LivaNova is scrapping its Caisson transcatheter mitral valve replacement (TMVR) program because of declines its heart valve business has seen over the last five years. Plans now call for the London-based company to enter into a restructuring plan for its heart valve business, which brought in $130 million in revenue in 2018.
Under the restructuring plan, it is expected that about 150 employees could be potentially impacted in the three sites of Saluggia, Vancouver, and Minneapolis. LivaNova’s Saluggia, Italy facility will now become dedicated to R&D and production of mechanical heart valves, rings, accessories, and Nitinol stents. LivaNova tissue heart valve production will be concentrated in the company’s Vancouver, Canada plant. The closure of Caisson TMVR operations in Minneapolis will be effective at the end of 2019. Patients who participated in clinical trials related to TMVR will continue to be followed within the parameters of the trial.
“The time has come to address the continued declines we have experienced in our heart valve business. We will restructure and simplify our heart valve manufacturing network, which will eliminate operational overlap between facilities and enable us to address new regulatory requirements,” Damien McDonald, CEO of LivaNova, said in a release. “As we evaluated these changes along with those in the structural heart market, we determined it was no longer viable to continue to invest in our TMVR program. As a result, we will close our Caisson TMVR operations.”
LivaNova had been an investor in Caisson since 2012 and finally acquired the TMVR specialist for $72 million in 2017. In August of 2018, LivaNova said it had completed PRELUDE, the U.S. feasibility study of the Caisson TMVR system and would focus on enrolling patients into its INTERLUDE CE mark trial and finalize the protocol for, ENSEMBLE, the U.S. pivotal trial.
This marks the second program a medtech company has either jettisoned or scrapped this week. Marlborough, MA-based Hologic divested Cynosure because the medical aesthetics business had been consistently underperforming. Hologic acquired Cynosure about two years ago for $1.65 billion but sold it to an affiliate of investment funds managed by Clayton, Dubilier & Rice for $208 million.
The Mitral Valve Revolution
Mitral valve replacement/repair is one of the hottest up and coming markets in medtech. In addition to LivaNova, there have been other companies that have made investments and acquisitions in the space.
Edwards Lifesciences, a pioneer in the transcatheter valve replacement (TAVR) market, set the tone for the 2015 mitral valve buying spree, by spending up to $400 million to acquire CardiAQ Valve Technologies and its transcatheter mitral valve replacement (TMVR) system.
In 2016, Edwards would go on to acquire Yehuda, Israel-based Valtech Cardio Ltd. for about $340 million, with about $350 million in milestone payments. Valtech has developed the Cardioband transseptal mitral repair system.
Abbott Laboratories strengthened its mitral valve portfolio when it acquired Roseville, MN-based Tendyne for $250 million. Around the same time, Abbott made an unspecified investment in Santa Cruz, CA-based Cephea Valve Technologies, a mitral valve repair company. In September, Abbott presented promising early data from SUMMIT, an early feasibility study of the Tendyne Valve. Not to be left out of the TMVR action, Dublin-based Medtronic picked up Twelve in a deal worth up to $458 million, shortly after Abbott’s Tendyne acquisition was announced.
And late last year, Boston Scientific rounded out its record M&A spending spree by doling out $325 million to acquire the remaining shares of Millipede, the developer of the Iris Transcatheter Annuloplasty Ring System for the treatment of patients with severe mitral regurgitation. In January of 2018, MD+DI reported the Marlborough, MA-based company had previously taken a $90 million stake in Millipede.