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BioElectronics Responds to FDA’s 510(k) Additional Information Requests for its Musculoskeletal Pain Relief and Postoperative Pain Applications
GlobeNewswire•April 23, 2019
FREDERICK, MD, April 23, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com announced that the Company has submitted its response to the U.S. Food and Drug Administration’s (FDA) request for additional information on its ActiPatch® 510(k) market clearance application for “treatment of musculoskeletal pain in women”. Additionally, the Company has requested a conference call with the FDA to seek clarification on additional information requested on the RecoveryRx® 510(k) market application for “treatment of postoperative pain”.
The FDA’s additional information requested on the musculoskeletal 510(k) was for the submission of women’s clinical performance data from the Company’s clinical studies on knee osteoarthritis, plantar fasciitis and low back pain. The nature of the request was focused on the clinical performance comparison between men and women to assess the Company’s assertion that ActiPatch more preferentially treats musculoskeletal pain in women than men. In addition to the data, the FDA requested an explanation on how the proposed analyses support the market clearance indication and precludes the need for any additional information.
Sree Koneru, Ph.D., VP Product Development, said, “The clinical data from all three studies clearly indicates that the ActiPatch treats musculoskeletal pain significantly better in women than men. We have provided a detailed explanation on how our existing data meets the FDA’s clinical performance data requirement, and that additional studies are not required. Given the FDA’s guidance on gender analysis in clinical studies, precedent for gender-specific approvals and development of least burdensome guidelines, we are looking forward to a favorable outcome of our responses by the FDA.”
The ActiPatch product is already FDA-cleared for over-the-counter adjunctive treatment of pain from knee osteoarthritis (25 million Americans) and plantar fasciitis (2 million Americans annually).
BioElectronics Responds to FDA’s 510(k) Additional Information Requests for its Musculoskeletal Pain Relief and Postoperative Pain Applications
GlobeNewswire•April 23, 2019
FREDERICK, MD, April 23, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com announced that the Company has submitted its response to the U.S. Food and Drug Administration’s (FDA) request for additional information on its ActiPatch® 510(k) market clearance application for “treatment of musculoskeletal pain in women”. Additionally, the Company has requested a conference call with the FDA to seek clarification on additional information requested on the RecoveryRx® 510(k) market application for “treatment of postoperative pain”.
The FDA’s additional information requested on the musculoskeletal 510(k) was for the submission of women’s clinical performance data from the Company’s clinical studies on knee osteoarthritis, plantar fasciitis and low back pain. The nature of the request was focused on the clinical performance comparison between men and women to assess the Company’s assertion that ActiPatch more preferentially treats musculoskeletal pain in women than men. In addition to the data, the FDA requested an explanation on how the proposed analyses support the market clearance indication and precludes the need for any additional information.
Sree Koneru, Ph.D., VP Product Development, said, “The clinical data from all three studies clearly indicates that the ActiPatch treats musculoskeletal pain significantly better in women than men. We have provided a detailed explanation on how our existing data meets the FDA’s clinical performance data requirement, and that additional studies are not required. Given the FDA’s guidance on gender analysis in clinical studies, precedent for gender-specific approvals and development of least burdensome guidelines, we are looking forward to a favorable outcome of our responses by the FDA.”
The ActiPatch product is already FDA-cleared for over-the-counter adjunctive treatment of pain from knee osteoarthritis (25 million Americans) and plantar fasciitis (2 million Americans annually).
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