Curasan AG, a leading specialist for medical products in the field of orthobiologics, has received the market clearance of the Food and Drug Administration (FDA) and thus the authorization to market its synthetic bone regeneration material CERASORB Ortho FOAM in the United States.
The innovative product made of resorbable ceramic and porcine collagen can now be used for bone defect treatment in extremities and pelvis on the US market as well as in all other countries where the FDA certification is recognized.
Curasan has been actively preparing the market launch of the product in recent months. Back in May, Shane Ray, an experienced orthopedic regenerative medicine sales and marketing executive, was appointed as the President of the US subsidiary curasan, Inc.
The FDA approval of CERASORB Ortho FOAM is an extremely important milestone for us in the re-orientation of our US business, which will open up a potential market worth more than US$ 900 million,” emphasized Michael Schlenk, CEO of curasan AG. “Even before the approval, major customers indicated during exploratory discussions that the flexible and mouldable version of CERASORB meets the demands of the US customers perfectly, much more so than any of our other products.”
Shane Ray, President of the US subsidiary curasan, Inc.
Ahead of the market launch of the product the American subsidiary also successfully completed its structural reorganization in the fourth quarter to align the ability to be successful in dental and orthopedics business within North America.
”Being able to report this important strategic milestone in the fourth quarter is due to the profound expertise of our internal approval department, which was optimally prepared for the dialogue with the FDA and could answer all of their questions quickly. I’m very proud of our team!”
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