Company engaging in multiple options for a constructive resolution

HeartBeam, Inc., a medical technology company focused on transforming cardiac care by providing powerful personalized insights, announced its regulatory strategy following receipt of a Not Substantially Equivalent (NSE) decision on the Company’s 510(k) submission for its 12-lead Electrocardiogram (ECG) Synthesis Software.

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Immediately following the receipt of the NSE letter and through presently, HeartBeam has been engaging with the Food and Drug Administration (FDA) review staff to better understand the concerns and determine the best path forward.

  • The FDA has signaled a willingness to work with the Company towards a constructive resolution.
  • The Company stands behind the clinical study (VALID-ECG) submitted in support of the application. The study met its clinical endpoints and the Company believes it has a viable argument to address outstanding concerns of the agency.
  • The Company believes these concerns can be addressed through modifications to the proposed labeling of the device.

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HeartBeam has determined that the best course of action to reach a favorable resolution with the FDA is to pursue multiple parallel paths, which are designed for this type of situation.

  • The range of options include, but are not limited to, an appeal process or a resubmission of a 510(k) application.
  • Based on the recent discussions with the FDA and the information available at present, the Company believes there is a path forward under an appeal process.
  • The official appeal process has a timeline of approximately 60 days from submission of an appeal to resolution.

The Company looks forward to working with the agency to resolve the unexpected NSE letter. While this regulatory process moves forward, the Company will continue to provide shareholders with updates on the commercial launch and funding plans.

“HeartBeam appreciates the extensive interactions with the FDA on the HeartBeam 12-lead Synthesis Software,” said Robert Eno, Chief Executive Officer of HeartBeam. “We have engaged in good faith with the agency over a period of two years and have had extremely positive interactions. Together with the agency, we resolved the vast majority of open questions.

“After assessing our options, we believe that the best way to resolve the open questions and to get this technology into the hands of patients is to engage in the multiple paths available for constructive resolution. Since the remaining concerns from the FDA are well defined and can be readily addressed by our team, we believe these paths can lead to a favorable resolution.”

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Source- businesswire