It’s not enough to be researchers. We are pioneers.

Steve is a consummate problem solver. After earning a BSc in Chemistry & Mathematics at the University of Waterloo in Ontario, Canada, he went on to earn a MSc in Information & Systems Science from Carleton University also in Ontario, Canada, and then a PhD in Chemometrics and Analytical Chemistry from the University of Delaware.

Steve had worked with Dupont during his graduate school years, and the company was eager to hire him when he finished his PhD program. He spent several years as a research chemist at the Central Experimental Station in Delaware developing analytical methods for controlling active ingredients and impurities in crop protection products. His next position, as Senior Algorithm Scientist with MediSpectra, was personally fulfilling for Steve as he helped develop predictive models for an optically-based system that detected cervical cancer cells. After completing the clinical studies, the FDA ultimately granted premarket approval of the system. In the interim, Infraredx came calling with Steve’s next challenge in optical disease detection.

Steve began his tenure at Infraredx in developing a catheter-based system for cardiovascular disease detection as a Senior Algorithm Scientist. He was soon promoted to Principal Scientist of Algorithm Development and then Director of Biomedical Systems. He spent four years as Vice President of Research and Development and another four as Senior Vice President of Technology Innovation and Regulatory Affairs. He then took the lead as Senior Vice President of additional departments including Clinical Research and Quality Affairs, in addition to returning to the helm of Research and Development before being promoted to his current role.

As President and CEO, Steve exemplifies the Nipro purpose that “every product developed, every service offered, every piece of knowledge shared, contributes to a world where everyone can truly ‘Live Longer. Live Better.’” He maintains strong relationships with opinion leaders in cardiology to understand where some of their challenges are, and he ensures that each new iteration of Infraredx devices aligns with customer needs. “Being able to understand what MDs need to better identify high-risk patients and helping to define new standards of care⎯that’s what really keeps me going every day.”

As Director of Quality since February 2022, Steve leads the strategy, direction, and compliance of the Quality Management System while serving as the company’s Management Representative. In this role, he provides cross-functional leadership to ensure that quality practices not only meet regulatory requirements but also support organizational growth and operational excellence.

Before taking on his current role, Steve served as the Manager and Senior Manager of Quality at Infraredx. Prior to that, he held a series of progressive roles of increasing responsibility within Quality for Class II and Class III medical device manufacturers. Steve brings deep expertise in root cause analysis, continuous improvement, supplier management, and developing creative solutions to complex challenges. Some of his key accomplishments at Infraredx include implementing a cloud-based PLM system, achieving certification under new and evolving regulations, improving process efficiency and enhancing compliance, and scaling the QMS to accommodate business growth and expand market access.

Steve is a passionate and transformative leader who combines strategic thinking with practical decision-making in order to deliver meaningful results. His leadership style fosters collaboration, innovation, and creates a culture of continuous improvement across all levels of the organization. Steve holds a Bachelor of Science in Industrial Engineering from Northeastern University.

Michael Hendricks brings over 20 years of intravascular imaging and interventional cardiology research and product development experience. He holds a degree in Chemical Engineering from the Massachusetts Institute of Technology.

Michael has continually adapted to apply his creativity to the field. Initially translating his knowledge of chemical engineering principles to radiation modeling and interventional cardiology research by combining it with the observations from thousands of hours in the Massachusetts General Hospital cath lab control rooms while managing IDE research. Maintaining a line of sight to the unmet need in the field, he had oversight of conduct of the SPECTAL and COLOR studies that cleared the way for 510k clearance for NIRS and helped establish fundamental understanding of disease distribution as viewed through this new technique. These projects and understanding led to the development of critical measures that underpin current NIRS research, lesion level LCBI and maxLCBI4mm, and guidance for standardizing reading of chemgorams for clinical application.

Michael now adapts this experience to evolving the product to meet the expectations of our global users to address the challenges presented by the #1 cause of death world-wide and to provide guidance to those seeking to look beyond the limits of today’s practice of medicine. In addition to evolving the product, Michael coordinates and evaluates expansion into new fields and application of the technologies of Infraredx to new procedures to encourage therapy development and evaluation.
Interventional medicine has been confined to a reactive treatment for too long, it’s time to take its rightful place in the proactive management of patient health.

Katie Nazzaro is a strategic and people-focused HR executive with a proven track record of aligning human capital strategies with business goals. Since joining Infraredx in 2008, she has been instrumental in driving organizational growth, operational efficiency, and a culture of continuous improvement. Promoted to Vice President of Human Resources in 2022, Katie brings a thoughtful, results-oriented approach to advancing the company’s mission and long-term success.

Throughout her career, she has led key HR initiatives across talent acquisition, employee engagement, organizational development, and operational excellence. Her leadership during Infraredx’s 2015 acquisition by Nipro Corporation—and beyond—has helped strengthen the organization through strategic restructuring, technology upgrades, and cost-saving talent strategies.

Katie holds a B.S. in Biology from the University of Massachusetts Lowell, an MBA in Human Resource Management from Franklin Pierce University, and an Advanced Certificate in Strategic HR Management from Cornell University. She is an active member of SHRM and a strong advocate for employee well-being and continuous improvement.

Stephen is an accomplished executive with over 25 years of leadership experience in the medical device industry. At Infraredx, he leads global manufacturing, supply chain, and field service operations supporting the company’s mission to improve lives through innovative medical products.
Stephen has a proven track record of scaling operations, optimizing systems, and building high-performing teams aligned with strategic business goals. He has held senior leadership positions at leading organizations, including Abbott (formerly St. Jude Medical) and Smith+Nephew Inc., where he managed global manufacturing operations for cardiovascular diagnostics and endoscopy devices.

His expertise spans managing vertically integrated, full-service outsourcing partnerships both domestically and internationally, delivering operational scalability and efficiency while fostering long-term strategic value.

He holds a Bachelor of Science in Manufacturing Engineering from Wentworth Institute of Technology.

Priti Shah is an accomplished clinical research professional with over 20 years of experience in the field. She holds a Bachelor of Science in Biosystems Engineering from Michigan State University and a Master of Science in Biomedical Engineering.

Since beginning her career in clinical research, Priti has played a pivotal role in advancing medical technologies and studies. For the past 18 years, she has been a key contributor at Infraredx, where she has applied her expertise to support groundbreaking clinical research and innovation in cardiovascular imaging and diagnostics. Her dedication and extensive experience conducting large investigational device studies, registries, and outcome studies have made her a respected leader in the industry, committed to improving patient outcomes through advanced clinical research.