Asensus Surgical targets FDA clearance for Luna surgical robot in 2025

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The Luna surgical robotics platform. Source: Asensus Surgical]

Asensus Surgical (NYSE:ASXC) announced its second-quarter financial results and shared an update on its Luna surgical robot platform.

Shares of ASXC rose 9.8% at 36¢ apiece in late-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even.

Research Triangle Park, North Carolina-based Asensus unveiled the next-generation Luna platform in February. It designed Luna as an integrated digital surgery solution. It features a next-generation surgical platform and instruments, plus real-time intraoperative clinical intelligence. Its final component, a secure cloud platform, applies machine learning to deliver clinical insights. Altogether, the Luna platform enables Asensus’ vision of performance-guided surgery, the company says.

The company now says that it made “notable progress in R&D” related to Luna’s development. It’s now transitioning to testing and evaluation before filing for regulatory approvals. Asensus plans for integrated system testing in the coming quarter, along with the finalization of its manufacturing strategy.

By the fourth quarter, Asensus expects to conclude its pre-clinical evaluation, potentially freezing the design by the first quarter of 2024. The company expects to submit to the FDA and other regulatory bodies by the end of 2024. Asensus then projects FDA clearance in mid-2025, followed by a pilot commercial launch in the second half of that year.

Based on communications with the FDA and in-house regulatory expertise, Asensus plans to utilize a 510(k) pathway for Luna. It believes the streamlined strategy applies to Europe, Japan and other geographies.

“The company believes that there is a clear regulatory pathway for the Luna system,” Asensus said in a news release. “This de-risked regulatory process should allow for a quicker time-to-market compared to new entrants in this space.”

The second-quarter results for Asensus

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

Losses per share came in 1¢ behind expectations on Wall Street.

Aside from the Luna developments, Asensus recorded 27% year-over-year growth in surgical procedures. It’s initiated two Senhance programs so far this year and expects a further 10-12.

“During the second quarter, we continued to make progress on all fronts, highlighted by strong 27% year-over-year growth in procedure volumes. This continued growth plays a vital role in our ability to expand and optimize our digital surgery capabilities, enabling our machine learning engine to better provide valuable clinical intelligence to surgeons through the ISU,” said Anthony Fernando, Asensus Surgical president and CEO. “Our focus for the remainder of the year will be on expanding the utilization of Senhance and advancing our clinical body of evidence. Additionally, we have some exciting milestones on the horizon, including the initiation of a preclinical evaluation of the Luna surgical system.”