Bioelectronics Corp (BIEL)

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Apparently the following company company communications were missed:


* Quarterly Sales Growth, KT Health and DJO Launches Outpacing Forecasts
APRIL 19, 2021 BLOG, NEWS, PRESS RELEASES 0 COMMENTS [e-mail]
FREDERICK, MD, April 19, 2021 (GLOBE NEWSWIRE) — via NewMediaWire —

BioElectronics Corporation (https://www.bielcorp.com/ OTC PINK: BIEL) is pleased to report Q1 2021 revenue figures, the progress on three different product launches into the OTC and medical markets, ongoing efforts to expand international distribution, and finally, new initiatives into strengthening R&D/manufacturing capabilities.

First quarter sales were $605,675 which is 18% higher than Q4 2020 sales, and an impressive 73% of total 2020 revenue; these percentage increases not only document the Company’s strong growth, but also serve as objective evidence of effectiveness for the Company’s strategic repositioning as an OEM manufacturer. The Q1 2021 sales figure is robust, as there is over $306,000 of deferred sales incoming from signed contracts, for products that have yet to be shipped.

Looking ahead, the Company is now working with their three major channel partners, i.e., KT Health and Scott Specialties in the OTC space, and Medi-Launch in the prescription medical market, to solidify new orders after strong initial product launches that took place in Q1 2021. Kelly Whelan, President & CEO, expressed enthusiasm, “Initial OTC feedback has been very positive, as witnessed by strong consumer reviews (averaging over 4.5 out of 5 on Amazon.com and their company websites) for both the KT Recovery+ Wave™ and DonJoy® EME products. The launch into the medical channel was slowed by the pandemic but has recently accelerated as hospitals are resuming non-emergency surgical procedures.”

The Company is also pushing forward on the international sales front. In addition to re-acquiring their CE mark (which allows the Company to sell in most international countries) in late 2020, it also obtained MDSAP certification in Q1 2021, which now allows for product distribution in Canada, Australia, and New Zealand. Ms. Whelan also said, “We are now exploring expanding our OTC sales into more countries in the EU using the same strategy of identifying firms with strong retail experience selling their branded products into the retail market. We hope to be able to announce the results of these conversations in the near future. In addition, through Medi-Launch, we have signed four new international distributorships contracts for our RecoveryRx line.”

Mr. Richard Staelin, Chairman of the Board, commented, “We believe it is important to keep investing in one of our core capabilities, i.e., designing and manufacturing Pulsed Short Wave Therapy medical devices. With this in mind, we are in active talks to conduct new clinical trials both with our RecoveryRx product and extensions of our OTC devices. We are also working with our contract manufacturer to strengthen our manufacturing capabilities to accommodate for increased production, amid international volatility in raw material costs.”


* 3/11/2021

Fellow Shareholders,

We have been seeing lots of comments and receiving lots of questions about advertising and promotion.

As you are aware, we have shifted the focus of BioElectronics Corporation. We are now operating as an OEM in the over-the-counter retail space. We manufacture devices- we do not market, advertise or promote.

In the past year, we built the KT Recovery+ Wave to the specifications of the customer- color, battery life, package design, etc. We have also manufactured devices for use in the DJO Advantage Line back and knee wraps.

The Recovery+ Wave product “officially” launched on February 22nd. The product is currently being placed on shelf in CVS stores. We have no expectation that KT Health would spend money advertising or promoting the product until the shelf placements are complete. That would simply make no sense. We have been informed that DJO is currently crafting their marketing and advertising campaign. As with most multi-billion dollar companies, things simply don’t happen quickly at DJO.

The simple fact of the matter is that we do not advertise, promote or market the over-the-counter retail products. As an OEM, our profit is made when we sell the devices to each marketing partner.

We do not set wholesale or retail pricing and we have no direct contact with the retail buyers.

Simultaneously, we have been building a contract sales force to promote the technology and the brand name RecoveryRx to the medical professional’s market- physical therapy, surgeons, pain doctors and the like.

I thank each of you for being a shareholder. Our team appreciates your support.

