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Humacyte Secures New Patent Protection Until 2043
Humacyte announced the issuance of a new U.S. patent covering key aspects of the manufacturing, sterilization, storage and shipping of Symvess and other bioengineered human tissues. U.S. Patent No. 12,742,144, titled "Systems, Devices and Methods for Engineered Tissue Construct Transport and Containment" provides protection into 2043 and complements a family of existing patents and patent applications encompassing the design and composition of Humacyte's products and their methods of manufacture.
Humacyte's Symvess Hospital Orders Increase by 44%
Humacyte provided a commercial update highlighting increasing momentum in the launch of Symvess, its FDA-approved acellular tissue engineered vessel for vascular trauma. The number of hospitals that have ordered Symvess increased by 44% during Q3, from 34 hospitals at the end of Q2 to 49 hospitals as of September 30, showcasing the potential to surpass Humacyte's goal of adding 20 new hospitals by year-end. Commercial sales accelerated, as new hospital ordering activity increased sequentially each month of Q3.
Humacyte Adds Scott Coward and Paul Kuznik to Board of Directors
Humacyte announced the addition of Scott Coward and Paul Kuznik to the Company's Board of Directors. Scott Coward served as Executive Vice President, Chief Legal Officer, Chief Administrative Officer and Secretary of Exact Sciences Corporation from January 2015 to December 2022. Paul Kuznik served as the Chief Executive Officer and a member of the Board of Directors from 2015 to 2018 at Bolton Medical
Humacyte Receives FDA Approval for Symvess Expiration Extension to 36 Months
Humacyte announced that the FDA has authorized an extension of the expiration dating period for Symvess from 18 months to 36 months when stored refrigerated at 2 degrees C to 8 degrees C. The expiration dating extension is supported by additional stability data demonstrating that Symvess continues to meet all established product quality specifications throughout the extended 36-month dating period when stored under approved conditions. The extended shelf life helps hospitals keep Symvess on hand for urgent vascular repairs while simplifying inventory planning and reducing product waste.
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.
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