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Highland Instruments, Inc. Announces Presentation of "Electrosonic Stimulation As Adjunctive Therapy To Dopaminergic Treatments In Parkinson's Disease", Discussing the Highland Instruments ElectroSonic Stimulation ("ESStimâ„¢") Technology During the 5th International Symposium on Neuromodulation, Held September 16-18, 2013 at Mackenzie Presbyterian University, Sao Paulo, Brazil



12/2/2013 6:59:32 AM

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BOSTON, Dec. 2, 2013 /PRNewswire/ -- Highland Instruments, Inc., ("Highland") today announced Presentation of "Electrosonic Stimulation As Adjunctive Therapy To Dopaminergic Treatments In Parkinson's Disease", discussing the Highland Instruments' ElectroSonic Stimulation ("ESStim") Technology during the 5th International Symposium on Neuromodulation, held September 16-18, 2013 at Mackenzie Presbyterian University, Sao Paulo, Brazil. This research was conducted at the Spaulding Rehabilitation ("Spaulding") Hospital's Laboratory of Neuromodulation (Boston). Felipe Fregni1, MD, PhD, MPH, was the Lead Clinical Investigator at Spaulding. Dr. Fregni is the Director of the Laboratory of Neuromodulation at Spaulding Rehabilitation Hospital and Associate Professor of Physical Medicine and Rehabilitation (PM&R) and Neurology at Harvard Medical School. The clinical data presented was conducted under part 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 ESStim technology for the treatment of Parkinson's Disease ("PD")2.

Timothy Wagner, PhD, Chief Scientific Officer and Founder for Highland commented, "Following years of extensive pre-clinical development, I am excited to see the benefits of ESStim being brought into the clinical environment. I am looking forward to assisting in bringing relief to the millions of Parkinson's patients who are not managed by current therapies." Dr. Wagner continued, "We firmly believe that ESStim overcomes limitations of other reported noninvasive brain stimulation technologies through our advances in tissue targeting, stimulation depth obtained, and sustained therapeutic effect."

Dr. Felipe Fregni commented, "Our preliminary analysis in a series of patients with PD undergoing ESStim treatment demonstrated statistically significant improvement in key clinical measurements employed to manage PD patients. Specifically, 20 PD patients were recruited (10 Active, 10 SHAM). Safety and motor assessments were completed for patients following ESStim treatment given 20 minutes/day for 10 days (5 days/week). Tests were completed at the conclusion of each stimulation visit and one, two, four, and six weeks post stimulation with patients in their "ON" state; that is, we assessed patients while they were under the effects of their current therapies. This is important because we assessed the effects of stimulation beyond what conventional drug therapies provide."

Dr. Fregni continued, "Our results showed that patients undergoing ESStim treatment experienced significant improvements relative to baseline measurements when compared to SHAM stimulation for the following clinical measurements: (1) Walking times improved (p<0.01), (2) Unified Parkinson's Disease Rating Scale ("UPDRS") improved (p=0.058), (3) UPDRS Part III related to bradykinesia and rigidity improved (p<0.05), (4) Bradykinesia test times improved (p<0.01). We also demonstrated that significant effects lasted up to 4 weeks post stimulation. Furthermore, safety data monitored following ESStim treatment demonstrated no neurocognitive decline, no seizure activity on EEG, and no new neurological signs or symptoms."

Dr. Fregni concluded, "ESStim has shown preliminary positive results for PD patients. We are pleased that our Laboratory of Neuromodulation at Spaulding Rehabilitation Hospital is a critical component of this investigation. We will be shortly reporting additional clinical results from our investigation into ESStim for other clinical indications."

Ciro Ramos Estebanez, M.D., PhD3, Neurologist and Assistant Professor of Neurology at Case Western Reserve University, who did not participate in the Phase I trial, independently evaluated the results and stated, "These results are particularly encouraging as the noninvasive ESStim therapy was provided and assessed while patients were receiving their standard therapies. Thus, the data suggests ESStim can elicit safe effective motor improvements in Parkinson patients beyond what their current therapies are providing."

Highland previously reported on November 11, 2013, Presentation of "Effects of Electrosonic Stimulation on the Perception of Chronic Pain Due to Osteoarthritis of the Knee."

Highland previously reported on September 23, 2013, New Award of Small Business Innovation Research ("SBIR") Grant for Clinical Evaluation of Noninvasive Neural Stimulation Technology ("ESStim") in patients with Parkinson's Disease.

Highland previously reported on October 23, 2012, Institutional Review Board ("IRB") approval to initiate clinical evaluation of noninvasive brain stimulation technologies in patients with Parkinson's Disease.

Highland previously reported on July 30, 2012, Award of Small Business Innovation Research ("SBIR") Grant for clinical evaluation of noninvasive brain stimulation technologies.

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 of ESStim for the management of chronic pain due to osteoarthritis.

About Parkinson's Disease
Parkinson's Disease ("PD") is a progressive and ultimately fatal neurodegenerative disease characterized by debilitating physical symptoms including resting tremor, rigidity, bradykinesia, and gait dysfunction4,5. Approximately 50,000-100,000 Americans are diagnosed with PD each year, with over 1 million Americans affected at any given time 2,3. 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 406. Parkinson's disease was listed by the National Center for Health Statistics ("NCHS") as one of the top 15 causes of death during 20077. In 2007, there were 20,000 Parkinson's-related fatalities in the US4. It is estimated that the annual costs of Parkinson's disease exceeds $25 billion8.

About ElectroSonic Stimulation ("ESStim") Technology
Electrosonic Stimulation9 (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. Highland Instruments previously received 510K premarket clearance for the ESStim 001, which implements Electrosonic Stimulation technology.

About the 5th International Symposium on Neuromodulation
The International Symposium on Neuromodulation in partnership with the University Mackenzie (Sao Paulo, Brazil) is an international gathering of clinical and scientific experts in the field of neuromodulation. The Symposium offers participants the latest information regarding innovations in research on brain stimulation techniques.

About Spaulding Rehabilitation Hospital
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 6.

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.

About Highland Instruments, Inc.
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.

1 Dr. Fregni has no financial interest in Highland Instruments.
2 Research reported in this publication is 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.
3 Dr. Ramos Estebanez has no financial interest in Highland Instruments.
4 American Journal of Epidemiology, 2003. 157(11): p. 1015-22
5 Annual Review of Neuroscience, 2006
6http://parkinsons-disease.emedtv.com/parkinson%27s-disease/parkinson%27s-disease-statistics.html
7 National Vital Statistics Reports. Volume 58, Number 19
8 Movement Disorders, 2005 Nov;20(11):1449-54
9 Patents Issued and Pending

Contact:
Bill Edelman, CEO
bill.edelman@highlandinstruments.com
(781) 436-0509

Tim Wagner, PhD, CSO
twagner@highlandinstruments.com
(617) 504-6031

SOURCE Highland Instruments, Inc.



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