Summary of Nyxoah's Conference Call Company Overview - **Company**: Nyxoah - **Industry**: MedTech, specifically focused on the treatment of obstructive sleep apnea (OSA) through neuromodulation solutions - **Market Opportunity**: The U.S. OSA market is valued at approximately $10 billion, identified as a blockbuster market with significant under-penetration [2][3] Core Points and Arguments - **FDA Approval**: Nyxoah has received FDA approval and is actively launching its product in the U.S. market [2] - **Technology Differentiation**: The Genio system offers a unique bilateral mode of action, which is minimally invasive and does not require an implanted battery, making it distinct from competitors [3][9] - **Clinical Evidence**: The DREAM study demonstrated a 63.5% reduction in the Apnea-Hypopnea Index (AHI) and a 71.3% oxygen desaturation responder rate, indicating strong efficacy and safety [15][16] - **Market Penetration**: Nyxoah has implanted over 1,000 patients in Europe and is commercially reimbursed in several countries, including Germany, the U.K., and the UAE [3][19] - **U.S. Commercial Strategy**: The company focuses on high-volume hypoglossal nerve implanting accounts, which represent about 70% of the total market volume in the U.S. [19][20] - **Sales Team**: Nyxoah has a dedicated U.S. sales team of approximately 60 people, with 40 focused on high-volume accounts [20] Reimbursement Insights - **CPT Codes**: Nyxoah has secured CPT codes recognized by both Medicare and private payers, including major insurers like UnitedHealthcare and Blue Cross Blue Shield [22][36] - **CMS Communication**: Recent updates from CMS indicate that both Genio and its competitors will receive a facility fee of $31,526 for implants, ensuring continued reimbursement [37][40] - **Market Dynamics**: There is a clear need for dedicated codes for hypoglossal nerve stimulation (HGNS) as the market evolves with multiple technologies [36][37] Competitive Landscape - **Demand Drivers**: The demand for Genio is driven by physician and patient needs for alternatives to battery-implanted devices, as well as the clinical superiority of the Genio system in treating complex airway obstructions [29][30] - **Patient Preferences**: Patients prefer the discreet single incision and the absence of a battery replacement requirement, which enhances the appeal of Genio [32] Financial Outlook - **Revenue Break-Even**: Nyxoah aims to achieve revenue break-even at approximately EUR 150 million, with an expected gross margin of over 80% [42] - **Operational Leverage**: The company has built out its organization to scale effectively, with limited direct-to-consumer (DTC) spending compared to competitors [43] Additional Insights - **Geographic Expansion**: Nyxoah is selectively expanding into international markets, with plans to enter Singapore and other Asian markets [24] - **Patient Engagement**: The Genio system includes a smart wearable component and an app for monitoring sleep data, enhancing patient involvement and data collection for healthcare management [12][13] Conclusion - Nyxoah is positioned as a significant player in the OSA treatment market with a differentiated technology, strong clinical evidence, and a focused commercialization strategy. The company is navigating the complexities of reimbursement while expanding its market presence and enhancing its product offerings [25][36]

For now, the evidence for neuromodulation products is slim https://t.co/c2EBrAnMvJ ...

