ExThera Medical Announces Creation of European Subsidiary
Carla brings more than 30 years of experience in clinical research and the commercialization of new medical devices in the European market to ExThera Medical, where she will oversee the strategic direction for ExThera’s European operations.
“The establishment of our European subsidiary is an exciting milestone as we prepare for commercialization,” said Robert Ward, President and CEO of ExThera Medical. “Carla has a distinguished track record in medical device development and commercialization, including overseeing clinical research, regulatory affairs, quality assurance, and operations. As CEO of her company, Meditech, she successfully supported the rapid clinical adoption of many new medical devices. Carla’s strategic leadership will be invaluable as we continue our clinical research in Europe and build our operations and infrastructure for commercialization.”
Carla was most recently interim CEO and board chairwoman of Vimecon GmbH, which provides laser-based treatment of atrial fibrillation. In 2000, she founded MediTech Strategic Consultants in the Netherlands, a contract research organization for medical devices, and served as the company’s CEO until the company was acquired by MedPace in 2012. She has served as a board director for Shape Memory Therapeutics, Replication Medical, and as advisor to Greenhills Ventures. Carla has also been active in the EU Commission and Dutch Standardization Institute and has received several industry awards recognizing her accomplishments including the Next Women 100 Award in 2013, recognizing her as one of the 100 most influential business women in the Netherlands, and the Federation Businesswomen Award, as the best international female entrepreneur in 2010.
“Seraph holds incredible promise to transform the treatment of potentially lethal bloodstream infections,” said Kikken-Jussen. “Traditional treatments are costly and often result in poor outcomes, while contributing to drug resistance. They can also require lengthy hospital stays, and frequently fail to prevent patients from developing sepsis. I am eager to drive the completion of ongoing clinical trials in Europe and prepare for the commercialization of Seraph.”
Interim safety and performance data from the ongoing European clinical trial of the ‘Seraph® 100’ Blood Filter will be presented on March 20, 2018 at the International Symposium on Intensive Care and Emergency Medicine Congress in Brussels by Prof. Jan Kielstein of Academic Teaching Hospital in Braunschweig, Germany.
ExThera Medical is focused on developing easy-to-use devices for the rapid treatment of life-threatening/drug-resistant bloodstream infections, especially in the face of rising incidence rates and the spread of drug-resistant pathogens worldwide. The company’s Seraph® Microbind® Affinity Blood Filters can remove a broad range of sepsis-causing bacteria, viruses and toxins from whole blood. The technologies are currently under evaluation in a promising European clinical trial and recently designated by FDA for inclusion in their Expedited Access Pathway (EAP) program (Seraph 100). EAP designation is granted to devices that have the potential to satisfy unmet clinical needs in the prevention of fatal or debilitating diseases.