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
Formae, Inc’s CyborGel® is a novel, biomimetic hydrogel cartilage implant system designed by leading specialists. It is being studied for the treatment of progressive and post-traumatic Osteoarthritis with the goal of resurfacing and helping to replace the irreversibly damaged cartilage in synovial joints, such as the knee.
CyborGel® has been engineered to mimic and reproduce the structure, microanatomy, and functional properties of natural joint cartilage. It is being investigated for a minimally invasive procedure (Arthroscopy) with the goal of supporting a rapid recovery that would potentially enable patients to walk unassisted the same day of installation.
⦾ Help resurface damaged articular cartilage with our Biomimetic CyborGel® implant system, with the goal of functional joint restoration.
⦾ Help provide pain relief from arthritic bone-on-bone wear.
⦾ Help reduce progressive deterioration of synovial joints, thereby supporting to reduce the clinical need for Total Joint Replacement.
Osteoarthritis impacts the everyday quality of life for 20 Million Americans and around 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 system, CyborGel®, has the potential to bridge this long-standing Treatment Gap.
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 properties of natural joint cartilage. It is being investigated for a minimally invasive procedure (Arthroscopy) with the goal of supporting a rapid recovery that would potentially enable patients to walk unassisted the same day of installation.
The ultimate goals of this joint sparing procedure are to:
⦾ Help resurface damaged articular cartilage with our Biomimetic CyborGel® implant system, with the goal of functional joint restoration.
⦾ Help provide immediate and long-lasting pain relief from arthritic bone-on-bone wear.
⦾ Help reduce progressive deterioration of synovial joints, thereby delaying the clinical need for Total Joint Replacement.
Osteoarthritis impacts the everyday quality of life for 20 Million Americans and around 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.
CyborGel® biomimetic implant system utilizes a 3D printed Trabecular Porous Metal Anchor™, designed to support osseointegration (bone ingrowth) for stable bone-implant fixation. In independent Exponent preclinical trials at Colorado State University, our hydrogel synthetic cartilage endured over 10M cycles 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.
Initial testing indicates the potential for a long term solution to OA. 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, the durability of our CyborGel implants suggests the potential to be a long-term solution to Osteoarthritis of the knee and to help delay the need for a Total Knee Replacement.
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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.
The 1.7M patients actively delaying TKR indicate a significant market need for a Early Intervention 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 potential $3.5B Market. If we expand to include potential forays into Veterinary Medicine and ultimately the expansion of CyborGel techonology to address Osteoqrthritis of all joints (the shoulder, hip, wrist, and ankle), the opportunities are substantial, expanding towards an $8.5B Market.
Using FDA approved protocols, CyborGel® demonstrated successful Animal Studies, Wear, Failure Mode and comprehensive Bio-compatability testing. CyborGel® has received FDA “Breakthrough Device Designation”. Formae is now focused on the final FDA independent testing necessary for authorization to launch human clinical trials.
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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.
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.
.png?width=1360&height=1017&name=osseointegration-in-sheep2%20(1).png)
Using FDA approved protocols, CyborGel® demonstrated successful Animal Studies, Wear, Failure Mode and comprehensive Bio-compatability testing. Formae is now focused on the final FDA independent testing necessary for authorization to launch human clinical trials.
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.
Using FDA approved protocols, CyborGel® demonstrated successful Animal Studies, Wear, Failure Mode and comprehensive Bio-compatability testing. CyborGel® has received FDA “Breakthrough Device Designation”. Formae is now focused on the final FDA independent testing necessary for authorization to launch human clinical trials.
