Imricor reactivates hospital customer sites in Q1 CY24 with momentum building
Company progresses pivotal VISABL-AFL trial during quarter required for US FDA approval
IMR receives Medical Device Marketing Authorisation from the Saudi Food & Drug Authority
Special Report: Focused on improving safety and first time success rates in cardiac catheter ablation, Imricor Medical Systems says reactivation of customer sites is underway, with momentum building after Covid-19 pandemic delays.
Imricor Medical Systems (ASX:IMR) says a major milestone required for FDA approval is the successful execution of a pivotal clinical trial, named Vision-MR Ablation of Atrial FlutterVISABL-AFL.
New drugs and complex medical devices must be proven safe and effective by the all-powerful Food and Drug Administration (FDA) before companies can sell them into the lucrative US market. It is a huge milestone for any medtech listed on the ASX.
IMR’s trial will provide the clinical evidence required for IMR’s higher-classification products, in particular the Vision-MR Ablation Catheter and HAT 500 Ablation Generator.
During the period, IMR says it achieved many key milestones toward FDA approval, including:
Approval from Johns Hopkins Hospital’s Institutional Review Board, in Baltimore, USA, to commence VISABL-AFL (the final approval required at Johns Hopkins);
Approval from Lausanne University Hospital (CHUV) Ethics Committee, in Switzerland to commence VISABL-AFL (the first of two approvals required at CHUV);
Approval from the Cardiovascular Institute of South Paris (ICPS) Ethics Committee, in
France, to commence VISABL-AFL (the first of two approvals required at ICPS); and
Approval of an Investigational Device Exemption (IDE) for Imricor’s NorthStar 3D
mapping system to be added to the VISABL-AFL trial.
After the period, IMR further received the second and final approval by the French Competent Authority to commence VISABL-AFL at ICPS. Swiss Competent authority approval for CHUV is expected in the coming weeks.
With the successful completion of these multiple milestones, VISABL-AFL is fully cleared to start at Johns Hopkins and ICPS, with CHUV to follow soon.
Amsterdam UMC is also expected to join the VISABL-AFL trial, and the required Ethics Committee submission will take place once the Amsterdam UMC Ethics Committee approves the VISABL-VT trial in the coming weeks.
All 91 patients in the VISABL-AFL trial are expected to be treated by year-end CY24, opening the door for FDA approval of IMR’s platform of capital and consumable devices in CY25.
European growth strategy a success
IMR’s strategy of engaging closely with European customers last year to establish consistent procedure volumes at active sites and increase active sites in 2024 is proving successful.
The company says it saw a consistent schedule of procedures at the Leipzig Heart Center in Germany during Q1 CY24 as well as the reactivation of Amsterdam UMC in April.
Also in April, Dubrava University Hospital in Croatia issued their first purchase order catheters and other disposables.
Dubrava previously ordered the required capital equipment from IMR, and the lab installation has been completed.
The MRI software upgrades required for real-time imaging were installed by Siemens over the last week of April, and procedures at Dubrava are expected to commence in May.
Also, during the quarter, Semmelweis University Heart and Vascular Centre in Hungary published a tender for the acquisition of iCMR lab infrastructure.
IMR is the only company globally able to bid because it produces the MRI compatible equipment requested in the tender.
Procedures are expected to commence at Semmelweis in late Q2 or early Q3 CY24.
IMR’s Vision-MR Diagnostic Catheter received CE mark certification in the period.
The diagnostic catheter is the first IMR device to receive approval under the new, stricter
European Union Medical Device Regulations (EU MDR).
IMR says the vision-MR Diagnostic Catheter is a lower-cost non-ablating catheter which can replace the second ablation catheter in atrial flutter procedures, thereby increasing margins.
Moving ahead in Middle East
During the quarter IMR received Medical Device Marketing Authorisation (MDMA) from the Saudi Food & Drug Authority (SFDA), opening commercialisation efforts in Saudi Arabia through its exclusive distributor, Al Faisaliah Medical Systems (FMS).
IMR says FMS, with a strong track record and expansive distribution network, is positioned to propel its technology in a market where ~50,000 cardiac ablation procedures are conducted annually.
Furthermore, IMR’s cutting edge technology aligns with the growth objectives of Saudi Vision 2030’s Health Sector Transformation Program.
The company says SFDA approval also opens the door for commercialisation efforts in Qatar.
In late 2022, IMR entered into a 5-year distribution agreement with East Agency WWL, a prominent distributor in Qatar.
The deal grants exclusive rights for the distribution of IMR’s innovative iCMR family of ablation products in the country.
‘Laying the foundations’ for growth
IMR says after quarter end, April consumer revenue had already exceeded Q1 with more site activations to come during Q2.
“We have been laying the foundations for Imricor and our customers to move this new field forward,” IMR chair and CEO Steve Wedan says.
“Each new site we activate provides near term capital and consumable revenue to Imricor”
“More importantly however, these same sites will then perform more complex procedures like ventricular tachycardia and atrial fibrillation.”
This article was developed in collaboration with Imricor, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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