Highland Instruments, Inc., Announces Institutional Review Board (“IRB”) Approval to Initiate Clinical Evaluation of Non-Invasive Brain Stimulation Technologies In Patients with Parkinson’s Disease

The IRB Approval Enables Clinical Evaluation of Highland’s ElectroSonic Stimulation (“ESStim™”) in Patients with Parkinson’s Disease at the Spaulding Rehabilitation Hospital (Boston)

Highland Instruments, Inc., Announces Institutional Review Board (“IRB”) Approval to Initiate Clinical Evaluation of Non-Invasive Brain Stimulation Technologies In Patients with Parkinson’s Disease

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

Highland Instruments, Inc., (“Highland”) today announced IRB approval to initiate a clinical evaluation of Highland’s ElectroSonic Stimulation (“ESStim™”) technology for the treatment of Parkinson’s Disease (“PD”). The clinical evaluation “Effects of Non-Invasive Neurostimulation Methods on Motor Function in Parkinson’s Disease Patients” will be conducted at the 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 Associate Professor of Neurology at Harvard Medical School.

Bill Edelman, Chairman of the Board for Highland, commented, “We are thrilled to have received IRB approval to initiate the clinical evaluation of ESStim in patients with Parkinson’s Disease. Dr. Fregni is a pioneer in the world of non-invasive 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 of 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, "IRB approval will enable us to 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. 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."

On July 31, 2012, Highland announced award of a Small Business Innovation Research (“SBIR”) Grant for the clinical Evaluation of Highland’s ElectroSonic Stimulation (“ESStim™”) technology for the treatment of Parkinson’s Disease (“PD”).

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 non-invasive 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 non-invasive 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.

Highland Instruments is a privately held medical device company pioneering the development and commercialization of ESStim™, an innovative non-invasive 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 non-invasively stimulating the nervous system via electrosonic fields. Today Highland is developing ESStim technology to treat osteoarthritis patients suffering from chronic pain as well as 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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