FREDERICK, MD--(Marketwired - Feb 28, 2017) - BioElectronics Corporation (OTC PINK: BIEL)
The following is a statement by BioElectronics Corporation President Andrew J. Whelan:
Dear Fellow Shareholders,
US FDA Over-the Counter Market Clearance
The US FDA has now cleared ActiPatch for over-the-counter sales for the adjunctive treatment of musculoskeletal pain related to: (1) heel pain and (2) osteoarthritis of the knee.
We would have preferred an even broader clearance, but this is a great start. We have an ongoing back pain study in progress at the Oxford University Hospital that should suffice to obtain a broader market clearance in the near future.
BioElectronics Corporation is well poised to capture the paradigm shift in medicine towards electroceuticals. The Company's immediate objectives are:
1. Enter a License and Supply Agreement with a major OTC marketing partner. We seek a partner that has boots on the ground and the managerial and financial resources to execute immediate worldwide retail market penetration. We believe the recent US FDA over-the-counter clearances coupled with the following make us very attractive to major consumer health product companies:
- Impressive Efficacy of ActiPatch: 65% of subjects attain a 57% VAS pain score reduction allowing a good night's rest, restoration of daily activities, and an improved quality of life.
- Safety profile of ActiPatch: No reported adverse events, no side effects.
- ActiPatch's ability to help mitigate the opioid addiction epidemic: surveys that indicate our customers on average have a 50% Reduction in Medication Use, including opioids.
- ActiPatch's Exceptional Consumer Acceptance and Demonstrated Marketability: We have developed an innovative approach on how to market an OTC disposable medical device to consumers. The Company's Try & Tell Sales and Marketing Campaign won the OTC Bulletin "Best OTC Marketing Campaign on a Small Budget" award. Since current chronic pain therapies do not meet the need for chronic pain relief, pain sufferers are skeptical of new products. To overcome this skepticism and accelerate product acceptance, we promote and sell a discounted 7-Day Trial ActiPatch device for $9.95 without an on/off switch. Of the trial users, 58% purchased the 720-hour retail units for $30.00, with an average purchase of 1.7 devices within 90 days and 2.7 devices over 1 year.
2. Obtain reimbursement clearance from the National Health System in the UK and Canada. Recently we received a request for additional information on the cost benefit of ActiPatch from the NHS in the UK.
3. Complete the development and testing of the extra strength prescription post-operative chronic wound care device.
4. Complete the clinical trial for back pain at Oxford University Hospital and conduct the migraine headache study. The R&D team has put together a protocol to investigate the efficacy of the ActiPatch in preventing the onset of migraine attacks and/or reducing pain during an attack. The protocol was submitted to Binghamton University's IRB and is awaiting approval. The study will commence in March 2017 and is expected to be completed in June 2017.
This research effort is a collaboration between BioElectronics Corporation, Binghamton University and Eppley Plastic Surgery. Dr. Ken McLeod, from Binghamton University is the principal investigator and a pioneer researcher in the world of bioelectromagnetics. Dr. Barry Eppley, from Eppley Plastic Surgery is a co-investigator and has years of experience treating chronic migraines. Dr. Ian Rawe and Dr. Sree Koneru, both from BioElectronics Corporation, are co-investigators and bring in their clinical and engineering research expertise respectively.
5. Expand clinical evidence on the use of ActiPatch in lieu of or for the reduction of opioids or other narcotics.
6. Continue to seek out international distribution partners. Recently we entered agreements for Lebanon, Bangladesh, and Thailand.
On behalf of the entire staff of BioElectronics, I want to thank all you for your faith in the future of our Company. Please be sure you have "liked" ActiPatch on Facebook and share our posts with your friends and family. You can also let friends and family know that our products can be ordered at www.tryactipatch.com and via Amazon.
Andrew J. Whelan