Financial Data and Key Metrics Changes - The company reported a 27% increase in revenue to $14.5 million for Q4 2025, with full-year revenue also growing 27% to $52.2 million compared to 2024 [4][18] - Gross profit for Q4 was $11.1 million, up from $8.5 million in the prior year, increasing gross margin to 76% [19] - Net income for Q4 was $2.9 million, compared to $1.5 million in the same period of 2024, with full-year net income of approximately $7.6 million compared to $2.9 million in 2024 [23] Business Line Data and Key Metrics Changes - The company shipped 95 Deep TMS systems during Q4, bringing the total installed base to approximately 1,700 systems, a 26% increase year-over-year [4][18] - The book-to-bill ratio improved to 1.4x from 1.2x in the previous quarter, indicating strong demand [5] - Remaining performance obligations reached $70 million, representing a 43% growth from $49 million a year ago [5][24] Market Data and Key Metrics Changes - The company has penetrated less than 10% of the market for Deep TMS, indicating significant growth potential [7] - The FDA granted label expansion for Deep TMS to treat adolescents aged 15 to 21 with major depressive disorder, expanding the addressable patient population [9][10] Company Strategy and Development Direction - The company is focusing on expanding reimbursement coverage with payers across the U.S. to support broader adoption of Deep TMS [8] - A strategic initiative is in place to secure minority equity investments in high-performing mental health providers, which is expected to facilitate faster access to interventional psychiatry modalities [14][15] - The long-term vision includes developing a portfolio of data-driven technology-enabled neuromodulation solutions to serve more patients [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in the business and expects revenue in the range of $66 million to $68 million for 2026, representing a year-over-year growth rate of 27%-30% [24] - The company anticipates adjusted EBITDA of $12 million to $14 million for 2026, indicating expected growth of 86%-100% over 2025 [25] Other Important Information - The company received a $2.5 million NIH grant for a study on Deep TMS for alcohol use disorder, highlighting ongoing clinical research efforts [12][13] - The SWIFT Deep TMS protocol was validated through peer-reviewed studies, which could significantly improve patient access and treatment efficiency [11] Q&A Session Summary Question: Can you give us a better sense of the fourth quarter placements as far as units sold, units leased, and also any color regarding OCD placements? - The company shipped 95 systems during Q4, with more than 50% including the H7 coils [26] Question: Can you talk about the Deep TMS 360 trial that's going on? - The TMS 360 trial is actively recruiting patients for alcohol use disorder in 10 centers across the U.S., aiming to recruit over 200 patients [28][29] Question: Was there any pricing change in 2025 or anticipated for 2026? - The company does not anticipate a decrease in average selling price and aims to optimize pricing based on the value provided [31] Question: What percentage of the $70 million obligations relates to commitments from existing strategic partners? - The minority investment program is expected to deliver new backlog or bookings of between $3-$5 million on a yearly basis from each center [35][36] Question: Do you anticipate significant utilization of the SWIFT protocol in conjunction with other therapies? - There is strong demand for TMS, particularly with the SWIFT protocol, which is being used alongside other modalities like psychedelics and medication management [41]

Financial Data and Key Metrics Changes - The company reported a 27% increase in revenue to $14.5 million for Q4 2025, with full-year revenue also growing 27% to $52.2 million compared to 2024 [4][18] - Gross profit for Q4 was $11.1 million, up from $8.5 million in the prior year, increasing gross margin to 76% [19] - Net income for Q4 was $2.9 million, compared to $1.5 million in the same period of 2024, with full-year net income of approximately $7.6 million compared to $2.9 million in 2024 [23] Business Line Data and Key Metrics Changes - A total of 95 Deep TMS systems were shipped during Q4, bringing the installed base to approximately 1,700 systems, a 26% increase year-over-year [4][18] - The book-to-bill ratio improved to 1.4x from 1.2x in the previous quarter, indicating strong demand [5] Market Data and Key Metrics Changes - Remaining performance obligations reached $70 million, representing a 43% growth from $49 million a year ago, reflecting strong demand and long-term commitments [5][24] - The company estimates it has penetrated less than 10% of the market for Deep TMS, indicating significant growth potential [7] Company Strategy and Development Direction - The company is focusing on expanding reimbursement coverage with payers across the U.S. to increase market share [8] - A strategic initiative is in place to secure minority equity investments in high-performing mental health providers, which is expected to facilitate faster access to interventional psychiatry modalities [14][15] - The company aims to develop a portfolio of data-driven technology-enabled neuromodulation solutions to serve more patients and settings [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in the business and expects revenue in the range of $66 million to $68 million for 2026, representing a year-over-year growth rate of 27%-30% [24][25] - The company anticipates adjusted EBITDA of $12 million to $14 million for 2026, indicating expected growth of 86%-100% over 2025 [25] Other Important Information - The FDA granted label expansion for the Deep TMS system to treat adolescents aged 15 to 21 suffering from major depressive disorder, expanding the addressable patient population [9] - The company received a $2.5 million NIH grant for a study on Deep TMS for alcohol use disorder, highlighting ongoing clinical research efforts [12][13] Q&A Session Summary Question: Can you give us a better sense of the Q4 placements as far as units sold, units leased, and also any color regarding OCD placements? - Management reported that 95 systems were shipped during Q4, with more than 50% including H7 coils [26] Question: Can you talk about the Deep TMS 360 trial? - The trial is designed for addiction and neurology markets, with 10 centers actively recruiting patients for alcohol use disorder and three centers for Alzheimer's disease [28][29] Question: Was there any pricing change in 2025 or anticipated for 2026? - Management does not anticipate a decrease in average selling price and aims to optimize pricing based on the value provided [31]

