Xeltis Develops First Ever Bio-Absorbable Heart Valve
By Jof Enriquez,
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Swiss medtech startup Xeltis recently announced positive results of a second clinical trial of the world's first bioabsorbable heart valve. The company envisions the expansion of this new class of cardiovascular medical devices from the initial set of pediatric patients into the larger, adult population in the near future.
In the study conducted at the Bakoulev Center for Cardiovascular Surgery in Moscow, Russia, children born with only one ventricle and who were implanted with Xeltis' cardiovascular patch did not have any post-operative complications, and did not demonstrate functional impairment requiring intervention one year after surgery, according to a company press release.
Xeltis' technology is based on Endogenous Tissue Restoration (ETR), an emerging therapeutic modality based on the work in supramolecular chemistry by Nobel Laureate and professor Jean-Marie Lehn, who serves as a scientific advisor for Xeltis.
According to the company's website, its synthetic heart valves and vascular grafts consist of synthetic bioabsorbable polymers, structured as matrices, that are implanted to replace diseased heart valves and blood vessels. As part of the body's natural healing response, endogenous tissue begins to develop in and around the implanted matrices, creating a new, functioning heart valve or blood vessels. The synthetic material biodegrades over time, leaving no foreign material inside the body, which could minimize complications and the need for revision surgeries associated with cardiac valve replacements.
"The positive results of our second feasibility trial confirm the extraordinary potential of our bioabsorbable technology for a number of different cardiovascular applications,” Laurent Grandidier, CEO at Xeltis, said in the release. “We are confident that bioabsorbable cardiovascular devices will be able to replace most commonly used implantable devices, and that ETR will improve patient outcomes while reducing the economic burden for healthcare systems."
Xeltis' initial focus is pediatric heart patients, and the company plans to launch soon its first commercial product: a pulmonary valve for children born with very severe heart malformations, Grandidier said in an interview with European CEO. He believes their breakthrough technology eventually will extend to adult cardiac populations.
"The technology we are developing is not a one-product technology: it’s a platform technology that can be applied to a multitude of cardio-vascular treatments, promising to really change the way cardio-vascular patients are treated today," Grandidier told European CEO.
Xeltis' bioabsorbable technology could upend standard cardiac heart valve replacement therapy, which presents some drawbacks. According to one study, bioprosthetic valves are likely to require reoperation within 10 to 15 years, and mechanical valves are more likely to cause major bleeding and clotting, and to require long-term anti-coagulant therapy. Tissue-engineered valves have a tendency to shrink after the scaffolding is absorbed into the body. Researchers are also working on a hybrid valve combining metal and engineered tissue to address these issues.
The completion and positive results of the second clinical trial are a significant milestone for Xeltis, which began as a university spin-off that attracted a sizable chunk of early-round investment. The company successfully closed a series B financing round of €27 million in November 2014, participated in by Life Sciences Partners, The Netherlands (LSP), Kurma Partners, France (Kurma), VI Partners, Switzerland (VI) and private shareholders. The coupling of game-changing technology and clinical evidence bodes well for the company's future.
"I think what we’re going to see from the investor appetite point of view is, they will not invest anymore in innovation for the sake of innovation. They will look for innovation that not only can improve patient outcomes, but can also improve or reduce the burden on the healthcare systems," Grandidier told European CEO.