Discusses Clinical Trial Progress and Potential Legal Action Against MundiPharma
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
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
The second study is being conducted at
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
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
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
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.
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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