Financial Data and Key Metrics Changes - Company reported a 27% increase in revenue to $14.5 million for Q4 2025, with full-year revenue also growing 27% to $52.2 million compared to 2024 [4][17] - Gross profit for Q4 was $11.1 million, up from $8.5 million in the prior year, with gross margin increasing to 76% [18] - Operating income for Q4 was approximately $1.9 million, a significant increase from $0.4 million in the same period last year [21] - Net income for Q4 was $2.9 million, compared to $1.5 million in Q4 2024, with full-year net income of approximately $7.6 million compared to $2.9 million in 2024 [22] Business Line Data and Key Metrics Changes - 95 Deep TMS systems were shipped in Q4, bringing the total installed base to approximately 1,700 systems, a 26% increase year-over-year [4][17] - The book-to-bill ratio improved to 1.4x from 1.2x in the previous quarter, indicating strong demand [5] - Remaining performance obligation reached $70 million, representing a 43% growth from $49 million a year ago [5][22] Market Data and Key Metrics Changes - Company estimates it has penetrated less than 10% of the market for Deep TMS, indicating significant growth potential [6] - The FDA granted label expansion for Deep TMS to treat adolescents aged 15 to 21 with major depressive disorder, expanding the addressable patient population [8] Company Strategy and Development Direction - Company is focusing on expanding reimbursement coverage with payers across the U.S. to increase market share [7] - A strategic initiative is in place to secure minority equity investments in high-performing mental health providers, which is expected to facilitate growth and access to interventional psychiatry [13][14] - Long-term vision includes developing a portfolio of data-driven technology-enabled neuromodulation solutions to serve more patients [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in the business and expects revenue for 2026 to be in the range of $66 million to $68 million, representing a year-over-year growth rate of 27%-30% [23] - The company anticipates adjusted EBITDA of $12 million to $14 million for 2026, indicating expected growth of 86%-100% over 2025 [24] Other Important Information - Company maintained a strong cash position with $68 million in cash and cash equivalents as of December 31, 2025, supporting growth initiatives [22] - The SWIFT Deep TMS protocol is expected to significantly improve patient access and treatment efficiency, reducing the number of required office visits by 70% [10][11] Q&A Session Summary Question: Can you give us a little better sense of the fourth quarter placements as far as units sold, units leased, and also any color regarding OCD placements? - Company shipped 95 systems during Q4, with more than 50% including the H7 coils [25] Question: Can you talk about the Deep TMS 360 trial that's going on? - The TMS 360 is designed for addiction and neurology markets, with active recruitment for the alcohol use disorder trial in 10 centers across the U.S. [26][27] Question: As far as pricing, was there any pricing that you took in 2025 or would you anticipate any pricing for 2026? - Company does not anticipate any decrease in average selling price and aims to optimize pricing based on value provided [29] Question: What percentage of the $70 million obligations relates to commitments from existing strategic partners? - Each minority investment center is expected to deliver new backlog or booking of between $3-$5 million on a yearly basis [34] Question: Do you anticipate significant utilization of the SWIFT protocol for Deep TMS in conjunction with other therapies? - There is strong demand for TMS, and the SWIFT protocol is expected to be used in conjunction with other modalities, including psychedelics and medication management [39]

For now, the evidence for neuromodulation products is slim https://t.co/hltmeu6rVV ...

