We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Woundchek Partners with SerenaGroup to Complete U.S. Clinical Trails

Woundchek Partners with SerenaGroup to Complete U.S. Clinical Trails

July 9, 2014

Woundchek Laboratories is partnering with the SerenaGroup, a Cambridge, Mass.-based network of 20 wound care centers, to complete two clinical trials in 2014 aimed at gaining FDA clearance for the company’s two products.

U.S. studies of Woundchek’s Protease Status and Bacterial Status diagnostic tests are set to begin this month, Jack Wilkens, president and CEO, told Device Daily Bulletin.

According to the North Yorkshire, England wound care products maker, Protease Status is the world’s first point-of-care test to detect elevated protease activity in chronic wounds. Wounds with EPA have a 90 percent chance of healing improperly without protease modulating intervention and also carry a higher likelihood of graft failure than wounds with low protease activity, the company said.

The other product, Bacterial Status, assesses bacterial protease activity in chronic wounds, indicating if a wound requires intervention for bacterial infection.

Global costs of ineffective wound treatment run from $20 billion to $25 billion annually, Wilkens said, adding that the planned trials bring Woundchek closer to introducing wound diagnostics in the U.S. market.

Protease Status is currently available in Europe, the Middle East and South Africa. Bacterial Status is still in development. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Medical Devices Research and Development Commercial Operations

Upcoming Events

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

  • 10Aug

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Provides Update on GE Healthcare’s Recall of Its Carescape R860 Ventilators

  • Gilead Resubmits NDA for Lenacapavir Following Complete Response Letter

  • FDA Warns Baby Neck Floats Used in Water Therapy Can Cause Death or Injury

  • U.S. Government Inks $3.2 Billion Contract With Pfizer-BioNTech for Vaccine Booster Campaign

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing