In the wake of clearance from the U.S. Food and Drug Administration (FDA), arrhythmia management company Acutus Medical (NASDAQ:AFIB) just announced the commercial launch of its expanded suite of heart-access products. As a result, AFIB stock is pumping higher on heavy trading volume.
Acutus is a tiny medial device company with a roughly $30 million market capitalization. However, the company has a suite of heart-access products, including the TruSeal and FXD delivery systems. With the new regulatory clearance, Acutus is now able to include its AcQCross Qx system and commercialize its full product suite.
The revenue-generation implications here are huge. According to the Millennium Research Group, more than 50,000 “left-atrial appendage closure procedures” will happen in the U.S. this year. Acutus clarified that, with the new clearance, it now offers devices “that cover 409,000 electrophysiology and structural heart procedures.”
What’s Happening with AFIB Stock?
When a stock trades at low prices, big moves can happen fast. As of this morning, AFIB stock has already doubled, touching the crucial $1 per share level. This is significant because the Nasdaq often warns companies that they risk delisting if their shares are below $1 for too long.
AFIB shareholders have every reason to celebrate this regulatory clearance and product commercialization, of course. However, some investors still have a long way to go before they can break even on their investment. Acutus has a 52-week high of $17.77 per share. Investors have clearly struggled in recent months.
That said, today’s news certainly offers a glimmer of hope for shareholders and heart patients alike.
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On the date of publication, David Moadel did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.