Core Insights - BrainsWay Ltd. has introduced new clinical data demonstrating a faster, noninvasive treatment for depression, enhancing its neuromodulation platform aimed at improving brain health [1][2] Group 1: Clinical Efficacy - The SWIFT™ accelerated Deep TMS™ protocol achieved an 87.8% response rate and a 78.0% remission rate for Major Depressive Disorder, comparable to traditional methods [10] - The median time to remission was reduced to 21 days with SWIFT compared to 28 days under the standard protocol [10][8] - Approximately 70% of participants reported no longer suffering from severe quality of life impairment, and around 60% returned to normal functioning after treatment [9] Group 2: Patient Experience - Patients reported earlier symptom improvement and significant enhancements in quality of life, with scores improving by approximately 32 percentage points from baseline by week six [11] - The proportion of patients experiencing severe functional impairment decreased from 85-100% at baseline to 15-17% by the end of treatment [11] Group 3: Accessibility and Impact - The SWIFT approach reduces the number of clinic visits in the acute phase by about 70%, addressing logistical barriers that hinder access to treatment [3][4] - The innovation is expected to improve patient retention and expand clinical options, particularly as demand for non-drug therapies rises [3][4] - BrainsWay's CEO emphasized the importance of addressing accessibility and scalability in mental health innovation, marking a new era for the company [7]

Core Insights - NeuroPace reported a total revenue of $26.6 million for Q4 2025, reflecting a 24% year-over-year increase, primarily driven by RNS System sales which reached $22.4 million, up 26% from the previous year [3][7] - The company anticipates a long-term growth trajectory of at least 20% in its core RNS business within the current adult focal epilepsy indication [2] - For the full year 2025, total revenue was $100 million, a 25% increase year-over-year, with RNS System sales also up 25% [12] Financial Performance - Gross margin for Q4 was 77.4%, an improvement from 75.4% in the prior year, driven by higher-margin RNS revenue and improved manufacturing efficiency [8] - Adjusted EBITDA was positive at $0.9 million for the second consecutive quarter, with a net loss of $2.7 million, improved from $5.3 million a year earlier [9][13] - Operating expenses for Q4 were $22.3 million, up from $19.8 million a year ago, but growth remained below revenue growth, indicating operational leverage [9] Regulatory and Product Development - The FDA accepted a PMA supplement to expand RNS into idiopathic generalized epilepsy, with a 180-day review period initiated [5][20] - The AI-enabled SeizureID platform is expected to be approved in H1 2026, aimed at enhancing clinician efficiency [5][22] - NeuroPace is also advancing remote care initiatives, allowing physicians to adjust therapy settings during telehealth visits [23] Future Guidance - For 2026, the company reiterated revenue guidance of $98–100 million on a continuing-operations basis, implying underlying RNS growth of 20–22% [6][15] - The company expects adjusted operating expenses of $90–92 million and an adjusted EBITDA loss of $9–10 million for 2026 [19] - For Q1 2026, revenue is expected to be between $21 million and $22 million, with growth rates typically moderating in the first half of the year [16]

