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Ra Medical Systems, Inc. (symbol: RMED) is a U.S.-based medical device company specializing in advanced excimer laser-based vascular and dermatological therapies. The company leverages its innovative laser technology to treat vascular and dermatological diseases, aiming to enhance patients' quality of life by restoring blood flow in arteries and alleviating chronic skin conditions.
The company markets two primary products:
- DABRA Catheter and Laser: Cleared by the U.S. FDA for minimally invasive endovascular treatment of vascular blockages resulting from lower extremity vascular disease, including peripheral artery disease (PAD).
- Pharos Excimer Laser: Designed for treating inflammatory skin conditions such as psoriasis, atopic dermatitis, and leukoderma, and also FDA-cleared.
Ra Medical, through its wholly owned subsidiary Catheter Precision, continues to make strides in the medical device industry with recent advancements and strategic partnerships. The VIVO™ system, a non-invasive 3D imaging technology, is used in pre-procedure planning for ventricular ablations, and has been adopted by numerous hospitals for its effectiveness in identifying the earliest electrical activation of ventricular arrhythmias.
One of the company's recent achievements includes the completion of 100 ventricular ablation procedures at the Heart Hospital of New Mexico at Lovelace Medical Center. This milestone highlights the growing recognition of VIVO's benefits in streamlining complex medical procedures.
Ra Medical Systems is also expanding its international footprint. The company has filed for CE Mark for its LockeT device, a suture retention product intended to assist in hemostasis after percutaneous venous punctures. Expected within the third quarter of 2023, this CE Mark will open new markets in Europe and beyond.
Amidst these developments, Ra Medical is preparing for a corporate name change to Catheter Precision, Inc., effective August 17, 2023, with a new ticker symbol VTAK. This change marks a strategic shift focusing solely on cardiac electrophysiology, away from its previous laser catheter business.
Ra Medical's commitment to innovation and collaboration with medical professionals underscores its mission to deliver groundbreaking technology for better patient outcomes in the treatment of cardiac arrhythmias.
Ra Medical Systems (NYSE American: RMED) announced its pivotal clinical study's milestone with the enrollment of 100 subjects for the DABRA excimer laser system, aimed at treating peripheral arterial disease (PAD). The study is cleared for a total of 125 participants. CEO Will McGuire emphasized the importance of achieving this enrollment despite challenges from the COVID-19 pandemic. The combined market for crossing chronic total occlusions and atherectomy is projected to reach
Ra Medical Systems (RMED) reported Q4 2021 net revenue of $5,000, up from $0 in Q4 2020, with a total operating loss of $8.3 million. For 2021, net revenue was $22,000 compared to $0.3 million in 2020. The company filed a 510(k) application for its new DABRA catheter and increased clinical study enrollment from 100 to 125 subjects. Cash as of Dec 31, 2021, stood at $15 million. The net loss for 2021 was $27.3 million, or $5.39 per share, reduced from a loss of $35.3 million in 2020. Adjusted EBITDA improved to negative $26.5 million from negative $29.7 million the previous year.
Ra Medical Systems (NYSE American: RMED) will announce its 2021 fourth quarter and full year financial results on March 23, 2022, after market close. An investment community conference call will follow at 1:30 p.m. PT (4:30 p.m. ET) to discuss these results and provide updates. Participants can pre-register for the call and access it via phone or a live webcast, which will also be archived for 30 days. Ra Medical is known for its DABRA excimer laser system used in treating vascular diseases, with FDA and CE mark clearances for various applications.
Ra Medical Systems (NYSE American: RMED) has filed a 510(k) application with the FDA for its next-generation DABRA catheter, designed to treat chronic total occlusions in patients with vascular disease. The catheter features a braided overjacket for improved robustness and kink-resistance. CEO Will McGuire highlighted this filing as a key milestone in developing their flagship DABRA catheter. The company also emphasizes the ongoing support from their team and physician partners during the development process.
Ra Medical Systems, Inc. (AMEX: RMED) announces that enrollment in its pivotal clinical trial for the DABRA excimer laser system has reached 95 subjects, with FDA approval to increase enrollment from 100 to 125 due to COVID-19 related follow-up issues. The trial aims to evaluate the safety and efficacy of DABRA for treating peripheral arterial disease (PAD). The FDA clearance for an atherectomy indication could significantly expand Ra Medical's market, estimated at approximately $900 million in the U.S. for 2022.
Ra Medical Systems (NYSE American: RMED) announced on
Ra Medical Systems, Inc. (NYSE American: RMED) has successfully closed an underwritten public offering, raising approximately
Ra Medical Systems (NYSE American: RMED) has announced the pricing of an underwritten public offering, aiming for gross proceeds of approximately $12.0 million. The offer includes 9,535,000 units priced at $0.50 each, comprising common stock and two series of warrants. Additionally, 14,467,893 pre-funded units are priced at $0.4999 per unit. Closing is expected around February 8, 2022, pending customary conditions.
Ra Medical Systems, Inc. (RMED) has announced engineering advancements to enhance the performance of its DABRA catheter, targeting chronic total occlusions in patients with peripheral artery disease. Key improvements include a braided overjacket design aimed at increasing deliverability and kink resistance, with a 510(k) application planned for FDA submission in Q1 2022. The company is also conducting a pivotal clinical trial for atherectomy, enrolling 90 out of 100 subjects. Additionally, efforts are underway to extend the catheter's shelf life from six to twelve months, pending FDA clearance.
Ra Medical Systems (RMED) reported its financial results for Q3 and the nine months ending September 30, 2021. The company generated net revenue of $5,000, significantly down from $68,000 in Q3 2020, with a total loss from continuing operations of $7.4 million, or $1.15 per share. The firm completed the sale of its dermatology business for $3.5 million and enrolled 85 subjects in a pivotal clinical study for its atherectomy device, focusing on the $900 million peripheral artery disease market. Cash reserves stood at $20.6 million by the end of Q3 2021.
FAQ
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