Imricor Medical Systems Inc

Saville Capital Emerging Companies Fund continues to hold Imricor Medical Systems Inc. (IMR) due to the company’s recent progress in securing key regulatory approvals. IMR received Medical Device Marketing Authorisation from the Saudi Food & Drug Authority, marking the beginning of its commercialisation efforts in Saudi Arabia, a significant market with nearly 50,000 annual cardiac ablation procedures. The first system sale is expected within six months, providing substantial growth potential. Additionally, IMR obtained approval from the John Hopkins Hospital’s Institutional Review Board for its VISABL-AFL clinical trial, a critical step toward FDA approval. With existing CE Mark approval for atrial flutter applications, IMR is well-positioned for continued success in Europe and other markets where the CE Mark applies. These developments support Saville Capital’s confidence in IMR’s prospects, and the fund continues to hold the stock as the company expands its global footprint and progresses toward FDA approval.

Saville Capital Emerging Companies Fund is optimistic about Imricor Medical Systems Inc's updated trajectory following its recent entitlement offer and subsequent key regulatory approvals. With the FDA clinical trials set to commence and the CE Mark approval granted for the new Vision-MR Diagnostic Catheter, Saville notes a significant enhancement in IMR’s product offering. The Vision-MR Diagnostic Catheter is anticipated to replace the need for a second ablation catheter in procedures, allowing for improved margins due to its approximately 35% lower manufacturing cost. Collectively, these developments position IMR for an improved revenue profile as well as potential share price re-rating, marking a positive shift after challenging years. Saville Capital believes these advancements signify a compelling opportunity in the healthcare sector, which they are closely monitoring.

Saville Capital Emerging Companies Fund continues to hold its position in Imricor Medical Systems Inc. due to the company's recent significant developments and milestones. IMR has successfully commenced the VISABLAFL trial, which supports its US FDA approval efforts, with two procedures already performed at the Cardiovascular Institute of South Paris. The multi-site study aims to enroll 91 patients swiftly, with expectations to complete this phase by year-end. Additionally, the Dubrava University Hospital in Zagreb conducted its first iCMR-guided atrial flutter ablation using IMR’s technology and is already scheduling more procedures, reflecting a strong demand evidenced by their order of ten catheter kits. Furthermore, the addition of Semmelweis University as a client, along with their purchase of multiple IMR products and capital devices, highlights the growing adoption of IMR’s solutions. The planned installation of iCMR lab equipment and the upcoming cases at Semmelweis signify promising prospects for the company in the near future.

Saville Capital Emerging Companies Fund continues to hold an optimistic stance on Imricor Medical Systems Inc following its recent successful $35 million institutional placement, which included new domestic and offshore institutional investors. The proceeds will be strategically directed towards completing the US FDA Clinical Trial, expanding treatments through the VISABL-VT Trial, and enhancing commercialization by activating new sites in Europe and the Middle East. Additionally, Imricor plans to expand into Australia and New Zealand pending imminent TGA approval. This capital raise alleviates prior financial pressures, positioning the company for a pivotal growth phase aimed at achieving sustained profitability. With the forthcoming US$8 million investment from North Dakota’s Pioneer Capital Fund, Saville Capital believes this funding will secure the company’s pathway to becoming self-funding in the near future.

Saville Capital Emerging Companies Fund updates its investment thesis on Imricor Medical Systems Inc. based on recent advancements in regulatory activities and the integration of its 3D mapping software, Northstar, with major MRI providers. The US FDA approval process is progressing on schedule, while the initiation of a pivotal VT trial in Europe has been adjusted to this quarter to accommodate necessary enhancements. Notably, Northstar is expected to be commercially available next year with the Siemens MRI platform, and its integration with the Philips MRI platform now has a clear path toward commercialization. Additionally, progress is being made with GE Healthcare for Northstar's deployment on their MRI platform. These strides are significant, as they are anticipated to facilitate faster adoption of IMR technology by hospital sites. Northstar not only improves procedural efficacy for physicians but also generates ongoing licensing revenue, complementing IMR's existing revenue from consumable devices used in procedures.

Saville Capital Emerging Companies Fund continues to hold a positive outlook on Imricor Medical Systems Inc following recent developments. The announcement of Lausanne University Hospital performing its first iCMR ablation procedure marks the addition of a third active site to the ongoing VISABL-AFL clinical trial, which is instrumental for securing US FDA approval. By joining established sites like Johns Hopkins Hospital and the Cardiovascular Institute of South Paris, CHUV enhances the trial's credibility. Furthermore, CHUV's dedicated iCMR lab positions it as a European Centre of Excellence, facilitating physician training in real-time iCMR cardiac ablations. Additionally, IMR's recent licensing agreement with ADIS SA for the NorthStar AI modules outlines commercial terms ahead of their anticipated launches in Europe, the US, and the Middle East in 2025. While regulatory approvals are still progressing, these moves signal strong commercial momentum and an expanding market presence for Imricor, reinforcing the fund's investment thesis.

Saville Capital Emerging Companies Fund updates its investment thesis on Imricor Medical Systems Inc, highlighting the company's recent regulatory approvals in Qatar and Saudi Arabia in 2024. IMR is actively collaborating with distributor partners to introduce MRI-guided ablations at top hospitals in the Middle East. A significant milestone was reached in December with the receipt of the first purchase order for capital equipment and consumables from Qatar, signaling the commencement of the rollout of iCMR labs in the region. This development positions Imricor favorably in a growing market, reinforcing Saville Capital's confidence in the company's potential for future expansion and success.

Saville Capital Emerging Companies Fund continues to hold Imricor Medical Systems Inc. (IMR) following the company's announcement that its 2nd generation Vision-MR Ablation Catheter has received CE mark certification under the new, more stringent European Medical Device Regulation (MDR). This catheter is pivotal in the ongoing VISABL-VT and VISABL-AFL clinical trials for treating type 1 atrial flutter (AF) in Europe and the U.S. With the successful certification, IMR plans to submit the catheter for approval by the Australian Therapeutic Goods Administration (TGA). Additionally, the company is focused on activating and reactivating more clinical sites in Europe and the Middle East for AF ablation procedures using the new catheter. Saville Capital Emerging Companies Fund is encouraged by these regulatory advancements and ongoing global expansion, which strengthen the company’s growth trajectory.