Brings over 30 years of experience in cardiovascular clinical research, business development, training, education, and medical affairs
Strengthens Xeltis’ leadership team following IDE approval for initiation of US pivotal study for aXess™, its restorative vascular access conduit
EINDHOVEN, The Netherlands, Nov. 5, 2024 /PRNewswire/ — 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 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 commercializing 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 commercialization.”
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 hemodialysis 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 commercialization and the discovery of potential new therapeutic indications for its unique technology.
About Xeltis
Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient’s own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis’ most advanced product currently under clinical development is aXessTM, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases.
Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.
About aXess
aXess is a restorative conduit which enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of a fistula with the speed to treatment of an AV graft. The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by renal disease patients.
A first-in-human trial of aXess demonstrated a significant improvement in performance compared to hemodialysis vascular access solutions. A pivotal trial of aXess is currently enrolling up to 110 patients in nine EU countries.
Go to axesspivotal.com for more details.
SOURCE Xeltis
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