BioElectronics Corporation Announces the Publication of Pilot Study Results

Beneficial Treatment Effect for Phantom and Residual Limb Pain Identified

FREDERICK, MD, Feb. 23, 2024 (GLOBE NEWSWIRE) -- via – BioElectronics Corporation ( 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:   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.

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