Key Developments: Stentys SA (STEN.PA)

STEN.PA on Paris Stock Exchange

17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Stentys SA signs distribution partnerships in Asia
Wednesday, 8 Jan 2014 11:45am EST 

Stentys SA:Signs the first distribution partnerships for its stents in Asia with national distributors specialized in cardiovascular products in Singapore, Hong Kong and Malaysia.  Full Article

Stentys SA Announces Positive Results of Its OPEN II study of Self-Apposing Stent
Wednesday, 30 Oct 2013 12:45pm EDT 

Stentys SA announced positive results from the OPEN II study of its Self-Apposing Stent to treat acute myocardial infarction (AMI). OPEN II was a prospective, single-arm trial that enrolled 217 patients treated for chest pain due to a narrowing at a coronary artery bifurcation with the Company's paclitaxel-eluting stent in 21 hospitals in six European countries. The primary endpoint of MACE (composite of cardiac death, myocardial infarction, emergent by-pass surgery and target lesion revascularization) at six months was 10.1% for the whole study group, with a rate of 6.9% in patients with simple lesions. These results are favorably compared to the comparable trials in this area.  Full Article

Stentys SA Sirolimus-Eluting Stent Demonstrates Faster Arterial Healing Than Conventional Drug-Eluting Stent
Tuesday, 29 Oct 2013 12:45pm EDT 

Stentys SA announced that results from the 4-month arm of the APPOSITION IV study of its new Self-Apposing Sirolimus-eluting stent during the TCT (Transcatheter Cardiovascular Therapeutics) conference. The APPOSITION IV trial enrolled 152 patients suffering from ST-elevation Myocardial Infarction (STEMI) in a double-randomized trial to compare the STENTYS Sirolimus-eluting stent to Medtronic’s Resolute zotarolimus-eluting stent at two different time points, 4 and 9 months, evaluating stent apposition and strut coverage under intra-vascular OCT imaging (optical coherence tomography). Among the 62 patients enrolled in the 4-month group, those treated with a STENTYS stent had better apposition than the control stent (p=0.006). The imaging analysis also quantified the number of stent struts “covered” by tissue, an indication that the endothelium cells lining the artery wall have grown around the stent and that the vessel has healed. At 4 months, 32% of the STENTYS stents had all struts already covered compared to 4% for the Resolute (p=0.03).  Full Article

Stentys SA Receives Approval to Expand CE Mark Indications of Its Self-Apposing Stent-DJ
Wednesday, 10 Jul 2013 05:45pm EDT 

Dow Jones reported that Stentys SA announced that it received approval from its European Notified Body to expand the CE Mark indications of the Self-Apposing stent. The Company's Self-Apposing Stent is engineered to solve the dilemma of artery diameter discrepancy. The CE Mark certificate of the Self-Apposing Stent was updated on the basis of additional clinical evaluation to include specific patient subsets such as those with tapered, aneurysmatic, ectatic (dilated) or very large vessels or those with bypass grafts. Contraindications such as chronic total occlusions and left main bifurcations have also been lifted. These changes allow the Company to commercialize its Self-Apposing Stent in new market segments that represent approximately 10% of all percutaneous coronary interventions in Europe.  Full Article

Stentys SA Proposes No Dividend for FY 2012
Sunday, 2 Jun 2013 08:00pm EDT 

Stentys SA announced that it will not propose the payment of a dividend for fiscal year 2012 to its Annual General Meeting. The Company has not paid a dividend for the last three fiscal years.  Full Article

Stentys SA Announces Positive Interim Results of APPOSITION III Clinical Trial of STENTYS Self-Apposing Stents
Wednesday, 22 May 2013 01:30pm EDT 

Stentys SA announced new one-year data from the APPOSITION III clinical trial, designed to assess the long-term performance of STENTYS Self-Apposing Stents in routine clinical practice in Europe among 1000 patients suffering a heart attack. At one year, the mortality rate was 2.0%, re-infarction was 1.3% and the overall MACE rate (cardiac death, target vessel re-MI, emergent by-pass, or clinically-driven TVR) was 9.3%. Further analysis of data showed that the STENTYS Self-Apposing Stent performs equally well in many sub-groups. The first five patients treated in a center exhibited no statistically significant difference in MACE compared to patients treated onwards, indicating the absence of a learning curve in using the STENTYS Self-Apposing Stent.  Full Article

Stentys SA Announces Board Changes
Thursday, 28 Mar 2013 02:30am EDT 

Stentys SA announced that following the FDA approval of its clinical trial in the United States, a decisive development milestone, Professor Jacques Séguin decided to step down as a Director to focus on new early-stage projects and proposed to join the Scientific Advisory Board in order to continue advising STENTYS` clinical strategy. The Board of Directors has unanimously voted Michel Darnaud, as its new Chairman.  Full Article

Stentys SA's Self-Apposing Stent Demonstrates Lowest Mortality Rate Among Large Heart Attack Trials
Saturday, 9 Mar 2013 09:00am EST 

Stentys SA announced one-year results of the APPOSITION III clinical trial in 1,000 patients post treatment of a severe heart attack at ACC.13, the American College of Cardiology’s Scientific Session & Expo. The APPOSITION III trial is a prospective, single-arm, multi-center study designed to assess the long term performance of STENTYS Self-Apposing Stents in routine clinical practice in Europe among patients suffering from ST-elevation myocardial infarction (STEMI). The primary endpoint, Major Adverse Cardiac Events rate (MACE, defined as cardiac death, target vessel re-MI, emergent by-pass, or clinically-driven TVR) at one year, was 9.3%, where conventional stents average 11.1% in a pooled analysis from ACTION Study Group (Pitié-Salpêtrière Hospital, Paris). At the one-year time point, the cardiac death rate was 2.0%, as compared with rates for conventional stents in other published trials which average 3.9%, the lowest rate being 2.2%.  Full Article

Stentys SA Announces Results of Clinical Stuy Comparing Self-Apposing Stents with Conventional Stents
Thursday, 3 Jan 2013 12:00pm EST 

Stentys SA announced that results from the foundational APPOSITION II clinical trial were published in the December issue of the American College of Cardiology’s journal, JACC Cardiovascular Interventions. The study, conducted between December 2009 and June 2010, compared the accurate implantation of the STENTYS Self-Apposing stent against a conventional balloon-expandable stent in 80 patients treated for a severe form of heart attack, called ST-segment elevation myocardial infarction (STEMI). Placement accuracy was measured by high-definition imaging inside the artery (OCT) three days after treatment. The study results showed that 28% of the patients treated with conventional stents had a gap between the stent mesh and the artery wall (also called malapposition) whereas 0% of the patients with STENTYS stents had malapposed stents. This result was statistically significant (p<0.001).  Full Article

Stentys SA Completes EUR 6 Million Capital Increase
Tuesday, 13 Nov 2012 12:15pm EST 

Stentys SA announced the completion of its capital increase with preemptive rights launched on October 23, 2012. The final gross proceeds of the transaction amount to EUR 36,364,968 corresponding to the issuance of 3,030,414 new shares. Total subscription orders for this capital increase amounted to approximately EUR 47.6 million, i.e., a subscription rate of approximately 131.0%. 2,944,800 new shares were subscribed on an irreducible basis (“a titre irreductible”), representing approximately 97.2% of the new shares to be issued. Subscription orders subject to reduction (“a titre reductible”) amounted to 1,025,510 new shares and will, as a result, be satisfied only in part, i.e. for 85,614 new shares.  Full Article

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