| Beijing,
China -July 8, 2008 - Applied Harmonics
Corporation (AHC), a pioneer in
developing medical laser systems
for the surgical treatment of enlarged
prostate, today announced that it
has received approval from China's
State Food and Drug Administration
(SFDA) to market its proprietary,
high-powered green laser system
in China. With the approval, AHC
will immediately commence the marketing
of its laser system in China.
Enlarged
prostate, also known as benign prostatic
hyperplasia (BPH), is the second
most common disease for men over
60 years old worldwide. Green laser
minimally-invasive surgery for BPH
is the latest advanced application
of medical laser systems, delivering
safe and effective results with
fewer complications, shorter or
no hospitalization, and faster recovery
time.
"SFDA
approval of our system is an important
milestone for AHC and for the China
market," said Dr. Liyue Mu,
CEO. "Our system, with average
output power over 100 watts, becomes
only the world's second high-powered
green light laser system approved
for BPH treatment. We now provide
a more advanced yet cost-effective
alternative to the laser system
offered by the one other company
in the world to have developed such
systems".
During
the annual meeting of the American
Urological Association in Orlando
in May 2008, green laser technology
drew great attention and was regarded
as one of the most advanced surgical
systems for BPH treatment.
"AHC's
green light surgical system has
been well-recognized by US urological
experts for its ease-of-use, safety
and effectiveness," said Dr.
Rajesh Shinghal, Associate Chief
of Urology, Santa Clara Valley Medical
Center and faculty in the Department
of Urology at Stanford Medical Center.
"We look forward to AHC's system
receiving US FDA approval in the
near future".
Founded
in 1999, AHC started focusing on
laser-based medical applications
in 2003 and conducted clinical trials
of its BPH surgical system in China
during 2005-2006, treating over
90 patients with impressive results.
AHC's laser system was granted a
US patent in late 2007.
AHC
received its first round of institutional
funding in 2007 from CSV Capital
Partners, a China-focused early-stage
private equity firm, and currently
plans to raise a second round of
venture capital funding in the second
half of 2008. The anticipated proceeds
from the second round of funding
will be used to support the marketing
rollout of its system in China and
to initiate its 510(k) application
process with the US FDA.
"We
are very pleased with AHC's progress
since our investment last year,"
said Earl Yen, managing director
of CSV Capital Partners. "We
look forward to supporting the company
as it progresses from the regulatory
to the marketing phase in China,
and as it starts the regulatory
application process in key overseas
markets".
About Applied Harmonics
Corporation
Applied Harmonics is a developer
of powerful, cost effective laser
systems used in the surgical treatment
of benign prostatic hyperplasia
(BPH), a condition commonly known
as enlarged prostate. Applied Harmonics'
system allows for safe and effective
outpatient surgical treatment, with
fewer complications and faster recovery
time. Headquartered in Fremont,
CA, Applied Harmonics has a subsidiary
in Beijing, China.
For more information,
please see: www.realtonlaser.com.
About CSV Capital Partners
CSV
Capital Partners is a private equity
firm targeting early-stage growth
capital investments in emerging
companies with significant operations
in Greater China. CSV's partners
combine extensive private equity,
operating, and China market experiences
to assist entrepreneurs in creating
industry-leading companies. Headquartered
in Shanghai, CSV offers access to
high quality partners in Asia and
the United States and an extensive
network of resources to support
its portfolio companies.
For more information:
www.csvcp.com |
