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Transcatheter heart valve replacements, or repair devices, are growing in use due to their non-invasive nature and quick patient recovery times compared to open surgery procedures.

Recent advancements in these devices have allowed for indication expansions to include an increasing number of treatable patients, however, the devices still face a number of limitations. In particular, all current commercially available transcatheter heart valve devices are composed of inert material that does not grow with the patient, which is problematic in younger patients (especially children) who often require repeated replacement interventions or surgery throughout their lives.

To address these challenges in cardiovascular implant technology, a start-up operating as part of the Wyss Translational Center in Zurich, Switzerland, has developed LifeMatrix technology.

LifeMatix is a scalable tissue engineering technology that creates novel biomimetic cardiovascular implants with capacity for self-renewal, remodelling and growth.

In essence, this involves growing donor human cells from so-called master cell banks onto biodegradable polymer scaffolds outside of the body with specific stimulants so that they produce extracellular matrix (ECM). The human donor cells are then removed, leaving behind an off-the-shelf and cell-free implant which can be implanted into every patient without eliciting an immune response. LifeMatrix biomimetic implants are dynamic, have the capacity to grow and transform into living tissue after implantation and repopulation with the recipient’s cells. In addition, the LifeMatrix process is scalable, since the same donor cells can be used to create thousands of individual biomimetic implants.

So far, LifeMatrix devices have undergone several stages of preclinical testing and successfully shown feasibility, safety and efficacy for a number of different indications.

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By GlobalData

The first indication targeted for clinical trials in humans using these biomimetic devices was as a cavopulmonary shunt in pediatric patients with single ventricle anatomy. Animal testing using LifeMatrix devices as heart valve replacements has also proven to be successful; a LifeMatrix valve was implanted as a pulmonary valve replacement using transcatheter delivery techniques in a translational sheep model, according to a 2018 report by Emmert and colleagues in Science Translational Medicine.

First proof-of-concept studies have furthermore confirmed the feasibility of LifeMatrix technology for transcatheter aortic valve replacement (TAVR). In future, the company is planning additional cardiovascular indications.

The tissue engineering-based LifeMatrix platform shows the potential to be a hugely disruptive technology in the cardiovascular implant market. GlobalData estimates that the TAVR market alone represents a global market value of $3.41bn in 2019, and projects a double-digit compound annual growth rate (CAGR) of this market value across the globe. If LifeMatrix is able to demonstrate clinical advantages of its platform through rigorous human clinical trial testing, GlobalData believes the advantages of this technology will establish it as a competitive player in the TAVR and other cardiovascular markets in the near future.