COMMITTED TO DECREASING
The high mortality rates caused by endotoxic septic shock.
At Spectral Medical, we are pioneering a transformative theranostic approach that will enable improved outcomes for patients with endotoxic septic shock (ESS).
ESS is a life-threatening condition that arises when the body’s response to infection spirals into a storm of systemic inflammation. It’s characterized by a dangerous drop in blood pressure and a cascade of multiple organ failure caused by the presence of a bacterial toxin, known as endotoxin.
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with endotoxic septic shock, Polymyxin B hemoadsorption (“PMX”). PMX is a therapeutic hemoadsorption device that removes endotoxin from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for endotoxin in the bloodstream.
EAA™ and PMX are both Health Canada licensed and commercially available in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock.
Spectral strives to exceed the highest ethical, financial and scientific standards in all our operations and activities. By maintaining excellent relationships within the clinical community, as well as with customers and business partners.
Leading with precision and innovation, Spectral is unwavering in the fight against endotoxic septic shock and is committed to reducing mortality from this deadly disease.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT.
Chris SetoChief Executive Officer
MEET OUR
Chris Seto
Chief Executive Officer
Chris Seto is the Chief Executive Officer of Spectral Medical. In his role, he oversees the financial management of the company including, finance, accounting, treasury and capital market financings as well as corporate planning/development and investor relations.
Prior to joining Spectral Medical, Chris was the CFO of MJardin Group Inc. (CSE:MJAR) and GrowForce Holdings Inc. Additionally, Chris has over 20 years of capital markets and financial management experience, including senior investment banking positions with Paradigm Capital, UBS Securities and CIBC World Markets; and financial management experience in the telecom and healthcare industries with Bell Canada and Warren Shepell.
Chris holds a B. Comm. from McMaster University, an MBA from Richard Ivey School of Business, and a Certified Management Accountant designation (C.M.A. 1999).
Blair McInnis
Chief Financial Officer
Blair McInnis is the Chief Financial Officer of Spectral Medical. In his role, he oversees the financial management of the company including, finance, accounting, treasury as well as corporate planning/development and investor relations.
Mr. McInnis has 15 years of corporate finance and reporting experience. Prior to joining Spectral Medical, Blair was the Vice President Finance at SMTC Corporation, a provider of global electronics manufacturing services with annualized revenues in excess of $450 million, where he managed financial reporting, budgeting, treasury management and forecasting for the organization. Previously, Blair served as Assurance Manager at Ernst & Young LLP, where he managed audits of both private and public companies, and serviced a broad range of industries including healthcare, manufacturing, logistics, telecommunications, and more.
Blair holds a B. Comm. from Laurentian University (2007) and a Certified Public Accountant designation.
John A. Kellum, MD, MCCM
Chief Medical Officer
Dr. Kellum is Chief Medical Officer for Spectral and its wholly owned subsidiary, Dialco Medical Inc. He is responsible for leading all medical and scientific activities, clinical activities and scientific evaluation of all partnership opportunities.
Prior to joining Spectral he was Director of the Center for Critical Care Nephrology and Vice-Chair for Research in the Department of Critical Care Medicine at the University of Pittsburgh. Dr. Kellum is a Professor of Critical Care Medicine, Medicine, Bioengineering, and Clinical and Translational Science at the University of Pittsburgh. He was the inaugural recipient of the UPMC endowed Chair in Critical Care Research. A world expert in sepsis, acute kidney injury and blood purification, Dr. Kellum has authored more than 400 publications and is one of the most high-cited investigators in the world.
He received his medical degree from the Medical College of Ohio and completed residency and fellowship training at the Universities of Rochester and Pittsburgh. He is a Master in the American College of Critical Care Medicine and Honorary life-time member of the European Society of Critical Care Medicine.
Debra M. Foster, BSc.
Vice President, Clinical Development
Ms. Foster brings more than 20 years of experience to the Spectral team. Initially her career focused on critical care nursing and then critical care clinical research.
Ms. Foster values many years as a member of the Canadian Critical Care Trials Group where she developed expertise in clinical trial design, operation and execution.
She brings to Spectral an innovative approach to managing clinical trials and has lectured to medical professionals on the topics of sepsis and clinical trials for sepsis internationally. She has extensive experience in leading both regulatory and quality system portfolios.
