Take heed to this text

The Luna surgical robotics platform. Supply: Asensus Surgical]

Asensus Surgical (NYSE:ASXC) introduced its second-quarter monetary outcomes and shared an replace on its Luna surgical robotic platform.

Shares of ASXC rose 9.8% at 36¢ apiece in late-afternoon buying and selling right this moment. MassDevice’s MedTech 100 Index — which incorporates shares of the world’s largest medical system corporations — stayed even.

Analysis Triangle Park, North Carolina-based Asensus unveiled the next-generation Luna platform in February. It designed Luna as an built-in digital surgical procedure answer. It incorporates a next-generation surgical platform and devices, plus real-time intraoperative scientific intelligence. Its remaining part, a safe cloud platform, applies machine studying to ship scientific insights. Altogether, the Luna platform permits Asensus’ imaginative and prescient of performance-guided surgical procedure, the corporate says.

The corporate now says that it made “notable progress in R&D” associated to Luna’s improvement. It’s now transitioning to testing and analysis earlier than submitting for regulatory approvals. Asensus plans for built-in system testing within the coming quarter, together with the finalization of its manufacturing technique.

By the fourth quarter, Asensus expects to conclude its pre-clinical analysis, doubtlessly freezing the design by the primary quarter of 2024. The corporate expects to undergo the FDA and different regulatory our bodies by the top of 2024. Asensus then initiatives FDA clearance in mid-2025, adopted by a pilot industrial launch within the second half of that 12 months.

Primarily based on communications with the FDA and in-house regulatory experience, Asensus plans to make the most of a 510(okay) pathway for Luna. It believes the streamlined technique applies to Europe, Japan and different geographies.

“The corporate believes that there’s a clear regulatory pathway for the Luna system,” Asensus mentioned in a information launch. “This de-risked regulatory course of ought to permit for a faster time-to-market in comparison with new entrants on this house.”

The second-quarter outcomes for Asensus

Asensus posted losses of $20.7 million or 9¢ per share within the quarter. It recorded gross sales of $1.1 million for the three months ended June 30, 2023. The corporate recorded a 5.3% bottom-line slide on gross sales progress of 8.8%

Losses per share got here in 1¢ behind expectations on Wall Road.

Except for the Luna developments, Asensus recorded 27% year-over-year progress in surgical procedures. It’s initiated two Senhance applications up to now this 12 months and expects an additional 10-12.

“In the course of the second quarter, we continued to make progress on all fronts, highlighted by sturdy 27% year-over-year progress in process volumes. This continued progress performs a significant position in our potential to develop and optimize our digital surgical procedure capabilities, enabling our machine studying engine to raised present priceless scientific intelligence to surgeons via the ISU,” mentioned Anthony Fernando, Asensus Surgical president and CEO. “Our focus for the rest of the 12 months will probably be on increasing the utilization of Senhance and advancing our scientific physique of proof. Moreover, now we have some thrilling milestones on the horizon, together with the initiation of a preclinical analysis of the Luna surgical system.”