Mike Pollock

Mike Pollock asked for a detailed explanation of the expanded clinical specialist role, including how it differs from previous roles, its incentives, and whether it will be deployed across all territories or focused on specific accounts. He also inquired about the high-level specifications of the FDA post-approval study, such as its size, patient focus, and endpoints, and what the company hopes to achieve with its late-breaker presentation at the American Heart Association Scientific Sessions.

Answer

President and CEO Brian Webster explained that the expanded clinical specialist role aims to transition account management responsibilities from sales reps in high-performing territories, allowing reps to cultivate new prescribers and accounts. This strategy will initially focus on high-performing territories. Regarding the FDA post-approval study, Webster stated it concluded enrollment with 24,000-25,000 patients, making it the largest WCD study ever published. Primary endpoints include shock success rate and safety (inappropriate shocks), with other endpoints like false alarm rate and patient compliance. He emphasized that the AHA presentation would address the competitive argument about Kestra's clinical data, providing an "incredible body of clinical data."

Mike Pollock asked for details on Kestra Medical Technologies' expanded clinical specialist role, including its differentiation, incentives, and deployment strategy. He also sought information on the FDA post-approval study's high-level specifications, expected data, and the anticipated impact of its late-breaker presentation at the American Heart Association Scientific Sessions.

Answer

Brian Webster (President and CEO) explained that clinical specialists will assume account management responsibilities in high-performing territories, allowing sales reps to cultivate new prescribers. He detailed the post-approval study, which includes 24,000-25,000 patients over three years, with endpoints such as shock success rate, inappropriate shocks, false alarm rate, and patient compliance. The AHA presentation aims to counter competitive arguments about Kestra's clinical data and highlight the ASSURE system's effectiveness.