Expanded Access

Merakris Therapeutics is seeking to improve healing outcomes of cutaneous wounds using cell-free, subcutaneous injectable biologic therapy under its investigational new drug, Dermacyte® Liquid. We engage with healthcare professionals to learn from their experiences in advanced wound care therapies to guide our work.

We are committed to scientific advances in regenerative medicine through well-designed clinical development programs, to evaluate the safety and efficacy of Dermacyte Liquid, while minimizing safety risks to patients. Our clinical trials aim to establish the safety and effectiveness of our drug product, Dermacyte Liquid, with the goal of supporting a marketing approval from regulatory health authorities to make cutaneous wound healing treatments broadly available to the patients world-wide.

We recognize that some patients with serious or life-threatening conditions will not qualify for our Dermacyte Liquid clinical trial and may seek access to this investigational medicine, also known as Expanded Access. While participation in clinical trials is our preferred way for patients to gain access to Dermacyte Liquid investigational therapy, Expanded Access requests will be considered in situations according to available guidelines from regulatory authorities including, but not limited to, the following criteria:

• The condition or disease for which the product is being requested for use is serious, irreversibly disabling or immediately life-threatening and there are no available alternative treatments for the patient.
• The patient is not eligible for an ongoing or planned Merakris Therapeutics-sponsored clinical trial of the investigational product for their condition.
• The request for expanded access has been made by a qualified and licensed physician with capabilities to monitor, manage and report side effects of the therapy as well as patient experience.
• There is sufficient evidence of safety and at least preliminary clinical evidence of efficacy or pharmacologic effect for the investigational product, and the potential benefits to the patient outweigh the potential risks.
• There is adequate supply of the Dermacyte Liquid to support our ongoing clinical trials.
• The patient is willing to travel to a Merakris Therapeutics-approved clinical trial site or the treating physician is qualified and agrees to comply with Merakris’ clinical trial procedures and policies, including completion of a clinical trial agreement and applicable Statement of Investigator, Form FDA 1572.
• Providing expanded access to the investigational product is not expected to adversely interfere with or compromise the clinical development process.
• The patient meets any other relevant medical criteria for expanded access to the investigational product, as determined by Merakris Therapeutics.

Complete requests for expanded access will be evaluated in a fair, equitable manner; however, Merakris Therapeutics cannot guarantee that Dermacyte Liquid will be available to a specific patient. Any expanded access will be subject to local laws or regulations, and the patient must provide informed consent. Approval of requests for Expanded Access must be obtained from the applicable regulatory health authority and Institutional Review Board or Ethics Committee.

Further information on available Dermacyte Liquid clinical trials can be found at the U.S. Government’s website for clinical trials, www.clinicaltrials.gov. Requests for information on expanded access to investigational products must be made by a licensed physician and may be submitted to MedicalAffairs@Merakris.com. It is anticipated the acknowledgement of any expanded access questions or requests will be made by a Merakris Therapeutics representative within five (5) business days of receipt. Merakris Therapeutics reserves the right to revise this policy at any time, in accordance with the 21st Century Cures Act.