UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events |
On December 7, 2023, five Medicare Administrative Contractors (“MACs”), National Government Services, WPS Government Health Administrators, Palmetto GBA, Celerian Group Company, and Noridian Healthcare Solutions, each updated their respective future effective local coverage determinations (“LCDs”) on Micro-Invasive Glaucoma Surgery to delay the effective date of these LCDs from December 24, 2023 to January 29, 2024.
As previously disclosed, the LCDs each identify certain procedures as investigational in patients over the age of 18 for glaucoma management, including canaloplasty in combination with trabeculotomy ab interno which is a procedural description associated with Sight Sciences, Inc.’s (the “Company”) OMNI® Surgical System (“OMNI”).
Each LCD lists goniotomy as a covered procedure with certain coverage limitations. The Company is still assessing each LCD’s goniotomy coverage determinations and their potential impact on continued or discontinued coverage for its SIONTM Surgical Instrument technology.
If the LCDs become effective in their current form, the procedures identified in the LCDs as investigational would be noncovered for Medicare beneficiaries in the states administered by these five MACs. The states served by these five MACs accounted for an aggregate of approximately 63% of the Company’s Surgical Glaucoma revenue in 2022.
The Company strongly disagrees with each LCD’s characterization of adult canaloplasty in combination with trabeculotomy ab interno, a procedural description associated with the OMNI technology, as investigational and is pursuing all remediation possibilities to maintain or reinstate coverage. The Company’s continuing efforts include concerted engagement with each MAC, the Centers for Medicare & Medicaid Services, and clinical societies, as well as sharing clinical data supporting the long-term safety and efficacy of OMNI with these entities, to maintain or reinstate coverage for procedures performed with the OMNI technology. However, if the LCDs become effective in their current form, the Company intends to promptly initiate an LCD reconsideration request process with each MAC, in addition to taking such other measures as it may deem necessary or advisable.
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 and Section 21E of the Securities Exchange Act of 1934, as amended 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 effectiveness of the LCDs and their potential impact on the Company’s business, operating results and financial condition; the characterization of procedures associated with OMNI as investigational; and the Company’s plans to engage the MACs and other stakeholders to maintain or reinstate coverage, including initiation of an LCD reconsideration request if needed. 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® is a registered trademark of Sight Sciences, Inc. SION™ is a trademark 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.
| Sight Sciences, Inc. | ||||||
| Date: December 7, 2023 | By: | /s/ Alison Bauerlein | ||||
| Chief Financial Officer | ||||||