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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 at present. MassDevice’s MedTech 100 Index — which incorporates shares of the world’s largest medical system firms — 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 includes a next-generation surgical platform and devices, plus real-time intraoperative scientific intelligence. Its ultimate element, a safe cloud platform, applies machine studying to ship scientific insights. Altogether, the Luna platform allows 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 tasks FDA clearance in mid-2025, adopted by a pilot business launch within the second half of that yr.
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 enable for a faster time-to-market in comparison with new entrants on this area.”
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 Avenue.
Other than the Luna developments, Asensus recorded 27% year-over-year progress in surgical procedures. It’s initiated two Senhance packages to this point this yr and expects an extra 10-12.
“Through 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 capability to increase and optimize our digital surgical procedure capabilities, enabling our machine studying engine to raised present worthwhile scientific intelligence to surgeons by the ISU,” mentioned Anthony Fernando, Asensus Surgical president and CEO. “Our focus for the rest of the yr might be on increasing the utilization of Senhance and advancing our scientific physique of proof. Moreover, we’ve some thrilling milestones on the horizon, together with the initiation of a preclinical analysis of the Luna surgical system.”
Editor’s Notice: This text was republished from MassDevice, a sister publication of The Robotic Report.