BioElectronics Company Updates
Thursday, August 6, 2015
BioElectronics Files 510(k) Premarket Notification for ActiPatch® Therapy with FDA
We are pleased to announce we have filed a 510K Premarket Notification for ActiPatch® Therapy with the US Food and Drug Administration.
As most of you know, the FDA has not yet published the reclassification for pulsed shortwave from Class III to Class II as proposed in February of 2013. The mechanism of action of our device is different from traditional devices. We have filed a request for clarification to determine if we should continue to use the pulsed shortwave classification of our devices clarified, we have decided not to wait. We do not foresee adjusting or resubmitting the application to accommodate a different FDA action.
“I am pleased with the strength of this filing and confident that it will satisfy the agency staff,” said Andrew J. Whelan, President and CEO. “We felt the overwhelming nature of our evidence, the solid legal and regulatory support from the law firm of Goodwin Proctor, and the American consumers’ dire need for safe pain relief warranted filing. Our request for over-the-counter market clearance is strengthened by three clinical trials on ActiPatch use in osteoarthritis knees, plantar fasciitis and post-operative pain, our explanation of the mechanism of action, the overwhelmingly positive results of the recently published United Kingdom and Ireland Registry assessment of 5,000+ users, our surveys of users published this week in Pain Management, and the sale of hundreds of thousands of devices.
The extreme need for an effective, safe treatment for pain without the dangers of narcotics should move the FDA to a prompt and positive action.
BioElectronics’ Landmark 5,000+ Chronic Pain Patient Study Published in Pain Management Medical Journal
BioElectronics Corporation recently announced that its registry study of 44,000 users of its ActiPatch 7-day trial device has been published in the prominent peer reviewed medical journal Pain Management http://www.futuremedicine.com/doi/full/10.2217/PMT.15.35. More than 5,000 chronic pain sufferers responded to the survey and submitted an assessment.
Chronic pain is a major unmet medical need that affects 20 to 40 % of the global population (more than diabetes, heart disease and cancer combined.) The majority of chronic pain causes, 80-85%, are musculoskeletal in nature. Despite using an average of 1.9 drugs for pain, 86% of the respondents reported that prior to using ActiPatch, they had pain levels of 8+ on a 11 point VAS scale- indicating severe unresolved pain. Pain was reduced an average of 57% for 65% of ActiPatch Therapy users who reported suffering from conditions such as osteoarthritis, rheumatoid arthritis, fibromyalgia, sports injuries, post-surgical pain, tendonitis, and neuropathy. There were no side effects reported.
A 3-month follow-up survey indicated 80% of ActiPatch users continued to purchase and use ActiPatch. The long-term effectiveness of ActiPatch therapy was confirmed by 93% of survey respondents reporting sustained pain relief, a distinct decrease in their medication use, and a significant improvement in their quality of life.
Dr. Deepak Kotak, Executive VP of BioElectronics, a Fellow of the Royal College of Anesthesiologists said “Musculoskeletal pain is an increasing problem with few appropriate, safe, drug solutions. ActiPatch is a safe, affordable, self-treatment for chronic pain.”
UpTick News Wire Radio Show Interview with BioElectronics’ CEO Andrew Whelan
BioElectronics Corporation recently announced that its registry study of 44,000 users of its ActiPatch 7-day trial device has been
Andrew J. Whelan was interviewed by Stu Taylor on his program “On Business“ on August 9th. Mr. Whelan reported the exceptional acceptance the company’s flagship product ActiPatch Therapy, is achieving in the UK. Other topics for discussion include upcoming clinical publications and the status of its US FDA market clearance progress.
To listen to the interview, please visit:
UK Pharmacy Show 2015
BioElectronics will be exhibiting at The Pharmacy Show (www.thepharmacyshow.co.uk) on October 18-19, 2015. Pharmacy owners and their teams together with pharmacy buyers, wholesalers and allied professionals are invited to take part in two unique days of product sourcing, learning and networking at the UK’s leading exhibition and conference dedicated to pharmacy in the community.
As the NHS moves towards placing a greater role on community in the delivery of patient care, visitors can expect exciting new developments as the show’s education programme evolves to meet the needs and future shape of community pharmacy. With 7,000 + expected visitors, why not join the 400+ exhibitors at this years’ show and have your sales team walk away with 100’s of educated and qualified business leads for immediate follow up.
European Pain Federation EFIC® 2015
The European Pain Federation EFIC® (http://efic.kenes.com/) is a multidisciplinary professional organisation in the field of pain research and medicine, consisting of the 36 chapters of the International Association for the Study of Pain (IASP®), which are the IASP approved official National Pain Societies in each country. Established in 1993, EFIC’s constituent chapters represent Pain Societies from 36 European countries and close to 20,000 physicians, basic researchers, nurses, physiotherapists, psychologists and other healthcare professionals across Europe, who are involved in pain management and pain research.
Dr. Deepak Kotak, Executive Vice President at BioElectronics, Ian Rawe Ph.D, Director of Clinical Research and Dr Bagnatos have been accepted to make presentations at the conference.
BioElectronics Social Media
Next Company Update: Thursday, September 3, 2015
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