Humacyte

A major milestone for Humacyte and the future of cardiovascular care!

The FDA has accepted our IND application for the first-in-human clinical study of the Coronary Tissue Engineered Vessel (CTEV) in coronary artery bypass grafting (CABG). CTEV is a first-in-class, universally implantable bioengineered human blood vessel produced using the same platform as Humacyte's FDA-approved acellular tissue engineered vessel (ATEV) and is designed to be available off-the-shelf, eliminating the need to harvest a patient's own vessel for bypass surgery.

This important regulatory milestone brings us one step closer to evaluating a potential new treatment option for patients undergoing one of the most common cardiovascular procedures performed today.

Phase 2a study initiation is expected this quarter.

For more details read the full press release here: 🔗 https://bit.ly/4x7D6d3

The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

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Trademarks are property of Humacyte Global, Inc
© 2026 Humacyte Global Inc. All Rights Reserved.

As Men's Health Month comes to a close, it's a reminder that taking care of your health isn't just about today—it's about being there for the people and moments that matter most.

The support of family and loved ones can make a meaningful difference in building healthy habits, staying active, and supporting long-term vascular health.¹

Caring for your health today can help you stay engaged in life's milestones tomorrow—from family celebrations and summer adventures to everyday moments spent with those you love.

Talk with your healthcare provider about your vascular health, stay active, and lean on your support network as you work toward a healthier future.

At Humacyte, we support efforts to raise awareness of vascular health and encourage men to have conversations with their healthcare providers about their health.

Learn more about Humacyte's commitment to advancing innovation in vascular medicine at Humacyte.com

References:
1. American Heart Association. How Is PAD Treated? Updated April 27, 2026.

Humacyte is a registered trademark and is property of Humacyte Global, Inc.
© 2026 Humacyte Global Inc. All Rights Reserved.

Men's Health Month is a reminder that small steps can make a lasting difference.

Many cardiovascular risk factors, including blood pressure, cholesterol, and activity level, are controllable with support from your healthcare provider.1

Staying active, monitoring blood pressure and cholesterol, and maintaining strong connections with family, friends, and healthcare providers can all contribute to better cardiovascular health over time. Peer support from people with shared experiences can also encourage healthier behaviors and help individuals stay engaged in lifestyle changes.2

At Humacyte, we support awareness of cardiovascular health and the importance of proactive care. Learn more at www.Humacyte.com.

References:
1. Wadhera RK, et al. Cardiovascular Statistics in the United States, 2026. J Am Coll Cardiol. 2026
2. Sharp P, et al. Men’s peer support for mental health challenges. Health Promot Int. 2024.

Humacyte is a trademark and property of Humacyte Global, Inc.
© 2026 Humacyte Global Inc. All Rights Reserved.

We hope you had the opportunity to connect with our team and learn more about Symvess® acellular tissue engineered vessel-tyod at the TOUCHPOINT Hands-on / SIM Lab, The Women in Vascular Surgery Forum, or our exhibit booth at the VAM 2026 conference. We truly appreciate the engagement and interest in Symvess—our first-in-class, universally implantable, bioengineered human vessel indicated for urgent extremity arterial injury.

We are excited to continue supporting you and your teams in learning more about this innovative repair option, and we sincerely value the thoughtful questions and discussions.

VAM 2026 offered so many valuable educational opportunities. Contact us to keep the discussion going. We look forward to connecting soon!

Contact Us Here: https://symvess.com/contact-us/

Learn more about Symvess here: https://bit.ly/atev_prod_huma

PLEASE SEE IMPORTANT SAFETY INFORMATION INCLUDING THE BOXED WARNING, AND FULL PRESCRIBING INFORMATION at https://bit.ly/4dl5tuL

INDICATION
SYMVESS is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

BOXED WARNING: GRAFT FAILURE: Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.

DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy after acute injury resolution.

WARNINGS AND PRECAUTIONS: Vascular Graft Rupture, Anastomotic Failure, and Thrombosis have occurred in patients treated with SYMVESS. SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or agents; none have been reported during clinical testing.

ADVERSE REACTIONS: most common (≥3%): thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.

Trademarks are property of Humacyte Global, Inc
© 2026 Humacyte Global Inc. All Rights Reserved. US-SYM-000349

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🚨 New Clinical Milestone from Humacyte in AV Access!

Humacyte recently announced interim Phase 3 (V012) results in female dialysis access patients. The ATEV met V012’s primary endpoint and showed superior catheter-free days (p=0.00070) compared with autologous arteriovenous fistula (AVF), the current standard of care. Women who received Humacyte's ATEV experienced an average of three more months without a dialysis catheter than women who received an AVF.

The data reinforce the potential to improve outcomes in a patient population with a high unmet need.

This major milestone marks the end of the Phase 3 study enrollment and will support Humacyte’s plans to file a supplemental Biologic License Application (BLA) with the Food and Drug Administration (FDA) during the second half of 2026.

Full results were presented June 11 at the Society for Vascular Surgery Annual Meeting in Boston during the Women’s Health Seminar.

