$NMTC Our new Southern California distribution agreement for the OneRF® Trigeminal Nerve Ablation System builds on our initial commercialization efforts and supports our broader strategy to develop a distribution network across key U.S. markets.
Southern California represents an important market for the OneRF® Trigeminal Nerve Ablation System, and this agreement expands commercial access across key counties, including the Los Angeles metropolitan area.
As we move forward, we expect to continue evaluating additional distribution relationships to broaden access to the system in other important U.S. markets.
$GMED $BSX
$NMTC We are expanding the U.S. commercialization of our FDA-cleared OneRF® Trigeminal Nerve Ablation System through a new distribution agreement covering key Southern California counties, including the Los Angeles metropolitan area.
This agreement marks another step in broadening commercial access to OneRF® and expanding our presence across important U.S. markets.
As we continue our commercialization efforts, we remain focused on bringing our technology to more physicians and expanding access for patients suffering from trigeminal neuralgia.
$GMED $BSX
$NMTC Our basivertebral nerve ablation program reflects our strategy of applying NeuroOne’s established technology and experience to additional therapeutic areas.
We have completed the program’s regulatory strategy, with the system currently expected to follow a 510(k) pathway. Device optimization remains underway, including work to optimize lesion size.
We are also engaged in advanced discussions with a potential tier-one strategic partner to develop and supply the access tools for the system as we continue evaluating this opportunity in chronic vertebrogenic lower back pain.
$BSX $GMED
$NMTC StereoCED™ represents an important extension of our core electrode technology into precision intracranial drug delivery.
Following three successful large-animal procedures, development of devices for animal use was completed ahead of schedule, allowing sales to begin earlier than anticipated. We expect to recognize the related revenue from this research program during fiscal Q4 2026.
Development of devices for human investigational use also remains on track as we continue advancing toward the planned use of StereoCED™ in FDA approved investigational studies.
$CLPT $GMED
$NMTC Our fiscal Q3 results demonstrated progress not only in product revenue, but also in the underlying economics of our commercial business.
Product gross profit increased 29% year over year to $1.2 million, while product gross margin reached a record 59.9%, compared with 53.9% during the same period last year. The improvement reflected a more favorable product mix, while higher OneRF® product sales were the primary driver of revenue growth.
Together with our ISO 13485 certification, these results strengthen the foundation supporting continued product adoption and our plans to selectively pursue international commercial opportunities.
$ABT $MDT $GMED
We continue working closely with our manufacturing partners to maximize shipments and convert this demand into recognized revenue as we build on the commercial momentum across our portfolio.
$CLPT $MDT
Orders exceeded recognized revenue during the quarter, contributing to a $1.7 million backlog as of June 30. As of our Q3 update, we had received approximately $11.2 million in product orders for fiscal 2026.
Fiscal Q3 reflected progress across both sides of this strategy: strengthening the commercial foundation of our business today while continuing to advance the opportunities that may support our longer-term growth.
$NMTC $MDT $ABT
$NMTC AT NeuroOne, we are building a medical technology platform focused on expanding the role of minimally invasive solutions across neurological disorders and chronic pain.
Our commercial portfolio continues to generate growing demand, while programs such as StereoCED™ and basivertebral nerve ablation are designed to extend our technology into additional applications.
Across our broader portfolio, we continue to extend that technology into additional diagnostic and therapeutic applications, with a focus on addressing meaningful unmet needs in neurology and pain management.
As StereoCED™ advances toward human investigational use, we see the program as another application of our core technology, combining targeted drug delivery with electrophysiological recording.
The recently completed three large-animal procedures demonstrated repeatability across the integrated robotic placement and drug delivery workflow, with two procedures also demonstrating electrophysiological recording from the same targeted regions.