EBR Systems (ASX: EBR)
EBR Systems (ASX: EBR) has completed key progress in 2024, moving closer to commercialising its WiSE CRT system, a leadless cardiac pacing technology designed for heart failure patients who don’t respond to traditional lead-based treatments. The company touched a critical milestone by submitting the final module of its PMA application to the FDA in August 2024, followed by a successful Day-100 meeting and a clean Pre-Approval Inspection of its manufacturing facilities in January 2025. Clinical validation was further strengthened by the publication of the pivotal SOLVE-CRT trial in JAMA Cardiology, supporting the clinical need and physician confidence in EBR’s solution. These developments align with the company’s strategy to initially target a US$3.6 billion market in the US and later expand globally.
EBR has laid the groundwork for commercialisation in the US, targeting first sales in the second half of 2025. In preparation, the company submitted an NTAP reimbursement application to CMS and was accepted into the CMS Transitional Coverage for Emerging Technologies program, a selective pathway that accelerates Medicare coverage for breakthrough innovations. EBR also plans to pursue outpatient reimbursement through the TPT program once FDA approval is granted. These efforts are supported by a A$50 million capital raise and a new 11-year lease for a 51,000-square-foot facility that will house corporate, R&D, and manufacturing operations, providing scalability for future demand.
The WiSE system addresses a critical gap in heart failure treatment, particularly for patients who may require an upgrade from leadless pacemakers. With traditional leadless devices often causing pacing-induced heart failure in up to 30% of cases over time, WiSE stands out as the only leadless upgrade option for these patients. A 14-patient clinical study demonstrated that WiSE can successfully work with Medtronic’s Micra to deliver effective leadless biventricular pacing, giving EBR a unique position in an evolving market with growing clinical and economic needs.
Cogstate Ltd (ASX: CGS)
Cogstate Ltd (ASX: CGS), on 20 February 2025 announced a strong first half in FY25.
The company Gross margins stood at 61%, and EBIT margins reached 20%, supported by $5 million in positive operating cashflow. Revenue quality improved due to a favorable mix of contracts, adding $12.4 million to FY25 revenue from $20.3 million in new deals. Operational efficiencies followed investments in automation, especially across data analytics and management workflows, resulting in lower headcount and leaner operations. The company is also ramping up its focus on data science and advanced analytics to support its core product capabilities in automated error detection.
Clinical Trials remained the key growth engine, with strong in-period revenue yield and a return to a more favorable software licensing mix. And the Healthcare revenue declined due to a revised global licensing agreement, though margins were preserved through cost controls. Receipts from customers increased by $6.6 million, while cash outflows rose only modestly, reflecting tight cost management. Share buybacks were reduced, contributing to lower financing outflows. The company is also benefiting from a growing pipeline in the central nervous system (CNS) market, with increasing global R&D activity and strategic transactions in the space boosting demand for cognitive testing solutions.
Cogstate’s partnership with Medidata is bringing in new opportunities across 28 unique customers and a broad range of indications including Alzheimer's, ADHD, Parkinson’s, and Schizophrenia. The company's platform enhancements—like workflow automations, advanced data visualizations, and app-triggered clinician reviews—are enabling scalable delivery. For 2H25, the company revenue is expected to match 1H25, backed by a solid contracted revenue base and potential upside if sales outperform. Margins and operating cashflow are expected to stay consistent, excluding timing effects from a $1.5 million tax payment.
(Source: Company Announcements)
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.
