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Item 1B. Unresolved Staff Comments

2025-06-20 compared with 2024-06-21 · 51 added, 51 removed, 4 unchanged (96% of the section changed)

1 unchanged sentence

CYBERSECURITY

We believe a robust

and proactive approach to cybersecurity risks and threats is essential to achieving our strategic business objectives and protecting

our business.

We may face a wide range of cybersecurity threats, such as ransomware and denial-of-service attacks.

Our customers, suppliers

and other business partners may also face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these third

parties could have a material adverse effect on our business and results of operations.

Due to the risks that cybersecurity threats can

pose to our business, we intend to continually evaluate best practices and methods, including cyber defense systems and training programs,

to protect our business from a wide range of potential threats.

We continue to evaluate

our cybersecurity control processes and procedures to address the evolving cybersecurity risks that we may face in an increasingly technically

capable environment.

We are implementing policies to educate and provide guidance to our personnel, including awareness programs and

other related cybersecurity best practices.

We plan to conduct technical risk assessments to identify cybersecurity threats, as well

as assessments in the event of a material change in our business practices that may affect information systems that are vulnerable to

such cybersecurity threats.

We also plan to conduct programmatic risk assessments, including identification of reasonably foreseeable

internal and external risks, the likelihood and potential damage that could result from such risks, and the sufficiency of existing policies,

procedures, systems, and safeguards in place to manage such risks.

We believe a robust and proactive approach

to cybersecurity risks and threats is essential to achieving our strategic business objectives and protecting our business.

a wide range of cybersecurity threats, such as ransomware and denial-of- service attacks.

Our customers, suppliers and other business

partners may also face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these third parties could have

a material adverse effect on our business and results of operations.

Due to the risks that cybersecurity threats can pose to our business,

we intend to continually evaluate best practices and methods, including cyber defense systems and training programs, to protect our business

from a wide range of potential threats.

We continue to evaluate our cybersecurity control processes and procedures

to address the evolving cybersecurity risks that we may face in an increasingly technically capable environment.

We have implemented practices

and intend to implement policies to educate and provide guidance to our personnel, including awareness programs and other related cybersecurity

best practices.

We plan to conduct technical risk assessments to identify cybersecurity threats, as well as assessments in the event of

a material change in our business practices that may affect information systems that are vulnerable to such cybersecurity threats.

also plan to conduct programmatic risk assessments, including identification of reasonably foreseeable internal and external risks, the

likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems, and

safeguards in place to manage such risks.

Following these risk assessments, we will evaluate:

i) whether and

how to implement, and maintain reasonable safeguards to minimize identified risks, ii) how to reasonably address any identified gaps

in existing safeguards;

and how to regularly monitor the effectiveness of our safeguards.

As we are a small pre-revenue company, we currently

outsource our information technology (IT) functions to a third party.

Working with the outsourced IT firm, our president will manage

the risk assessment and mitigation process.

i) whether and how to implement, and maintain

reasonable safeguards to minimize identified risks, ii) how to reasonably address any identified gaps in existing safeguards;

to regularly monitor the effectiveness of our safeguards.

As we are a small pre-revenue company, we currently outsource our information

technology (IT) functions to a third party.

Working with the outsourced IT firm, our president will manage the risk assessment and mitigation

Third parties will play an important role in our cybersecurity program.

We intend to engage

third-party service providers to conduct evaluations of our security controls, including penetration testing and consulting on best practices.

The third-party services include testing both the design and operational effectiveness of security controls.

This dependence exposes

us, along with others who use such service providers, to the impact of a cyber-attack on their service providers.

It is possible for

a cyber-attack at a third-party service provider to have a significant financial, operational, or reputational impact to us.

the effective impact to us of a cyber-attack on a third-party service provider, we intend to monitor the risks associated with our service

providers through periodic review of these providers’ cybersecurity programs.

board of directors, through its audit committee, oversees our processes for identifying and mitigating risks, including cybersecurity

Management will periodically brief the audit committee and/or the board of directors on our cybersecurity and information security

policies and plans.

Our board of directors will be apprised of cybersecurity incidents deemed to have a moderate or higher business impact,

and we will provide updates on management’s incident response plan for addressing and mitigating any impacts and risks associated

with such an incident.

We intend to develop a formal incident response plan, which sets forth the steps to be followed from incident

detection and assessment to mitigation, recovery and notification and reporting within our organization and to our board of directors.

For additional information

regarding whether 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, please refer to Item 1A, “Risk Factors,” in this Report,

including the risk factor entitled “Third parties might attempt to gain unauthorized access to our network or seek to compromise

our insulin pump product.”

We intend to engage third-party service providers to

conduct evaluations of our security controls, including penetration testing and consulting on best practices.

The third-party services

include testing both the design and operational effectiveness of security controls.

This dependence exposes us, along with others who

use such service providers, to the impact of a cyber-attack on their service providers.

It is possible for a cyber-attack at a third-

party service provider to have a significant financial, operational, or reputational impact to us.

To reduce the effective impact to us

of a cyber-attack on a third-party service provider, we intend to monitor the risks associated with our service providers through periodic

review of these providers’ cybersecurity programs.

Our board of directors, through its audit

committee , oversees our processes for identifying and mitigating risks, including cybersecurity risks.

Management will periodically brief

the audit committee and/or the board of directors on our cybersecurity and information security policies and plans.

Our board of directors

will be apprised of cybersecurity incidents deemed to have a moderate or higher business impact, and we will provide updates on management’s

incident response plan for addressing and mitigating any impacts and risks associated with such an incident.

We intend to develop a formal

incident response plan, which sets forth the steps to be followed from incident detection and assessment to mitigation, recovery and notification

and reporting within our organization and to our board of directors.

For additional information regarding whether

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, please refer to Item 1A, “Risk Factors,” in this Report, including

the risk factor entitled “Third parties might attempt to gain unauthorized access to our network or seek to compromise our insulin

pump product.”

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