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ASX:IMR
Imricor Medical Systems Inc
Investment Summary
The fund managers believe that Imricor Medical Systems Inc. (IMR) is on a robust path to growth, evidenced by key milestones achieved in recent months. IMR has received significant regulatory approvals, including marketing authorisation in Saudi Arabia and CE Mark approval for its Vision-MR Diagnostic Catheter, which is expected to enhance profit margins by reducing manufacturing costs by 35%. In their opinion, the successful commencement of the VISABL-AFL clinical trial, with multiple sites actively enrolling patients, positions IMR favorably for FDA approval. Furthermore, the successful fundraising of $35 million enhances IMR's financial footing, allowing for expanded U.S. clinical trials and entry into Australian and New Zealand markets. The integration of its Northstar 3D mapping software with major MRI providers is viewed as a pivotal advancement, likely to accelerate hospital adoption. Overall, the fund managers express confidence that IMR is poised for a potential share price re-rating based on its compelling healthcare investment proposition and improving revenue profile.
Commentary From The Managers
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.
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.
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.
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
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.
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.
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.
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.
Please note: The completeness, accuracy or current status of the investments referenced are not guaranteed.
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