Humacyte Presents Positive Long-Term Results of ATEV™ in Treatment of Vascular Trauma in Military Setting from Ukraine Humanitarian Program

Rhea-AI Summary

Humacyte (Nasdaq: HUMA) presented positive long-term results from a humanitarian program in Ukraine using their investigational acellular tissue engineered vessel (ATEV) to treat vascular injuries. The study, known as the 'V017 trial', showed high rates of patency and avoidance of amputation and infection in severe wartime injuries.

Key findings include:

• 12-month primary and secondary patency rates of 87.1%
• Zero instances of ATEV infections, amputations, or deaths
• Mean follow-up duration of 357.9 days
• Only one event of ATEV thrombosis after month six
• No reports of ATEV aneurysm or pseudo-aneurysm

The ATEV is designed as an off-the-shelf, universally implantable vascular conduit for arterial replacement, repair, and hemodialysis access. It is still investigational and not yet approved for sale by the FDA or other regulatory agencies.

Positive

• High 12-month patency rate of 87.1% for ATEV in vascular trauma treatment
• Zero instances of infection, amputation, or death during long-term follow-up
• ATEV showed potential as an off-the-shelf alternative to autologous veins in combat settings
• Reduced time of acute ischemia following injury, potentially improving limb salvage rates
• ATEV demonstrated excellent immunological and infection resistance in combat injuries

Negative

• One event of ATEV thrombosis occurred after month six
• ATEV is still an investigational product, not yet approved for sale by FDA or other regulatory agencies

Medical Research Analyst

The long-term results from Humacyte's humanitarian program in Ukraine demonstrate promising outcomes for their investigational acellular tissue engineered vessel (ATEV) in treating severe vascular trauma. The 12-month patency rate of 87.1% is impressive, especially considering the challenging wartime conditions. Notably, there were zero instances of infection, amputation, or death during the follow-up period, which is remarkable given the severity of injuries (mean Injury Severity Score of 20.1).

The ATEV's performance in high-risk scenarios, including mine blasts and high-velocity ballistics, suggests potential for widespread application in combat medicine. The absence of ATEV-related infections and the low rate of complications (only one thrombosis event after six months) indicate a favorable safety profile. These results could position ATEV as a game-changing alternative to autologous vein grafts in trauma settings, potentially reducing surgical time and improving outcomes.

Vascular Surgeon

As a vascular surgeon, I'm particularly impressed by the ATEV's performance in this challenging military setting. The 87.1% 12-month patency rate is comparable to, if not better than, many autologous vein grafts in similar high-risk scenarios. The absence of infections is crucial, as post-traumatic vascular graft infections can be devastating.

The off-the-shelf availability of ATEV could be a significant advantage in trauma situations, potentially reducing ischemia time and improving limb salvage rates. However, it's important to note that while these results are promising, they come from a small sample size (16 patients). Larger, randomized controlled trials will be necessary to confirm these findings and establish ATEV as a standard of care in vascular trauma management.

Biotech Industry Analyst

From an investment perspective, these results are highly encouraging for Humacyte (Nasdaq: HUMA). The positive long-term data in a real-world, high-stakes environment significantly de-risks the ATEV technology and could accelerate its path to market. The potential applications in both military and civilian trauma care represent a substantial market opportunity.

Key factors that could drive Humacyte's value include:

• Potential for expedited regulatory approval given the unmet need in trauma care
• Scalability of the bioengineered tissue platform for other applications
• Possible interest from larger medical device or biotech companies for partnerships or acquisition

However, investors should be aware that as an investigational product, ATEV still faces regulatory hurdles. The company's ability to scale production and navigate the complex healthcare reimbursement landscape will be critical for commercial success.

