Humacyte, Inc.

Improving Lives Through HAVs

The existing treatment options to replace and repair blood vessels include use of autologous vessels and synthetic grafts. Autologous vessels are associated with extensive surgical wounds caused by harvesting veins for the procedure and prolonged periods before proper blood flow is restored to the injured limb, while synthetic graphs have a higher risk of infection that leads to longer hospitalizations and eventual limb loss. Human acellular vessels, or HAVs, are human vascular tissues designed to be implanted into any patient and they are believed to offer substantial benefits over these traditional treatment options. They are actual human tissues that replicate key aspects of human physiology to prevent the body from initiating a negative foreign body response or immune rejection.

Humacyte develops HAVs of various diameters and lengths from its working cell stock of human aortic vascular cells, which are derived from donor aorta tissues and cryopreserved. Humacyte then expands its cell stock and transfers the cells onto a biodegradable polymer mesh in the shape of a tube where the cells proliferate into a cell-composed conduit over the course of a few weeks. The end result is a bioengineered vessel that retains the biomechanical properties of human aorta cells without any additional components that could generate a negative response when implanted into the body. Humacyte HAVs can be used efficiently in any medical setting as they are ready for immediate patient use after removal from refrigeration and packaging.

Humacyte undertakes its proprietary HAV manufacturing process in its own established manufacturing facility. The company has developed the LUNA200 system, which is capable of manufacturing 200 HAVs per batch. The FDA has already approved the HAVs developed from the LUNA200 in the clinical trial setting. If Humacyte’s HAVs are approved for commercial treatment, the company can scale its current manufacturing facility to 40 LUNA200 systems to meet market demand for the product.

Humacyte HAVs have already been implanted in nearly 500 patients over the span of 9 years, with zero instances of clinical rejection. Furthermore, obtained clinical samples have shown that the HAVs actually become populated with healthy vascular cells from the patient, proving acceptance by the body. Humacyte HAVs are currently undergoing clinical trials for three medical indications. Beyond vascular issues, Humacyte is also exploring the application of its HAVs in other medical scenarios, like pediatric heart surgery, delivery of cellular therapies, and development of urinary, trachea, esophagus conduits.

Humacyte HAVs for Trauma

Vascular trauma can occur in both military settings and civilian populations, most commonly by motor vehicle accident, gun violence, stabbings, and blunt trauma. These types of arterial injuries frequently result in the loss of limb or death. Humacyte has developed a strong working relationship with the US Department of Defence (DoD) and has even received a $7 million grant to develop its HAV technology for use in the resource-limited, time-constrained battlefield environment. HAVs for vascular trauma are currently undergoing phase 3 clinical trials.

Humacyte HAVs for Arteriovenous Access for Hemodialysis

Hemodialysis is a procedure where a dialysis machine and an artificial kidney are used to clean your blood and is often used during kidney transplant. Hemodialysis requires a point of vascular access to be conducted, so the patient's blood can be transported between their circulatory system and the artificial kidney. The three traditional methods for this vascular access include a catheter, an AV fistula, and a synthetic graft, all of which have their own substantial limitations. HAVs for arteriovenous access for hemodialysis have shown promising results over the long-term, with below a 1% infection rate during the procedure and favorable results compared to the alternative methods. HAVs for arteriovenous access are currently in phase 3 clinical trials.

Humacyte HAVs for PAD

Peripheral arterial disease, or PAD, is a common condition in which narrowed arteries reduce blood flow to the arms or legs. PAD affects 6.5 million people aged 40 and older in the United States. Humacyte is currently continuing long-term follow ups of its phase 2 trial on HAVs for PAD. So far, follow ups on clinical trial patients found implanted HAVs to be mechanically stable and functioning well overall.

Operational Overview

Humacyte has not yet received commercial approval for its HAV technology in any medical indication and therefore has generated no revenue from the sale of commercial products. The company has primarily funded operations through the sale of equity securities, convertible debt, and government grants. Outside of future anticipated product sales, Humacyte plans to potentially generate revenue from licensing payments, grants, or further collaboration agreements.

Humacyte has a distribution agreement in place with Fresenius Medical Care, whereby Humacyte granted Fresenius Medical Care and its affiliates exclusive rights to develop its 6 millimeter x 42cm HAV outside of the United States and European Union. Humacyte has a revenue share agreement in place with Fresenius Medical Care for sales within the United States, and Fresenius will pay Humacyte a fixed dollar amount per unit for sales outside the United States.

Conclusion

Humacyte’s proprietary technology platform and HAV development infrastructure have enormous potential in improving treatment of not just vascular conditions, but a wide array of medical procedures. The company’s technology is protected by its patent portfolio of 15 patent families and it has even received backing from major institutions like the Department of Defence, National Institute of Health, and the California Institute of Regenerative Medicine. Although Humacyte has accumulated a hefty deficit since its inception in 2004, the company appears on the verge of moving its HAV products into commercial use. If approved, Humacyte’s HAVs could substantially enhance treatments and procedures where conduits are necessary to increase patient healthspan and improve longevity.