Product Revenue

FY 2025

$8 million to $10 million; increase of 132%–190% versus $3.5 million in FY 2024 " " "

$8 million to $10 million; increase of 132%–190% over fiscal 2024 " "

no change

Product Gross Margin

FY 2025

47%–51%, compared to 31% in FY 2024 " " "

47%–51%, compared to 31% in FY 2024 "

no change

Zimmer Biomet Partnership and Revenue Concentration

Q1 2025 discussed an expanded exclusive partnership with Zimmer Biomet driving record product sales and revenue concentration. " " Q4 2024 noted milestone license payments and significant revenue growth from the partnership. " " Q3 2024 mentioned revenue concentration details from collaboration. "

Q2 2025 reaffirmed the exclusive distribution agreement with Zimmer Biomet and stated that nearly all revenue will come from this partnership. " " "

Consistent emphasis with an increased focus on revenue dependency, highlighting both growth and concentration concerns.

OneRF Ablation System Commercialization and Clinical Performance

Q1 2025, Q4 2024, and Q3 2024 provided details on FDA clearance, strong clinical outcomes, record product sales, and initial commercialization milestones. " " " " "

Q2 2025 continues to highlight robust clinical success, commercialization progress including international expansion efforts, and improved patient outcomes. " " "

Steady, positive performance with continuous market adoption and broadened commercialization efforts.

FDA Clearance and Regulatory Approval Challenges

Previous periods (Q3 2024, Q4 2024, Q1 2025) described achieving 510(k) clearance for the OneRF system and outlined upcoming FDA submissions (including for trigeminal nerve applications) with minimal reported challenges. " " "

In Q2 2025, the company reiterated its FDA clearance status for OneRF and reported filing the 510(k) submission for the trigeminal nerve ablation system ahead of schedule, along with proactive steps for international regulatory approvals. " "

Consistent regulatory success with a proactive, challenge‐free posture and a forward-looking submission strategy.

Financial Health, Liquidity Management, and Capital Raising

Q1 2025, Q4 2024, and Q3 2024 reported improving financial performance through reduced net losses, strengthened liquidity from milestone license payments and private placements, and effective capital management. " " "

Q2 2025 reported a significant improvement in net loss, a boosted cash position due to an oversubscribed capital raise, and confirmed funding through fiscal 2026. " " "

Stable financial improvement and effective liquidity management remain a consistent strength, with further capital-raising success recently reported.

Gross Margin Sustainability and Profitability Outlook

Q1 2025 showcased product gross margins above guidance (58.9% vs. 47–51%) and Q4 2024 emphasized a move from 31% margins in fiscal 2024 to an expected 47–51% range. Q3 2024 hinted at margin improvements. " " " "

Q2 2025 reported first-half product gross margins of 57.9% and Q2 results at 55.6%, while reaffirming guidance, with improved profitability metrics (net loss reduced to $0.5 million). " "

A clear upward trajectory in margins and profitability continues, though a normalization to guidance levels is anticipated.

Strategic Leadership Additions and Product Innovation Initiatives

Q4 2024 and Q3 2024 focused on product innovation (e.g., extending the OneRF platform to other indications and exploring adjunct technologies), while Q1 2025 did not mention leadership updates. " "

Q2 2025 introduced key leadership additions (a new Chief Medical Adviser and General Counsel) alongside continued initiatives such as expanding into trigeminal nerve treatment, international certification for broader commercialization, and exploration of further applications. " "

New leadership fortifies the already robust product innovation strategy, marking an enhancement in strategic direction.

Trigeminal Nerve RF Ablation System Development

Q1 2025 and Q4 2024 provided timelines for a 510(k) submission in the first half of 2025 and noted its revenue potential, while Q3 2024 did not address this product. " " "

Q2 2025 confirmed that the 510(k) submission for the trigeminal nerve system has been filed ahead of schedule, emphasizing market potential for treating trigeminal neuralgia. "

Consistent development with an accelerating pace, positioning the new system as a key near-term growth driver.

Nasdaq Compliance and Stock Price Concerns

Q1 2025 reported regaining NASDAQ share price compliance " and Q4 2024 mentioned ongoing monitoring of the stock’s closing bid to meet minimum requirements; Q3 2024 did not mention the topic. "

Q2 2025 did not mention Nasdaq compliance or stock price concerns.

Decreased focus in Q2 2025 suggests resolution or reduced priority of the issue relative to previous periods.

Limited Revenue Diversification Risk

Q3 2024 highlighted a heavy reliance on product revenue with minimal diversification. Q4 2024’s revenue sources point to dependency on key partnerships, while Q1 2025 did not explicitly address this risk. " "

Q2 2025 explicitly noted that nearly all revenue is expected to originate from Zimmer Biomet, underlining a concentration risk.

An increasing focus on the risk of revenue concentration, signaling potential vulnerabilities despite the strong partnership performance.

Uncertainty in Strategic Distribution Partnerships

Q3 2024 included mention of a nonbinding term sheet with an undisclosed partner, reflecting negotiation uncertainties, while Q1 2025 and Q4 2024 emphasized positive and definitive aspects of the arrangement with Zimmer Biomet. " " "

Q2 2025 focused solely on the robust Zimmer Biomet partnership along with proactive discussions on new strategic partners, with no mention of uncertainty.

A shift from prior uncertainty to a more confident stance, as key distribution agreements appear solidified and additional opportunities are actively explored.