Spectral Appoints Vice President of Sales and Marketing
10 Maio 2013 - 11:11AM
OTC Markets
Spectral Diagnostics Inc., (TSX:SDI / OTCQX:
DIAGF), a Phase III company
developing the first theranostic treatment for patients with septic
shock, today
announced the appointment of Dr. Gualtiero Guadagni as the
Company's Vice
President, Sales and Marketing.
Dr. Guadagni will
primarily be
responsible for the development and expansion of commercial
opportunities for
Toraymyxin and Spectral's Endotoxin Activity Assay (EAA™) in
Canada, the United
States and Europe.
"We are very excited to add Dr.
Guadagni to the Spectral team at this stage of our clinical
development
plan for EAA and Toraymyxin." said Dr. Paul
Walker,
President and CEO of Spectral Diagnostics. "Dr.
Guadagni has extensive experience in market development and
sales of the
EAA and Toraymyxin theranostic approach to the management of septic
shock in
regions outside of North
America."
Prior to joining Spectral, Dr.
Guadagni spent 10 years at ESTOR S.P.A where he was the
company's sales
and marketing director, and scientific consultant for Toraymyxin.
ESTOR is a
Milano-based company specialized in the production, promotion and
sale of
advanced biomedical devices in the areas of dialysis, intensive
care and
hemodynamics.
As ESTOR's European sales and marketing
director, Dr. Guadagni managed an
18-person sales team that
focussed on selling and marketing Toraymyxin and EAA in
Italy, Switzerland and
Austria where the sales of EAA and
Toraymyxin
have grown annually.
As a scientific consultant for ESTOR, he
coordinated a number
of post-marketing clinical trials such as the "Euphas" trial (Early
Use of
Polymyxin B Hemoperfusion In Abdominal septic Shock). In 2010, he
coordinated
Euphas2 (www.euphas2.eu), an
international data registry for Toraymyxin and EAA use in
critically ill
patients with septic shock, in multiple countries worldwide.
Dr. Guadagni has
a PhD in
bioengineering and a master's degree in biomedical engineering,
both from
Politecnico di Milano University
in Italy.
Spectral's EUPHRATES trial second planned
interim analysis will
occur after 184 randomized patients have been followed for 28 days.
At the
second analysis, the trial's Data and Safety Monitoring Board
(DSMB) will advise
Spectral on the trial's safety, efficacy or futility, with stopping
rules in
place for efficacy and futility. A sample size recalculation will
be done if
necessary.
Management expects to disclose information from
the second
interim analysis in the first half of 2014.
About Spectral Diagnostics
Spectral is a Phase III
company seeking U.S. FDA approval for its lead theranostics product
for the
treatment of severe sepsis with septic shock. Toraymyxin is a
therapeutic
hemoperfusion device that removes endotoxin, which can cause
sepsis, from the
bloodstream. Directed by the Company's Endotoxin Activity Assay
(EAA™), the only
FDA cleared diagnostic for the risk of developing sepsis.
Spectral's EUPHRATES
trial is the world's first theranostics trial in the area of
sepsis.
Toraymyxin has been approved for therapeutic use
in Japan and Europe, and
has been used safely and effectively on more than 100,000 patients
to date. In
March 2009, Spectral obtained the
exclusive
development and commercial rights in the U.S. for Toraymyxin, and
in November 2010, signed an exclusive
distribution agreement
for this product in Canada. More
than 250,000
patients are diagnosed with severe sepsis and septic shock in
North America each year,
representing a greater than
$1 billion market opportunity for
Spectral. Spectral
is listed on the Toronto Stock
Exchange under the
symbol SDI, and on the OTCQX under the symbol DIAGF. For more
information please
visit www.spectraldx.com
Forward-looking statement
Information in this news release that is not
current or
historical factual information may constitute forward-looking
information within
the meaning of securities laws. Implicit in this information,
particularly in
respect of the future outlook of Spectral and anticipated events or
results, are
assumptions based on beliefs of Spectral's senior management as
well as
information currently available to it. While these assumptions were
considered
reasonable by Spectral at the time of preparation, they may prove
to be
incorrect. Readers are cautioned that actual results are subject to
a number of
risks and uncertainties, including the availability of funds and
resources to
pursue R&D projects, the successful and timely completion of
clinical
studies, the ability of Spectral to take advantage of business
opportunities in
the biomedical industry, the granting of necessary approvals by
regulatory
authorities as well as general economic, market and business
conditions, and
could differ materially from what is currently expected.
The TSX has not reviewed and does not accept
responsibility
for the adequacy or accuracy of this statement.
SOURCE: Spectral Diagnostics Inc.
For further information:
Anthony Businskas
Executive Vice President and CFO
416-626-3233 ext.
2200
Adam Peeler
Investor Relations
TMX Equicom
416-815-0700
ext. 225
apeeler@tmxequicom.com
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