COMMITTED TO REDUCING
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.
Endotoxic septic shock affects approximately 140,000 patients each year with a mortality rate > 50%.
Spectral is a Phase 3 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 340,000 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. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. EAA™ and PMX are both Health Canada licensed and commercially available in Canada.
The Tigris Clinical Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.
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.
MEET OUR
Chris Seto
Chief Executive Officer (and Interim CFO)
Chris Seto is the Chief Executive Officer of Spectral Medical. In this role, he is responsible for Spectral Medical’s overall operational performance, financial management, and strategic direction. He also leads the Company’s corporate planning, development initiatives, capital markets activities, and investor relations.
Mr. Seto brings over 25 years of capital markets and financial management experience, including a career as a senior M&A investment banker, where he advised companies across a broad spectrum of sectors. During this time, he worked on some of the largest cross-border M&A transactions in Canada, providing him with deep expertise in mergers and acquisitions, equity and debt financings, and capital markets strategy. He held senior banking positions with Paradigm Capital, UBS Securities, and CIBC World Markets. Earlier in his career, he gained financial management experience in the telecom and healthcare industries with Bell Canada and Warren Shepell Consultants. Prior to joining Spectral, Mr. Seto served as Chief Financial Officer of MJardin Group Inc. (CSE: MJAR) and GrowForce Holdings Inc., where he oversaw financial operations, capital raising, and strategic growth initiatives.
Mr. Seto holds a Bachelor of Commerce from McMaster University, an MBA from the Richard Ivey School of Business, and a Certified Management Accountant designation (C.M.A. 1999).
John A. Kellum, MD, MCCM
Chief Medical Officer
Dr. Kellum is Chief Medical Officer for Spectral and 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.
Esha Kamaluddin
Vice President, Clinical Operations
Esha Kamaluddin is the Vice President of Clinical Operations for Spectral Medical. Esha is responsible for the clinical development of the Company’s products through the design and implementation of its trial operations and delivery of clinical outputs for regulatory submissions. In her role, she works closely with Spectral’s executive team for the development of clinical corporate objectives. Esha has over 15 years of experience in clinical research and regulatory governance with a commitment to prioritizing quality and upholding industry best practices. Her experience ranges from CRO to industry, small to large scale multi-national trials in various phases of research development (Phases I-III and Bio-Equivalent clinical trials).
Esha holds a Honours Bachelor of Science degree in Human Biology, Criminology and Psychology from the University of Toronto and Project Management Certification from Humber College.
Pareshkumar Pujara
Vice President Technical Operations
Paresh Pujara is the Vice President of Technical Operations at Spectral Medical Inc. In his role, he oversees GMP manufacturing and R&D operations. With over 17 years of combined experience in the biopharmaceutical and medical device industries, Paresh has a proven track record of leading strategic initiatives on production capacity expansion, facility upgrades, yield improvements, product development, and technology transfer. Prior to joining Spectral Medical, Paresh was part of the vaccine manufacturing leadership team at Sanofi. His expertise focuses on optimizing operational efficiency while ensuring products are manufactured and distributed to the highest quality standards in a safe environment.
Paresh holds a BSc in Microbiology from Gujarat Vidyapith, an MSc in Biotechnology from Ganpat University, an MBA in Biotechnology Management from the National Institute of Management India, and an MSc in Biochemistry from the University of Saskatchewan.
Narvin Ali
Vice President of Quality Assurance and Regulatory Affairs
Narvin Ali is the Vice President of Quality Assurance and Regulatory Affairs at Spectral Medical. In his role, he is responsible for overseeing the Company’s global quality and regulatory strategies, ensuring compliance with international standards, and supporting the advancement of Spectral’s clinical and commercial programs.
With over 20 years of GMP experience, Narvin is a seasoned subject matter expert in pharmaceutical and medical device quality systems. His career has encompassed diverse roles, including managing compliance with FDA, Health Canada, and EU regulations; leading the design and implementation of robust quality systems; and overseeing third-party manufacturers to ensure supply chain integrity. As well as conducting numerous internal and external audits. Since joining Spectral in 2022, Narvin has successfully led initiatives for MDSAP compliance, driven improvements in Quality Assurance processes, and advanced operational efficiency through process optimization. Passionate about fostering a culture of quality and innovation, Narvin is committed to upholding the highest regulatory and compliance standards to support Spectral’s mission of delivering life-saving therapies.
Narvin holds a Bachelor of Pure and Applied Science degree from York University.
Medha Gupta
Vice President, Finance
Medha Gupta is the Vice President of Finance of Spectral Medical. In her role, she oversees the financial management of the company including, financial reporting, accounting, treasury and corporate financial planning and analysis. Ms. Gupta has over 17 years of corporate finance and reporting experience. Prior to joining Spectral Medical, she was the Controller (Finance Head) at Pfaff Holdings, the family office of one of biggest Canadian auto distributor and a private investor, where she managed financial reporting, budgeting, treasury management and forecasting for the organization. Previously, Ms. Gupta served as a Corporate Controller at Timken (Canada) where she managed financial reporting, budgeting, treasury management and forecasting for the organization. She has more than 9 years of experience in audits of both private and public companies, and serviced a broad range of industries including healthcare, manufacturing, logistics, telecommunications, and more.
Ms. Gupta holds a B. Comm. from Delhi University (2009), a Chartered Accountant designation from India (2012) and a Chartered Professional Accountant designation from Ontario, Canada (2018). Ms. Gupta is also SAP certified consultant from SAP, Germany and IFRS (International Financial Reporting Standard) certified from ACCA, United Kingdom.
SPECTRAL MEDICAL'S
Paul Walker
Chairman of the Board
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.
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.
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 this role, he is responsible for Spectral Medical’s overall operational performance, financial management, and strategic direction. He also leads the Company’s corporate planning, development initiatives, capital markets activities, and investor relations.
Mr. Seto brings over 25 years of capital markets and financial management experience, including a career as a senior M&A investment banker, where he advised companies across a broad spectrum of sectors. During this time, he worked on some of the largest cross-border M&A transactions in Canada, providing him with deep expertise in mergers and acquisitions, equity and debt financings, and capital markets strategy. He held senior banking positions with Paradigm Capital, UBS Securities, and CIBC World Markets. Earlier in his career, he gained financial management experience in the telecom and healthcare industries with Bell Canada and Warren Shepell Consultants. Prior to joining Spectral, Mr. Seto served as Chief Financial Officer of MJardin Group Inc. (CSE: MJAR) and GrowForce Holdings Inc., where he oversaw financial operations, capital raising, and strategic growth initiatives.
Mr. Seto holds a Bachelor of Commerce from McMaster University, an MBA from the Richard Ivey School of Business, and a Certified Management Accountant designation (C.M.A. 1999).
Cristiano Franzi
Director
Mr. Franzi is a seasoned global healthcare executive and board director with a 30-year track record at leading global Med-Tech companies. As Regional President for businesses of up to $4 billion in size at Solventum, Baxter, Medtronic, and Covidien, Mr. Franzi has proven his ability to deliver value by developing compelling visions, identifying new market opportunities, and articulating clear growth strategies while streamlining operations and implementing highly disciplined business models.
Mr. Franzi currently serves as SVP International at Solventum, which in April 2024 spun from 3M. From 2017 to 2023, Mr. Franzi served as President of Baxter EMEA, where he also served as the interim global lead for the spin-off of the $4.5 billion Renal Care business (“Vantive”). Prior to Baxter, Mr. Franzi served as President, EMEA at Medtronic, and prior to that as President, EMEA at Covidien. Before that, he covered roles of increasing responsibilities at ev3, a private equity-backed medical device start up, where he played a key role in the international expansion of the company from inception to its $156 million IPO in 2005.
He has overseen large acquisitions, mergers, integrations, and divestitures: he worked with Baxter’s Board on the strategy, due diligence, and integration for the $10.5 billion Hillrom acquisition and the preparations for the spin-off of the Renal Care business; he co-led the integration of Covidien at Medtronic in EMEA following the $42.9 billion acquisition.
Additionally, he has served as an industry leader on the Board of MedTech Europe, the industry association in Europe. Mr. Franzi also serves as an expert advisor to leading global private equity firms and is an angel investor in MedTech startups. Mr. Franzi completed the Advanced Management Program (AMP197) at Harvard Business School, holds an MBA from George Washington University, and a bachelor’s degree in business administration from The American University.