Imricor Medical Systems (IMR: $0.29) is pioneering MRI-guided cardiac ablation, rather than ablation procedures conducted using x-ray fluoroscopy imaging. It is the only company in the world that sells MRI-compatible consumable devices used for cardiac ablation.
Cardiac ablation is a minimally invasive procedure whereby electrical abnormalities in the heart, which cause abnormal heart rhythms, are corrected by heating or freezing cardiac tissue inside the heart via a catheter. The issue with using x-ray to help guide the procedures is that the heart is almost invisible to x-rays.
Some ablation procedures can be technically challenging. Better imaging during the procedure has the capacity to improve treatment outcomes, assist in faster procedures and with lower risks to the patient. Using MRI imaging also allows the surgeons to visualise physiological changes during the procedure.
MRI machines are not generally found in cardiac ablation centres which means that iCMR (interventional cardiac magnetic resonance) labs need to be established first in most cases. However once established only the Imricor devices can be used in the labs according to Imricor CEO and founder Steve Wedan.
European Sales Re-Launch
Its first product is being sold into Europe, with receipts from customers totalling US$251,000 for the quarter, up from $103,000 in the previous quarter. Currently the company's products are approved only for the treatment of atrial flutter. The company has re-launched its products in Europe this year following the restrictions on elective procedures over the last two years. There has been a backlog of patients due to the pandemic which is also expected to be a factor in accelerating sales.
The company now has six contracted sites in Europe that are using the Imricor technology with one new site added during the quarter.
VT Indication to Drive Increased Adoption
The technology can be expected to experience greater demand for more complex ablation procedures, such as VT (ventricular tachycardia). A VT study using the Imricor technology is due to commence in Europe with all of the clinical sites visited in the June quarter to prepare for this study. Once approved, these sites will also likely become commercial customers for Imricor's products. The trial submission is expected to be completed this month.
The company has also submitted its second generation ablation device for approval in Europe which can be used not just for atrial flutter ablations but also for VT applications.
Cost Reductions Put in Place
The net cash outflow from operations in the June quarter was US$4.2 million with a cash balance at the end of June of US$9.1 million. The company has reduced its expected cash spend to the end of next year by US$10 million with the main two areas of focus being European sales and executing the VT trial in Europe. Commencing a study in the US for US approval may wait until the company is comfortable that it has sufficient funding.
Imricor is nearing the completion of development of its 3D cardiac mapping software which Wedan said has been a major achievement in just seven months. The company secured two licenses with Siemens in the June quarter to integrate its software and catheters with the Siemens MRI machines.
Key milestones ahead for the company will be a ramp up in the number of new labs that are signed up to adopt the technology, more procedures from existing contracted sites, and the start of the VT study according to Wedan.
Imricor is capitalised at $42 million.
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