- Acutus Medical Inc. (AFIB) develops products for cardiac arrhythmias treatment.
- The healthcare company was founded in 2011.
- On Monday, it received FDA clearance to market its products.
Shares of Acutus Medical, Inc. (NASDAQ: AFIB) rose over 100% on Monday morning after the US Food and Drug Administration (FDA) gave the go-ahead to market its products.
The stock was priced at US$1.0799 at 12:25 pm ET. The company said it is expanding its suite of left-heart access products, including the AcQCross and FXD (TM) delivery system for the Watchman Left Atrial Appendage Closure (LAAC) device after the FDA clearance.
AcQCross is a transseptal system with an integrated needle and dilator to reduce exchanging of wires and needles. Earlier, physicians needed to follow a multi-step process involving wires and needle exchange to gain access to the left atrium.
AcQCross enables repositioning without exchanging wire and needles, and its compatibility with Watchman makes it safer for patients and efficient for physicians.
With the FDA clearance, the company can now offer transseptal access devices for structural heart procedures and electrophysiology in the US.
According to David Roman, interim CEO and CFO of Acutus Medical, AcQCross’ expanded product line would bring innovative technology to a wider range of procedures. He added that physicians could use AcQCross with their preferred sheaths for left-heart access procedures.
Acutus has a market capitalization of US$26.6 million. Its stock traded in the range of US$17.83 to US$0.48 in the last 52 weeks.
The Carlsbad, California-based company develops electrophysiology products for cardiac arrhythmias diagnosis and treatment. It has a presence globally.
Its product portfolio includes sheaths, diagnostic and mapping catheters, ablation catheters, transseptal crossing tools, mapping and imaging consoles and accessories, etc.
The company was founded in 2011.
On April 27, 2022, Acutus announced selling its left-heart access portfolio to Medtronic for US$50 million in an all-cash deal. The company did so in an effort to refinance its existing debt with a new credit for the longer term and recapitalize the business for future strategic growth.
For the quarter ended March 31, 2022, the company reported a revenue of US$3.68 million compared to US$3.59 million in the same quarter a year ago.
Its net loss was US$40 million or US$1.42 per diluted share compared to the net loss of US$29.4 million or US$1.04 per diluted share in the March quarter of 2021.
Its cash and cash equivalents were US$12.3 million as of March 31, 2022.
The company’s product line and cash position are expected to improve in the future with the FDA’s clearance for marketing its products. However, investors should analyze the stock fundamentals and the external factors before investing in them.