Humacyte, Inc. (NASDAQ: HUMA)

Humacyte, Inc., trading under the symbol HUMA, is a biotechnology company that specializes in the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs, and organ systems. The company's regenerative medicine technology holds the potential to surpass limitations in existing standards of care and address the dearth of significant innovation in products that aid tissue repair, reconstruction, and replacement.

Humacyte's primary business activities revolve around the use of proprietary scientific technology to create bioengineered human tissues known as HAVs (Human Aortic Vascular). These tissues are designed to provide an effective solution in all time-constrained surgical environments and in resource-limited, infection-prone battlefield conditions. The company's operations span across the United States, with clinical trials and implantations also taking place in seven other countries.

The company generates revenue through the provision of its HAVs, which are manufactured using a proprietary scientific technology platform. This platform utilizes primary human aortic vascular cells from a working cell stock, isolated from donor tissues and cryopreserved. The HAVs have been implanted in approximately 573 patients, across various clinical trials and studies, for a total of more than 945 patient-years of exposure, as of December 31, 2023. Throughout these trials, Humacyte has observed consistent and sustained high primary patency rates, ranging from 95% to 100% at 30 days. Secondary patency of the HAV at 6 months ranges from 84% to 100%.

Humacyte's HAVs have been shown to have a low infection susceptibility during use for hemodialysis, with a rate lower than 1% per patient-year across all studies. This low infection susceptibility may be a result of the HAV's potential to become a living tissue as it becomes populated by cells from the patient's body.

In terms of competition, Humacyte stands as a pioneer in the field of off-the-shelf, universally implantable, bioengineered human tissues. While there may be other companies operating in the broader field of biotechnology and regenerative medicine, Humacyte's specific focus and proprietary technology set it apart.

The company's HAVs have been used in various clinical trials and studies, including a study in up to 30 patients with chronic limb-threatening ischemia (CLTI) at the Mayo Clinic. The study reported interim results, including the conclusion that the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage. Of the 29 patients enrolled, 97% had previously experienced unsuccessful revascularization procedures on the extremity, and 21 (72%) had tissue loss or gangrene. At a median follow-up of nine months, the secondary patency rate for patients implanted with the HAV was 97%.

In addition to its HAV products, Humacyte is also developing its 6 millimeter HAV for use as a bypass conduit for patients with peripheral arterial disease (PAD). The company has conducted two Phase 2 trials to evaluate the safety and efficacy of its 6 millimeter HAV for use as a bypass conduit with PAD. In both trials, Humacyte's HAVs were implanted as a femoral-popliteal bypass graft in patients with PAD. The company has observed strong patency rates and no reported cases of infection for the HAV in PAD in clinical studies to date.