Commercial Momentum Accelerates with Record OneRF® Procedure Volume in Fiscal Q1 ‘26 and Early Trigeminal Success
Platform Advancing Across Three New $1B+ Market Opportunities With Key Milestones Expected in 2026
EDEN PRAIRIE, MINN. - March 9, 2026 (NEWMEDIAWIRE) - NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, today issued a letter to shareholders from Dave Rosa, Chief Executive Officer.
Dear Shareholders,
As we move through fiscal 2026, I want to take this opportunity to share a comprehensive update on our business - the progress we are making across our commercial and pre-commercial markets, the financial momentum we have established, and an important vote we are asking you to cast at our Annual Meeting on April 3, 2026. The short version: our technology is working, our customers are telling us so, and we have never been better positioned to deliver on the promise of the NeuroOne platform technology.
We are strategically focused on three critical areas - brain, pain, and advanced drug delivery. In each of these markets, our core commitment is the same: we only compete where our technology offers a meaningful improvement over the existing standard of care for both patient and physician. That discipline, combined with a diversified portfolio across these segments, is what we believe makes NeuroOne a compelling and differentiated investment.
Our confidence is grounded in clinical evidence. We have patients who have been successfully treated with our technology and who are willing to share their stories. Following treatment with our OneRF® ablation system, a professional pianist from Chicago resumed his career and a teenage girl who for years experienced an average of 10 seizures nightly became seizure-free for over a year along with an improved quality of life.* The first nine patients treated for trigeminal neuralgia - one of the most severe pain conditions in medicine - are all reportedly pain-free. These transformational outcomes for patients reinforce our conviction in the long-term potential of the NeuroOne platform technology.
As we look ahead, we believe the most exciting commercial opportunities for the NeuroOne platform lie in front of us. Today, we estimate the market opportunity for our currently approved commercial applications to be over $200 million in the U.S. Beyond these initial indications, however, the opportunity expands significantly. Drug delivery, basivertebral nerve ablation (BVNA), and spinal cord stimulation each represent addressable markets that we believe could exceed $1 billion annually in the U.S.
As one example of the strategic interest in these larger opportunities, Boston Scientific acquired Relievant Medsystems, the developer of the Intracept® basivertebral nerve ablation system, in late 2023 for approximately $850 million upfront plus additional contingent payments, representing roughly a 12× multiple of expected revenue at the time of the transaction. The therapy has since become one of the fastest-growing products in Boston Scientific’s pain management portfolio. The category has also attracted new product launches from companies such as Stryker, which we believe further validates the clinical need and expands the long-term market opportunity. The strength of the NeuroOne platform lies in our ability to leverage our existing FDA-cleared technology to efficiently develop new, highly differentiated products for the BVNA market that we believe can offer strong competition versus existing commercialized technologies in the United States. We believe the same platform advantages can be applied to our drug delivery and spinal cord stimulation programs as we pursue these additional large market opportunities.
Commercialization Updates and Pipeline Milestones
Our commercialization track record continues to validate our approach. To date, we have secured four FDA 510(k) clearances and remain confident in the strategies guiding our remaining pipeline programs. Two years ago, it was our OneRF® brain ablation system. Last year, trigeminal neuralgia. This year, we expect our drug delivery product to reach commercial readiness for use in investigational clinical studies or animal studies. That pattern of consistent, annual advancement - achieved by a lean and highly motivated team - reflects both the strength of our platform and the operational discipline that defines how we run this company.
OneRF® Ablation System in the Brain. Our brain ablation program, commercialized through our exclusive distribution partnership with Zimmer Biomet, delivered its strongest quarter in Q1 fiscal 2026 since the launch by Zimmer Biomet. Nearly 50% of all ablations performed with the system since its introduction in 2024 were completed in that single quarter alone - a powerful indicator of growing real-world adoption. Zimmer Biomet covers all marketing and sales costs under our distribution agreement, which means every incremental procedure directly benefits our margin structure. Physicians from the Mayo Clinic in Jacksonville shared their positive clinical experience with the system at the American Epilepsy Society meeting in December, and our first post-market patient registry cases are expected to begin in July 2026. We are also making progress toward ISO 13485 certification, a requirement for international distribution.
