TORONTO, May 7, 2013 /CNW/ - 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
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
"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
Dr. Guadagni has a PhD in bioengineering and a master's degree in
biomedical engineering, both from Politecnico di Milano University in
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
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
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:
Executive Vice President and CFO
416-626-3233 ext. 2200
416-815-0700 ext. 225