Fund Manager Summary
The fund managers believe that Imricor Medical Systems Inc. is poised for significant growth, particularly following recent key approvals. In their opinion, the Medical Device Marketing Authorisation from the Saudi Food & Drug Authority opens up a substantial market, with nearly 50,000 cardiac ablation procedures performed annually in Saudi Arabia. They anticipate the first system sale in this region within six months, which could greatly enhance revenue streams. Additionally, the approval from Johns Hopkins Hospital’s Institutional Review Board for the VISABL-AFL clinical trial, set to commence in February, is seen as a critical step towards FDA approval of IMR's products. This follows their existing CE Mark approval for atrial flutter applications, allowing for ongoing commercial operations in Europe and the Middle East. Overall, the outlook for IMR appears promising.
Source: Trading View
Commentary From The Managers
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Saville Capital
31 Oct 2025
$1.43
Summary
- IMR has completed the first Pulsed Field Ablation (PFA) under real-time MRI guidance, validating its proprietary technology.
- PFA is a promising new energy source for treating atrial fibrillation (AF), showing efficiency and safety advantages.
- Current clinical data does not show superior efficacy over conventional radiofrequency (RF) ablation.
- IMR’s technology allows for real-time MRI-guided cardiac ablation, eliminating exposure to ionising radiation.
- This technology provides gold-standard soft tissue imaging for planning and executing procedures.
- Atrial fibrillation ablations make up about 65–70% of all cardiac ablation procedures globally.
- Industry estimates suggest PFA could account for 50–60% of the cardiac ablation market.
- Saville Capital continues to hold because IMR is committed to enabling MRI-guided procedures regardless of the energy source.
- This commitment ensures that physicians and patients benefit from the advantages of MRI-guided electrophysiology.
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Commentary From The Managers
Saville Capital
31 Oct 2025
$1.43
- IMR has completed the first Pulsed Field Ablation (PFA) under real-time MRI guidance, validating its proprietary technology.
- PFA is a promising new energy source for treating atrial fibrillation (AF), showing efficiency and safety advantages.
- Current clinical data does not show superior efficacy over conventional radiofrequency (RF) ablation.
- IMR’s technology allows for real-time MRI-guided cardiac ablation, eliminating exposure to ionising radiation.
- This technology provides gold-standard soft tissue imaging for planning and executing procedures.
- Atrial fibrillation ablations make up about 65–70% of all cardiac ablation procedures globally.
- Industry estimates suggest PFA could account for 50–60% of the cardiac ablation market.
- Saville Capital continues to hold because IMR is committed to enabling MRI-guided procedures regardless of the energy source.
- This commitment ensures that physicians and patients benefit from the advantages of MRI-guided electrophysiology.
Summary
Saville Capital
30 Sept 2025
$1.41
- Saville Capital updates its investment thesis on Imricor Medical Systems Inc. based on recent developments.
- IMR successfully completed its Human Factors (HF) study for all devices under FDA review.
- The HF study involved 46 healthcare professionals, including 23 electrophysiologists and 23 EP nurses/technologists.
- This 7-month usability study was conducted across ~20 hospitals in the US.
- Completion of the HF study is a critical step in the FDA approval process, ensuring safe and effective use of devices.
- This milestone advances IMR towards FDA market approval, representing significant growth potential.
- The project required comprehensive testing across multiple devices, workflows, and clinical scenarios.
- This underscores the strong momentum IMR is building in its regulatory pathway.
- Saville Capital continues to hold because this represents a major inflection point in IMR's global strategy.
Summary
Saville Capital
31 July 2025
$1.23
- Saville Capital notes that IMR has submitted NorthStar to the FDA, with approval anticipated in CY25.
- Approval of NorthStar will serve as the commercial entry point for IMR in the US market.
- This will allow the sales team to initiate site engagement and pipeline development.
- Multiple capital equipment and consumable devices are on track for submission and approval by the end of CY25.
- There has been a delay due to a change in the FDA reviewer for the 2nd PMA module, which pertains to the ablation catheter and RF generator.
- Most products remain unaffected by this change.
- Slower than expected enrolment in the VISABL-AFL Clinical trial has delayed final approval by at least six months.
- Despite these delays, Saville Capital believes they won't materially impact the company’s commercial trajectory.
- Discussions with hospitals can commence ahead of PMA approvals, once NorthStar and capital equipment are approved.
- The recent announcement led to aggressive selling, primarily from one institution, causing a temporary dip in share price.
- However, the stock has shown resilience and has continued to recover strongly in August.
Summary
Saville Capital
30 June 2025
$1.52
- IMR received CE Mark certification for its NorthStar Mapping System under EU MDR.
- This system is IMR's first commercial software-centric product globally.
- The certification strengthens IMR's position as a market leader in interventional cardiac MRI (iCMR).
- NorthStar broadens IMR's offerings across Europe and the Middle East.
- NorthStar aims to transform MR imaging from static images to dynamic video-like experiences.
- This approval signifies the launch of IMR's software era.
- As IMR expands interventional MRI applications, NorthStar could become the central hub for interventional MRI practices.
