For patients with chronic osteoarthritis knee pain, the standard of care often involves a difficult choice: manage with escalating doses of medication or consider invasive surgery. A small company in Braintree, Massachusetts, is betting there is a third way, using a noninvasive neuromodulation device that has quietly progressed through a series of government-funded clinical trials. Highland Instruments, founded in 2017 by scientists from Harvard Medical School and MIT, is developing ESStim, a platform that combines electromagnetic and ultrasonic fields to modulate brain activity for conditions ranging from chronic pain to Parkinson's disease [Highland Instruments website]. The company's path is defined not by venture capital but by peer-reviewed science, having secured over $850,000 in grants from the SBIR Targeted Technologies Program and the National Institutes of Health to fund its research [CBInsights] [inknowvation.com].
The Electrosonic Wedge
Highland's core technology, ESStim, couples two established noninvasive brain stimulation techniques: transcranial ultrasound (TUS) and transcranial direct current stimulation (tDCS) [Highland Instruments website]. The hypothesis is that the combined electrosonic approach can achieve deeper, more targeted neuromodulation than either modality alone, potentially offering a drug-free alternative for managing neurological symptoms. The company has completed multiple randomized, double-blind, placebo-controlled trials, with results consistently showing statistically significant benefits [Highland Instruments website].
A Grant-Fueled Clinical Roadmap
Highland's development strategy is etched in its clinical trial registry. The company is systematically investigating ESStim across a spectrum of hard-to-treat conditions, with each study backed by competitive federal grants.
| Condition | Trial Phase | Key Partner | Reported Outcome |
|---|---|---|---|
| Chronic Osteoarthritis Knee Pain | Phase II (ALGEA 2) | Spaulding Rehabilitation Hospital | Positive outcomes vs. sham stimulation reported [PRNewswire] |
| Carpal Tunnel Syndrome | Phase II | Spaulding Rehabilitation Hospital | Phase I showed statistically significant improvements [BioSpace] |
| Parkinson's Disease Postural Instability | Phase II RCT | NIH/NINDS SBIR-funded | Ongoing [Physical Therapy Products] |
| Parkinson's Disease (Adjunctive Therapy) | Phase I (JANUS 3A) | NIH SBIR-funded | Improved UPDRS and gait/postural metrics [Physical Therapy Products] |
| Opioid Use Disorder | Research Award | NIH | Additional funding awarded in 2022 [PRNewswire, Aug 2022] |
The Patient Population and Standard of Care
Highland's work is aimed squarely at patients for whom existing treatments are inadequate or carry significant burdens. For the roughly 10 million Americans with symptomatic knee osteoarthritis, the journey often progresses from over-the-counter pain relievers to corticosteroid injections, and eventually to total knee arthroplasty. For individuals with Parkinson's disease, postural instability and gait freezing are debilitating symptoms that dopaminergic medications often fail to address fully. Highland's bet is that a device-based, noninvasive therapy could fill this gap, offering a new tool for neurologists and rehabilitation specialists without the side-effect profile of systemic drugs.
The Risks of the Grant-Only Path
While the NIH stamp of approval is a powerful signal of scientific merit, it also outlines the company's primary challenge: the transition from clinical research to commercial product. Grant funding is excellent for proving efficacy and safety, but it is not designed to scale manufacturing, build a commercial team, or navigate the FDA's de novo or 510(k) clearance pathways. With an estimated team of 1-10 employees and revenue around $200,000, Highland remains a research entity by commercial biotech standards [Explorium.ai] [RocketReach]. The company's next twelve months will be critical. Watch for three signals that the bet is moving from the lab toward the clinic:
- Regulatory strategy: The first submission for FDA clearance, likely for chronic pain, would mark a major inflection point.
- Commercial partnership: A licensing deal or development partnership with a larger medtech company would provide capital and distribution muscle.
- Follow-on financing: A venture round or strategic investment would be needed to fund the pivotal trials required for regulatory approval and initial commercial launch.