BioInformant

Your Global Leader in Stem Cell Market Research

MENUMENU
  • Blog
    • Interviews
  • News
  • Stem Cells
    • iPS Cells
    • MSCs
    • HSCs
    • Adipose SCs
    • Neural Stem Cells
  • Exosomes
  • CAR-T
  • Cord Blood
  • Shop
    • Products
    • Submit PR
    • Advertise
  • About
    • Testimonials
    • Story
    • Guarantee
    • Contact
  • Home
  • Blog
    • Stem Cells
      • HSCs
      • iPS Cells
      • MSCs
      • Neural Stem Cells
      • Adipose SCs
    • Exosomes
    • Cell Therapy
      • CAR-T
    • Cord Blood
    • Stem Cell News
    • Interviews
  • COVID-19
  • Shop
  • Submit PR
  • Company
    • Advertise
    • Testimonials
    • Story
    • Job Posts
    • Guarantee
    • Privacy Policy
    • Contact
Home » MiMedx’s AmnioFix® Injectable Awarded 15th RMAT Designation in the U.S.
Mimedx RMAT

MiMedx’s AmnioFix® Injectable Awarded 15th RMAT Designation in the U.S.

March 9, 2018 By Cade Hildreth (CEO) Leave a Comment

MiMedx GroupIn major news released today, MiMedx Group announced that their AmnioFix® Injectable was awarded RMAT status by the U.S. FDA. This is the third RMAT designation awarded by the FDA this year and the 15th RMAT overall since the designation was introduced by the 21st Century Cures Act. The “Regenerative Medicine Advanced Therapy” (RMAT) Designation was introduced on December 13, 2016, when Congress included several provisions in the 21st Century Cures Act, an act signed into law by the 114th United States Congress authorizing $6.3 billion in funding, the bulk of which is allocated for programs supported by the National Institutes of Health (NIH).

Discover class-defining bioproduction tools.

The 21st Century Cures Act has had a profound effect on the regenerative medicine industry, supporting expansion of this industry to 600+ companies worldwide. The act also accompanies accelerated regulatory pathways that have been introduced in several other countries worldwide, including Japan, South Korea, and the E.U.

Within the U.S., sponsors of cell and gene therapies are eligible to obtain an RMAT designation if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it could address unmet medical needs.

bitbio

As announced in the press release issued March 9, 2018, by MiMedx Group:

AmnioFix InjectableMiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, announced that the U.S. Food and Drug Administration (FDA) has granted MiMedx’s micronized amniotic tissue, AmnioFix® Injectable, the Regenerative Medicine Advanced Therapy (RMAT) designation for use in the treatment of Osteoarthritis (OA) of the knee.

In its letter to the Company, the FDA confirmed its determination that MiMedx Allogeneic Micronized Dehydrated Human Amnion/Chorion Membrane (micronized dHACM) for the treatment of OA of the knee meets the criteria for RMAT designation. The FDA further stated that MiMedx has provided clinical information to demonstrate preliminary clinical evidence to indicate that the drug has the potential to address unmet medical needs for this condition.

Pluristyx

To learn more, read the full press release here.

5/5 - (2 votes)

Filed Under: Cell Therapy, Press Releases, Stem Cell News Tagged With: fda, RMAT

Related

About Cade Hildreth (CEO)

Cade Hildreth is the Founder of BioInformant.com, the world's largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine. 

Tell Us What You Think! Cancel reply

Nanocellect

Marathon Products

Let’s Get Social

  • Facebook
  • Twitter
  • LinkedIn
  • Pinterest
  • Instagram
Menu
  • Blog
  • Stem Cell News
    • Press Releases
  • Stem Cells
    • HSCs
    • iPS Cells
    • MSCs
    • Neural Stem Cells
    • Adipose SCs
  • Exosomes
  • Cell Therapy
    • CAR-T
  • Cord Blood
  • Interviews

Cart

Featured Posts

Cord Blood Market Segmentation

Cord Blood Market Segmentation – Biobanking, HSCT, Cellular Therapy, Genetic Manipulation, & Research Tools

CAR-T Companies

CAR-T Cell Companies Proliferate: List of CAR-T Companies Worldwide

Who discovered stem cells?

Who Discovered Stem Cells? The Answers Revealed

My Tweets

BioInformant's World-Class Clients

  • Submit Press Release
  • Advertise
  • Privacy and Terms

Copyright © 2022 · BIOINFORMANT, Your Global Leader in Stem Cell Market Research

| Email: Info@BioInformant.com | Phone: 703-859-7617 |

800 Corporate Drive, Suite 301, Stafford, VA 22554, United States

Disclaimer: All statements made on this website are NOT expressed as medical claims or advice. They are not intended to diagnose, treat, cure or prevent any disease or condition. If you have a health condition or concern, consult your physician or health care provider.