BioElectronics Issues Letter to Shareholders
FREDERICK, Md., May 4, 2012 /PRNewswire/ — BioElectronics Corporation. (OTC-PINK: BIEL), the maker of disposable, inexpensive drug-free topical pain and healing devices, today issued a letter to its shareholders. It is posted on the web site www.bielcorp.com and follows in full:
Dear BioElectronics Corporation Shareholders:
Subject: Update Regarding Status of FDA applications
I know many of you are anxious for information regarding the FDA approvals. We have not had anything new to report until now. We have been awaiting a response to our three open applications and have for more than a year been getting no response other than they are “under review.”
Last month we asked Senator Barbara Mikulski, D-MD, to try to help move the FDA. She wrote to FDA Commissioner Margaret Hamburg. We have now been informed that FDA Commissioner Hamburg has forwarded our complaint up to the Inspector General of Health and Human Services. We hope that this action will rationalize the review process. We want to prevent the issuance of additional responses like the recent denial of the De Novo reclassification application for our Allay(TM) Menstrual Pain Therapy product. That letter states Allay will remain a Class III Premarket product for reasons that are wrong both in the application of the technology and the law.
We have sent a formal appeal of the denial to the FDA. We have also asked Senator Mikulski’s office to forward a copy to the Inspector General. The oversights or errors in the denial of our application for De Novo reclassification of Allay Therapy from Class III to Class II include the following:
The FDA reviewers mislabeled the technology as “non-thermal diathermy.” We believe that the FDA should use product code IMJ, which are Class II devices. Deep heat devices are Product Code IMJ, Class II because the mechanism of action – deep heating – is well understood. The IMJ ‘deep heat generation’ product code is indicated for “treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.” The FDA has cleared for marketing 31 devices in the IMJ code.
Heat is the most common form of therapy for menstrual pain and we have demonstrated and documented that our device delivers adequate heat to create a metabolic effect. The mechanism of action is simply heat and the only question is: is it adequate heat.
Our documentation has clearly demonstrated that our Allay product is effective for the following reasons:
- The power, pulse duration and pulse rate of the device generates sufficient energy to raise tissue temperatures up to 1 degree C in muscle tissue 3-5 cm below the skin surface This level of heating (greater than 0.3 degrees C) is physiologically significant. This clearly shows that the device produces an effective heat level.
- The heat generation capacity or Time Averaged Power Density and degrees per second dosage are greater than the lower settings on some approved IMJ heat generation devices. It is physically impossible for the Allay device to heat any body tissue above 3 degrees C or to heat tissue more than 5 cm below the skin surface. This makes the device an inherently safe thermal device.
- The Class I, Over-the-Counter (OTC) cleared heat wraps that use a chemical exothermic reaction for producing heat up to 40 degrees C for up to 8 hours necessitate extensive heat warnings to preclude tissue damage particularly in the elderly, diabetic, arthritic, and the cardiovascular and kidney compromised patient population.
- Effectiveness of heating to treat dysmenorrhea is evident primarily through the millions of women who have used this intervention strategy for thousands of years.
- The effectiveness and safety have been clearly shown through the clinical acceptance and OTC use of the Allay medical device in countries around the world. This consumer acceptance is further supported by our own clinical trial conducted by two independent and credible physicians.
Our other pending FDA market clearances are:
- RecoveryRx(TM) for post-operative pain and edema. For surgical wounds, we have designed a very inexpensive disposable device that delivers exactly the same dosage of energy to the tissue as larger, more expensive predicate devices that have been cleared by the FDA for postoperative pain and edema. The FDA’s sole task is to determine if the dosage from our device is equivalent. This requires a simple measurement of electromagnetic power density (Watts per square centimeter). Utilizing the FDA’s own prescribed measurement techniques, we have shown the Rx power density to be equivalent to that of FDA approved devices.
- ActiPatch® Pain Therapy for musculoskeletal pain relief. As you know, we have FDA market clearance for the treatment of edema following blepharoplasty (eye surgery). Further, the literature is replete with effective clinical studies using higher power levels for musculoskeletal pain and we have provided significant additional clinical evidence of the effectiveness of our low power device and specific studies on musculoskeletal pain. The efficacy and safety of our device is well established. The FDA’s sole task, we believe, is to determine if the ActiPatch device’s dosage is adequate for musculoskeletal pain.
We will continue to pursue our market clearances with the able assistance of Senator Mikulski and her staff office urging the FDA to act responsibly and quickly on our applications.
Andrew J. Whelan
Contact: E & E Communications
SOURCE BioElectronics Corporation