Humacyte ( HUMA Quick Quote HUMA - Free Report) rose almost 13% on Apr 11, post the completion of patient enrollment in the phase III, V007 clinical study on the human acellular vessel (HAV) product.
The study aims at providing vascular access in hemodialysis patients with end-stage renal failure. It also focuses on assessing the efficacy and safety of HAV in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) compared to autogenous arteriovenous (AV) fistulas.
The abovementioned study enrolled 240 hemodialysis patients in the United States. Its efficacy assessments include the conduit’s usability for dialysis at six and 12 months, and a comparison of secondary patency evaluated at 12 months.
The rate of dialysis-related infections in both HAV and fistula subjects will also be tracked as a secondary endpoint.
If the HAV proves safe and effective, it can transform the way nephrologists treat their patients and substantially reduce the risk of infections.
Shares of Humacyte have plunged 46.6% in the past year compared with the
industry's 15% decline. Image Source: Zacks Investment Research
ESRD is a disease that develops when chronic kidney disease progresses to a point where either dialysis or a kidney transplant is required for survival. Dialysis treatments involve transferring a large volume of blood to the dialysis machine and then sending it back to the patient’s body. This whole process requires a durable point of access to the patient's circulatory system.
However, the current standard of care for establishing vascular access bears significant risks and shortcomings. Catheters have high bloodstream infection rates, while autogenous AV fistulas exhibit a high rate of early maturation failure. This forces patients to rely longer on infection-prone catheters.
The HAV is a universally implantable, durable tissue-engineered vascular conduit that is observed over time to combine with the patient's cells to create a living blood vessel. It is designed to be highly resistant to infection. This conduit can potentially be used for dialysis more rapidly after implant, resulting in reduced time on catheters and lower potential risks for patients.
The completion of the phase III, V007 clinical study enrollment is a significant milestone for the company as it brings it closer to its goal of providing better vascular access for dialysis patients.
Zacks Rank & Stocks to Consider
Currently, Humacyte has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are
CRISPR Therapeutics ( CRSP Quick Quote CRSP - Free Report) , Kala Pharmaceuticals ( KALA Quick Quote KALA - Free Report) and Allogene Therapeutics ( ALLO Quick Quote ALLO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
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