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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 (RMED) has announced a merger with Catheter Precision, a medical device company focusing on cardiac electrophysiology. This stock-for-stock reverse merger will result in Catheter Precision becoming a wholly owned subsidiary of Ra Medical. Catheter Precision's lead product, VIVO™, aims to improve treatment for ventricular arrhythmias, a significant market opportunity. The merger is expected to close by the end of 2022, pending shareholder approval. Post-merger, Catheter Precision stakeholders are projected to own 80% of the combined entity, enhancing growth potential in the cardiac market.
Ra Medical Systems (RMED) received a notice from NYSE American on August 31, 2022, indicating low trading prices for its shares. To maintain its listing, RMED must either implement a reverse stock split or demonstrate price improvement by February 28, 2023. The company plans to hold a Special Meeting on September 20, 2022, to seek stockholder approval for a reverse stock split ranging from 1-for-20 to 1-for-50. Stockholders are encouraged to vote, as their participation is crucial for the company's future on the exchange.
Ra Medical Systems (RMED) reported Q2 2022 revenues of $5,000, a decline from $9,000 in Q2 2021. The company's net loss from continuing operations was $8.4 million, or $0.26 per share, compared to $4.7 million, or $1.15 per share, in the prior year. SG&A expenses decreased to $2.5 million from $3.4 million, while R&D expenses slightly decreased to $2.4 million. The company is pursuing a merger with Catheter Precision, which carries uncertainty regarding its future business strategy. As of June 30, 2022, the company had $11.1 million in cash.
Ra Medical Systems (NYSE American: RMED) disclosed that its audited financial statements for the fiscal year ending December 31, 2021, included an audit report with a 'going concern' emphasis. This follows filings with the SEC on March 24, 2022, and an amended 10-K/A on July 7, 2022. No changes were made to previous filings. Ra Medical is known for its DABRA excimer laser and catheters used in vascular disease treatment, having received FDA and CE mark approvals for various applications. This information is mandated under NYSE American Company Guide Section 610(b).
Ra Medical Systems (RMED) announced a reduction in the exercise price of existing warrants from $0.50 to $0.28 per share, expecting to generate approximately $6.2 million from the exercise of Series A Warrants. Additionally, the company signed a non-binding Term Sheet to merge with Catheter Precision, where Catheter Precision securityholders would own 83.3% of the combined entity. The merger is subject to due diligence and may not be finalized, which poses potential uncertainties for shareholders.
Ra Medical Systems announced the appointment of Brian D. Conn as interim Chief Financial Officer, effective immediately. Conn has extensive experience in financial roles within the medical device sector and previously served as CFO for various companies. He replaces Will McGuire, who will retain his position as Chief Executive Officer. This leadership change comes as the board assesses strategic alternatives to maximize shareholder value. Ra Medical manufactures the DABRA excimer laser for treating vascular diseases, having received FDA and CE mark clearances for its use.
Ra Medical Systems (RMED) has received FDA 510(k) clearance for its DABRA 2.0 catheter, designed to enhance deliverability and kink resistance in vascular treatments. This clearance comes as the Company’s Board reviews strategic alternatives amid a challenging economic landscape. The CEO indicated no immediate plans for commercialization of the DABRA 2.0. Previously, a significant workforce reduction was announced in June 2022 to preserve capital. Ra Medical focuses on developing laser systems for vascular diseases and maintains a vertically integrated manufacturing facility in California.
Ra Medical Systems (RMED) reported its Q1 2022 financial results, highlighting increasing clinical trial enrollment and strategic actions for shareholder value maximization. Key achievements included a rise in enrollment to 107 subjects and a successful public offering netting approximately $9.7 million. Revenues reached $9,000, up from $4,000 year-over-year, while total costs reduced significantly. However, the company reported a loss from continuing operations of $5.5 million. Cash and equivalents stood at $17.7 million as of March 31, 2022.
Ra Medical Systems (AMEX: RMED) will report its financial results for Q1 2022 on May 16, 2022, after market close. A conference call is scheduled for 1:30 p.m. PT to discuss these results and provide company updates. The DABRA excimer laser and catheters, manufactured in Carlsbad, California, are FDA-cleared for treating vascular diseases, including chronic total occlusions. The facility is ISO 13485 certified and licensed for manufacturing sterile catheters.
Ra Medical Systems, Inc. (NYSE American: RMED) announced the granting of a U.S. patent (11,284,941) for its innovative liquid-filled laser ablation catheter design, enhancing the ablation surface area without increasing the catheter profile. This achievement marks the 11th U.S. patent awarded to the company and supports their DABRA technology, aimed at treating vascular diseases. CEO Will McGuire emphasized that this patent is a strategic move to fortify their competitive position and expand product offerings for larger vessels.
FAQ
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