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Discusses Clinical Trial Progress and Potential Legal Action Against MundiPharma
FREDERICK, MD – 
The intent of this short update is to provide potential investors and current stockholders as much information as possible on the progress of our Company over these last three months and our future plans. As I have mentioned many times, I believe our strategic mission is to focus and succeed on three major fronts, these being research, manufacturing processes, and sales. Today, I will focus on the first of these, although I will briefly mention the two other vital components of our mission.
CLINICAL TRIALS IN PROGRESS
We have two investigator sponsored clinical trials now in the field. The first is a surgical analgesia trial being conducted at the University of San Diego. This is a major double-blind, randomized assignment study, involving 120 post-surgical patients who have undergone one of eleven different types of surgery often associated with at least moderate pain. Examples are knee and hip arthroplasty, non-mastectomy breast surgery and hernia repair. These patients are being studied for 180 days, with the primary outcome measures being pain levels and opioid consumption measured on postoperative days 1,2,3 and 7 with follow up measures taken on days 14, 21, 28 and 180 days. These latter measures are important since acute surgical pain can turn into chronic pain. Thus, the study will be able to assess the efficacy of our model 088 in not only reducing the acute surgical pain and opioid use, but also reducing or even eliminating any chronic pain resulting from surgery. Such findings will be new to the literature and should provide important evidence on reducing opioid use and minimizing post-surgical chronic pain.
The last of the 120 patients was enrolled in October of 2023 and the anticipated end date for this 180-day study is now expected to be March 20, 2024. For more information: https://clinicaltrials.gov/study/NCT05399355
The second study is being conducted at Stanford University Medical Center and is focused on thumb arthritics using a modified version of our 088 model device designed especially for the use around the thumb joint. This double-blind, randomized controlled study will involve 60 subjects who are suffering from arthritic pain in the thumb area of the hand. Like the UCSD study, this four-week study is nearing completion. Interim results on 40 patients have already been analyzed and at least 53 patients have been enrolled. The primary measure for this study is the reduction of pain after 4 weeks. The researchers tell us that they are looking at an April-May time frame to finish the study. Assuming continued favorable results, this study should provide access to a new market for the Company. For more information: https://clinicaltrials.gov/study/NCT05315297
COMPLETED STUDIES NOW UNDER PEER REVIEW
There are two randomized controlled studies that have been completed. The first was an investigator sponsored study to treat chronic post-amputation pain with our nonthermal, pulsed shortwave (radiofrequency) therapy using our model 088 device. This study used a cross-over design where the subject got both the active and sham device for 4 weeks and after each of these four-week periods the subjects record the change in average residual and phantom limb pain. This study is complete and the results are now in press and will appear in the Regional Anesthesia and Pain Medicine journal. The abstract will be presented at the American Society of Regional Anesthesia conference in March. Pending publication, we intend to pursue marketing into this pain market given its size (over 1.5 million people have lost a limb). Importantly, up until now there is no effective way of treating phantom limb pain.
The second completed double-blind randomized controlled study looked at increasing the quality of life of canines suffering from symptoms of osteoarthritis. This clinical trial studied 60 canines and found significant improvements in a) behavioral measures often associated with pain and b) range of motion in the affected limbs. In fact, 96% of the treated dogs showed significant improvements in one or both of these measures compared to 4% for the dogs that got the placebo device. The paper documenting these results is currently under third round peer review at the Veterinary Medicine and Science journal. The authors anticipate hearing back within a month as the last request for changes indicated the need for only minor revisions. Based on these positive results, the Company has already designed and ordered new veterinary packaging and plans to commence selling into the veterinary market.
MANUFACTURING
The Company, working with its Chinese manufacturer, recently redesigned the manufacturing process to increase the reliability and shelf life of its current OTC product. The Company also did a proof-of-concept production run of its newly designed RecoveryRx product that is 50% more powerful and has a larger antenna thereby increasing the size of the surgical incision that can be treated. The plan is to test market these devices in the near future.
SALES
Company representatives attended the Modern Musculoskeletal Care Symposium this past weekend in Columbus, Ohio. We were once again invited to exhibit and Dr. Berend spoke to the medical professionals in attendance about “Non Thermal Pulsed Shortwave Therapy for Pre and Post Op Pain” Our attendance at the show was predicated on the expectation that the use of RecoveryRx will expand through the OrthoAlliance (https://orthoalliance.com/) organization in the next few months.
The Company is continuing talks with major distributors, both internationally and domestically. These talks are in different stages of progress, from discussing final approval and registration, to initial exploration of possible interest. Given the unique advantages of our product offerings, these discussions often take a long time, especially with major distributors that have multiple levels of management review.
POSSIBLE LEGAL ACTION
The Company is exploring entering into legal action against Mundi Pharma South East Asia for breach of contract. They signed a five-year contract in October of 2018 with BioElectronics Corporation, agreeing to purchase a minimum of approximately $14,000,000 worth of product from us over the next five years of the contract. However, they never completed the registration of the products into the five territories that we granted them exclusive distributorship and only took ownership of a small amount of the inventory. We have engaged both local counsel and counsel in Singapore, where any arbitration action would need to take place. The Company is actively seeking financial backing to support this legal action.
SUMMARY
I am happy to report that the Company is still making progress, especially in terms of research. However, we still have a long way to go in terms of generating significant sales. Thus, it is important that we continue to look for strong partners who can take our innovative product into the marketplace and generate the sales that we need to become the vibrant company that we aspire to be, one that is not only profitable, but also provides products that significantly relieve both acute and chronic pain.
Finally, I want to thank our shareholders who have shown support for us over these years. We acknowledge that our progress has been slow at times and that we have yet to deliver the hoped-for home run in terms of profit, but I can guarantee you that the Company remains committed to staying the course and turning our expertise in pulsed shortwave therapy into a profitable company.
Richard Staelin, PhD
Certain information set forth in this release contains “forward-looking information”, including “future-oriented financial information” and “financial outlook”, under applicable securities laws (collectively referred to herein as forward-looking statements). Except for statements of historical fact, the information contained herein constitutes forward-looking statements and includes, but is not limited to, the (i) projected financial performance of the Company; (ii) completion of, and the use of proceeds from, the sale of the shares being offered hereunder; (iii) the expected development of the Company’s business, projects, and joint ventures; (iv) execution of the Company’s vision and growth strategy, including with respect to future M&A activity and global growth; (v) sources and availability of third-party financing for the Company’s projects; (vi) completion of the Company’s projects that are currently underway, in development or otherwise under consideration; (vii) renewal of the Company’s current customer, supplier and other material agreements; and (viii) future liquidity, working capital, and capital requirements. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment.
These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
IR@bielcorp.com
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