Kelly Whelan

President

BioElectronics Corporation


* 3/3/2021

From BIEL. Many of you over the years have asked for a spokesperson for products:

Super proud to have paralympian and world champion Oksana Masters promoting the KT Recovery+ Wave (manufactured by BioElectronics Corporation) #teambiel #TeamUSA #innovation #neuromodulation #electroceuticals #rollout #drugfreepainrelief #sportsmedicine #otc #fdacleared #onshelf


* Release #:812-197420-rl-1190694:
BioElectronics Corporation Announces Substantial Increase in 4th Quarter 2020 Revenue; Major Convertible Debt Holders Agree to Forego Interest in 2021

Frederick, Maryland, Jan. 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioElectronics Corporation (OTC PINK:BIEL) is pleased to report that Q4 revenue for 2020 exceeded $519,000, representing an increase of 241% when compared to Q3 revenue in 2020 ($151,956). Correspondingly, Q4 2020 revenue represents an increase of 233% when compared to the cumulative revenue of Q1 and Q2 in 2020 ($155,818).

As of today, the Company has $554,074 in deferred revenue remaining on the books, at least half of which is scheduled to ship in Q1 of 2021.

Richard Staelin, Ph.D., Chairman of the Board, said, “We believe this increase in both revenue and deferred revenue is a strong signal that the firm is moving in the right direction.” He attributes this robust growth to the firm’s unique portfolio of products and the management’s decision to prioritize partnerships with entities that have a strong brand recognition and significant retail presence.

Keith Nalepka, VP of Sales, commented: “We are pleased with the increase in revenue and look forward to the national retail rollout of KT Recovery+Wave™ and the DonJoy® Advantage products, Powered by ActiPatch®. We are simultaneously bringing on more international distribution channels and ramping up our efforts to market and sell the RecoveryRx® brand domestically.”

The managers of the firm’s two largest lenders, which are both controlled by Whelan family members, Ibex LLC and St. John’s LLC, have agreed to extend foregoing of interest due on their convertible debt notes through the end of 2021. Kelly Whelan, President & CEO of BioElectronics, stated: “It is the goal of both BioElectronics’ management team and the Whelan family to bring the Company to profitability as swiftly as possible, for the benefit of all shareholders. The Whelan family has collectively foregone interest in excess of $750,000 in 2020, and will extend this hiatus on interest collection through at least 2021.”

Dr. Staelin noted that “the Board is deeply appreciative of the Whelan family foregoing any interest in 2020 and 2021. This decrease in interest expenses coupled with a steady increase in sales will bring the firm much closer to its goal of posting profits in the near future.”


* BioElectronics Executes Distribution Agreement with KT Health, LLC for North American Retail Market
DECEMBER 15, 2020 BLOG, NEWS, PRESS RELEASES

BioElectronics Executes Distribution Agreement with KT Health, LLC for North American Retail Market FREDERICK, MD, Dec. 15, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — BioElectronics Corporation (OTC PINK: BIEL), (www.bielcorp.com) is pleased to announce that it has executed an OEM agreement with KT Health, LLC to bring its innovative pain management devices to encompass retail and e-commerce distribution throughout North America, as well as several additional key international markets.

The agreement incorporates BioElectronics’ ActiPatch® technology into KT Health’s KT Recovery+® product line, which will be marketed under the proprietary trade name KT Recovery+ Wave™. KT Health will leverage BioElectronics’ FDA 510(k) clearance to market, promote, and distribute the devices for the treatment of general musculoskeletal pain. As part of this agreement BioElectronics will cease active promotion of the brand name ActiPatch in North America. Existing channel partners in the USA will continue promoting the ActiPatch brand name, while BioElectronics will continue expanding its network of international distributors for ActiPatch.

Keith Nalepka, VP Sales and Marketing for BioElectronics, said, “This is an amazing win for our Company. KT Recovery+ Wave™ combines our drug-free pain relief technology with the brand power and adhesives expertise of the recognized leader in drug-free pain treatment and recovery. Consumers will be able to easily place the KT Recovery+ Wave™ device anywhere on the body to treat musculoskeletal pain. We believe KT Health is an excellent match for our technology and can effectively leverage its large customer base that is already comfortable with wearables.”

