Outlines Sales Activities, Clinical Trials, and a Potential Legal Action Against MundiPharma
FREDERICK, Md., Oct. 16, 2024 (GLOBE NEWSWIRE) -- BioElectronics Corporation (https://www.bielcorp.com/ OTC: BIEL a developer of medical technology products, today releases an update from its Chairman, Richard Staelin, PhD.
Dear Shareholders,
It has been a while since I provided an update on BioElectronics Corporation's activities. Below are some of the most significant.
Current Medical (RecoveryRx) Sales
Although our RecoveryRx product is well accepted in professional practices that offer cash services or products, most medical offices deal strictly with items billable to insurance. Although we have tried to obtain insurance coverage for our medical devices, we have not been successful in the United States. This has led us to re-focus our efforts on channels where the product is paid for by the system and not the patient. Consequently, we recently contracted with a service-disabled veteran-owned small business (SDVOSB) to bring RecoveryRx into the VA system, leading in part to getting an unsolicited testimonial from Congressional Medal of Honor recipient Major General Livingston which can be viewed here: https://youtu.be/jljs7QPX7KE?si=TSX71Dh-kvG4tzOL It is our current expectation that this testimonial, coupled with an aggressive sales effort from the SDVOSB sales force, will soon result in not only our veterans getting needed relief from our RecoveryRx medical device, but also an increased volume of sales for the RecoveryRx product.
A second line of attack to increase sales is to launch our RecoveryRx product into the veterinary market, since this is a market where customers are used to paying cash for their pet's needs. We have built this launch plan around our strong clinical findings that show our device greatly increases the quality of life of older canines who suffer from osteoarthrosis. We recently obtained a sales presentation meeting with the President and executive veterinarian of one of the larger corporate-owned veterinary clinics that operates both within the US and globally. Based on this presentation, they decided to formally evaluate our products. Assuming a positive outcome, this will mean that each of the 1000 or so clinics in the United States will be able to use and sell our products.
In addition, we have gradually built-up demand for our RecoveryRx product among independent veterinarians who order directly from us. Our product has a decided cost advantage for treating animals for osteoarthrosis compared to the most popular pharmaceutical solutions and the Assisi device.
Finally, we have undertaken to redesign the RecoveryRx product to better fit a small animal. This new design is currently being evaluated in the field.
Additional Clinical Trials
Our distribution partner in Italy informs us that a study entitled "Effectiveness of Actipatch in the Management and Prevention of Pillar Pain Following open Carpal Tunnel Release Surgery in weight-bearing hand of Elderly Patients: An Observational Study" has been accepted for publication. Pillar pain is a complication observed in post-surgical carpal tunnel release. Although pillar pain typically subsides within three months post-surgery, a small percentage of individuals might endure its effects for up to six months. The cause of pillar pain is unknown and there is no absolutely effective treatment, nor is there agreement on the treatment. The conclusion from the study is the use of our model 088 medical device proves to be a viable and effective approach for managing and preventing pillar pain in elderly patients with weight-bearing hands who have undergone carpal tunnel release surgery.
Possible Legal Action against Mundipharma for breach of contract
In September of 2023 the Company terminated a contract with Mundipharma Southeast Asia. In that contract, Mundipharma guaranteed to purchase a volume of product costing about $14 million over the 5-year period starting in late 2018. In return, we agreed to grant them exclusive distributorship in five SEA countries. However, these purchases never approached this required amount, nor did Mundipharma meet their obligation to register the product in four of the five territories. Consequently, at the end of the contract the Company began negotiations with Mundipharma to reach an equitable solution concerning its obligations to purchase and register our products. However, even after correspondence with Mundipharma’s C-suite executives, no such agreement was reached, leaving us with the next (very expensive) option which is to enter into binding arbitration to settle this dispute. Consequently, we sought outside support to move to this next level. The Company is now in the final stages of obtaining the necessary litigation financing with a firm that has already independently evaluated our case against Mundipharma for their breach of contract. Although no final decision has been reached, their expert legal advisor has indicated that we have a strong case. Assuming we secure the litigation financing, we intend to pursue our action against Mundipharma.
Synergy Corporation Contract
I want to address the failed contract with Synergy Corporation, since a number of investors have asked about this contract. After completing due diligence using two independent advisors and noting that Synergy had already signed a contract with a west coast firm, we executed an agreement with Synergy in July of 2022 and soon afterward announced this to the public. The agreement required Synergy to register our products with multiple local health authorities and place their initial stocking order. Despite promises, numerous meetings, and assurances by Synergy's management and CEO, they failed to meet their obligations. We concluded and still believe they submitted false information to our management team. In June of 2023, BioElectronics terminated the contract.
Other Possible Sales Contracts
As stated several years ago, we believe our core capabilities are in R&D and manufacturing. We do not have the financial or personnel resources to launch a major product brand. Instead, we have focused our efforts to work with third-party experts with the capital and marketing expertise required to educate and reach customers looking for a pain relief solution. These third-party experts can be medical professionals (e.g., veterinarians, doctors, etc.) if the customer is looking for medical advice or marketing and sales firms if the customer is looking for a solution via an over-the-counter product. We continue to search out well-qualified third-party partners, both internationally and domestically and regularly engage in meetings and conversations with such potential partners. These discussions are in different stages of progress, from discussing final approval and registration, to initial exploration of possible interest. Given our product offerings' unique advantages and regulatory requirements, these discussions often take a long time, especially with major distributors with multiple levels of management review. I would like to assure our investors that we are laser-focused on identifying the best partners and then making certain that both parties find economic value in the relationship.
Finally, I want to thank our investors who have been with the Company for many years. Our progress has been slow and at times frustrating. However, we still strongly believe our products provide effective pain relief for many conditions. An increasing body of clinical studies confirms this belief, and we continue seeking researchers to study additional conditions. Our vision and goal remain, i.e., use our core capabilities to realize our mission of reducing human and animal suffering from pain and providing good economic returns to our investors.
Richard Staelin, PhD Chairman of the Board
Contact:
Kelly Whelan, President 301-874-4890 ir@bielcorp.com
