Bioelectronics Corp (BIEL)

[srinsocal]

In addition to the 2023 financials BIEL has communicated with shareholders 3 times this year, one COB Update on 2/15/2024 and two PRs, 2/23/2024 and 3/25/2024.

As you well know BIEL has moved to the annual only financial report to save the expense of Quarterly reporting.

Here are the 3 communications since you appear to have forgotten about them:


FREDERICK, MD, Feb. 15, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – BioElectronics Corporation (https://www.bielcorp.com/ OTC: BIEL a developer of medical technology products, today releases an update from its Chairman, Richard Staelin, PhD.

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
************************************************************************************************************
Beneficial Treatment Effect for Phantom and Residual Limb Pain Identified
FREDERICK, MD, Feb. 23, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – BioElectronics Corporation (https://www.bielcorp.com/ OTC: BIEL a developer of medical technology products, today announces the publication of a study investigating the treatment of phantom and residual limb pain using its pulsed shortwave therapy device.

"Treating intractable postamputation pain with wearable, non-invasive, non-thermal, pulsed shortwave (radiofrequency) therapy: a randomized, double-masked, sham-controlled, crossover pilot study" is now published at: https://rapm.bmj.com/content/early/2024/02/21/rapm-2023-105154 The study was investigator sponsored and funded by the University of California San Diego Department of Anesthesiology.

The study design had patients first wear BioElectronics’ Model 088 device (about ½ wore the sham device and the remaining wore the active device) on the residual part of the limb for 28 days. After 28 days, the patient began wearing the opposite device, i.e., the sham group wore the active device, and the treatment group wore the sham device, again for 28 days. Three major measures were obtained for both phantom pain and residual pain along with a global assessment of change in both phantom and residual pain before, during, and after each 28 days.

The researchers presented their findings in a series of graphs over time depending on whether the patient was wearing the sham or active device. When wearing the sham device, patients reported, on average, no change in the median phantom limb pain or pain in the residual limb. They also reported no median change in their global assessment of pain. In contrast, when the patients were wearing the active device, they reported, on average, a 40% to 50% decrease in the median measures for both average and worst residual and phantom limb pain by day 7 and this reduction continued through day 28. Moreover, a majority of patients, when wearing the active device, reported the highest level of global change in residual pain, i.e., “very much better” by day 21 and this continued through day 28. This measure on the phantom limb pain was also positive, with the majority of subjects reporting being “much better”.

The researchers conclude that further study is warranted given that an identified beneficial treatment effect is associated with using BioElectronics’ Model 088 in the setting of a low-cost and low-risk intervention.

Currently, there are 1.6 million people in the United States who are living with the loss of a limb. Due to the rising number of people who have diabetes, a major cause of amputations, it is estimated that the number of amputations could grow to as many as 3.6 million by 2050. More than 7 in 10 people who have had an arm or leg amputated have pain in the lost limb, which they perceive as still present. Nearly 4 in 10 have severe pain, and many also report depression and anxiety linked with phantom limb pain making it hard to sleep, work, and take part in family and social activities. People who have phantom limb pain are often prescribed medications, including opioids, but opioid medications are effective in only about half of these patients and can also have serious side effects, including the risk of addiction.

Armed with these published results, BioElectronics Corporation will pursue appropriately qualified distribution partners to market and sell its unique pulsed shortwave device to address this significant unmet medical need.
******************************************************************************************************
BioElectronics Corporation Announces the Publication of a Canine Arthritis Study
FREDERICK, MD, March 25, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioElectronics Corporation (https://www.bielcorp.com/ OTC: BIEL) a developer of medical technology products, announces the results and publication of a study investigating the efficacy of its FDA-cleared pulsed-shortwave-therapy (PSWT)device in initiating a systemic anti-inflammatory response to improve functionality of canines diagnosed with osteoarthritis. 96% of the treatment group showed either increased passive range of motion, improved behavioral changes, or both compared to 4% for the placebo group. The study was published online by Veterinary Medicine & Science, and can be viewed here: https://doi.org/10.1002/vms3.1408

A randomized, blinded, placebo-controlled 14-day study of 60 dogs having prior veterinary-diagnosis OA in at least one limb joint. Two outcomes measuring the dog’s quality of life were assessed: subjectively determined changes in eight behaviors associated with discomfort, and objectively determined changes in passive range of motion (PROM). BioElectronics’ Model 088 device was secured near the cervical region of the dog’s spine. PROM measures were taken at baseline and day 14. Behavioral measures were taken daily.

Forty-nine animals completed the study. No negative side effects were reported. Average subjective discomfort scores for the treatment group (N=26) were reduced from 4.26 to 2.31 (45%) compared to no improvement in the placebo group (N=23) over the study period. Average PROM scores increased by 5.51 (4.59--6.23) degrees relative to the placebo group. Ninety-six percent of the treatment group showed either increased PROM or improved behavioral changes or both compared to 4% for the placebo group. Most changes occurred within the first 8 days of treatment.

Osteoarthritis is the most common type of arthritis in dogs and is the most common source of chronic pain in older dogs. This is due to the constant wearing away of the cartilage from dogs running, jumping, and other strenuous exercise. The prevalence of osteoarthritis can be as high as 20% in dogs more than a year old, with middle-aged and older dogs being at higher risk. Dogs that are diagnosed with arthritis tend to be lethargic, have difficulty moving from a sitting or lying position, cracking joints, stiffness, muscle wastage, and visible pain. Current treatment options for arthritis are typically NSAIDs given alone or in combination with other disease-modifying agents. In recent years, chronic use of NSAIDs has been linked to numerous side effects, including gastrointestinal (GI) bleeding, and renal and hepatic dysfunction. Anti-inflammatory drugs such as aspirin and ibuprofen may also result in side effects, such as GI bleeding. BioElectronics Model 088 applied at the cervical spine level, may have the potential to significantly improve the quality of life for dogs and other small domestic animals with OA.

Armed with these published results, BioElectronics Corporation will pursue appropriately qualified distribution partners to market and sell its unique pulsed shortwave device into the veterinary medicine market.