Asensus Surgical Provides Preliminary 2023 Year-End Corporate Update
2023 Full Year Highlights
- Over 3,550 procedures were performed globally, representing 14% growth compared to 2022
- In 2023, eight Senhance Surgical Programs were initiated, which is in line with guidance of 8-10 systems
- The Company had unaudited cash, cash equivalents and short-term investments, excluding restricted cash of approximately
$21.0 millionon December 31, 2023
- Full year 2023 unaudited revenue is expected to be approximately
$8.2- $8.8 million
Fourth Quarter Highlights
- Over 835 procedures were performed globally using the Senhance® Surgical System
- Five Senhance Surgical Programs were initiated, including one in
Germany, one in Romania, two in the CIS region and one in Japanat Nagoya University Hospital
- Fourth quarter unaudited revenue is expected to be approximately
$5.1- $5.7 million
"I'm pleased with the progress we've made throughout 2023 and the solid foundation we've built for the future,” said
2023 Senhance Program Initiations
During the fourth quarter of 2023, the Company initiated five new Senhance Surgical System placements, one in
In 2023, the Company initiated eight new Senhance Surgical System placements: one in
In 2023, surgeons performed over 3,550 procedures utilizing the Senhance System, representing a 14% increase over the previous year. These procedures included general surgery, gynecology, urology, colorectal, pediatric, and bariatric surgical cases.
In 2023, the Company made notable progress in improving pediatric care. A key milestone was the
Clinical Registry (TRUST)
The Company continues to leverage its growing body of real-world clinical data through the utilization of its TRUST™ clinical registry. The Company believes TRUST is the largest multi-specialty robotic-assisted laparoscopic registry in the industry, with approximately 3,200 patients enrolled to date, a 45% increase from 2022.
During the year, there were nine peer-reviewed clinical papers published providing further support for the clinical utility of the Senhance System across a variety of surgical specialties. These papers, along with a library of similar papers, can be found on the Company’s website: https://www.asensus.com/resources/clinical-publications.
LUNA™ Surgical Robotic System
The LUNA Surgical System's development is in progress and is now in the testing and evaluation phase before regulatory submissions. In
Future milestones include freezing the system's design in early 2024, followed by verification and validation testing, and pilot manufacturing. The Company is confident in the regulatory pathway for the LUNA System. Ongoing communication with the FDA, along with strong in-house regulatory expertise and past successful submissions for the Senhance System, lead the Company to anticipate using a traditional 510(k) submission pathway in the
Agreement with Flex for LUNA Surgical System Design and Advanced Manufacturing Services
In November, the Company announced an agreement with Flex for design and manufacturing support for the LUNA Surgical System. This collaboration aims to facilitate the efficient market entry of LUNA by leveraging Flex's expertise in electromechanical systems. The agreement underscores a joint commitment to advancing surgical technology for improved patient care.
Collaboration with NVIDIA to Enhance Augmented Intelligence Capabilities of the ISU
In September, the Company announced a collaboration with NVIDIA to enhance the capabilities of the Company’s Intelligent Surgical Unit. The collaboration aims to improve the ISU's Augmented Intelligence features, providing surgeons with advanced clinical insights. Utilizing a suite of NVIDIA tools, Asensus will accelerate the development of ISU, refining real-time features like digital tags, 3D measurement, and enhanced camera control. Since 2021, the ISU, powered by NVIDIA accelerated computing technology, has been contributing to surgical advancements.
The Company was invited to participate in an online series, Changing the Face of Surgery, as part of the Connecting The Dots online series, presented by MedTech Europe and produced by BBC StoryWorks. Featuring the Senhance Surgical System installation at
New Website Launch
Last month, the Company launched its revamped website at https://www.asensus.com/. This website serves as a central hub, providing a seamless experience for prospective hospitals, surgeons, and stakeholders. The user experience has been enhanced with better navigation and animation features, and a growing resource library showcasing our innovative approach to surgery. The new site is optimized to provide a consistent experience from any device.
Fourth Quarter and Full Year 2023 Revenue
For the quarter ending on
Email Alerts: https://ir.asensus.com/email-alerts
This press release includes statements relating to the Senhance Surgical System, the LUNA Surgical Robotic System, our preliminary 2023 fourth quarter and year end results. These statements 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 we will be able to continue to progress our strategic plan and reach important milestones in 2024; whether final 2023 fourth quarter and full year revenue will meet expectations; whether the Company’s TRUST clinical registry is the largest multi-specialty robotic-assisted laparoscopic registry in the industry and whether the Company will continue to grow the TRUST registry data to support its commercial strategy; whether the Company will be able to use a traditional 510(k) pathway in the
Source: Asensus Surgical, Inc.