PRINCETON, N.J.& PARIS--(BUSINESS WIRE)--STENTYS (FR0010949404 – STNT), a medical technology company commercializing, in Europe, the world's first and only Self-Apposing® stent to treat acute myocardial infarction (AMI), today reports its second quarter and first half-year revenues through 30 June 2013, as well as its cash position on that date.
- Half-year and quarterly revenues*
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| Half year – 6 months | Quarterly – 3 months | |||||||||||||||||||
| € thousands | H1 2013 | H1 2012 | Var. (%) | Q2 2013 | Q2 2012 | Var. (%) | ||||||||||||||
| Revenues | 1,638.4 | 1,149.6 | +42.5% | 913.4 | 655.6 | +39.3% | ||||||||||||||
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* Audited data |
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Revenues totaled €913.4 thousand over the second quarter of 2013, up 39% compared with the second quarter of last year. For the entire first half of 2013, revenues were up 43% at €1,638.4 thousand.
This increase in revenues reflects the growing routine use of STENTYS self-apposing stents by cardiologists in European and Middle-Eastern hospitals where the stent is currently marketed.
- A solid cash position for further international expansion
At 30 June 2013, STENTYS had a cash position of €39 million. This cash enables the Company to pursue its clinical development in the United States and its marketing development in high-potential CE Mark regions.
- Key developments during the second quarter
- APPOSITION V clinical trial
The FDA-approved comparative study on 880 patients was started in May with the enrollment of the first patient. All the patients in this trial will have follow up at 30 days, as well as six, nine and twelve months, with an annual checkup for three years. Subject to positive results from this clinical trial, STENTYS could file a Premarket Approval (PMA) application with the FDA in 2015 to market its stent in the US.
- CE Mark expanded to additional indications
As announced in its recent press release, STENTYS has received approval to expand the CE Mark of its self-apposing stent into additional coronary indications, in addition to the treatment of myocardial infarction. These new market segments represent approximately 10% of all percutaneous coronary interventions in Europe.
Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, concludes: “The steady sales growth quarter after quarter reflects the high demand by cardiologists in Europe and the Middle East, where STENTYS’ technology received a clear welcome. The demand should be reinforced by the recent CE Mark expansion to additional indications.”
- Upcoming Financial Results
STENTYS expects to publish its financial results for the first half of 2013 on 29 August 2013.
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.
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’ 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. For further information, please go to 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 June 25, 2012 under number R.12-033 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
