BTX smart to get device approval in EU first....CYTX rejected by FDA
(Reuters) - A U.S. appeals court ruled on Friday that the Food and Drug Administration (FDA) acted correctly Medical device maker Cytori Therapeutics loses approval fight
(Reuters) - A U.S. appeals court ruled on Friday that the Food and Drug Administration (FDA) acted correctly when it denied fast-track approval of two stem cell-related medical devices made by Cytori Therapeutics Inc .
The FDA had reasonable evidence to find that the devices were not substantially equivalent to devices already on the market, according to the unanimous ruling from the U.S. Court of Appeals for the District of Columbia Circuit.
The FDA's decision meant that Cytori had to conduct extensive clinical research as part of premarket approval.
"This is an important step forward in our commercialization efforts and brings us closer to delivering this much-needed matrix technology for the emerging field of regenerative medicine," stated William P. Tew , PhD, Chief Commercialization Officer of BioTime, Inc. "The technology forms a foundation for the delivery of cell-based therapeutic products in both the adult and embryonic stem cell marketplace. Current preclinical studies at leading medical institutions have shown that HyStem® hydrogels are compatible with a wide variety of tissue types including brain, bone, skin, nerve, cartilage, and heart."
In the clinical application described in this CIP, ReneviaTM will be used as a delivery matrix for autologous adipose cells in order to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects. Restoration of the normal skin contour is an important quality-of-life issue, not only in elective cosmetic procedures, but also in reconstructive surgeries needed to repair deformities and traumatic injuries to the face and upper extremities. BioTime's plan is to bring ReneviaTM to the medical market first in the European Union , where the regulatory pathway will allow for faster approval. Once the use of ReneviaTM is established in Europe , BioTime plans to address an even larger potential market in the United States