Replies to post #17 on Nuo Therapeutics Inc. (fka NUOTQ)

[Telephonics]

I did my DD. Here is the approval statement

Cytomedix Chronic Wound Gel Gets FDA Clearance; Company Agrees to Post-Market Study


ROCKVILLE, Md. (AP) -- Biotechnology company Cytomedix Inc. said Thursday it received clearance from the Food and Drug Administration for its AutoloGel System, a gel for treating various types of chronic wounds.
As part of the clearance, Cytomedix has agreed to a post-market study to monitor the safety of bovine thrombin, a clotting agent derived from cows, as used in the AutoloGel System.

The gel produced by AutoloGel is designed to treat wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.

Last October, Cytomedix said the FDA denied the company's marketing claim that its AutoloGel wound treatment is equivalent to similar treatments on the market. The company appealed the decision and in response to the FDA's request, outlined a post-marketing surveillance study, addressing the FDA's concerns on the use of bovine thrombin

Where is this marketing approval limited??? Not only did the FDA approve its use they also approved it for more applications than the company asked for.
PLEASE REPLY! This is now the only FDA approved product that is used when all other wound health procedures have failed. Doctor's with such a patient to treat will not require much convincing at all.

[Telephonics]

More info for you.

Have you ever seen an emerging company with a full scale sales force in place before their product was approved for marketing by the FDA??

But also please note=
"The Company's clinical trial results demonstrate healing rates of 68% (p-value of 0.125) and 81% (p-value of 0.036) for AutoloGel(tm) treated patients achieving total wound closure in the per-protocol (i.e. patients treated as provided in the study protocol) and majority-wound (i.e. wound sizes smaller than 7 sq cm in the per-protocol cohort) groups respectively. These are higher healing rates than those in any other similar data for other chronic wound treatment products with which the Company is familiar.

Cytomedix plans to leverage AutoloGel(tm)'s position as the only FDA cleared PRP gel system with a specific wound indication, the compelling results of the Company's clinical trial, as well as the unique competitive advantages of the distinct, patented formulation of AutoloGel(tm). The Company believes marketing clearance would enhance the Company's ability to secure Medicare and other third party coverage for AutoloGel(tm); develop further marketing data and achieve broad clinical acceptance; and, address the needs of large numbers of patients; all critical factors to the achievement of the Company's long-term strategic goals.

[boomer23]

dreamz....this product has been in use for 15 years. The animal products used in A-gel were approved by the FDA over 25 years ago. This is the ONLY product approved by the FDA in wound care with a "specific indication for wound healing". The doctors understand this even if you don't. This is an extremely strong and broad endorsement from the FDA. As far a "sales team" being in place...don't look for one from GTF. There is a reason why GTF has never licensed A-gel specifically and yet has licensed all other fields of uses. Do your DD before YOU post such gibberish!!