It is estimated that more than 10 million medical implants are implanted in patients each year worldwide, notably for cardiovascular and plastic surgery.
Due to sub-optimal biocompatibility of existing medical implants, every time one is placed in a patient by a surgeon, fibrosis occurs in the surrounding tissue: the patient’s immune system responds with the so-called foreign body reaction, in which the hosting tissue recognizes the implant as foreign and covers it with a thick layer of fibrotic tissue, in the attempt of isolating, destroying and expelling it.
Fibrosis is among the primary causes for malfunction and failure of implantable medical devices. In addition, fibrosis is associated with infections and can cause pain to the patients. Consequently, revision surgeries are often required post-implant, leading to a costly and lengthy recovery process. It has been reported that up to 20% of all implanted patients need correcting intervention and implant replacement due to fibrosis.
To address this critical medical need, the HYLOMORPH team has developed a unique surgical membrane that optimizes the interface between implants and human tissue. Preparation of the membrane consists of a patented biotech process, in which a non-pathogenic bacteria is cultured in combination with micro-engineered silicone surfaces to produce thin films of nano-cellulose, featuring a finely controlled surface topography. In pre-clinical studies conducted by the team, micro-structured biosynthesized cellulose membranes led to an 80% reduction in fibrotic tissue formation at three months after surgery.
Based on these promising results, the team is now working in close collaboration with the German Heart Institute Berlin (Deutsches Herzzentrum Berlin, DHZB) and the University Hospital Zurich to prepare for the first-in-man application of cellulose membranes on implantable loop recorders (electrocardiographic monitoring devices). If the results are confirmed in humans, micro-structured biosynthesized cellulose membranes could be the first anti-fibrotic solution for medical implants for the prevention of associated surgical complications.
The HYLOMORPH project was started at Wyss Zurich as a collaboration (“HeartOne”) with the Zurich Heart, a research initiative of Hochschulmedizin Zürich that aims at revolutionizing VAD technologies based on a variety of novel approaches.
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University Hospital Zurich
Deutsches Herzzentrum Berlin
Simone Bottan is Project Leader at HYLOMORPH and responsible for the development of anti-fibrotic solutions applicable to Pacemakers and Implantable Cardioverter Defibrillators for the project. Simone received his MSc in Biomedical Engineering from the Polytechnic University of Milan in 2008 and his PhD from the Department of Mechanical and Process Engineering of ETH Zurich in 2012. Awarded Pioneer Fellow by the Innovation and Entrepreneurship Lab of ETH Zurich, Simone integrated his academic R&D expertise into Product and Business Development activities related to Medical Devices. He co-founded the ETH Zurich spin-off HYLOMORPH AG and was awarded the venture leaders USA 2015 prize. His professional mission statement is “to establish cutting edge technologies in the MedTech fields with high impact on social and healthcare systems, supported by strong ethics”.
Francesco Robotti is responsible for product development at HYLOMORPH. Francesco has an interdisciplinary education in Energy Engineering (MSc, Politecnico of Turin, 2013 and Milan, 2014) and Mechanical Engineering (PhD Candidate, ETH Zurich). Alongside his MSc, he was also selected for Alta Scuola Politecnica, an excellence program offered by Politecnico of Turin and Milan, focusing on the formation of talented engineers able to pursue complex innovation projects in a team work context, with the mission of combining in-depth (vertical) disciplinary knowledge with interdisciplinary (horizontal) skills. He then turned with interest and enthusiasm towards the Biomedical Engineering field, with a PhD at ETH Zurich, where he focused at engineering and investigating key functional aspects of the HYLOMORPH technology. He is first author of three peer reviewed publications on this topic and presented the results and the vision of the HYLOMORPH project in several events and courses, among which the 3rd ETH-Chalmers Bilateral Workshop in Gothenburg, Sweden (2014), the Annual Symposium of the Competence Center for Materials and Processes in Zürich, Switzerland (2015) and the Material Research Society Fall Meeting in Boston, USA (2015). His professional mission statement is “to combine engineering skills, open-mind and habit to work into a highly interdisciplinary environment to design and create a product with a high impact on people’s health and life”.
Regulatory Affairs Manager
Sónia Schmocker joined Wyss Zurich in July 2016 as responsible person for regulatory and quality activities within the HYLOMORPH project, where she also actively supports several aspects of product development. Sónia has several years of experience as a project leader in the medical devices industry (Zimmer and Qmedics AG), from class I through innovative class III medical devices. Until 2008 she was Assistant Professor at Polytechnic School of Technology in Setúbal (Portugal) and worked as a graduated researcher at ISR-IST Lisbon.
Due to her keen interest in interfacing medicine with technology, Sónia studied biomedical engineering and received a bachelor’s degree in 2007. In 2009, she received her PhD in electrical and computer engineering for her work on satellite estimation (ISR-IST Lisbon).