Enabling Surgical Pocket REgeneration

Project Information

ESPREE

Grant agreement ID: 946140

DOI

10.3030/946140

Project closed

EC signature date 20 April 2020

Start date 1 May 2020

End date 30 April 2023

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 134 093,75

EU contribution

€ 1 493 865,00

Coordinated by

HYLOMORPH AG
Switzerland

Periodic Reporting for period 2 - ESPREE (Enabling Surgical Pocket REgeneration)

Reporting period: 2021-05-01 to 2023-04-30

Summary of the context and overall objectives of the project

All medical devices implanted into the human body are perceived as foreign objects, resulting in an attempt by the body to reject them through a process called foreign body reaction. This can result in either the failure of the medical device and/or significant clinical complications. Hylomorph has developed Hylomate, the world's first solution to protect all implantable medical devices in contact with soft tissues from foreign body reaction, acting as an "invisibility" cloak through complex interactions at the microscopic level with the surrounding tissue.

Hylomate is a platform technology that addresses all causes of severe complications connected to the implantation of synthetic materials. It ensures an all-round protection of the surgical pocket, preventing infection, hematoma, foreign body reaction and fibrotic encapsulation. Hylomate increases the lifespan of implants and minimizes exposure to life-threatening risk. This results in (1) improve quality - of - life for patients (2) better quality-of-care for healthcare providers and (3) reduced health economics burden. The first application for Hylomate will be in the field of cardiac rhythm management in combination with pacemakers, implantable cardioverter defibrillators and cardiac resynchronization therapy devices.

The completion of ESPREE will put Hylomorph in the position to successfully pursue an additional financing round, to set-up sales and marketing forces in the US and Europe to demonstrate commercial traction of Hylomate during the showcasing phase.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

35 patients have been implanted for more than 1 year, having completed the full course of Visits (Visit 1 to Visit 4). The longest implant has now reached 38 months. The overall monitoring of the implant recipient’s health confirms the general optimal safety profile of the Hylomate. Next to the PI’s opinion, the DSMB has reviewed the 1 year follow up data of all the patients and adjudicated that no device related adverse events occurred in the study.
Overall, the clinical investigation results collected are within statistical conditions to demonstrate that primary and secondary endpoints are met and ultimately confirm the safety and efficacy of the Hylomate.
The innovative approach for non-invasive monitoring of fibrotic tissue formation using highresolution imaging (Figure 3) and the significant reduction visualized around Hylomate are the subject of an abstract submitted to the international conference of the European Heart Rhythm Association (EHRA– https://www.escardio.org/Congresses-Events/EHRA-Congress). The contribution will be presented by the Hylomate clinical study PI: Prof. Dr. MD. Christoph Starck.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Hylomate differs substantially from the current state of the art products regarding main function, mechanism of action, and product features. Hylomate fully exploits its unique material and the micro and nano engineering characteristics to block foreign body reaction ultimately providing the first-all-round solution to surgical pocket complication of implantable medical devices.

Through prevention of surgical pocket complications and the subsequent need for revision surgeries, Hylomate shall eliminate life-threatening risks for patients and enable a significant cut-down in healthcare costs, benefiting hospitals and health insurance organizations. Hylomate is the ideal improvement for the quality of care provided by surgeons and hospitals and the quality of life of patients. It shall impact health economics significantly reducing the overall healthcare costs.

picture1.jpg

picture2.jpg