Xeltis BV has secured CE mark approval for Axess, its restorative vascular access conduit for hemodialysis. The company also released 12-month data from its EU pivotal trial on the technology, which showed strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient-year, as well as a substantial reduction in infection burden.

Investors poured a further $13 million into Vicentra BV for Kaleido, its insulin patch pump system, taking the total raised in the company’s series D financing round to $98 million. The funds come amid significant changes across diabetes technology, particularly the acceleration of patch pumps. Kaleido is one of the smallest, lightest, and most precise insulin patch pumps available.

Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development, clinical validation, regulatory approval, and commercial launch of the diagnostic platform.

Xeltis BV secured €47.5 million in financing to help bring Axess, its vascular access conduit for hemodialysis, to the market. The funds include a venture debt package of up to €37.5 million from the European Investment Bank and €10 million from existing shareholders.

Xeltis BV reported successful clinical data from the Axess EU pivotal trial which demonstrated the transformative potential of its restorative vascular access conduit, Axess, in hemodialysis treatment.

An international team of researchers has successfully used Onward Medical N.V.’s ARC-IM therapy to develop a neurostimulation system that improves blood pressure stability in patients with spinal cord injuries. According to data from two studies published in Nature and Nature Medicine, the implanted system also led to durable reduction of hypotensive symptoms, resulting in an improvement in the quality of life of patients.

Vicentra BV’s insulin patch pump, Kaleido, will soon reach more patients with diabetes after it raised $85 million in a series D funding round. The company said the Kaleido is among the smallest, lightest, and most precise insulin patch pumps available.

Onward Medical NV secured U.S. FDA investigational device exemption (IDE) approval for a pivotal study to assess the safety and efficacy of its implantable spinal stimulation technology, the ARC-IM system. The Empower study BP study will focus on addressing blood pressure instability in patients with spinal cord injury (SCI).

AMT Medical BV raised $25 million in a series B financing round for its Excimer Laser Assisted Non-Occlusive Anastomosis heart bypass system. The funds will go towards clinical trials and regulatory approval for its sutureless coronary bypass technology designed to replace traditional open-heart bypass surgery.

Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.