Thank you for your interest in Fomae’s CyborGel®. 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.
Formae's CyborGel Synthetic Cartilage Implant System,
FDA Designated Breakthrough Device
CyborGel® has been engineered to mimic and reproduce the structure, microanatomy, and functional performance of natural joint cartilage, while utilizing advancements in Arthroscopy and Resurfacing Implants for a minimally invasive procedure that would allow patients to walk unassisted the same day of installation.
⦾ Resurface damaged articular cartilage with our Biomimetic CyborGel® implant system for functional joint restoration.
⦾ Provide immediate pain relief from arthritic bone-on-bone wear.
⦾ Reduce progressive deterioration of synovial joints, thereby forestalling the clinical need for Total Joint Replacement, indefinitely.
Osteoarthritis impacts the everyday quality of life for 20-40 Million Americans and around 500 Million people worldwide (7% of the global population). However the standard of care has not significantly changed in over 40 years.
Patients are encouraged to manage their pain with painkillers or steroids until the progressive degeneration of the disease necessitates a Total Knee Replacement, an invasive procedure that sets patients back upwards of $50K and a 6 to 12 week (and potentially longer) recovery period.
It’s no surprise that upwards of 2 Million American patients are delaying treatment every year, and with good reason. There is a huge gap in Early Intervention and Preventative Treatment options for patients suffering with OA. We’ve identified this need and believe our patented Arthroscopic Joint Resurfacing implant, CyborGel®, is the solution.
Our Solution:
Our CyborGel® biomimetic implant system utilizes a 3D printed Trabecular Porous Metal Anchor, facilitating osseointegration (bone ingrowth) for stable bone healing fixation. Our hydrogel synthetic cartilage has endured over 10M cycles (and counting) without progressive wear. The average person walks 1M cycles in a year.
*GLP Mode I Knee Simulated Tribology:
CyborGel Synthetic Cartilage hits 10M cycles without progressive wear.
A ten year solution to OA is already viable for the marketplace. But testing is ongoing and our CyborGel implants are holding strong. This means CyborGel could very well be a permanent solution to Osteoarthritis of the knee and delay the need for a Total Knee Replacement indefinitely.
The 1.7M patients actively delaying TKR indicate an immediate marketplace viability for CyborGel as a revolutionary Early Treatment Option for OA, even before we consider the patients undergoing a TKR (~800,000 / yr) that would be thrilled to have an alternative. At a $5K ASP, those 1.7M convert to a $8.5B Market. But if we zoom out further to include potential forays into Veterinary Medicine and ultimately the expansion of CyborGel techonology to address OsteoArthritis of all joints (the shoulder, hip, wrist, and ankle), well this is just the start.
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Thank you for your interest in Fomae’s CyborGel®. 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.
Formae's CyborGel Synthetic Cartilage Implant System,
FDA Designated Breakthrough Device
CyborGel® has been engineered to mimic and reproduce the structure, microanatomy, and functional performance of natural joint cartilage, while utilizing advancements in Arthroscopy and Resurfacing Implants for a minimally invasive procedure that would allow patients to walk unassisted the same day of installation.
The ultimate goals of this joint sparing procedure are to:
⦾ Resurface damaged articular cartilage with our Biomimetic CyborGel® implant system for functional joint restoration.
⦾ Provide immediate pain relief from arthritic bone-on-bone wear.
⦾ Reduce progressive deterioration of synovial joints, thereby forestalling the clinical need for Total Joint Replacement, indefinitely.
Osteoarthritis impacts the everyday quality of life for 20-40 Million Americans and around 500 Million people worldwide (7% of the global population). However the standard of care has not significantly changed in over 40 years.
Patients are encouraged to manage their pain with painkillers or steroids until the progressive degeneration of the disease necessitates a Total Knee Replacement, an invasive procedure that sets patients back upwards of $50K and a 6 to 12 week (and potentially longer) recovery period.
Our Solution:
Our CyborGel® biomimetic implant system utilizes a 3D printed Trabecular Porous Metal Anchor, facilitating osseointegration (bone ingrowth) for stable bone healing fixation. Our hydrogel synthetic cartilage has endured over 10M cycles (and counting) without progressive wear. The average person walks 1M cycles in a year.
*GLP Mode I Knee Simulated Tribology:
CyborGel Synthetic Cartilage hits 10M cycles without progressive wear.
A ten year solution to OA is already viable for the marketplace. But testing is ongoing and our CyborGel implants are holding strong. This means CyborGel could very well be a permanent solution to Osteoarthritis of the knee and delay the need for a Total Knee Replacement indefinitely.
The 1.7M patients actively delaying TKR indicate an immediate marketplace viability for CyborGel as a revolutionary Early Treatment Option for OA, even before we consider the patients undergoing a TKR (~800,000 / yr) that would be thrilled to have an alternative. At a $5K ASP, those 1.7M convert to a $8.5B Market. But if we zoom out further to include potential forays into Veterinary Medicine and ultimately the expansion of CyborGel technology to address OsteoArthritis of all joints (the shoulder, hip, wrist, and ankle), well this is just the start.
