UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 13, 2015
CYTORI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-34375 | 33-0827593 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
3020 Callan Road, San Diego, California 92121
(Address of principal executive offices, with zip code)
(858) 458-0900
(Registrant’s telephone number, including area code)
n/a
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events
On April 13, 2015, Cytori Therapeutics, Inc. (the “Company”) issued a press release announcing preliminary top-line 12 month follow-up data from the 12 patient investigator initiated Scleradec-I trial clinical trial conducted by Professor B. Granel and Professor G. Magalon from the Assistance Publique des Hôpitaux de Marseille. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Description | |
| Exhibit 99.1 | Cytori Therapeutics, Inc. Press Release, dated April 13, 2015 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CYTORI THERAPEUTICS, INC. | ||||||
| Date: April 13, 2015 | By: /s/ Tiago Girao | |||||
| Tiago Girao | ||||||
| VP Finance and Chief Financial Officer | ||||||
Exhibit Index
| Exhibit Number |
Description | |
| Exhibit 99.1 | Cytori Therapeutics, Inc. Press Release, dated April 13, 2015 | |
Exhibit 99.1
Cytori Provides Twelve Month Data Update on Scleradec-I Trial
April 13, 2015
SAN DIEGO — Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today preliminary 12 month follow-up data from the 12 patient investigator initiated Scleradec-I clinical trial conducted by Prof. B. Granel and Prof. G. Magalon from the Assistance Publique des Hôpitaux de Marseille.
In the previously published six month follow-up data, Cytori’s ECCS-50 therapeutic showed:
| • | Improvement in Cochin Hand Function Scale (CHFS) from mean of 48.5 at baseline to 21.2 at six months |
| • | Improvement in Hand Pain (Visual Analog Scale) from mean of 59.4 at baseline to 17.8 at six months |
| • | Improvement in Raynaud’s Condition Score (RCS) from mean of 7.2 at baseline to 2.9 at six months |
| • | Improvement in Scleroderma Health Assessment Questionnaire (SHAQ) score from mean of 1.4 at baseline to 0.8 at six months |
The manuscript describing these data in detail can be viewed at http://ard.bmj.com/content/early/2014/08/10/annrheumdis-2014-205681.long.
A preliminary assessment for 12 month follow-up data has been reviewed by the Company which management believes reflects:
| • | No reports of adverse events or safety concerns |
| • | Average values for CHFS, RCS, and SHAQ score are statistically consistent with those at the 6 month follow up visit |
| • | While the average hand pain at 12 months was lower than that at baseline (reflecting overall symptom improvement over baseline), there was an approximately 50% reduction in the average therapeutic benefit on hand pain from six to twelve months |
The investigators have prepared and submitted for publication a scientific manuscript based on final 12 month data. Once this manuscript has been accepted for publication and a publication date announced, Cytori will provide an update to investors.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
Cytori Therapeutics, Inc.
Shawn Richardson, 1.858.875.5279
ir@cytori.com