Highland Instruments Receives NIH NINDS Phase IIB SBIR Award to Advance ESStim™ for Parkinson's Disease

CAMBRIDGE, Mass. - Amzeal -- Highland Instruments today announced that it has received a Phase IIB Small Business Innovation Research award from the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), to support development of ESStim™ for the treatment of postural instability in patients with Parkinson's Disease (PD).

The award provides approximately $1.5 million in current-year funding, with approximately $1.4 million in recommended future-year support, for up to $2.9 million total, subject to availability of funds and satisfactory progress.

ESStim™ is Highland's novel noninvasive neuromodulation platform combining independently controlled transcranial electrical stimulation and transcranial ultrasound stimulation. The therapy is designed to target motor networks involved in PD symptoms, including gait impairment, balance and postural control deficits, and slowness of movement.

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Highland has previously completed four randomized, double-blind, sham-controlled PD studies involving 130 total patients. In each of the four studies, patients receiving ESStim™ demonstrated clinically and statistically significant improvements in motor symptoms compared to both baseline and sham stimulation.

"This Phase IIB award is an important milestone for Highland and for the continued development of ESStim™ as a potential noninvasive treatment option for patients with PD," said Tim Wagner, PhD, Founder and Chief Scientific Officer of Highland Instruments. "We are grateful for NINDS support as we advance ESStim™ toward the next stage of clinical and regulatory development."

"ESStim™ has demonstrated encouraging clinical results in patients with moderate PD, particularly for motor symptoms involving gait impairment, postural instability, and bradykinesia," said Laura Dipietro, PhD, Chief Technology Officer of Highland Instruments. "This award supports our continued work to translate that clinical foundation into a treatment option for moderate PD."

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About Highland Instruments

Highland Instruments is a neurotechnology company developing ESStim™, a novel noninvasive neuromodulation platform designed to help patients address movement disorders, chronic pain, and other neurological conditions. Learn more at www.highlandinstruments.com.

ESStim™ has not been approved by the Food and Drug Administration for a specific clinical indication. This technology is not in commercial distribution in the United States or internationally. Please contact Highland Instruments for additional information regarding this technology and potential clinical application.

The Phase IIB research described in this press release is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number R44NS110237. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.