Medical device company Ra Medical Systems Inc. (RMED:NYSE), which is focused on the development and manufacture of excimer laser systems used in the treatment of vascular diseases, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its DABRA 2.0 catheter as a new critical integrated part of its DABRA Excimer Laser System.
The company stated that "this next-generation DABRA catheter features enhancements including a braided overjacket design that's intended to improve deliverability and kink resistance when navigating tortuous anatomy, as well as a six-month shelf life."
The firm's advanced excimer laser system is a surgical tool used in procedures conducted by endovascular surgeons to clear and restore blood flow in the arteries in patients diagnosed with peripheral artery disease (PAD). The minimally invasive excimer lasers and accompanying single-use catheters are utilized to repair blockages by breaking down and dissolving plaque.
Ra Medical Systems CEO Will McGuire commented, "While we are pleased to receive this regulatory clearance, it comes as our Board continues its evaluation of strategic alternatives to optimize our Company's path forward in the current challenging economic environment…As we have previously announced, the DABRA 2.0 catheter represents an interim step in our work to develop a guidewire-compatible version of the DABRA catheter, and at this time we have no plans to commercialize the DABRA 2.0."
The company noted that as its Board of Directors recently disclosed on May 16, 2022, the firm is a range of strategic options for the purpose of maximizing shareholder value. Following the announcement, the company initiated a reduction in its staff by approximately 65%. The remaining employees were then each offered conditional retention arrangements for a period of around 60 days during which time the Board planned to evaluate various operating and financial options for proceeding forward. Ra Medical Systems advised that it made the difficult decision to reduce the workforce to preserve capital and to provide the company with the greatest number of strategic alternatives.
Ra Medical Systems is engaged in the design, manufacture, and marketing of advanced DABRA excimer lasers and catheters for use in surgical procedures in treatment of vascular immune-mediated inflammatory diseases. The company's minimally invasive DABRA excimer laser and single-use catheter system is used by physicians as a key tool in addressing vascular blockages in the lower extremities due to PAD in the legs both above and below the knees. The company explains on its website that "DABRA breaks down plaque to its fundamental chemistry, such as proteins, lipids, and other chemical compounds, eliminating blockages by essentially dissolving them."
The firm listed that the DABRA has an intended use for ablating a channel in occlusive peripheral vascular disease and has now been approved by the FDA for "crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease." The company manufactures the DABRA excimer lasers and sterile, single-use catheters at its 32,000 sq. ft. facility in Carlsbad, Calif.
Ra Medical started off the day with a market cap of around $9.9 million with approximately 32.3 million shares outstanding and a short interest of about 7.5%. RMED shares opened 44% higher today at $0.445 (+$0.136, +44.01%) over Friday's $0.309 closing price. The stock has traded today between $0.4081 and $0.59 per share and is currently trading at $0.4205 (+$0.1115, +36.08%).
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