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]

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