Noticias y eventos de Humacyte Inc (HUMA)HUMAHumacyte Inc

Humacyte to File Supplemental BLA for ATEV in November

Humacyte announced that recent discussions with the FDA confirm the company's plans and expectations for filing a supplemental biologic license application, or BLA, with the FDA for the acellular tissue engineered vessel, or ATEV, in dialysis access. Humacyte expects to file the supplemental BLA during November, seeking to add dialysis access as the second approved indication for the ATEV after its December 2024 FDA approval in the vascular trauma indication.

Humacyte Publishes One-Year Results of V007 Clinical Trial

Humacyte announced the publication of one-year results from the V007 Phase 3 clinical trial of the acellular tissue engineered vessel in arteriovenous access for hemodialysis patients in The Lancet Digital Health. The publication, titled "A Multi-center Randomized Trial of a Bioengineered Acellular Tissue Engineered Vessel versus Autogenous Fistula for Hemodialysis Access," demonstrates the findings from Humacyte's V007 trial, previously presented at major medical conferences, showing the superiority of the ATEV over autogenous arteriovenous fistula for hemodialysis vascular access after one year of follow up, particularly for all female patients and male patients with obesity and diabetes, groups that often face higher rates of AVF failure.

Humacyte Q2 Revenue $406K, Below Consensus $1.11M

Reports Q2 revenue $406,000, consensus $1.11M. "Our second quarter and recent weeks have been a transformative period for Humacyte and our pipeline expansion, led by the presentation of breakthrough top-line interim results from our V012 Phase 3 trial in female dialysis access patients at the Society of Vascular Surgery's Vascular Annual Meeting in Boston," said Laura Niklason, Founder and Chief Executive Officer of Humacyte. "Results from this trial exceeded our expectations, and our acellular tissue engineered vessel outperformed autologous arteriovenous fistula, the current standard of care for patients on dialysis. We look forward to using this data to file a supplemental BLA with the FDA later this year. We are also pleased that the FDA recently accepted our Investigational New Drug application for our coronary tissue engineered vessel, and plan to initiate a Phase 2a study in coronary artery bypass grafting during the third quarter. No new off-the-shelf conduits have been introduced for CABG in the past 40 years, and our preclinical results suggest that the CTEV may be a promising off-the-shelf alternative to saphenous vein grafts in CABG."