One month after halting sales of its closely watched Lotus transcatheter heart valve, Boston Scientific Corp. has agreed to pay $435 million in cash to buy a European company that makes a competing device in the hot product niche.
Boston Scientific announced Thursday that it has reached a definitive agreement to acquire Symetis SA, a private company based in Switzerland, that makes minimally invasive transcatheter aortic heart valves called the Acurate TA and Acurate neo/TF.
The deal announcement comes just ahead of an initial public offering of stock that Symetis had planned for April 4.
Traditional artificial heart valves require open-chest surgery, but minimally invasive "transcatheter" valves like the Acurate valves are designed to fold up into a narrow tube called a catheter, which can be advanced into position in the native aortic valve through a small incision in the leg. The valve is then unfurled inside the heart, avoiding surgery and a lengthy recovery time.
Boston Scientific rival Medtronic is one of just two companies that have sales approval in the fast-growing U.S. market for transcatheter valves. Neither of Symetis' Acurate valves are approved in the U.S., but they are cleared for sale in Europe and other areas to treat high-risk patients with severe and symptomatic aortic stenosis.
The company is also developing the Acurate neo/AS, a "next-generation" valve currently in clinical trials that will eventually be submitted for European sales approval.
In Europe, Symetis holds 7 percent of the market for transcatheter valves, while Boston Scientific's Lotus held an 8 percent market share, according to an analysis from trade-news publication EP Vantage that was distributed Thursday by investor-news service Seeking Alpha.
The Acurate valves treat the same group of aortic stenosis patients as Boston Scientific's Lotus valve. Last month, the Massachusetts-based company, which has major operations in the Twin Cities, announced a worldwide recall of all models of unused Lotus valves, which was at least the second sales pause for the device.
Both recalls were triggered by reports of problems with how the device is deployed inside the heart. (Devices already implanted in patients were not affected.)
A company spokesperson told the Star Tribune at the time that the Feb. 23 Lotus recall came about after the company received reports of problems, including one patient who died following an attempt to implant a second valve after the first attempt to deploy a Lotus valve failed. Boston Scientific lowered its revenue outlook in its structural heart division by $50 million after the Lotus recall.
On Thursday, a Boston Scientific spokeswoman said the company still expects to bring the Lotus valve back to the European market by the end of 2017, and that it intends to submit clinical data for U.S. approval by the same deadline, with the goal of a U.S. launch by mid-2018.
Despite that reassurance, stock analysts with Leerink Securities wrote Thursday that the deal to acquire Symetis raises at least some concern about Boston Scientific's confidence that Lotus will return to the market and be commercially viable.
"We believe Symetis does two things for BSX: 1) provides 'air cover' for the six-plus months ... that Lotus will be off the European market, to help stem share loss; and 2) Allows BSX to throw significantly more money behind commercialization of Acurate and potentially place it on a path to a faster U.S. entry," Leerink analysts wrote, using the company's BSX stock symbol.
Boston Scientific's news release on the Symetis deal noted that the announcement follows its recent acquisition of manufacturing assets from another transcatheter valve company called NeoVasc.
"The steps we are taking reflect our commitment to being a leader in [transcatheter aortic valve replacement] and structural heart technologies now and over the long term," Dr. Ian Meredith, global chief medical officer for Boston Scientific, said in the release.
The deal to acquire Symetis, which had been in the works for two years, is slated to close by the end of June. Symetis is a privately held company with 300 employees.
In 2015, the company floated plans for an initial public offering, but canceled the IPO after shares were priced at a level that implied a company value of up to 240 million Swiss francs (or about $240.75 million), Reuters reported at the time.
This month, Symetis again announced IPO plans, and had projected to start trading on the Euronext Paris exchange on April 4.
The EP Vantage analysis of the deal speculated, "This is a clear win for Symetis, which appears to have pulled off the time-honored trick of announcing IPO plans to make a vacillating buyer sign on the line."
Joe Carlson • 612-673-4779
