Breathing New Life into Respiratory Care: ORBIS and the Future of Implantable Ventilation
August 5, 2025
Europe’s leadership in medical research is indisputable—but for many rare respiratory diseases, everyday reality remains grim. Patients with Duchenne or Becker Muscular Dystrophy (DMD/BMD), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), or high cervical spinal cord injury (SCI) often face life-long dependence on invasive ventilators. These devices save lives but bring a host of complications: persistent infection risk from tracheostomy tubes, airway injury, impaired speech, limited mobility, and social isolation.
Enter ORBIS—the ORphan Breathing Implanted System. Under the Horizon Europe call HORIZON-HLTH-2025-03-IND-03, a five-year Innovation Action is underway to bring this first-of-its-kind technology to patients who have run out of options. ORBIS reimagines mechanical ventilation by harnessing negative-pressure ventilation (NPV) in a fully implantable form:
Natural breathing mechanics. An internal actuator gently expands the chest wall—just like a healthy diaphragm—drawing air into intact lungs.
Closed-loop intelligence. An ECG-like sensor picks up patients’ own respiratory effort and guides each breath, even when neural drive is severely weakened.
Infection reduction. By eliminating permanent tubes and external braces, ORBIS slashes ventilator-associated pneumonia and skin-site infections.
Patient freedom. A discreet, pacemaker-style external battery powers the implant, freeing users to speak, swallow, walk, and live more comfortably.
Yet innovation alone isn’t enough. The ORBIS consortium, led by Eagle Synergy Network and comprising BreathIN (device developer), will methodically generate the evidence needed for CE marking under EU MDR 2017/745.
Key milestones include:
Preclinical & in silico validation (ISO 10993 biocompatibility, bench testing, digital-twin modeling)
ISO 14155-compliant, multicentre clinical trials in Israel and Bulgaria
Technical documentation for Annex II/III and Notified Body review
Early HTA & economic models to ready ORBIS for reimbursement
By the end of Year 5, ORBIS aims to secure CE approval and lay the groundwork for market entry—offering real hope to patients with orphan respiratory conditions.
Join the ORBIS Journey
We’re building a network of experts and organizations to accelerate this transformation. If you’re a:
Thoracic surgical centre with implant experience
Clinical research site treating rare neuromuscular patients
Regulatory/QMS specialist in Class III CE marking
Digital-health innovator in AI, sensors, or simulation
HTA/payer engagement expert
Patient organization committed to respiratory care
…we’d love to collaborate.
Contact us:
Goldi Kozloski – goldi@eagle-synergy.com
Pini Sabach – pini@eagle-synergy.com
Together, let’s give Europe’s orphan respiratory patients the breath of life they deserve.