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LENSAR Announces U.S. Food and Drug Administration Acceptance of 510(k) Submission for ALLY
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Rhea-AI Summary
LENSAR, Inc. (NASDAQ: LNSR) announced FDA acceptance of its 510(k) submission for the ALLY™ Adaptive Cataract Treatment System. This submission marks a key milestone in its two-step commercialization strategy, aimed at enhancing cataract surgery with improved technology. The company plans to file an additional application for phacoemulsification features later in 2022. If cleared, LENSAR expects to launch the ALLY system in the second half of 2022, which may optimize surgical efficiency and patient outcomes, according to CEO Nick Curtis.
Positive
FDA acceptance of the 510(k) submission for the ALLY system is a significant milestone.
Potential to enhance surgeon efficiencies and patient outcomes if the ALLY system is cleared.
Negative
None.
ORLANDO, Fla.--(BUSINESS WIRE)--
LENSAR, Inc. (NASDAQ: LNSR) (“LENSAR” or “the Company”), a global medical technology company focused on advanced femtosecond laser surgical solutions for the treatment of cataracts, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its 510(k) submission for its next-generation ALLY™ Adaptive Cataract Treatment System for substantive review. The submission seeks marketing clearance for the ALLY Adaptive Cataract Treatment System and is the first stage of a planned, two step commercial release strategy. As part of this strategy, the Company plans to submit an additional 510(k) application seeking clearance for the phacoemulsification features within the integrated ALLY system later in 2022.
“FDA acceptance for substantive review of the 510(k) submission for ALLY marks an important milestone for LENSAR and is the result of several years of diligent teamwork and focused effort on the part of our development team. We believe that, if ALLY is cleared by the FDA, this staged-approach would allow for an expeditious and efficient path to commercialization,” said Nick Curtis, Chief Executive Officer of LENSAR. “The vast majority of cataract surgeons performing FLACS procedures rely on aging femtosecond lasers. ALLY’s design includes a small footprint, enhanced ergonomics, superior imaging, dual-pulsed laser, and advanced astigmatism management tools which we believe, if cleared, would set the new standard of femtosecond laser cataract technology. We believe ALLY has the potential to improve surgeon efficiencies, including optimizing FLACS procedures in any operating room, and to enable surgeons to deliver improved outcomes for patients. We look forward to the FDA’s review of the 510(k).”
LENSAR expects to launch ALLY in the second half of 2022, if cleared. The Company will discuss this significant milestone and its fourth quarter and full year 2021 results on a conference call scheduled for March 3, 2022 at 8:30 a.m. ET.
About LENSAR
LENSAR is a commercial-stage medical device company focused on designing, developing and marketing an advanced femtosecond laser system for the treatment of cataracts and the management of pre-existing or surgically induced corneal astigmatism. Its LENSAR Laser System incorporates a range of proprietary technologies designed to assist the surgeon in obtaining better visual outcomes, efficiency and reproducibility by providing advanced imaging, simplified procedure planning, efficient design and precision.
Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 development, the future market potential of the ALLY™ Adaptive Cataract Treatment System and the anticipated clearance of the 510(k) filing. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “may,” “will,” “would,” “should,” “could,” “target,” “potential,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.
Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company’s assets and business include, without limitation, its history of operating losses and ability to generate revenue; its ability to maintain, grow market acceptance of and enhance its LENSAR Laser System; the impact of the COVID-19 pandemic and the Company’s ability to grow revenues; the Company’s ability to obtain the necessary clearances or approvals for the ALLY Adaptive Cataract Treatment System; the willingness of patients to pay the price difference for LENSAR products; its ability to grow a U.S. sales and marketing organization; its ability to meet its future capital needs; the impact of any material disruption to the supply or manufacture of the LENSAR Laser Systems; the ability of the Company to compete against competitors that have longer operating histories and more established products than the Company; the Company’s ability to address numerous international business risks; and the other 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 September 30, 2021, filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in its other filings with the SEC, each accessible on the SEC’s website at www.sec.gov and the Investor Relations section of the Company’s website at https://ir.lensar.com. 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 LENSAR’s views as of any date subsequent to the date of this press release.
