Lymphatica Medtech awarded FDA Breakthrough Device Designation

Chronic lymphedema, characterized by debilitating swelling of limbs, poses a considerable challenge for millions worldwide, particularly those who have undergone cancer treatment involving lymph node removal or damage. LymphoDrain, an innovative implantable device, offers a promising solution to drain interstitial fluid from edematous limbs to areas with functional lymphatic vessels, thus addressing a critical unmet medical need in adult patients.

The FDA's Breakthrough Device designation program facilitates an expedited review process for products demonstrating potential to provide more effective treatment for irreversibly debilitating diseases. LymphoDrain's designation underscores its status as a breakthrough technology, offering significant advantages over existing alternatives, and prioritizes patient access to transformative therapies.

In response to the FDA decision, Marco Pisano, co-founder and CEO of Lymphatica Medtech, said: "Our mission at Lymphatica Medtech is to empower vascular doctors with innovative solutions that enhance patients' health and quality of life. The FDA's validation of LymphoDrain's potential as a breakthrough therapy reaffirms our commitment to revolutionizing lymphedema treatment and alleviating the burden faced by patients worldwide."

Supported by a successful first-in-human clinical trial

Lymphatica Medtech's journey to FDA Breakthrough Device Designation was supported by a successful first-in-human clinical trial conducted in collaboration with the University Hospital of Lausanne (CHUV – Switzerland), led by Prof. Lucia Mazzolai. As part of the Breakthrough program, Lymphatica will benefit from expedited interactions with FDA experts, potentially accelerating the pathway to market. Lymphatica Medtech is supported by the Innosuisse Swiss Accelerator innovation program.

(Press release)