- This expansion has the potential to significantly increase IMR's revenue base.
Summary
Wilson Asset Management
30 Apr 2025
$1.62
- Imricor Medical Systems specializes in MRI-compatible medical devices.
- The company’s technology enhances real-time cardiac imaging and ablation procedures.
- In April, Imricor Medical Systems received approval for its entire product portfolio under the EU’s new Medical Device Regulation.
- This approval facilitates wider adoption of their technology across Europe.
- Looking ahead, significant developments are expected in June with the launch of the 2nd generation Vision-MR Ablation Catheter and new Advantage-MR system.
- These advancements are anticipated to drive growth and increase market share for Imricor Medical Systems.
Summary
Saville Capital
30 Apr 2025
$1.62
- Saville Capital notes a major milestone with the official commencement of the VISABL-VT clinical trial.
- The trial follows the first in-human ventricular ablation guided by real-time interventional cardiac magnetic resonance (iCMR).
- The procedure was successfully performed at Amsterdam University Medical Centre (AUMC), recognized as a leading hospital globally.
- The significance of MRI-guided ablation procedures is highlighted, especially compared to traditional X-ray methods.
- As the complexity of operations increases, IMR anticipates rapid adoption of its technology post-trial completion and regulatory approval.
- Saville Capital continues to hold its position based on these developments.
Summary
Saville Capital
31 Mar 2025
$1.38
- Saville Capital reports that IMR raised A$70m via a placement at an offer price of A$1.41, with no discount to the market.
- This capital increase boosts cash reserves to A$87.3m, ensuring funding for at least the next three years.
- Funds will support growth strategies, including expanding the installed base and indications in Europe.
- Expansion of commercial operations into key markets such as the USA and Middle East is planned.
- Ongoing R&D activities and regulatory efforts (including FDA and TGA) will also be funded.
- The capital raising was well-supported by existing and new institutions, indicated by the lack of discount to market.
- IMR is approaching inclusion in the ASX300, likely increasing passive ownership of the stock.
- The next key catalyst is the expected completion of the first heart ablation operation using IMR’s Vision-MR Ablation Catheter in April.
Summary
Saville Capital
28 Feb 2025
$1.58
- Saville Capital highlights that IMR's 2nd generation Vision-MR Ablation Catheter has received CE mark certification under the new European Medical Device Regulation (MDR).
- This catheter is critical for both the VISABL-VT clinical trial in Europe and the VISABL-AFL clinical trial in support of FDA approval in the US.
- With the successful CE mark certification, the company plans to submit the catheter for approval by the Australian Therapeutic Goods Administration (TGA).
- IMR is actively activating and re-activating sites in Europe and the Middle East for AF ablation procedures using the new catheter.
- Saville Capital continues to hold because these developments strengthen IMR's position in the market.
Summary
Saville Capital
31 Dec 2024
$1.36
- Saville Capital believes in the potential of Imricor Medical Systems Inc (IMR) following recent regulatory approvals in Qatar and Saudi Arabia in 2024.
- The fund manager initiated a position due to IMR's collaboration with distributor partners to introduce MRI-guided ablations in leading Middle Eastern hospitals.
- A significant milestone was achieved with the receipt of the first purchase order for capital equipment and consumables from Qatar in December.
- This purchase order marks the beginning of the rollout of iCMR labs in the region, showcasing IMR's growth potential.
Summary
Saville Capital
30 Nov 2024
$1.14
- IMR announced its first iCMR ablation procedure performed at Lausanne University Hospital (CHUV) in November.
- CHUV adds a third active site to the VISABL-AFL clinical trial, joining Johns Hopkins Hospital and the Cardiovascular Institute of South Paris.
- CHUV has constructed a dedicated iCMR lab specifically for IMR’s procedures, enhancing operational capabilities.
- CHUV is set to be one of IMR’s European Centres of Excellence, facilitating training for physicians on iCMR cardiac ablations.
- IMR has signed a license agreement with ADIS SA regarding the commercial terms for NorthStar AI modules.
- While NorthStar AI modules are not yet approved for commercial sale, regulatory processes are advancing towards launches planned for 2025 across Europe, the US, and the Middle East.
- The licensing agreement allows IMR to offer NorthStar AI modules as software license options and share revenue with ADIS.
Summary
Saville Capital
31 Oct 2024
$0.63
- Saville Capital updates its investment thesis on Imricor Medical Systems Inc. (IMR)
- US FDA approval process continues to advance at or ahead of schedule
- VT trial commencement date in Europe pushed to 4Q CY24 for enhancements approval
- Northstar 3D mapping software expected to be commercially available next year for Siemens MRI platform
- Clear path to commercialization on the Philips MRI platform following extensive testing
- Progress being made with GE Healthcare for Northstar delivery on their MRI platform
- Hospital sites likely to accelerate take-up of IMR technology due to software integrations
- Northstar enhances procedural efficacy for doctors
- Provides ongoing licensing revenue, supplementing consumable device revenue
- Saville Capital continues to hold because of these favorable developments
Summary
Saville Capital
31 July 2024
$0.58
- Saville Capital participated in Imricor's recent $35m institutional placement.
