NeuroOne Medical Technologies Receives FDA Approval for OneRF Trigeminal Nerve Ablation System

Biotech Stock Gains: Small-cap biotech stocks TELO, PCSA, RVPH, NMTC, and BRTX experienced significant after-hours gains driven by speculative trading and company updates, despite the absence of new disclosures.

Telomir Pharmaceuticals (TELO): TELO shares surged 43% after-hours, attributed to renewed interest in its in vitro data showcasing Telomir-1's unique targeting capabilities in cancer therapies.

Processa Pharmaceuticals (PCSA): PCSA shares rose 32.6% in after-hours trading, continuing a rally from the regular session, with no recent official news or updates from the company.

NeuroOne Medical Technologies (NMTC): NMTC shares increased 9.5% after announcing a 163% rise in preliminary product revenue for fiscal year 2025, alongside an upcoming virtual webinar, which sparked investor interest.

Biotech Stocks Performance: Biotech stocks experienced strong after-hours gains, with notable rebounds from small-cap companies like Ovid Therapeutics, NeuroOne Medical, and PepGen, driven by positive sentiment following Pfizer's drug price cuts and investment in domestic manufacturing.

Ovid Therapeutics Update: Ovid Therapeutics saw a 7.69% increase in after-hours trading, supported by a recent Buy rating from Lucid Capital and a narrower quarterly loss, alongside a $7 million royalty sale agreement related to future revenues.

PepGen's Recent Surge: PepGen's stock rose 3.03% after-hours, continuing a volatile week with over 120% growth, attributed to positive Phase 2 trial results for its myotonic dystrophy treatment and a successful $100 million public offering.

Reviva Pharmaceuticals and Anika Therapeutics: Reviva Pharmaceuticals gained 5.81% after-hours following a significant intraday surge, while Anika Therapeutics rose 5.53% ahead of its upcoming earnings report, despite a quiet news cycle for both companies.

FDA Clearance: NeuroOne Medical Technologies has received FDA clearance for its OneRF® Trigeminal Nerve Ablation System, aimed at treating trigeminal neuralgia through minimally invasive procedures.

Technology Features: The system utilizes a unique multi-contact RF probe to deliver targeted radiofrequency energy, enhancing safety and accuracy while potentially reducing procedural time and improving patient comfort.

Market Potential: This marks NeuroOne's entry into pain management therapies, with plans for a limited commercial launch in late 2025 and opportunities to expand into other neurological disorders and therapeutic applications.

Company Overview: NeuroOne focuses on developing minimally invasive solutions for various neurological conditions, aiming to improve patient outcomes and reduce procedural costs.

FDA Clearance: NeuroOne Medical Technologies Corporation has received FDA clearance to market its OneRF Trigeminal Nerve Ablation System for creating radiofrequency lesions to treat pain and for functional neurosurgical procedures.

Target Market: The system is aimed at treating trigeminal neuralgia, a chronic facial pain condition affecting around 150,000 people annually in the U.S.

Commercial Launch Plans: The company plans a limited commercial launch of the product in the fourth quarter of this year.

Revenue Potential: NeuroOne anticipates potential revenue generation from trigeminal nerve ablation as early as late calendar year 2025, following discussions with strategic partners.

Company Performance: NeuroOne Medical Technologies reported a 105% increase in revenue to US$1.70 million, while net loss narrowed by 46%, with earnings per share improving significantly compared to the previous year; however, revenue fell short of analyst expectations by 6.8%.

Future Outlook and Concerns: The company forecasts an average revenue growth of 36% annually over the next three years, outpacing the industry average, but there are four warning signs that raise concerns about its performance.