What is causing the supplier/backlog issues (components/labor)? Will the second site resolve the backlog by year-end?

Lead times are up to 6 months, and changes in product mix impact ability to respond. The second manufacturing site, expected online in early 2027, is much larger and should address capacity issues. The company prioritizes large orders for margin efficiency. “So the supplier situation is we -- the company has lead times and the lead times are roughly -- it can take as long as 6 months. So there is an ordering process that's in place with Zimmer Biomet today, where they give us orders in advance so that we can manufacture the product and then ship it to them on time.”

Details on ex-U.S. distribution discussions and potential opportunities for OneRF following ISO certification.

ISO certification is key for international shipping. Zimmer Biomet is assessing geographies based on existing relationships and economics. NeuroOne will explore independent distributors for territories not covered by Zimmer. Timelines vary by region (e.g., Europe requires clinical data). Firm answers expected next quarter. “Zimmer, per our last amendment that we signed over a year ago, they have certain geographies internationally, and they're assessing which ones they want to go to first. And again, the idea is how can we hit the ground running.”

Is StereoCED meaningful for drugs in development or only for approved agents?

StereoCED can be used in preclinical, clinical, and commercial stages. However, pharmaceutical companies are unlikely to switch delivery devices mid-clinical trial (Phase II/III) to mitigate risk. Once a therapy is approved, NeuroOne would seek 510(k) clearance to be used with it. “I think it could be used in both the clinical stage -- well, actually, the preclinical stage, which is what we're seeing now with like the University of Minnesota as well as the clinical stage and then obviously, the commercialization piece as well.”

NMTC

NeuroOne (NMTC) Q3 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q3 FY26)· Health Care· Aug 13, 2026

Source: earnings call transcript

Executive summary

NeuroOne Q3 FY26 — Strong Revenue Growth, ISO Certification, and Pipeline Progress

NeuroOne delivered a strong quarter with double-digit revenue growth and significant gross margin expansion, driven by its OneRF Brain Ablation System. The company achieved a major milestone with ISO 13485 certification, opening doors for international expansion with Zimmer Biomet and independent partners. While manufacturing delays impacted full-year revenue recognition, the company is addressing this with plans for a second manufacturing site and continues to advance its StereoCED drug delivery system and BVNA back pain program through strategic collaborations and regulatory pathways.

Highlights

Product revenue for OneRF Brain Ablation System grew 16% year-over-year to $2.0 million.
Product orders increased 43% year-over-year to $2.7 million.
Gross margins expanded to 59.9% from 53.9% year-over-year due to favorable product mix.
Received ISO 13485 certification, enabling international market entry.
Lead investor increased holdings from 7.4% to 12.5%.

Concerns

Fiscal year 2026 recognized revenue guidance narrowed to $9.2 million-$10.5 million, down from a potential $11.2 million in orders, due to manufacturing delays.
Cash and cash equivalents decreased to $2.0 million as of June 30, 2026, from $6.6 million as of September 30, 2025.
Net loss increased to $2.0 million in Q3 FY26 from $1.5 million in Q3 FY25.

Guidance & targets

Category	Target	Timeline	Confidence
Fiscal Year 2026 Product Orders	approximately $11.2 million high materiality	FY26	High
Fiscal Year 2026 Recognized Revenue	between $9.2 million to $10.5 million high materiality	FY26	Medium

Deals & partnerships

Zimmer Biomet Distribution partner for OneRF Brain Ablation System and other products in international markets.

Working closely to enter international geographies that optimize existing customer relationships and have favorable economics, following ISO 13485 certification.

University of Minnesota Collaboration for preclinical research on StereoCED in epilepsy.

First animal studies are scheduled to begin this month, with data expected this fall to support future clinical development.

Mayo Clinic Collaboration for preclinical research on StereoCED in diffuse midline glioma.

First animal studies are scheduled to begin this month, with data expected this fall to support future clinical development.

Risks & headwinds

Manufacturing Delays & Product Backlog Q4 calendar 2026 (for clearing backlog), early 2027 (for new site online)

FY26 recognized revenue guidance of $9.2 million-$10.5 million, compared to $11.2 million in product orders. $1.7 million backlog as of June 30, 2026.

Mitigation:Working to expedite manufacturing; qualifying a second, larger manufacturing site expected online in early 2027 to increase capacity and reduce lead times.