Greg Venner, CEO of KT Health, commented, “We are extremely pleased to be partnering with BioElectronics on such an innovative and effective product. KT Recovery+ Wave™ allows KT Health to broaden our drug-free pain relief options, expanding our product line into the chronic pain category. We look forward to a long and productive partnership with BioElectronics.”


* THANKSGIVING LETTER FROM THE CHAIRMAN

November 26th, 2020

Dear Shareholders,

It has been a few months since I wrote a Chairman’s letter laying out our new OEM strategy that we implemented just about a year ago. The purpose of this letter is to document some of our accomplishments over the last 12 months and to share with you some of the major events that have occurred, or we believe will be occurring in the early part of 2021.

Sales

Soon after the management reorganization, our sales team got on the phones to re-establish relationships with firms that the Company had talked to over the last few years. After a few false starts, the team re-engaged with three firms with interest of selling our medical devices into the domestic OTC market. The first was Scott Specialty. This firm was in the process of developing specialty wraps for DonJoy. Scott placed their first order in August and we anticipate that the final units associated with this initial order will be delivered by early December. (DonJoy is already selling units online and we are told they will be placing units in brick and mortar outlets next month.) We are anticipating a new order from Scott just after the new year.

Two other firms have also placed orders to sell our device in the domestic OTC market. However, they have yet to distribute their products into retail and thus we are not able to identify them. With this noted, both will be receiving delivery of units in December and thus we anticipate booking sales to these customers in fourth quarter 2020. (These two customers anticipate selling into their retail markets in first quarter 2021.)

Internationally, we landed a contract with Adcock, a large firm in South Africa. Adcock is now in the process of registering the product and first sales to them should occur in early 2021. In addition, now that we have re-acquired our CE mark, we are able to reopen communications with our international distributors. We anticipate (or have already received) new orders from Romania, Italy, Australia, Sweden, the UK, and Spain. These sales should be booked in 4th quarter 2020 or 1st quarter 2021. In addition, one of our major domestic customers has been talking to us about also acquiring distribution internationally. These talks will probably continue into 2021.

Finally, we are in the early stages of selling into the medical professional channel with our RecoveryRx product. The plan is to use a 300+ salesforce of independent reps. This salesforce is being set up by Medi-Launch, a firm that has expertise in forming medical salesforce teams and launching new medical products. We have already signed up over 275 salespeople who have distributed more than 1500 samples to surgeons and other medical professionals. These samples allow the medical professionals evaluate our product for post-surgical pain and wound care, the claim associated with our non-OTC 510 (k). A few sales have already been booked and ultimately, we believe this channel of distribution could account for as much as 15% of our total sales volume.

Although I suspect most of you are primarily interested in the above information on sales (and ultimately profits) I would briefly like to mention the support activities that have occurred over this time period to make all these sales happen.

Modifying the product design and building up production capability. One of our customers wanted major design changes to our 720 hour device. This required extensive internal design changes to the device and modifications of the manufacturing processes. In addition this customer wanted to completely redesign the packaging. Coordinating all these changes resulted in extensive communications with the customer’s design team (and their top management) as well as nightly calls to our overseas manufacturer. There were surprisingly few bumps in the road and we are well on the way to fulfill their order. Importantly, this experience has greatly enhanced our core capabilities in product design and manufacturing.

Regulatory issues

We started off the year with significant regulatory issues. The regulatory team worked tirelessly with the firm, NEMCO, to get re-certified. It was a long battle, but we received notification in early November. This certification was critical as it allows us to again sell internationally.

I wish this was the only regulatory issue that we faced this year. We also need to get another certification, called MDSAP. This certification will allow us to sell in Canada and Australia among other countries. The short story is that we are well positioned to complete all the audits needed for certification by late January 2021. In the process we have developed a totally new inventory tracking system needed to augment our quality control processes. Development of this system has been a total team effort.

