Core Insights - Nyxoah (NYXH) has received a significant boost in reimbursement rates for its Genio hypoglossal nerve stimulation (HGNS) implants following the finalization of the CY2026 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgery Center (ASC) Rule by the U.S. Centers for Medicare & Medicaid Services (CMS) [1][8] Group 1: Reimbursement Changes - The CPT Code 64568 for Genio implants has been assigned to New Technology Ambulatory Payment Classification (APC) 1580, leading to increased reimbursement rates [1][9] - The new reimbursement rate for hospital outpatient departments is approximately $45,000, reflecting a 48% increase from 2025 levels [9] - The ASC facility reimbursement rate is set at $42,373, which is a 58% increase compared to 2025 [9][10] Group 2: Market Impact - The increase in reimbursement rates is expected to enhance the adoption of Genio implants, driving procedural throughput and expansion in Medicare-heavy institutions [5][10] - The single-incision procedure of Genio is well-suited for the ASC environment, creating new opportunities for therapy expansion [10] - Despite a 40% decline in share price this year, the improved reimbursement landscape may positively influence Nyxoah's prospects in 2026 [4][5] Group 3: Product Approval and Market Position - The Genio implant is approved for treating obstructive sleep apnea (OSA) through neuromodulation, with initial CE mark received in 2019 [2] - FDA approval was granted in August for a subset of adult patients with moderate to severe OSA [3] - The recognition of hypoglossal nerve stimulation as a high-value therapy for OSA is reinforced by the significant reimbursement rate increases [10]

Core Insights - Mineralys Therapeutics announced positive topline results from pivotal trials Launch-HTN and Advance-HTN, demonstrating the efficacy and safety of lorundrostat for treating uncontrolled or resistant hypertension [2][3] - The company anticipates topline data from the Explore-CKD Phase 2 trial in Q2 2025 and has initiated the Explore-OSA Phase 2 trial in Q1 2025 [1][12] - The company reported a net loss of $42.2 million for Q1 2025, an increase from $31.5 million in Q1 2024, primarily due to rising research and development expenses [8][22] Clinical Trials and Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 9.1 mmHg, and sustained benefits through week 12 [3] - The Advance-HTN trial reported a 15.4 mmHg absolute reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 7.9 mmHg [3] - Both trials demonstrated a favorable safety profile, with low incidences of hyperkalemia at 1.1% and 1.5% for the 50 mg and 50 to 100 mg arms in the Launch-HTN trial, respectively [3] Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $343.0 million, up from $198.2 million at the end of 2024 [5][24] - Research and development expenses for Q1 2025 were $37.9 million, compared to $30.8 million in Q1 2024, driven by increased clinical costs and compensation expenses [6][22] - General and administrative expenses rose to $6.6 million in Q1 2025 from $4.6 million in Q1 2024, attributed to higher compensation and professional fees [7][22] Corporate Developments - Eric Warren has been appointed as Chief Commercial Officer, bringing extensive experience in cardiovascular disease to support the company's commercial strategy [2][12] - The company completed a public equity financing on March 18, 2025, raising approximately $201.2 million to strengthen its balance sheet [12] Upcoming Milestones - The Explore-CKD Phase 2 trial is expected to deliver topline data in Q2 2025, focusing on the safety and efficacy of lorundrostat in patients with chronic kidney disease [1][12] - The Explore-OSA Phase 2 trial has been initiated to evaluate lorundrostat in overweight and obese subjects with moderate-to-severe obstructive sleep apnea and hypertension [1][12]