Aug 20th 2019 Release #:812-182936-rl-799272: Bio
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Posted On: 08/20/2019 8:20:12 PM
Aug 20th 2019 Release #:812-182936-rl-799272:
BioElectronics Files FDA 510(k) Application for Musculoskeletal Pain Complaints; Clinical Data Demonstrates Superior Drug Free Pain Relief to Prescription Strength NSAID Drug
FREDERICK, MD, Aug. 20, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, is pleased to announce that it has filed a 510(k), Premarket Notification application with the U.S. Food and Drug Administration (FDA). The application is to seek expanded market clearance for the drug free, over-the-counter ActiPatch® Musculoskeletal Pain Therapy medical device for the indication: “adjunctive treatment of musculoskeletal complaints pain.”
The cervical osteoarthritis (neck pain) study submitted directly compares the effectiveness of ActiPatch treatment to that of a standard of care treatment: prescription NSAID (Cox-2 inhibitor) therapy, Etoricoxib 60mg (like Celebrex). Subjects were randomly assigned either to receive the Etoricoxib therapy or ActiPatch. Data from the study indicates that both treatments significantly reduced neck pain, but that ActiPatch was superior to NSAID treatment (statistically significant).
The ActiPatch is already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain). Keith Nalepka, VP Sales and Marketing, expressed enthusiasm on the market opportunity: “Obtaining full musculoskeletal complaints clearance will make the ActiPatch device available to more than 125 million Americans and paves the way for new products and approved medical claims for the back, knee, muscles, joints, hips, wrists, carpal tunnel, tennis elbow, ankle sprains, Achilles tendonitis, etc.”
The 510(k) application was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University, Ian Rawe, Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics. Dr. Koneru, who coordinated the 510(k) effort, said, “The clinical data represents our largest ever study, and our team has made a strong case. We look forward to a successful review of the application with the FDA.”
BioElectronics Files FDA 510(k) Application for Musculoskeletal Pain Complaints; Clinical Data Demonstrates Superior Drug Free Pain Relief to Prescription Strength NSAID Drug
FREDERICK, MD, Aug. 20, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, is pleased to announce that it has filed a 510(k), Premarket Notification application with the U.S. Food and Drug Administration (FDA). The application is to seek expanded market clearance for the drug free, over-the-counter ActiPatch® Musculoskeletal Pain Therapy medical device for the indication: “adjunctive treatment of musculoskeletal complaints pain.”
The cervical osteoarthritis (neck pain) study submitted directly compares the effectiveness of ActiPatch treatment to that of a standard of care treatment: prescription NSAID (Cox-2 inhibitor) therapy, Etoricoxib 60mg (like Celebrex). Subjects were randomly assigned either to receive the Etoricoxib therapy or ActiPatch. Data from the study indicates that both treatments significantly reduced neck pain, but that ActiPatch was superior to NSAID treatment (statistically significant).
The ActiPatch is already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain). Keith Nalepka, VP Sales and Marketing, expressed enthusiasm on the market opportunity: “Obtaining full musculoskeletal complaints clearance will make the ActiPatch device available to more than 125 million Americans and paves the way for new products and approved medical claims for the back, knee, muscles, joints, hips, wrists, carpal tunnel, tennis elbow, ankle sprains, Achilles tendonitis, etc.”
The 510(k) application was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University, Ian Rawe, Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics. Dr. Koneru, who coordinated the 510(k) effort, said, “The clinical data represents our largest ever study, and our team has made a strong case. We look forward to a successful review of the application with the FDA.”
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