Nyxoah (NasdaqGM:NYXH) FY Conference Transcript

Nyxoah Conference Call Summary Company Overview - Company: Nyxoah - Industry: Medical Technology, specifically focused on obstructive sleep apnea (OSA) treatment Key Points and Arguments Innovative Technology - Nyxoah offers a next-generation neuromodulation solution for moderate to severe OSA patients, utilizing hypoglossal nerve stimulation with bilateral stimulation and single-incision implants [3][4] - The system is designed to be fully MRI compatible and does not require an implantable battery, eliminating the need for re-surgery when the battery is depleted or when software upgrades are needed [3][4] Clinical Evidence and DREAM Study - The DREAM pivotal study aimed to reduce the apnea-hypopnea index (AHI) by at least 50% and bring the overall number of events below 20 [5][6] - The study reported a severe obstructive event percentage of 8.7%, significantly lower than the competition's nearly 20% [6] - Median reduction in AHI was reported at 70%, with 82% of participants achieving an AHI below 15, which is a critical threshold for treatment eligibility [8][9] FDA Approval and Market Entry - Nyxoah received FDA approval on August 8, allowing the company to launch its product in the U.S. market [10][11] - The approval includes specific indications for patients with extreme difficult airway openings, which are contraindicated for current AGNS technology [10][11] Commercial Strategy - The company has a two-pronged launch strategy targeting both sleep physicians and ENT surgeons, emphasizing the role of sleep physicians in patient management [15][17] - Nyxoah has already trained over 100 physicians and aims to expand its commercial team to increase market penetration [13][36] Market Penetration and Competition - Nyxoah aims to capture high-volume implanting sites, with a goal of reaching 400 sites that represent 80% of the total volume in the U.S. [18][20] - The company has successfully captured a 25% market share in Germany within two years and aims to replicate this success in the U.S. [20][21] Reimbursement Strategy - Nyxoah is actively working with payers to ensure reimbursement for its technology, leveraging existing CPT codes and engaging with major commercial payers [22][23] - The company has received positive feedback from Medicare regarding coding acceptance, which is crucial for scaling up operations [23][24] Future Innovations and R&D - Nyxoah is focused on continuous innovation, including developing a more intelligent implantable device and a wearable component that provides real-time feedback to patients [44][45] - The company is exploring the potential for a pillow charging concept for its devices, aiming for a seamless user experience [45][49] Patient Profile and Market Trends - The ideal patient profile for Nyxoah's treatment includes individuals aged around 53-54 who are health-conscious and motivated to maintain a healthy lifestyle [29][30] - The emergence of GLP-1 therapeutics may expand the patient pool by enabling weight loss in individuals with higher BMIs, which could lead to increased demand for Nyxoah's technology [33][35] Access Trial and Clinical Validation - The ACCESS trial aims to validate the effectiveness of Nyxoah's technology for patients with complete concentric collapse (CCC), with a submission for label expansion expected by Q1 2027 [50][52] Differentiation and Manufacturing - Nyxoah emphasizes the differentiation of its technology through bilateral stimulation and the scalability of its platform, which is designed to benefit patients significantly [54][55] Additional Important Insights - The company has made strategic decisions to manufacture in the U.S. for the U.S. market, which is seen as a beneficial move given current market dynamics [54]