About the Guest
Michael Mangano is the President and CEO of ABK Biomedical, a company developing novel technology for Y90 radioembolization. He brings over 30 years of medical device experience, including 15 years at Boston Scientific in commercial and international leadership roles. He previously served as CEO of ReShape Medical and as President of the Americas for Sirtex Medical, scaling regional revenues from $34 million to over $130 million.
Interview Summary
With more than three decades of experience in medical devices, including helping build Sirtex Medical into one of the pioneers in radioembolization — Michael joined ABK in 2018 to lead the company's next phase of growth.
Founded in 2012, ABK initially focused on developing radiopaque embolization microspheres that could be visualized under X-ray. By the time Michael joined the board, however, the company's original target market had become less attractive. Rather than abandon the underlying technology, ABK pivoted into Y-90 radioembolization, leveraging its existing microsphere platform to develop Eye90 microspheres, its flagship Yttrium-90 (Y90) radioembolization device for treating primary liver cancer. ABK also continues to advance Easi-Vue, its FDA 510(k)-cleared imageable embolization microsphere for bland embolization.
Eye90 combines radiopaque glass microspheres, patient-specific dosing, and proprietary imaging software to give physicians immediate visibility into where treatment has been delivered and whether a therapeutic dose has reached the tumor. To retain control over product development and innovation, ABK also invested in a vertically integrated manufacturing strategy, including a long-term partnership with the University of Missouri Research Reactor and a dedicated commercial manufacturing facility in Missouri for its medical radioisotope platform.
Eye90 received FDA Breakthrough Device designation in 2023, and ABK recently completed enrollment in the 120-patient, Phase III ROUTE90 pivotal IDE study evaluating the investigational device in patients with unresectable hepatocellular carcinoma. With patient follow-up underway, the company is preparing for PMA submission while building its commercial infrastructure following a $35 million Series D financing completed in 2025.
Top Takeaways
Continually evaluate whether your product is aimed at the right market. A technology's first application is not always its best commercial opportunity. As markets evolve, reassess where your solution can create the greatest value, then align your product roadmap, capital, engineering resources, and commercialization plans behind that opportunity. Staying focused on the highest-potential market may mean changing direction or delaying launches that don't support the long-term strategy.
Retain clinical trial ownership, even during shared operational execution. Clinical research organizations (CROs) can provide essential operational support, but your company should remain the face of the trial. Keep internal cross-functional teams directly involved with investigators, procedures, physician training, and reviewing outcomes so the knowledge is retained inside the company. Operational responsibilities can be shared, but ownership of the trial should not.
When entering an established market, build advantages that compound over time. Markets often reward fast-followers who think beyond first-generation differentiation. Instead of relying on a single breakthrough, build the capabilities that let you iterate faster and keep improving, even after your initial commercial launch. Whether that's manufacturing, critical infrastructure, core technology, or internal operational expertise, those capabilities compound into advantages that competitors can't quickly replicate.
Build a team of player-coaches. The strongest startup cultures don't separate leadership from execution. Hire people who can execute without constant oversight, give them a stake in the company's success through equity, and reinforce that ownership by setting clear, measurable goals. Create a player-coach culture where everyone, including the CEO, does the heavy lifting. That's how startups move at a pace strategics often can't match.
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