Highland Instruments, Inc., Announces Award of Small Business Innovation Research (“SBIR”) Grant for Clinical Evaluation of Non-Invasive Brain Stimulation Technologies

The SBIR Grant Enables Clinical Evaluation of Highland’s ElectroSonic Stimulation (“ESStim™”) In Patients with Parkinson’s Disease

Highland Instruments, Inc., Announces Award of Small Business Innovation Research (“SBIR”) Grant for Clinical Evaluation of Non-Invasive Brain Stimulation Technologies

<0> Highland Instruments, Inc.Bill Edelman, 781-436-0509CEOorTim Wagner, 617-504-6031PhD, CSO </0>

Highland Instruments, Inc., (“Highland”) today announced award of a multi-year SBIR Grant from the National Institutes of Health National Institute of Neurological Disorders and Stroke (“NIH-NINDS”) for the clinical evaluation of Highland’s ElectroSonic Stimulation (“ESStim™”) technology for the treatment of Parkinson’s Disease (“PD”). The main academic partner collaborator in this grant and location of the clinical trial will be Spaulding Rehabilitation (“Spaulding”) Hospital’s Laboratory of Neuromodulation (Boston). Felipe Fregni, MD, PhD, MPH, will be the Lead Clinical Investigator. Dr. Fregni is the Director of the Laboratory of Neuromodulation at Spaulding Rehabilitation Hospital and Assistant Professor of Neurology at Harvard Medical School.

Bill Edelman, CEO and Chairman of the Board for Highland commented, “We are thrilled to have received award of the SBIR Grant for the clinical evaluation of ESStim. We are currently investigating the potential benefits of ESStim for the management of osteoarthritis pain and look forward to potentially expanding the clinical capabilities of this technology in Parkinson’s disease. Dr. Fregni is a pioneer in the world of noninvasive brain stimulation, having conducted groundbreaking trials exploring neuromodulation treatments for chronic pain, Parkinson's disease, and stroke.”

Timothy Wagner, PhD, Chief Scientific Officer and Founder for Highland commented, “Following years of extensive pre-clinical development, I am excited to see the potential benefits of ESStim being brought into the clinic.” Dr. Wagner continued, “We hope that ESStim will overcome limitations of other reported non-invasive brain stimulation technologies.”

Dr. Felipe Fregni commented, "Receiving this highly competitive grant is encouraging for the development of this novel method of stimulation as we investigate the clinical utility of ESStim as a possible therapy for PD. Investigators have been studying a variety of neurostimulation technologies for several decades and the capabilities of ESStim appear very promising. This large NIH grant will be important to advance our knowledge of noninvasive brain stimulation and we are glad that our Laboratory of Neuromodulation at Spaulding Rehabilitation Hospital is a critical component of this investigation. We look forward to the clinical evaluation of ESStim in this collaborative grant."

During October 2011, Highland initiated a clinical evaluation of ESStim in patients with chronic pain due to osteoarthritis.

On December 16, 2010, Highland received Institutional Review Board (“IRB”) approval at Spaulding Rehabilitation Hospital to initiate clinical evaluation ESStim for the management of chronic pain due to osteoarthritis.

Parkinson’s Disease (“PD”) is a progressive and ultimately fatal neurodegenerative disease characterized by debilitating physical symptoms including resting tremor, rigidity, bradykinesia, and gait dysfunction. Approximately 50,000-100,000 Americans are diagnosed with PD each year, with over 1 million Americans affected at any given time . PD is a disease of late middle age, usually affecting people over the age of 50. Recently, some healthcare providers have reported increasing cases of "early-onset" Parkinson's disease in the past several years, and some have estimated that 5 to 10 percent of those sufferers are under the age of 40. Parkinson’s disease was listed by the National Center for Health Statistics (NCHS) as one of the top 15 causes of death during 2007. In 2007, there were 20,000 Parkinson’s - related fatalities in the US. It is estimated that the annual costs of Parkinson’s disease exceeds $25 billion.

Electrosonic Stimulation (ESStim™) is an innovative noninvasive neurostimulation technology. ESStim combines independently controlled electromagnetic and ultrasonic fields. The combined fields focus and boost neurostimulation currents via tuned electromechanical coupling in neural tissue. Preliminary ESStim studies have demonstrated a significantly improved duration and magnitude of stimulation effect compared to other reported dose-matched noninvasive stimulation modalities in electrophysiology, metabolic, and behavioral studies.

Spaulding Rehabilitation Hospital is affiliated with Harvard Medical School, the Massachusetts General Hospital Institute of Health Professionals, and Partners Health Care System, an integrated health care delivery system that includes Massachusetts General Hospital and Brigham and Women’s Hospital. SRH is one of the largest rehabilitation facilities in the U.S. and is a leader in the greater Boston metropolitan area in providing comprehensive rehabilitation and complex medical management services. It is the only rehabilitation hospital in New England to maintain a ranking in the top 10 in U.S. News and World Report’s Best Hospitals survey since 1995; this year it was ranked number 5.

The Harvard Medical School Department of Physical Medicine and Rehabilitation is based at Spaulding. Spaulding is one of the largest rehabilitation hospitals of its kind in the United States, with 296 beds, more than 3000 inpatient admissions per year and a large outpatient service. The main campus also offers more than 15 specialty rehabilitation programs with representatives from 30 medical specialties, including Cardiology, Pulmonology, and Rheumatology to name a few. For this particular study, Spaulding Rehabilitation Hospital is home to the Neurology Rehabilitation Program. The staff in this department will assist with recruitment and care and follow-up with Parkinson’s disease patients. The Neurology Rehabilitation Program at Spaulding Rehabilitation Hospital specializes in a variety of inpatient and outpatient services, including daily medical management, education, and support for Parkinson’s patients and their families. The team works with each patient towards individual goals.

Highland Instruments is a privately held medical device company pioneering the development and commercialization of ESStim™, an innovative noninvasive electrosonic brain stimulation technology for the treatment of brain-based movement disorders as well as chronic pain management. Highland Instruments was founded in 2007 by researchers trained at Harvard Medical School and MIT. International clinical trials with ESStim demonstrated the company's novel therapy for noninvasively stimulating the nervous system via electrosonic fields. Today Highland is developing ESStim technology to treat osteoarthritis patients suffering from chronic pain as well patients with brain-based movement disorders.

Research reported in this publication is to be supported by the National Institute Of Neurological Disorders and Stroke of the National Institutes of Health under Award Number R44NS080632. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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