Other issues—Salesforce sales, Rebranding and R&D

Three other efforts that are currently in progress deserve mention. The first involves developing systems to handle sales through our new salesforce network and new marketing and training materials to support this salesforce. The training materials have been developed and are being used in numerous training zoom meetings, where we educate the independent sales reps on how to present the information concerning our device.

This new emphasis on selling our Rx product has also led us to revise our branding strategy so as to better differentiate the RecoveryRx device from the ActiPatch device. This rebranding is particularly important because the sales prices for these two devices are quite different. Our current plan is to discontinue North American sales under the brand name of ActiPatch by the end of the year. OTC sales in North America will be under the brand names of our marketing partners- essentially a license and supply agreement. We will retain the ActiPatch brand for units embedded into an appliance and sold under the appliance manufacturer’s brand name as “Powered by ActiPatch.”

Last, but not the least, we have made good progress with our R&D efforts. We started basic research to ascertain how our device affects brain waves. This project could open up the doors to solving numerous other diseases/ailments. We have also received notification that our neck study paper has been accepted for publication. The results reported in this paper not only show efficacy of the device over NSAID’s but also strong evidence supporting our claim that our device works via central sensitization. This latter finding is very useful when talking to medical professionals, since they want to know the “mechanism of action”, i.e., why our device works.

Summary

In summary, it has been a busy and productive year. The Company is moving in the right direction. Numerous new systems have been developed to support our new OEM strategy. Our core capabilities of R&D and expertise in designing and manufacturing Pulsed Short Wave Therapy devices have increased. The forecast for the next year has us above breakeven sales. Meeting these projections will not be easy, but it is doable. I am sure there will be some bumps, but the BIEL team will rise to the challenge and come out stronger. Thank you for your continued support, have a great Thanksgiving and stay safe.




* BioElectronics Earns CE Mark for the ActiPatch and RecoveryRx -- Drug-Free Pain Therapy Devices, Opens the Sales Market for 33+ Additional Countries

FREDERICK, MD, Nov. 12, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that it has received the CE (Conformité Européenne) Mark for its ActiPatch® and RecoveryRx® Pulsed Shortwave Therapy (PSWT) medical devices.

The ActiPatch is indicated for the treatment of general musculoskeletal/soft-tissue pain, while the RecoveryRx is indicated for the treatment of postoperative pain. These wearable devices can now be sold over the counter in 33 European Union (EU) countries, and many other non-EU countries like Australia that recognize the CE mark.

Keith Nalepka, VP Sales and Marketing for BioElectronics, said: “This is the latest in a series of wins for the Company. The CE mark will allow us to resume fulfilling substantial orders for existing international partners, and close pending deals that were contingent on the CE mark. We are excited that 2021 will be a great year of sales for the Company.”

The certification for the CE mark is valid until May 2024, and the Company’s updated quality management system will ensure prompt recertification.


* BioElectronics’ ActiPatch® Therapy To Be Marketed By DonJoy® Advantage
NOVEMBER 6, 2020 BLOG, NEWS, PRESS RELEASES

FREDERICK, Md., Nov. 6, 2020 /PRNewswire/ — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.comis pleased to announce the execution of a commercial partnership agreement with Scott Specialties Inc (SS http://scottspecialties.com/) to bring their innovative pain management devices to the retail consumer healthcare marketplace under the DonJoy® (DJO www.djoglobal.com) Advantage product line.

This commercial partnership will leverage the ActiPatch’s broad indications for use and offer an active-passive treatment combination product to treat pain, increase physical functionality and improve overall quality of life. The new products will be marketed under DJO’s DonJoy Advantage (DJA) line of orthopedic appliances and sold as an EME Knee Wrap and an EME Back Wrap, “powered by ActiPatch“. In January 2020, BioElectronics obtained a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the drug free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.” With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain.

