-surgery pain and prevents opioid use disorder. It helps patients develop skills for living with their pain.
• An experiential learning system technology aims to help people cope with pain by providing the brain a new set of signals that affect pain perception.
• A gene therapy product aims to relieve pain in a non-permanent, non-addictive, and long-lasting way by shutting off a molecular pain gateway.
• A new way to deliver long-acting buprenorphine intends to treat post-operative pain after major surgeries such as bunionectomy, abdominoplasty, thoracotomy, and knee and hip surgery.

HEAL-funded small businesses are also augmenting research capacity and tools, such as:

• KnowPain, a wrist band device that senses information related to chronic pain including motion, heart rate, skin surface temperature, and skin conductivity. It is intended to be a tool for clinicians, providing an easy-to-understand report about pain characteristics of individual patients.
• A human-on-a-chip microdevice is being used in a Phase 2 clinical trial. It contains various mini-organs, depending on what drug is being tested: liver, kidney, heart, skeletal muscle, and neurons.
• IMPACT is a device that analyzes changes in pupil dilation to measure pain in patients using opioid therapy. It can be used with critically ill patients who are sedated and intubated, unconscious, or unable to communicate verbally.
• A low-cost, 10-minute urine drug test for opioids is intended for use during healthcare visits. It does not require experienced personnel, time, and a laboratory setup. 

These are just some examples of HEAL-funded small businesses that are committed to making a difference for patients as quickly as possible. It’s important to emphasize that the value of this research goes beyond publications: the typical output of a research grant. Federally funded small business projects are validated by the market – meaning success equals convincing investors or larger company partners to work together toward commercialization.

All told, small businesses employ nearly half of the entire American workforce. The U.S. Small Business Administration coordinates work with 11 federal agencies, including NIH, to support more than $4 billion a year in federal early-stage research and development funding for small businesses. HEAL values this public‒private partnership to speed commercialization of creative ideas to treatments for people with under-treated pain and addiction.

As always, share information about HEAL with your networks and remember that we want to hear from you. It just takes a quick email to [email protected].