HeartBeam Inc. (NASDAQ:BEAT) surged 40.75% in after-hours trading on Wednesday, closing at $0.85, after announcing its regulatory strategy following the Food and Drug Administration's Not Substantially Equivalent (NSE) decision on its 12-lead Electrocardiogram Synthesis Software.
Check out the current price of BEAT stock here.
Regulatory Path Forward
The Santa Clara-based medical technology company is pursuing multiple options, including an appeal process or a 510(k) resubmission, a premarket FDA filing showing the device is equivalent to legally marketed products.
HeartBeam reported constructive engagement with FDA review staff since receiving the NSE letter.
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After the date of submission, the formal appeal procedure takes roughly sixty days.
Clinical Data Remains Strong
The company’s VALID-ECG clinical study met all agreed-upon endpoints.
Robert Eno, CEO of HeartBeam, said in a company statement, "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."
Stock Performance
The stock has dropped 74.31% so far this year.
BEAT shares have a 52-week range of $0.54 to $3.48, with a market capitalization of $23.66 million.
Price Action: According to Benzinga Pro data, HeartBeam closed on Wednesday at $0.60, up 3.62%.
Benzinga’s Edge Stock Rankings indicate that BEAT has a negative price trend across all time frames. Here is how the stock fares on other parameters.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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