EINDHOVEN, The Netherlands and ZURICH, November 15, 2017 /PRNewswire/ --
The Series C financing will support continuation of clinical activities and acceleration of product and market development for the company's novel aortic and pulmonary valve programs. This is the largest investment round for a private medical device company in Europe in 2017.
"Xeltis is eager to provide patients who need heart valve replacement with a new option offered through our restorative technology, to ultimately improve their lives and reduce healthcare system costs," said Xeltis Chief Executive Officer (CEO) Laurent Grandidier. "This robust financing provides us with the resources necessary to catapult our strategy forward - supporting quick expansion of our aortic and pulmonary valve programs and strengthening our quest to redefine heart valve replacement therapy."
Xeltis' heart valves enable the patient's own body to naturally restore a new heart valve through a therapeutic approach called Endogenous Tissue Restoration (ETR). With ETR, the patient's natural healing system develops tissue that pervades Xeltis' heart valve, forming a new, natural and fully functional valve within it. As ETR occurs, Xeltis implants are gradually absorbed by the body. ETR is enabled by bioabsorbable polymers based on Nobel Prize awarded science.
Ongoing Trial Programs
At TCT 2017, Xeltis announced the latest study results from the Xeltis preclinical aortic valve program during a session dedicated to its innovative technology. The 12-month preliminary aortic valve data showed promising results with good hemodynamic performance and fully functional valves in vivo 12 months after implantation.
The first feasibility clinical trial for Xeltis' pulmonary valve, Xplore-I, is underway in Europe and Asia. In January, the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for Early Feasibility Study (EFS) to implant Xeltis' pulmonary valve in 10 patients. Four prominent U.S. centers are now participating in the clinical trial called Xplore-II.
Previously, Xeltis shared up to 31-month data from a pediatric feasibility study of a vascular graft. The study showed positive functionality results with no device-related adverse events, and significant improvement in patients' general conditions.
Xeltis is currently investigating additional applications of its innovative approach to restore other heart valves and blood vessels.
About Heart Valve Replacement
In industrialized countries, heart valve disease is estimated to affect approximately two percent, of the population, with hundreds of thousands of patients undergoing heart valve intervention every year., Today, patients with artificial heart valves generally endure the risk of repeated replacement procedures or take long-term medication with potentially severe side effects.
Xeltis' novel restorative approach has the potential to overcome the limitations of current artificial heart valves and to improve the lives of hundreds of thousands of patients requiring heart valve replacements, while reducing overall healthcare system costs.
Xeltis is a clinical-stage medical device company developing the first heart valves and blood vessels enabling the body's natural restoration of heart valve function through a therapeutic approach called Endogenous Tissue Restoration (ETR).
The company's cardiovascular implants are made of bioabsorbable polymers based on Nobel Prize awarded science.
For more information, please visit http://www.xeltis.com
CAUTION: The Xeltis technology is an investigational device and NOT approved for sale.
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2. Nkomo VT [ https://www.ncbi.nlm.nih.gov/pubmed/?term=Nkomo%20VT%5BAuthor%5D&cauthor=true&cauthor_uid=16980116 ]1, Gardin JM [ https://www.ncbi.nlm.nih.gov/pubmed/?term=Gardin%20JM%5BAuthor%5D&cauthor=true&cauthor_uid=16980116 ] et al. Burden of valvular heart diseases: a population-based study. Lancet. [https://www.ncbi.nlm.nih.gov/pubmed/16980116] 2006 Sep 16;368(9540):1005-11. Retrieved online on 30Aug2017 https://www.ncbi.nlm.nih.gov/pubmed/16980116
3. American Heart Association. Heart Disease and Stroke Statistics - 2017 Update. Retrieved online on 30Aug2017 http://circ.ahajournals.org/content/circulationaha/early/2017/01/25/CIR.0000000000000485.full.pdf
4. Millennium Research Group (December 2013). European Markets for Heart Valve Devices 2014: France, Germany, Italy, Spain, UK.
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