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Humacyte to Present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference at Nasdaq

MWN-AI** Summary

Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform focused on developing universally implantable bioengineered human tissues, is set to present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at Nasdaq World Headquarters in New York. Laura Niklason, M.D., Ph.D., Founder, President, and CEO of Humacyte, will represent the company in a presentation at 12:30 p.m. EST. Attendees will have the opportunity for one-on-one meetings with management following the presentation. A webcast of the event can be accessed via Humacyte's website, where a replay will also be available afterwards.

Humacyte is pioneering a revolutionary approach to medicine through its advanced tissue constructs, aimed at treating a variety of diseases, injuries, and chronic conditions. The company’s notable achievement includes the FDA approval of its acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024. Currently, Humacyte is advancing ATEVs through late-stage clinical trials for several applications, including arteriovenous access for hemodialysis and peripheral artery disease. Furthermore, the company is in preclinical development phases for additional applications such as coronary artery bypass grafts and pediatric heart surgery.

Humacyte's 6mm ATEV for AV access has been awarded the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, alongside receiving Fast Track designation for its innovation in regenerative medicine. The company has also garnered priority designation by the U.S. Secretary of Defense for its ATEV in treating vascular trauma. Humacyte continues to position itself at the forefront of biotechnological advancements, as it explores further applications and solidifies its role in transforming medical practices. For further details, visit www.Humacyte.com.

MWN-AI** Analysis

Humacyte, Inc. (Nasdaq: HUMA) is poised to leverage its presentation at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, as a platform to showcase its unique position within the biotechnology sector. As a company specializing in universally implantable, bioengineered human tissues, the significance of its recent FDA approval for the acellular tissue engineered vessel (ATEV) for vascular trauma cannot be overstated.

The market's response to the company's advancements in biomanufacturing and the potential applications of its technology—ranging from treatment for hemodialysis to chronic conditions like type 1 diabetes—could provide a catalyst for stock performance. Investors should pay close attention to the outcomes of ongoing late-stage trials and preclinical developments, as successful results could lead to new commercial opportunities and additional FDA designations.

Furthermore, the fact that Humacyte's ATEV product has received multiple designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track, underscores its potential for expansion within the medical community. These designations, along with priority treatment options for U.S. military applications, may enhance Humacyte's reputation and visibility, building significant investor confidence.

As the company's management engages with investors through one-on-one meetings and a scheduled fireside chat, market participants should gauge how executives articulate their strategic vision and timelines for upcoming milestones in product development.

In conclusion, while maintaining a cautious approach given the volatility typically associated with biotech investments, Humacyte presents an intriguing opportunity for growth within the sector. Monitoring the outcomes of its ongoing clinical trials and strategic communications from the conference will be critical for both short-term and long-term investment decisions.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

DURHAM, N.C., May 19, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference at Nasdaq in New York, NY on Tuesday, May 20, 2025. Management will also be available for one-on-one meetings.

Event: H.C. Wainwright 3rd Annual BioConnect Investor Conference at Nasdaq
Location: Nasdaq World Headquarters, New York, NY
Fireside Chat: Tuesday, May 20, 12:30 p.m. EST
Webcast: https://journey.ct.events/view/66adb5ff-a0d8-42aa-b1d2-70b2e6d726f1

A replay will be available for a limited time following the presentation on the Events & Presentations portion of the Humacyte website.

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 Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). 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 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 .

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.

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**

How does Humacyte Inc. HUMA plan to scale its production of bioengineered human tissues to meet increasing demand, especially following the recent FDA approval for the acellular tissue engineered vessel (ATEV)?

Humacyte Inc. plans to scale its production of bioengineered human tissues by leveraging FDA approval for its acellular tissue engineered vessel (ATEV) to expand manufacturing capabilities, enhance processes, and meet the rising demand in regenerative medicine.

What specific advancements can investors expect from Humacyte Inc. HUMA's ongoing late-stage clinical trials targeting vascular applications like AV access for hemodialysis and peripheral artery disease?

Investors can expect significant advancements from Humacyte Inc.'s ongoing late-stage clinical trials, including potential FDA approvals for their human Acellular Vascular Graft (HAV) products, which could revolutionize treatments for AV access in hemodialysis and peripheral artery disease.

With the acceptance of the Biologics License Application, what impact does Humacyte Inc. HUMA anticipate on revenue growth and market expansion within the biotechnology sector?

With the acceptance of the Biologics License Application, Humacyte Inc. (HUMA) anticipates significant revenue growth and expanded market opportunities in the biotechnology sector by potentially driving increased demand for its innovative cell-based medical products.

Can Humacyte Inc. HUMA share more about its preclinical development pipeline and how these initiatives could potentially transform treatment options for conditions like type 1 diabetes and pediatric heart surgery?

Humacyte Inc. is advancing its preclinical development pipeline focused on creating bioengineered tissues and vascular grafts that could revolutionize treatment for conditions like type 1 diabetes and pediatric heart surgery by providing innovative, scalable, and durable solutions.

**MWN-AI FAQ is based on asking OpenAI questions about Humacyte Inc. (NASDAQ: HUMA).

Humacyte Inc.

NASDAQ: HUMA

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