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TORONTO, CANADA – February 1, 2021 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly owned subsidiary Dialco Medical Inc. (“Dialco”), today announced the appointment of Dr. John Kellum, MD, MCCM as Chief Medical Officer.
Dr. Kellum’s appointment is effective March 1, 2021. He will assume the full-time role of Chief Medical Officer at both Spectral and Dialco, where he will be responsible for leading all medical and scientific activities, clinical activities and scientific evaluation of all partnership opportunities.
Dr. Kellum is considered one of the leading critical care researchers and world’s foremost experts on blood purification and acute kidney injury (“AKI”). He has pioneered research in the area of blood purification and has published original work on its application to clinical practice. Dr. Kellum is a founding member and past president of the Acute Dialysis Quality Initiative (ADQI) where he developed the first widely accepted consensus definition for acute renal failure – the original manuscript has been cited over 6,000 times. He is also a co-chair of the Kidney Diseases Improving Global Outcomes (KDIGO) clinical practice guideline on acute kidney injury. His research has received continuous funding from the National Institutes of Health since 2001. In addition, Dr. Kellum has served as a consultant to the FDA, the Department of Defense, the medical device industry and the pharmaceutical sector.
At the University of Pittsburgh, Dr. Kellum is a Professor of Medicine, Bioengineering, and Clinical & Translational Science, and serves as a Chair in Critical Research. He is also Vice Chair for Research within the Department of Critical Care Medicine and Director of the Center for Critical Care Nephrology. He has authored more than 400 publications. He lectures widely and has given more than 300 seminars and invited lectures worldwide related to his research.
“We are honored that Dr. Kellum has agreed to serve as our Chief Medical Officer,” stated Dr. Paul Walker, President and CEO of Spectral Medical Inc. “As one of the preeminent critical care researchers in the world in the field of sepsis, we expect he will be invaluable in helping complete our Tigris pivotal trial of PMX (Toraymyxin™ PMX-20R) for the treatment of patients with septic shock and endotoxemia, proven by an elevated endotoxin activity assay (“EAA”). The appointment of such a highly accomplished and respected clinician will be integral to the next phase of our growth as we move forward with our goal of combatting sepsis with our personalized therapeutic approach. Dr. Kellum’s international leadership in the critical role of directed renal replacement therapy will help guide the commercial rollout of our new “SAMI” and “DIMI” platforms targeting both the acute and chronic renal dialysis therapy markets. Given his unique capabilities and relationships, Dr. Kellum will also assist us in exploring new strategic opportunities, which could include partnerships, grants or opportunistic acquisitions of complementary assets and therapies in the fields of septic shock and acute kidney disease.”
“I am very pleased to join the Spectral and Dialco teams,” said Dr. John Kellum. “Their combined diagnostic and therapeutic approach to the treatment of septic shock is unique and I believe this represents the most likely pathway to success. This approach to personalized medicine is also applicable in many other disease processes and can lead to improved patient outcomes. I look forward to helping bring new approaches to renal replacement therapy, both in the intensive care units as well as in-home. Dialco’s instrumentation offers distinctive advantages for both acute and chronic renal failure and the opportunity to improve the lives of a large number of patients.”
About Spectral
Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 200,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. Dialco is also seeking regulatory approval for in-home use of “DIMI” which is based on the same RRT platform, but will be intended for home hemodialysis use. “DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.