The spin-off Tesai Care has launched a clinical trial for the heecap device, aiming to demonstrate its safety in preventing respiratory muscle atrophy in patients who have required mechanical ventilation (MV) during their hospitalization in an Intensive Care Unit (ICU), a condition that affects over 3 million people globally each year.

The company’s clinical trial — a spin-off of the Parc Taulí Research and Innovation Institute (I3PT) and Vall d’Hebron Research Institute (VHIR) — begins now with patients admitted to the Hospital Universitari Parc Taulí, after receiving approval from the Spanish Agency for Medicines and Medical Devices (AEMPS) in late October.

Mechanical ventilation is a life-saving technique for critical patients, but it presents a significant challenge: 76% of ventilated patients develop respiratory muscle atrophy due to prolonged disuse of the diaphragm and other respiratory muscles. This weakness complicates weaning from ventilation, prolonging ICU stays and delaying recovery.

The heecap device employs Transcutaneous Electrical Stimulation of Respiratory Muscles (TERM), synchronizing with the patient’s breathing to strengthen both inspiratory and expiratory muscles. This technique aims to improve muscle strength and facilitate the process of weaning from mechanical ventilation.

The device comprises three main components: electrodes customized to the patient, an electrical stimulation device, and an algorithm that synchronizes stimulation with respiratory cycles. This initial clinical trial at Parc Taulí aims to confirm the system's safety and the algorithm’s precision.

According to Oriol Roca, clinical director of the spin-off and head of the Intensive Medicine Service at Bellvitge University Hospital, “this product represents a breakthrough in managing critical patients. Currently, no device on the market prevents respiratory muscle atrophy in a non-invasive and synchronized manner with the ventilator, and heecap has the potential to significantly impact weaning from mechanical ventilation.”

The clinical trial will be followed by a pivotal study scheduled for 2025, in collaboration with Vall d’Hebron University Hospital and other centres, to validate the device’s effectiveness and obtain CE marking as a medical device.

Financial backing

Tesai Care has secured €2.77 million in funding, combining private and public resources. Private investors include Nara Capital, along with CDTI-INNVIERTE and the Catalan Institute of Finance. On the public side, the company has received support from prominent programs such as Public-Private Collaboration Projects, the European Women Tech EU grant, and ENISA Digital Entrepreneurs.

Laura Lizama, CEO and co-founder of Tesai Care, stated, “These funds will enable us to advance the clinical trials necessary to bring heecap to market, aiming to apply for CE marking as a medical device in 2026. We are confident that heecap will benefit ventilated patients by accelerating their recovery and will also help ICUs by optimizing resource management,” Lizama emphasized.

A Transformative Impact

heecap has the potential to significantly enhance the quality of life for critical patients, accelerating their respiratory autonomy, reducing days on mechanical ventilation and ICU stays, and lowering associated complications such as infections. Renowned Canadian intensivist Ewan Goligher noted, “The technical approach of heecap has a strong chance of becoming a new standard of care for ventilated patients.”

With heecap, I3PT and VHIR strengthen their positions as leading research institutes in technological innovation within the biomedical field.