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Sight Sciences Launches the Ergo-Series of the OMNI® Surgical System
ソース: Nasdaq GlobeNewswire / 09 3 2023 08:30:00 America/New_York
MENLO PARK, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative technology that provides solutions intended to transform care and improve patients' lives, today announced the United States launch of the Ergo-Series of the OMNI® Surgical System, a technology that facilitates surgeons’ ability to perform minimally invasive, implant-free glaucoma procedures in adults with primary open-angle glaucoma.
The OMNI Surgical System enables a minimally invasive glaucoma surgery (MIGS) that addresses all three known points of resistance in the aqueous outflow system: the trabecular meshwork, Schlemm’s canal, and the collector channels. It can be used before, in combination with, or following cataract surgery. The new features of the Ergo-Series include:
- Improved Handle Ergonomics: New enhancements enable surgeons to more easily rotate and position the cannula tip within Schlemm’s canal with precise finger rotations versus wrist adjustments.
- Simplified Viscoelastic Preparation: The handle’s viscoelastic luer connector is now removable and detaches when the viscoelastic cartridge is removed, resulting in more clearance with the surgical microscope.
- New Cannula Tip Design: The Ergo-Series cannula tip has a new profile that enables gentle and precise access to Schlemm's canal while continuing to enable full 360-degree catheterization associated with the OMNI procedure.
Reay Brown, MD, a Glaucoma Specialist and Sight Science's Chief Medical Officer, said "The Ergo-Series maintains the same therapeutic functionality as the second-generation OMNI Surgical System. The technology enhancements provide additional benefits that enable surgeons to perform an innovative, minimally invasive glaucoma surgery."
“For me, the new cannula tip technology is the biggest improvement,” said Zarmeena Vendal, MD, glaucoma surgeon and founder of Westlake Eye Specialists in Austin, Texas. “The profile of the tip enables me to score the trabecular meshwork more confidently and makes entry into Schlemm’s canal gentler. In addition, when I deploy the catheter, I can follow the path of the Schlemm’s canal a bit more naturally. In our glaucoma surgery practice, access to the OMNI Surgical System lets us provide these new technology procedures for the benefit of our patients.”
OMNI Surgical System, Ergo-Series enables surgeons to provide a minimally invasive, implant-free surgery to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma. The device’s indications for use, contraindications, warning, and precautions remain unchanged. The OMNI Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. It can be used before, in combination with, or following cataract surgery.
Paul Badawi, CEO and co-founder of Sight Sciences, added, “OMNI is an innovative technology developed to enable a surgeon to perform a circumferential and complete outflow procedure that addresses all three known points of resistance in the aqueous outflow system through a single clear corneal incision. We are committed to continually innovating and improving our core technologies alongside our surgeon partners in order to provide the greatest benefit to patients suffering from primary open-angle glaucoma. Based on the initial feedback, we are confident the Ergo-Series of the OMNI Surgical System will continue to raise the bar.”
The Ergo-Series of the OMNI Surgical System is expected to be available outside the United States later this year.
About Sight Sciences
Sight Sciences is an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI® Surgical System is a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. The SION™ Surgical Instrument is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The Company’s TearCare® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), enabling office-based clearance of gland obstructions by physicians to address the leading cause of dry eye disease.For more information, visit SightSciences.com.
About the OMNI Surgical System
The OMNI® Surgical System technology consists of a handheld, single-use therapeutic device for minimally invasive glaucoma surgery (MIGS). OMNI allows surgeons to access 360 degrees and three primary points of resistance of an eye’s diseased conventional outflow pathway (trabecular meshwork, Schlemm’s canal, and collector channels) through a single clear corneal microincision.OMNI's FDA-cleared indication is for canaloplasty (the microcatheterization and viscodilation of Schlemm’s canal) followed by trabeculotomy (the cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. OMNI has a CE Mark for the
catheterization and transluminal viscodilation of Schlemm’s canal and the cutting of trabecular
meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.OMNI should not be used in any situations where the iridocorneal angle is compromised or has been damaged since it may not be possible to visualize the angle or to properly pass the microcatheter. Do
not use the OMNI in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris or in
quadrants with previous MIGS implants.OMNI technology is protected by a global patent portfolio including 32 issued patents worldwide.
For more information, visit www.OMNIsurgical.com
Forward-Looking Statements
This press release, together with other statements and information publicly disseminated by the Company, contains certain 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. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release or during the earnings call that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies. These statements often include words such as "anticipate," "expect," "suggests," "plan," "believe," "intend," "estimates," "targets," "projects," "should," "could," "would," "may," "will," "forecast" and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our business, results of operations and financial condition and could cause actual results to differ materially from those expressed in the forward-looking statements. These statements are not guarantees of future performance or results. The forward-looking statements are subject to and involve risks, uncertainties and assumptions, and you should not place undue reliance on these forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following: estimates of our total addressable market, future revenue, expenses, capital requirements, and our needs for additional financing; our ability to enter into and compete in new markets; execution of our market strategies; the impact of the COVID-19 pandemic on our business, our customers' and suppliers' businesses and the general economy; our ability to compete effectively with existing competitors and new market entrants; our ability to scale our infrastructure; our ability to manage and grow our business by expanding our sales to existing customers or introducing our products to new customers; our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement; potential effects of extensive government regulation; our abilities to obtain and maintain regulatory approvals and clearances for our products that support our revenue projections, business strategies and growth; our ability to successfully execute our clinical trial roadmap; our ability to obtain and maintain sufficient reimbursement for our products; our abilities to protect and scale our intellectual property portfolio; our ability to hire and retain key personnel; our ability to obtain financing in future offerings; the volatility of the trading price of our common stock; our expectation regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the "JOBS Act"); our ability to maintain proper and effective internal controls; and the other important factors discussed under the caption "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, as may be updated from time to time in subsequent filings. These cautionary statements should not be construed by you to be exhaustive and are made only as of the date of this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.Media contact
Carmen Caricchio
C2M Group
pr@SightSciences.comInvestor contact
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com© 2023 Sight Sciences. All rights reserved. Dr. Vendal is a paid consultant of Sight Sciences. OMNI and SION are trademarks or registered trademarks of Sight Sciences. 02/2023 OM-2790-US.v1
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- Improved Handle Ergonomics: New enhancements enable surgeons to more easily rotate and position the cannula tip within Schlemm’s canal with precise finger rotations versus wrist adjustments.