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Re: pharma_trader post# 83868

Wednesday, 10/29/2014 12:33:00 PM

Wednesday, October 29, 2014 12:33:00 PM

Post# of 97239
CYTX, .49 bounce play. Closed financing on Oct 10th, recently received FDA approval to resume Athena Trial (news below). Chart:

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Cytori Therapeutics Receives FDA Approval to Resume ATHENA Trial Enrollment
6:18p ET October 22, 2014


Cytori Therapeutics, Inc. (NASDAQ: CYTX) has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials.

The ATHENA trials have enrolled a total of 31 patients thus far but enrollment was stopped last May by the company based on meeting the trials' internal stopping rules related to potential cerebrovascular events affecting both cell and placebo treated patients.

Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. In addition, Cytori implemented several protocol changes to enhance the safety of the trial procedures for patients. The FDA response to Cytori's submission was received on October 22, 2014.

"Cytori is first and foremost focused on patient safety in all its endeavors, and we are pleased to have successfully navigated this issue. Such issues are not uncommon in development programs involving novel technology for a severely ill population," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "Currently, we are assessing what this delay means for this particular trial and will provide an updated plan on our forthcoming quarterly investor call."


Cytori Therapeutics, Inc. Announces Closing of Financing
4:05p ET October 10, 2014



Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that it has completed the previously announced sale of shares of its Series A 3.6% convertible preferred stock pursuant to a registered direct offering representing gross proceeds of approximately $13.5 million. The preferred stock is convertible into shares of Cytori's common stock at the option of the investors at a conversion price of $0.52. Cytori also issued warrants to purchase an aggregate of 25,961,541 shares of Cytori's common stock at an exercise price of $0.5771 per share in the offering.

Cytori plans to use the net proceeds from this offering for working capital and general corporate purposes, which include funding its ongoing and future clinical studies.

Roth Capital Partners acted as the lead placement agent for the offering and Maxim Group LLC served as a co-placement agent for the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of Cytori, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. This press release is being issued pursuant to and in accordance with Rule 134 under the Securities Act of 1933, as amended.
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