Humacyte’s SYMVESS Achieves FDA Approval, Opening New Horizons for Arterial Injury Treatment
Humacyte’s SYMVESS receives FDA approval as a bioengineered vascular conduit showing promising clinical outcomes for arterial injury repair.
Overview of SYMVESS Approval
Humacyte, Inc. has announced that the FDA has fully approved SYMVESS, a bioengineered human tissue intended for use as a vascular conduit in patients suffering from extremity arterial injuries when traditional vein grafting is unfeasible. Results from clinical trials have shown high rates of blood flow, combined with low infection and amputation rates, highlighting an important step forward in regenerative medicine. The company is now poised for a successful commercial launch, confident that SYMVESS can greatly enhance the treatment of arterial injuries, particularly in trauma care. Importantly, SYMVESS can be implanted immediately, eliminating the need for additional surgical procedures, which can benefit patients in urgent situations.
Advantages of SYMVESS
- Receiving full FDA approval represents a significant breakthrough for Humacyte and its bioengineering platform.
- Clinical testing of SYMVESS showed high patency rates alongside low instances of amputation and infection, indicating it could enhance patient outcomes in vascular trauma management.
- A skilled sales team has been trained and prepared for a successful launch, positioning Humacyte effectively in the market.
Challenges Ahead
- The approval process indicated potential concerns, with a review extension noted on August 9, 2024, suggesting complexities during the examination.
- Serious safety warnings associated with SYMVESS raise issues regarding graft failure and complications, which could affect public confidence and market receptivity.
- Some clinical trial data were adjusted by the FDA, including the inclusion of unfavorable patient outcomes, prompting questions about the data’s reliability regarding efficacy and safety.
Frequently Asked Questions
What is SYMVESS and its intended use?
SYMVESS is a bioengineered human tissue designed as a vascular conduit for arterial replacement in adults at risk of limb loss.
How does SYMVESS compare to traditional vein grafts?
Unlike traditional vein grafts, SYMVESS is available off-the-shelf, which helps to reduce surgical time and the risks involved with harvesting veins from patients.
What clinical benefits were observed during SYMVESS testing?
SYMVESS showed high patency rates and low occurrences of amputation and infection during its clinical trials.
Who was involved in developing SYMVESS?
Humacyte’s development of SYMVESS included contributions from patients, healthcare providers, and its dedicated team, all of which enhanced its effectiveness.
When did the FDA approve SYMVESS?
The FDA approved SYMVESS on December 19, 2024, marking a noteworthy achievement in vascular medicine.
Disclaimer: This summary was generated based on information from a press release by GlobeNewswire. The summary may not include all details, and the full release can be reviewed for more comprehensive information.
$HUMA Insider Trading Activity
Insiders at $HUMA have engaged in stock trading on the open market 25 times in the past six months, comprising 6 purchases and 19 sales.
Here’s a summary of the insider trading activity:
- MICHAEL T. CONSTANTINO has conducted 2 transactions, making 2 purchases of 7,700 shares and recorded no sales.
- LAURA E NIKLASON (President, CEO, and Director) has made 10 trades, including 2 purchases totaling 3,019 shares, while selling 2,828,256 shares.
- BRADY W DOUGAN also executed 10 trades with similar activity to Niklason, including purchasing 3,019 shares and selling 2,828,256 shares.
- KATHLEEN SEBELIUS made 2 transactions without any purchases, selling 5,182 shares instead.
- DALE A. SANDER (CFO and Chief Corporate Development Officer) sold 39,389 shares.
To keep track of insider transactions, refer to Quiver Quantitative’s insider trading dashboard.
$HUMA Hedge Fund Activity
Recently, 89 institutional investors increased their holdings of $HUMA shares, while 54 reduced their positions in the last quarter.
Recent notable movements include:
- AIGH CAPITAL MANAGEMENT LLC decreased its holdings by removing 2,155,958 shares (-100.0%) in Q2 2024.
- SIO CAPITAL MANAGEMENT, LLC also completely exited with a removal of 2,000,000 shares (-100.0%) in Q2 2024.
