U.S. Kidney Patients Help Drive Care Innovation Patient insights Accelerate Research and Development

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Washington, D.C. – The largest and oldest, fully independent kidney patient organization in the U.S., the American Association of Kidney Patients (AAKP), recently highlighted its developmental collaboration with Humacyte on vascular access patient quality of life measures as an example of how kidney patient insights are revolutionizing innovation and business development in the renal disease field.

Humacyte is a leading innovator within vascular access for patients with End Stage Renal Disease (ESRD) who require dialysis as a life-sustaining treatment and has received international attention and interest for development of its investigational human acellular vessel – HUMACYL®. Currently being studied in trials in the U.S., Europe, and Israel, HUMACYL vessels are created in vitro from donated human smooth muscle cells, which grow around a tubular scaffold made from biodegradable suture material. The cells then generate collagen to form the vessel, and are then removed at the end of the process to avoid triggering an immune response. Humacyte and Fresenius Medical Care AG (FME.XE) recently announced a strategic global partnership, and Fresenius made a $150 million equity investment in Humacyte.

Paul T. Conway, president of AAKP, stated, “AAKP has a uniquely large and diverse membership and our private sector engagement strategy over the past several years is aimed to directly impact both innovation and policy, especially through our Center for Patient Research and Education. Our technical capacities to leverage patient insights help companies like Humacyte speed innovation and that results in potentially higher quality care choices for patients and the creation of high tech jobs.” Conway is a former Chief of Staff of the U.S. Department of Labor and has managed kidney disease for over thirty-seven years.

Theodore D. Lithgow, Ph.D., chief operating officer of Humacyte added, “We are grateful for the work of AAKP, to better equip companies like Humacyte in the development of patient-focused innovations, through their real-life, day-to-day patient insights. Through a strategic alliance with AAKP, our entire development, regulatory, and reimbursement functions are now closer to addressing the unmet medical needs of many patients suffering from ESRD. Listening to the voice of the patient is critical for the entire healthcare system. These unique insights have allowed us to significantly enhance the developmental cycle and help bring us closer to commercialization of our investigative HUMACYL product to patients.”

Diana Clynes, Executive Director of AAKP, stated, “This is a promising development for individuals with kidney disease that may progress to dialysis since a vascular access is a patient’s lifeline, and new options that may reduce the potential for infection and other access complications is significant.”

About AAKP:
Founded in 1969, AAKP is the largest and oldest, fully independent kidney patient organization in America. Governed by a patient-majority Board of Directors, AAKP conducts national education programs designed to better inform kidney patients, care-givers and policy-makers about the true impacts of kidney disease, prevention efforts and treatment methods. AAKP executes a national advocacy strategy in conjunction with allied kidney organizations designed to insert the patient voice into proposed policies, research efforts and care deliberations before the Executive Branch and the U.S. Congress. The organization website is www.aakp.org.

About Humacyte:
Humacyte, Inc., a privately held company founded by Dr. Laura E. Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.

All statements, other than statements of historical fact, included in this announcement are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “will”, “anticipate”, “expect”, “believe”, “intend” and “should” or the negative of these terms or other comparable terminology. These statements relate to future events or Humacyte’s clinical development programs, reflect management’s current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Humacyte’s actual results, performance or achievements to be materially different. Except as required by law, Humacyte assumes no obligation to update these forward-looking statements.