ReFlow Therapeutics Expands Management Teamadmin
ReFlow Therapeutics Expands Management Team
Baar, Switzerland, April 4th 2017
ReFlow Therapeutics AG today announced that the Company has added two experienced medical device professionals to its management team.
Ms. Blathnaid Feldman is appointed ReFlow’s Vice President of Quality and Regulatory Affairs. Blathnaid joins ReFlow from Biotronik Schweiz AG where she was their Senior Regulatory Affairs Manager responsible for a wide range of regulatory activities. These included regulatory aspects for drug eluting stents and balloons, European registrations of interventional devices and pre-submission activities with the US Food and Drug Administration (FDA) and PMDA (Japan). Before joining Biotronik, Blathnaid worked four years with Zimmer as their Regulatory Affairs Senior Specialist. As a qualified pharmacist, she also has a strong background in medicinal product regulations.
Mr. Oliver Bludau joins ReFlow as R&D Manager responsible for all product development activities including coordination of ReFlow’s development partners. Before joining ReFlow, Oliver was project manager and deputy Chief Technology Officer (CTO) at Osypka AG. At Osypka, Oliver was responsible for developing electrophysiology catheters and has been a project manager for Class III devices for neuro-modulation. He has also been responsible for completing design dossiers for CE-mark approvals according to ISO 13485 requirements as well as providing supporting documentation for approval processes in Latin-America and Japan.
“Blathnaid and Oliver add substantial medical device experience to the ReFlow management team. Their insights and dedication have proven invaluable in the early phases of the ReFlow development processes, and they will continue to add value as these activities intensify”, said Jon H. Hoem, ReFlow’s CEO and Co-Founder.
ReFlow is developing the Controlled Flow Infusion (CoFITM) console and rapid exchange (RX) catheter for non-clinical trials to generate data for its regulatory design dossiers. The Company targets to complete these development stages over the next 16 months and will provide regular updates on the progress of the Company.
The ReFlow team during a recent meeting in the ReFlow headquarters in Baar, Switzerland. The team in co-located to shorten the communication paths and improve quality in the dynamic early phases of the project. From left to right: Ute Wiesemann (Quality Manager), Caroline G. Hoem (Finance & Office Manager), Jon H. Hoem (CEO & Co-Founder), Blathnaid Feldman (VP Quality & Regulatory Affairs) and Oliver Bludau (R&D Manager). For a complete overview of the ReFlow Founding Team, Board of Directors and management team, please visit the ReFlow teampage.