BioElectronics Company Update – June 8, 2016

US FDA Meeting

On May 24, 2016, we met with FDA reviewer for our ActiPatch device, key management from the Physical Medicine and Neurotherapeutic Devices Branch, senior leadership from the Division of Neurological and Physical Medicine Devices, and a Regulatory Advisor, Office of Device Evaluation.

BioElectronics Attendees:

  • Richard Staelin, PhD, Chairman of Board, PhD in Statistics, University of Michigan;
  • Andrew Whelan, President;
  • Ian Rawe  D., Biophysics, Open University, Faculty, Harvard Med School, 2000-2010, Director of Clinical Research;
  • Kenneth McLeod, PhD in Electrical Engineering, MIT, Post Doctorial Fellowship, Tufts Medical School, Director – Clinical Science and Engineering Research Center, New York State  University, Binghamton; and
  • Attorneys from Goodwin Procter LLP

Dr. McLeod explained ActiPatch’s mechanism of action and presented physiological test results that illustrated how ActiPatch’s nerve modulation negates centralized pain.

Dr. Staelin presented the published musculoskeletal pain reduction data from the Plantar Fasciitis, Post-surgical Acute Pain, and the Osteoarthritis of the Knee studies along with data analyses that followed FDA recommendations. He also reviewed our Customer Assessments of 11,250 users showing the effectiveness and safety of the device without a healthcare practitioner’s involvement.

The FDA’s position is that the ActiPatch has a new intended use because we are requesting over-the-counter (nonprescription) status for the device and this would involve a different patient population compared to our predicate device. The Agency’s concern is the ability of the patients to determine the origin of the pain without a physician being present. Therefore, the agency representatives stated, the de novo classification pathway would be more appropriate for the ActiPatch than the 510(k) premarket notification review process.

Dr. McLeod stated that the risk situation would be no different from that of a person taking Pepto-Bismol for an upset stomach when the underlying condition is really appendicitis. He added that Pepto-Bismol, and other products, can be sold OTC because they have labeling regarding discontinuance if there is no relief within a specified time. Users know whether they get relief from the product and will see a physician if the condition persists. Mr. Whelan added that there are much riskier devices, e.g., TENS devices and heat wraps that are sold without a prescription. Dr. Staelin pointed out that our customer assessment data show that consumers discontinue using the product if it does not provide pain reduction.

Our attorneys responded that:

  • OTC switches have been done for over 30 years in the context of 510(k) submissions and that the 510(k) pathway is appropriate and available;
  • There is no new intended use; instead, there is a new indication and the Company can support an OTC switch by submitting information showing that the product, when sold without a prescription, is as safe and effective as the prescription predicate; and,
  • Any concerns regarding a difference in patient population can be addressed through labeling.

The meeting ended upon the FDA’s management committing to review the information and slides presented during the meeting, and to address the two regulatory issues: (1) the regulatory pathway (510(k) premarket notification or de novo submission) and, (2) the applicable timeframe.

On June 8, an FDA representative notified company counsel that the agency believes that the 510(k) pathway may be available for the ActiPatch device, the agency staff is reviewing the company’s data, and the agency would be back to the company shortly with its pathway determination and advice regarding whether additional information is necessary.


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