Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that its
exclusive licensee, Lorem Vascular, has been granted regulatory
clearance for the Cytori Celution® System by the State Food and Drug
Administration of the People’s Republic of China (CFDA). This regulatory
clearance officially makes Cytori’s Celution System available in the
largest healthcare market in the world and triggers a substantial 2015
product purchase order for Cytori from Lorem Vascular.
Cytori’s exclusive licensee in the region, Lorem Vascular, has worked
closely with Cytori during the last year preparing for CFDA clearance
and planning for commercial introduction of the Celution family of
products in China. Today’s news marks the first time that Cytori’s
Celution System has gained any level of access to the mainland Chinese
healthcare market. Lorem Vascular will begin product launch of Celution
in key hospitals in China immediately.
“Our combined teams have spent the past year examining the delivery of
healthcare in China and it is clear that diseases endemic is western
countries are a rapidly growing burden on millions of citizens and
already represent a heavy drain on resources of the healthcare system,”
said David C. Oxley, Chief Executive Officer of Lorem Vascular. “With
CFDA clearance, Lorem Vascular will now begin to consummate partnerships
with key hospitals throughout China to address specific vascular and
non-vascular applications using patients’ own adipose derived
regenerative cells, which have demonstrated clinical promise in studies
around the world.”
In November 2013, Cytori Therapeutics and Lorem Vascular entered into a
30-year exclusive licensing agreement to commercialize Cytori Celution
System in China, Hong Kong, Malaysia, Singapore, and Australia. As part
of that agreement, Lorem Vascular agreed to pay up to $500 million in
fees to Cytori for a 30-year exclusive license for all indications,
excluding alopecia, in the licensed territories following specific
revenue milestones, as well as royalties of 30% on gross profits from
Lorem’s operations in China, Malaysia and Hong Kong. Furthermore,
following today’s news, Lorem Vascular placed an opening order of 23
Celution Devices and 1,100 Celution Consumable Sets, which is
anticipated to be fulfilled throughout 2015. Following this opening
order, Lorem Vascular has agreed to purchase annually a minimum of fifty
(50) Celution Devices and fifty (50) Celution Consumable Sets for each
of the Celution Devices for the next three years from CFDA clearance.
“Lorem Vascular’s commitment to the Chinese market, along with today’s
CFDA clearance and receipt of the opening order from Lorem Vascular is
an important part of our 2015 plan and a key milestone for the year,”
said Tiago Girao, Vice President of Finance and CFO of Cytori
Therapeutics. “We intend to continue our full support of Lorem Vascular
as it expands its commercial efforts throughout its territories in the
years ahead.”
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing
laboratory equipment and 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.
About Lorem Vascular
Lorem Vascular Pte. Ltd. is a leader in the new field of regenerative
medicine. Headquartered in Singapore, with offices in Australia, China,
Hong Kong, and Malaysia, Lorem Vascular is transforming the quality of
patient care by enabling hospitals and doctors to address a variety of
major vascular and non-vascular diseases using patients’ own cells.
Copyright Business Wire 2015