Humacyte Reaches Milestone: Completion of Enrollment for Revolutionary HAV™ Trial in End-Stage Renal Disease Patients!

V007 is a groundbreaking Phase 3 trial that is set to revolutionize dialysis for those suffering from ESRD in the United States. 240 patients were randomly assigned to either a HAV or an AV fistula. The trial is set to evaluate the usability of the conduit for dialysis at six and 12 months, as well as compare the secondary patency of both options at 12 months. Additionally, the trial is set to track the rate of dialysis-related infections in both groups. This innovative trial is sure to make a huge impact in the world of dialysis.

Humacyte, Inc., a clinical-stage biotechnology platform company, is celebrating a major breakthrough in their groundbreaking Phase 3 trial, the V007 Trial. This trial is evaluating the potential of their Human Acellular Vessel (HAV) to provide vascular access for end-stage renal disease patients requiring hemodialysis.

It will compare its performance to the traditional autogenous arteriovenous (AV) fistulas. This trial marks a crucial step in Humacyte’s mission to develop universally implantable bioengineered human tissue on a commercial scale.

Humacyte is on the brink of revolutionizing dialysis treatment for patients with its regenerative medicine technology. With the completion of its Phase 3 trial, Humacyte is edging closer to its goal of providing vascular access for dialysis patients that can be used quickly after implantation and diminish the need for catheter-based treatments.

The potential of this technology to improve the quality of care for nephrology patients, as well as reduce the failure rate and risk of infection associated with current AV access options, is immense. Chief Medical Officer Shamik Parikh MD is confident that Humacyte is paving the way for a brighter future for dialysis care.

Nearly 786,000 Americans are living with a life-threatening condition known as End-Stage Renal Disease (ESRD). This disease is the result of prolonged and severe damage to the kidneys, causing them to become unable to adequately filter waste from the bloodstream.

To keep these individuals alive, dialysis treatments or a kidney transplant are needed. During dialysis, the patient’s blood is cycled through a dialysis machine, with a durable point of access to the patient’s circulatory system allowing for the efficient transfer of large volumes of blood.

The current standard of care for establishing vascular access has significant risks and shortcomings, with catheters tunneled beneath the skin exhibiting high rates of bloodstream infection and autogenous AV fistulas exhibiting a high rate of early maturation failure.

This leaves many patients to rely on infection-prone catheters for far longer than desired and unable to benefit from the creation of fistulas due to small vessel anatomy, advanced age, obesity, or other comorbidities. A much-needed solution is needed in order to provide safe and reliable vascular access for all patients.

Humacyte’s HAV is designed to revolutionize the way dialysis patients access their treatment. This tissue-engineered vascular conduit is implantable and resistant to infection, and has been scientifically proven to combine with a patient’s own cells to create a living blood vessel.

With the HAV, dialysis access is achieved faster and with less risk of infection than traditional AV fistula procedures. This remarkable breakthrough has the potential to transform the lives of patients around the world.

Dr. John Lane, a vascular surgeon at VA San Diego and V007 investigator, is enthusiastic about the use of Human Acellular Vessels in the VA population. Through the clinical trial, he is able to provide patients with the most advanced technology, offering a glimpse into the exciting innovations that lay ahead for hemodialysis access.

Humacyte is paving the way for expanded hemodialysis treatment options with the launch of its Phase 3 V007 trial. This trial builds upon the Company’s impressive clinical trial history, which includes receiving the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation in 2017 and a FDA Fast Track designation in 2014 for its innovative 6mm HAV for AV access for hemodialysis product. Humacyte is determined to revolutionize the hemodialysis field with its cutting-edge technology.

The HAV is an exciting new product that has the potential to revolutionize healthcare, but is still awaiting approval from the FDA and other regulatory agencies. With its potential for transformative change, this investigational product is sure to be one to watch!

About Humacyte

Humacyte, Inc., listed on the Nasdaq as HUMA, is revolutionizing the medical world with its biotechnology platform designed to deliver implantable human tissues, advanced tissue constructs, and organ systems. The company is developing a portfolio of Human Acellular Vessels (HAVs) to treat a variety of diseases, injuries, and chronic conditions.

The 6mm HAV product is the first to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, as well as Fast Track designation, and Priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. With these regulatory achievements, Humacyte is leading the way in providing innovative solutions to improve the quality of life for patients worldwide.

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