| February 2009
|
Urodynamix obtained a CE Mark for the
uroNIRS 2000™ Bladder Monitor System and
will officially launch the product in Europe
with its distribution partner Medical
Measurement Systems B.V. (MMS).
|
| January 2009
|
Urodynamix obtained 510(k) clearance from
the U.S. Food and Drug Administration to
market its second generation device - the
uroNIRS 2000™ Bladder Monitor System.
|
|
October 2008
|
Urodynamix amended its distribution
agreement with Laborie Medical to include
worldwide non-exclusive sales, marketing and
distribution rights for the Tetra™ Bladder
Monitor System in the physician office and
outpatient clinic markets in addition to the
rights for the acute care setting previously
granted.
|
|
October 2008
|
Urodynamix and Timm Medical signed an agreement which grants Timm
Medical exclusive worldwide distribution rights of
the NIRS technology for applications in
erectile dysfunction.
|
|
September 2008
|
Urodynamix entered into an agreement with
Pfizer to collaborate on a series of
promotional programs to increase awareness
of NIRS bladder monitor technology among
urologists, medical professionals, and key
opinion leaders in the United States.
|
|
September 2008
|
Urodynamix’ worldwide distribution partner,
Laborie Medical, received CE Mark and Health
Canada approvals to begin marketing the
Tetra™ Bladder Monitor System in Europe and
Canada.
|
|
August 2008
|
Urodynamix received a grant from the
National Research Council Canada Industrial
Research Assistance Program (NRC-IRAP) to
help accelerate the development and
commercialization of NIRS technology for the
detection of prostate cancer during the
digital rectal examination.
|
|
May 2008
|
The Tetra™ Bladder Monitor System was
launched in the United States.
|
|
March 2008
|
Urodynamix’ worldwide distribution partner,
Laborie Medical, obtained 510(k) clearance
from the U.S. Food and Drug Administration
to market the non-invasive Tetra™ Bladder
Monitor System.
|
|
December 2007
|
Results from a pivotal clinical trial
established the safety and efficacy of
Urodynamix’ NIRS technology for the
non-invasive diagnosis of male patients with
lower urinary tract symptoms.
|
|
October 2007
|
Following a preliminary study showing that
the NIRS sensor was able to quantify blood
flow in different quadrants of the prostate,
the company developed a device to improve
accuracy in the diagnosis and localization
of prostate cancer during a digital rectal
examination. |
|
June 2007
|
The company filed a series of patents with
the United States Patent and Trademark
Office for inventions related to medical
applications of NIRS technology.
|
|
May 2007
|
Urodynamix entered into a worldwide
distribution agreement, granting Laborie
Medical worldwide distribution rights to the
uroNIRS Bladder Monitor System.
|
|
February 2007
|
Urodynamix
initiated a second clinical study to
evaluate the efficacy of the NIRS device for
applications in diagnosis and
characterization of male erectile
dysfunction.
|
|
February 2007
|
Urodynamix formed a medical advisory board
comprised of internationally renowned
experts in the fields of NIRS, urological
disorders and sexual dysfunction.
|
|
July 2006
|
Completed a study that evaluates NIRS
capability in diagnosing stress urinary
incontinence and overactive bladder in women.
The study showed that NIRS technology (1)
detected statistically significant
differences in measured changes in
oxygenated hemoglobin (Hb02),
deoxygenated hemoglobin (Hb), and cytochromes (Cyt) for
positive versus
normal
subjects; (2) accurately measured and
identified bladder conditions when compared
to existing invasive catheter based systems.
The study concluded that NIRS provided
quantifiable evidence of OAB and SUI in the
study population.
|
|
July 2006
|
Successfully completed the first major
clinical study of NIRS technology. The study concluded that NIRS
provided quantifiable evidence of the
presence or absence of bladder outlet
obstruction in its study population.
|
|
September 2005
|
The Canadian Institutes of Health Research
(CIHR) awarded a grant to support research
to advance development of Urodynamix' NIRS
technology for the urology application.
|
|
June 2005
|
Urodynamix completed a license agreement
with the University of British Columbia for
the exclusive global rights to develop,
manufacture and market NIRS technology for
non-invasive diagnosis of urinary
incontinence and bladder disorders.
|
|
Summer 2003 |
The urology application of near infrared
spectroscopy technology was
discovered by an interdisciplinary team
comprised of internationally recognized
experts in the field of NIRS research and
leading urologists at the University of
British Columbia in Vancouver, Canada.
|
