On Wednesday, Stifel maintained a Buy rating on LivaNova (NASDAQ:LIVN) with a steady price target of $65.00. The reaffirmation comes as LivaNova announced the early conclusion of its OSPREY trial for obstructive sleep apnea (OSA) due to positive predictive outcomes. The trial, which was initially set to enroll 150 patients, stopped early after a favorable analysis at 90 patients.
The OSPREY trial's early cessation is based on criteria suggesting that the hypoglossal nerve stimulation (HGNS) device is likely to show statistical superiority over the control group. The device's responder rate, which is a 50% reduction in the apnea-hypopnea index, is projected to be 97.5% superior to the control group after a seven-month follow-up.
LivaNova has expressed optimism about the early results, but management is awaiting the complete 13-month data set to fully evaluate the trial's outcomes compared to peers. The company is eyeing the 13-month patient AHI responder rate data, which is expected around April or May 2025, as a significant competitive benchmark. This data will be compared to results from similar trials by other companies.
The next steps for the OSPREY trial include completing the seven-month patient follow-up, which is likely to occur in late October or early November. Following this, LivaNova is expected to release top-line primary endpoint outcomes and other key data metrics, potentially before the end of 2024. If all goes according to plan, the OSPREY trial could be submitted to the FDA in the first quarter of 2025.
Stifel's note emphasizes that while the early stop of the OSPREY trial is a positive development for LivaNova, the final 13-month AHI responder rate data is crucial to assess the product's competitive position and commercial viability, as well as its financial implications for the company.
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