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.
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
million on 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 Japan
at 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 Anthony
Fernando, Asensus Surgical President and CEO. “Looking ahead to
2024, we're optimistic about reaching important milestones in the
coming quarters. The LUNA™ Surgical System program is on track,
with our primary focus on the testing and evaluation phase before
regulatory submissions. Additionally, we're excited to see positive
developments in the pediatrics space, reflecting our commitment to
advancing surgical technology for all patients through the unique
features of the Senhance System."
Market Development
2023 Senhance Program InitiationsDuring the fourth quarter of
2023, the Company initiated five new Senhance Surgical System
placements, one in Germany, one in Romania, two in the CIS region
and one in Japan at Nagoya University Hospital.
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 VolumesIn 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.
Pediatric UpdateIn 2023, the Company made notable progress in
improving pediatric care. A key milestone was the FDA's clearance
for the Senhance System, marking it as the first approved digital
laparoscopic surgery solution for pediatric patients in the U.S.
This clearance, alongside existing approvals in the EU and Japan,
highlights the Senhance System's unique features, including 3mm
instrumentation, a 5mm camera scope, haptic feedback, and advanced
clinical intelligence from the Intelligent Surgical Unit™(ISU™).
These features work together to contribute to a less invasive
approach in pediatric robotic surgery. In addition to regulatory
milestones, the Company has introduced four Senhance System
programs dedicated to pediatric departments in the U.S. and
internationally.
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.
Clinical ValidationDuring 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
LUNA DevelopmentThe LUNA Surgical System's development is in
progress and is now in the testing and evaluation phase before
regulatory submissions. In December 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 LUNA system's functionality through thirteen
procedures across gynecology, urology, and general surgery. For a
closer look at the Surgeon Lab and insights from the participating
surgeons, a video is available at
https://ir.asensus.com/events-and-presentations. The video provides
an overview of the LUNA system's features, demonstrating its range
of motion, instrument strength, and ergonomic benefits.
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 ServicesIn 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 ISUIn 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.
BBC - Changing the Face of SurgeryThe 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 Evangelisches Krankenhaus Wesel
GmbH in Germany, the film demonstrates how Augmented Intelligence
is not just transforming surgery, but also nurturing a deeper
connection between surgeons and technology. The video is available
at https://www.youtube.com/watch?v=9k41wWp35IQ.
New Website LaunchLast 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 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.
Follow Asensus
Email Alerts: https://ir.asensus.com/email-alerts
LinkedIn:
https://www.linkedin.com/company/asensus-surgical-inc/
Twitter: https://twitter.com/AsensusSurgical
YouTube: https://www.youtube.com/@AsensusSurgical
Vimeo: https://vimeo.com/asxc
Forward-Looking Statements
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
U.S. and globally in its regulatory submission for the LUNA
Surgical Robotic System and whether the LUNA Surgical Robotic
System will be successfully developed and receive regulatory
clearances on the timeline the Company anticipates. 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). 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
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