Back to Company SearchSBIR-STTR-Tibbetts Award Winner - Pain Care Labs (a dba of MMJ Labs)
2020 Tibbetts Award Winner In 2009 an SBIR award allowed Amy Baxter a Pediatric Emergency MD to deve...
Company
Portfolio Data
MMJ Labs, LLC
UEI: MRK1VCY9DMB6
Number of Employees: 7
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2009
3
Phase I Awards
2
Phase II Awards
66.67%
Conversion Rate
$504,989
Phase I Dollars
$2,527,368
Phase II Dollars
$3,032,357
Total Awarded
Success Stories
See what our company has achieved through SBIR/STTR funding.
Awards
Creation and Validation of the Dose-Opioid-Source Evaluation tool (DOSE) -a Robust Opioid Use Clinical Outcome Assessment for Qualification as an FDA Medical Device Development Tool (MDDT)
Amount: $159,110 Topic: NIDA
Project Summary This project will develop a Clinical Outcome Assessment (COA) for the FDA’s Medical Device Development Tool (MDDT) program assessing patient-reported outpatient opioid use, then calculating the gold standard metric of milligrams of morphine equivalents (MME) using the CDC MME Conversion dataset. In the qualified context of use of a clinical trial with informed consent to report all opioid use, the tool will be a robust survey module capable of capturing and standardizing use of prescribed, purchased or borrowed opioids. Such a research tool will support investigators and medical product developers seeking regulatory approval for opioid-sparing and substance use disorder (SUD) interventions. Devices, digital health solutions and over the counter physical interventions reduce pain,[1-3] but physicians and payor programs need codes to implement proven solutions, and regulatory agencies increasingly prioritize proof of opioid reduction in addition to pain relief. To facilitate medical product development and evaluation, there is a public health need for a robust opioid use measure qualified by the FDA to encourage medical device innovation and allow for intra-trial standardization. Current methods of gathering opioid use information include paper surveys, web-based surveys, and apps. These non-validated collection methods are often pre-loaded with a specific set of opioids limited to those commonly prescribed by the practice where the clinical trial is taking place and are often unique to the trial. While these tools and methods fail to capture of opioids from other sources, nor are they robust enough to be a standard data collection tool for this context of use. Over 90% of opioid prescribed in previous years are unused;[4] only 22% say they got their opioids from a prescriber rather than friends and family.[5] Phase 1 will confirm with the FDA to confirm that the Phase 2 project meets the MDDT guidelines, establish CDC compliance, conduct expert content mapping, and obtain IRB approval for Phase 2 clinical trials. During Phase 2, after structured usability interviews of any edits of the existing survey, programmed logic will optimize interoperability with existing clinical trial data collection software. The survey will be validated in the context of use of a pain-relieving medical device trial, and will be validated for reliability, internal consistency, MME algorithm accuracy, and convergent and divergent validity in a substance use reduction clinic. The DOSE tool will then be incorporated into a secure web-based server for accessed use as an MDDT.
Tagged as:
SBIR
Phase I
2023
HHS
NIH
Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain.