- Results presented at the Department of Defense’s Military Health System Research Symposium (MHSRS) -

- In real-world military setting the ATEV was observed to have 12-month patency of 87.1% -

- There were zero instances of infection, amputation or death during the long-term follow-up period despite the severity of the wartime injuries treated -

DURHAM, N.C., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, yesterday presented positive long-term results from a humanitarian program conducted in Ukraine under which the investigational acellular tissue engineered vessel (ATEV) was used to treat vascular injuries suffered during the ongoing conflict. Long-term follow-up results were presented for the first time and showed high rates of patency (blood flow) and the avoidance of amputation and infection despite the severe nature of the wartime injuries treated. The results were presented at the Military Health System Research Symposium (MHSRS), the U.S. Department of Defense’s foremost scientific meeting, held in Kissimmee, Florida.

The presentation highlighted the results for 16 extremity patients treated in Ukraine who provided consent for use of their results, a set of data known as the “V017 trial.” The primary analyses for the V017 trial were at 30 days of follow up, and as previously reported the rate of success for treatment of patients with the ATEV at this time point was high with primary and secondary patency of 93.8%, zero amputations, and zero cases of infection of the ATEV. Longer-term results for the V017 patients were presented for the first time at the MHSRS meeting, with a mean follow-up duration of 357.9 days. Kaplan-Meier estimates of 12-month primary and secondary patency both were 87.1%. There were no instances of ATEV infections, amputation of affected limbs, or deaths related to ATEV through the end of long-term follow-up. There was one event of ATEV thrombosis after month six. There were no reports of ATEV aneurysm or pseudo-aneurysm. These results were achieved despite the fact that all patients had a high risk of wound infection and were severely injured, with a mean Injury Severity Score (ISS) of 20.1. Patients treated with the ATEV included those injured due to mine blasts, shrapnel and high velocity ballistics.

“We are pleased that the long-term results in a military setting are consistent with the 30-day results previously observed and support the potential durability of the ATEV in vascular trauma patients,” said Shamik Parikh, M.D., Chief Medical Officer of Humacyte. “For repair or reconstruction of traumatic vascular injuries when autologous veins are not feasible, the ATEV may offer combat surgical teams an off-the-shelf and universally implantable alternative that has shown extremely low rates of infection, potentially offering durable performance and help with limb salvage.”

“We are very grateful for the invaluable support during this difficult time,” said Oleksandr Sokolov, M.D., Ph.D., a Ukrainian vascular surgeon who treated patients with the ATEV under the humanitarian program. “The ATEV implantations performed for those wounded by blast injuries have significantly reduced the time of acute ischemia following injury, which has a positive impact on the preservation of lives and limbs. These implantations are quicker due to the absence of the need for vein harvesting for graft preparation and have excellent immunological and infection resistance, making them particularly effective in the context of combat injuries.”

The ATEV is an investigational, first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair, and for use as hemodialysis access. While harvesting vein from a trauma patient requires critical surgical time, the ATEV is designed to be available off-the-shelf. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the outcome of the FDA’s review of our BLA seeking approval of the ATEV in the vascular trauma indication; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, the anticipated characteristics and performance of our ATEV; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com

FAQ

What were the key results of Humacyte's ATEV trial in Ukraine for vascular trauma treatment?

Humacyte's ATEV trial in Ukraine showed a 12-month patency rate of 87.1%, with zero instances of infection, amputation, or death during long-term follow-up. The mean follow-up duration was 357.9 days, and only one event of ATEV thrombosis occurred after month six.

How does Humacyte's ATEV compare to traditional vein grafts in treating vascular trauma?

Humacyte's ATEV is designed as an off-the-shelf alternative to autologous vein grafts, potentially reducing surgical time and offering excellent immunological and infection resistance. It has shown promising results in treating severe wartime vascular injuries, with high patency rates and low complications.

What is the current regulatory status of Humacyte's ATEV (HUMA)?

Humacyte's ATEV (HUMA) is currently an investigational product and has not been approved for sale by the FDA or any other regulatory agency. It is being studied for use in arterial replacement, repair, and hemodialysis access.

What types of injuries were treated with Humacyte's ATEV in the Ukraine humanitarian program?

In the Ukraine humanitarian program, Humacyte's ATEV was used to treat severe vascular injuries resulting from mine blasts, shrapnel, and high-velocity ballistics. The patients had a high risk of wound infection and a mean Injury Severity Score (ISS) of 20.1.