Highland Instruments, Inc., Announces Presentation of “Effects of Electrosonic Stimulation on the Perception of Chronic Pain Due to Osteoarthritis of the Knee”

Highland Instruments, Inc., Announces Presentation of “Effects of Electrosonic Stimulation on the Perception of Chronic Pain Due to Osteoarthritis of the Knee,” Discussing the Highland Instruments ElectroSonic Stimulation (“ESStim™”) Technology During the 5th International Symposium on Neuromodulation, held September 16-18, 2013 at Mackenzie Presbyterian University, São Paulo, Brazil

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ESStim has shown positive preliminary results in alleviating chronic pain in OA patients.

Boston, MA (PRWEB) November 18, 2013

Highland Instruments, Inc., (“Highland”) today announced Presentation of “Effects of Electrosonic Stimulation on the Perception of Chronic Pain Due to Osteoarthritis of the Knee”, discussing the Highland Instruments’ ElectroSonic Stimulation (“ESStim™”) Technology during the 5th International Symposium on Neuromodulation, held September 16-18, 2013 at Mackenzie Presbyterian University, São Paulo, Brazil. This research was conducted at the Spaulding Rehabilitation (“Spaulding”) Hospital’s Laboratory of Neuromodulation (Boston). Felipe Fregni (1), MD, PhD, MPH, was Lead Clinical Investigator. 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.

Timothy Wagner, PhD, Chief Scientific Officer and Founder of 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 Osteoarthritis (OA) patients who are not managed by current therapies.” Dr. Wagner continued, “We firmly believe that ESStim overcomes limitations of other reported non-invasive 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 18 patients with osteoarthritis (OA) of the knee undergoing ESStim treatment demonstrated statistically significant improvement in key clinical measurements employed to manage OA patients. Specifically, we assessed pain via a Visual Analog Scale (VAS) in 18 OA patients with chronic knee pain (9 Active, 9 Sham) following fixed doses of ESStim for 5 days, 20 minutes/day. VAS scores were taken at the end of the stimulation visits and at two, four, and six weeks post stimulation. Patients that received Active ESStim showed significant effects lasting up to four weeks post stimulation. A 2-way ANOVA of the VAS scores was significant for visit number (p<0.05) and stimulation type (p <0.001).”

Dr. Fregni concluded, “ESStim has shown positive preliminary results in alleviating chronic pain in OA 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.”

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 non-invasive 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 non-invasive 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 ESStim for the management of chronic pain due to osteoarthritis.

About Osteoarthritis of the Knee
Osteoarthritis (OA) is the most common form of knee arthritis. OA is usually a slowly progressive degenerative disease in which the joint cartilage gradually wears away. It most often affects middle-aged and older people(2). OA is the most common form of arthritis, affecting nearly 27 million Americans or 12.1% of the adult population of the United States(3). In the U.S. alone, more than 10 million people are estimated to have OA in one or both knees(4). The combined annual costs of knee and hip arthroplasty in 2007 are estimated to have been approximately $15.6 billion based on data compiled by the Healthcare Costs and Utilization Project (HCUP)(5).

About ElectroSonic Stimulation (“ESStim™”) Technology
ElectroSonic Stimulation (ESStim™) is an innovative noninvasive brain stimulation 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 510(k) premarket clearance for the ESStim 001, which implements ESStim technology.

About the 5th International Symposium on Neuromodulation
The International Symposium on Neuromodulation in partnership with the Mackenzie Presbyterian University (São 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.

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1 Dr. Fregni has no financial interest in Highland Instruments.
2 http://orthoinfo.aaos.org/topic.cfm?topic=a00212
3 Arthritis Rheum. 2008;58(1):26-35.
4 http://www.synviscone.com/about-knee-osteoarthritis.aspx
5 Agency for Healthcare Research and Quality Web site. http://hcupnet.ahrq.gov/HCUPnet.jsp
6 Patents Issued and Pending.


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