Sec Filing Transmedics

XVIVO Submits An IDE Application To US FDA For Its Innovative Heart Technology A Significant Milestone

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Sec Filing Transmedics

GOTHENBURG, SE / ACCESSWIRE / April 27, 2022 / XVIVO Infusion AB XVIVO (LSE: 0RKL) (FRA: 3XV)

XVIVO is pleased to announce an application to the U.S. Food and Drug Administration (FDA) for an exemption from research device (IDE) requirements. It will support initial FDA regulatory approval for the PRESERVE Clinical Trials: a prospective, single-group, open-label, multi-center trial of transplanted hearts following nonischemic heart PRESERVE from long-term donors.

This is in accordance with the previously announced FDA breakthrough designation of XVIVO Cardiac Technology, a non-ischemic heart preservation device (NIHP). At pre-application meetings, XVIVO worked constructively with FDA to discuss issues and concerns and used FDA feedback to determine next steps for its IDE application. The IDE allows for the use of an experimental device in a clinical study to collect safety and efficacy data that XVIVO will use to support Pre-Sale Authorization (PMA).

In 2019, 112,000 Americans were on the national transplant waiting list, while only 39,718 transplants were performed. With the increasing scarcity of organs, the importance of preserving existing organs increases. The XVIVO Cardiac Technology is designed to preserve donor hearts during transport by non-ischemic cold perfusion for use in transplant surgery.

The technology was invented by Professor Stig Steen of Igelösa Lifescience and developed in collaboration with XVIVO. Both the device and the patented solution are patented by XVIVO.

"We are very pleased with the investigation plan presented in the IDE documentation, which we believe accurately reflects the spirit of innovation, and we look forward to the agency's feedback," said Jaya Tivari, vice president of clinical affairs and regulation at XVIVO. , UNITED STATES OF AMERICA. “We anticipate completing our discussions with the FDA in the first half of 2022 to begin patient enrollment in the summer at several leading US agencies that have already shown significant interest in participating in this study have expressed. We are planning further talks. " Details on testing after approval of our IDE application ".

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“This important event is a testament to our commitment to ensuring that no one dies waiting for a new body. The United States is our largest market, and as such, foreign direct investment demand for our heart technology will be an important continuation of the test. Ongoing clinical trials in Europe, Australia and New Zealand As XVIVO is engaged in research, it is gratifying to see hard work yield solid results,” said Doug Anderson, CEO of XVIVO.

April 22, 2022, Gothenburg, Doug Anderson, CEO of XVIVI Perfusion AB (publication)

For more information contact:

Doug Anderson, CEO, +46 76 643 30 31, email: dag.andersson@xvivogroup.com Christopher Nordstrom, Chief Financial Officer, +46 73 519 21 64, email: kristoffer.nordstrom@xvivogroup.

about us

Founded in 1998, XVIVO is the only medical technology company that extends the life of all major organs, enabling transplant teams around the world to save more lives. Our solutions enable leading physicians and researchers to push the boundaries of transplant medicine. Headquartered in Gothenburg, Sweden, XVIVO has offices and research centers on two continents. The company is listed on Nasdaq and has the symbol XVIVO. Visit www.xvivogroup.com for more information.

Attachments

XVIVO submits SDI application for innovative heart technology to the US Food and Drug Administration – an important milestone

SOURCE: XVIVO Perfusion AB

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https://www.accesswire.com/699066/XVIVO-submits-an-IDE-application-to-the-US-FDA-for-its-innovative-heart-technology-a-significant-milestone

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