formarlogotake2grey-minPreserve 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 20-40 Million Americans suffering with arthritic joint pain an Early Intervention solution. As an FDA designated breakthrough device, we are on the brink of FDA approval and are expanding our medical community.

Are you interested in receiving training to install our CyborGel® hydrogel implant system?

Orthopedic Surgeon performing Arthroscopic Joint Resurfacing with CyborGel

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?

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Formae's CyborGel Synthetic Cartilage Implant System, 
FDA Designated Breakthrough Device

 

Formae’s CyborGel® biomimetic cartilage implant system is filling the treatment gap at long last. As an FDA designated breakthrough device, we are on the brink of FDA approval and are expanding our medical community.
 
 

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The CG implant is designed for installation earlier in the disease process, before bone deformity and irreversible joint destruction. CG studies have documented the implant’s durability to bear the maximum load capacity of the knee joint. In a study in a large animal model (sheep) in Colorado, the CG implant 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 heals to the bone.

 

procedure

 

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*GLP Mode I Knee Simulated Tribology:
Gravimetric Archimede's CyborGel Synthetic Cartilage hits 10M cycles with no progressive wear.

 

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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. These results are very optimistic towards viability for a longterm, early intervention solution to Osteoarthritis, and an indefinite postponement of the clinical need for a total joint replacement.

 

 

A Note from our Founder & CEO


 

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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 filling the treatment gap by offering immediate pain relief and the delay / potentially indefinite prevention of 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, with reproducible and minimally invasive surgical technique, stable bone healing fixation, and clinical longevity. We have utilized and contributed to advancements in Arthroscopic Surgery to develop a minimally invasive procedure with a short recovery period, allowing patients to walk unassisted the same day as the procedure. I am honored to present CyborGel® to you today.

 

fdaduediligence

 

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Join our Mailing List of Providers to learn about CyborGel Implant System and Surgical Tools
 

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?

 

CG_whitewlogo

Formae's CyborGel Synthetic Cartilage Implant System, 
FDA Designated Breakthrough Device

Formae’s CyborGel® biomimetic cartilage implant system is filling the treatment gap at long last.

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 20-40 Million Americans suffering with arthritic joint pain an Early Intervention solution. 

 

 
 
 
 
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CyborGel® Synthetic Cartilage Implant System has been developed for anatomic joint resurfacing, utilizing a minimally invasive procedure with an accelerated recovery rate.
 
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CyborGel® is a flexible, tough, durable, and lubricious hydrogel, which mimics the structure, microanatomy, and functional performance of natural joint cartilage.
 
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CyborGel® is currently produced in three different sizes (12mm, 16mm, and 20mm) for a range of application. While CyborGel‘s knee surface conformed gel was designed as an early treatment option for Osteoarthritis of the knee, our state of the art hydrogel is applicable for use in any joint.
 
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CyborGel® implant system is comprised of a *knee surface conformed Synthetic Cartilage Implant (SCI) with a weight bearing surface, mounted on a 3D printed Trabecular Porous Metal (TPM) anchor that promotes osseointegration to organically fuse the implant in place.

 

 

 

Material_properties_5.2cg1

 

The CG implant is designed for installation earlier in the disease process, before bone deformity and irreversible joint destruction. CG studies have documented the implant’s durability to bear the maximum load capacity of the knee joint. In a study in a large animal model (sheep) in Colorado, the CG implant 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 heals to the bone.

 

procedure_mobile2

 

no-progressive-wear_mobile1-1

*GLP Mode I Knee Simulated Tribology:
Gravimetric Archimede's CyborGel Synthetic Cartilage hits 10M cycles with no progressive wear.

 

masswearrate_5.10-1

 

 

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. These results are very optimistic towards viability for a longterm, early intervention solution to Osteoarthritis, and an indefinite postponement of the clinical need for a total joint replacement.

CG_white2
 

 

 

A Note from our Founder & CEO


 

kevinmansmann_note-1

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 filling the treatment gap by offering immediate pain relief and the delay / potentially indefinite prevention of 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, with reproducible and minimally invasive surgical technique, stable bone healing fixation, and clinical longevity. We have utilized and contributed to advancements in Arthroscopic Surgery to develop a minimally invasive procedure with a short recovery period, allowing patients to walk unassisted the same day as the procedure. I am honored to present CyborGel® to you today.

 

CG_white_new3

 

 

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.

 
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