Amount: $1,589,400 Topic: NIDA
Project Summary The goal of this project is to develop a multimodal neuromodulatory opioid-sparing device for low back pain, demonstrate effective pain relief, then evaluate opioid reduction for patients with acute or chronic back pain presenting for treatment. Pain and opioid use disorder (OUD) are intricately related: dependence begins for up to 80% with medications prescribed for pain, either directly or through pills left in circulation. Currently, there is no proven approach to help reduce long-term opioid use for patients with chronic non-cancer pain. What is known is that prescriptions of opioids for acute low back pain are a factor in eventual OUD, and unused opioids in circulation are increasingly abused for non-medical reasons. For the already dependent with chronic pain, one barrier to reduction is fear of ongoing or increasing pain. An effective non-pharmaceutical pain reliever could reduce home opioid prescriptions for acute pain, and aid chronic pain patients seeking to wean. Acute and chronic low back pain are among the most common sources of short and long term disability. Opioids are commonly prescribed, but no better than non- addictive solutions for chronic low back pain. Neuromodulation (cold, high frequency vibration, low frequency whole body vibration, acupressure), heat, and support are effective for many, but no current device combines these multiple modalities of pain relief. One recent study found a surgically placed neuromodulatory device significantly decreased opioid use for patients with chronic low back pain. Low back pain would be the most impactful clinical scenario in which to test an external multi-modal neuromodulatory pain reliever for its impact on initial and chronic opioid use. Patients with chronic pain report benefitting from multiple pain relief strategies over time. Because having options improves the perception of control, the ideal pain relief device would incorporate multiple pain relieving modalities to reduce catastrophizing. To relieve sharp pain, we created an NICHD-funded “Buzzy” neuromodulatory device combining high frequency vibration and ice, now proven effective in over 28 independent clinical trials. To address low back pain, our “DuoTherm” device incorporates the Buzzy frequency, cold, heat, acupressure, and two additional frequencies. Preliminary data from 32 subjects demonstrated substantial and sustained pain reduction, distinct preferences for vibration frequencies, and strong commercial desire for the product. This project will develop and clinically evaluate DuoTherm, an innovative opioid-sparing therapeutic. This patient-controlled external neuromodulation device will be designed to address acute and chronic LBP. After validating effective pain relief with DuoTherm compared to placebo, we will test whether an effective low back pain relief device reduces opioid use for acute and chronic low back pain patients.
Tagged as:
SBIR
Phase II
2020
HHS
NIH
Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain.
Amount: $221,959 Topic: NIDA
Project Summary The goal of this project is to develop a multimodal neuromodulatory opioid sparing device for low back paindemonstrate effective pain reliefthen evaluate opioid reduction for patients with acute or chronic back pain presenting for treatmentPain and opioid use disorderOUDare intricately relateddependence begins for up towith medications prescribed for paineither directly or through pills left in circulationCurrentlythere is no proven approach to help reduce long term opioid use for patients with chronic non cancer painWhat is known is that prescriptions of opioids for acute low back pain are a factor in eventual OUDand unused opioids in circulation are increasingly abused for non medical reasonsFor the already dependent with chronic painone barrier to reduction is fear of ongoing or increasing painAn effective non pharmaceutical pain reliever could reduce home opioid prescriptions for acute painand aid chronic pain patients seeking to weanAcute and chronic low back pain are among the most common sources of short and long term disabilityOpioids are commonly prescribedbut no better than nonaddictive solutions for chronic low back painNeuromodulationcoldhigh frequency vibrationlow frequency whole body vibrationacupressureheatand support are effective for manybut no current device combines these multiple modalities of pain reliefOne recent study found a surgically placed neuromodulatory device significantly decreased opioid use for patients with chronic low back painLow back pain would be the most impactful clinical scenario in which to test an external multi modal neuromodulatory pain reliever for its impact on initial and chronic opioid usePatients with chronic pain report benefitting from multiple pain relief strategies over timeBecause having options improves the perception of controlthe ideal pain relief device would incorporate multiple pain relieving modalities to reduce catastrophizingTo relieve sharp painwe created an NICHD fundedBuzzyneuromodulatory device combining high frequency vibration and icenow proven effective in overindependent clinical trialsTo address low back painourDuoThermdevice incorporates the Buzzy frequencycoldheatacupressureand two additional frequenciesPreliminary data fromsubjects demonstrated substantial and sustained pain reductiondistinct preferences for vibration frequenciesand strong commercial desire for the productThis project will develop and clinically evaluate DuoTherman innovative opioid sparing therapeuticThis patient controlled external neuromodulation device will be designed to address acute and chronic LBPAfter validating effective pain relief with DuoTherm compared to placebowe will test whether an effective low back pain relief device reduces opioid use for acute and chronic low back pain patients Project Narrative The goal of this project is to develop an opioid sparing therapeutic consumer device for low back painwith multiple patient controlled effective neuromodulatory pain relief options including vibrationpressurecold and heatFear of pain and disabilityorcatastrophizingincreases opioid usebut is reduced when patients have effective options and feel control over painAfter proving that providing a multimodal device is effective for painthe project will determine whether the availability of an effective home therapy device reduces opioid use for acute and chronic low back pain patients
