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Humacyte intends to use the net proceeds for the clinical development of HAV (human acellular vessel) for the treatment of arterial repair following extremity vascular trauma.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: HAV
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: TD Cowen
Deal Size: $40.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 29, 2024
Details:
HAV (human acellular vessel) is a sterile acellular tubular graft composed of human collagen types I and III & other extracellular matrix proteins, including fibronectin and vitronectin. It is under development for patients with life or limb threatening vascular trauma.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: HAV
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2024
Details:
Company submitted a Biologics License Application (BLA) to USFDA for its RMAT designated product, Human Acellular Vessel, meant for the treatment of vascular trauma.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: V005
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2023
Details:
Human Acellular Vessel (HAV) in establishing vascular access and plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2023
Details:
Human Acellular Vessel (HAV) is the off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
Human Acellular Vessel (HAV) is the off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2023
Details:
The financing will be used to support planned development and commercialization of Humacyte’s Human Acellular Vessel™ (HAV™) for use in urgent arterial repair following extremity vascular trauma and earlier-stage product candidates.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Oberland Capital
Deal Size: $160.0 million Upfront Cash: $40.0 million
Deal Type: Financing May 12, 2023
Details:
U.S. Food and Drug Administration’s (FDA’s) granted regenerative medicine advanced therapy (RMAT) designation for its human acellular vessel (HAV) for urgent arterial repair following extremity vascular trauma.
Lead Product(s): Human Acellular Vessel
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: V005
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2023
Details:
Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.
Lead Product(s): Human Acellular Vessels
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2023
Details:
Human Acellular Vessels (HAV) are investigational engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. It is currently being developed for vascular trauma.
Lead Product(s): Human Acellular Vessels
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
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