Funded Projects

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

The use of a pain imaging technology would allow for objective efficacy data (both pre-clinically and in clinical trials), and reduce costs by enabling smaller sample sizes due to more homogeneous populations; i.e. with a particular “pain signal,” and more accurate measurement of analgesic effects. This research team recently invented a novel positron emission tomography (PET) imaging agent as a tool to address these issues in pain care and therapy development. Although the ability of PET to detect pathological changes for (early) disease detection is widely used in cancer and neurological diseases, it has not yet been used for pain indications. The goals of this project are: 1) to change the evaluation of (experimental) pain therapies, and 2) the standard of care in pain assessment through molecular imaging. The proposed study is designed to determine the feasibility of our imaging agent to objectively measure pain in rodents. This will set the stage for a Phase II study that further develops this agent into a tool for quantifying pain/analgesia.

NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: NS-20-011
Summary:

Over-the-counter medicines such as non-steroidal anti-inflammatory drugs are ineffective for treating severe chronic pain and may have serious side effects from continued use, which limits treatment options. A kinase (an enzyme whose activity targets a specific molecule) called TAK1 is involved in the chronic pain process. This research will develop a molecule previously shown to be effective in a model of inflammatory pain that also inhibits TAK1. A main goal will be to determine if this inhibitor (takinib analog HS-276) can cross the blood-brain barrier and, if successful, pursue FDA  Investigative New Drug-enabling safety studies leading to a Phase I clinical trial and a potential new chronic pain treatment.

NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: NS-20-011
Summary:

To avoid the reliance on opioids for treatment of pain, researchers are investigating alternative approaches to disrupt the transmission of pain signals by specialized neurons in the body, such as dorsal root ganglion neurons in the spinal cord. Molecules called voltage-gated sodium channels that are located in the membranes of dorsal root ganglion neurons are essential for transmission of the pain signals. People carrying a specific variant of these channels, NaV1.7, are insensitive to pain; therefore, strategies to block this particular channel might help in the development of non-addictive pain treatment approaches. Navega Therapeutics is developing an innovative gene therapy that specifically targets NaV1.7. Using studies in human cell lines, they will identify the best designs to then test this gene therapy approach in human dorsal root ganglion neurons.

NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Many current pain relief treatments rely on use of opioid drugs. This research is conducting preclinical development on a non-addictive, non-opioid therapeutic that uses antibodies to target the sodium channel Nav1.7. This channel is known to be one of the primary routes for generating pain signals – thus it is a target for reducing pain. The antibody approach offers potential for greater specificity than small molecule approaches, potentially resulting in fewer side effects.

NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Optogenetics is a method of controlling nerve or brain activity using light-sensitive cell receptors (opsins). Optogenetics has been used in brain research for decades, allowing researchers to understand the brain and its associated disorders by selectively turning on and off specific nerve cells. This project will develop and refine use of an opsin and a light-stimulation device to control nerve cells contributing to the sensation of pain. 

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

 Quell Therapeutics uses the Optopatch platform for making all-optical electrophysiology measurements in neurons at a throughput sufficient for phenotypic screening. Using engineered optogenetic proteins, blue and red light can be used to stimulate and record neuronal activity, respectively. Custom microscopes enable electrophysiology recordings from 100’s of individual neurons in parallel with high sensitivity and temporal resolution, a capability currently not available with any other platform screening technology. Here, researchers combine the Optopatch platform with an in vitro model of chronic pain, where dorsal root ganglion (DRG) sensory neurons are bathed in a mixture of inflammatory mediators found in the joints of osteoarthritis patients. The neurons treated with the inflammatory mixture become hyperexcitable, mimicking the anticipated cellular pain response. Investigators calculate the functional phenotype of arthritis pain, which captures the difference in action potential shape and firing rate in response to diverse stimuli. The team will screen for small molecule compounds that reverse the pain phenotype while minimizing perturbation of neuronal behavior orthogonal to the pain phenotype, the in vitro “side effects.” The highest ranking compounds will be chemically optimized and their pharmacokinetic, drug metabolism, and in vivo efficacy will be characterized. The goal is to advance therapeutic discovery for pain, which may ultimately help relieve the US opioid crisis.

NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-23-006
Summary:

Every year, more than 330,000 Americans are hospitalized for hip fractures. Rapid surgical intervention and pain treatment is critical to recover mobility and reduce other health complications. Ultrasound-guided regional anesthesia techniques are an effective alternative to opioid medication, but require specialized training for use in the emergency department. This project will develop and validate an easy-to-use ultrasound-based regional anesthesia guidance system, to ultimately improve access to non-opioid-pain treatment for hip fracture pain.