Tagged as:
SBIR
Phase I
2019
HHS
NIH
Relieving Pediatric Immunization Pain Using A Reusable Personal Device
Amount: $937,968
DESCRIPTION (provided by applicant): Needle sticks are the most frequent and most distressing medical procedure children experience. Resultant needle phobia decreases parents' compliance with immunizations and affects patients' subsequent interactions with health care systems, resulting in delayed diagnoses, refusal to donate blood, and even death. Current products rely on health care professionals to voluntarily use messy, ineffective, and time-consuming interventions for a pain many consider insignificant. An immediately effective reusable pain relief device available directly to consumers could reduce morbidity and suffering worldwide. The market for rapid venipuncture pain relief is large; the market for immediate immunization relief is larger and untapped. A small non-invasive device placed centimeters proximal to the needle site significantly reduced venipuncture pain in adults without impacting IV start success. Phase I of this project evaluates pain and anxiety relief, ease of use, and product acceptance using the device versus standard care in 60 children ages 4 - 6 receiving school-entry immunizations. Concurrently, the prototype will be enhanced to promote pediatric pain relief with distracting cute designs. Phase II of the project is a three arm, placebo-controlled trial to demonstrate pain reduction in four age groups receiving scheduled vaccinations: 4-6 months (n=120), 12-15 months (n=60), 4-6 years (n=60), and 11-12 years (n=75). Using a variety of age-appropriate measures, pain relief will be assessed by videotape coding by blinded researchers, and by parent, nurse, and child self-report when appropriate. Patients will be randomized to one of three groups: placebo, standard care, and using the device. Further professional design will incorporate microelectronic enhancement, internal cooling components, the option to grab and bunch skin for self-injection, durability testing, and power efficiency improvement. Copious literature alludes to the impact of pediatric needle pain and the lack of a good solution. The proposed device overcomes failings in existing products and is easy for consumers to bring to the doctor and apply themselves. These projects will improve and demonstrate the efficacy of a much-needed intervention for pain inflicted on every child.
Tagged as:
SBIR
Phase II
2009
HHS
NIH
Relieving Pediatric Immunization Pain Using A Reusable Personal Device
Amount: $123,920
DESCRIPTION (provided by applicant): Needle sticks are the most frequent and most distressing medical procedure children experience. Resultant needle phobia decreases parents' compliance with immunizations and affects patients' subsequent interactions with health care systems, resulting in delayed diagnoses, refusal to donate blood, and even death. Current products rely on health care professionals to voluntarily use messy, ineffective, and time-consuming interventions for a pain many consider insignificant. An immediately effective reusable pain relief device available directly to consumers could reduce morbidity and suffering worldwide. The market for rapid venipuncture pain relief is large; the market for immediate immunization relief is larger and untapped. A small non-invasive device placed centimeters proximal to the needle site significantly reduced venipuncture pain in adults without impacting IV start success. Phase I of this project evaluates pain and anxiety relief, ease of use, and product acceptance using the device versus standard care in 60 children ages 4 - 6 receiving school-entry immunizations. Concurrently, the prototype will be enhanced to promote pediatric pain relief with distracting cute designs. Phase II of the project is a three arm, placebo-controlled trial to demonstrate pain reduction in four age groups receiving scheduled vaccinations: 4-6 months (n=120), 12-15 months (n=60), 4-6 years (n=60), and 11-12 years (n=75). Using a variety of age-appropriate measures, pain relief will be assessed by videotape coding by blinded researchers, and by parent, nurse, and child self-report when appropriate. Patients will be randomized to one of three groups: placebo, standard care, and using the device. Further professional design will incorporate microelectronic enhancement, internal cooling components, the option to grab and bunch skin for self-injection, durability testing, and power efficiency improvement. Copious literature alludes to the impact of pediatric needle pain and the lack of a good solution. The proposed device overcomes failings in existing products and is easy for consumers to bring to the doctor and apply themselves. These projects will improve and demonstrate the efficacy of a much-needed intervention for pain inflicted on every child. PUBLIC HEALTH RELEVANCE: This project seeks to optimize and test in children a novel inexpensive reusable device to reduce or eliminate immunization pain. Pediatric needle pain leads to reluctance to access health care, delayed diagnoses, noncompliance with vaccines and treatment, and refusal to donate blood. Reducing needle pain is an overlooked opportunity to reduce suffering worldwide.
Tagged as:
SBIR
Phase I
2009
HHS
NIH