FREDERICK, Md., Aug. 4, 2014 /PRNewswire/ -- The following is a
letter from the President of BioElectronics Corporation (OTC
Pink: BIEL) to shareholders:
Dear BIEL Shareholders:
BioElectronics Corporation's mission is to change the way people
heal and relieve their pain. As the chart below, that clearly
demonstrates that, we have done exactly that.
Chronic pain sufferers in the United
Kingdom said that ActiPatch reduced their pain by more than
50%. This is what the BioElectronics team has worked so hard
to achieve. It is also the reason so many of you have stuck
with us through some terrible economic times and the frustration of
the U.S. regulatory environment.
This year has been an exciting period of positive change for the
medical device industry and especially for
BioElectronics. I am anxious to share with you an update
on the progress we made on the four-part growth strategy we
initiated last year. Some high points were: our first
successful retail launch at Boots in the UK; expanded distribution
in Europe; successful clinical
trials completed on osteoarthritis of the knees, long-term plantar
fasciitis and lower back pain; and more awards from industry
publications.
Central to our success in executing this strategy has been the
addition of Dr. Deepak Kotak, M.D.
to our senior leadership team. His multi-faceted strengths as
a critical care physician, anesthesiologist and also as civil
attorney in the UK, has been and continues to be invaluable.
He has taken the lead in critical discussions with prospective
partners for sales, distribution agreements, and technology
licenses. His understanding of the many unmet medical needs,
combined with a creative vision of BioElectronics patented
technology, has added diversity and depth to the pipeline that will
enable BioElectronics to lead and dominate the market. I am
confident his leadership will serve shareholders for many years to
come. Moreover, his current location in London has been critical in strengthening our
engagement and visibility with European customers and partners.
We have made progress because we've stayed focused on the four
strategic initiatives and expanding the scope as opportunities
arose. Those ongoing efforts are:
- Executing an aggressive marketing and sales program in the
large European market and other select global markets;
- Developing political and public support to induce the US FDA to
recognize our safe therapeutic solution to address the dire need
for an alternative to the devastating side effects, complications
and addictions of OTC and prescription analgesic drugs;
- Continuing clinical research to develop new products and
substantiate our efficacy in new indications with large markets and
significant unmet medical needs; and
- Lowering our cost of capital to finance expansion.
First – Global Marketing Program
Sales of our ActiPatch® Therapy products are steadily increasing
in Boots, the dominant pharmacy chain in the United Kingdom and a role model in the
industry. The introduction last fall got a slow start because
it was off-cycle from the Boots normal product introduction
calendar and our product was initially only available in some Boots
retail stores. Nevertheless, we have seen steady and now
accelerating growth in sales, both online, and in the stores thanks
in large measure to our social media sampling program, "Try It and
Tell Us," on Facebook.
This program has multiple advantages: it lowers the
perceived risk of trying our innovative product by putting 7-day
sample devices directly in the hands of the consumers poorly served
by current analgesics; it supports word-of-mouth about the
product's efficacy; it is building a strong body of anecdotal
testimonials and feeding our growing body of data on customer
experience. It is especially promising that survey results
indicate about 70% of those people with chronic pain, who have
tried a sample, are planning to buy the product. This far
exceeds the industry standard. You can read the first-hand
reports at http://www.bielcorp.com/ or on the ActiPatch Facebook
page.
The successful sales growth experience at Boots will facilitate
and accelerate getting the product in more retail outlets around
the world. Boots pharmacies are a strategic member of the
Boots-Alliance, the world's first global pharmacy-led health and
well-being enterprise that includes Walgreens, the largest
drugstore chain in the US.
Other global recognition for ActiPatch Therapy included
citations in two award categories from the OTC
Bulletin, the leading global trade publication
for over-the-counter healthcare products. The Smart Insole™
Heel Pain Therapy product was highly commended as
the "Most Innovative New OTC Product
Award" and the ActiPatch® Musculoskeletal Therapy was
runner-up for its "Best New OTC Packaging Design
Award."
We also expanded our geographic reach this year by adding new
distribution partners with strong, medical distribution experience
and existing product lines.
Second – Developing political and public support to induce
the US FDA to recognize our therapeutic solution
This year, we saw some progress with the FDA. We were very
pleased by the FDA recommendations announced in February in
their Docket No. FDA-2012-N-0378, "Physical Medicine Devices;
Reclassification and Renaming of Shortwave Diathermy for All Other
Uses."
