“We recognized the potential of the talented Caisson team and its technology several years ago. This team will now be the cornerstone for our planned entry into the TMVR space, which has the potential to be an important growth platform for us in the future,” said LivaNova’s CEO Damien McDonald. “We intend to invest in the clinical studies, regulatory approvals, product enhancements and other steps needed to launch this mitral valve replacement system commercially. We expect it will become a strategic complement to our heart valve portfolio for heart team physicians, allowing us to offer patients the most advanced, minimally invasive mitral valve replacement option.”
Caisson’s device is unique, being the only TMVR product designed solely for trans-septal approach and delivered through a single venous access. The system is also designed for the implant to be fully retrieved following functional evaluation, but prior to final release—a safety feature important to physicians.
“We created this percutaneous mitral valve replacement implant, procedure and delivery system to offer a significant new therapy to patients with severe mitral regurgitation,” said Caisson COO and co-founder Todd Mortier.
Caisson initiated its clinical trials through the U.S. FDA Early Feasibility Study program, and will add clinical sites in Europe and Canada.
“We look forward to joining LivaNova to combine our efforts in bringing a superior technology to market,” added Caisson CEO and co-founder C.J. Schweich, Jr., M.D.
LivaNova has been an investor in Caisson since 2012 and has agreed to pay up to $72 million, net of $6 million of debt forgiveness, to acquire the remaining 51 percent of the company. The first payment of $18 million was made at closing with the balance paid on a schedule driven primarily by regulatory approvals and sales earn outs. As a result of the acquisition, LivaNova expects to recognize a pre-tax non-cash gain during the second quarter on the $15 million book value of its existing investment in Caisson. The acquisition will be dilutive to earnings for several years, but LivaNova fully anticipates this transaction will meet all long-term financial metrics and internal standards. 2017 guidance will be updated to include the estimated impact of the acquisition during LivaNova’s first quarter earnings call tomorrow morning.
The Caisson TMVR system is not approved for sale in any country.