Ms. Foster is responsible for the clinical evaluation as needed for design validation of Spectral devices. She also oversees the company’s Regulatory and Quality Assurance operations.
Ms. Foster holds a Bachelor of Sciences degree in Human Biology from the University of Toronto.
SPECTRAL MEDICAL'S
Anthony Bihl
Chairman of the Board
Mr. Bihl has served on the Board since March 2008. He is an experienced executive with more than 30 years in leadership of global healthcare businesses including a broad base of operational, financial, and senior executive positions. Mr. Bihl is currently the CEO of Bioventus LLC, a global provider of ortho biologic products, and has held this role since December 2013. He served on the Board of Directors of Greatbatch Inc., now Integer, from 2011 to December 2015, and joined the board of Nuvectra Inc., in February 2016, where he now serves as Chairman of the Board, and a member of the Audit Committee. He is also member of the Board of Directors of the Arthritis Foundation.
Mr. Bihl was Group President of American Medical Systems (“AMS”), a subsidiary of Endo Pharmaceuticals, in Minneapolis, Minnesota. From 2008 to 2011, Mr. Bihl was the President and Chief Executive Officer of AMS, Inc. From 2000 to 2007, Mr. Bihl served in various senior leadership positions at Bayer Healthcare Diagnostics Division including Vice President of Finance, Senior Vice President of Business Planning and Administration, and President, Diagnostics Division. Subsequently, he was Chief Executive Officer of Siemens DX upon the acquisition of Bayer’s Diagnostics Division by Siemens AG.
Paul Walker
Director
Dr. Walker joined Spectral as President and CEO in April 2001. Prior to that, he held the position of COO of the Toronto General Hospital, and was Surgeon in Chief and Vice President of the Surgical Directorate of the University Hospital Network. Dr. Walker was an active Vascular Surgeon and the Director of the Intensive Care Program, and Professor of Medicine at the University of Toronto. As CEO of Spectral, Dr. Walker lead the transformation of Spectral from a diagnostic company to a leading theragnostics company focused on bringing unique commercial products to market that fill unmet medical needs
A pioneer in the area of endotoxin and its role in sepsis, and the co-inventor of the Endotoxin Activity Assay (EAA™), Dr. Walker is a frequent participant at leading sepsis and critical care conferences, has been a keynote speaker at symposiums focusing on the role of endotoxin in sepsis, and is the author of over 100 scientific publications. He received his M.D. from the University of Western Ontario, his Ph.D. from the Salgrenska University of Göteborg, Sweden, and is a graduate of the Advanced Management Program from Harvard School of Business.
Jun Hayakawa
Director
Jun Hayakawa received his master in Organic Chemistry at Keio University in 1990 and joined Toray Industries the very same year. In his 29 years with the company, he was responsible for medicinal chemistry of opioid compounds; invented Remitch (relief for a complication of kidney and liver failure); responsible for R&D management and licensing and business development for pharmaceutical products. He is currently responsible for all business alliances and licenses in both pharmaceutical and medical device departments.
William Stevens
Director
Mr. Stevens has served on the Board since September 2014. Mr. Stevens brings over 20 years of experience in the capital markets and investment industry to the Company. He is currently the President of GS Investment Corp and was Managing Director of Westerkirk Capital Corp., both private investment management companies. He has held senior roles in investment banking and private equity and has a successful track record of value creation for shareholders. Mr. Stevens’ educational background includes an M.B.A from the Harvard University Graduate School of Business Administration.
John Nosenzo
Director
Mr. Nosenzo joined the Board in August 2020. He brings extensive commercialization experience in the healthcare sector, where he has held numerous senior executive positions in healthcare sales, marketing, service, and general management within multi-billion dollar organizations Mr. Nosenzo is currently the Chief Commercial Officer of Bioventus LLC, a global provider of ortho biologic products, and has held this role since February 2017, where he is responsible for leading a 450+ salesforce team across 30 countries.