NOFO Title: Wearable to Track Recovery and Relapse Factors for People w/ Addiction (R43/R44)
NOFO Number: RFA-DA-18-010
Summary:

For many individuals in recovery from a substance use disorder, certain cues—including stress and drug-related cues—can trigger a physiological state in which they are more likely to relapse. In this SBIR project, the investigators intend to deploy a system—consisting of a wearable sensor, a smartphone app, and a clinical portal—to provide individuals in recovery and their treatment providers with an opportunity to identify moments of high risk for relapse and to access real-time intervention opportunities. The sensors will identify signals of stress or drug use, interface with a smartphone app, and provide options for annotations, stress-reduction techniques, or contact with an individual’s support system and treatment providers, as well as log and encourage healthy behaviors. This study will deploy and optimize the system, as well as test its effects on addiction-related outcomes, such as rate of relapse.

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

Newborn Abstinence Syndrome, which results from maternal opioid drug use prior to birth, is a serious condition that affects approximately 6% of all neonates born today in the U.S. and which is increasing rapidly in incidence because of this epidemic. Availability of a rapid screening test that can be administered at the point of care to all neonates would allow for early intervention, reducing costs of treatment and reducing pain and suffering for this vulnerable and helpless patient population. Providing a platform to accurately monitor actual levels of these drugs and their metabolites in such patients would allow better-controlled use of these pain management treatments, personalized to the needs of the individual neonate, and would reduce the probability of addiction and resulting complications, which include deleterious neurological effects. The purpose of this FastTrack SBIR project is to expand upon preliminary results that a device can sensitively and accurately detect opioids and their primary urinary metabolites in one-microliter urine samples, in less than a minute after sample introduction into the device, and adapt the device into a point-of-care instrument for use in hospitals, clinics, and other venues in which such tests are likely to be deployed.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Opioid agonist therapy (OAT), such as buprenorphine/naloxone (BUP/NAL), is proven effective against opioid use disorder (OUD), but poor medication adherence is a major barrier. This project aims to substantially increase adherence to oral BUP/NAL with Pillsy, a smart technology platform, which acts like a digital medication coach, providing education and reminders using a mobile app, text messages, and automated phone calls. The platform is built around a Bluetooth-based smart pill bottle cap that automatically tracks doses and timing, and sends intelligent reminders to create a unique feedback loop, which allows constant optimization of the incentive/reminder messages to meet user needs to increase adherence. A dashboard enables providers to easily track medication use and patient engagement. The Pillsy platform only nominally increases the cost of oral BUP/NAL treatment, and physicians can bill for monitoring time (CPT code 99091). The project team will adapt the current Pillsy platform and perform a randomized efficacy trial of BUP/NAL adherence.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Acute and chronic low back pain are among the most common sources of short- and long-term disability. Fear of pain and disability, or “catastrophizing,” increases opioid use, but is reduced when patients have effective options and feel control over pain. The goal of this project is to develop an opioid-sparing therapeutic consumer device for low back pain, with multiple patient-controlled effective neuromodulatory pain relief options, including vibration, pressure, cold, and heat. After proving that providing a multimodal device is effective for pain, the project will determine whether the availability of an effective home therapy device reduces opioid use for patients with acute and chronic low back pain.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Deaths from opioid overdose are highly preventable with early detection and administration of naloxone, but overdose victims often die because they are alone or among untrained or impaired bystanders and thus do not receive timely resuscitation. There is an urgent, unmet need for a low-barrier, easily scalable solution that can identify opioid overdoses in real time and rapidly connect victims to naloxone therapy. This proposal seeks to commercialize an innovative overdose detection software product that can be downloaded on any commodity smartphone and can detect opioid- induced respiratory failure (i.e., overdose) and summon help. The software-only product, SecondChance, converts a smartphone into a short-range active sonar system capable of monitoring breathing and detecting overdose.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Rates of neonatal abstinence syndrome (NAS) have skyrocketed during the last decade, and estimates suggest that 5% of mothers use at least one addictive drug during their pregnancy. To address this public health crisis, multiple groups—including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics—recommend universal screening of substance use in pregnancy using standardized behavioral scoring tools. Unfortunately, such tools are often biased due to subjective scoring or self-reporting errors, and fail to identify babies who did not receive proper prenatal care. This project will develop a fast and accurate NAS screening tool that pairs a simple sample preparation protocol with a high-sensitivity panel of homogeneous enzyme immunoassays recognizing five common classes of drugs: fentanyl, morphine, amphetamine/methamphetamine, cocaine, and benzodiazepines. The potential benefits of such a system include reduced length of hospitalization for unaffected newborns, accelerated time to confirmatory results (under 2 hours), faster resolution of acute withdrawal symptoms, and improved referral to family/maternal support services.