• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Zimmer Biomet touts preliminary data for stem cell therapy

November 15, 2016 By Sarah Faulkner

Zimmer Biomet touts preliminary data for stem cell therapyZimmer Biomet (NYSE:ZBH) touted data today from an investigational device exemption trial evaluating the use of autologous concentrated bone marrow aspirate for the treatment of critical limb ischemia. The stem cell study is the 1st pivotal trial of its kind to complete enrollment and a 1-year follow-up in a patient population that is ineligible for revascularization, the company said.

Warsaw, Ind.-based Zimmer Biomet’s trial is a prospective, randomized, double-blind study of stem cells injected intramuscularly into the affected limb to prevent or delay major amputation or death in patients with critical limb ischemia. The primary efficacy endpoint is the time to major amputation and all-cause mortality at 1 year.

Preliminary results from a partial data set found that treatment with concentrated bone marrow aspirate improved amputation-free survival compared to a placebo, while maintaining a safety profile similar to the placebo.

“We’re excited to announce positive progress on our investigational treatment for critical limb ischemia that anchors our emerging biologics pipeline and highlights the breadth of our innovative research and development capability,” president David Nolan said in prepared remarks. “The positive data from our IDE trial places Zimmer Biomet at the forefront of advancing our understanding of the clinical utility of autologous cell therapy, which is one of the most promising areas within biologics. We look forward to completing the analysis of the full data set, unveiling the final results, and finalizing our regulatory submission to the FDA.”

“There is an urgent need for alternatives to amputations in patients with advanced critical limb ischemia, nearly 30% of whom never fully recover and require chronic professional assistance at home or in an institution,” added lead investigator Dr. Michael Murphy of the Indiana University School of Medicine.

Filed Under: Clinical Trials, Featured, Regulatory/Compliance, Stem Cells Tagged With: Zimmer Biomet

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

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.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. 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 | RSS