In a neurovascular market dominated by big players like Medtronic and Johnson & Johnson, French medical device maker Balt is carving out its place at its Irvine lab.
Balt, whose products are used to treat strokes and brain aneurysms, established Balt USA LLC in 2016, which has since grown to 1,006 global employees, including more than 400 locally.
“The pool of employees in the Orange County area is fantastic,” Fred Gunderman, senior vice president of Balt USA, told the Business Journal. “We frequently don’t have to go outside of this area to recruit those individual spots. And then when it comes to the operators on the floor, there’s a fantastic opportunity of employees throughout Orange County because it’s been so established over the years.
“Orange County has access to medical, healthcare, and manufacturing professionals who make a huge difference.”
That growth is accelerating in Irvine, where Balt last year doubled the size of its clean room to 17,000 square feet. It also recently leased the next-door building to house its R&D and commercial teams, fueled by growing U.S. demand.
“The physicians in the U.S. are always asking for some bulk products we don’t have in the States, so we’re working to bring those products here,” Gunderman said.
Gunderman said that Balt has sustained high double-digit growth since its U.S. inception.
The company generated about $350 million in global revenue last year, with 30% from the U.S., driven by its interventional neurovascular products for treating strokes and aneurysms.
“The introduction of Balt in the United States is really much more than just a French company coming here,” Gunderman said during a tour of the facility. “It’s an investment in the U.S. infrastructure and economy.”
The company has 15 locations worldwide, anchored by its parent company in France and extending to Canada, London and China, among other regions. Irvine serves as Balt’s U.S. headquarters, with some executives working out of a corporate office in Boston.
Balt is making its first appearance this week on the Business Journal’s annual list of medical device makers, ranked No. 13 with 432 OC employees.
Company Founded by Polish Scientist
Balt was founded in 1977 by Polish scientist Leopold Płowiecki in his garage in France.
Gunderman said that Płowiecki’s neighbors were neuro interventionalists in need of better products.
In 1987, the company’s first product was the Magic catheter, an early microcatheter that could navigate the brain’s very small vessels and is still on the market today.
Balt remained a small family business until 2015 when Bridgepoint Advisers acquired a majority stake, which “changed the trajectory of the company,” according to Gunderman.
Pre-acquisition, Balt was a $40 million company and has since grown to $350 million in global sales last year.
“It’s been a good relationship over time, and we’ve worked together to transform the family business into a world-class manufacturing and global product portfolio,” Gunderman said.
Part of its evolution involved moving away from a distributorship model.
In the past, products were manufactured in Paris and shipped to distributors, who then delivered them to physicians worldwide.
Balt began acquiring some of these distributors as direct employees.
“That changed our ability to educate physicians, collaborate with them and develop even more products down the road,” Gunderman said.
Gunderman said that Balt has no intention of going public.
“We don’t really want to borrow our growth,” he said. “We invest back into the company based on performance.”
Leases 24K-Sq.-Ft. Building for R&D, Commercial Teams
Following the Bridgepoint acquisition, employees moved into the Irvine site in 2017.
Located at 29 Parker near Irvine Spectrum Center, the facility spans 60,000 square feet and includes manufacturing and R&D capabilities.
Products made in Irvine include coils, catheters and liquid embolics, with stents expected to follow, according to Vice President of Operations Ameer Ibrahim.
“We have very technical processes we have to do to build the product,” Ibrahim told the Business Journal. “There are labor pools around here that we can tap into very easily to be able to get that skilled workforce.”
Balt is beginning to build out a local campus with last year’s lease of a 24,000-square-foot building next door to house its R&D and commercial teams.
Having the second building will free up space for future expansion; the grand opening is set for May 12.
“There’s an advantage to having your R&D team close to your manufacturing site, which helps enable that transfer from idea to design development to manufacturing,” Ibrahim said.
Ibrahim said they aim to expand the cleanroom again next year, adding another third of the space they currently have to meet demand driven by both the U.S. and global markets.
“The new products that the R&D team here is developing, we’re registering them outside of the U.S.,” Ibrahim said. “We can distribute those globally, so there’s demand from both inside and outside the U.S. that’s driving this expansion.”
The company’s leading U.S. products are its coils, which are used to stop bleeding, followed by access devices that allow catheters to reach deeper into the brain for more complex procedures, according to Gunderman.
Balt’s portfolio spans both hemorrhagic and ischemic stroke, with the company recently expanding further into the latter in the U.S. Hemorrhagic strokes occur due to bleeding, while ischemic strokes are caused by the blockage of blood flow to the brain.
Balt currently has 14 products approved in the U.S. and plans to launch 18 more by 2028 across its hemorrhagic and ischemic stroke portfolios. The company is also looking to expand into pediatrics and cerebral venous disorders.
“They’re not primary areas of focus, but niches that we will expand into and likely become more significant,” Gunderman said.
Physician Demand Drives Innovation
Unlike some of its competitors, Gunderman says Balt is a “pure play” neuro-intervention and peripheral vascular disease company.
“Those companies have multiple different devices in their portfolio that go well beyond neuro intervention,” he said.
In 2018, Balt was approached by physicians who said the number one diagnosis in neuro intervention is chronic subdural hematoma, or a bleed on the surface of the brain that’s common in patients 60 years or older on antiplatelet medications, according to Gunderman.
“These antiplatelets are really saving people’s lives, but simultaneously, there’s a downside that is if they hit their head or have some sort of trauma, they will develop a bleed,” he said.
“So, they came to us and recognized that one of our products could potentially treat this by injecting the materials into a vessel that feeds the outside of the skull.”
Balt partnered with the physicians on a randomized controlled trial for a liquid embolic to treat chronic subdural hematoma—originally approved in Europe in 2012. The trial concluded two years ago, and the company received FDA premarket approval for the product in January.
“Physicians didn’t necessarily knock on Balt’s door first, but we were the first to actually answer,” Ibrahim said.
The company’s next product in development is the Silk Vista flow diverter, which is currently undergoing clinical trials.
In the U.S., Balt’s goal is to have a second premarket approved device by 2028 and to round out its ischemic stroke portfolio within the next two years, Gunderman said.
