Transcription of The Stock Network Interview with EBR Systems (ASX:EBR), Chief Corporate Development Officer Andrew Shute
Lel Smits: EBR Systems continues its US rollout of the WISE CRT system, the world’s only wireless cardiac pacing device for heart failure. Since last speaking with the Stock Network in June, the number of physicians trained to implant WISE has reached 100 and EBR has now signed more than 50 hospital purchasing contracts. I’m joined by EBR Systems Chief Corporate Development Officer Andrew Shute to discuss Medicare payments, hospital uptake and the move to in-house manufacturing.
Andrew, welcome back to the Stock Network.
Andrew Shute: Thanks, Lel, always good to catch up. Now, this month, Medicare moved to eligible WISE procedures into the same higher paying groups as leadless pacemakers.
Lel Smits: Andrew, what are the implications for the WISE rollout?
Andrew Shute: I think firstly, congratulations to our market access team. You know, they did an amazing job lobbying CMS to, I guess, to reassign our procedure to a higher paying DRG that resulted in that increase in base Medicare reimbursement. This increased reimbursement really made the economics of inpatient treatment more favourable.
It’s going to support contract negotiations and remove any reimbursement barriers to WISE implants.
Lel Smits: Excellent. And EBR’s field team is now focused on hospitals already performing WISE with John McCutcheon leading the commercial organisation directly. Andrew, what’s helping a hospital move from occasional WISE cases to a regular implant schedule here?
Andrew Shute: I think credit again to our field team. You know, we’ve now trained 100 physicians. We’ve had 57 purchasing agreements signed and 40 accounts activated.
But really to move that utilisation rate on a hospital level, firstly, it’s seeing good clinical outcomes. When physicians see their own patients respond positively to the therapy, that’s always going to encourage them to schedule additional patients. But deeper penetration, it’s really a result of our reps focusing more on a smaller number of hospitals not being overstretched.
And that allow them time to develop internal referral pathways. And more time in an account means more time working with the staff in the cath lab, the staff in the pacing clinics to help identify suitable patients.
Lel Smits: And finally, Andrew, the FDA has completed its inspection of EBR’s new Santa Clara facility, which also has gained international quality certification.
What remains before the site is approved? And also, what are the milestones are ahead into the next year?
Andrew Shute: Yeah, well, I think for the FDA, they’ll review their inspection record. And we continue to anticipate PMA approval of that new facility by the end of this calendar year. Looking ahead, CMS will publish their national coverage determination recommendation in early December.
We expect a final decision in March 2027. And we’ll look to see an increase in utilisation rates as a result of those organisational changes that we made.
Lel Smits: Well, thank you for the update from EBR Systems, Andrew.
Andrew Shute: Thanks, Lel, appreciate your time.
Ends