Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1R43DE029369-01	A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures	Cross-Cutting Research	Small Business Programs	NIDCR	LAUNCHPAD MEDICAL, LLC	JADIA, RAHUL; KAY, GEORGE	Boston, MA	2019
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: There is a compelling need to develop a front line, non-opioid-based acute pain management strategy for outpatient oral surgical procedures. LaunchPad Medical has developed Tetranite® (TN), a novel bone regenerative mineral-organic self-setting adhesive biomaterial. TN has been extensively studied in vivo in a canine jaw model and shown to be effective and well-tolerated. In this project, researchers will demonstrate that drug-loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrations. The ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioids. This novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacement, spinal fusions or reconstructive trauma surgery. In Phase II the team will conduct an in vivo study to assess efficacy of medicated TN to address post-operative pain following wisdom tooth odontectomy, optimize incorporation and release of medications in TN formulations, develop cGMP manufacturing process for the compounded product, and ultimately conduct clinical trials for bone void filler using medicated TN.
1R43DE029379-01	Therapeutic in Situ Analgesic Implant for improved Oral-Facial Post-Operative Pain Outcomes	Cross-Cutting Research	Small Business Programs	NIDCR	EPIGEN BIOSCIENCES, INC.	FRIEDMAN, CRAIG; CAUDLE, ROBERT M	San Diego, CA	2019
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: Analgesia for post-operative populations remains a significant health need that calls for innovative therapies which improve both safety and outcome measures. Recent FDA drug safety warnings and studies focusing on post-operative analgesia have highlighted the imperative need for new approaches that can be utilized for common clinical scenarios. Accordingly, novel treatment options that are safe and afford additional benefit in relief of pain are needed. In this proposal, the development of an innovative surgical sealant technology is proposed that functions at the level of the surgical wound bed and actively delivers local pharmacologic agents to therapeutically address post-operative pain. New formulations of several analgesic regimens will be assessed for their ability to seal wounds and provide appropriate pain management.
1R43HD107727-01A1	Novel Approach to Personalize and Monitor Therapeutic Training At Home in Chronic Pelvic Pain Management	Cross-Cutting Research	Small Business Programs	NICHD	Hillmed, Inc.	DIAS, NICHOLAS	Katy, TX	2022
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: Chronic pelvic pain is a debilitating condition that negatively affects the social and sexual quality of life for up to 20% of American women. Pelvic floor muscle (PFM) pain is caused by many factors, as well as by incorrect posture and excessive sensitization of the peripheral nervous system. This project will introduce a prototype of the Chronic Pelvic Pain (CPP) HomeTrainer that monitors, quantitatively and in real time, both PFM activation capacity and muscle interactions between the PFM and hip/trunk muscles and adapts the PFM training to the user’s needs in their own home. The proposed CPP HomeTrainer offers biofeedback to aid myofascial physical therapy and movement pattern training by tailoring the protocol to specifically correct interactions between the PFM and problematic hip/trunk muscles.
1R43HD111082-01A1	Novel Venous Device for the Treatment of Chronic Pelvic Pain	Cross-Cutting Research	Small Business Programs	NICHD	V-FLOW MEDICAL, INC.	BRENNEMAN, RODNEY	San Juan Capistrano, CA	2023
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: Pelvic venous compression is a common cause of chronic pelvic pain in women. Because many women do not receive an accurate diagnosis for the cause of their pelvic pain, some take opioids to help manage their symptoms. This project will further develop a new diagnostic system specifically designed to treat limited blood flow in pelvic region. This system visualizes pelvic veins toward development of a method to relieve pressure that causes pain.
1R43HD112219-01A1	Targeted Temperature Modulation with Smart Radiometric Monitoring for Effective and Long-Lasting Opioid-Free Pelvic Pain Relief: A Novel Low-Cost, Portable, Tampon-Sized Thermal Transfer Device	Cross-Cutting Research	Small Business Programs	NICHD	H3PELVIC THERAPY SYSTEMS, INC.	LYON, ZACHARY W	Lewisville, NC	2023
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: Pelvic pain (PP) includes more than 20 different painful and debilitating conditions, such as urinary tract infections, menstrual cramps, endometriosis, overactive bladder, and interstitial cystitis, and affects millions of people. Globally, pelvic pain affects 1 in 5 women and 1 in 12 men. This project will develop an instrument to monitor and treat pain-associated temperature changes in the pelvic region to reduce chronic pelvic pain. This novel system is intended to be used at home with personalized settings.
