Shares in EBR Systems Ltd (ASX: EBR) were trading higher on Friday after the company said it had implanted the first patient in a key clinical trial.
The company told the ASX in a statement that the first patient had been enrolled and implanted in the "totally leadless CRT" study being carried out at the Princess Alexandra Hospital in Brisbane.
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Groundbreaking technology
EBR's key technology is the Wireless Stimulation Endocardially (WiSE) technology, which was developed to eliminate the need for cardiac pacing leads.
The company said in its statement that such leads were "historically the major source of complications, effectiveness and reliability issues in cardiac rhythm disease management''.
It went on to say:
The initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring Cardiac Resynchronisation Therapy (CRT). Future products potentially address wireless endocardial stimulation for bradycardia and other non-cardiac indications.
The first implant procedure announced to the ASX on Friday was carried out the day before by electrophysiologist Dr Paul Gould.
The company said the new study would build on previous work and potentially open up a much larger addressable market.
Totally Leadless CRT, pairing EBR's WiSE System with a leadless right ventricle pacemaker, has been previously published, and is already included in the FDA-approved labelling for patients with an existing leadless pacemaker who subsequently develop pacing-induced heart failure and require an upgrade to CRT. The TLC-AU study will build on this previous published experience by treating newly diagnosed heart failure patients requiring CRT. These de novo patients will receive a leadless pacemaker and the WiSE System. De novo patients account for around 75% of the CRT market, meaning this indication has the potential to significantly expand EBR's total addressable market and establishing WiSE as a potential first-line option for patients requiring CRT.
EBR president John McCutcheon said it was a significant achievement for the company.
He went on to say:
The first implant in the TLC-AU Study is a significant milestone for EBR, marking our entry into the much larger frontline CRT market. TLC-AU allows us to build on the FDA labelled upgrade indication and generate the evidence needed to position WiSE CRT as a fully leadless alternative for patients requiring resynchronisation therapy. As leadless pacing rapidly becomes standard of care, advancing a totally leadless CRT solution strengthens EBR's leadership in the next major evolution of heart-failure treatment.
EBR shares were 3.3% higher in early trade at 93.5 cents. The shares have traded as high as $2.08 over the past year and currently are not far off their 12-month lows of 86 cents.
The company was valued at $407.3 million at the close of trade on Thursday.