Core Insights - CVRx, Inc. announced the schedule for scientific presentations on Barostim therapy at the Technology and Heart Failure Therapeutics 2026 meeting, highlighting its focus on innovative neuromodulation solutions for cardiovascular diseases [1][6] Group 1: Scientific Presentations - The presentations will include late-breaking clinical data, oral sessions, and posters that cover real-world outcomes, cardiac energetics, hospitalization impact, left ventricular ejection fraction (LVEF) improvements, and changes in advanced hemodynamics [2] - Dr. Dmitry Yaranov will present data from the REBALANCE Registry, which evaluates the safety and benefits of Barostim therapy in a commercial setting, focusing on six-month outcomes from over 400 patients [3] Group 2: Clinical Trials and Studies - CVRx will host a satellite program featuring updates on the REBALANCE Registry, the BREATHE-HF trial, and the BENEFIT-HF trial, with the latter being a landmark randomized study supported by CMS Category B IDE coverage [4] - The BENEFIT-HF trial aims to evaluate the impact of Barostim in a broader heart failure population, with a primary endpoint of all-cause mortality and heart failure decompensation events, and enrollment is expected to begin in the first half of 2026 [4] Group 3: Company Overview - CVRx is a commercial-stage medical device company that has developed Barostim, the first FDA-approved neuromodulation technology for improving heart failure symptoms [6] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, designed to restore balance to the autonomic nervous system and reduce heart failure symptoms [6]

Financial Data and Key Metrics Changes - In Q4 2025, revenue was $361 million, reflecting a 9.5% increase on a constant currency and organic basis compared to the prior year [22] - Adjusted diluted earnings per share increased to $0.86 from $0.81 in Q4 2024, driven by strong revenue growth and effective cost management [24] - Cash balance at December 31, 2025, was $636 million, up from $429 million at year-end 2024, reflecting improved operating cash flows [25] - Total debt decreased to $377 million from $628 million at year-end 2024 due to early repayments [25] Business Line Data and Key Metrics Changes - Cardiopulmonary segment revenue was $207 million in Q4 2025, a 10% increase year-over-year, with full-year revenue growing 13% [8] - Epilepsy segment revenue increased by 9% in Q4 2025, with full-year revenue growth of 6% [10][11] - Cardiopulmonary consumables revenue grew in the mid-teens in Q4, driven by market share gains and strong demand [9] Market Data and Key Metrics Changes - U.S. epilepsy revenue grew 8% year-over-year, while Europe and Rest of World regions combined saw a 17% increase [10] - The reimbursement for VNS Therapy procedures under Medicare increased significantly, with hospital outpatient payments rising by approximately 48% for new patient implants [12] Company Strategy and Development Direction - The company aims to transform into a best-in-class med tech company, focusing on high-growth markets like obstructive sleep apnea (OSA) [6] - Investments in innovation and digital platforms are prioritized to enhance patient access and improve care pathways [7] - The company plans to leverage competitive advantages through disciplined capital allocation and focused execution [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver sustained value for shareholders, highlighting strong execution across core businesses [31] - The company anticipates continued growth driven by healthy markets and strategic investments in innovation [14] - Management remains optimistic about the potential of the OSA market, viewing it as a compelling opportunity [17] Other Important Information - The company expects full-year 2026 revenue growth between 6% and 7%, consistent with the 2025 to 2028 framework [30] - Adjusted free cash flow for 2026 is projected to be in the range of $160 million to $180 million, reflecting increased capital spending [28] Q&A Session Summary Question: Insights on cardiopulmonary growth guidance for FY 2026 - Management expects continued growth drivers from Essenz upgrades, market share gains, and pricing strategies [35] Question: Clarification on epilepsy business guidance - Management noted significant tailwinds from improved reimbursement and clinical evidence, which are expected to support growth [42] Question: Impact of reimbursement changes on VNS business - Management indicated no significant negative impact from recent reimbursement changes, with ongoing efforts to improve penetration [49] Question: Specifics on tender timing and geographic impact - Management confirmed that the shift in placements was immaterial and will be fully captured in Q1 2026 [38] Question: Updates on Medicaid reimbursement changes - Management stated that Medicaid is expected to follow Medicare reimbursement improvements over time [83]