UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 8.01. Other Events
On October 3, 2024, four Medicare Administrative Contractors (“MACs”), Palmetto GBA, CGS Administrators, National Government Services, and WPS Government Health Administrators, each individually published final local coverage determinations and related final local coverage articles (collectively, the “Final LCDs”) regarding Micro-Invasive Glaucoma Surgery (“MIGS”). The Final LCDs, which are substantially similar to the proposed local coverage determinations published by each MAC in May 2024, confirm Medicare coverage for phacoemulsification / intraocular lens placement procedures performed with a single MIGS procedure. A “MIGS” procedure includes canaloplasty in combination with trabeculotomy ab interno, which is a procedural description associated with the Company’s OMNI ® Surgical System (“OMNI”), and goniotomy, which is a procedural description associated with the Company’s SION ® Surgical Instrument (“SION”) technology. Accordingly, Medicare coverage for canaloplasty in combination with trabeculotomy ab interno procedures and goniotomy procedures will continue in the states covered by these MACs. The anticipated effective date of the Final LCDs is November 17, 2024.
The Final LCDs adopt coverage limitations or non-coverage policies for MIGS procedures as first-line treatments for mild-to-moderate glaucoma, for surgical MIGS procedures (such as canaloplasty or goniotomy), when performed at the same time of service in the same patient eye as an aqueous shunt procedure, and for phacoemulsification / intraocular lens placement, when performed with a combination of MIGS procedures (e.g., cataract, stent, and either canaloplasty or goniotomy) at the same time of service in the same eye.
The Company plans to continue to engage with each MAC, the Centers for Medicare and Medicaid Services, and the clinical societies in continued support of procedures performed with OMNI and SION.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K (this “Current Report”), 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 (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which statements are subject to considerable risks and uncertainties. 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 Current Report that are not statements of historical fact, including statements about the Company’s beliefs and estimates, are forward-looking statements and should be evaluated as such. These forward-looking statements include, but are not limited to, statements regarding, the continued coverage of the procedures referenced in the Final LCDs, the anticipated effective date of the Final LCDs, and the Company’s plans to continue to engage with each MAC, the Centers for Medicare and Medicaid Services and clinical societies. Such statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “designed,” “seeks,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. The Company bases these forward-looking statements on management’s current expectations, plans and assumptions that it has made in light of its experience in the industry, as well as its perceptions of historical trends, current conditions, expected future developments and other factors management believes are appropriate under the circumstances at such time. Although management believes these forward-looking statements are based upon reasonable assumptions at the time they are made, it cannot guarantee their accuracy or completeness. Forward-looking statements are subject to and involve risks, uncertainties and assumptions that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance, or achievements predicted, assumed or implied by such forward-looking statements, including the important factors discussed under the caption “Risk Factors” in the Company’s 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 Current Report. The Company undertakes 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.
OMNI® and SION® are registered trademarks of Sight Sciences, Inc.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Sight Sciences, Inc. |
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Date: |
October 3, 2024 |
By: |
/s/ Alison Bauerlein |
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Chief Financial Officer |