In Vivo 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

A Last Gasp for Stryker with OP-1? Not Likely.

Executive Summary

Few were surprised when an FDA advisory panel recommended against approving Stryker's OP-1 device for spinal fusion. Plus, given the recent focus on off-label use of orthobiologics, OP-1 was not likely to displace its only competitor, InFuse. That said, the off label issue may well influence the future of OP-1 as Stryker contemplates whether and how to retool clinical development.

You may also be interested in...



Cartilage Repair: What's the Right Combination?

START-UP counts some 40 commercial development efforts in cartilage repair and regeneration. Some are implanting synthetic scaffolds, and some are offering cell-based therapies used with or without scaffolds. It's a crowded and confusing category. So many companies are chasing a market that is still somewhat undefined and doesn't seem large enough to support them all. What's clear, however, is that almost 15 years after the introduction of Carticel, the first cell-based implant for cartilage repari, there is still an unsatisified market of patients aged 20-60 with knee pain due to cartilage damage or degeneration.

Orthopedic Devices Panel Rejects Stryker’s OP-1 Putty For Spinal Fusion

FDA's Orthopedic and Rehabilitation Devices advisory panel voted 6-1 to recommend against approval of Stryker Biotech's OP-1 Putty spinal fusion product March 31

Spine Market: A Perfect Storm

While most Wall Street analysts predict that the current economic crisis will have little effect on the spine industry over the long haul, there are storm clouds on the horizon that should put spine product manufacturers on guard. With crackdowns by the Department of Justice tipping over into the spine arena and whistleblower lawsuits regarding surgeon/industry relationships in the news, along with several important bills before Congress designed to change how the business of spine surgery is done, current financial constraints may be only the tip of the iceberg in terms of things to come.

Related Content

Topics

UsernamePublicRestriction

Register

LL111109

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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