STNT NEWS STENTYS to Present First Results of Sirolimus-eluting Self-Apposing® Stent at TCT Conference
Regulatory News :
STENTYS (Paris:STNT) (FR0010949404 – STNT), a medical technology company commercializing the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), today announced that the 4-month results of the APPOSITION IV trial will be disclosed during the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Dr Robert-Jan van Geuns, M.D., Ph.D., of Erasmus MC (Rotterdam, the Netherlands) and co-Principal Investigator, will present “Sirolimus-Eluting Self-Apposing Stent: Preliminary Results of the APPOSITION IV Study and Future Developments”, during a Satellite Symposium on October 29 at 7:00am.
The Self-Apposing stent will also be featured in multiple presentations throughout the congress, including results on series of patients outside of the AMI indication. Results of the OPEN II trial, a 200 patient European study evaluating the Self-Apposing DES in the treatment of coronary bifurcation lesions, will be presented by the Principal Investigator of the study, Dr Christoph K. Naber, M.D., Ph.D. of Contilia Heart and Vascular Center (Essen, Germany) on October 28 at 4:30pm.
Conference attendees can find logistical details on the presentations on the company’s webpage.
About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. Its flexible, self expanding design takes the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel, in particular after an AMI as the vessel dilates and the clot dissolves. It reduces the risk of malapposition and complications associated with conventional stents in this setting. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent is expected to receive CE Mark in H2 2014.
About the APPOSITION IV Study
APPOSITION IV is a prospective, randomized, two-arm, multi-center study designed to compare the apposition of the STENTYS Sirolimus eluting stent with Medtronic Resolute® in 150 patients suffering from ST-elevation Myocardial Infarction. Patients will be followed up at either 4 or 9 months (double randomization). The powered primary endpoint is strut apposition at 9 months under OCT. The secondary endpoints are strut apposition at 4 months under OCT, and strut coverage at 4 and 9 months. The final results are expected to be announced in Q2 2014.
About STENTYS
STENTYS is developing and commercializing innovative solutions for the treatment of patients with acute myocardial infarction (AMI, or heart attack) and complex coronary artery disease. STENTYS’s Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters, particularly in the post-infarction phase, in order to prevent the malapposition problems associated with conventional stents. In the APPOSITION III clinical trial, STENTYS stents demonstrated a very low one year mortality rate among 1,000 high-risk AMI patients when compared to recent studies with conventional stents.
More information is available at www.stentys.com.
This press release contains forward looking statements about the Company’s business. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company’s products, market acceptance of the Company’s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, including with respect to a pre-market approval for the Company’s BMS, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 “Risk Factors” of the Company’s 2011 Registration Document (document de référence) filed with the Autorité des Marchés Financiers in France on August 27, 2013 under number R.13-040 as such section may be updated from time to time.
STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT
STENTYS
Stanislas Piot, Tel.: +33 (0)1 44 53 99 42
CFO
stan.p@stentys.com
or
NewCap.
Financial Communication / Investor Relations
Dusan Oresansky / Pierre Laurent
Tel.: +33 (0)1 44 71 94 93
stentys@newcap.fr
or
US: MacDougall Biomedical Communications
Charles Liles, Tel.: 781 235 3060
or
Christine Labaree or Hunter Marshall, Tel.: 650 339 7533
stentys@macbiocom.com
Regulatory News :
STENTYS (Paris:STNT) (FR0010949404 – STNT), a medical technology company commercializing the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), today announced that the 4-month results of the APPOSITION IV trial will be disclosed during the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Dr Robert-Jan van Geuns, M.D., Ph.D., of Erasmus MC (Rotterdam, the Netherlands) and co-Principal Investigator, will present “Sirolimus-Eluting Self-Apposing Stent: Preliminary Results of the APPOSITION IV Study and Future Developments”, during a Satellite Symposium on October 29 at 7:00am.
The Self-Apposing stent will also be featured in multiple presentations throughout the congress, including results on series of patients outside of the AMI indication. Results of the OPEN II trial, a 200 patient European study evaluating the Self-Apposing DES in the treatment of coronary bifurcation lesions, will be presented by the Principal Investigator of the study, Dr Christoph K. Naber, M.D., Ph.D. of Contilia Heart and Vascular Center (Essen, Germany) on October 28 at 4:30pm.
Conference attendees can find logistical details on the presentations on the company’s webpage.
About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. Its flexible, self expanding design takes the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel, in particular after an AMI as the vessel dilates and the clot dissolves. It reduces the risk of malapposition and complications associated with conventional stents in this setting. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent is expected to receive CE Mark in H2 2014.
About the APPOSITION IV Study
APPOSITION IV is a prospective, randomized, two-arm, multi-center study designed to compare the apposition of the STENTYS Sirolimus eluting stent with Medtronic Resolute® in 150 patients suffering from ST-elevation Myocardial Infarction. Patients will be followed up at either 4 or 9 months (double randomization). The powered primary endpoint is strut apposition at 9 months under OCT. The secondary endpoints are strut apposition at 4 months under OCT, and strut coverage at 4 and 9 months. The final results are expected to be announced in Q2 2014.
About STENTYS
STENTYS is developing and commercializing innovative solutions for the treatment of patients with acute myocardial infarction (AMI, or heart attack) and complex coronary artery disease. STENTYS’s Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters, particularly in the post-infarction phase, in order to prevent the malapposition problems associated with conventional stents. In the APPOSITION III clinical trial, STENTYS stents demonstrated a very low one year mortality rate among 1,000 high-risk AMI patients when compared to recent studies with conventional stents.
More information is available at www.stentys.com.
This press release contains forward looking statements about the Company’s business. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company’s products, market acceptance of the Company’s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, including with respect to a pre-market approval for the Company’s BMS, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 “Risk Factors” of the Company’s 2011 Registration Document (document de référence) filed with the Autorité des Marchés Financiers in France on August 27, 2013 under number R.13-040 as such section may be updated from time to time.
STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT
STENTYS
Stanislas Piot, Tel.: +33 (0)1 44 53 99 42
CFO
stan.p@stentys.com
or
NewCap.
Financial Communication / Investor Relations
Dusan Oresansky / Pierre Laurent
Tel.: +33 (0)1 44 71 94 93
stentys@newcap.fr
or
US: MacDougall Biomedical Communications
Charles Liles, Tel.: 781 235 3060
or
Christine Labaree or Hunter Marshall, Tel.: 650 339 7533
stentys@macbiocom.com
