Cook MyoSite, Incorporated

Single-Patient EA Policies/Criteria Cook MyoSite is committed to conducting rigorous, controlled clinical trials with variable inclusion and exclusion criteria based upon the indicated use under investigation. These trials are designed to demonstrate to regulatory authorities that our investigational product is safe and effective, and as a result, allow our investigational cell therapy product to become a valuable treatment option for a wide range of patients. Participation in our clinical trials is the first and most preferable route to access our investigational product. Cook MyoSite will consider providing an investigational product to a qualified requesting physician currently licensed within the United States via the United States Food and Drug Administration’s (FDA’s) expanded access pathway outside of an active clinical trial when the following general requirements are met: • The patient has a serious or life-threatening disease or condition with no satisfactory alternative; • Positive assessment that the anticipated benefits outweigh the risks to the patient; • Positive assessment that Cook MyoSite has an adequate supply of resources for producing the investigational product; • A determination that expanded access will not interfere with Cook MyoSite’s ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients; • The patient can undergo a muscle biopsy procedure(s), and; • The patient can undergo Cook MyoSite’s required donor screening and testing. For additional information, please refer to our website: https://resources.cookmyosite.com/terms-and-conditions-of-sale-and-delivery-0 Available Therapies via Single-Patient EA Autologous Muscle Derived cells (AMDC). Single-patient EA studies have included AMDC for the treatment of esophageal aperistalsis and AMDC for the treatment of underactive bladder