NEWS

At Imviva Biotech we are committed to developing innovative, cell-based therapies for patients with serious or life-threatening diseases, especially where existing treatment options are limited or ineffective. While participation in clinical trials is the primary way to access our investigational therapies, we understand that some patients may not be eligible for ongoing studies.

To support patients in these circumstances, Imviva has established an Expanded Access Policy (also known as “compassionate use”) that allows for the potential use of our investigational products outside of clinical trials, in accordance with the U.S. Food and Drug Administration (FDA) regulations. Each request is evaluated individually, and approval is not guaranteed even when eligibility criteria are met.

Key Points of Our Expanded Access Policy

• Eligibility Criteria

We will consider expanded access requests when all of the following criteria are met:

• Patient has a serious or life-threatening condition;
• Patient has no comparable or satisfactory alternative treatment options;
• Patient is not eligible or able to participate in a relevant clinical trial;
• Potential benefits justify the potential risks of treatment;
• Providing the investigational product will not interfere with investigational trials that could support the product’s development or marketing approval for the treatment indication.
• Regulatory Complianc 

        All requests must come from a licensed U.S. physician who is responsible for the patient’s care and who agrees to comply with FDA regulations and Imviva’s reporting requirements.

• Review Process

        Requests are reviewed by Imviva’s subject matter experts. Non-emergency requests are typically evaluated within 5–10 business days once complete information is provided.

• Product Availability & Development Considerations:

         Approval of expanded access use is subject to product availability and must not interfere with ongoing clinical trials, regulatory plans, or patient safety.

• Compliance Requirements:

Approved  requests must follow all applicable regulatory guidelines, including FDA authorization, Institutional Review Board (IRB) approval, and informed consent from the patient or their legal representative.

How to Submit a Request:

Treating physicians may submit inquiries or formal requests by contacting us at: clinicaltrials@bioheng.com

As authorized by the 21st Century Cures Act, Imviva may revise this expanded access policy at any time.  Additionally, the posting of this policy by Imviva shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.