Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Navidea deals NA Lymphoseek rights to Cardinal Health in $310m deal
Navidea Biopharmaceuticals said today that it inked a definitive asset purchase agreement with Cardinal Health for Navidea’s Lymphoseek product.
Dublin, Ohio-based Navidea said that it will receive $80 million at closing for it’s lymphatic mapping and lymph node biopsy product, plus the opportunity for $230 million in milestone payments through 2026. More than $20 million of that amount is guaranteed over the next 3 years. Read more
4. B. Braun’s Aesculap puts nearly $3m into ApiFix
B. Braun’s Aesculap division today invested $2.8 million into ApiFix’s $5 million Series B financing round to help support ApiFix’s minimally invasive, non-fusion spinal implant system designed to treat adolescent idiopathic scoliosis.
The ApiFix device, which won CE Mark clearance for use in the European Union in 2012, is designed to correct adolescent idiopathic scoliosis without the use of fusion to avoid the potential for loss of spine mobility, the company said. Read more
3. Neovasc wins approvals for European trial of Tiara replacement heart valve
Neovasc said today that it won regulatory and ethics committee approval for a clinical trial of its Tiara replacement heart valve in Italy that it plans to use to back a bid for CE Mark approval in the European Union.
Vancouver-based Neovasc said the 115-patient Tiara II study is designed to evaluate safety and effectiveness using a transapical approach for implantation of the valve. The 1st site for the study is expected to sign on before the end of the year, with patient enrollment slated for early 2017 and approvals in other jurisdictions on tap. Read more
2. European anti-trust regulators grant conditional approval for Abbott’s $25B St. Jude Medical buy
Anti-trust regulators in the European Union last week granted conditional approval for the $25 billion merger of Abbott and St. Jude Medical.
The European Commission’s decision on the deal requires the divestiture of a pair of device lines: St. Jude must deal its Angio-Seal and Femoseal vascular closure assets, including a manufacturing plant in Puerto Rico, and Abbott must deal the Vado steerable sheath it bought with the acquisition of Kalila Medical earlier this year. Read more
1. Edwards Lifesciences to acquire Valtech Cardio in $690m deal
Edwards Lifesciences said today that it agreed to put $690 million on the table for Valtech Cardio and most of the heart valve repair technologies it’s developing.
The deal, which calls for $340 million in up-front cash and another $350 million in milestones, does not include Valtech Cardio’s transseptal mitral valve replacement program. That business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards is due to keep an option to buy, the company said. Read more
The post MassDevice.com +5 | The top 5 medtech stories for November 28, 2016 appeared first on MassDevice.
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The FDA today released a list of hospitals tagged over inadequate medical device reporting issues, naming 17 in a review covering the period between April, 2016 and now.
Researchers have developed a method to engineer sugar clusters attached to proteins or lipids, called glycan complexes, to target particular organs of the body. A team from the Riken Biofunctional Synthetic Chemistry Laboratory in Japan and Kazan Federal University in Russia published their work in Advanced Science.