- STATE STREET CORP expanded its investment by adding 1,895,529 shares (+66.1%) in Q3 2024.
- NUVEEN ASSET MANAGEMENT, LLC trimmed its stake, removing 848,538 shares (-68.2%) in Q3 2024.
- WOODLINE PARTNERS LP increased its holdings by acquiring 848,534 shares (+inf%) in Q3 2024.
- RENAISSANCE TECHNOLOGIES LLC exited its position, selling 600,300 shares (-100.0%) in Q3 2024.
- VOLORIDGE INVESTMENT MANAGEMENT, LLC raised its stake, adding 572,644 shares (+83.3%) in Q3 2024.
For more insights into hedge fund activities and stock portfolios, visit Quiver Quantitative’s institutional holdings dashboard.
Full Release
– SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair –
– In clinical testing, SYMVESS demonstrated high rates of patency, or blood flow,
and low rates of amputation and infection –
– A highly experienced sales team has been recruited and trained to ensure a successful commercial launch –
DURHAM, N.C., Dec. 19, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform firm known for developing universally implantable, bioengineered human tissues at a commercial scale, has announced that the U.S. Food and Drug Administration (FDA) has fully approved SYMVESS (acellular tissue engineered vessel) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is vital to avoid imminent limb loss, and when autologous vein grafting is not possible.
“We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. SYMVESS is a result of our groundbreaking bioengineering science and the contributions of many patients, healthcare providers, and the Humacyte team,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “The FDA’s full approval of SYMVESS for arterial injury repair represents a historic moment for regenerative medicine and for Humacyte. This development is transformational for the Company and illustrates the potential of our bioengineering technology platform. SYMVESS presents a new opportunity to treat patients with serious arterial injuries, a area that has not seen significant innovation in decades. We look forward with great anticipation to our upcoming commercial launch and have assembled a strong team to effectively handle our sales and marketing efforts.”
“The approval of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will significantly improve the quality of trauma care globally,” concluded Charles J. Fox, MD, FACS, Director of Vascular Surgery.
SYMVESS: A Breakthrough in Vascular Trauma Treatment
Experts in the medical field are celebrating the introduction of SYMVESS, a revolutionary bioengineered vascular conduit designed for immediate use in patients suffering from traumatic vascular injuries. This advancement promises improved outcomes for patients facing life-threatening conditions.
What is SYMVESS?
SYMVESS, also known as ATEV™, is a first-of-its-kind tissue-engineered human vessel aimed at replacing and repairing arteries. Traditional methods often involve harvesting a vein from the patient, which can be time-consuming and invasive. In contrast, SYMVESS is ready-to-use right out of the box, eliminating the need for additional surgical procedures that can further compromise the patient’s health.
Dr. Eric Fox from the University of Maryland Capital Region expressed high regard for SYMVESS, stating, “It reduces the time necessary to save both life and limbs.” With its potential to significantly lower amputation rates from traumatic injuries, he sees SYMVESS as a major advancement in the field.
Clinically Proven Effectiveness
The effectiveness of SYMVESS has been backed by positive results from the V005 pivotal Phase 2/3 clinical trial and observations from its use in wartime Ukraine. Chosen for its success in treating various traumatic injuries—including car accidents, gunshot wounds, and industrial incidents—SYMVESS has demonstrated high rates of blood flow and low incidences of infection and amputation.
“SYMVESS will revolutionize vascular trauma care and be profoundly beneficial to our patients,” said Dr. Rishi Kundi, a surgical critical care and vascular surgery expert. He emphasized that this innovation could lead to more successful reconstructions that were previously deemed impossible due to contamination risks.
Rapid FDA Approval and Future Implications
In a significant development for healthcare, the FDA granted full approval for SYMVESS, designating it as a critical tool for complex vascular injuries, particularly those prone to infection. Dr. Ernest E. Moore, Director of Research at Denver Health, noted that he eagerly anticipates using SYMVESS in clinical practice.
