Cytori to Initiate U.S. Clinical Trial of Adipose-Derived Regenerative Cells in Hamstring Injuries

  Cytori to Initiate U.S. Clinical Trial of Adipose-Derived Regenerative Cells
  in Hamstring Injuries

Business Wire

SAN DIEGO -- January 13, 2014

Cytori Therapeutics (NASDAQ:CYTX) has received Investigational Device
Exemption (IDE) approval from the FDA to begin a prospective clinical trial to
evaluate the safety and feasibility of Cytori Cell Therapy as a potential
treatment for hamstring injuries. The trial, referred to as RECOVER, will
begin as a ten-patient, open label study in 2014. Following a 90-day
assessment of the first ten patients, Cytori is approved by the FDA to expand
RECOVER to a multi-dose, multi-center, double-blind, placebo-controlled trial.
Cytori Cell Therapy is derived from the Company’s Celution® System, which
enables access to a patient’s own adipose-derived regenerative cells (ADRCs)
at the point-of-care.

RECOVER will evaluate Cytori Cell Therapy in patients with Grade II tears of
the hamstring muscle. RECOVER will initially enroll ten patients in the United
States. The first ten patients will be given one of two doses of Cytori Cell
Therapy in an open-label manner, with the first five patients receiving the
lower dose and the second five patients receiving the higher dose. Once the
safety and feasibility of administering Cytori Cell Therapy has been confirmed
in the first ten patients (Part A), Cytori has the option to expand RECOVER to
include an additional 60-patients in the multi-center, double-blind,
placebo-controlled phase of the trial (Part B). The 60 patients would be
divided into three groups of 20 patients. Patients in a given group will
receive a lower dose, a higher dose or placebo. The study would assess safety
and tolerability and evaluate the effect of the cells on how fast the muscle
tear heals (ultrasound and MRI), muscle strength, muscle function and pain.
The timeline to complete the first phase of the study will be provided once
the trial is initiated and Cytori is able to forecast enrollment.

“We have been studying ADRCs in acute and chronic muscle injuries in the heart
for more than a decade and Cytori Cell Therapy is thought to play a role in
improving perfusion and reducing inflammation in damaged cardiac muscle,” said
Christopher J. Calhoun, Chief Executive Officer of Cytori. “Similarly, we
believe ADRCs could support healing in injured skeletal muscle such as that of
a hamstring injury. Initially, RECOVER involves a minimal, incremental
investment for the first ten patients. If successful, RECOVER may provide an
accelerated path to market in the U.S. targeting the millions of recreational
and professional sports injuries that occur each year.”

Cytori is building a cell therapy sports medicine business. In the U.S., the
Company is pursuing a clinical development strategy initially with the RECOVER
trial. Internationally, the Company is in the process of initiating two
multi-center registries for related indications in countries where the
Celution® System is available for commercial use. The ACHILLES Registry will
collect data from patients with muscle and ligament injuries treated with
Cytori Cell Therapy and the RELIEVE Registry will collect data from patients
with osteoarthritis. Both registries will collect patient data and may support
future regulatory and reimbursement efforts.

About Hamstring Injury

Hamstring injuries are a persistent problem among elite and amateur athletes
given the high incidence and recurrence rates, as well as the lengthy recovery
time. According to the Journal of Orthopaedic & Sports Physical Therapy,
nearly one third of hamstring injuries recur within the first year following a
return to sport, with subsequent injuries often being more severe than the
original.

About Cytori Cell Therapy and ADRCs

Cytori Cell Therapy is a proprietary formulation of a patient’s own
regenerative cells derived from their own adipose (fat) tissue that is
delivered in the same surgical procedure using the Company’s Celution® System.
Adipose tissue is the richest source of stem and regenerative cells in the
body. This mixed population of cells, collectively referred to as ADRCs, is
accessible at the point-of-care through the Celution® System for use in the
same patient, creating new treatment opportunities for currently unmet medical
needs. ADRCs collectively contribute to the healing process via cell-to-cell
signaling, supporting improved blood flow and regulation of the inflammatory
response.

About Cytori

Cytori Therapeutics is developing cell therapies based on autologous
adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and
other medical conditions. Our scientific data suggest ADRCs improve blood
flow, moderate the inflammatory response and keep tissue at risk of dying
alive. As a result, we believe these cells can be applied across multiple
“ischemic” conditions. These therapies are made available to the physician and
patient at the point-of-care by Cytori’s proprietary technologies and
products, including the Celution System product family. www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding future events
and expectations, including but not limited to our belief that Cytori Cell
Therapy could support healing in injured skeletal muscles, the potential for
RECOVER trial data to accelerate market access and the potential impact of
registry data on future regulatory or reimbursement efforts. These forward
looking statements involve risks and uncertainties, including the Company’s
ability to manage a multi-center clinical trial, regulatory uncertainties, the
performance of our products in skeletal muscles, dependence on third party
performance, as well as other factors which may be beyond the Company’s
control. For additional disclosure regarding these and other risks faced by
Cytori Therapeutics, we refer the reader to carefully review the section
titled "Risk Factors" in Cytori's filings with the SEC, including its annual
report on Form 10-K and subsequent quarterly reports on Form 10-Q. Cytori
assumes no responsibility to update any forward-looking statements contained
in this press release to reflect events, trends or circumstances after the
date of this press release.

Contact:

Cytori Therapeutics
Megan McCormick, +1-858-875-5279
mmccormick@cytori.com
 
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