Invest In Harmonic Health

Harmonic Pain Solutions (HPS) delivers next-gen, prescription wearable pain relief devices, built on two decades of industry-defining work by Pain Care Labs. Our clinically-proven THERMOMECHANICAL stimulation technology alleviates spine, nerve, and muscular pain by inducing neuromodulatory frequencies in harmonic sequences, with a superior safety and efficacy profile compared to electrical stim. Our NIH-funded DuoTherm(tm) reduced low back pain 57% for both acute and chronic pain. Enrollment for the pivotal FDA trials was completed in 2023, with data collection ending June 29, 2024.*

Combining Pain Care Labs' groundbreaking research in neuroscience with a novel harmonic multimodal stimulation, we conquer pain production at the tissue level, and pain perception via conduction and central mechanisms . By leveraging brain connectivity, we unlock the brain's plasticity needed to reverse chronic pain. HPS applies this advanced neuro-physiological insight through precision engineering for hospital and neurosurgical contexts. Our VibraCool Pro devices are FDA 510K cleared for post-op pain relief. Our goal for DuoTherm is to be the first to gain De Novo FDA clearance for a low back pain solution that reduces the risk of healthcare disparities and opioid dependency with acute low back injury, eliminating the need for surgery with chronic low back pain.

With market-ready solutions for back and extremity pain, HPS can extend the platform into pelvic and shoulder indications. We are exploring commercialization partners to disrupt the current paradigm of pain care.

*The primary aim of reducing or eliminating opioid use will be evaluated with initial use, initiation for acute back pain, and daily opioid use for chronic back pain. Intention for surgery, pain intensity and interference, and resolution of pain are secondary outcomes.

World-class team with combined 60+ years of medical device experience: led by scientist-entrepreneur and NIH pioneer in vibration pain reduction, advised by biotech consultants from City Science Center and Columbia University, with successful FDA 510(k) and ISO-13485 certs.
Pivotal NIH acute and chronic low back pain trials underway; Pilot reduced pain 57%: our devices are ready for distribution, awaiting the first De Novo indication for opioid use pending the completion of the acute and chronic low back pain trials NCT04491175 and NCT04494698.
Already raised $5M in non-dilutive grants for project: No previous dilution.
Established key accounts and TAM of $4.3B: 11M failed epidurals, recovery from .5M lumbar surgeries, 1M injuries covered by workers comp and poor surgical candidates are our target markets for the devices, replacing opioids or even surgery.
Novel technology for an unsatisfied market: The spine pain market is $122BN, with most patients seeking any option other than surgery. We have been first to market with our pain-canceling frequency for MSK pain, and have 12 issued utility patents and CIPs supporting our novel multimodal array of harmonic frequencies and thermal combinations.
Winner of National Institutes of Health SBA Tibbetts award: Our two SBIR Fast Tracks led to discoveries of the optimal combination of frequency and thermal pain relief. The Tibbetts award recognizes the "economic, technical, and societal benefits of SBIR Funding". This is the same award 23&me won in 2016.

The preceding analysis should be read in conjunction with all materials included with it. This analysis contains forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Any statements that are not statements of historical fact are forward-looking statements. When used, as well as whether or not used but are implied, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect," and the like, and/or future-tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements in these materials. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors such as those included in the supporting materials provided herewith. We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this projection's preparation.

The Future of Physics Medicine:

Neuroscience + Precision Vibration Harmonics Deliver Power Over Pain

Why Motion Is Medicine: Neuroscience Blog Series

Use Mobility To Reduce Pain

Leverage Passive Movement

Context Changes Pain

Cutting-Edge Technology

Researchers study pain-relieving neural mechanisms by activation of the motor cortex:

Zheng Gan et al, Layer-specific pain relief pathways originating from primary motor cortex, Science (2022)

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