OneRF® Trigeminal Nerve Ablation System. Following FDA 510(k) clearance last August, we have now completed nine cases across three centers. All nine patients are reportedly pain-free. Trigeminal neuralgia affects an estimated 150,000 new patients annually in the United States and is widely regarded as one of the most debilitating pain conditions known to medicine. Our limited market release is expected to be completed by the end of the second quarter of fiscal 2026. We are currently evaluating both a direct commercialization path and a strategic licensing partnership - discussions that are in active diligence. A transaction, if completed, would represent incremental revenue beyond our existing 2026 guidance and potentially a non-dilutive licensing fee.
sEEG-Based Drug Delivery Program. Our drug delivery system is now six months ahead of its original development schedule, and we are targeting commercial readiness for use in investigational clinical studies or animal studies by the end of Q3 fiscal 2026. We are focused initially on glioblastoma - an aggressive form of brain cancer with a median survival measured in months - as well as gene and cell-based therapies. We are establishing a physician advisory board to determine customer needs so that we can offer a differentiated system that improves quality of life. We remain in active discussions with two potential partners. Drug delivery exemplifies what we believe is the unique versatility of the NeuroOne platform: the same foundational electrode technology adapted to address an entirely new, high-unmet-need clinical challenge.
Basivertebral Nerve Ablation. Multiple advisory board meetings with leading pain specialists have confirmed the clinical rationale and design principles of our Basivertebral Nerve Ablation system for chronic low back pain. Our strategy is capital-efficient: leverage the existing OneRF® generator, temperature probe, and ablation electrode while outsourcing the access tools. We believe strongly one of our major advantages pertains to our multi-contact sEEG probes which would allow doctors more flexibility when placing the device. We are in advanced discussions with multiple potential strategic partners.
Spinal Cord Stimulation Percutaneous Paddle Lead. We have initiated a six-month animal study in the second quarter of fiscal 2026 in preparation for a first-in-man study, with potential strategic partners engaged in diligence discussions to accelerate the path to commercialization. The system was presented and displayed at the Business of Pain and NANS meetings, generating early-stage physician interest. Our solution utilizes a percutaneously-placed thin-film paddle electrode to deliver precise electrical stimulation to the spinal cord, blocking pain signals from reaching the brain thereby providing relief to patients. This capability opens the use and implantation of paddle electrodes to both pain management doctors and neurosurgeons. Currently, surgeons predominantly place paddle electrodes through an invasive procedure. Our paddle electrode is designed so that both pain doctors and neurosurgeons can easily place paddle electrodes percutaneously
Leadership Update. In March 2026, we appointed David Wambeke as Chief Business Officer. David brings experience in healthcare capital markets, corporate strategy, and business development. He will lead our drug delivery device program and partner with the executive team to refine product requirements, prioritize and advance high-impact programs, expand relationships with key opinion leaders in targeted disease areas, and engage prospective pharmaceutical partners to evaluate strategic alternatives. He will also oversee investor relations, including messaging, investor materials, and conference participation, and will support broader business development initiatives. To demonstrate alignment with shareholders, David purchased 1,000,000 shares of NeuroOne common stock in a private placement priced at market.
Annual Meeting of Stockholders and Reverse Stock Split
On February 27, 2026, we filed a proxy statement in connection with our Annual Meeting of Stockholders, to be held on Friday, April 3, 2026, at 9:00 a.m. Central Time at our offices in Eden Prairie, Minnesota. In addition to director elections and other routine proposals, the Board of Directors is requesting that stockholders of record as of February 20, 2026 approve an amendment to our Certificate of Incorporation to effect a reverse split of our outstanding common stock at a ratio in the range of 1-for-2 to 1-for-15, to be determined at the discretion of the Board, in order to maintain compliance with Nasdaq’s continued listing requirements.