Previous to Bioventus LLC, from 2011 to 2017, Mr. Nosenzo was Senior Vice President, Global Customer Operations at Beckman Coulter Diagnostics, a Danaher operating company. From 2010 to 2011, Mr. Nosenzo was Senior Vice President, Customer Relations Management at Siemens Healthcare. From 2008 to 2010, Mr. Nosenzo was Vice President, Marketing & Sales at Quest Diagnostics. From 2001 to 2008, Mr. Nosenzo served in various senior positions at Siemens Medical Solutions Diagnostics, including Senior Vice President, General Manager – Americas. From 1985 to 2001, Mr. Nosenzo served in various senior leadership positions at Bayer Healthcare including Vice President of Sales for the both the Specialty Products and Generic Products Divisions.
Jan D’Alvise
Director
Ms. D’Alvise has extensive experience in the pharmaceutical, diagnostic, medical device, and drug discovery research segments of the healthcare industry. From 2016 to present, Ms. D’Alvise continues as the President and CEO of Acasti Pharma (ACST), a specialty pharma company, and serves on their board of directors.
Prior to Acasti, Ms. D’Alvise was the President and Chairman of Pediatric Bioscience, a private company that was developing a diagnostic test for autism. Before that, she was the CEO of Gish Biomedical, a cardiopulmonary medical device company, that she sold to the Sorin Group. Prior to Gish, Ms. D’Alvise was the CEO and member of the board of trustees for the Sidney Kimmel Cancer Center (SKCC), a drug discovery research institute focused on translational medicine in oncology that she sold to the Sanford Burnham Institute. Prior to SKCC, she was the Co-Founder/President & CEO/Chairman of NuGEN, Inc., and the Co-Founder, Executive VP/COO and a board member of Metrika Inc. Ms. D’Alvise built both companies from a technology concept through to successful regulatory approvals, product introduction and sustainable revenue growth. Ms. D’Alvise was also a VP of Drug Development at Syntex/Roche, and Business Unit Director of their Pain and Inflammation business, and VP of Commercial Operations at SYVA, (Syntex’s clinical diagnostics division).
Ms. D’Alvise has a B.S. in Biochemistry from Michigan Technological University and completed post-graduate studies at the University of Michigan, Stanford University, and the Wharton Business Schools. In addition to Acasti and Spectral Medical, Ms. D’Alvise serves as the Chairman of The ObG Project, Inc, a private company. She has previously served on the boards of numerous private companies and non-profits and as an entrepreneur in residence for the Stanford Graduate School of Business and the von Liebig Institute of Entrepreneurship at the University of California at San Diego.
Chris Seto
Director
Chris Seto is the Chief Executive Officer of Spectral Medical. In his role, he oversees the financial management of the company including, finance, accounting, treasury and capital market financings as well as corporate planning/development and investor relations.
Prior to joining Spectral Medical, Chris was the CFO of MJardin Group Inc. (CSE:MJAR) and GrowForce Holdings Inc. Additionally, Chris has over 20 years of capital markets and financial management experience, including senior investment banking positions with Paradigm Capital, UBS Securities and CIBC World Markets; and financial management experience in the telecom and healthcare industries with Bell Canada and Warren Shepell.
Chris holds a B. Comm. from McMaster University, an MBA from Richard Ivey School of Business, and a Certified Management Accountant designation (C.M.A. 1999).
David Feigal
Director
Dr. Feigal brings over four decades of experience in regulatory affairs and clinical research of medical devices, biologics, and products in multiple therapeutic areas. He is currently a Partner in NDA Partners. He spent 12 years with the US Food & Drug Administration (FDA) where he was Director, Center for Devices & Radiological Health (CDRH), Director, Division of Anti-infective & Antiviral Drug Products, Center for Drug Evaluation & Research (CDER), and Deputy Director, Center for Biologics Evaluation & Research (CBER). He is the former Vice President of Global Regulatory Strategy, Amgen, and former Senior Vice President, Head of Global Regulatory and Global Safety Surveillance at Elan Corporation. Before joining the FDA, he worked for 10 years within the academic and hospital settings of the University of California in San Diego, San Francisco, and Davis.
Dr. Feigal has contributed to global government programs conducted by the World Health Organization, the European Medicines Evaluation Agency (EMEA), the National Institutes of Health, and others. He has served on numerous committees within the U.S. Department of Health and Human Services, has served on boards of both companies and funds, is a renowned speaker, and has published over 50 papers. He holds a BA from University of Minnesota, an MD from Stanford University and a Master of Public Health from the University of California, Berkeley.