BIOSENSORS INTERNATIONAL ANNOUNCES ENROLLMENT OF FIRST PATIENT IN PIVOTAL TRIAL OF NEW CORONARY MICROCATHETER - "BIOMICS".

MORGES, Switzerland, April 5th, 2022

Biosensors International Group, Ltd. ("Biosensors" or the "Company"), a developer, manufacturer and supplier of innovative medical devices, announced today the enrollment of the first patient in the BIOMICS study, a prospective, multi-center evaluation of the safety and effectiveness of the Biosensors Microcatheter in patients undergoing Percutaneous Coronary Intervention (PCI) for the treatment of chronic total occlusions (CTO). Biosensors are conducting BIOMICS as part of their product development activities for the new coronary microcatheter. The trial will include up to 10 sites in the United Kingdom and is being conducted under the leadership of Dr Margaret McEntegart, Golden Jubilee National Hospital, Glasgow and Dr James Spratt, St George’s Hospital, London. The BIOMICS trial, utilizing the Biosensors’ Microcatheter Biosensors Chief Medical Officer Prof Keith G Oldroyd said, “We are confident that this new microcatheter design will help interventional cardiologists to further improve the already excellent results they are achieving in CTO-PCI”. Dr Margaret McEntegart and Dr Aadil Shaukat enrolled the first BIOMICS patients at the Golden Jubilee National Hospital in Glasgow. “We are very excited to have performed the first in human cases with the new microcatheter from Biosensors as part of the BIOMICS study here at GJNH. The new microcatheter was successful in crossing the CTO with no complications. We look forward to recruiting more patients in coming weeks”.

About Biosensors’ Microcatheter

This device represents the latest development in Biosensors Interventional Cardiology portfolio. The design incorporates tungsten braiding with stainless steel coils and a tip profile matching current bestin-class microcatheters but with a larger internal diameter to facilitate wire manipulation and exchange and the crossing of the occluded segment in patients undergoing PCI of chronic total occlusions.

About Bluesail Medical

Bluesail Medical Co., Ltd. is a subsidiary of the Bluesail Group and represents its medical industrial arm. Founded in 2002 as a China Mainland-Hong Kong joint venture enterprise (former Shandong Blue Sail Plastic & Rubber Co., Ltd); and successfully listed on the Shenzhen Stock Exchange on April 2, 2010 (stock code 002382). Bluesail Medical has two primary business divisions: protective and sanitary products and cardiovascular and neurovascular devices. Protective and sanitary products are manufactured in Asia and Greater China region. Its sales network covers over 100 different countries and regions in North and South America, Europe, Oceania, and other regions. The products are taking up 22% of the industry’s global market share. Since 2012, Bluesail Medical has become the leading enterprise in this industry. The cardiovascular and neurovascular devices business is undertaken by its subsidiary Biosensors which was formed in 1990. Biosensors has production centers in Singapore and China. Its products are sold in over 90 countries and regions. It is the world’s top four companies engaged in the research and development, manufacturing and sales of stents business. 

Forward-Looking Statements

Certain statements herein include forward-looking statements which generally can be identified by the use of forward-looking terminology, such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “project” or “continue” or the negative thereof or other similar words. All forward looking statements involve risks and uncertainties, including, but not limited to, customer acceptance and market share gains, competition from companies that have greater financial resources; introduction of new products into the marketplace by competitors; successful product development; dependence on significant customers; the ability to recruit and retain quality employees as Bluesail Medical and Biosensors grow; and economic and political conditions globally. Actual results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward-looking statements speak only as of the date of this release and Bluesail Medical or Biosensors assumes no duty to update them to reflect new, changing or unanticipated events or circumstances.

Not approved for commercial use and not available for sale, the microcatheter is limited to investigational use in the United Kingdom.

11/01/2022