Southbury, CT, November 12, 2009 – Doctors Research Group, Inc. announced today that it has received 510(k) approval from the U.S. Food and Drug Administration (FDA) to market KRYPTONITE™ Bone Cement for cranioplasty applications.
KRYPTONITE™ Bone Cement represents a major advancement in treating cranial defects due to trauma and surgery and is the first non-toxic, low exotherm cement and bone void filler approved for cranioplasty applications that offers strong adhesive properties to organic and inorganic materials. For more than six decades, surgeons have been using products containing polymethyl methacrylate (PMMA), a brittle, non-adhesive thermoplastic filler that cures in the body at high temperatures, capable of causing necrosis to surrounding tissue. Additionally, previous treatment options presented environmental hazards to medical personal due to the toxic fumes released during mixing and preparation. KRYPTONITE™ Bone Cement eliminates these hazards.
On sale for several years in Europe, and more recently in Canada, Latin America and Australia, KRYPTONITE™ Bone Cement is a self-setting bone cement formed by combining three naturally occurring components to create an adhesive, low exotherm, non-toxic bone repair solution that cures with porous properties and is engineered to mimic natural bone. KRYPTONITE™ Bone Cement polymerizes in stages, offering surgeons the option to inject it as a liquid, to secure bone-to-bone adhesion, or to shape it as a moldable putty, to create form fitting plates which eliminate the need for painful bone grafts that prolong patient recovery times.
“This represents an enormous step for surgical options and patient recovery,” said Richard J. Deslauriers, MD, President and CEO of Doctors Research Group. “The Company has invested considerable time, money and resources in developing a new and effective bone repair solution that is safer and more effective.”
Doctors Research Group intends to begin marketing KRYPTONITE™ Bone Cement to U.S. surgeons and hospitals immediately.
Doctors Research Group, Inc. is a privately held biomedical company located in Southbury, Connecticut. KRYPTONITE™ Bone Cement is a resinous material for repairing cranial defects.