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EDTXF Spectral Medical Inc (PK)

0.34615
-0.00305 (-0.87%)
31 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Spectral Medical Inc (PK) USOTC:EDTXF OTCMarkets Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -0.00305 -0.87% 0.34615 0.34 0.3631 0.34615 0.34615 0.34615 8,000 21:00:11

Spectral Appoints Vice President of Sales and Marketing

10/05/2013 3:11pm

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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