1R43HL167661-01A1	Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions	Cross-Cutting Research	Small Business Programs	NHLBI	OPALGENIX, INC.	PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR	Carmel, IN	2023
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: Thoracic (chest) surgeries often cause both short-term (acute) and long-term (chronic) pain and long-term opioid use. Unique genetic and clinical risk factors affect individual responses to surgical pain and pain medications. Current trial-and-error approaches to managing post-surgical pain and opioid prescribing are not ideal. This project will develop predictive software within a medical device that takes into account an individual’s genetic and clinical information to predict the likelihood of chronic pain following thoracic surgery.
1R43HL167661-01A1	Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions	Cross-Cutting Research	Small Business Programs	NHLBI	OPALGENIX, INC.	PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR	Indianapolis, IN	2023
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
1R43NR017575-01A1	Using Virtual Reality Psychological Therapy to Develop a Non-Opioid Chronic Pain Therapy	Cross-Cutting Research	Small Business Programs	NINR	COGNIFISENSE, INC.	BAEUERLE, TASSILO; CEKO, MARTA ; WEBSTER, LYNN	Sunnyvale, CA	2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) NOFO Number: PA-17-302 Summary: Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic pain.
1R43NS110117-01	Development of a novel anti-migraine therapeutics	Cross-Cutting Research	Small Business Programs	NINDS	ADEPTHERA, LLC	HSU, SHEAU-YU TEDDY	Palo Alto, CA	2019
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: New approaches that can effectively ameliorate acute and chronic migraine pain are urgently needed. Due to its critical roles in inducing migraine pain, CGRP and its receptor complex, the calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1) have been targeted for migraine treatment. A new strategy for targeting the CGRP-mediated signaling pathway is needed to meet the medical need of migraine patients. The team developed a group of long-acting CGRP/RAMP1-specific peptide super-antagonists that form gels in situ in aqueous solution. Based on this exciting finding, the investigators propose to develop and identify the most potent antagonistic analog candidates (Aim 1), and characterize the pharmacokinetics of gel depots made of the selected candidates in vivo (Aim 2). This feasibility study is needed to explore the translational potential of these newly invented super-antagonists for the treatment of chronic migraine in combination with conventional migraine agents.
1R43NS112088-01A1	Repression of Sodium Channels via a Gene Therapy for Treatment of Chronic Neuropathic Pain	Cross-Cutting Research	Small Business Programs	NINDS	NAVEGA THERAPEUTICS, INC.	MORENO, ANA MARIA; ALEMAN GUILLEN, FERNANDO	San Diego, CA	2019
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: Voltage-gated sodium channels are responsible for the transmission of pain signals. Nine genes have been identified, each having unique properties and tissue distribution patterns. Genetic studies have correlated a hereditary loss-of-function mutation in one human Na+ channel isoform – ?Na?V?1.7 – with a rare genetic disorder known as Congenital Insensitivity to Pain (CIP). Individuals with CIP are not able to feel pain without any significant secondary alteration. Thus, selective inhibition of ?Na?V?1.7 in normal humans could recapitulate the phenotype of CIP. This research team developed a non-permanent gene therapy to target pain that is non-addictive (because it targets a non-opioid pathway), highly specific (only targeting the gene of interest), and long-term lasting (around 3 weeks in preliminary assays in mice). During this Phase I , the team will 1) test additional pain targets ?in vitro?, and 2) evaluate the new targets ?in vivo ?in mice models of inflammatory and neuropathic pain.
1R43NS113726-01	Pharmacokinetic and toxicology studies of AYX2, a transcription factor decoy, non-opioid, disease modifying drug candidate for the long-term treatment of chronic pain	Cross-Cutting Research	Small Business Programs	NINDS	ADYNXX, INC.	MAMET, JULIEN	San Francisco, CA	2019
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: Chronic focal neuropathic pain, which includes pain etiologies such as radiculopathy and radiculitis, focal peripheral neuropathies, and low back pain, affects as many as 25 million patients annually in the United States. Chronic focal neuropathic pain is maintained by genome-wide transcription regulation in the dorsal root ganglia (DRG) / spinal cord network. The transcription factors driving this regulation constitute a promising class of targets with the potential to alter the course of pain with a single treatment. DNA decoys are oligonucleotides that specifically inhibit the activity of certain transcription factors. AYX2 binds and inhibits Krüppel-like transcription factors (KLF) in the DRG-spinal cord. The goal of this Phase 1 proposal is to advance AYX2 toward an IND submission, allowing for human clinical trials. We propose in Aim 1 to characterize AYX2 pharmacokinetics in the cerebrospinal fluid and plasma and its distribution in the DRG, spinal cord and brain following an IT injection. With this information, AYX2 will be tested in a panel of complementary toxicology studies in Aim 2 to allow for final IND-enabling studies, supported by Phase 2 of the grant. This research will accelerate development of AYX2 as a novel drug candidate for the non-opioid treatment of pain.