We want to address this proposal directly and without ambiguity. A reverse stock split is a structural compliance mechanism - not a reflection of our operational performance or the significant potential of our business. If approved and implemented, it consolidates the number of shares outstanding while leaving total market capitalization and each shareholder’s proportional ownership of the Company completely unchanged. Your percentage stake in NeuroOne is unaffected. The reverse split does not authorize the issuance of any new shares; that is an entirely separate corporate action.
Maintaining our Nasdaq listing is in every shareholder’s interest. It preserves liquidity, supports price discovery, provides access to institutional capital, and keeps us positioned to pursue the licensing and strategic transactions currently in progress. We are proactively seeking this authorization to retain that optionality. The Board reserves the right to delay or forgo implementation if market conditions make it unnecessary, and management remains focused on sustaining compliance without executing a split if possible. But having the authorization in place is the responsible step to take now, and the Board unanimously recommends a vote FOR this proposal.
2026 Outlook
Financially, we are in a strong position with growing revenues and ample working capital. As of December 31, 2025, we carry zero debt, with $3.6 million in cash and cash equivalents, $2.7 million in accounts receivable, and $6.8 million in working capital. The accounts receivable balance - which increased by $1.4 million in Q1 alone - reflects higher billing activity from Zimmer Biomet, and converts to cash in the ordinary course of business. Product gross margin was 54.2% in Q1, with gross profit growing sequentially. SG&A declined 7.7% year-over-year, reflecting continued financial discipline.
We are guiding to at least $10.5 million in product revenue for fiscal year 2026, a minimum 17% increase over fiscal year 2025. This guidance does not include any contribution from our most recent 510(k) clearance for trigeminal nerve ablation. We are also in active discussions which could generate non-dilutive cash in 2026.
In summary, the investment thesis for NeuroOne is straightforward. We have built a platform that works, in markets where it matters, with partners that validate our technology, and with patients who are living the results. We have four FDA clearances, a growing intellectual property portfolio of 13 U.S. patents issued or pending plus four internationally, and a commercial infrastructure through Zimmer Biomet that gives us national reach without the corresponding SG&A burden. Our revenue is growing, we expect our capital needs to decline, and the largest commercial opportunities still lie ahead in BVNA, drug delivery, and spinal cord stimulation - areas where we believe the NeuroOne platform is positioned for several important strategic and commercial inflection points beginning in 2026.
I look forward to seeing many of you on our upcoming Virtual Investor Webinar March 12, 2026 at 11:30 a.m. Eastern Time and continuing to update you as we execute on our 2026 milestones.
Sincerely,
Dave Rosa
Chief Executive Officer
About NeuroOne
NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo® Cortical Electrodes, Evo® sEEG Electrodes, OneRF® Ablation System (for brain), and OneRF® Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions. The Company is engaged in research and development for drug delivery and spinal cord stimulation programs. For more information, visit nmtc1.com.
Forward Looking Statements
This letter may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this letter may be a forward-looking statement that reflects NeuroOne’s current views about future events and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the words or phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “forecasts,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue,” “focused on,” “committed to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements may include statements regarding the Company’s 2026 revenue guidance, the continued development of the Company’s electrode technology program (including its drug delivery program, basivertebral nerve ablation program and spinal cord stimulation program); business strategy, market sizes, potential growth opportunities, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology, risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials, risks related to uncertainties associated with the Company’s capital requirements to achieve its business objectives and ability to raise additional funds, the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology, uncertainties inherent in the development process of our technology, risks related to changes in regulatory requirements or decisions of regulatory authorities, risks that we may not have accurately estimated the size and growth potential of the markets for our technology, risks related to clinical trial patient enrollment and the results of clinical trials, and risks that we may be unable to protect our intellectual property rights, and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this letter and NeuroOne undertakes no obligation to revise or update any forward-looking statements for any reason, even if new information becomes available in the future.
Caution: Federal law restricts this device to sale by or on the order of a physician.
* Disclaimer: This recounts several patients' experiences and may not be representative of all patient outcomes.
IR Contact
MZ Group – MZ North America
NMTC@mzgroup.us
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