PARIS--(BUSINESS WIRE)--LimFlow SA, developer of minimally-invasive technology for the treatment of end-stage critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD), today announced the expansion of the company’s senior management team. Sophie Humbert, PhD, has been appointed to the role of chief operating officer (COO) and Thomas Engels, III, assumes the role of vice president of clinical affairs. The Paris-based company also announced the opening of its first U.S. office in Silicon Valley, California.
Sophie Humbert brings to LimFlow more than 15 years of experience in the medical technology industry and a strong track record of bringing innovation from ideation to market. Prior to joining LimFlow, Sophie was the COO of Arterial Remodeling Technologies (Terumo). There, she helped the company earn a CE Mark for its first-generation bio-resorbable cardiovascular stent and develop its second-generation, drug-coated bio-resorbable stent. Previously, Sophie was CEO at CermaVein, where she led the company through CE marking and to commercialization in several markets. Sophie holds a PhD in Pharmaceutical Sciences from the University of Geneva, a Master’s degree in Management from EM Lyon and a Pharma doctorate from the University Claude Bernard in Lyon.
Thomas Engels possesses more than 20 years of clinical research experience for pharma, biotech, and medical devices, with 15 years in interventional cardiology. Prior to joining LimFlow, Thomas was vice president of clinical affairs for Claret Medical, Micell Technologies and CardioKinetix, taking the companies’ novel devices through trials to achieve CE Mark, European post-marketing safety surveillance, Chinese (CFDA) approval and de novo FDA clearance. Previously, Thomas was director of clinical research for 10 years at Abbott Vascular, where he managed its global portfolio of interventional cardiology studies. He holds a BS from Louisiana State University and MBA degrees from the Columbia Business School and the Haas School of Business at University of California, Berkeley.
“Sophie and Thomas bring impressive experience in the cardiovascular space and a track record of achieving clinical, regulatory and commercial milestones for new technologies. Their addition to the company demonstrates our commitment to hiring the top talent in the industry,” said Dan Rose, chief executive officer of LimFlow.
He continued, “We are also excited to expand our operation into the U.S. to support our ongoing U.S. clinical work. By locating our first office in Silicon Valley, we have chosen a location with a heritage of innovation that reflects our mission of transforming the treatment of CLI globally.”
In April, the U.S. Food and Drug Administration (FDA) approved the company’s Investigational Device Exemption for a feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System.
About LimFlow SA
LimFlow is a private, venture-backed medical device company transforming the treatment of Critical Limb Ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease and an aging population. The LimFlow Percutaneous Deep Vein Arterialization (pDVA) is designed to bypass blocked arteries in the leg and rush oxygenated blood back into the foot. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, promotes wound healing and prevents major amputation. For more information, visit www.limflow.com.
CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.