Favorable Clinical Results Are a Significant Demonstration of ATEV's Potential in Hemodialysis; Supplemental BLA Should Follow

Research evidence excerpt

Favorable Clinical Results Are a Significant Demonstration of ATEV's Potential in Hemodialysis; Supplemental BLA Should Follow

KOL Feedback on V012 Results

■ KOL feedback: Dr. Mohamad A. Hussain, a lead investigator in the V012 trial, provided highly positive feedback on HUMA's

off-the-shelf ATEV. From a surgeon's perspective, he echoed the ATEV as being easy to handle and closely mimicking the feelMEDICAL of a native blood vessel. Clinically, he emphasized that the ATEV seamlessly integrates with patient tissue without triggering

immune rejection, which drastically reduces infection risks and catheter dependence compared to traditional synthetic grafts.

He highlighted this as a major breakthrough for high-risk populations prone to fistula failure, such as women, the elderly,

and diabetic or obese patients. HUMA also noted that unlike synthetic alternatives, the ATEV does not dilate or become

aneurysmal over time. This is important because it protects the patient's heart function and preserves their eligibility for

potential future kidney transplants, making ATEV a superior option for both elective and urgent dialysis access procedures.

■ Generalizing V012 results: Dr. Hussain characterized V012 as the next layer of evidence on top of an already robust body

of data. He noted that V007 enrolled all comers including men, and was also positive for the ATEV, with subgroup analysesTECHNOLOGY

showing particular benefit in high-risk males with obesity and diabetes. V012 now provides Level A evidence specifically in

women, and he expressed comfort applying the data broadly to high-risk patients regardless of gender.

■ Regulatory package and FDA interactions: Mgmt.