In civilian contexts, arterial injuries are common due to motor vehicle accidents, gun violence, and other traumatic events. The opportunity to use an off-the-shelf solution like SYMVESS can vastly improve urgency in care, as it eliminates the need for vein harvesting which can delay essential treatment.
Safety Information and Guidelines
SYMVESS is indicated for use in adults facing extremity arterial injuries where urgent revascularization is required, and autologous vein grafts are not an option.
IMPORTANT SAFETY WARNING: There is a risk of graft failure, which can cause serious bleeding. Patients must be monitored for signs of complications, including pain and swelling.
Contraindications exist for patients who cannot undergo long-term antiplatelet therapy, as maintaining blood flow is critical after receiving SYMVESS. Monitoring for graft rupture or thrombosis is advised, ensuring that any problems can be addressed swiftly.
Overall, SYMVESS represents a significant evolution in treating traumatic vascular injuries, with its ability to save lives while reducing complications tied to traditional vein harvesting. This breakthrough technology stands to enhance patient care significantly.
Humacyte Advances Biotech with SYMVESS Approval Amid Adverse Effects
Humacyte, Inc. is making headlines with its advances in biotechnology, particularly following the FDA’s approval of their product, SYMVESS, designed for vascular trauma repair.
Safety Measures and Adverse Reactions
Humacyte implements rigorous sourcing of fetal bovine serum to lower the risk of transmitting infectious diseases, like bovine spongiform encephalopathy, which can cause a fatal condition in humans known as variant Creutzfeldt-Jakob disease. During clinical tests, there haven’t been reports of transmitted infections.
The most commonly reported side effects of SYMVESS (occurring in over 10% of patients) include vascular graft thrombosis, fever (pyrexia), and pain.
For comprehensive safety details and warnings, refer to the full Prescribing Information for SYMVESS.
Clinical Data and Regulatory Challenges
Humacyte has submitted a Biologics License Application (BLA) based on data collected from trauma clinical trials. This data, analyzed statistically and peer-reviewed, was featured in JAMA Surgery on November 20, 2024. However, the FDA’s package insert for SYMVESS omitted the synthetic graft comparator included in the original analysis. Furthermore, the FDA applied a new methodology for calculating patient data, leading to some patients being inaccurately categorized as failures. Notably, individuals who never had amputations were also misclassified regarding limb salvage outcomes.
About Humacyte
Founded in 2015, Humacyte, Inc. (Nasdaq: HUMA) is focused on creating groundbreaking biotechnology solutions, particularly bioengineered human tissues. Their primary offerings include acellular tissue-engineered vessels (ATEVs), which are currently in late-stage trials for various vascular conditions. The FDA approved the BLA for their ATEV targeting vascular trauma in December 2024. Research is also ongoing for applications in coronary artery bypass grafts, diabetes treatment, and more.
The company’s 6mm ATEV received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, marking it as a significant product for urgent arterial repairs and other advanced vascular treatments. Additionally, this graft earned priority designation from the U.S. Secretary of Defense.
It’s important to note that outside of the approved vascular trauma indication, the ATEV remains an investigational product, meaning it has not been approved for other uses yet.
Forward-Looking Statements
This press release contains forward-looking statements based on Humacyte’s beliefs and current information. Words such as “may,” “will,” “should,” and “anticipate” indicate predictions about the future. However, these statements carry inherent risks and uncertainties that may lead to actual outcomes differing significantly from expectations.
For example, Humacyte’s progress in commercializing ATEVs in the U.S. under the SYMVESS brand, as well as the results of ongoing trials, remains uncertain. Potential factors affecting company operations include regulatory changes and market conditions. Interested parties should consult the “Risk Factors” section in Humacyte’s reports to the SEC for detailed information.
Though there is no commitment to update forward-looking statements publicly, stakeholders are advised to approach these assertions with caution.
Investor Contact at Humacyte:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Media Contact at Humacyte:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
This article was first published on Quiver News. Read the full story.
The views expressed here are those of the author and do not necessarily reflect those of Nasdaq, Inc.
