LENSAR Announces Certification for the ALLY® Adaptive Cataract Treatment System in the European Union
07 Agosto 2024 - 1:00PM
Business Wire
First EU ALLY Commercial Installation Planned
for August 2024
LENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”), a
global medical technology company focused on advanced laser
solutions for the treatment of cataracts, today announced that the
ALLY Adaptive Cataract Treatment System (“ALLY” or “ALLY System”)
has received certification under the European Union’s (“EU”)
Medical Device Regulation (“MDR”).
“We are thrilled to receive EU MDR certification for ALLY, which
marks a significant milestone for LENSAR. We believe ALLY’s
commercial availability in the EU creates a significant growth
opportunity for us, through the ability to provide new capabilities
and advanced next-generation laser technology to European
surgeons,” said Nick Curtis, President and CEO of LENSAR. “European
cataract surgeons now have access to a technology that has
demonstrated to not only enhance the precision, efficiency and
patient satisfaction associated with the procedure, but also to
significantly improve practice workflow and economics.”
Receiving MDR certification enables LENSAR to begin providing EU
surgeons a transformative technology solution for cataract
procedures. ALLY is the first platform to enable surgeons to
perform a laser cataract procedure seamlessly in a single, sterile
environment. Due to its highly ergonomic design, enhanced speed and
features, ALLY increases both patient and practice efficiencies.
The Company is commercializing ALLY through its distributor network
in the EU and expects to place the first ALLY Systems with European
surgeons in the third quarter of 2024.
The ALLY System is designed to address the performance
limitations of aging, first-generation technologies while
simultaneously enabling physicians to maximize efficiency in the
operating room, as supported by recently published time and motion
studies. These studies have shown significant procedure time
savings resulting in increased revenue opportunities for both
surgeons and ambulatory surgery centers, as well as less throughput
time for patients, beginning with the time they enter the facility
until they leave post-procedure.
ALLY’s small footprint and enhanced ergonomics provide surgeons
a unique opportunity to improve efficiencies in any operating room
or in-office surgical suite. ALLY is the first and only cataract
laser to use artificial intelligence in the iris registration and
surface identification of astigmatism management, as well as to
automatically determine cataract density, optimize fragmentation
patterns and energy settings, with the goal of minimizing the
overall energy delivered to complete the cataract procedure more
efficiently and help contribute to quicker visual recovery and
better patient outcomes. These proprietary features provide new
opportunities for surgeons in laser cataract surgery
procedures.
About LENSAR
LENSAR is a commercial-stage medical device company focused on
designing, developing, and marketing advanced systems for the
treatment of cataracts and the management of astigmatism as an
integral aspect of the cataract procedure. LENSAR has developed its
ALLY® Adaptive Cataract Treatment System as a compact, highly
ergonomic system utilizing an extremely fast dual-pulse laser and
integrating AI into proprietary imaging and software. ALLY is
designed to transform premium cataract surgery by utilizing
LENSAR’s advanced technologies with the ability to perform the
entire procedure in a sterile operating room or in-office surgical
suite, delivering operational efficiencies and reducing overhead.
ALLY includes LENSAR’s proprietary Streamline® software technology,
which is designed to guide surgeons to achieve better outcomes.
Forward-looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including, without limitation,
statements regarding the Company’s business strategies, expected
growth, commercialization of the ALLY® Adaptive Cataract Treatment
System in the EU, and the ALLY System’s performance and market
adoptions and usage. In some cases, you can identify
forward-looking statements by terms such as “aim,” “anticipate,”
“approach,” “believe,” “contemplate,” “could,” “estimate,”
“expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,”
“possible,” “potential,” “predict,” “project,” “pursue,” “should,”
“target,” “will,” “would,” or the negative thereof and similar
words and expressions.
Forward-looking statements are based on management’s current
expectations, beliefs and assumptions and on information currently
available to us. Such statements are subject to a number of known
and unknown risks, uncertainties and assumptions, and actual
results may differ materially from those expressed or implied in
the forward-looking statements due to various important factors,
including, but not limited to, the important factors that are
disclosed under the heading “Risk Factors” contained in the
Company’s Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2024 filed with the Securities and Exchange
Commission (“SEC”), as such factors may be updated from time to
time in the Company’s other filings with the SEC. All
forward-looking statements are expressly qualified in their
entirety by such factors. Except as required by law, the Company
undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date of this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20240806362024/en/
Thomas R. Staab, II, CFO ir.contact@lensar.com
Lee Roth / Cameron Radinovic Burns McClellan for LENSAR
lroth@burnsmc.com / cradinovic@burnsmc.com
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