From ASX listed companies, this healthcare stock, which is almost 200% up in a year, is again on the move. Rising more than 10% in early trades today, this could become one of the best growth stocks to buy now
Imricor Medical Systems, Inc. (ASX: IMR),
Imricor Medical Systems recently reported significant progress in both regulatory and commercial milestones for the 2024 financial year. The company successfully submitted its second Premarket Approval (PMA) module to the U.S. Food and Drug Administration (FDA), covering the manufacturing and quality control processes for seven devices. This follows the submission of the first module, which was reviewed without deficiencies. The NorthStar 3D mapping and guidance system is also advancing, with CE Mark approval currently under review and a 510(k) submission to the FDA planned for early 2025. Imricor expects NorthStar to be commercially available in the U.S. by the third quarter of 2025, with a European launch anticipated by mid-year.
Financially, Imricor is among the growing companies to invest in having demonstrated strong revenue growth, reporting a 56% increase in total revenue to US$959,000, while operating costs remained well managed, declining by 1% to US$17.3 million. The company maintained a robust cash position of US$15.7 million, ensuring adequate funding for key regulatory and commercial milestones in 2025. The fourth-quarter cash burn was in line with projections at US$3.8 million, reflecting disciplined financial management.
From a clinical and market expansion perspective, Imricor achieved a major breakthrough with the first MRI-guided ablation procedure conducted in the U.S. at Johns Hopkins University as part of the VISABL-AFL trial. Additionally, the company secured regulatory approvals in Saudi Arabia and Qatar, expanding its footprint in the Middle East. In Europe, Imricor has commenced enrolment for the VISABL-AFL global pivotal trial in France, the U.S., and Switzerland, further strengthening its clinical validation efforts.
The company is experiencing strong momentum, with new site activations across France, the Netherlands, Croatia, and Switzerland. The installation of its systems in Hungary has been completed, and the first procedures are being scheduled. Imricor also received its first purchase orders from Qatar, signaling growth opportunities in the Middle East. Moreover, the company has strengthened its European sales team and is preparing for a full-scale U.S. commercial launch by expanding its domestic team and training programs.
Imricor is well-positioned for a breakout year in 2025, with multiple product approvals expected to drive commercial sales in the U.S. market. The U.S. alone represents half of the estimated US$10 billion global market for cardiac ablation procedures, with reimbursement rates significantly higher than in some European countries. The company’s strategic initiatives, including its VISABL-VT and VISABL-AFL trials and the expansion of iCMR-guided ablation into new geographies, are set to propel its growth. CEO Steve Wedan emphasized that Imricor’s regulatory, commercial, and clinical advancements have set the stage for substantial market expansion, reinforcing the company’s position as a pioneer in MRI-guided interventional medicine.
(Source: Company's Report)
Veye Pty Ltd(ABN 58 623 120 865), holds (AFSL No. 523157 ). All information provided by Veye Pty Ltd through its website, reports, and newsletters is general financial product advice only and should not be considered a personal recommendation to buy or sell any asset or security. Before acting on the advice, you should consider whether it’s appropriate to you, in light of your objectives, financial situation, or needs. You should look at the Product Disclosure Statement or other offer document associated with the security or product before making a decision on acquiring the security or product. You can refer to our Terms & Conditions and Financial Services Guide for more information. Any recommendation contained herein may not be suitable for all investors as it does not take into account your personal financial needs or investment objectives. Although Veye takes the utmost care to ensure accuracy of the content and that the information is gathered and processed from reliable resources, we strongly recommend that you seek professional advice from your financial advisor or stockbroker before making any investment decision based on any of our recommendations. All the information we share represents our views on the date of publishing as stocks are subject to real time changes and therefore may change without notice. Please remember that investments can go up and down and past performance is not necessarily indicative of future returns. We request our readers not to interpret our reports as direct recommendations. To the extent permitted by law, Veye Pty Ltd excludes all liability for any loss or damage arising from the use of this website and any information published (including any indirect or consequential loss, any data loss, or data corruption) (as mentioned on the website www.veye.com.au), and confirms that the employees and/or associates of Veye Pty Ltd do not hold positions in any of the financial products covered on the website on the date of publishing this report. Veye Pty Ltd hereby limits its liability, to the extent permitted by law to the resupply of services.
