Occlutech Holding AG (Occlutech), a leading specialist provider of minimally invasive structural heart implants, has signed an exclusive distribution agreement with B. Braun Interventional Systems Inc. (BIS) as an important next step in Occlutech’s commercial development in the US. The agreement is in effect immediately as Occlutech works collaboratively with the U.S. Food and Drug Administration (FDA) to gain Pre-Market Authorization (PMA) Approval for the Flex II ASD Occluder. Occlutech expects FDA approval within 2022.
Occlutech has signed an exclusive distribution agreement with B. Braun Interventional Systems Inc (BIS). Under this agreement, BIS will initiate the US commercialization activities for Occlutech’s Flex II ASD Occluder with the support of the global Occlutech team. Through the collaboration, Occlutech positions itself for success in the strategically important US market, which is characterized as a premier and commercially attractive healthcare system, while BIS increases its portfolio’s relevancy around its strong congenital and structural heart focus.
"We are proud and honored to align our US commercial team’s capabilities with Occlutech and their clinically proven portfolio of minimally invasive cardiac implants,” said Dave Mittl, VP Sales and Marketing, B. Braun Interventional Systems. “From the very beginning of our engagement with the Occlutech leadership team, it was clear that our missions to serve the needs of congenital and structural heart interventional cardiologists and the patients they serve were well aligned. Our shared prioritization and focus fundamentally position our teams for long-term success.”
“The agreement with B. Braun Interventional Systems is a major stepping-stone to realizing Occlutech's US growth strategy. B. Braun's excellent reputation and proven sales capabilities will significantly improve Occlutech’s commercial strength in the largest congenital and structural heart device market in the world,” said Sabine Bois, CEO, Occlutech. “I am convinced that this collaboration will successfully drive our market entry, not least through our great cultural fit.”
Occlutech is a leading specialist provider of minimally invasive structural heart implants, with a mission to improve the quality of life for people with heart conditions. The vision is to become a leading global specialist in cardiac implants, addressing congenital heart defects, stroke prevention and heart failure. Since 2003, the company has developed, manufactured, and commercialized occluders and interatrial shunt products. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 146,000 products sold. The company markets and sells its products in around 85 countries. The company has around 290 employees and is a public limited liability company registered in Switzerland. For more information: www.occlutech.com.
About B. Braun Interventional Systems
B. Braun Interventional Systems offers interventional solutions designed with the patient in mind. Many of the products offered have been developed in response to the needs of physicians, technicians, and nurses. The company is committed to delivering safety, precision and convenience to interventional procedures. B. Braun Interventional Systems Inc. is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Medical Inc., Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Interventional Systems Inc., visit www.bisusa.org/about-us and connect with B. Braun Interventional Systems on LinkedIn.
For more information please contact:
Director, Corporate Communications, B. Braun Medical Inc.