CytexOrtho gains approval to proceed with human clinical trials
Durham-based CytexOrtho, a company working to advance orthopedic joint preservation, has received approval from the U.S. Food and Drug Administration (FDA) to begin a first-in-human clinical study to evaluate the safety and efficacy of its ReNew Hip Implant cartilage repair technology.
The ReNew Hip Implant uses a unique, highly porous, bioabsorbable device designed to mimic the properties of healthy articular cartilage. The device provides instant structural support while promoting the body’s natural regenerative, healing processes to restore the joint.
“The FDA’s approval of this first human clinical trial brings us closer to delivering new options to
the clinic for patients with hip disease,” said Brad Estes, Ph.D., CEO and co-founder of CytexOrtho. “Our ReNew Hip Implant aims to change the game by restoring the joint’s anatomical contour with natural tissue regeneration.”
Restoring joints instead of replacing
If successful, the technology could offer a much-needed treatment option for the more than one million Americans under the age of 65 who suffer from chronic hip pain. Many of these patients avoid hip replacements because of concerns about the high risk of implant wear and future implant revisions. Plus, they don’t want to reduce high-impact activities that must be avoided to extend the implant’s lifespan. Most active patients won’t settle for that quality-of-life change until they have no other options.
The phase I clinical trial will include up to 15 patients who are 14-to-55 years old with hip disease and loss of articular cartilage integrity on the femoral head. The study will be used to establish the safety of the implant and its ability to improve pain and function over 12 months. Patients will be followed for 60 months after the implant surgery.
“We believe the ReNew Hip Implant has tremendous potential to solve a very difficult hip problem where loss of cartilage occurs in the hip joint,” said Jeff Nepple, M.D., assistant professor of orthopedics at Washington University School of Medicine. “The ReNew Hip implant has a rich pre-clinical validation of its potential to harness the body’s own healing potential to enable cartilage regrowth.”
The ReNew Hip implant integrates a 3D-woven textile and a high-precision Tru3D printed component to form an implant that recreates the form and contour of a healthy articular joint surface while mimicking the function of articular cartilage and bone. Because the implant restores the joint to its proper form and contour, only the damaged tissue needs to be removed. Over time, cells will begin to grow in the gaps of the implant, gradually forming functional tissue as the implant is slowly absorbed into the body.
A Duke University spin-off
CytexOrtho was founded out of Duke University by Estes, Farshid Guilak, Ph.D., chair of the CytexOrtho board, and Frank Moutos, Ph.D., the company’s vice president of technology development. Previously a professor at Duke University Medical Center, Guilak and his team developed the implant technology that won the Duke Start-Up Challenge, leading to the establishment of CytexOrtho after Estes and Moutos received their doctorates in biomedical engineering from Duke.
CytexOrtho has received $18.4 million in competitive grant funding from the National Institutes of Health to develop the ReNew Hip implant. The North Carolina Biotechnology Center also awarded the company a Small Business Research Loan of $250,000 in June 2022 and a $350,000 Small Business Research Loan earlier in 2024 to support the first-in-human clinical studies.
“NCBiotech has been an invaluable partner to us,” said Estes. “The funding provided by the research loans has provided critical capital, helping us reach a stage where our clinical projects are ready to take on private investment. Beyond funding, NCBiotech has also provided valuable advice, connections, and encouragement. They have truly been an outstanding resource for us!”
The ReNew Hip implant received FDA Breakthrough Device designation in early 2023. This designation accelerates the development and review process for innovative medical technologies with the potential to significantly improve patient outcomes, enabling quicker access to essential treatments.
Read more about CytexOrtho and the ReNew Hip technology:
CytexOrtho wins first-ever OrthoPitch Technology Competition
CytexOrtho Developing Innovative Alternative to Hip Replacement Surgery