For more details, read the full press release here: 🔗 https://bit.ly/3SaQzSc

Learn more about Humacyte at www.humacyte.com

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Trademarks are the property of Humacyte Global, Inc.
© 2026 Humacyte Global, Inc. All rights reserved.

June is Men’s Health Month, an important time to focus on conditions that quietly impact long term health—starting with vascular disease.

Peripheral artery disease (PAD) affects millions of Americans and can quietly lead to serious outcomes like mobility loss, cardiovascular events, and even amputation. Each year, about 150,000 nontraumatic lower‑extremity amputations occur in the United States, with men representing the majority of patients.1,2
For men with advanced PAD, treatment can be especially challenging. Clinical studies show that 15–45% of patients with severe PAD or chronic limb threatening ischemia lack a suitable saphenous vein for use in bypassing the diseased artery, limiting traditional surgical options.3,4

Raising awareness of PAD and encouraging earlier conversations about vascular health can make a real difference—for long term limb and life outcomes. This Men’s Health Month, Humacyte encourages continued education, early PAD recognition, and informed conversations around vascular health—because circulation plays a critical role in long term limb and life outcomes.

Learn more about Humacyte and our groundbreaking science and vascular innovations at https://humacyte.com

References:
1. Creager MA, Matsush*ta K, Arya S, et al. Reducing nontraumatic lower extremity amputations by 20% by 2030: a policy statement from the American Heart Association. Circulation. 2021;143:e108‑e124.
2. Gill SS, Chaudhary M, Zakrison TL. Nontraumatic amputations in the United States—an urgent matter of equity. JAMA Surg. 2024;159(1):76‑77. doi:10.1001/jamasurg.2023.5523
3. Garbaisz D, Osztrogonácz P, Boros AM, Hidi L, Sótonyi P, Szeberin Z. Comparison of arterial and venous allograft bypass in chronic limb‑threatening ischemia. PLoS One. 2022;17(10):e0275628. doi:10.1371/journal.pone.0275628
4. Taylor LM Jr, Edwards JM, Brant B, Phinney ES, Porter JM. Autogenous reversed vein bypass for lower extremity ischemia in patients with absent or inadequate greater saphenous vein. Am J Surg. 1987;153(5):505‑510. doi:10.1016/0002‑9610(87)90803‑8

Humacyte is a trademark and property of Humacyte Global, Inc. © 2026 Humacyte Global Inc. All Rights Reserved.

Join Us Tonight to Learn More !

There are clear unmet needs in AV Access for Women. (1,2)

Join leaders in vascular innovation at the Women in Vascular Surgery Forum, sponsored by Humacyte. The team will share recent Interim Results from the Women-Only Study in AV Access.

Thursday, June 11, 2026
7:00–8:30 PM EST
Sheraton, 2nd Floor, Back Bay C

Speakers:
Young Erben, MD, FACS
Associate Professor of Surgery
Mayo Clinic in Jacksonville, FL

Laura Niklason, MD, PhD
Founder, President & CEO
Humacyte Global, Inc.

Be part of the conversation advancing care for women.

ALSO VISIT our MEDICAL INFORMATION TEAM at SVS - BOOTH #307

Learn more about Humacyte here: https://humacyte.com

For uses other than the FDA approval in the extremity vascular injury indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Sources: 1. USRDS 2025 Annual Data. 2. Coker et al., The Journal of Vascular Access, 2018.

Trademarks are property of Humacyte Global, Inc
© 2026 Humacyte Global, Inc. All Rights Reserved.

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Join us at the Hands-On Simulation lab!
The Humacyte® team is proud to host a Hands on SIM Lab featuring Symvess® acellular tissue engineered vessel-type (ATEV)—and it’s happening today and tomorrow.

During the Society for Vascular Surgery VAM 2026 TOUCHPOINT Hands on / SIM Lab, participants can practice handling and implantation techniques, perform anastomosis, and apply proper clamping and procedural methods, with support from the Humacyte team throughout the session.

SIM Lab Location: Hynes Convention Center, Second Level, Auditorium (in the Exhibit Hall)
• Thursday, June 11: 10:15 AM – 6:15 PM
• Friday, June 12: 9:30 AM – 2:00 PM

While you’re here, stop by Booth 307 to connect with the Humacyte team and continue the conversation.

Contact Us Here: https://symvess.com/contact-us/

Learn more about Symvess here: https://bit.ly/atev_prod_huma

PLEASE SEE IMPORTANT SAFETY INFORMATION INCLUDING THE BOXED WARNING, AND FULL PRESCRIBING INFORMATION at https://bit.ly/4dl5tuL

INDICATION
SYMVESS is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

BOXED WARNING: GRAFT FAILURE: Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.

DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy after acute injury resolution.

WARNINGS AND PRECAUTIONS: Vascular Graft Rupture, Anastomotic Failure, and Thrombosis have occurred in patients treated with SYMVESS. SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or agents; none have been reported during clinical testing.

ADVERSE REACTIONS: most common (≥3%): thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.

Trademarks are property of Humacyte Global, Inc
Other trademarks are property of their respective owners.
© 2026 Humacyte Global Inc. All Rights Reserved. US-SYM-000348

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