Release Date: March 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide an update on the reimbursement strategy for Genio, specifically regarding the use of CPT code 64568? A: Olivier Taelman, CEO: We acknowledge that the physician fee associated with CPT code 64568 is not the strongest. However, having an established code is crucial for market entry. We are pleased to have identified this code, which is the same as the current HGNS technology. We plan to explore ways to optimize the code to reflect Genio's unique bilateral stimulation, potentially making it more attractive for physicians.
Q: How do you plan to approach the US market launch, and what is the expected pace of new account openings? A: Olivier Taelman, CEO: We have over 75 US physicians trained on Genio technology. Our strategy is to target high-volume HGNS implanting centers, which represent 70-75% of total HGNS revenue. We have a team of 50 trained sales professionals ready to launch, and we plan to scale up quarterly, aiming to cover all Tier 1 high-volume HGNS accounts within 12 to 18 months.
Q: What gives you confidence in receiving FDA approval by the end of March, given the current political climate and agency cuts? A: Olivier Taelman, CEO: Despite recent government challenges, our interactions with the FDA have been consistent and thorough. We are in the final stages, focusing on labeling discussions. The 90-day review clock ends this month, and we have not seen any negative impact from political changes, maintaining our confidence in receiving approval by the end of March.
Q: How do you anticipate the commercial payer landscape evolving for Genio in 2025? A: Olivier Taelman, CEO: We expect to work with preauthorizations and have patients lined up post-FDA approval. We anticipate securing the first commercial payers by Q3 or Q4 of 2025. Additionally, we expect government payers like CMS to provide payments from the start, leveraging the established CPT code for OSA.
Q: Can you elaborate on the manufacturing and supply chain readiness for the US launch? A: Olivier Taelman, CEO: We have ensured significant inventory and manufacturing capacity to meet demand. Notably, we manufacture products for the US market domestically, avoiding global shipping delays and aligning with our US-focused strategy.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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