Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”)
today announced that the Company has received approval for the
Celution Cell Therapy System consumable bundle in Japan as a Class
III medical device. The Class III designation will allow Cytori to
expand its current commercial efforts in Japan and provides a clear
framework for future expanded regulatory claims and reimbursement
under the November 2014 PMD Act.
Furthermore, Cytori announced today that the Company has
successfully outsourced an important assembly portion of the
production process for its Celution Cell Therapy consumables from
San Diego, CA to Viant Medical in San Antonio, Texas. The first
consumable lots following this new process were shipped to
customers in November 2018.
“Obtaining Class III designation follows many months of
constructive interaction with the Japanese Ministry of Health,
Labour and Welfare following the approval of the 2014 PMD Act,”
said Marc H. Hedrick, MD, President and Chief Executive Officer of
Cytori Therapeutics. “This approval coupled with the outsourced
production allows Cytori to meet forecasted product demand,
particularly in Japan, and better prepares us for the data read out
in our Japan ADRESU pivotal trial next year.”
In Japan, Class III and Class IV medical devices require the
highest levels of safety and efficacy data In Japan. These devices
are also required to have special controls. Other such examples of
Class III medical devices include: hemodialysis equipment,
artificial bones and joints, mechanical ventilation apparatus, and
balloon catheters.
Cytori currently has a fully functional logistics, sales and
marketing team in Japan dedicated to commercialization of the
Celution Cell Therapy System. Cytori is forecasting double digit
growth in consumable utilization in Japan for 2018. Prior to the
class III approval, Cytori has been selling the Celution technology
mostly for aesthetic and orthopedic indications under a Class I
designation.
ADRESU is an investigator-initiated, multicenter, 45 patient,
open-label, single arm clinical trial of Cytori’s ECCI-50 cellular
therapeutic, comprised of Celution®-prepared autologous Adipose
Derived Regenerative Cells (ADRCs) and Adipose Cells for men with
stress urinary incontinence as a complication of prostate
intervention. A total of 45 patients, all treated in Japan,
were enrolled in this potential approval trial. One-year data
readout from ADRESU is anticipated in the first half of 2019.
The ADRESU trial was based on a promising pilot trial with
short-term data of 11 patients published in the International
Journal of Urology in 2014 and long-term data of 14 patients
presented at the International Continence Society in 2017, which
“demonstrated that transurethral injection of autologous ADRCs can
be a safe and effective treatment modality for postprostatectomy
incontinence”. Details of the ADRESU protocol and trial can
be found on BMC Urology, clinicaltrials.gov and
the University Hospital Medical Information Network
website.
The primary endpoint for the ADRESU trial is the percentage of
patients who experience greater than 50% reduction in urinary
leakage volume from baseline (as measured by the weight of
unintended urinary leakage over 24 hours) at 52 weeks after
treatment. A number of other key secondary endpoints are also being
assessed. If the primary endpoint is successfully achieved, the
data may be used to seek approval of ECCI-50 for this
indication.
The trial costs are substantially supported by the Japan Agency
for Medical Research and Development, an independent administrative
agency of the Government of Japan, with additional support from
Cytori. The trial is sponsored by the lead institution,
Nagoya University.
About ADRESU InvestigatorsThe ADRESU trial is
being led by Dr. Momokazu Gotoh at Nagoya University, Aichi,
Japan. The other participating investigators and institutes
include Dr. Kazutaka Narimoto at Kanazawa University Hospital
(Ishikawa, Japan), Dr. Osamu Ishizuka at Shinshu University
Hospital (Nagano, Japan) and Dr. Tomonori Yamanashi at Dokkyo
Medical University (Tochigi, Japan).
About Male Stress Urinary
IncontinenceMale stress urinary incontinence is a
post-surgical complication of radical prostatectomy and surgeries
for benign prostatic hyperplasia with limited treatment options,
representing an unmet medical need. In 2016, the Ministry of
Health, Labor and Welfare (MHLW) reported approximately 20,000
prostate cancer surgeries and 22,000 benign prostatic hyperplasia
procedures performed at Diagnostic Procedure Combination (DPC)
participating hospitals.
About Cytori Cell Therapy™Cytori is developing
cell therapies that harness the unique attributes of
adipose-derived regenerative cells (ADRCs), which are living cells
that are present in an adult human’s own adipose tissue.
Cytori Cell Therapy™ is a suspension of ADRCs that are
manufactured from a single lipoaspirate (material removed via
liposuction, a procedure in which fat is removed from under the
skin by suction). The process concentrates ADRCs intended for
autologous re-implantation subcutaneously into the digits. The
resultant cell suspension contains critical cells naturally
occurring in the patient’s own tissue. Preparation of autologous
ADRCs for subcutaneous delivery involves no cell culture and can be
prepared and re-implanted into the same patient within 4 hours
About Cytori Therapeutics, Inc.Cytori is
developing, manufacturing, and commercializing
nanoparticle-delivered oncology drugs and autologous
adipose-derived regenerative cell (ADRC) therapies within its
Nanomedicine™ and Cell Therapy™ franchises, respectively.
Cytori Nanomedicine™ is focused on the liposomal encapsulation of
anti-neoplastic chemotherapy agents, which may enable the effective
delivery of the agents to target sites while reducing systemic
toxicity. The Cytori Nanomedicine™ product pipeline consists
of ATI-0918 pegylated liposomal doxorubicin hydrochloride for
breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s
sarcoma, a complex/hybrid generic drug, and ATI-1123 patented
albumin-stabilized pegylated liposomal docetaxel for multiple solid
tumors. Cytori Cell Therapy™, prepared within several hours
with the proprietary Celution® System and administered to the
patient the same day, has been shown in preclinical and clinical
studies to act 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. For more information, visit
www.cytori.com.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release includes forward-looking
statements regarding events, trends and business prospects, which
may affect our future operating results and financial position.
Such statements, including, without limitation, conduct of clinical
trials involving our technology, clinical performance, product
approvals and product reimbursement, are all subject to risks and
uncertainties that could cause our actual results and financial
position to differ materially. Some of these risks and
uncertainties include, but are not limited to, inherent risk and
uncertainty in the protection intellectual property rights,
regulatory uncertainties, risks in the conduct of clinical trials,
risks in the collection and results of clinical data, final
clinical outcomes, dependence on third party performance,
performance and acceptance of our products in the marketplace, as
well as other risks and uncertainties described under the heading
"Risk Factors" in Cytori's Securities and Exchange Commission
Filings on Form 10-K and Form 10-Q. We assume no responsibility to
update or revise any forward-looking statements to reflect events,
trends or circumstances after the date they are made.
Investor Contact:Tiago GiraoCytori
Therapeutics, Inc. 1-858-458-0900 ir@cytori.com
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