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For more than 25 years, the Biosensors International Group (“Biosensors”) has been designing, manufacturing and marketing innovative medical devices used during heart surgery and intensive care treatment.
Continually striving to be at the forefront of product innovation, with a focus on improving patient outcomes today, we are driving the development of tomorrow’s next generation medical technology.
In the year 2000 we entered the interventional cardiology market and immediately became the first cardiology company to develop and patent their own proprietary limus agent, Biolimus A9™ (BA9™), a highly lipophilic anti-restenotic drug designed for cardiovascular stent technologies.
We were also the first stent company to develop and launch a biodegradable polymer stent with only the abluminal side coated with polymer and drug to reduce systemic exposure2.
Over the last two-decades Biosensors has become one of the largest manufacturers and suppliers of cardiovascular stents globally.
Biosensors International strives to reduce its waste through the implementation of lean manufacturing and continuous improvement initiatives, such as energy saving and recycling processes.
Biosensors International has adopted a systematic approach with the implementation of an environmental management system that aims to contribute to environmental sustainability. As a result, three sites are now ISO 14001:2015 certified: the manufacturing site located in Singapore (certified in August 2018), the European warehouse in the Netherlands and the European headquarter offices in Switzerland (both certified in March 2019). Such environmental management system supports Biosensors International’s commitment to contribute to protect the environment and respond to changing environmental conditions in balance with socio-economic needs.
We are committed to:
Build awareness in our company as well as other persons working under our company’s control in relation to our Environmental Management System and environmental performance, in order to enhance knowledge and promote behavior to achieve continual improvement.
Identify and having access to compliance obligations and understand how they apply to our company to ensure fulfilment of our compliance obligations
Generate appropriate operational controls in order to protect the environment, including prevention of pollution: promoting the use of sustainable resources, striving for recycling, and maximizing the use of primary sources of energy
Towards this end, our key objectives include:
– Continuously improving the efficiency and sustainability of our business activities and products using a life cycle perspective, resulting in the lowering of greenhouse gas emissions and water use wherever feasible
– Minimizing the generation of hazardous and non-hazardous waste and recycling wastes wherever feasible
– Reuse, recycle, composting materials and conserve energy wherever feasible.
Our key 2024 objectives are:
In Singapore:
Achieve overall objectives hit rate by more than 85%
Initiate programs to support BIG decarbonization roadmap, minimum one program/initiative
Eliminate use of papers through implementation of electronic platform for QEMS processes
Reduce colour printing by another 2%
Reduce drug waste by decreasing its retention at incoming
Complete building energy audit
Implement eDHR for minimum one production line
Replace all inkjet printers in order to reduce cartridge wastes
Achieve REACH compliance for all new product projects
In Europe:
Sales & Marketing:
– Not exceed CO2 emissions from EMEA business travels versus 2023 by publishing some rules
– Maximize digital sponsorship activities: Reduce by 10% printed materials used for meetings
Supply chain:
– Reduce scrapping by 20% compared to max. expected in 2024
– Reduce by 20% the product stock expiring between January and August 2025
– Reduce outbound shipments in EMEA direct markets by 20% compared to 2023
Clinical activities:
– Use the tool to measure the carbon footprint of completed trials and identify which elements of trials are carbon-heavy
– Decrease the impact of clinical trials activities by updating procedures to mandate the following
The Investigator meetings, monitoring activities and CEC meetings conducted remotely
– CRO request of proposal will include the use of electronic signature systems
Electronic Investigator Site File will be recommended to all sites participating in “in-house” studies
European warehouse:
– 5% Decrease the normal heating (gas) compared to 2023
– Work on green heat strategy by 2035 to switch to another energy than gas to heat the building
BESA Offices:
– Commuting policy to be developed for a Go live in 2025 if expected achievement of 15% reduction of CO2 emission can be reached from this policy
– Implement a common objective with « Ecole de Transition » located in the same building on an EMS topic
Biosensors manufactures and markets innovative medical devices for interventional cardiology.
Our aim is to improve patients’ lives through pioneering medical technology that pushes the boundaries of innovation.
Through our high quality medical devices we impact the lives we touch and we are committed to continued investment in the development of pioneering medical technology, robust clinical data and engineering new medical devices that will further benefit your patients.
This will create the greatest possible patient outcomes and provide value to our stakeholders including customers, employees, communities and shareholders.
The Biosensors International Group has operations worldwide and is headquartered in Singapore. The European headquarters are located in Morges (Switzerland). With the combination of a direct sales network and distributors across the world, Biosensors is dedicated to serving the needs of the healthcare community and is committed to, the support of bona fide medical education, advancing the progress of medical science and improving patient care, through training courses, scientific summits and symposia and related events on a regular basis, both in international forums and at national level. Biosensors also participate in some of the major cardiology congresses throughout the world – doing so in a way that complies with all ethical and legal requirements.
1. Data on file Biosensors International Group Ltd – Report RD – 200020 – Validation / Verification of ElogPoct Determination Method and Measurement of ElogPoct for Zotarolimus
2. Ostojic and al – The pharmacokinetics of Biolimus A9 after elution from the BioMatrix II stent in patients with coronary artery disease: The Stealth PK Study; Ostojic et al., Eur J Clin Pharmacol (2011) 67:389–398
CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.
The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the “Instructions for Use” supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.
Biosensors’ interventional cardiology products, including BioMatrix NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J® and RISE™ NC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.
BioMatrix NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, BMX-J, Juno, S-Stent and Rise NC are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. All other cited trademarks are the property of their respective owners.
The Biosensors International Group (“Biosensors” or “Biosensors “International”) develops, manufactures and markets innovative medical devices, designed to improve patients’ lives through pioneering medical technology, which pushes the boundaries of innovation.
