Introduction

AnGes USA, Inc. is dedicated to developing innovative gene therapies for serious medical conditions, including critical limb-threatening ischemia (CLTI). Our mission is to ensure that these therapies are safe and effective for patients worldwide. Clinical trials are fundamental to this process, as they provide the necessary data to achieve regulatory approvals and ensure broader patient access.

Policy on Expanded Access

At this time, AnGes USA does not offer expanded access to our investigational gene therapy for CLTI outside of clinical trials. This decision aligns with our commitment to maintaining the integrity of our clinical development program and ensuring the collection of comprehensive safety and efficacy data.

Rationale

Our focus is on conducting rigorous clinical trials to evaluate the safety and efficacy of our gene therapy for CLTI. Expanded access, also known as compassionate use, refers to the use of an investigational therapy outside of a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. At this stage, offering expanded access could potentially compromise the clinical trial process and delay the approval of the therapy for the broader patient population.

Clinical Trial Participation

We encourage patients and healthcare providers to consider participation in our clinical trials. Enrollment in clinical trials ensures that patients receive investigational therapies in a controlled environment with appropriate monitoring and data collection. Information about our ongoing clinical trials is available on ClinicalTrials.gov.

Future Considerations

As our clinical development program progresses, we may reassess our expanded access policy. Any updates will be communicated through our website and other appropriate channels.

Contact Information

For questions regarding our investigational therapies or clinical trials, please contact us at regulatory@anges-usa.com.

Conclusion

AnGes USA, Inc. is committed to developing safe and effective gene therapies for patients with CLTI and other serious conditions. We believe that focusing on our clinical trials is the most effective way to achieve this goal and bring new treatments to patients as swiftly as possible.

AnGes USA, Inc. Expanded Access Policy,
rev. March 2025.