Four years ago, CathWorks and Medtronic plc, one of the world’s largest medical device makers, struck up a co-promotion agreement with the option for Medtronic to buy the Irvine-based cardiac-focused device maker within five years.
Last week, Medtronic exercised that option and announced it was acquiring CathWorks for $585 million, including potential undisclosed earn-out payments.
“Our team has been working on this deal now a little over 42 months, so it’s been a long time in the making,” CathWorks Chief Executive Ramin Mousavi told the Business Journal.
“We’re very happy to have been able to deliver on what we hoped to be the outcome of the deal, and beyond anything else, the promise it has both for the technology and the patients across the globe.”
As part of the transaction, CathWorks’ FFRangio System, which creates a 3D image of the heart to help doctors identify coronary issues, will join Medtronic’s portfolio.
The deal is expected to close by the end of Medtronic’s fiscal year, which is in April, pending clearance from the U.S. Federal Trade Commission.
Post-acquisition, Medtronic intends to keep CathWorks’ current offices in Newport Beach, Israel and Japan, as well as the company’s 100 employees, according to Mousavi. About half are based locally here in Orange County.
Mousavi said that while it’s too early to say if he’ll remain CEO of CathWorks after the deal closes, “there’s no shortage of talent at the leadership level, both within CathWorks and Medtronic.”
“I think that will be the least of the problems. Whether I stay or not, I think the company will be in good shape,” he said.
Mousavi is a two-time winner of Business Journal accolades. He won the Excellence in Entrepreneurship Award in 2022 and the Innovator of the Year Award in 2023.
Co-Promotion Agreement to Acquisition
The deal was first announced in 2022.
Medtronic, which has been a minority investor in CathWorks since 2018, began co-promoting the FFRangio System in the U.S., Europe and Japan. At the time, it also invested $75 million in CathWorks, marking the largest investment to date for the company. The agreement additionally provided Medtronic the option to buy CathWorks within a five year period.
“The goal of this deal structure was to see if you can have the best of both worlds,” Mousavi said. “Meaning, they would invest in CathWorks so as a startup we could innovate at a very rapid pace, which we did.”
Part of convincing Medtronic, which counts a $131 billion market cap, to acquire CathWorks included hitting key clinical and commercial milestones, Mousavi said (NYSE: MDT).
CathWorks currently has 5,000 patients enrolled in various global clinical studies, including a 2,000-patient randomized controlled trial called All-Rise, which the company will present results from at the American College of Cardiology on March 29.
The landmark study will compare the clinical outcomes between patients using FFRangio and traditional invasive catheter wires.
“If that study ends up having positive results, you’re going to see a significant shift which will basically prime the space for our technology to become the standard of care,” Mousavi said.
Before CathWorks entered the co-promotion with Medtronic, the company’s platform had helped about 1,000 patients globally, according to Mousavi. This year, that figure has surpassed more than 100,000 patients.
“I think this combination is what gave Medtronic the confidence about the true potential of the platform,” Mousavi said.
Non-Invasive Way to Diagnose Heart Disease
CathWorks was founded in 2013 by Israeli inventors Ran Kornowski, Guy Lavi and Ifat Lavi.
It opened its U.S. headquarters in Aliso Viejo under the guidance of Jim Corbett, a former president at Boston Scientific.
The company received FDA clearance for its FFRangio system in 2018, becoming the first non-invasive device of its kind to use Percutaneous Coronary Intervention (PCI) assessment, according to the company.
“When we first collaborated, we were trying to solve a real dilemma that interventional cardiologists faced,” Kornowski said in a statement at the time of FDA clearance.
They developed a noninvasive way of diagnosing heart disease.
In the standard testing procedure, a catheter is inserted into a heart, and drugs are administered to dilate blood vessels to monitor blood flow with physicians eyeballing X-rays to determine if a stent should be inserted.
By contrast, CathWorks’ FFRangio System uses a noninvasive five-minute procedure that doesn’t require drugs, and instead, uses a combination of advanced algorithms, AI and machine learning to create a 3D model of the heart.
“Medtronic has a very vast portfolio of coronary products like stents and balloons,” Mousavi said. “What they didn’t have is any sort of diagnostic tool.”
The system allows physicians not only to diagnose patients who have coronary artery disease but will also help them determine which Medtronic products are best suited to treat patients, according to Mousavi.
In 2024, CathWorks fully moved into new headquarters in Newport Beach from Irvine, nearly tripling the size of its footprint.
While he declined to disclose annual revenue run rate, Mousavi said that 2025 marked the 20th consecutive quarter of quarter-over-quarter average growth of 25%.
“2025 was an amazing year and continuation of the trend we’ve had for the last few years,” Mousavi said.
“We’ve entered 2026, hitting the ground running and are very excited about the potential expansion that the acquisition brings for CathWorks globally.”