By reclassifying this technology to reflect its safety and
efficacy, the FDA appears to be making scientific evidence the
determinant for additional market clearances, not out-dated
categorizations. Once the agency finally makes a ruling
(comments closed on May 21 and as of
this date, we have no further news), the Company plans to submit
new 510K applications with our extensive clinical data coming from
the world's leading medical institutions.
U.S. pain sufferers need ready access to this safe, drug-free
and cost-effective technology that offers superior pain relief and
accelerates healing. It will be twelve years next week since
the FDA granted market clearance to us for the reduction of edema
following blepharoplasty. Out-dated classifications put this
breakthrough technology in a bureaucratic maze that delayed getting
new indications and over-the-counter approval. Our ActiPatch
Therapy is an over-the-counter electronic bandage that could give
quick relief to millions of American pain sufferers at breakthrough
prices.
Now with the new FDA approach to classification, we are hopeful
that we will get equivalent U.S. market clearances to those we have
earned in Canada, the European
Common Market and much of the rest of the world at a faster
pace. However, I want to assure shareholders that while
the U.S. market is important, it is not critical to the
success of BioElectronics. Our retail launch in the UK and
the signing of new distributors around the world shows that
BioElectronics Corporation will succeed with or without an FDA
clearance for OTC in the U.S.
Third – Continuing high quality clinical research, to further
substantiate clinical efficacy and establish more indications of
use.
Since my last shareholder report, we have successfully completed
three clinical studies, some observational studies, and collected a
growing body of consumer testimonials and pain data. The
double-blind placebo controlled studies were for the following
indications: osteoarthritis of the knee, long-term plantar
fasciitis and lower back pain.
The randomized, double blind, placebo controlled trial on
osteoarthritis of the knee (knee pain) using ActiPatch® Therapy was
conducted by Dr. Gianluca Bagnato,
Division of Rheumatology, University Hospital Gaetano Martino,
Messina, Italy. Results
showed statistically significant improvements in all three measures
for the group wearing the active ActiPatch device relative to the
group wearing the non-active device.
At the Division of Sports Medicine, University of British Columbia, Dr. Jack Taunton completed a randomized,
placebo-controlled crossover trial on chronic plantar fasciitis
(heel pain) using ActiPatch Therapy. The study results showed
strong improvement on a week-by-week basis, statistically above
baseline at 4 weeks, 9 weeks and 26 weeks, with 26 weeks showing
the most improvement for both pain and disability.
Improvement at 26 weeks was the study primary end point and is
indicative of tissue remodeling and healing.
An observational study conducted in Italy demonstrated the value of our technology
in the large dental implant market. Dr. Bartolomeo Operti MD, Chief of Anesthesia
Department Day Hospital Section of Maria Adelaide Hospital and Dr.
Tiziano Tealdo, Clinical Instructor
at University of Genova, Valle
Belbo Implant Center have completed a white paper detailing their
results regarding the use of BioElectronics medical
device, RecoveryRx Therapy in treating swelling and pain in
their dental implant patients following extractions.
Global leaders in research are continuing work on additional
clinical studies at the following institutions: Tufts Dental School, University of British Columbia, University Hospital
Ghent, Belgium, and University
Hospital G. Martin, Messina,
Italy.
Fourth -- Lowering our cost of capital to finance
expansion.
There are a number of potential applications of our underlying
technology that we have had to put on the back burner because of
resource issues. One way we are moving to reduce our cost of
capital is by exploring the possibility of partnering in specific
key markets with companies that have established sales and
marketing presence.
We were also successful in getting the Depository Trust Company
to end the deposit transaction restriction (the Deposit Chill) it
had previously placed on shares of BioElectronics.
I will continue to keep you posted on the progress of our
four-pronged strategy. The successful retail introduction in
Boots is sparking the interest of other leading retailers around
the world. We will continue to pursue FDA approval as new
classification unlocks opportunity. We have a pipeline of new
clinical studies that will support additional indications and new
market opportunities. All of this will allow us to lower our
cost of capital and achieve our potential.
Our core advantage continues to be the strength of our patented
Bioelectroceutical technology that powers our current product line
and is enabling a very strong growing pipeline of new
products. The products in development will allow us to
address additional lucrative markets in the years to
come.
On behalf of the board and management of BioElectronics, I want
to thank all our long-term investors for their patience and faith
in the future of our Company. We will continue to expend
every effort to fulfill its promise.
Sincerely,
Andrew J. Whelan
President
* * * * *
Web site: www.bielcorp.com
Contact: Paul Knopick,
940.262.3584, pknopick@eandecommunications.com
Photo - http://photos.prnewswire.com/prnh/20140801/132705
SOURCE BioElectronics Corporation