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22.01.2015 18:33:00

STENTYS 2014 Annual Revenues up 13% to €3.9 Million

Regulatory News:

STENTYS (Paris:STNT) (FR0010949404 — STNT – PEA PME eligible), a medical technology company commercializing the world's first and only Self-Apposing® coronary stent, today announces its consolidated revenues for the 4th quarter and full year 2014.

  • 2014 fourth-quarter and annual revenues*
    Annual – 12 months   Quarterly – 3 months
€ thousand 2014   2013   Var. % Q4 2014   Q4 2013   Var. %
Revenues 3,851.0   3,393.6   +13% 1,038.7   986.9   +5%

* Data reviewed by statutory auditors

For the year, revenues were up 13% at €3.9 million. The enhancement of the product portfolio, following the CE marking of the new Sirolimus-eluting stent (STENTYS SES), commenced at the very end of the year and contributed little to annual sales. However, a number of new accounts were opened in Italy, Germany, Poland, Finland and the Netherlands in December.

  • Solid cash position

At December 31, 2014, STENTYS had cash and equivalents of €18.6 million vs. €20 million at September 30, 2014.

  • Intense marketing program expected in 2015

In 2015, STENTYS will enter into an intensive commercial development phase marked by three successive new product launches:

1. STENTYS SES, the self-apposing Sirolimus-eluting stent

Now that this stent has obtained the CE mark, STENTYS will intensify its marketing throughout the European Union and register the product in other countries that recognize the CE mark where distributors have been appointed.

2. The new delivery catheter marketed under the Xposition brand name

This new delivery technology, which enables self-apposing stents to be implanted in the same manner as conventional balloon-expandable stents, will boost their adoption by cardiologists. This new product, which will be commercialized under the Xposition brand name, is expected to receive the CE mark during the 2nd half of 2015.

3. MiStent SES®, the bioabsorbable-coated stent

The MiStent SES®, the world’s first drug-eluting stent with sustained sirolimus elution beyond fast polymer bioabsorption, is a workhorse solution that perfectly complements the self-apposing technology. The MiStent SES is already CE marked and will be sold by the worldwide distribution network put in place by STENTYS in recent years.

  • Initiation of the DESSOLVE III study on the MiStent SES®

STENTYS and Micell Technologies will partner on MiStent’s post-market clinical trial, DESSOLVE III. This international multi-center prospective "all comers” study will enroll 1,400 patients. The primary endpoint will be the 12-month rate of target lesion failure and patients will be followed up to three years.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, comments: "Following a year of subdued growth in 2014, we are very optimistic and confident regarding 2015. Indeed, the enhancement and expansion of our product portfolio through highly differentiated products with meaningful clinical benefits will enable us to accelerate the commercialization through our distribution network which now covers 30 countries.

  • 2015 financial calendar*
Event         Date *
Full-Year Results 2014         Tuesday, March 31, 2015
Q1 Sales 2015         Thursday, April 16, 2015
Q2 Sales 2015         Thursday, July 23, 2015
Half-Year Results 2015         Thursday, August 27, 2015
Q3 Sales 2015         Thursday, October 22, 2015

Financial year ended 31 December

* Subject to modification. Press releases are distributed after the financial markets close.

About STENTYS
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex coronary artery disease. STENTYS’ Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters 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 heart attack patients when compared to recent studies with conventional stents. More information is available at www.stentys.com.

Forward Looking Statements
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, 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 French Autorité des Marchés Financiers 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 Euronext Paris
ISIN: FR0010949404 – Ticker: STNT

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