Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ReGen moves meniscus implant closer to the US:

This article was originally published in Clinica

Executive Summary

Orthopaedic products firm ReGen Biologics has moved a step closer to taking its collagen meniscus implant (CMI) to the US market, after submitting to the FDA the manufacturing module of its premarket approval application for the product. The first product to use the Franklin Lakes, New Jersey firm's patented core technology, the CMI uses the body's own healing process to grow new tissue in the meniscus, and restore activity levels for patients with meniscus loss. The company said it expected to file a preclinical module in the next few months, and to conclude with the filing of a clinical module in the first or second quarter of 2005. The CMI is currently distributed in several countries, including Australia, Chile and those in Europe, on a non-exclusive basis, through the Centerpulse unit of Zimmer Holdings.

Topics

UsernamePublicRestriction

Register

MT059201

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel