Preserve the joint.
CyborGel® is a novel, biomimetic hydrogel cartilage implant designed for the treatment of progressive and post-traumatic Osteoarthritis. Formae is looking to revolutionize the standard of care for OA of the knee and provide the 20 Million Americans suffering with arthritic joint pain an Early Intervention solution. As an FDA designated breakthrough device, we are expanding our medical community as we move through the review process.
Are you interested in receiving training to install our CyborGel® Synthetic Cartilage Implant System?
Thank you for your interest in Fomae’s CyborGel®. As you may be aware, there is currently a “Treatment Gap” with no reliable treatment options for early osteoarthritis to predictably forestall or prevent progression towards the clinical need for a total joint replacement.
What treatment options do you currently have when scoping a middle aged knee and discovering focal bone defects? How frequently does this occur, despite extensive screening with weight bearing X-rays and MRI’s?
Formae's CyborGel Synthetic Cartilage Implant System,
FDA Designated Breakthrough Device
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The CG implant is designed for installation earlier in the disease progression, before bone deformity and irreversible joint destruction. Independent Exponent studies have evaluated the implant’s durability to bear the maximum load capacity of the knee joint. In a study in a large animal model (sheep) at Colorado State University, CyborGel implant system was successfully used to re-surface a portion of the knee joint. The results showed that the implant can be successfully delivered and secured, and that the anchor successfully integrates with the bone across 18/18 sheep.
*GLP Mode I Knee Simulated Tribology:
Gravimetric Archimede's CyborGel Synthetic Cartilage hits 10M cycles with no progressive wear.
We have rigorously tested Formae’s CyborGel® Synthetic Cartilage through Simulated Knee Tribology. To date, we have recorded 10M cycles with no progressive wear. The average person walks 1 Million cycles in a year. While CyborGel®'s safety and effectiveness in humans have not been established, and favorable preclinical results do not guarantee favorable results in human clinical studies, these results are very optimistic towards a potential long term solution to Osteoarthritis and to help delay the clinical need for a Total Knee Replacement.
The Delivery — Optimized for Surgical Usability
Designed for seamless OR integration, CyborGel's single-step press-fit delivery requires minimal instrumentation. BC Surgeons demonstrated an immediate learning curve in a cadaveric model, reducing implantation times to as little as 4 min: 10 sec by their third use.
An independent 1 year Pivotal study at Colorado State University, demonstrated the implant “produces high quality integration between the device and surrounding native bone in 18 of 18 sheep, demonstrating the potential to provide a secure, cartilage bearing surface capable of remaining in the joint space for a minimum of 52 weeks without demonstrating wear.
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A Note from our Founder & CEO
As I began my journey as an Orthopedic Surgeon specializing in sports & arthritis, I quickly became frustrated by the limited Early Intervention and Preventative Treatment options for Osteoarthritis of the knee, before a total knee replacement becomes absolutely necessary. Filling this treatment gap has become the focus of my career. And after two decades of work and innovation, I’m proud to say, CyborGel is being studied to address the treatment gap by helping to provide pain relief and the potential to delay osteoarthritic degeneration towards the clinical need for a total joint replacement.
Our hydrogel is the culmination of my experience as a surgeon and of 25+ years of rigorous trials in order to identify, verify and reproduce a tough, lubricious biomimetic cartilage. The procedure is designed to use a reproducible and minimally invasive surgical technique, and is being studied for its potential to support stable bone healing fixation and clinical longevity. We have utilized and contributed to advancements in Arthroscopic Surgery to develop a minimally invasive procedure, with the goal of supporting a short recovery period and enabling patients to walk unassisted the same day as the procedure. I am honored to present CyborGel® to you today.
Join our list of medical providers to receive exclusive access to our provider portal, including CyborGel® procedural models, information on past and upcoming trials, and additional medical resources.
Are you interested in receiving procedural training to install our CyborGel® hydrogel implant system?
Thank you for your interest in Fomae’s CyborGel®. As you may be aware, there is currently a “Treatment Gap” with no reliable treatment options for early osteoarthritis to predictably forestall or prevent progression towards the clinical need for a total joint replacement.
What treatment options do you currently have when scoping a middle aged knee and discovering focal bone defects? How frequently does this occur, despite extensive screening with weight bearing X-rays and MRI’s?
Formae's CyborGel Synthetic Cartilage Implant System,
FDA Designated Breakthrough Device
Formae’s CyborGel® biomimetic cartilage implant system has the potential to fill the treatment gap. As an FDA designated breakthrough device, we are expanding our medical community so this technology is accessible to those in need.
CyborGel® is a novel, biomimetic hydrogel cartilage implant designed for the treatment of progressive and post-traumatic Osteoarthritis of the knee.
Formae is looking to revolutionize the standard of care for OA and provide the 20 Million Americans suffering with arthritic joint pain an Early Intervention solution.
.png?width=590&height=496&name=%E2%80%9CDial%20In%E2%80%9D%20Joint%20Cartilage%20Properties%20(5).png)
The CG implant is designed for installation earlier in the disease process, before bone deformity and irreversible joint destruction. Independent Exponent studies have documented the implant’s durability to bear the maximum load capacity of the knee joint. In a year-long study in a large animal model (sheep) at Colorado State University, the CyborGel implant system was successfully used to re-surface a portion of the knee joint. The results showed that the implant can be successfully delivered and secured, and that the anchor successfully integrated to the bone across 18/18 sheep.
The Delivery — Optimized for Surgical Usability
Designed for seamless OR integration, CyborGel's single-step press-fit delivery requires minimal instrumentation. BC Surgeons demonstrated an immediate learning curve in a cadaveric model, reducing implantation times to as little as 4 min: 10 sec by their third use.
An independent 1 year Pivotal study at Colorado State University, demonstrated the implant “produces high quality integration between the device and surrounding native bone in 18 of 18 sheep, demonstrating the potential to provide a secure, cartilage bearing surface capable of remaining in the joint space for a minimum of 52 weeks without demonstrating wear.
*GLP Mode I Knee Simulated Tribology:
Gravimetric Archimede's CyborGel Synthetic Cartilage hits 10M cycles with no progressive wear.
We have rigorously tested Formae’s CyborGel® synthetic cartilage through Simulated Knee Tribology. To date, we have recorded 10M cycles (and counting) with no progressive wear. The average person walks 1 Million cycles in a year. While CyborGel®'s safety and effectiveness in humans have not been established, and favorable preclinical results do not guarantee favorable results in human clinical studies, these results are very optimistic, and the device is being investigated as a potential long term, early intervention solution to Osteoarthritis and to help delay the clinical need for a Total Joint Replacement.
A Note from our Founder & CEO
As I began my journey as an Orthopedic Surgeon specializing in sports & arthritis, I quickly became frustrated by the limited Early Intervention and Preventative Treatment options for Osteoarthritis of the knee, before a total knee replacement becomes absolutely necessary. Filling this treatment gap has become the focus of my career. And after two decades of work and innovation, I’m proud to say, CyborGel is being studied to address the treatment gap by helping to provide pain relief and the potential to delay osteoarthritic degeneration towards the clinical need for a total joint replacement.
Our hydrogel is the culmination of my experience as a surgeon and of 25+ years of rigorous trials in order to identify, verify and reproduce a tough, lubricious biomimetic cartilage. The procedure is designed to use a reproducible and minimally invasive surgical technique, and is being studied for its potential to support stable bone healing fixation and clinical longevity. We have utilized and contributed to advancements in Arthroscopic Surgery to develop a minimally invasive procedure, with the goal of supporting a short recovery period and enabling patients to walk unassisted the same day as the procedure. I am honored to present CyborGel® to you today.
Join our list of medical providers to receive exclusive access to our provider portal, including CyborGel® procedural models, information on past and upcoming trials, and additional medical resources.
