Edwards Lifesciences is dropping about $1.6 billion on a pair of acquisitions to bolster its structural heart portfolio.
They comprise JenaValve Technology, which is developing a transcatheter valve aimed at aortic regurgitation, and Endotronix, the maker of an implantable heart failure monitor.
Currently in the U.S., transcatheter aortic valve replacement systems have only been approved by the FDA for treating stenosis, where the valve narrows to the point of hampering blood flow. Edwards said that if JenaValve clears the FDA as it expects in late 2025, it may be the first minimally invasive therapy for regurgitation, where loose flaps allow blood to flow backward through the valve.
Treating aortic regurgitation has been tricky from a transcatheter approach, because the condition usually lacks the calcification and tightened valve areas seen in stenosis, which TAVR valves typically use to anchor themselves in place.
Last year, JenaValve presented clinical results from a single-arm trial of its Trilogy valve system, which includes a sealing ring that conforms to the shape of the natural valve. It met its primary endpoints in 30-day safety rates as well as one-year rates of all-cause mortality.
Significant residual regurgitation was also eliminated in all patients. The study’s results were published earlier this year in The Lancet. JenaValve previously raised $100 million in venture capital funding in August 2022 to support Trilogy’s development.
Meanwhile, Endotronix collected an approval from the FDA in late June for its Cordella sensor for monitoring blood pressure within the pulmonary artery among patients with serious and potentially worsening heart failure.
The former Fierce Medtech Fierce 15 winner’s minimally invasive system connects with a hand-held scanner, allowing patients to take daily readings at home. Alongside a traditional blood pressure cuff, Endotronix said its approach can provide a much more detailed picture of the patient’s cardiac health.
Edwards previously invested in the company in 2016 and is now exercising its option to acquire the outfit and use it to enter a new therapeutic area—as it anticipates a national coverage determination for Cordella from the Centers for Medicare & Medicaid Services in early 2025.
Along with JenaValve’s expected approval later that year, Edwards said it is not planning for either company to make strong contributions to its bottom line until at least 2026, and instead pitched them as long-term opportunities.
The deal includes $1.2 billion in aggregate upfront cash for the two companies—the split was not disclosed—plus up to $445 million in additional milestone payments, according to a Securities and Exchange Commission filing.
The dual acquisitions come on the heels of Edwards’ purchase of Innovalve earlier this month, a $300 million deal that includes a mitral valve replacement implant—as well as its $4.2 billion sale of its hospital monitoring business to BD in early June.
This week, Edwards also reported its second-quarter earnings results, with sales up 8% for a total of $1.6 billion.
However, growth was lower than expected for its mainstay TAVR business, amounting to $1.06 billion for a 6% gain. Edwards said it expects that growth rate to continue in TAVR throughout the second half of 2024, down from its previous forecasts of 8% to 10% increases year over year. The news sent the company’s stock down by about 25% in aftermarket trading to about $65.11 per share.
“Edwards’ competitive position did not meaningfully change globally, although we experienced some regional pressure and we maintain pricing,” CEO Bernard Zovighian said on a call with investors. “We are actively pursuing significant opportunities to grow TAVR globally over the long term.”
At the same time, the company reported 75% growth in its sales for the heart’s other valves, with transcatheter mitral and tricuspid systems bringing in $83 million. Edwards received the FDA’s first approval of a transcatheter tricuspid regurgitation treatment with its Evoque implant in February.