CYTORI THERAPEUTICS, INC. (NASDAQ:CYTX) Files An 8-K Other Events
Item 8.01.Other Events.

On March 13, 2018, Cytori Therapeutics, Inc. (the “Company” or “Cytori”) met with the U.S. Food and Drug Administration (“FDA”) to discuss the outcome of the STAR (Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells) clinical trial and the Company’s plans for Habeo Cell Therapy.The STAR trial was a prospective, double-blind, randomized, multicenter, parallel-group Phase III pivotal study assessing the safety and efficacy of a single, subcutaneous administration of Habeo Cell Therapy, a Cytori Cell Therapy based candidate, into the fingers of patients with hand dysfunction due to scleroderma.At the meeting, the FDA provided verbal feedback that was generally consistent with the Company’s belief that a clinical trial focused on more severely affected diffuse systemic sclerosis patients could be an appropriate next step given the results of the STAR clinical trial.The Company intends to finalize meeting minutes and pursue additional dialogue with the FDA to clarify the parameters and key aspects of a potential follow-on clinical trial of Habeo Cell Therapy before making financial commitments to further pursue a follow-on clinical trial.

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Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K includes forward-looking statements regarding events, trends and business prospects, which may affect Cytori’s future operating results and financial position. Such statements, including, but not limited to, statements regarding the Cytori’s plans to pursue dialogue with the FDA and possible future clinical trials of Habeo Cell Therapy that could cause Cytori’s actual results and financial position to differ materially. These risks and uncertainties include inherent uncertainties in the conduct of clinical studies and trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Cell Therapy), risks associated with clinical use of Cytori Cell Therapy in studies and trials not controlled by Cytori, risks to Cytori’s intellectual property portfolio, the risk that Habeo Cell Therapy may never be successfully commercialized or receive anticipated levels of commercial acceptance, risks associated with Cytori’s ability to raise additional funding that it may need to continue to pursue any follow-on clinical trials, and other risks described under the heading “Risk Factors” in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date hereof.

About CYTORI THERAPEUTICS, INC. (NASDAQ:CYTX)

Cytori Therapeutics, Inc. (Cytori) is a biotechnology company engaged in the development of treatments and devices for a range of disorders using cells as a key part of the therapy. The Company develops cellular therapeutics formulated and optimized for specific diseases and medical conditions and related products. It is focused on developing primary product, Cytori Cell Therapy, for patients with scleroderma hand dysfunction, orthopedic disorders, cardiovascular disease, urinary incontinence and thermal burns, including those complicated by radiation. Its cellular therapeutics are collectively known by the name, Cytori Cell Therapy, which consists of a heterogeneous population of specialized cells, including stem cells that are involved in response to injury, repair and healing. These cells are extracted from an adult patient’s own adipose tissue using its automated, enzymatic, sterile Celution System devices and consumable sets at the place where the patient is receiving their care.