The Breton biotechnology company Hemarina obtains CE marking for an unprecedented technology: HEMO2life®, a pioneering oxygenation solution that is revolutionizing the preservation of grafts and significantly improving patient survival. “This CE marking confirms a collective adventure and will allow the deployment of the first oxygen carrier in the world for the preservation of kidney grafts”rejoices Franck Zal, founder of Hemarina.
Made from the arenicole worm or marine worm, HEMO2life® technology optimizes the preservation time of kidney grafts and their quality in order to accelerate post-transplant function recovery. With this CE marking, this technology can now be a preferred solution for each intervention in the countries of the European Union and those where the CE marking is recognized. “The CE marking reflects the compliance of the HEMO2life® medical device with the essential safety and clinical benefit requirements set by European regulations and allows it to be placed on the European market.“, underlines Franck Zal, founder in 2007 of Hemarina and discoverer of this breakthrough innovation.
The consecration of 15 years of research
For more than 15 years, Doctor Franck Zal conducts research on the properties of the extracellular hemoglobin of the sandworm.”250 times smaller than human hemoglobin, this hemoglobin is able to carry 40 times more oxygen“, he explains. From his laboratory located in Morlaix, Franck Zal was able to conduct several clinical studies alongside the University Hospital of Brest, under the responsibility of Professor Yannick Le Meur. Several transplant patients were followed over 4 years. , making it possible to demonstrate, “for a patient transplanted with HEMO2life® a survival rate of 98.3% after 4 years compared to 86% under conventional preservation conditions“, reports the study.
>>> Read also: Morlaix (29). Hemarina participates in a world first in India: a double upper limb transplant using HEMO2life® (bretagne-economique.com)
A global development
From fundamental research to the operating room, HEMO2life® is now the first oxygen carrier in the world to obtain marketing authorization : “ This certification crowns several years of hard work by a team of collaborators whose work is worthy of this success. They never gave up, and made it possible to make a crazy dream come true, to treat patients with sea worm hemoglobin, to a unique health company in the world “says Franck Zal.
With market access for its flagship solution, Hemarina is thus entering a new era in its global development: ” We have all the cards in hand to become one of the next French unicorns adds the founder.