Milestones & Highlights

2015 - Present

The primary end point of LEADERS FREE III was presented confirming the safety and efficacy of BioFreedom Ultra at PCR eCourse [2020]
 
Blue Sail Medical and Biosensors International achieve a milestone towards entering the Structural Heart business, as they finalize the acquisition of Switzerland based NVT AG. [2020]
 
LEADERS FREE pre-specified non-cardiac surgery subgroup presented at TCT [2019]. Published in 2020.
 
The primary end point of the Alpha registry was presented at EuroPCR [2019]. Published in 2020.
 
The primary end point of LEADERS FREE II was presented and confirmed the reproducibility of the LEADERS FREE results in a North American population at TCT [2018]. Published in 2020.
 
New Valve Technology became a BlueSail Medical Company [2020]
 
CE approval received for the ALLEGRA™ Valve in Valve indication [2020]
 
NVT and Biosensors International will build on the strength of their parent company and the co-development opportunities, Production facility founded in Singapore. [2020]
 
The primary endpoint of GLOBAL LEADERS was presented and confirmed the excellent safety of the BioMatrix DES at 2 years at ESC [2018]. Published in 2018.
 
Expansion of facilities in Hechingen Medical Valley [2018]
 
LEADERS FREE Japan presented at CVIT and e-poster at EuroPCR. [2017]
 
BioFreedom is launched in Japan. [2017]
 
LEADERS FREE II completed enrolment of 1,200 patients in September. [2017]
 
Primary endpoint of BioFreedom USA presented at AHA 2016, and CRT. [2017]. Published in 2017.
 
VIVALL study initiated [2017]
 
CE approval received for the ALLEGRA™ aortic valve [2017]
 
First TRICENTO tricuspid valve implanted into a patient at the Lucerne canton hospital by Dr. med. Stefan Toggweiler [2017]
 
Sales company in Italy founded [2017]
 
Sales company in Germany founded [2017]
 
Launch of our first, cobalt chromium biodegradable polymer drug-eluting stent. [2016]
 
FDA approves Leaders Free II which began enrolment in the USA and Europe. [2016]
 
Several pre-specified subgroups of LEADERS FREE are presented and confirm that BioFreedom benefits all patient subgroups: Acute Coronary Syndrome (ACS) are Oral Anti Coagulant (OAC) are presented at EuroPCR and Elderly patients at ESC. [2016]. Published in 2017.
 
LEADERS FREE 2 year follow up is presented at TCT and confirms the long term benefit of BioFreedom over BMS in HBR patients with the absence of late catch-up. [2016]. Published in 2017.
 
Sales company in Spain founded [2016]
 
Winner of the “EACTS Techno College Innovation Award” in Barcelona for a new globally unique cardiac valve prosthesis [2016]
 
One-year results from LEADERS FREE presented at TCT. 1-month only DAPT course both significantly safer and more effective than a bare metal stent in High Bleeding Risk (HBR) Patients. [2015]
 
Enrolment of Biosensors first trial in the USA “BioFreedom USA” was completed. [2015]
 
Enrolment of LEADERS FREE Japan was completed. [2015]
 
OCT findings from EGO BioFreedom™ were presented at EuroPCR. [2015]
 
RUDI FREE began enrolment. The first all comers registry for BioFreedom™ [2015]

2012 – 2014

Enrolment in LEADERS Free complete: Patient population data presented at EuroPCR. [2014]

Chroma Cobalt-Chromium BMS launched at EuroPCR. [2014]

BioFreedom granted conditional IDE for US-based clinical trial. [2014]

4-year results from BioFreedom FIM study presented at TCT: comparable long-term safety and efficacy to DES demonstrated. [2014]

Own clean room facilities opened in Hechingen [2014]

Launch of Chroma™ our first cobalt chromium bare metal stent. [2013]

e-BioMatrix registry data presented at EuroPCR: confirms safety of BioMatrix over 12 months in ‘real world’ patient population of 5,000. [2013]

BioMatrix NeoFlex gains CE Mark approval. [2013]

BioFreedom gains CE Mark approval. [2013]

First ALLEGRA™ aortic valve implanted into an 85-year-old woman at the university hospital of Bern by Prof. Dr. med. Stephan Windecker and Prof. Dr. med. Peter Wenaweser [2013]

First patient enrolled in LEADERS Free, world’s first prospective, randomised double-blind trial employing only a one-month course of DAPT after implantation of active stent. [2012]

Final 5-year results from LEADERS presented at TCT: reduced risk of clinical events vs Cypher Select, associated with reduced risk of VLST. [2012]

Comfortable AMI results published in JAMA: BioMatrix shown to reduce cardiac events in acute MI patients more effectively than a BMS. [2012]

BioMatrix Flex chosen as stent used in GLOBAL LEADERS, largest ever randomised clinical trial involving DES: Aim to enrol 16,000 patients from all-comers population to assess benefits of new antiplatelet regimens. [2012]


2007 - 2011

LEADERS 4-yr data presented at TCT & published in Lancet; show improved long-term outcomes for BioMatrix Flex compared with durable polymer DES. [2011]

BioFreedom 2-year FIM results presented at TCT: show comparable safety and efficacy to DES. [2011]

Biosensors International acquires remaining 50% of joint venture in China, J W Medical Systems Ltd. [2011]

LEADERS 3-yr data presented at TCT. [2010]

Biosensors International launches BioMatrix Flex™ abluminal biodegradable polymer DES. [2010]

NVT GmbH founded in Germany at Lotzenäcker 17 in Hechingen as a production and development site [2010]

Biosensors International presents 9, 12 months and 24 months LEADERS results showing comparable safety and efficacy to industry leading drug-eluting stent at ESC and TCT congresses. Peer-reviewed article highlighting 9-month LEADERS results published in The Lancet. [2008]

Biosensors International receives CE Mark approval for its BioMatrix™ abluminal biodegradable polymer DES and launch across Europe. [2008]

NVT AG founded in Muri, Canton of Aargau, Switzerland; development work began at the facilities in Hechingen [2007]


1989 – 2006

Biosensors International launches PTCA catheters. [2000]

Biosensors Japan receives Japanese Ministry of Health, Labor and Welfare approval for its coronary bare metal S-Stent™. [2006]

Biosensors International makes First-In-Man implantation of its BioFreedom™ polymer-free drug-eluting stent. [2006]

Axxion™ drug-eluting stent receives CE Mark approval for commercialization in the European Union countries. [2005]

Biosensors International receives patent from U.S. Patent and Trademark Office covering the use of anti-restenotic, immunosuppressive drugs in combination with a biodegradable drug-release polymer coating on a stent. [2005]

Biosensors International enters into Asset Purchase and Licensing Agreement with Advanced Cardiovascular Systems, Inc., a subsidiary of Guidant Corporation to utilize Biosensors' biodegradable polymer technology and clinical data generated under the FUTURE I and FUTURE II clinical trials conducted by Biosensors. [2003]

Biosensors International enters into agreement with Terumo Corporation with respect to the manufacturing, supply and distribution of Biosensors’ DES technologies on an exclusive basis in Japan and on a non-exclusive basis elsewhere in the world outside of the U.S. [2003]

Biosensors International acquires Occam International B.V. [2001]

Biosensors International makes its first entry into the interventional cardiology products market with commercialization of its CE Marked S-Stent™ bare metal stent. [2000]

Biosensors International starts development of drug-eluting stents. [1999]

Start of in-house research and development. [1995]

Biosensors International Pte Ltd is founded by Yoh-Chie Lu as a contract manufacturing company for critical care products. [1989]


11881-000-EN - Rev.04

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.