Asensus Surgical Completes In Vivo Surgeon Lab for LUNA Surgical Robotic System

Rhea-AI Summary

Asensus Surgical, Inc. (NYSE American: ASXC) announced a key development milestone for LUNA™, its second-generation surgical robotic system. Surgeons applauded the innovative capabilities of LUNA during an in vivo evaluation in porcine models. The system's impressive arm range of motion, instrument dexterity, and ergonomic design were highlighted, with positive feedback from participating surgeons. LUNA is designed to elevate the standards of robotic-assisted surgery and is currently under development.

Medical Device Analyst

The recent in vivo evaluation of Asensus Surgical's LUNA system represents a significant step in the medical device industry, particularly in the field of robotic-assisted surgery. The feedback from surgeons on the system's hardware and software capabilities is critical as it directly influences the final product's design and functionality. The emphasis on the system's precision, range of motion and ergonomic design suggests that LUNA may address some of the existing limitations in current surgical robotics technologies. This could potentially lead to improved surgical outcomes and greater adoption of robotic systems in operating rooms.

From an investment perspective, the development of LUNA is poised to capture the attention of stakeholders within the healthcare sector. Asensus Surgical's focus on digital surgery platforms aligns with the growing trend towards minimization of invasive procedures and enhancement of surgical precision. If LUNA meets regulatory requirements and demonstrates clear advantages over competitors, it could result in significant market share growth for Asensus Surgical. However, investors should be aware of the risks associated with the lengthy and uncertain regulatory process, as well as the substantial investment required for research and development in this high-tech segment.

Market Research Analyst

The surgical robotics market is rapidly expanding, with an increasing demand for precision and minimally invasive procedures. The introduction of LUNA's innovative features, such as the TrueWrist instruments and the ergonomic surgeon console, is strategically positioned to meet these market demands. The market impact of LUNA will depend on its ability to differentiate itself from existing platforms, such as those offered by industry leaders like Intuitive Surgical. Market penetration will require substantial evidence of LUNA's clinical benefits and cost-effectiveness.

Moreover, the timing of the product's release in relation to competitors' product cycles and the evolution of surgical practices will influence its market success. Asensus Surgical's proactive engagement with the surgical community, as evidenced by the Surgeon Lab event, is a positive indicator of their commitment to aligning product development with end-user needs, which can be a key driver of product adoption.

Healthcare Economist

The development of advanced surgical systems like LUNA has broad implications for healthcare economics. The potential for improved surgical precision and outcomes can lead to reduced hospital stays and lower complication rates, which are critical factors in controlling healthcare costs. However, the high initial costs of surgical robotic systems and the necessary training for their use could pose economic challenges for healthcare providers.

Long-term, the adoption of systems like LUNA could drive down procedural costs and improve the efficiency of surgical teams. The economic analysis of LUNA's impact will need to consider the total cost of ownership, including maintenance and potential increases in surgical volume due to enhanced capabilities. Healthcare providers will weigh these factors against the expected improvements in patient outcomes and operational efficiency to determine the value proposition of incorporating LUNA into their surgical repertoire.

Surgeons Applaud LUNA's Innovative Capabilities

RESEARCH TRIANGLE PARK, N.C., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient, announced a key development milestone for LUNA™, the Company’s second-generation surgical robotic system.

During the week of December 11, 2023, the Company hosted a Surgeon Lab in Research Triangle Park, North Carolina to conduct an in vivo evaluation of LUNA’s hardware, software and instruments in porcine models. The lab allowed nine participating surgeons to evaluate the system's functionality through thirteen different procedures across gynecology, urology, and general surgery.

Anthony Fernando, President and CEO of Asensus Surgical, provided a detailed update during a recent presentation, highlighting surgeon feedback on the innovative features of LUNA. For a closer look at the Surgeon Lab and insights from the participating surgeons, a video is available on the Company’s website at https://ir.asensus.com/events-and-presentations. The video provides an overview of the system's features, demonstrating its dextrous 5mm TrueWrist™ instruments range, its unique surgeon console and its ergonomic benefits.