Biosensors International consistently innovates in stent technology. Our (DES) system marketed from 2008 onwards was the first to feature a unique abluminally-coated stent with a biodegradable polymer, absorbed synchronously with their proprietary limus1. Our highly lipophilic BA9™ anti-restenotic drug was specifically developed by Biosensors International for use on coronary stent applications.
An enhanced version was then launched in Asia, Europe, the Middle East and Africa in May 2010, and had the drug and polymer coated on a highly flexible platform designed to enhance deliverability. Our second generation DES entered the market in 2013 with a further enhanced delivery system. The stent is deployed using an advanced delivery system, featuring a low tip entry profile, longer distal shaft and a reduction in shaft diameter for 5F compatibility2.
Our third generation DES was launched in January 2016, utilizing the same biodegradable polymer and proprietary limus agent on a CoCr stent platform. This platform features a hybrid stent design, combining straight and s-shaped link3 connectors, providing enhanced longitudinal strength while maintaining flexibility. This unique design, combining the cobalt chromium alloy with the proven coating of our proprietary biodegradable polymer and Biolimus A9™, gives us a market leading DES.
The DES family allows treatment of simple and complex coronary lesions4,5,6 and offers unparalleled performance in all coronary lesion types. The excellent technical characteristics are complemented by an extensive clinical research program.
Biosensors’ latest innovation is our unique Drug Coated Stent (DCS) (combination of our proprietary drug Biolimus A9™ coated without polymer and carrier). It represents the latest development in Biosensors stent technology and differentiates radically from current DES.
It is a polymer and carrier-free DCS that combines the advantages in efficacy of a DES with the safety of a bare metal stent (BMS).
The combination of a selectively micro-structured surface (SMS) and the rapid transfer of Biosensors own highly lipophilic limus agent Biolimus A9™, makes our DCS the most relevant choice of stent for High Bleeding Risk (HBR) patients who cannot tolerate long dual antiplatelet therapy (DAPT).
These DCS’s unique characteristics, allows neointimal proliferation inhibition like any other DES having various polymer without the potential side effects of long term exposure to a polymer7.
Our DCS is now listed as stent of choice in ESC DAPT guidelines, for 1-month ultra-short DAPT in patients whom longer DAPT regimes poses safety concerns8.
The heart is what keeps us going. It powers the body; it gives us life and energy. So does it fuel our commitment to address valvular heart disease as this can have a major impact on our wellbeing and be life-threatening.
The ALLEGRA™ TAVI System TF has been designed for uncompromised hemodynamic performance with single digit mean pressure gradients and high effective orifice areas.13-14
It is a catheter-based transfemoral heart valve system, indicated for the treatment of severe calcified aortic valve stenosis in high risk patients with elevated surgical risk or in patients with a symptomatic degeneration of an aortic valve bioprosthesis.
ALLEGRA™ has been designed for uncompromised hemodynamic performance with single digit mean pressure gradients and high effective orifice areas13-14. The outstanding hemodynamics of the ALLEGRA™ are particularly important in small native annuli and surgical valves (ViV). Whatever the anatomic situation, coronary access must be maintained. Durability of a transcatheter heart valve is critically important in younger patients.
At Biosensors International, we are committed to continuing investment in developing pioneering medical technology and engineering new medical devices, that will further benefit patients. Strongly committed to the values of an Evidence Based Medicine approach, Biosensors was the first company to sponsor a randomized head-to-head comparison against a sirolimus eluting stent in an all-comer setting. The LEADERS trial proved non-inferiority on a clinical endpoint against Cypher® Select in 2008 with primary endpoint analysis published in the Lancet9 and continuous positive long term results up to 5 years10.
Supporting our unique DCS, LEADERS FREE11 is the world’s first prospective, randomized double-blind trial of an active stent, with only 1 month of DAPT mandated for all patients. The trial was specifically designed for High Bleeding Risk (HBR) patients only and had co-primary endpoints, to confirm that the DCS is as safe as a BMS with superior efficacy. The results were published in the New England Journal of Medicine in October 201511.
Both primary endpoints (safety and efficacy at 1 year) were met with impressive statistical significance and superior safety was achieved. The results were confirmed at 2 years.
1. Ostojic and al – The pharmacokinetics of Biolimus A9 after elution from the BioMatrix II stent in patients with coronary artery disease: The Stealth PK Study; Eur J Clin Pharmacol (2011) 67:389–398
2. SR-10401 – Comparative Performance Study of BioMatrix VI and Competitors’ Products
3. 11582-000-EN – Rev.01
4. Hildick-Smith D et al. EuroPCR 2015
5. Windecker S et al. Lancet. 2008; 372;1163-73
6. Serruys PW, et al. JACC Cardiovasc Interv. 2013; 6:777-89
7. S. WL LEE EuroPCR 2015
8. European Heart Journal (2018) 39, 213–254
9. Windecker S et al. Lancet 2008; 372: 1163–1173
10. JACC Cardiovasc Interv. 2013 Aug:6(8):777 89
11. Urban P. et al. N Engl J Med. 2015;373(21):2038-47
12. Garot P et al. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. JACC VOL.6 9, NO.2 , 2017
13. Wenaweser et al, Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve, EuroIntervention 2016
14. Schaefer et al, Thirty-d ay outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study; EuroIntervention, 2019
CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.
The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the “Instructions for Use” supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.
Biosensors’ interventional cardiology products, including BioMatrix NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J® and RISE™ NC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.
BioMatrix NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, BMX-J, Juno, S-Stent and Rise NC are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. All other cited trademarks are the property of their respective owners.