Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Axogen announces positive topline data from Phase 3 nerve graft study

By Brian Buntz | May 13, 2022

AxogenFocused on developing peripheral nerve regeneration and repair products, Axogen (Nasdaq:AXGN) announced that the Phase 3 RECON study met its primary endpoint in comparing its Avance nerve graft to conduits in digital nerve injuries.

The primary endpoint was the return of sensory function based on static two-point discrimination. This test measures the ability to detect that two close objects touching the skin are distinct points.

“The study data confirmed that as gap lengths increased, Avance returned superior levels of sensation, and this was achieved at earlier time points than those observed for conduits,” said co-lead Investigator Dr. Jonathan Isaacs, professor and chair, division of hand surgery at Virginia Commonwealth University.

The Avance nerve graft also had a good safety profile in the study.

Axogen plans to submit a Biologics License Application (BLA) for the product in the second half of 2023.

Karen Zaderej

Karen Zaderej

The company occupies a unique position in the marketplace, according to CEO Karen Zaderej. “I would say this market has really been an underserved area,” she said. “Traditionally, nerve injuries have been repaired predominately with surgical techniques and not products.”

But surgeons have had a limited toolset for peripheral nerve repair.

The results from the RECON study could have commercial advantages. Obtaining a BLA would allow the company to market Avance as a 351-Biologic product rather than an HCT/P 361-Tissue product, giving the company 12 years of data exclusivity and providing a barrier to entry for biosimilars.

“It’s a very important silver lining for us,” Zaderej said.

For one thing, the goal of potentially commercializing Avance as a biologic product is forcing the company to upgrade its quality system and physical infrastructure.

The company’s quality system is already prepared for the transition. “And we’re building a brand-new manufacturing facility,” Zaderej said. “We’re just finishing it out now.”

The new plant is based on good manufacturing practices for biologics processing.

Competitors would have to deal with a potentially steep learning curve if they don’t have prior biologics experience. “We feel like we have the right infrastructure, and it would be hard for someone else to come in in the marketplace and build that,” Zaderej said.

The fact that Axogen is now preparing for its future in biologics allows the company to “continue to focus on building the market versus sharing and fighting for share within a market,” Zaderej explained. “This is a very large and underserved market, both in pain and in traumatic injury as well as surgical areas. And we’re really focused on changing patient lives, and that’s where we want our attention to stay.”


Filed Under: Biologics, Women in Pharma and Biotech
Tagged With: Avance, Axogen, clinical trial, nerve graft
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

FDA approved ENFLONSIA for the prevention of RSV in Infants
Sanofi ramps up distribution of Beyfortus ahead of RSV season
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Cellares and UW-Madison partner to automate manufacturing for novel solid tumor CAR-T
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE