Tag Archive for: Medtech

Xeltis announces completion of enrolment in EU Pivotal Trial for aXess and prepares for market approval

Enrolment completed – 120 patients with end-stage renal disease in 22 centers in Europe Primary endpoint readouts anticipated in Q2 2025, first market approval expected in 2026 Capability to obtain market approval is further strengthened with the appointment of Rob Eyers as Chief Technology Officer. EINDHOVEN, The Netherlands, 7 January 2025 – Xeltis, a leading […]

Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis

alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis PMA Approval and FDA Breakthrough Device Designation US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease US commercial launch planned for H2 2025 […]

Weekly round-up: Ottimo Pharma Raises over $140 Million in Series A Financing 

Ottimo Pharma, a private biotech company pioneering bifunctional medicines to extend the lives of people living with cancer, on Thursday announced the completion of a Series A financing round of over $140 million. The financing will accelerate the lead asset, Jankistomig, a first-in-class PD1/VEGFR2 bifunctional antibody for multiple solid tumour indications, in both IV and […]

Xeltis expands leadership team with appointment of Luc Verhees as Vice President of Clinical Business Development

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 aXessTM, its restorative vascular access conduit EINDHOVEN, The Netherlands, 5 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural […]