Healthcare Industry News: hernia
News Release - August 3, 2010
BioElectronics Announces New FDA Market Application to Broaden Its Prescription Clearance
For C-Sections, hernias, Wound Care, and Other General SurgeriesFREDERICK, MD--(HSMN NewsFeed) - BioElectronics Corp. (Pinksheets:BIEL ), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announces that it has filed a 510(K) application with the U.S. Food and Drug Administration to expand market clearance for its RecoveryRx™and ActiPatchRx® products. BioElectronics updates its FDA OTC and new products application strategy:
RecoveryRx™ and ActiPatchRx™
BioElectronics submitted an application with the U.S. FDA for its new RecoveryRx™ and ActiPatchRx™ surgical and wound care devices. Currently, the Company's products' U.S. FDA approval is limited to the treatment of edema following blepharoplasty (eye surgery). "This additional clearance will allow BioElectronics to market to all surgical specialties for providing pain relief for post-surgical wounds. Our products have sold very well internationally for C-Sections, hernias, and other surgeries and we expect this further clearance to significantly increase U.S. sales," said Kristen Jeffery, Brand Manager -- RecoveryRx™.
ActiPatch® OTC
The Company received a Not Substantially Equivalent (NSE) letter from the FDA in response to their 510(K) application for ActiPatch® to be sold over-the-counter for the treatment of musculoskeletal pain. The FDA's decision is predicated on their assertion that the pulsed electromagnetic device category is restricted to treatment of postoperative pain and edema, not musculoskeletal conditions. As a result, the Company has formally requested that the ActiPatch® 510(k) product application be changed to Section 513(f)(2) De Novo Classification. The De Novo process is a request to create a new product category. BioElectronics continues to provide the FDA with additional research and clinical evidence to support this premarketing clearance.
New Chronic Pain Device
BioElectronics has developed a new prescription device for the treatment of chronic pain that will be eligible for reimbursement by Medicare, Medicaid and private insurers. When asked about the status of this project, CEO Andrew Whelan responded, "We were not fully satisfied with the initial version and we have built an enhanced model. We expect to complete the testing and file the 510(k) application within the next few weeks."
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 internationally 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. The Company is headquartered in Frederick, MD. For more information, visit www.bielcorp.com.
Source: BioElectronics
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