Second chance for a device for newborn babies with severe cardiac defects

EspeRare is a foundation founded in 2013 focusing on overcoming roadblocks that prevent new therapies to reach rare diseases patients. The foundation added a new program to its portfolio and announces the relaunch of a previously marketed active implantable medical device, FloWatch. EspeRare recently obtained the licensing rights to this clinically-proven device that has medical benefits in protecting the heart and lungs of babies born with severe congenital heart defects. This is EspeRare’s first “medical devices” program, adding diversification to the present portfolio of 4 therapeutic drug programs. This is also EspeRare’s first, market-ready therapeutic intervention. EspeRare’s medical devices team is working hard to have the first FloWatch units manufactured and marketed before the end of 2017.

The FloWatch technology was developed at EPFL (Switzerland) and combines a micro-engine inspired from Swiss watchmakers with a telemetric control system developed at ETH Zurich (Switzerland). According to the website of Leman Medical Technologies the device was further developed by Endoart and Leman Medical Technologies. EspeRare is relaunching the quality, regulatory and manufacturing processes in order to secure the European market authorization in 2017.

Over the next 2 to 3 years, EspeRare wishes to produce and distribute around 200 units. Fulfilling EspeRare’s not-for-profit goals, part of the FloWatch devices produced will be distributed in Africa and in Asia. In these regions, only a small number of newborns have access to the heart repair surgery so that protecting these babies’ hearts with FloWatch is even more pressing and can prove to be vitally important.

FloWatch is a technology that could be offered to up to 1000 babies per year in Europe and to over 30,000 in Africa and Asia. In these latter regions, and in line with EspeRare’s ethical goals of universal access to medicine, we are evaluating a distribution model for FloWatch that is socially responsible, maximizes medical impact, and whereby profits made from the FloWatch sales in the developed countries support philanthropic distribution in the poorer countries.

(SK)