Oct 28, 2026 earnings call — Drug delivery strategy and capital equipment growth
Revenue grew 36% year-over-year to $12.1 million in Q3 2026.
Revenue $0.0B (est $0.0B) · EPS $-0.24 (est $-0.32)
Key quotes
"We look forward to the next regulatory milestones for our partner, uniQure's BLA submission to the FDA for AMT-130 to treat Huntington's disease during the weeks and months ahead, which could result in the very first FDA-approved gene therapy for this terrible disease."
"For pillar #2, neurosurgery navigation, we saw our largest capital sales quarter in our history."
"These include launching our Shoreline software, our Dart catheter and our next-generation forward tunneling catheter as well as presenting results from the randomized ARCH trial and pursuing a specific on-label FDA indication for subdural hematoma, one of the largest potential indications for the IRRAflow product."
Analyst Q&A 3
Upcoming partner milestones and timelines
Q (Frank Takkinen · Lake Street): He asked which partner milestones to watch in early and late 2027 and wanted a ranking of catalysts. He also asked whether hospitals and partners have started making the front-loaded investments you mentioned before.
A: Management said they will not detail confidential partner timelines and pointed investors to partners' public information. They highlighted two near-term buckets: the uniQure BLA (FDA decision expected in the next month or so and potential approval mid to second half of next year if accepted) and many partners initiating Phase III trials that will drive new site installs, hiring, and investment in drug-delivery support. They also said ClearPoint is investing now in robotics and focused ultrasound to prepare and scale for future commercial drug delivery and to offer preclinical services at the CAL.
"If in a best case scenario, the BLA would be accepted." — Joseph Burnett (CEO)
Cash burn and spine LITT revenue per case
Q (Mathew Blackman · TD Cowen): He asked how to think about cash burn over the next 12 months relative to historical levels. He also asked the revenue per spine LITT procedure and whether NCI study data can support a label or if a separate path is needed.
A: Management said there will be capital expenditures for the CAL in the coming 12 months, and they expect operational burn to decline quarter-over-quarter over the next 4 to 6 quarters as revenue outpaces OpEx. On spine LITT, they explained technical differences for spine procedures, said the preclinical/NCI data should be usable for future clinical evidence and that the existing device label already covers neurosurgery including spine; they said current revenue per procedure is between $13,000 and $20,000 and that "$15,000" is a reasonable modeling assumption.
"I think of it probably as $15,000 would be a non-noisy assumption." — Joseph Burnett (CEO)
Q4 revenue drivers and 2027 growth outlook
Q (Thomas Stephan · Stifel): He asked what is driving the implied Q4 step-up to a $49 million midpoint and how confident management is that it is achievable. He also asked for an early view on 2027 base business growth (mid-teens?).
A: Management said three revenue buckets—capital equipment, disposables, and CAL services—could all contribute to the Q4 uptick, noting record capital sales, a larger funnel, disposables growth from new placements (including IRRAflow), and sequential CAL revenue growth expected in Q4. For 2027 they said they still feel good about mid-teens base growth but have not given official guidance yet and expect to provide more insight around the second week of January after observing near-term trial and regulatory developments.
"we still feel good from a base standpoint about that kind of mid-teens growth for 2027." — Joseph Burnett (CEO)