Cash Burn Ongoing

Cash and cash equivalents decreased from $6.6 million (Sep 30, 2025) to $2.0 million (Jun 30, 2026).

Mitigation:Raised $0.4 million via ATM in Q3 FY26 and another $1.0 million post-quarter end (July 13, 2026).

Regulatory Timelines for New Products H2 calendar 2027

BVNA FDA clearance submission expected in H2 calendar 2027, with management noting 'no guarantees' despite past 510(k) success.

Mitigation:Leveraging existing OneRF generator and ablation electrode; reconfirming 510(k) path based on prior successful submissions.

What to watch in Q4 FY26

Second Manufacturing Site Qualification

Early 2027

Current In progress

Target Online

Why it matters

Essential for increasing capacity, reducing lead times, and resolving product backlog, directly impacting revenue recognition.

Moving forward, we are working towards the qualification of a second manufacturing site, which will increase capacity and potentially reduce lead times.

Find out whether NMTC delivers this. Inve re-checks your case every morning.

Q&A highlights

What type of epilepsy (focal/general), study size, and timeline for the University of Minnesota collaboration?

The study is for focal epilepsy, and preclinical testing is expected in the next quarter. If successful, it would move to a Phase I human study.

“So at the University of Minnesota, it pertains to focal. And the first step in the process is for them to actually conduct preclinical testing on the therapy they've developed. And that will happen literally expectedly most likely in the next quarter.”

asked by Jeffrey Cohen · answered by David Rosa

2 min read 6 chapters

Detailed narrative

International Expansion

NeuroOne achieved ISO 13485 certification, a critical milestone for entering international markets with its OneRF Brain Ablation, OneRF Trigeminal Neuralgia Ablation, and Evo Cortical/sEEG diagnostic product lines. The company plans to collaborate with its distribution partner, Zimmer Biomet, to target geographies with favorable economics and existing customer relationships, while exploring independent partnerships for other regions.

The process involves varying requirements, from documentation to clinical data, depending on the specific geography.

OneRF Brain Ablation System Clinical Validation

The Journal of Neurosurgery published a retrospective observational study from the Mayo Clinic in Jacksonville, Florida, validating the use of NeuroOne's OneRF Brain Ablation System. The study demonstrated that procedures could be safely performed in patients with implanted neuromodulation devices without interference, leading to meaningful seizure reduction. This clinical evidence expands the treatable patient population and supports the system's efficacy.

OneRF Trigeminal Nerve Ablation System Commercialization

A recent patient success story, featured on Cleveland 19 News, highlighted the life-changing potential of the OneRF Trigeminal Nerve Ablation System, with the patient reporting to be pain-free after treatment. The U.S. market for disposables (excluding hardware) is estimated at $40 million, primarily concentrated in approximately 30 centers.

NeuroOne plans to expand commercialization by leveraging existing personnel and engaging independent distributors, anticipating a short learning curve to minimize support costs.

StereoCED Drug Delivery System Progress

NeuroOne's StereoCED robotic-assisted platform is designed to improve brain-delivered therapeutics by enabling efficient, reproducible, and scalable delivery. It aims to significantly reduce procedure times through simultaneous multi-trajectory delivery, leveraging existing neurosurgical equipment. The company anticipates StereoCED will be ready for investigational human clinical studies by the end of September, with preclinical animal studies starting this month in collaboration with the University of Minnesota and Mayo Clinic.

BVNA Back Pain Management Program

The company completed user design requirements and initiated preclinical testing for its Basivertebral Nerve Ablation (BVNA) System for back pain. The strategy involves leveraging the existing OneRF generator and ablation electrode while outsourcing access tools. NeuroOne reconfirmed that the regulatory path is likely a 510(k) submission, with an expected FDA clearance submission in the second half of calendar 2027, building on past success with 510(k) clearances.

Manufacturing and Supply Chain

NeuroOne is actively working to expedite manufacturing to address a $1.7 million product backlog as of June 30, 2026, with the goal of clearing it by the end of the fourth calendar quarter of 2026. To increase capacity and reduce lead times, the company is qualifying a second, larger manufacturing site, which is expected to become operational in the first part of 2027.

This initiative aims to improve efficiency and meet growing product demand.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.