Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has appointed Luc Verhees as its new vice president (VP) of clinical business development.
As Xeltis stated in a press release, Verhees’s appointment further strengthens the company’s leadership team, as it expands its clinical presence following the approval of an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a US pivotal study for aXess, its restorative vascular access conduit. Verhees is familiar to Xeltis, having previously served as senior VP of global clinical affairs from 2018 to 2020, and this previous experience of working with Xeltis’ transformative Endogenous Tissue Restoration (ETR) technology in a clinical capacity will be invaluable as the Company continues its development.
Eliane Schutte, chief executive officer (CEO) of Xeltis commented: “As we progress our clinical programmes and push towards commercialising aXess, Verhees brings great knowledge and familiarity of the clinical trials landscape across multiple continents. Verhees’s skills and track record will be invaluable as we prepare to initiate our US pivotal trial for aXess.”
Verhees also shared his thoughts, stating: “Xeltis’ novel technology is truly transformative, enabling the natural creation of living and long-lasting vessels. My passion for improving the standard of care in cardio-vascular therapies aligns perfectly with Xeltis’ mission to transform patient outcomes with its transformative implants. I am looking forward to contributing to the further development of aXess and the Company’s other clinical development programs and supporting Xeltis’ drive towards near-term commercialisation.”
Verhees brings over 30 years of experience in cardiovascular clinical research, business development, training & education, and medical affairs. He joins from Highlife, a trans-catheter, mitral valve replacement company, where he held the position of VP of clinical affairs. During his time at Highlife, Verhees played a critical role, amongst others, in developing the clinical investigation plan (CIP) for a US pivotal study and collaborated closely with the regulatory team to secure IDE approval. He successfully managed multiple clinical studies and was instrumental in selecting and activating clinical sites across the USA, Australia, and several European countries, even during the COVID-19 pandemic.
Throughout his career, Verhees has been involved in new breakthrough developments and held several senior management positions at LivaNova (Sorin), Medtronic, and Boston Scientific, as well as at start-up companies such as Spectranetics, Novoste, and Corevalve.
Xeltis’ US-based pivotal trial for aXess follows strong 12-month data from the first-in-human trial in Europe in comparison to haemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial. The IDE approval, along with the recent appointment of Shawn Gage as VP of clinical affairs, places the company in a strong position as it progresses towards commercialisation and the discovery of potential new therapeutic indications for its unique technology.
