Asensus Surgical, Inc. (NYSE American: ASXC), a medical device
company that is digitizing the interface between the surgeon and
the patient to pioneer a new era of Performance-Guided Surgery™,
today provided a preliminary 2022 year-end corporate update.
Fourth Quarter Highlights
- Over 690 procedures were performed globally during the quarter,
representing growth of over 23% compared to the fourth quarter
2021
- Five Senhance® Surgical Programs were initiated during the
quarter, including two in Germany, two in Japan, and one in the CIS
region
- Fourth quarter unaudited revenue is expected to be
approximately $2.2 - $2.8 million
2022 Full Year Highlights
- Approximately 2,650 procedures were performed globally,
representing growth of over 26% compared to 2021
- In 2022, nine Senhance Surgical Programs were initiated,
in-line with guidance of 8-10 systems
- The Company had unaudited cash, cash equivalents, short-term
and long-term investments, excluding restricted cash, of
approximately $74.4 million at December 31, 2022
- Full year 2022 unaudited revenue is expected to be
approximately $6.8 - $7.4 million
"We are very pleased with what we were able to achieve during
2022; which included making significant progress towards the
development of Performance-Guided Surgery, driving the continued
adoption of Senhance Surgical Programs, and materially increasing
its utilization globally,” said Anthony Fernando, Asensus Surgical
President and CEO. “As we look ahead to 2023, we remain bullish on
our ability to continue to develop the capabilities of our
cutting-edge digital clinical intelligence platform to
revolutionize the way surgery is performed and ultimately deliver
safer, more predictable outcomes for patients."
Market Development
2022 Senhance Program InitiationsDuring the fourth quarter of
2022, the Company initiated five new Senhance Surgical System
placements, two in Germany, two in Japan, and one in the CIS
region.
In 2022, the Company initiated nine new Senhance Surgical System
placements: four in Germany, three in Japan, and two in the CIS
region.
During the fourth quarter, the Company expanded its Senhance
Surgical Program at Kitakyushu General Hospital in Japan with the
initiation of a second Senhance Surgical System, representing the
first hospital to have a second Senhance system.
Germany and Japan, the second and third largest markets for
medical devices in the world respectively, remain key geographic
focus areas for the Company. The recent acceleration in adoption in
these geographies, as well as the CIS, validates the Company’s
strategy of demonstrating the exceptional capabilities of Senhance
and its industry-leading digital intelligence by facilitating
in-person hands-on access to the system.
Procedure VolumesIn 2022, surgeons performed over 2,650
procedures utilizing the Senhance System, representing a 26%
increase over the previous year. Compared to 2021, EMEA-based
procedures increased over 48%. These procedures included general
surgery, gynecology, urology, colorectal, pediatric, and bariatric
surgical cases.
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 over 2,200 patients enrolled to date, a 44%
increase from 2021. The registered procedures consist of
approximately 67% general surgery, including abdominal and
thoracic, 15% GYN, and 18% urology.
Clinical ValidationDuring the year, there were 16 peer-reviewed
clinical papers published providing further support for the
clinical utility of the Senhance System across a variety of
surgical specialties generated globally to support Senhance. In
particular, in October 2022 there was a milestone paper published
describing comparable intraoperative and short-term post-operative
complications outcomes between DaVinci and Senhance,
withsignificantly lower procedure cost with Senhance when
accounting for operative time, estimated blood loss, and other
equipment usage.
These papers, along with a library of similar papers, can be
found at the Company’s website,
www.senhance.com/us/resources.
Portfolio Expansion
Expanded Global ISU Machine Vision CapabilitiesThe Company
continues to expand the utilization and applicability of the
Intelligent Surgical Unit™ (ISU™) globally. The Company is seeking
CE Mark approval for expanded machine vision capabilities in
Europe, which the Company continues to expect to receive in early
2023. The newest ISU features include: real-time 3D measurement,
digital tagging, image enhancement, and enhanced camera control
based on real-time data while performing surgery.
This filing includes a review of the entire Senhance System
platform, and if successful, would represent one of the first
robotic surgical systems to be approved through the new, more
rigorous European Medical Device Regulation (MDR) process. The
expanded machine vision capabilities have both U.S. FDA 510(k)
clearance and Japanese PMDA approval.
Articulating Instrument LaunchThese instruments were
commercially launched in the U.S., Japan and Europe, in the fourth
quarter of 2022. Articulating Instruments offer better access to
difficult-to-reach areas of the anatomy by providing two additional
degrees of freedom.
U.S. Pediatric Regulatory SubmissionThe Company submitted its
U.S. FDA 510(k) application for pediatric clearance in the U.S.
during the third quarter of 2022. The Senhance System’s unique
combination of 3mm instrumentation with a 5mm camera scope combined
with haptic feedback make it a unique robotic assisted laparoscopic
solution for pediatric surgeries.
Fourth Quarter and Full Year 2022 Revenue
For the quarter ended December 31, 2022, the Company estimates
preliminary unaudited revenue of approximately $2.2 - $2.8 million.
For the full year, preliminary unaudited 2022 revenue is expected
to be approximately $6.8 - $7.4 million, representing revenues from
the sale of two Senhance Systems, system leasing, and related
revenues from instruments and accessories, and services.
Balance Sheet
As of December 31, 2022, the Company had preliminary unaudited
cash, cash equivalents, short-term and long-term investments,
excluding restricted cash, of approximately $74.4 million, and
there were approximately 236.9 million shares of 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. This
builds upon the foundation of Digital Laparoscopy with the Senhance
Surgical System powered by the Intelligent Surgical Unit (ISU) 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. Learn more about Performance-Guided Surgery and Digital
Laparoscopy with the Senhance Surgical System here:
www.senhance.com. Now available for sale in the US, EU, Japan,
Russia, and select other countries. For a complete list of
indications for use, visit: www.senhance.com/indications. For more
information, 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/c/transenterix
Vimeo: https://vimeo.com/asxc
TikTok: https://www.tiktok.com/@asensus_surgical
Forward-Looking Statements
This press release includes statements relating to the Senhance
Surgical System and our preliminary 2022 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 in 2023; whether
final 2022 fourth quarter and full year revenue will meet
expectations; whether we will be able to continue to develop our
cutting-edge digital clinical intelligence platform to
revolutionize the way surgery is performed and ultimately deliver
safer, more predictable outcomes for patients; 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 receive
CE Mark approval for expanded machine vision capabilities in Europe
in early 2023 and whether the Company will receive 510(k) clearance
for use of the Senhance System for pediatric patients in the U.S.
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, 443-213-0499invest@asensus.com
MEDIA CONTACT:
Isabella Rodriguez, 708-833-1572CG Lifeirodriguez@cglife.com
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