- New institutional investors have been added, both domestically and offshore.
- Proceeds will focus on:
- Completing the US FDA Clinical Trial.
- Expanding treatments with the VISABL-VT Trial and further commercialization efforts.
- Activating additional sites in Europe and the Middle East to grow the installed base.
- Expanding into Australia and New Zealand pending TGA approval, expected imminently.
- This capital raise alleviates significant stock overhang and supports the company through a crucial period.
- Anticipated US$8m investment from North Dakota’s Pioneer Capital Fund is still pending.
- Overall, the funding positions Imricor for sustainable profitability and paths toward becoming self-funding.
- Saville Capital continues to hold due to these developments.
Summary
Saville Capital
30 June 2024
$0.53
- IMR had a very active month in terms of news flow and key milestones being met.
- Announcement of VISABLAFL, the global clinical trial supporting US FDA approval, has commenced with two successful procedures at the Cardiovascular Institute of South Paris.
- The clinical trial will involve four sites across the US and Europe with a sample size of 91 patients, aiming for trial enrolment completion by the end of this year.
- Dubrava University Hospital in Croatia performed their first iCMR-guided atrial flutter ablation using IMR’s products, scheduling additional procedures regularly.
- The hospital has ordered an additional 10 catheter kits from IMR to meet growing demand.
- Semmelweis University in Hungary has been added as a new client, marking a positive expansion for IMR.
- The initial purchase included the Advantage-MR EP Recorder/Stimulator and consumable products for the first 15 procedures.
- Several third-party devices were also sold by IMR, enhancing their product offerings.
- Installation of iCMR lab equipment is scheduled for this month, with initial cases expected to commence in early 4Q CY24.
Summary
Saville Capital
31 Mar 2024
$0.54
- Saville Capital is optimistic following IMR's entitlement offer in February.
- IMR received key approvals for clinical trials aiming for FDA approval.
- CE Mark approval obtained for the Vision-MR Diagnostic Catheter, with manufacturing starting in April.
- Current purchase model involves a kit of two Vision-MR Ablation Catheters for each procedure.
- Introduction of the lower-cost Vision-MR Diagnostic Catheter will enhance margins.
- Cost to manufacture the Vision-MR Diagnostic Catheter is approximately 35% lower than the Ablation Catheter.
- IMR successfully raised an additional A$6.5m through placement of entitlement offer shortfall.
- Total funds raised amount to approximately A$15m.
- Post-COVID, Saville Capital is excited about IMR's improving revenue profile and potential for share price re-rating.
- IMR presents a compelling healthcare investment proposition.
Summary
Saville Capital
31 Jan 2024
Unknown
- Saville Capital updates their investment thesis on Imricor Medical Systems Inc. (IMR).
- IMR received Medical Device Marketing Authorisation from the Saudi Food & Drug Authority.
- Commercialisation efforts in Saudi Arabia are underway with first system sale expected within six months.
- Saudi Arabia performs nearly 50,000 cardiac ablation procedures per annum, indicating a significant market opportunity for IMR.
- Approval from John Hopkins Hospital’s Institutional Review Board for the VISABL-AFL clinical trial to commence in February.
- This trial is crucial for the FDA approval of IMR’s products.
- IMR holds a CE Mark approval for atrial flutter applications, enabling commercial operations in Europe and other CE Mark applicable markets.
Summary
Please note: The completeness, accuracy or current status of the investments referenced are not guaranteed.
ANALYST INSIGHT
Equity Research Analyst
With key approvals in hand, a significant market opportunity in Saudi Arabia appears to be unfolding for Imricor Medical Systems. The upcoming VISABL-AFL trial could pave the way for FDA approval, potentially positioning IMR as a disruptive force in the cardiac ablation landscape.
Last Updated: 31 Oct 2025
Query The Data
Frequently Asked Questions
Who is investing in Imricor Medical Systems Inc (ASX:IMR)?
Fund managers including Saville Capital and Wilson Asset Management have invested in Imricor Medical Systems Inc (ASX:IMR).
Why do fund managers invest in Imricor Medical Systems Inc?
Fund managers are investing in Imricor Medical Systems Inc. due to recent key approvals that enhance its market potential. The company received Medical Device Marketing Authorization from the Saudi Food & Drug Authority, enabling it to target a significant market of nearly 50,000 cardiac ablation procedures annually in Saudi Arabia. Additionally, approval from Johns Hopkins Hospital's Institutional Review Board for its VISABL-AFL clinical trial positions Imricor for potential FDA approval, complementing its existing CE Mark approval for atrial flutter applications in Europe and the Middle East.
What happened to Imricor Medical Systems Inc (ASX:IMR)?
Fund managers are investing in Imricor Medical Systems Inc. due to its strategic advancements in FDA approvals, particularly with the NorthStar device, which is set to facilitate its entry into the U.S. market. Recent milestones, including the successful completion of a Human Factors study and innovative real-time MRI-guided Pulsed Field Ablation procedures, underscore the company's commitment to enhancing cardiac ablation techniques. Despite some regulatory delays, the overall trajectory indicates significant growth potential in the expanding atrial fibrillation treatment market.