CathWorks’ diagnostic tool recently gained regulatory approval in the European Union, marking the third region where it’s commercially available.
Now, the Newport Beach-based medical device company is eyeing the rest of the world, Chief Executive and President Ramin Mousavi told the Business Journal.
The FFRangio System, a noninvasive method of diagnosing heart disease, is currently available in 45 U.S. states, over 200 hospitals in Japan and is expected to launch in five to seven countries in Europe with the recent approval.
CathWorks’ worldwide expansion is supported by its co-promotion partnership with Medtronic PLC, one of the world’s largest medical device makers, which was first announced in 2022.
“From a commercial perspective, the partnership with Medtronic has proven to be very effective,” Mousavi said. “The access to a few 100 Medtronic team members across the globe have been definitely one of main drivers of the growth.”
As part of the agreement, Medtronic said it’d invest up to $75 million in CathWorks, with the option to buy the company in the next five years at a $585 million valuation after it completes certain product milestones.
While the company had no official announcements to share on the acquisition front, Mousavi said CathWorks is progressing towards “hopefully exciting news.”
All-Rise Study
Since Mousavi was awarded the Business Journal’s Innovator of the Year Award last year, he has overseen the company’s global expansion and ongoing clinical trials.
CathWorks last June announced that it enrolled its first patient in its international All-Rise study, a randomized controlled trial comparing the clinical outcomes between patients using FFRangio and traditional invasive catheter wires.
The study is expected to enroll close to 2,000 patients at 60 sites across North America, Asia, Europe and the Middle East. It is now close to achieving half of its enrollment goal, Mousavi said.
Last year, Mousavi also told the Business Journal that CathWorks was making big strides in creating noninvasive approaches using artificial intelligence and computational science technology to diagnose cardiovascular disease.
He said he hopes to share new product announcements within the next 12 months.
CathWorks saw its largest growth in sales last year and is on track to more than double that figure this year, according to Mousavi.
The company has fully settled into its new headquarters, having relocated its U.S. headquarters from Irvine to a space in Newport Beach nearly triple its prior footprint last year.
If Medtronic were to acquire CathWorks, Mousavi believes it’d be beneficial to keep CathWorks in Orange County.
“I think it’d be a great addition to the Medtronic portfolio since they don’t have any cardiovascular presence yet in Orange County,” he said.
