CE Mark for Uscom BP+ Sale in Europe
CE Mark for Uscom BP+ Sale in Europe
Uscom Limited announced that the new Uscom BP+ is now eligible for Conformité Européenne (CE) mark allowing it for retail sale in Europe. This means that the new Uscom BP+ can now be sold into Hospital and Clinical markets in CE jurisdictions. This jurisdiction includes the 28 member states of the EU, plus Iceland, Norway, Liechtenstein, Switzerland and Turkey.
The Uscom BP+ suprasystolic oscillometric method is patent protected in many international jurisdictions and is currently being rolled out as regional regulatory approvals permit. Revenue is beginning and is expected to accelerate throughout 2018. The US FDA and Chinese CFDA submissions are currently in process and are expected within the next 12 months. The CE mark also opens the door to many other countries around the world including Asia and the Middle East where approval leverages off CE.
Executive Chairman of Uscom, Associate Professor Rob Phillips said “The CE mark provides us with the opportunity to sell our revolutionary Uscom BP+ into UK and Europe, and many jurisdictions which use CE as a regulatory standard. We currently have a network of distributors waiting on manufactured product with outstanding orders. The development and testing of this device has taken time, but the product represents revolutionary and practice changing science, as the recent publication recommending its routine use in pharma trials from authors at the Uni of Auckland (Auckland), Imperial College (London), Uni Cambridge (Cambridge), University College (London), Mass General/Harvard (Boston), the Austrian Institute of Technology (Vienna) and the Uni of Otago (Christchurch) demonstrated. While we could previously sell an earlier version of BP+ with limited functionality, this new CE marked product will deliver the full power of Uscom BP+ technology to the massive hypertension and heart failure market.”
The global hypertension device market is reported to be in the order of $5B USD, while $74B PA is reportedly spent on management of hypertension and hypertension complications in the US alone, making the scale of the global Uscom BP+ opportunity both substantial and difficult to define. While Uscom plans to retain the BP+ technology as a foundation for accelerated revenue growth over the next decade, it could also be strategically licensed or on sold into international distributors.