Compliance

California 2023 Compliance Policy and Declaration

DECLARATION FOR CALIFORNIA COMPLIANCE LAW

• As part of its ongoing compliance efforts, Mobia Medical, Inc. (“Mobia”) has established a Comprehensive Compliance Program designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. To Mobia’s knowledge, as of the date of this declaration, Mobia is in compliance with its Comprehensive Compliance Program, as described in this declaration, and with California Health & Safety Code §§ 119400-119402.
• Copies of Mobia’s Comprehensive Compliance Program CCP and Annual Declaration of Compliance can be obtained by calling 855-628-9375, emailing info@mobia.com, or visiting www.mobia.com
• Last updated: 03/26/2026

MOBIA’S COMPREHENSIVE COMPLIANCE PROGRAM

• Mobia has established a program designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. Mobia’s program is informed by the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General of the U.S. Department of Health and Human Services. That guidance describes seven elements of an effective compliance program, which are summarized below. As described below, these elements form the basis of the Mobia program for compliance with the standards regulating the marketing and promotion of its products. In addition, Mobia has implemented and maintains a website (https://mobia.allvoices.co) and a compliance hotline (888-718-7073) to facilitate communication and requests for information related to California State requirements.

• Written Policies and Procedures

  Mobia has written policies and procedures to assure substantial compliance with the applicable laws, regulations and standards governing the marketing and promotion of its products. Mobia follows the PhRMA Code on Interactions with Health Care Professionals (“PhRMA Code”). Mobia has established written policies and procedures that govern activities involving communicating with health care professionals about the appropriate use of its products, including appropriate instruction and education required for the safe and effective use of its products. Mobia also has policies and procedures governing activities involving the advancement of scientific and educational activities supporting medical research and education. These policies and procedures include:

  • Policy on Educational Grants and Research Grants

    Mobia may provide grants for specific educational purposes that benefit health care professionals. These may include, but are not limited to, continuing medical and paraprofessional education programs, fellowships provided to teaching institutions and similar organizations with a demonstrated commitment to scientific and technical education, and programs operated by organizations that provide high-quality, nationally recognized education. Funding of educational programs will generally be provided only to organizations and institutions and not to individual practitioners.
    Research grants to support physician-initiated research may be provided for programs involving research in areas of legitimate interest to Mobia. All requests are subject to scientific review prior to funding approval.

  • Policy on Charitable Contributions and Patient Assistance

    Mobia will consider charitable contributions and requests for patient assistance for costs associated with the Vivistim Paired VNS System placement procedure and rehabilitation therapy in chronic ischemic stroke patients meeting reasonable, verifiable, and uniform eligibility requirements.

  • Policy on Travel Expense Reimbursement for CME, Promotional or Product Training Meetings

    Mobia may reimburse attendees for their reasonable travel and lodging expenses associated with attendance at training meetings conducted by Mobia. Training meetings will be conducted in locations conducive to the exchange of information such as educational or conference settings. Where face-to-face health care professionals training is reasonably necessary for the safe and effective use of Mobia products is required, Mobia may provide training at Mobia facilities, at independent teaching centers such as medical institutions, or in other appropriate clinical settings.

  • Policy on Business Meals

    Mobia may occasionally offer a modest meal as part of an educational presentation or a business discussion. Entertainment or recreation at such meetings is not permitted. Attendance by spouses or guests at such meetings is not permitted unless the spouse or guest has a bona fide reason for attending, e.g., they are a health care professional interested in prescribing a Mobia product.

  • Policy on the Provision of Educational and Practice-Related Items

    Subject to approval from the Mobia Compliance Officer, Mobia representatives may provide items that benefit patients or serve a genuine educational function for health care professionals.
• Total Annual Dollar Limit for Meals, Educational or Practice-Related Items Training Expenses and Expense Reimbursement for Training Meetings
  Mobia has established an annual limit of $2,500 for meals and educational items as the aggregate value of the items or activities that may be provided to California health care professionals pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765).
• Policy Prohibiting Entertainment
  It is the policy of Mobia not to provide Entertainment (e.g., sporting events, golf outings, concerts, etc.) to health care professionals.
• Assigned Compliance Officer
  Mobia has a Compliance Officer who is empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management and board of directors.
  Mobia has a Compliance Committee comprised of Mobia’s Compliance Officer and members of Mobia’s management team.
• Training
  Mobia has an annual Compliance Training process. New employees receive training at the time of hire and annually thereafter. The training covers applicable guidelines governing Mobia’s compliance program. Employees are trained on the consequences of failure to comply with the requirements of Mobia’s compliance program.
• Communication
  Mobia encourages open and candid discussion between management and employees regarding any compliance concern. Mobia employees are encouraged to report their concerns to their manager or to the Compliance Officer. Employees also have the option to report potential violations anonymously using the Mobia Compliance Hotline at 888-718-7073.
• Auditing and Monitoring
  Mobia self-assesses and periodically audits its compliance with its policies and procedures.
• Enforcement and Disciplinary Guidelines
  Mobia may take disciplinary action, up to and including discharge/termination, in response to violation of Mobia’s compliance policies or procedures. Mobia may investigate matters that are brought to Mobia’s attention to ensure the consistent application of Mobia’s standards.
• Responses to Detected Problems and Actions to Correct Issues
  Mobia requires a prompt and diligent response to potential violations of Mobia’s compliance program, including its standards regulating the marketing and promotion of Mobia’s products. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.