COMPANY INFO
HistoSonics, Inc. is a privately held medical equipment manufacturing company founded in 2009 by scientists and engineers from the University of Michigan who developed the science of histotripsy. The company has around 214 employees and is headquartered in Plymouth, Minnesota. HistoSonics develops a non-invasive sonic beam therapy platform that uses focused ultrasound to mechanically destroy unwanted tissue and tumors, aiming to bring histotripsy into everyday clinical practice. Its industry is medical devices, specifically focused on non-invasive therapeutic technologies. The official website is https://histosonics.com.
HistoSonics, Inc. is a privately held medical equipment manufacturing company that has pioneered non-invasive therapies using focused ultrasound to mechanically destroy unwanted tissue and tumors. Founded by scientists and engineers from the University of Michigan in 2009, HistoSonics is dedicated to bringing histotripsy into everyday clinical practice through innovative, therapeutic technology.
The HistoSonics, Inc. management team comprises seasoned leaders with extensive backgrounds in the medical device industry, regulatory affairs, R&D, finance, and clinical program development. The HistoSonics leadership brings together a blend of scientific expertise, accomplished commercialization experience, and a passion for advancing life-saving technologies. As a result, the HistoSonics executives drive the company’s vision forward, ensuring both product innovation and successful market penetration in the evolving healthcare landscape.
Mike Blue serves as the President and CEO, steering HistoSonics with a focus on commercializing its non-invasive sonic beam therapy platform. Under his leadership, the company has expanded market reach and achieved significant milestones in product development, positioning HistoSonics as a trailblazer in histotripsy therapy.
Mike holds a BS in Marketing from Saint Joseph's University. He previously held senior positions at Johnson & Johnson, NeuWave Medical, and Covidien's Interventional Lung Solutions, amassing over two decades of expertise in medical device sales and marketing, particularly in interventional oncology and minimally invasive technology domains.
David Krenn, as Chief Financial Officer since 2022, oversees HistoSonics’ overall financial strategy, planning, and investor relations. He has played a crucial role in managing funding rounds, strengthening financial health, and enabling sustainable company growth.
David graduated with degrees in Accounting and Finance from Saint John's University. Prior to joining HistoSonics, he served as CFO at Marsh & McLennan Agency and ValenTx, Inc., and held financial leadership roles at CryoLife and Medtronic, building a foundation in healthcare and medical technology financial operations.
Dan Kosednar directs regulatory strategy and compliance, ensuring HistoSonics’ products achieve successful approvals and global market access. He is recognized for authoring over 25 510(k) submissions and is pivotal to the company’s regulatory path for innovative medical devices.
Dan holds a BS in English from the University of Wisconsin-Madison and is RAC certified. His regulatory leadership experience includes stints at NeuWave Medical, GE Healthcare, and Ethicon, with deep, cross-functional expertise in regulatory affairs and quality assurance.
Donald Hayden oversees global sales operations, driving the expansion and revenue growth of HistoSonics. He has a proven track record in commercializing advanced medical robotics and digital health solutions, strengthening the company’s international footprint.
Donald studied Marketing with a minor in Finance at Auburn University. His sales leadership journey features roles at Johnson & Johnson, Auris Health, Stryker, and NOVADAQ, where he led large teams and earned top sales rankings in the medical devices sector.
Joshua Stopek leads R&D, fostering innovation in histotripsy and overseeing new product development. His technical leadership advances HistoSonics' proprietary technology and guides strategic planning for clinical research and product pipeline growth.
Joshua earned a PhD in Materials Science and Engineering from the University of Florida. He has held leadership roles in R&D at Interventional Lung Solutions, Medtronic, and Covidien, bringing expertise in healthcare technology innovation and advanced device manufacturing.
Eric Clyse oversees operations, including supply chain, manufacturing, and quality compliance functions at HistoSonics. His stewardship ensures efficient, compliant, and cost-effective production of the company’s groundbreaking therapies.
Eric graduated with a degree in Chemical Engineering from the University of Wisconsin-Madison. Previously, he led operations at Virtual Incision Corp, NeuWave Medical, and GE Healthcare, with a focus on manufacturing and sourcing strategies for ultrasound and medical device products.
Josh King leads market access and strategic marketing at HistoSonics, focusing on driving commercialization strategy and expanding the reach of histotripsy therapy worldwide. He has been key to demand creation and establishing new markets for the company's innovative technologies.
Josh holds an MBA from the University of New Orleans. His marketing leadership includes experience at NeuWave Medical, Exact Sciences, and Covidien, all contributing to his proficiency in medical device commercialization and market development.
Amanda Cafaro oversees clinical affairs, leading strategy for clinical program development, evidence generation, and engagement with clinicians. Her leadership aids regulatory compliance and helps accelerate the clinical adoption of HistoSonics solutions.
Amanda earned a BS in Nursing from the University of Colorado Anschutz Medical Campus and a BA in Audiology & Speech Pathology from the University of Colorado Boulder. She brings clinical program leadership experience from Covidien, the Bill & Melinda Gates Foundation, and Medtronic.
David Vershum is responsible for the development of embedded systems, driving software engineering and digital health advancements at HistoSonics. His contributions enhance device functionality and reliability.
David holds a BS in Computer Engineering from the University of Illinois Urbana-Champaign and is a certified Project Management Professional (PMP). His prior roles span embecta, Cantel Medical, and Boston Scientific, with a focus on R&D for medical technologies.
Steve Augustine leads human resources, focusing on building organizational culture, talent strategy, and supporting company growth through people-first initiatives. His leadership ensures that HistoSonics maintains a high-performing, innovative, and mission-driven workforce.
Steve earned an MBA in Management from the University of St. Thomas - Opus College of Business and a Bachelor's degree from Indiana University Bloomington. He brings HR leadership experience from Relievant Medsystems, Deluxe Corporation, Coloplast, and Boston Scientific.
The HistoSonics management team combines scientific founders, experienced medical device executives, and cross-disciplinary leaders in finance, regulatory, operations, and clinical affairs. This collaborative structure enables HistoSonics to accelerate the growth of novel therapeutic solutions, establish strong clinical partnerships, and drive successful global commercialization. The company’s founders, Jim Bertolina and Christine Gibbons, established the culture of innovation and impact that continues to define the HistoSonics leadership team today.
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