Keith Nalepka, VP Sales and Marketing for BioElectronics expressed his enthusiasm for the market opportunity: “This is a great opportunity for the ActiPatch brand. We have executed on our OEM strategy by partnering with Scott Specialties this past spring and leveraging their relationship with DJO to drive ActiPatch sales. During the pandemic we have seen consumers continuing to seek alternatives to oral medicines for pain. By partnering with Scott Specialties and another soon-to-be-announced, major sports medicine company, we are confident that these innovative product offerings will meet the need for a growing demand.” Kelly Whelan, President of BioElectronics, stated “We are thrilled to have the marketing strength of DonJoy Advantage coupled with the power of ActiPatch in products available to consumers online now at www.donjoyperformance.com. A soft launch in retail outlets is scheduled for December and the products will be promoted by DJO’s sales force in Q1, 2021.”


* Release #:812-190762-rl-1190694:
Richard Staelin, Ph.D. Rejoins the Board of BioElectronics Corporation

FREDERICK, MD, June 15, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – BioElectronics Corporation (BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, announced today that it has appointed Richard Staelin, Ph.D. as the Chairman of the Board following the resignation and retirement of Ms. Patricia Whelan.

“The management team at BioElectronics thanks Patricia Whelan for her service and appreciates her willingness to stay on until a qualified replacement accepted a board position following the death of Andrew Whelan, the founder of BioElectronics Corporation,” said Keith Nalepka, Vice President of Sales.

"We are pleased to welcome Dr. Staelin as an independent director and Chairman to BioElectronics Corporation’s board. Dr. Staelin rejoins BioElectronics at an exciting time as we continue to drive our OEM strategy forward and build deeper relationships with current international distributors to fulfill our purpose of helping people live pain free. We are confident he will provide valuable perspective as we continue to execute our strategy, drive profitability and enhance value for all shareholders. We look forward to his contributions and are excited to welcome him back,” said Kelly Whelan, CEO.

Richard Staelin stated, “I look forward to again chairing the board at BioElectronics and helping to guide the firm to reach its enormous upside potential. Recently, Kelly Whelan and Keith Nalepka have taken over the management of the firm and not only have they shown strong leadership, they developed a new long-term vision for the firm. In addition, Dr. Koneru has been providing the technical expertise needed to help foster new product development. I see my challenge as helping the firm focus on actions that will quickly bring the Company to financial independence by building on BioElectronics’ core capability of a deep knowledge of Pulsed Short Wave Therapy (PSWT). The team is focused on building synergistic strategic alliances to facilitate efficient distribution of the Company’s products into North America while simultaneously working to develop new products aimed at mitigating chronic and acute pain.”

About Dr. Staelin: Richard Staelin is the Edward and Rose Donnell Professor of Business Administration at The Fuqua School of Business, Duke University. He served as Associate Dean for Faculty Affairs at The Fuqua School from 1984 until July 1991. For the next two years, he was Executive Director of Marketing Science Institute in Cambridge, Massachusetts. After that he served as Managing Director of The Fuqua School's Global Executive MBA program (GEMBA) 1995-1997, Associate Dean for Executive Education 2000-2002, Co-Director of the Teradata Center for Customer Relationship Management at Duke University 2000-2005, and Deputy Dean 2002-2004. As of July 1, 2004, he stepped down from his administrative duties to devote all his attention to research and teaching. Subsequent to that he was one of the initial members of BiVarus, a start-up that utilized his research on patient experience data and its relationship to the quality of health care.


* BioElectronics Announces FDA Market Clearance for Over-The-Counter Treatment of Musculoskeletal Pain
FEBRUARY 3, 2020 BLOG, EVENT, NEWS, PRESS RELEASES

FREDERICK, MD- February 3, 2020 – BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, is pleased to announce that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new, over-the counter marketing clearance was granted for the drug free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.”

The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints. Keith Nalepka, VP Sales and Marketing, expressed confidence on exploiting the expanded market opportunity: “The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain in the back, knee, hips, wrists, elbow, ankle etc.”

Kelly Whelan, President of BioElectronics, stated “The Company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business.” With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain.

The 510(k) application was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University, Ian Rawe, Ph.D., Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics.