BD Launches Industry-First Bioabsorbable Mesh Designed for Umbilical Hernia Repair

Rhea-AI Summary

BD (NYSE: BDX) has received FDA 510(k) clearance and launched the Phasix™ ST Umbilical Hernia Patch, marking a significant innovation in hernia repair as the first fully absorbable hernia patch specifically designed for umbilical hernias. The patch is made from Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, combined with a Sepra® Technology hydrogel barrier.

The product maintains the same surgical technique as traditional permanent mesh patches, featuring a pocket and strap design for easy placement. It builds on the success of the Ventralex™ ST Hernia Patch family, which has over two million implants globally. Survey data shows 60% of patients prefer non-permanent mesh options, with 70% of surgeons willing to accommodate these preferences.

The Phasix™ family of products has demonstrated success with over 385,000 implants globally, supported by more than 85 clinical publications studying over 4,000 patients. The new patch is available in three sizes to accommodate various umbilical soft tissue defects.

Positive

• FDA 510(k) clearance received for innovative first-in-class product
• Strong market potential with 60% of patients preferring non-permanent mesh
• Builds on proven success with over 385,000 global implants in Phasix family
• Extensive clinical validation with 85+ publications and 4,000+ patients studied

Negative

• None.

Phasix™ ST Umbilical Hernia Patch Leverages Same Surgical Technique as Permanent Mesh Procedures 

FRANKLIN LAKES, N.J., April 23, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) and the commercial launch of Phasix™ ST Umbilical Hernia Patch, the first and only fully absorbable hernia patch on the market designed specifically for umbilical hernias.  

"I've been waiting and hoping for this product to come to market for many years, and I'm thrilled that it's finally here for us to use," said Dr. Robert Harrell, a general surgeon from Live Oak, Texas. "The combination of the unique features of the Ventralex™ ST Hernia Patch with the bioabsorbable nature of Phasix™ Mesh is a wonderful fusion of technology."

Composed of Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, with the added benefits of a proven hydrogel barrier based on Sepra® Technology, Phasix™ ST Umbilical Hernia Patch offers a unique absorbable solution to umbilical hernia repair. It can be deployed using the same technique surgeons use with a traditional permanent mesh patch, while providing material optionality. The pocket and strap design facilitates placement, positioning, and lateral fixation, and is designed to duplicate the form, function, and technique of the Ventralex™ ST Hernia Patch – a product family with more than two million implants globally.

"BD is redefining tissue repair through advanced biomaterials and expanding treatment options to meet individual patient needs through proven, reliable alternatives to permanent mesh," said Ron Silverman, chief medical officer for BD. "This marks another milestone in hernia repair innovation and further positions BD as a leader in advanced biomaterial science – driving transformative change in tissue reconstruction."

Recent survey data indicates that 60% of patients prefer a non-permanent mesh for hernia repair option, and more than 70% of surgeons would be willing to respond to patient mesh preferences.¹ Phasix™ ST Umbilical is the latest addition to BD's growing family of Phasix™ Mesh absorbable products; a portfolio with over 385,000 implants globally, ² peer-reviewed in more than 85 clinical publications, with over 4,000 patients studied and proven clinical outcomes.¹ Available in three sizes, this patch enables the repair of a broad spectrum of umbilical soft tissue defects while accommodating surgeon preferences for adequate overlap.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson. 

References:

1. BD data on file.
2. Based on sales data.

Contacts:
Media:	Investors:
Fallon McLoughlin	Adam Reiffe
BD Corporate Communications	BD Investor Relations
201.258.0361	201.847.6927
Fallon.McLoughlin@bd.com	adam.reiffe@bd.com

 

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What makes the Phasix ST Umbilical Hernia Patch (BDX) unique in the market?

It's the first and only fully absorbable hernia patch specifically designed for umbilical hernias, combining P4HB material with Sepra® Technology hydrogel barrier.

How many global implants has BD's Phasix Mesh product line achieved?

The Phasix Mesh portfolio has achieved over 385,000 implants globally, with clinical evidence from more than 85 publications studying over 4,000 patients.

What percentage of patients prefer non-permanent mesh for hernia repair according to BD's survey?

According to survey data, 60% of patients prefer non-permanent mesh options for hernia repair.

How many size options are available for the Phasix ST Umbilical Hernia Patch?

The Phasix ST Umbilical Hernia Patch is available in three sizes to accommodate different umbilical soft tissue defects.