Edwards Lifesciences, a medical device manufacturer, has entered into an agreement to invest $35m in an exclusive right to acquire Corvia Medical.
Image: Edwards Lifesciences to acquire Corvia Medical. Photo: Courtesy of IndypendenZ/FreeDigitalPhotos.net.
Corvia Medical is a developer of transcatheter device designed for treating heart failure with preserved or mid-range ejection fraction.
The company’s InterAtrial Shunt Device (IASD) is designed to provide continuous and dynamic decompression of the left atrium, which could reduce symptoms and slow the heart failure’s progression. The therapy is being studied as part of a Food and Drug Administration pivotal clinical trial.
Corvia Medical stated that it will use the funds invested by Edwards Lifesciences to complete the REDUCE LAP-HF II clinical trial of the IASD, a transcatheter device for the treatment of heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF).
The devices received CE Mark designation in 2016 and NUB1 reimbursement status in Germany earlier this year.
Corvia Medical president and CEO George Fazio said: “We are extremely pleased to have the support of the global leader in patient-focused innovations for structural heart disease as we continue to advance this novel treatment for heart failure. We are proud of our accomplishments to date and look forward to completing the pivotal study with the support of our global clinical investigators.”
Separately, Edwards Lifesciences has also acquired some assets of Mitralign, which develops investigational transcatheter annuloplasty system for treating functional mitral and tricuspid regurgitation. The assets acquired include intellectual property and associated clinical and regulatory experience.
Last month, the company agreed to acquire CAS Medical Systems (CASMED), a medical technology company developing non-invasive monitoring of tissue oxygenation in the brain, for about $100m.
Edwards stated that it is yet to receive 510(k) clearance in the US for a smart cable and software module which allows compatibility between CASMED’s FORE-SIGHT sensor and HemoSphere, a hemodynamic monitoring platform. The technology was developed by Edwards and CASMED and it received CE Mark in Europe.