Dive Brief:
- Competition in the left atrial appendage (LAA) closure market intensified this week, once again, with Johnson & Johnson’s acquisition of Laminar, a Santa Rosa, California-based company that is developing a new approach to eliminate the LAA.
- J&J, which announced the deal Thursday morning, paid $400 million upfront to acquire the privately held company, with the potential for additional payments based on reaching clinical and regulatory milestones starting in 2024. J&J said it will take charges related to the deal that will reduce its 2023 earnings by about 17 cents per share from its previously issued forecast and lower its 2024 EPS by about 15 cents.
- The deal comes in the same week that Medtronic revealed it had acquired an LAA exclusion system in August from Miami-based medical device incubator Syntheon.
Dive Insight:
Closure of the left atrial appendage is intended to reduce the risk of stroke in patients who have atrial fibrillation (AFib), a common form of irregular heart rhythm in which the heart’s chambers beat out of sync. The LAA, a small pouch in the left atrium of the heart, is a major source of blood clots in AFib patients that can enter the bloodstream and cause a stroke.
The high-growth market for LAA closure devices is led by Boston Scientific’s Watchman franchise and includes Abbott’s Amplatzer Amulet and AtriCure’s AtriClip devices. Medtronic on Monday joined the field, announcing it is launching an implantable clip called Penditure that it acquired from Syntheon.
While J&J will need to catch up with those devices already on the market, the company is looking to differentiate itself with an offering that uses rotational motion to eliminate the LAA. J&J said Laminar has received Food and Drug Administration approval for a U.S. pivotal study of the device that will begin enrollment early next year.
J&J noted that nearly 40% of AFib patients cannot tolerate long-term blood thinners, which is driving the market for LAA closure devices. The Laminar device will complement J&J’s electrophysiology and intracardiac echocardiography technologies in its Biosense Webster business, the company said.
BTIG analyst Marie Thibault said Laminar adds to J&J's existing LAA portfolio, which includes the WaveCrest system acquired through the purchase of Coherex Medical in 2015. At a recent industry conference, J&J executives noted WaveCrest was in the product development stage, Thibault said.
"Unlike existing endovascular devices on the market that seal the LAA, Laminar plugs it with a rotating ball and lock mechanism," Thibault wrote in a note to clients.
J&J said it is now forecasting 2023 EPS in a range of $9.85 to $9.91 on an operational basis and $9.90 to $9.96 on a reported basis, due to an in-process research and development charge associated with the Laminar acquisition.
On Wednesday, the FDA updated a letter informing healthcare providers of new research comparing outcomes in women and men who receive LAA occlusion device implants. FDA said it has not changed its recommendations for use of the devices.
