Imricor (IMR) March Quarterly Report: Progressing Towards FDA Registration Strategy
2021-04-29 05:29:42 (AET) by Ring Zhang
Imricor Medical Systems (ASX: IMR) released its quarterly report for the three months ended 31 March 2021, providing investors with business updates associated with its leading MRI-guided cardiac ablation products, as well as financial and operational performance.
Imricor Medical Systems (ASX: IMR), an ASX-listed medical devices producer, released its quarterly report for the three months ended 31 March 2021, providing investors with business update associated with its leading MRI-guided cardiac ablation products, and financial and operational performance.
The company reported cash receipts from customer of US$0.234 million and held US$20.68 million at period end. Estimated quarters of funding available at the same spending level would be 5.1 quarters.
As most countries in Europe reinitiated COVID-19 measures in response to the new wave of outbreak, Imricor confirmed that it has slowed down its new iCMR Lab roll-out plan. Moreover, the company’s contracted partners, including Leipzig Heart Centre and Maastricht University Medical Centre, have both temporarily halted procedures again due to the latest lockdown measures undertaken in Germany and Netherlands.
The company expects the measures in Germany will remain until June this year, while the Netherlands will start to ease restrictions next week. Notwithstanding these restrictions, Imricor is working closely with contracted sites to progress installation, training, and the commencement of operations as soon as allowed.
Currently, Imricor has 9 contracted sites and revealed that the signing of new agreements will recommence in the second quarter and accelerate in the second half of FY21.
In addition, the company is advancing the implementation of FDA strategy for its MRI-guided cardiac ablation products. Following the third pre-submission meeting with the US FDA, the company is confident in the study design of the clinical program, which is scheduled to commence in July this year.
In Australia, Imricor has appointed a local specialist Regional Health Care Group (RHCG) to facilitate TGA approval. As part of the service agreement, RHCG will be the exclusive distributor of Imricor’s consumable products in Australia and New Zealand and a non-exclusive distributor of Imricor’s capital equipment.
Expanding indications and opportunities beyond cardiac ablation has been a priority of the company. Imricor is currently researching and developing steerable sheaths and transseptal needles which, in the future, will enable access to the left side of the heart via the intra-atrial septum, for some more complex procedures. It is anticipated that these products will be ready for clinical trial during 2021.
In the meantime, the development program of Imricor’s diagnostic catheter is progressing well, aiming for commercial releases in late 2021 or early 2022.