What changed in this filing

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Item 1B. Unresolved Staff Comments

2025-03-31 compared with 2024-03-28 · 76 added, 20 removed, 9 unchanged (91% of the section changed)

1 unchanged sentence

Cybersecurity

Company’s cybersecurity risks are theft of intellectual property, theft of other business data, fraud or extortion, lack of access

to our information systems, harm to employees, harm to business partners, violation of privacy laws, potential reputational risk, and

litigation or other legal risk if a cybersecurity incident were to occur.

It is difficult to assign a monetary materiality assessment

to these risks or to the impact if the Company were to sustain a breach of its systems.

Our approach is based on the premise that any

cybersecurity incident could result in material harm to the Company.

Audit Committee has been designated with oversight responsibility for cybersecurity risks and our Chief Financial Officer is responsible

for managing our efforts in this area.

Neither the Chief Financial Officer nor any member of the Audit Committee has relevant expertise

in cybersecurity.

Rather, the Company retains an outside technical expert to support our information technology systems including addressing

cybersecurity risks.

conduct annual risk assessments and quarterly vulnerability scans of risks posed by cybersecurity threats in conjunction with our insurance

renewal cycles.

As a result of these assessments, we have implemented technical, administrative, and, where appropriate, physical controls

and practices to proactively monitor our systems and user accounts including, but not limited to, deploying solutions to constantly monitor

users accessing systems, implementation of two factor authentication for logins, and improved rules for password maintenance.

Management and Strategy

recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to safeguard our information

systems and protect the confidentiality, integrity, and availability of our data.

The Company considers its primary cybersecurity risks

to be theft of intellectual property, theft of other business data, fraud or extortion, lack of access to its information systems, harm

to employees, harm to business partners, violation of privacy laws, potential reputational risk, and litigation or other legal risk if

a cybersecurity incident were to occur.

It is difficult to assign a monetary materiality assessment to these risks or to the impact if

the Company were to sustain a breach of its systems.

The Company’s approach to cybersecurity is based on the premise that any cybersecurity

incident could result in material harm to the Company.

We have a cybersecurity and risk management processes in place to oversee risks

associated with cybersecurity and respond to emerging threats in a timely and effective manner.

We monitor our systems to assess cybersecurity risks and threats.

Material Risks & Integrated Overall Risk Management

have integrated cybersecurity risk management into our broader risk management framework.

This integration ensures that cybersecurity

considerations are an integral part of our decision-making process.

We conduct annual risk assessments and quarterly vulnerability scans

of risks posed by cybersecurity threats in conjunction with our insurance renewal cycles.

As a result of these assessments, we have implemented

technical, administrative, and, where appropriate, physical controls and practices to proactively monitor our systems and user accounts

including, but not limited to, deploying solutions to constantly monitor users accessing systems, implementation of two factor authentication

for logins, and improved rules for password maintenance .

many companies, we make use of cloud-based solutions provided by several large service providers for critical information technology

5 unchanged sentences

that they have suffered a breach of their systems.

of our business partners also maintain data related to our trials and ongoing product development on servers they maintain.

these partners to comply with all HIPAA standards for maintaining security of their systems where this data resides.

Third Parties on Risk Management

Audit Committee has been designated with oversight responsibility for cybersecurity risks and our Chief Financial Officer is responsible

for managing our efforts in this area.

Neither the Chief Financial Officer nor any member of the Audit Committee has relevant expertise

in cybersecurity.

Recognizing the complexity and evolving nature of cybersecurity threats, the Company has retained an third-party technical

expert to support its information technology systems including addressing cybersecurity risks.

This relationship enables us to leverage

specialized knowledge and insights, to ensure our cybersecurity strategies and processes are aligned with industry best practices.

Third Party Risk

utilize various third-party software applications in the functioning of our core business.

We conduct assessments of all third-party

providers and maintain ongoing reviews to ensure compliance with our cybersecurity standards.

Our assessment of risks associated with

the use of third-party providers is part of our overall cybersecurity framework .

In addition, some of our business partners also

maintain data related to our trials and ongoing product development on servers they maintain.

We require these partners to comply with

all HIPAA standards for maintaining security of their systems where this data resides.

from Cybersecurity Threats

face risk from cybersecurity threats that could have a material adverse effect on our business, financial condition, results of operations,

cash flows or reputation.

For more information about the cybersecurity risks we face, see the risk factor entitled “ Security

threats to our information technology infrastructure could expose us to liability and damage our reputation and business .”

in Item 1A., Risk Factors .

Board of Directors is aware of the critical nature of managing risks associated with cybersecurity threats, and recognizes the

significance of these threats to our operational integrity and stockholder confidence.

Management Personnel

utilize an out-sourced information technology (IT) network and cybersecurity compliance service provider, Windstar Technologies,

(“Windstar”) Windstar, under the supervision of our Chief Financial Officer, is responsible for developing and

implementing our information security program.

Windstar provides managed IT network and cloud services, network, cyber and web

security services, cyber risk audits and compliance and penetration testing assessments.

of Directors Oversight

Our Board is aware of the critical nature of managing risks associated with cybersecurity threats, and recognizes

the significance of these threats to our operational integrity and stockholder confidence .

Audit Committee is central to the Board’s oversight of cybersecurity risks and bears the primary responsibility for this domain .

Role Managing Risk and Reporting to the Board

We do not currently have an employee who has significant and demonstrated professional IT management experience.

Presently, our Chief Financial Officer with assistance from our third-party IT services provider, Windstar,

are primarily responsible for informing the Audit Committee regarding cybersecurity risks.

They provide briefings to the Audit Committee

on a regular basis, with a minimum frequency of once per year .

addition to scheduled meetings, the Audit Committee and the Chief Financial Officer maintain an ongoing

dialogue regarding emerging or potential cybersecurity risks.

Together, they receive updates on any significant developments in the

cybersecurity domain, ensuring the Board’s oversight is proactive and responsive.

This involvement ensures that cybersecurity

considerations are integrated into the Company’s broader strategic objectives and helps in identify areas for improvement,

ensuring the alignment of cybersecurity efforts with the overall risk management framework.]

date, we have not experienced any previous cybersecurity incidents that have materially affected or are reasonably likely to materially

affect our business strategy, results of operations, or financial condition.

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