We are thrilled to announce that we just received a Breakthrough Device Designation from the United States Food and Drug Administration (FDA) for our novel hip cartilage repair technology. The intent of the Breakthrough Devices Program1 is to help patients have more timely access to medical breakthroughs by expediting their development, assessment, and review. To be clear, this does not mean that CytexOrtho has received approval from the FDA, but this designation will ultimately expedite and streamline the ability of CytexOrtho to bring this much-needed technology to the clinic.
We founded CytexOrtho with the goal of solving orthopedic problems that currently have no solutions, and we are delighted that the FDA also recognizes that no approved or cleared alternatives currently exist in the market and that our technology has the potential to provide treatment for irreversibly debilitating hip osteoarthritis.
“It has been an exciting journey for our team, and it’s great to see that the FDA recognizes the potential for our technology to transform the way early hip disease is treated,” said Dr. Estes, CytexOrtho’s CEO. “We have published 20+ peer reviewed scientific papers documenting our technology and have protected our intellectual property with 5 US patents and 14 international patents, all of which further confirm the novelty of our approach.” Dr. Estes added, “We look forward to working closely with the FDA through this expedited review process to bring our technology to the millions of patients who urgently need solutions to treat their hip disease.”
CytexOrtho is poised to change the standard of care for young patients with a first-mover solution that addresses joint degeneration without the need for a premature joint replacement.
Our technology is targeted at young or active patients who are in need of alternatives to restore their hips instead of replacing them.
CytexOrtho products are future technologies, not approved by the FDA, and not commercially available. The innovations described above are all currently in development, and actual results may differ materially from anticipated results. Access to future technologies is contingent upon regulatory approval. Approval timelines are subject to the regulatory process of individual countries and regions and not guaranteed.