1R43NS115294-01	Developing EXP-1801 as an imaging agent to quantify pain and analgesia	Cross-Cutting Research	Small Business Programs	NINDS	EXPESICOR, INC.	NORWOOD, BRAXTON	Kalispell, MT	2019
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.
1R43NS115312-01	Long-acting ghrelin for neuropathy	Cross-Cutting Research	Small Business Programs	NINDS	EXTEND BIOSCIENCES, INC.	SOLIMAN, TARIK	Newton, MA	2019
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: There is a need for safe, effective, well- tolerated drugs to treat painful neuropathy by halting or reversing the underlying pathology of the disease. One promising approach to treating painful neuropathy without opioids is the use of ghrelin, a 28-amino acid acylated peptide hormone. However, it has a short half-life and must be delivered via a constant intravenous infusion to have a therapeutic effect. Extend Biosciences' D-VITylation platform technology is truly enabling for small peptide-based therapeutics that are rapidly cleared from the bloodstream by renal filtration. The platform harnesses the naturally long half-life of vitamin D and its dedicated binding protein, VDBP. When the vitamin D molecule is conjugated to a biological therapeutic, it dramatically improves the half-life and bioavailability of the drug. Use of the technology should also allow the drug to be self-administered by subcutaneous injection. This would be of significant benefit to patients. In this project, the team will test the efficacy of EXT405 in a cell-based model of neuropathy as well as in animal models of CIPN and diabetes- induced neuropathy.
1R43NS119087-01A1	Evaluating the Blood-Brain Barrier Bioavailability and in vivo Efficacy Potential of a Novel TAK1 Inhibitor Targeting Chronic Pain	Cross-Cutting Research	Small Business Programs	NINDS	EYDIS BIO, INC.	SCARNEO, SCOTT (contact); HAYSTEAD, TIMOTHY A	Durham, NC	2021
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.
1R43NS120335-01	Closed-Loop Micromagnetic Neuromodulation as a Non-Opioid Treatment for Neuropathic Pain	Cross-Cutting Research	Small Business Programs	NINDS	QUANTUM NANOSTIM	REILLY, THOMAS	Treasure Island, FL	2021
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: Spinal cord stimulation (SCS) has been shown to provide effective relief for most people with chronic pain and eliminated the need for opioid therapy in more than half of those treated. However, traditional SCS approaches have encountered problems when glial cells coat the stimulation electrodes that distance the device from targeted neurons. This project will develop a novel hybrid Closed Loop Omnidirectional Neuromodulation with Electromagnetic fields (CLONE) system that is combined with magnetic-based stimulation to overcome glial coating of SCS electrodes, better target neurons in dorsal spine tissue, which may lead to better treatment of chronic neuropathic neck and low back pain.
1R43NS120410-01A1	Optimization of a Gene Therapy for Chronic Pain in Human DRGs	Cross-Cutting Research	Small Business Programs	NINDS	NAVEGA THERAPEUTICS, INC.	MORENO, ANA MARIA (contact); ALEMAN GUILLEN, FERNANDO	La Jolla, CA	2021
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.
1R43NS120617-01A1	Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials	Cross-Cutting Research	Small Business Programs	NINDS	PLUMERIA THERAPEUTICS, INC.	RICHARDSON, THOMAS P (contact); WANG, YIPING	Plainsboro, NJ	2021
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: Chronic pain is a major healthcare burden. However, the types and underlying mechanisms of pain vary greatly, as do patient responses to currently available pain medications. Inflammation in the nervous system (neuroinflammation) is involved in several types of pain, and targeting key molecules involved in neuroinflammation is therefore a promising treatment approach. The chemokine receptor system, a complex network of more than 20 different receptors and more than 80 molecules that bind to these receptors, has a central role in neuroinflammation. Researchers do not yet fully understand the functioning of this network and how specific receptors vary in different chronic pain conditions. Therefore, this project aims to further characterize the expression of one specific receptor, using samples collected from participants in clinical trials evaluating a compound that interferes with the receptor’s function. This information should allow researchers to classify pain patients and identify those most likely to benefit from a treatment with compounds targeting the receptor.
1R43NS124421-01A1	Development of Nav1.7 Monoclonal Antibodies for Treating Pain	Cross-Cutting Research	Small Business Programs	NINDS	INTEGRAL MOLECULAR	RUCKER, JOSEPH BENJAMIN	Philadelphia, PA	2021
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.