"The Surgeon Lab represents a crucial phase in the LUNA development journey," noted Anthony Fernando, President and CEO of Asensus Surgical. "The positive response from the participating surgeons reaffirms our commitment to further developing and delivering a surgical robotic system that not only meets but exceeds expectations. The insights gathered will contribute to the refinement of this late-stage engineering prototype, moving us closer to a finalized product. We will provide further details on LUNA's development and regulatory submission timeline during our upcoming earnings call to be scheduled to report on the fourth quarter and year end 2023.”

"The LUNA system showcased an impressive arm range of motion and instrument dexterity, providing a level of precision that is essential in surgical procedures. The strength and reliability of the 5mm TrueWrist instrument line stood out, offering versatility with different instrument types," mentioned Dr. Amit Trivedi, Chair Department of Surgery, Pascack Valley Medical Center in New Jersey. "The ergonomic design of the LUNA surgeon console and the easy patient access are notable features. I look forward to seeing how the system evolves and the potential positive outcomes it may bring to surgery."

The LUNA Surgical System is Asensus’ next generation digital surgery platform that is poised to revolutionize the way surgery is performed.

LUNA, the Company’s Next Generation Digital Surgery Platform

LUNA is designed to elevate the standards of robotic-assisted surgery. The system integrates carefully crafted hardware and software architecture to prioritize safety, reliability, and performance. LUNA's features include a surgeon console with unconstrained handles, an interactive touchscreen, and an Ultra-HD 3D monitor. Additionally, the system boasts up to four independent robotic manipulator arms for procedural flexibility, alongside a unique instrument drive system supporting various advanced instrumentation options. LUNA is currently under development and has not been submitted to, or cleared by, the US FDA or other global regulators, and is not available for sale in any market.

About Asensus Surgical, Inc.

Asensus Surgical, Inc. is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery™ by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of surgery. Based upon the foundations of Digital Laparoscopy and the Senhance® Surgical System, the Company is developing the LUNA Surgical System, a next generation robotic and instrument system as a foundation of its Digital Surgery solution. These systems will be powered by the Intelligent Surgical Unit™ to increase surgeon control and reduce surgical variability. With the addition of machine vision, Augmented Intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. The Senhance Surgical System is now available for sale in the US, EU, Japan and select other countries. For a complete list of indications for use, visit: www.senhance.com/indications. To learn more about Performance-Guided Surgery, and digital laparoscopy with the Senhance Surgical System visit www.asensus.com.

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Forward-Looking Statements

This press release includes statements relating to the LUNA Surgical Robotic System development, including the December 2023 surgeon lab and other statements regarding our future plans and goals constitute "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the LUNA Surgical Robotic System will be successfully developed and receive regulatory clearances on the timeline we anticipate. For a discussion of the risks and uncertainties associated with the Company’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 2, 2023 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:

Mark Klausner or Mike Vallie, 443-213-0499

invest@asensus.com

MEDIA CONTACT:

Dan Ventresca

Matter Communications

AsensusPR@matternow.com

617-874-5488

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/37115e8d-9772-4352-a919-c794b2d3aa77

FAQ

What is the company name and ticker symbol of the medical device company mentioned in the PR?

Asensus Surgical, Inc. (NYSE American: ASXC) is the medical device company mentioned in the PR.

What is the key development milestone announced for LUNA™?

The key development milestone announced for LUNA™ is the in vivo evaluation in porcine models to assess its hardware, software, and instruments.

What are the main features of LUNA™, the Company’s second-generation surgical robotic system?

LUNA™ features include a surgeon console with unconstrained handles, an interactive touchscreen, an Ultra-HD 3D monitor, and up to four independent robotic manipulator arms for procedural flexibility.

What regulatory status does LUNA™ currently have?

LUNA™ is currently under development and has not been submitted to, or cleared by, the US FDA or other global regulators, and is not available for sale in any market.