What changed in this filing

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Item 1B. Unresolved Staff Comments

2026-03-18 compared with 2025-03-12 · 46 added, 29 removed, 3 unchanged (96% of the section changed)

2 unchanged sentences

Management and Strategy

have developed and maintain a cybersecurity risk management program that focuses primarily on securing and safeguarding computer systems,

networks, cloud services, business applications, and data and that is integrated in our overall risk management strategy and framework.

We have implemented protocols to protect against cyber threats and ensure the containment and security of sensitive business data, including

ongoing security reviews of critical systems, continuous monitoring of event data, and employee training programs, which processes are

aligned with our overall business and operational goals and strategies.

Our risk assessment occurs on an ongoing basis and covers identification

of risks that could act against the company’s objectives as well as specific risks related to a compromise to the security of data.

engage a third-party to provide operational support for cybersecurity risks .

This forms a critical part of our risk management strategy,

facilitating effective management and mitigation of risks, and ensuring adherence to applicable regulatory and industry standards.

we believe that we have established a robust framework for confidentiality, integrity, and availability of information, adhering to relevant

security standards, practices, and compliance requirements.

In addition, we maintain insurance to help protect against risks associated

with cybersecurity threats.

As of the date of this report, we do not believe that any risks from cybersecurity threats have materially

affected, or are reasonably likely to materially affect, us, including our business strategy, results of operations, or financial condition.

However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced

an undetected cybersecurity incident.

For more information about these risks, please see “Item 1.A – Risk Factors –

Risks Related to Our Business Operations – Our business and operations would suffer in the event of computer system failures, cyber-attacks

or deficiencies in our cyber-security.” in this Form 10-K.

board of directors provides oversight of our cybersecurity program and helps guide our strategy for managing cybersecurity risks in the

context of our overall risk management system .

Our cybersecurity program is managed by our Executive Vice President of Finance and Regional

Manager, our internal IT team and our external Chief Information Security Officer (“CISO”) whose is responsible for leading

enterprise-wide cybersecurity strategy, protocols, framework, standards and processes .

The Executive Vice President of Finance and Regional

Manager reports to our board of directors, as well as our Chief Executive Officer and Chief Financial Officer and other members of senior

management as appropriate.

maintain a cybersecurity risk-management program that is scaled to our business, products, and data environment.

Our products are physical

medical devices without integrated software, and we do not collect or store patient health information in the ordinary course.

we do rely on information systems that support our operations, and we maintain sensitive business information.

cybersecurity processes include written policies and procedures that address threat identification,

user practices, incident response, backup and recovery, and data handling.

We periodically

engage third parties to assess our environment.

We periodically engage independent third-party

cybersecurity experts to perform risk assessments and penetration testing.

In the past, external

providers conducted cybersecurity assessments and provided advisory services, including CISO-as-a-service

In early 2026, we engaged another independent cybersecurity firm to perform an updated

cybersecurity risk assessment, and management intends to prioritize remediation activities

once the results are completed.

also manage certain third-party risks through vendor selection and contract provisions and by limiting access to our systems and data

to an extent reasonably practicable for business operations.

We do not disclose further technical details of our controls to avoid increasing

security risk.

board of directors oversees enterprise-level risks generally as part of its overall risk-management responsibilities.

Cybersecurity risk

is managed at the executive level and incorporated into this broader framework.

Management provides updates to our board of directors

on cybersecurity matters as appropriate in the context of overall operational risk.

Role and Expertise

Executive Vice President of Finance and Regional Manager has executive responsibility for cybersecurity risk management and coordinates

the program with our internal information technology (“IT”) team and external advisors.

Day-to-day cybersecurity activities

are performed by our internal IT staff, including an IT professional with hands-on experience in systems administration and cybersecurity

Our Management experience has been developed through overseeing our cybersecurity processes and working with external providers.

These responsibilities include, but are not limited to, maintaining and updating policies, coordinating periodic assessments and testing,

managing user access practices and backup routines, and leading incident response activities if needed.

use external cybersecurity firms for risk assessments, penetration testing, and advisory services.

These engagements supplement our internal

capabilities and help identify and prioritize risk mitigation.

Contracts with key providers contain customary security and confidentiality

Experience and Materiality

of the date of this Annual Report on Form 10-K, we have not identified any cybersecurity incidents that have materially affected our

business strategy, results of operations, or financial condition.

We cannot guarantee that future incidents will not occur, and we may

not promptly detect all incidents despite our efforts.

For more information about these risks, please see “Item 1.A – Risk

Factors – Risks Related to Our Business Operations – Our business and operations would suffer in the event of computer system

failures, cyber-attacks or deficiencies in our cyber-security.” in this Annual Report on Form 10-K.

maintain cyber risk insurance.

However, such insurance may not cover all losses or may be subject to exclusions or disputes.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1B. Unresolved Staff Comments