California Compliance

AngioSafe California Comprehensive Compliance Program and Declaration of Compliance

Posted Date: June 2026

NOTICE

This information is provided pursuant to California Health & Safety Code §§119400–119402, which requires medical device companies doing business in California to adopt a Comprehensive Compliance Program and make available an annual Declaration of Compliance.

This Declaration applies to AngioSafe, Inc. (“AngioSafe” or the “Company”), a medical device manufacturer headquartered in San Jose, California.

INTRODUCTION

AngioSafe is committed to conducting business with integrity and in compliance with all applicable federal and state laws, regulations, and industry standards governing interactions with healthcare professionals (“HCPs”), healthcare organizations, customers, and government entities.

AngioSafe has established a Comprehensive Compliance Program (“Compliance Program”) that is designed to:

  • Prevent, detect, and remediate violations of law and Company policy;
  • Promote ethical business conduct throughout the organization;
  • Support compliance with applicable healthcare laws and regulations;
  • Guide interactions with healthcare professionals and healthcare organizations; and
  • Align with recognized industry standards, including the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

While no compliance program can guarantee that individual misconduct will be eliminated entirely, AngioSafe maintains policies, controls, training, monitoring activities, and reporting mechanisms reasonably designed to promote compliance and ethical conduct.

OVERVIEW OF ANGIOSAFE’S COMPLIANCE PROGRAM

1. Compliance Leadership and Oversight

AngioSafe has designated a Compliance Officer to oversee the Company’s Compliance Program and report compliance matters to executive management. The Compliance Officer works collaboratively with leadership, Human Resources, Legal, Finance, Sales, Marketing, and Clinical Affairs to:

  • Develop compliance policies and procedures;
  • Monitor compliance activities;
  • Investigate reported concerns;
  • Recommend corrective actions; and
  • Promote a culture of ethics and accountability.

2. Written Policies and Procedures

AngioSafe maintains written policies and procedures addressing:

  • Interactions with healthcare professionals and healthcare organizations;
  • Sales and marketing activities;
  • Educational grants and charitable contributions;
  • Consultant and speaker engagements;
  • Meals and business courtesies;
  • Anti-corruption and anti-bribery requirements;
  • Sunshine Act/Open Payments reporting;
  • Travel and expense reimbursement;
  • Reporting of compliance concerns; and
  • Disciplinary standards for violations.

These policies are reviewed periodically and updated as necessary to reflect changes in applicable laws, regulations, and industry guidance.

3. Annual Spending Limit

Consistent with California Health & Safety Code §§119400–119402, AngioSafe has established an annual aggregate spending limit of:

$2,500 per individual California healthcare professional for promotional materials, educational items, and other permissible items and activities provided by AngioSafe.

This amount represents a maximum annual spending cap and is not intended to be an average or target amount.

The annual limit does not include:

  • Product evaluation units, demonstration devices, or training products;
  • Support for accredited continuing medical education (“CME”);
  • Financial support for educational grants and scholarships;
  • Fair market value compensation for bona fide consulting, speaking, research, or other professional services;
  • Reasonable travel, lodging, and meal expenses associated with the provision of legitimate professional services;
  • Patient educational materials.

AngioSafe maintains internal monitoring processes designed to support compliance with this annual spending limit.

4. Training and Education

AngioSafe provides compliance training to applicable personnel, including:

  • Sales personnel;
  • Marketing personnel;
  • Clinical and medical affairs personnel;
  • Customer-facing employees;
  • Managers and executives; and
  • Other employees whose responsibilities involve interactions with healthcare professionals.

Training is conducted during onboarding and periodically thereafter.

5. Communication and Reporting

AngioSafe encourages all personnel to raise compliance concerns without fear of retaliation.

Employees may seek guidance or report concerns through:

  • Supervisors and management;
  • Human Resources; or
  • The Compliance Officer.

6. Monitoring and Auditing

AngioSafe conducts periodic monitoring and auditing activities designed to assess compliance with the Company’s policies and procedures.

Findings are reviewed by management, and corrective actions are implemented as appropriate. Based on our ongoing compliance evaluations, we will identify potential risk areas and incorporate changes to our compliance program to address new or emerging risks.

7. Investigation and Corrective Action

Potential violations of law, regulations, industry standards, or Company policies are reviewed promptly and appropriately.

Where warranted, AngioSafe may:

  • Conduct internal investigations;
  • Implement corrective action plans;
  • Enhance training or controls;
  • Revise policies and procedures;
  • Increase monitoring activities; and
  • Impose disciplinary action up to and including termination of employment or contractual relationships.

ANNUAL DECLARATION OF COMPLIANCE

To the best of AngioSafe’s knowledge and based upon a good-faith understanding of the requirements of California Health & Safety Code §§119400–119402, AngioSafe has established a Comprehensive Compliance Program that is reasonably tailored to meet the specific needs of AngioSafe and designed to foster compliance with applicable laws, regulations, and industry standards governing the marketing and promotion of medical devices.

Based on the Company’s current compliance monitoring and review processes, AngioSafe declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program and its established annual spending limit of $2,500 per California healthcare professional for the current reporting period.

As recognized by the Office of Inspector General’s Compliance Program Guidance, even an effective compliance program cannot eliminate individual instances of non-compliance. Accordingly, this declaration should not be construed to mean that AngioSafe has identified no instances of non-compliance. When potential violations are identified, AngioSafe takes appropriate remedial and corrective actions consistent with its Compliance Program.

For additional information regarding AngioSafe’s Compliance Program or to request a copy of this Declaration, please contact:

Compliance Officer
AngioSafe, Inc.
San Jose, California
[email protected]