Additional Research and Findings Strengthen 510(k) Applications and Add Three New Products(2)
BioElectronics Corporation (PINKSHEETS: BIEL), developers of innovative topical pain-relieving medical devices, announced today it is strengthening its U.S. FDA clearance applications with additional research and findings to better articulate its product classification, claims and improve its patented pain products.
"The FDA approval process is long and arduous, particularly for unique and innovative products, but we are confident that with our additional research, findings and product options we will succeed," said Andrew Whelan, president and CEO of BioElectronics. "We intend to provide this additional data to the U.S. FDA to supplement our applications and obtain additional new product market clearances. After all, we have already sold more than 200,000 safe and effective devices around the world."
BioElectronics has outlined its existing OTC and new products application strategy:
ActiPatch@The ActiPatch@ 510(k) product application for the treatment of musculoskeletal pain is still under consideration by the U.S. FDA. BioElectronics is providing the FDA with additional research and documentation to support this premarketing clearance.
Additionally, the company is planning to file a new product 510(k) application for approval of an alternative over-the-counter product for the temporary relief of pain associated with sore and aching muscles. The Korean equivalent of the FDA has recently approved ActiPatch@ for the treatment of muscle soreness.
Allay Menstrual Pain TherapyFor its Allay menstrual pain relief product, BioElectronics has formally requested the change of its application from a 510(k) to Section 513(f)(2) de novo review. This classification request is being bolstered by additional research and clinical evidence that demonstrates the effectiveness of electro medicine treatments as an effective therapy for dysmenorrhea. Last week, Health Canada issued a license to market the Allay Menstrual Pain Therapy in Canada.
RecoveryRxTwo new product FDA applications will dramatically broaden this product line. RecoveryRx products are currently U.S. FDA approved only for the treatment of edema following blepharoplasty, which hinders U.S. sales and marketing to medical specialties other than plastic surgeons.
A new wound care product application will treat post-operative pain and edema. This broader indication of use label will allow all medical specialties, including chronic wound specialists, to confidently prescribe RecoveryRx products.
The company has also developed, and will submit for its 510(k) clearance, a new prescription device for the treatment of chronic pain that will be eligible for reimbursement by Medicare, Medicaid and private insurers.
For more information about BioElectronics' innovative pulse electromagnetic therapy devices, visit www.bielcorp.com (http://www.bielcorp.com/) .
About BioElectronics Corporation BioElectronics Corporation (PINKSHEETS: BIEL) is the maker of safe, inexpensive, drug-free medical devices and patches that deliver pulsed electromagnetic energy to relieve pain and inflammation. The company's wafer thin patches contain an embedded microchip and battery that deliver pulsed electromagnetic energy, a clinically proven and widely accepted anti-inflammatory and pain relief therapy that heretofore has only been possible to obtain from large, facility-based equipment. BioElectronics markets and sells its current products under the brand names ActiPatch@, RecoveryRx, Allay Menstrual Pain Therapy and HealFast Therapy for cats, dogs and horses. The company is headquartered in Frederick, MD. For more information, visit www.bielcorp.com (http://www.bielcorp.com/) .