Post by icemandios on Jan 8, 2024 14:51:21 GMT
Asensus Surgical Provides Preliminary 2023 Year-End Corporate Update
RESEARCH TRIANGLE PARK, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and patient, provided a preliminary 2023 year-end corporate update.
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 million on December 31, 2023
Full year 2023 unaudited revenue is expected to be approximately $8.2 - $8.8 million
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 Japan at Nagoya University Hospital
Fourth quarter unaudited revenue is expected to be approximately $5.1 - $5.7 million
Market Development
2023 Senhance Program Initiations
In 2023, the Company initiated eight new Senhance Surgical System placements: one in the United States, one in Germany, three in Japan, one in Romania, and two in the CIS region.
Procedure Volumes
Pediatric Update
Clinical Registry (TRUST)
Clinical Validation
LUNA ™ Surgical Robotic System
LUNA Development
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 U.S., rather than the more complex de novo pathway. This streamlined approach is expected to apply globally, offering a quicker market entry compared to new entrants. LUNA is currently under development and has not been submitted to, or cleared by, the U.S. FDA or other global regulators, and is not available for sale in any market.
Agreement with Flex for LUNA Surgical System Design and Advanced Manufacturing Services
Collaboration with NVIDIA to Enhance Augmented Intelligence Capabilities of the ISU
BBC - Changing the Face of Surgery
New Website Launch
Fourth Quarter and Full Year 2023 Revenue
For the quarter ending on December 31, 2023, the Company estimates preliminary unaudited revenue of approximately $5.1 - $5.7 million. For the full year, preliminary unaudited 2023 revenue is expected to be approximately $8.2 - $8.8 million, representing revenues from the sale of three Senhance Systems, multiple system leases, and related revenues from instruments, accessories, and services.
Balance Sheet
As of December 31, 2023, the Company had preliminary unaudited cash, cash equivalents and short-term investments, excluding restricted cash, of approximately $21.0 million, and there were approximately 264.9 million shares of unaudited common stock outstanding.
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 U.S., EU, Japan and select other countries. For a complete list of indications for use, visit: www.asensus.com/indications-for-use. To learn more about Performance-Guided Surgery, and digital laparoscopy with the Senhance Surgical System visit www.asensus.com.