Xeltis BV raised $15 million in series D2 funding to develop its restorative vascular access device for patients with chronic kidney disease who are on hemodialysis. The investment in this technology, called the Axess graft, came from Hong Kong-based China Grand Pharmaceutical and Healthcare Holdings Ltd. (Grand Pharma). The deal focuses mainly on commercializing Axess, but also involves other new products in the field of hemodialysis developed as part of the Xeltis technology platform. The commitment from Grand Pharma includes equity investment and product licensing, representing Xeltis’ first commercial deal and its first funding from an Asian concern.
Institut Mérieux SA is offering equity to a preferred partner via a restricted capital increase. Exor NV has consequently acquired 10% of Institut Mérieux’s capital by investing $850 million. A third of this new funding, some $285 million, will be injected immediately this summer, with the balance following over the coming 12 months.
Envision Technologies BV’s latest artificial intelligence (AI)-powered smart glasses for the blind and visually impaired are designed to help with reading, scanning faces and navigating everyday tasks. This visual assistant was introduced at California State University Northridge (CSUN) 2022 Assistive Technology Conference. Envision has updated its AI-based platform and ecosystem with improved optical character recognition (OCR) and better text recognition with contextual intelligence.
After three years of clinical research, Royal Philips NV said its Tack (4-F) endovascular system has shown promising results for arterial dissection repair following balloon angioplasty in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. The data was collected from a 36-month follow-up in the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee clinical trial.
Onward Medical NV reported initial patient enrollment in its Hemon early feasibility study and first-in-human trial of its ARC implantable pulse generator. The study will examine stabilization of hemodynamic function in patients with a spinal cord injury. It is taking place at Lausanne University Hospital (CHUV). “Implanting into a human for the first time is an important step forward for our neurostimulation technology, designed to help refine and implement epidural stimulation therapy in patients with spinal cord injury,” Dave Marver, CEO of Onward, told BioWorld.
Following an investigation into Leadiant Group’s pricing of a rare disease drug, the Italian Competition Authority fined the privately held company about €3.5 million (US$3.76 million) May 31 for charging the Italian National Health Service excessive prices since 2017 for Chenodeoxycholic Acid Leadiant.
Xeltis BV plans to expedite an international pivotal trial investigating its restorative hemodialysis access graft Axess following encouraging preliminary data. The company released results from a clinical trial investigating the graft at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London. Data showed the graft had 100% functional patency and safety in a patient cohort of 11, with a median follow-up of 6.5 months.
Royal Philips NV has been handed a health care policy order requiring it to recall and replace 277,500 defective respiratory therapy devices in France within four months. Twelve ranges of respiratory device for patients who depend on mechanical breathing assistance as well as continuous positive airway pressure devices used to treat sleep apnea, have been affected by a design issue.
Vicentra BV has closed a $74 million series C financing round to accelerate the European rollout of its wearable insulin patch. The small, lightweight system Kaleido is the company’s flagship product and consists of two pumps controlled by a Bluetooth wireless connected handset. The small size rests on a pumping action that – unlike a conventional syringe mechanism – uses micro-pulse technology to deliver accurate and consistent doses of insulin.
The European Investment Bank (EIB) pumped €15 million (US$17 million) into Xeltis BV to accelerate clinical programs for its polymer-based technology platform for cardiovascular restoration. The Eindhoven, Netherlands-based company is developing three types of cardiovascular implants. These are a pulmonary heart valve, coronary artery bypass graft and hemodialysis access grafts. The devices use a therapeutic approach called endogenous tissue restoration (ETR), which causes the patient’s own body to naturally restore a new blood valve. As the patient’s healing system develops a functional valve, Xeltis’ implant is gradually absorbed by the body.
