Asensus Surgical Receives FDA 510(k) Clearance For Pediatric Indication for Senhance Surgical System
20 Mars 2023 - 11:55AM
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™
(PGS), today announced that it has received 510(k) clearance from
the FDA for an expanded indication to treat pediatric patients with
the Senhance® System. The Senhance System is already approved for
pediatric patients in the EU and Japan.
With the combination of 3mm instrumentation, 5mm camera scope,
haptic feedback, and advanced clinical intelligence provided by the
Intelligent Surgical Unit™, the Company believes that the Senhance
System is uniquely positioned to bring the benefits of surgical
robotics to pediatric patients in a way that no other platform on
the market can, by offering a unique and unmatched reduction in
invasiveness on a robotic platform. We have seen strong early
clinical utilization in Europe, with surgeons having successfully
performed pediatric general, upper GI, colorectal and urologic
procedures using the Senhance System.
“We are excited to bring the benefits of surgical robotic
technology to the underserved pediatric patient population in the
United States. Given the small size of the patients, pediatric
surgery seeks to use the least invasive instruments and scopes,
while maintaining a high level of precision and stability. The
Senhance System is uniquely qualified to meet these needs of
pediatric surgeons,” said Anthony Fernando, Asensus Surgical
President and CEO. “We look forward to bringing all of our
learnings from over three years of performing pediatric procedures
in Europe and Japan to the US.”
Dr. Thom Lobe, Pediatric Surgeon at the Sinai Health System in
Chicago said, “The Senhance System is the perfect robotic platform
for use in pediatric patients. No other robotic system uses
reusable 3mm instruments suitable for smaller patients. For those
familiar with laparoscopic surgery, the system is easy to learn and
has several advantages including economical value, a camera system
controlled by the surgeon’s eyes, and improved safety features such
as haptic feedback.”
The Senhance System is now indicated to perform pediatric
procedures in the U.S., Europe, and Japan. Refer to
https://www.senhance.com/indications for the full indications for
use statements.
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, Russia, and select other countries. For a
complete list of indications for use, visit:
www.senhance.com/indications. To learn more about
Performance-Guided Surgery, Digital Laparoscopy with the Senhance
Surgical System and the new LUNA System visit www.asensus.com.
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Forward-Looking Statements
This press release includes statements relating to the Senhance
Surgical System and the FDA’s 510(k) clearance for a pediatric
indication for the Senhance Surgical System. 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 the Senhance Surgical System is
uniquely positioned to bring the benefits of digital laparoscopy to
pediatrics in a way that no other platform on the market can and
whether the Senhance Surgical System is the perfect platform for
use in pediatric patients. 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 VallieICR
Westwickeinvest@asensus.com443-213-0499
MEDIA CONTACT:Dan VentrescaMatter
CommunicationsAsensusPR@matternow.com617-874-5488
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