Aug 13, 2026 earnings call — OneRF growth and StereoCED progress
Product revenue grew 16% year-over-year to $2.0 million in Q3.
Revenue $0.0B (est $0.0B) · EPS $-0.23 (est $-0.21)
Key quotes
"I am very proud to announce that we received our certification recently, which now provides the opportunity to enter international markets with our OneRF Brain Ablation System, OneRF Trigeminal Neuralgia Ablation System and Evo Cortical and sEEG diagnostic product lines."
"We anticipate that it will be ready for investigational human clinical studies by the end of September and possibly sooner for animal research."
"we also completed our assessment of the regulatory path to gain clearance and reconfirm that it is likely a 510(k) submission."
Analyst Q&A 3
Epilepsy study, supplier delays, ISO certification
Q (Jeffrey Cohen · Ladenburg Thalmann): Is the University of Minnesota study for focal or general epilepsy, what is the study size and timeline? Also, are supplier/backlog issues components or labor, will backlog clear by Q4, status of second site, and what about ex-U.S. OneRF distribution?
A: They said the University of Minnesota study pertains to focal epilepsy and the site will do preclinical testing most likely next quarter, then pursue Phase I if that shows efficacy. They said supplier lead times can be as long as 6 months and the company builds to order, which limits responsiveness; a second, larger manufacturing site is expected to go online in the first part of 2027 to help. For international sales they said ISO certification is needed and Zimmer is assessing geographies, with a firmer decision expected next quarter.
"And the first step in the process is for them to actually conduct preclinical testing on the therapy they've developed." — David Rosa (CEO)
StereoCED use in drug trials and approval
Q (Justin Walsh · Jones Trading): Can StereoCED be meaningful when used with drugs in development, or must it be adopted only for an already approved agent?
A: They said StereoCED could be used in preclinical work, in clinical studies, and in commercialization. They also said pharma companies usually avoid changing delivery technology mid-study because of risk, but once a therapy is cleared they would submit a 510(k) for StereoCED to be used with the approved therapy.
"We really feel there's some significant differences and advantages of our system, even as it pertains to just how much time it takes to infuse a patient that may have one of these neurological conditions." — David Rosa (CEO)
Trigeminal plans, revenue guide, Zimmer data access
Q (Jeremy Pearlman · Maxim Group): Does Zimmer not want to add Trigeminal to their agreement? Is the revenue guidance range driven only by manufacturing speed? Do you have KPIs from Zimmer on new accounts versus existing account usage?
A: They said Zimmer is interested but delays on Trigeminal stem from a backlog in Brain Ablation devices and they prioritized units to Zimmer; they plan more devices and will open additional centers beyond this quarter. They said the revenue range is driven by manufacturing; they alerted the market that orders are $11.2 million but vendor feedback makes that number unlikely and they chose a more conservative range. They said they do not have contractual rights to detailed Zimmer data and only receive anecdotal feedback.
"Some of what's delayed us with Trigeminal is this backlog that we're dealing with, with the Brain Ablation devices." — David Rosa (CEO)