SB1AG091887

CRP: Noninvasive brain stimulation for chronic pain treatment - Proprietary: This proposal includes trade secrets and other proprietary or confidential information of Highland Instruments and is being provided for use by the National Institutes of Health (NIH) for the sole purpose of evaluating this SBIR proposal.

No other rights are conferred.

This proposal and the trade secrets and other proprietary or confidential information contained herein shall further not be disclosed in whole or in parts, outside of NIH without Highland Instrument's permission.

This restriction does not limit the NIH's right to use information contained in the data if it is obtained from another source without restriction.

This legend applies to the entire proposal, including, but not limited to the abstract, introduction, specific aims, research plan (all components), commercialization plan, and human subject's sections of this proposal.

Abstract. Chronic low back pain (CLBP) is a leading cause of pain and disability [1-5].

Over twenty million Americans suffer from CLBP; over three million Americans with CLBP are refractory to conservative therapies such as pain medication and physical therapy.

Those patients refractory to conservative therapies are left with two subpar options – continue to suffer from chronic pain or face invasive and risky surgical procedures such as implantation of spinal cord stimulators or spinal surgeries.

Furthermore, current therapies [4, 6-12] do not directly address the fact that chronic pain sensation is processed in the brain [4, 6, 7], even though CLBP symptomology can correlate with chronic pain-induced changes in brain activity and/or structure [13-21].

Non-invasive brain stimulation (NIBS) has been successfully applied for the treatment of chronic pain in some disease states, where treatment-induced changes in brain activity revert maladaptive plasticity associated with the sensation of chronic pain [14, 15, 22].

However, past NIBS methods have shown limited, if any, efficacy in treating CLBP [23-28].

It has been postulated that limitations in past NIBS techniques' focality, penetration, and targeting control limit their therapeutic efficacy [29-33].

Electrosonic stimulation (ESSTIM™) is an improved NIBS modality that combines independently controlled electromagnetic and ultrasonic fields; the combination has a synergistic effect which results in enhanced neuromodulation compared to previous NIBS methods.

This enhanced neuromodulation translates into improved real-world outcomes for CLBP patients such as reduction in pain, improvement in function, and enhanced quality of life as evidenced by our Phase I and Phase II randomized double-blind controlled trials.

Highland aims to translate its current device designed for clinical research into a commercially ready ESSTIM™ platform.

Highland will accomplish this by partnering with third party contract designers to conduct late-stage R&D activities.

These activities include, and are not limited to – finalizing design requirements, hardware development, software development, human factors refinement, verification and validation, documentation, optimizing manufacturing processes, and preparing materials for transferring to manufacturing for scale up.

Highland will also partner with Spaulding Rehabilitation Hospital/Harvard Medical School and University of Illinois Chicago for multiple iterations of usability studies to ensure optimal user experience for clinicians and patients.

Overall, the proposed activities will allow us to optimize the ESSTIM™ platform and prepare the commercial ready product for CLBP patients that are refractory to conservative treatment.

Highland Instruments

NOT APPLICABLE

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Wellesley Hills, Massachusetts 024811930 United States

Single Zip Code

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) (PAR-23-219)

Amendment Since initial award the total obligations have increased 93% from $2,055,669 to $3,972,237.