SGHT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• We sell OMNI and SION to facilities where ophthalmic surgeons perform outpatient procedures, such as ambulatory surgery centers (“ASCs”) and hospital outpatient departments (“HOPDs”), which are typically reimbursed by Medicare (or similar foreign governmental reimbursement entity) or private payors …

• We sell TearCare to ECPs, where eyecare providers perform evacuation of meibomian glands, using heat-delivered through wearable, open-eye eyelid treatment devices and manual expression, which TearCare is specifically designed for.

• We are continuing our TearCare commercial launch while focusing on our comprehensive, clinical data-driven, long-term market development plan that aims to improve awareness and patient access to TearCare. In addition, in the areas where appropriate fee schedules have been established for the TearCar…

• We do not have, and do not currently intend to develop, any internal manufacturing capabilities or infrastructure, and rely on a limited number of third-party manufacturers, many of which are single source suppliers, for the components, accessories and materials that are utilized in the assembly of …

• We believe there are several important factors that have impacted and that will continue to impact our business, financial condition, and results of operations. There have been no material changes to such factors from those described in our Annual Report under the heading "Factors Affecting Our Busi…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• We sell OMNI and SION to facilities where ophthalmic surgeons perform outpatient procedures, such as ambulatory surgery centers (“ASCs”) and hospital outpatient departments (“HOPDs”), which are typically reimbursed by Medicare or private payors for procedures using our products. We are focused on ed…

• We sell TearCare to ECPs. In October 2025, two Medicare Administrative Contractors (“MACs”), Novitas Solutions, Inc. (“Novitas”) and First Coast Service Options, Inc. (“FCSO”), each established jurisdiction-wide pricing, effective retroactively to January 1, 2025, for CPT code 0563T (evacuation of m…

• may agree to provide case-based coverage outside of a formal policy. We plan to continue to engage with other MACs, third-party payors, the clinical societies, and other stakeholders in continued support of patient access for interventional meibomian gland disease procedures performed with the TearC…

• We are continuing our commercial launch of TearCare and are focused on our comprehensive, clinical data-driven, long-term market development plan that aims to improve awareness and patient access to TearCare. In addition, in the areas where we have achieved some level of reimbursement coverage and/o…

• We have dedicated meaningful resources to execute our commercial strategy, while also seeking to reduce operating expenses and improve cost efficiencies to better align our operating structure for long-term, profitable growth. In the third quarter of 2025, we implemented a targeted restructuring pla…

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• the fair value of these assets as a result of changes in interest rates due to the short-term nature of our cash and cash equivalents.

• The Hercules Loan Agreement contains a floating rate equal to the greater of 10.35% or the Prime Rate plus 2.35%, with an interest rate equal to 10.35% as of March 31, 2026. Based upon the balance outstanding as of March 31, 2026, a hypothetical 1.0% (100 basis points) change in interest rates would…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• The Hercules Loan Agreement contains a floating rate equal to the greater of 10.35% or the Prime Rate plus 2.35%, with an interest rate equal to 10.35% as of September 30, 2025. Based upon the balance outstanding as of September 30, 2025, a hypothetical 1.0% (100 basis points) change in interest rat…

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• We are not aware of any material changes to the risks and uncertainties described under the heading “Risk Factors” in our Annual Report, which information is incorporated herein by reference. The risks described in our Annual Report are not the only ones we face. Additional risks we currently do not…

• believe to be immaterial may also impair our business, financial condition, operating results, liquidity, and future prospects.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Except as set forth below, we are not aware of any material changes to the risks and uncertainties described

• under the heading “Risk Factors” in our Annual Report or Quarterly Reports on Form 10-Q for the three months ended March 31, 2025 and June 30, 2025, respectively, which are incorporated herein by reference. The risks described in our Annual Report and Quarterly Reports are not the only ones we face.…

• We rely on third parties to manufacture and supply all of our products, and a substantial portion of our products and components are manufactured in China. A number of our suppliers are also single-source providers. We are subject to numerous risks relating to our reliance on such third-party suppli…

• Our business strategy depends on our ability to manufacture our current and future products in sufficient quantities, on terms acceptable to us, and on a timely basis to meet customer demand, while adhering to product quality standards, complying with regulatory requirements, and managing manufactur…

• Our suppliers must be able to provide us with products and components in compliance with regulatory requirements, including the FDA’s Quality System Regulation (“QSR”) and other applicable laws or regulations, in accordance with agreed-upon specifications, at acceptable costs and on a timely basis. …