Accessibility Statement Skip Navigation
  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing
  • Login
  • GDPR
  • Create a Free Account
Return to PRWeb homepage
  • News
  • Resources
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
  • Business & Money
      • Auto & Transportation

      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Hamburger menu
  • Cision PRWeb provides efficient communication tools to continuously engage with target audiences across multiple online channels
  • Create a Free Account
    • ALL CONTACT INFO
    • Contact Us


      11AM ET Sunday – 8PM ET Friday

  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR

Soft Tissue Regeneration Announces Initiation of L-C Ligament® Clinical Trial
  • USA - English


News provided by

Soft Tissue Regeneration, Inc.

Oct 19, 2015, 09:30 ET

Share this article

Share toX

Share this article

Share toX

New Haven, Conn. (PRWEB) October 19, 2015 -- Soft Tissue Regeneration, Inc. (STR), the developer of resorbable polymer scaffolds for the repair of soft tissue injuries, today announced it has initiated a randomized and controlled clinical study in Europe for its L-C Ligament® device for the reconstruction of a ruptured anterior cruciate ligament (ACL).

The results of this clinical study will be submitted to regulatory authorities to obtain approval (CE mark) for STR to market the L-C Ligament® in most European markets. On September 24, 2015, the first three patients of this clinical study were enrolled and treated at the Isala Klinieken in Zwolle, The Netherlands, by a team led by Dr. Kees van Egmond and supported by Drs. Peter Indelicato and Robert Stanton of the United States, both members of the STR Scientific Advisory Board. All three patients were treated successfully, including the two patients who received the L-C Ligament® device and one patient who was treated with tendon harvested from the patient’s own hamstring (autologous hamstring tendon).

“The repair of a ruptured ACL typically involves the surgical harvesting of the patient’s own hamstring or patellar tendon tissue, often resulting in pain, donor-site morbidity, impaired function, and additional operating time,” said Dr. van Egmond. “With few options to autograft available, the L-C Ligament® may fulfill a significant clinical need for a device that will regenerate a functioning ACL while avoiding the morbidity associated with autograft reconstructions and saving a considerable amount of operating time.”

Dr. van Egmond also performed the first-in-man L-C Ligament® implant procedure in June 2013, and was the primary investigator of STR’s earlier 15-patient safety and feasibility study.

The L-C Ligament® clinical trial is a prospective, multi-center, randomized controlled trial that will compare the L-C Ligament® to the hamstring autograft in 60 patients requiring a surgical reconstruction for an acute ACL injury. The primary endpoint of the study is the absence of revision surgery for graft failure and the function of the reconstruction as measured by established orthopedic evaluation scores for patients following knee surgery. The trial is being conducted in Europe to obtain a CE mark to allow STR to go to market in Europe. A larger global trial in the United States and Europe is anticipated to begin in late 2016.

“This is another major milestone for Soft Tissue Regeneration and the hundreds of thousands of people who suffer ACL injuries annually requiring surgery,” said Joseph Reilly, CEO and co-founder of STR. “It is another step that will help improve patient outcomes on so many levels. Other European sites are beginning the recruitment process and we expect up to six sites to be recruiting by year end.”

The L-C Ligament® is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery and regenerate the ACL. It is manufactured in a patented and proprietary process utilizing a clinically proven polymer called poly (L-lactic acid) or PLLA. This degradable polymer is widely used in orthopaedic implantable devices, and breaks down into naturally occurring lactic acid, which is also a byproduct of exercise.

The L-C ligament® addresses known risks and morbidity associated with allograft and autograft tissues for ACL reconstruction. In particular, no harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site. The L-C Ligament® is anticipated to encourage the regeneration of the patient’s own ligament tissue. To date, results from large-scale animal testing and a European safety study have demonstrated that the L-C Ligament® can successfully regenerate a native ligament in the intra-articular space.

STR is privileged to have the support of a prestigious and committed Scientific Advisory Board, two of whose members, Drs. Robert Stanton and Peter Indelicato, attended and advised on the surgeries of these first three patients enrolled in the CE Mark Study. Another member of the STR Scientific Advisory Board, Dr. Robert Arciero also has attended a patient surgery during the STR Safety and Feasibility Study. Drs. Arciero, Stanton, and Indelicato are each past Presidents of the leading academic sports medicine society, the American Orthopedic Society of Sports Medicine (“AOSSM”).

The L-C Ligament® is an investigational device and is not available for use or sale in the European Union or the United States. It is only available as part of the clinical trial.

About Soft Tissue Regeneration, Inc.
Soft Tissue Regeneration, Inc. (STR) is a medical device company whose aim is to apply its patented and proprietary technology comprised of PLLA, a degradable polymer, in orthopedic implant devices for regeneration and augmentation of soft tissue. In addition to the L-C Ligament®, STR is also leveraging its technology to develop a suite of complementary follow-on products and surgical meshes, including the STR GRAFT™, a FDA 510(k)-cleared innovative device for soft tissue augmentation, repair of tendons and ligaments and rotator cuff repair in the United States. To learn more about the company or about investing in the company, visit http://www.softtissueregeneration.com.

Joseph Reilly, Soft Tissue Regeneration, Inc., http://www.softtissueregeneration.com, +1 (973) 879-6367, [email protected]

Modal title

Contact PRWeb

  • 11AM ET Sunday – 8PM ET Friday
  • Contact Us

About PRWeb

  • About PRWeb
  • Partners
  • Partnership Programs
  • Editorial Guidelines
  • Resources

Why PRWeb

  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing

Accounts

  • Create a Free Account
  • Log in
  • Contact Us

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Legal
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 Cision US Inc.