Luna surgical robot will get to work in 2025

Asensus Surgical targets FDA clearance for Luna surgical robot in 2025.

Asensus Surgical announced its second quarter financial results and progress on its next-generation Luna robotic surgery platform. Shares rose nearly 10% on the developments for the digital surgery innovator.

Asensus unveiled Luna in February as an integrated solution combining surgical tools, real-time data analytics, and a cloud platform. The system aims to enable performance-guided surgery through machine learning and clinical insights.

The company reported notable R&D advancements on Luna, transitioning to testing and evaluation ahead of regulatory filings. Asensus plans integrated testing this quarter and finalizing manufacturing strategy.

By Q4, Asensus expects concluding pre-clinicals and potentially freezing the design. It plans regulatory submissions in late 2024, targeting FDA clearance in mid-2025 followed by a pilot commercial launch. Based on FDA communications, Asensus believes Luna qualifies for an expedited 510(k) pathway.

For Q2, Asensus posted $1.1 million in sales, up 8.8% year-over-year. Loss per share was $0.09, missing expectations by $0.01. However, surgical procedures grew 27% versus last year.

"We continued strong procedure growth in Q2, expanding our digital capabilities and clinical evidence," said CEO Anthony Fernando. "Upcoming milestones include starting Luna's preclinical evaluation."

The results and strategic updates demonstrate Asensus' progress on its vision for data-driven surgical automation. While strengthening utilization and capabilities of the Senhance system today, Luna represents the company's next frontier in intelligent robotics.

With designs on streamlined regulatory approval, Asensus aims to position Luna as a next-generation digital surgery platform. By integrating real-time analytics with advanced robotics, the system reflects the future of connected, insightful healthcare.

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