Spectral Diagnostics Inc. has 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. Walker continued, "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.