1R43NS125643-01	Development of an intranasal, direct to nerve treatment for headache disorders	Cross-Cutting Research	Small Business Programs	NINDS	Olfax, LLC	BECKWITH, JONATHAN G (contact); COOK, JASON T	Asheville, NC	2022
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: About 14% of U.S. adults report experiencing migraine symptoms within any given 3-month period, making it the second most disabling illness in the world. Nonspecific pain medications used in migraine (e.g., acetaminophen, nonsteroidal inflammatory drugs, opioids) are often not effective for severe migraine symptoms or cause significant adverse effects. A research team of migraine care specialists, device and drug developers, and clinical research specialists has created a technology for accurately delivering self-administered migraine medication to the upper nasal cavity. The technology enables development of a self-administered therapy to provide rapid pain relief without harsh and addictive side effects of existing migraine medications. This project will establish efficacy and evaluate commercial design feasibility for this treatment.
1R43NS132623-01	Optogenetic Pain Modulator for Non-Opioid Chronic Pain Management	Cross-Cutting Research	Small Business Programs	NINDS	OPSIN BIOTHERAPEUTICS, INC.	NARCISSE, DARRYL	Bedford, TX	2023
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.
1R43TR004743-01	The Pain in a Dish Assay (PIDA): A High Throughput System Featuring Human Stem Cell-Derived Nociceptors and Dorsal Horn Neurons to Test Compounds for Analgesic Activity	Cross-Cutting Research	Small Business Programs	NCATS	VALA SCIENCES, INC.	MCDONOUGH, PATRICK M	San Diego, CA	2023
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: This project will develop PIDA, which will allow researchers to measure the activity of pain-sensitive human neurons in response to pain stimuli and potential pain treatments. The tool will use automated digital microscopes in the absence or presence of a potential pain medication. Since this tool contains human neurons, it may be more effective at predicting the efficacy of potential pain drugs in human patients than the animal models that are currently used.
1R44AR074820-01A1	A phenotypic screen for osteoarthritic pain therapeutics using all-optical electrophysiology	Cross-Cutting Research	Small Business Programs	NIAMS	QUELL TX, INC.	LIU, PIN; MCMANUS, OWEN B	Cambridge, MA	2019
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.
1R44AR076885-01	Enhancing Physical Therapy: Noninvasive Brain Stimulation System for Treating Carpal Tunnel Syndrome	Cross-Cutting Research	Small Business Programs	NIAMS	HIGHLAND INSTRUMENTS, INC.	WAGNER, TIMOTHY ANDREW; DIPIETRO, LAURA	Cambridge, MA	2019
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 Required) NOFO Number: PA-18-573 Summary: Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of chronic pain (CP) in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [25-28]. However, the most common NIBS methods, e.g., transcranial direct current stimulation, have shown limited, if any, efficacy in treating neuropathic pain. It has been postulated that limitations in conventional NIBS techniques’ focality, penetration, and targeting control limit their therapeutic efficacy . Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue . This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat CP in carpal tunnel syndrome (CTS), both as a lone treatment and in conjunction with physical therapy (PT). Investigators hypothesize ESStim can be provided synergistically with PT, as both can encourage plasticity-dependent changes which could maximally improve a CTS patient’s pain free mobility. In parallel with the CTS treatments, the team will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics. The computational work will be used to develop an optimized CTS ESStim dosing model.
1R44AR083337-01	Development of a Regional Anesthesia Guidance System to Increase Patient Access to Opioid-Sparing Analgesia for Hip Fracture Pain	Cross-Cutting Research	Small Business Programs	NIAMS	RIVANNA MEDICAL, INC.	MAULDIN, FRANK WILLIAM	Charlottesville, VA	2023
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.
1R44CA271904-01A1	Novel Biologic to Treat Chemotherapy-Induced Neuropathic Pain	Cross-Cutting Research	Small Business Programs	NCI	RAFT PHARMACEUTICALS, LLC	KOGAN, YAKOV	San Diego, CA	2022
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: Some chemotherapy treatments damage nerves outside the brain and spinal cord. This condition, chemotherapy-induced peripheral neuropathy, involves tingling, burning, weakness, or numbness in hands and/or feet and affects nearly 70% of cancer patients receiving chemotherapy. Common pain medications, including opioids, can relieve pain for short intervals but are not suitable for long-term therapy. This project will conduct studies to investigate the safety and tolerability of a novel strategy to treat neuropathic pain: modifying the activity of the dorsal root ganglia, which are nerve cells in the spinal cord that communicate pain signals to and from the brain.