Key Highlights:
- Xeltis announced that it has appointed Luc Verhees as its new vice president of Clinical Business Development.
- Luc’s appointment further strengthens the company’s leadership team, as Xeltis expands its clinical presence following the approval of an Investigational Device Exemption from the FDA to initiate a US pivotal study for aXess.
- 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 the discovery of potential new therapeutic indications for its unique technology.
Xeltis, a developer of transformative implants that enable the natural creation of living and long-lasting vessels, announced that it has appointed Luc Verhees as its new vice president of Clinical Business Development.
Luc’s appointment further strengthens the company’s leadership team, as Xeltis 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. Luc is familiar to Xeltis having previously served as senior vice president 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, Xeltis commented: “As we progress our clinical programs and push towards commercialising aXess, Luc brings great knowledge and familiarity of the clinical trials landscape across multiple continents. Luc’s skills and track record will be invaluable as we prepare to initiate our US pivotal trial for aXess.”
Luc Verhees, vice president of Clinical Business Development, Xeltis said: “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.”
Luc 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 vice president of Clinical Affairs. During his time at Highlife, Luc 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 US, Australia, and several European countries, even during the Covid pandemic.
Throughout his career, Luc has always 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.