Humacyte, Inc., a clinical-stage biotechnology platform company (NASDAQ: HUMA), has completed enrollment of its Phase 2/3 vascular trauma trial, taking a monumental step forward toward potentially bringing its breakthrough HAV regenerative medicine product candidate to market. HAV is an off-the-shelf bioengineered human artery designed to repopulate with the patient’s own cells, providing a infection-resistant replacement for damaged or diseased arteries.
If successful, healthcare professionals worldwide could have the potential of restoring life and limb in even the most dire of circumstances, possibly becoming the gold standard for vascular trauma repair. The results from the Phase 2/3 trial are anticipated to serve as the basis for a FDA filing, slated for the fourth quarter of 2023.
Humacyte is on a mission to make a difference in the lives of patients suffering from vascular trauma with its V005 trial. The groundbreaking single-arm, open-label study is being conducted at Level 1 Trauma Centers in the U.S. and Israel, with the primary efficacy assessment based on a 30-day HAV patency (presence of blood flow) compared to literature benchmarks.
The Company is diligently working towards the locking of the trial database for reporting the trial results, with a goal of complete progress and top-line results before the end of the third quarter 2023.
Humacyte is revolutionizing the ability to save lives and limbs through their development of the HAV! The completion of the Phase 2/3 vascular trauma trial marks an important and groundbreaking moment in modern medicine, providing potential treatment options for patients who may be facing loss of life or limb, for whom current therapies are either inadequate or unavailable. With the successful enrollment of the trial, BLA submission is now expected, meaning that this life-saving technology is closer to being accessible for all.
Treating the traumatic injuries suffered in car accidents and gunshot wounds can be an immensely challenging task, especially due to the need for immediate treatment to avoid life-threatening complications.
The removal of a vein from the leg of the patient is usually the only available course of action, but this can add precious time in an emergency situation and requires a highly-trained surgeon to perform the procedure.
Moreover, the process of cutting into the leg can cause significant pain and wound complications. Off-the-shelf products like plastic vessel grafts are often used, but their poor infection resistance can put the patient’s health at risk. Fortunately, there are better alternatives which can greatly improve the safety and efficacy of trauma care in such cases.
Humacyte’s HAV offers a groundbreaking way to treat traumatic injuries. This revolutionary, bioengineered human artery is universally implantable, available to the surgeon immediately, and eliminates the need to harvest and repurpose a vein.
Clinical results show it is highly infection-resistant and since it is crafted from the same tissue as natural human vessels, it has the potential to repopulate with the patient’s own cells. On top of that, commercial scale production capabilities mean its potential to aid in saving lives is immense. With the HAV, time and complications can be saved while severely injured patients are treated.
Humacyte recently completed enrollment for its V005 study, which is intended to support its breakthrough BLA filing with the FDA for treating serious extremity vascular trauma. Having secured the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for its HAV therapy in May 2023, the collaboration between Humacyte and the FDA is now closer than ever – increasing the possibility of receiving a priority review of the BLA when it is finally filed.
With 68 patients receiving the HAV in the V005 trial, and 51 of them primarily suffering from extremity vascular trauma, Humacyte is confident that this revolutionary therapy will see success in the near future.
The V005 trial has proved the efficacy of the Hemodynamic Augmentation Valve (HAV) as a successful treatment for vascular trauma and other conditions, already treating 19 patients in Ukraine’s ongoing war with a high rate of favorable outcomes.
With more than 1,000 patient-years of experience in clinical trials across multiple indications, the HAV is gaining a strong case for FDA approval, the data from the Ukraine humanitarian program of which is being included in the submission.
The HAV is an incredible, groundbreaking product—but it still needs to be reviewed and approved by the FDA and other regulatory agencies before it can be released for sale. Its potential to revolutionize the industry is undeniable, and everyone is eagerly awaiting its arrival on the market.
Humacyte, Inc., proudly listed on the Nasdaq stock market as HUMA, is revolutionizing biotechnology with its groundbreaking platform to offer universally implantable bioengineered human tissues, cutting-edge advanced tissue constructs, and organ systems to improve the quality of life of patients across the globe.
With its pioneering acellular tissues to treat myriad diseases, injuries, and chronic conditions, Humacyte has advanced to late-stage clinical trials featuring its ambitious HAV portfolio – addressing a variety of vascular applications, such as trauma repair, AV access for hemodialysis, and peripheral arterial disease.
Humacyte is also pushing limits further by venturing onto uncharted research grounds like coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatments, and a myriad of other cell and tissue applications.
The 6mm HAV for AV access in hemodialysis has earned the distinction as the first product candidate to earn FDA’s RMAT (Regenerative Medicine Advanced Therapy) designation, with additional FDA Fast Track recognition.
The 6mm HAV for urgent arterial repair following extremity vascular trauma has, furthermore, been granted the prestigious RMAT designation. Such a feat has bestowed Humacyte the humble honor to receive priority designation from the