STENTYS May Solve One of The Biggest Problems In Acute Coronary Syndrome

Coronary stents have been the traditional form of treatment for acute coronary syndrome (ACS) and acute myocardial infarction (AMI), also known as a heart attack . Since 2006, STENTYS [EPA: STNT], a Paris and Princeton-based firm, has been developing progressive stent technology to better treat ACS and AMI. The company is traded on the Euronext Paris Stock Exchange.

Gonzague Issenmann, CEO and co-founder of STENTYS, spoke with OneMedRadio and shared his insights on the industry and how the company has become a success. STENTYS’ soft, flexible stent design has been developed to adapt to a patient’s artery subsequent to an AMI. As opposed to conventional, rigid stents – used for treating acute events – these cannot conform properly to the soft clot and environment in which they are implanted. When removing plaque from an artery, there tends to be a significant amount on the interior of the wall making it difficult to judge the actual size of the artery. STENTYS technology is designed for such situations because of the gentle, self-expanding nature of the stent. It provides excellent wall apposition as well as sustained coverage and support for any remaining plaque.

The product has been through multiple clinical trials including a randomized test where they exemplified the superiority over conventional stents. In Europe, commercialization began last year along with a two-year controlled release phase. The phase requires the company to concentrate in a limited amount of centers where they plan on proving that their technology can be used for all heart attacks. There have also been discussions with the FDA about an IDE in the coming years. See full interview and hear audio below.

Brett Johnson:   Welcome, this is Brett Johnson in New York City with OneMed Radio. Today, I’m with Gonz Issenmann who is the CEO and co-founder of STENTYS, symbol STNT, which is traded on the Euronext Paris Stock Exchange. It’s a Paris and Princeton-based firm that has developed a new generation of stent technology. The company went public last October and has been regarded as a success story. Shares have risen as high as 28 Euros and it came out at 12. It’s currently trading about 15 Euros. Thanks for joining us today, Gonz.

Gonzague Issenmann:  Hello. Thanks.

BJ:    So, can you first tell us a little bit about Stentys and your technology?

GI:   Certainly. In a few words, Stentys has developed this technology to solve one of the biggest problems in the treatment of acute coronary syndrome, which is often known as heart attacks. Heart attacks are now treated with conventional stents that are ill suited for that application because of the high level of recurrence of the event. Stentys has designed a very simple yet very effective tool to better treat AMI (Acute Myocardial Infarction) patients, heart attack patients. It’s a close to $2 billion market across the globe and we have approved the product in Europe. It has been through multiple clinical trials including a randomized trial where we showed the superiority of our product over conventional stents. We have started commercialization last year in Europe and we are in the process of discussing with the FDA for an IDE in the coming years.

Indeed, as you said in your introduction, we are now a listed company, listed on the Paris Stock Exchange and our mission is to basically make the Stentys technology become the standard of care for the treatment of acute myocardial infarction patients.

BJ:  Can you tell us a little bit about the current stents struggle?

GI:  Yes. Stents were designed about 20 years ago to treat narrowed arteries where the cholesterol builds up and forms a plaque and reduces the size of the artery, it narrows them down. So, the stent is, as you probably know, a tubular mesh tube, which is inserted into the artery and inflated by a balloon. Those stents that are used today were designed to break those plaques, those hard plaques of cholesterol that prevent blood from flowing; however, the heart attack is a very different disease. It’s a clot of blood that blocks an artery in a few minutes leading to either sudden death or a very severe acute infarction. In this case when stents are placed, with the conventional stents being rigid, they are not adapted properly to this soft clot and the soft environment in which they are implanted where the acute event occurred, therefore, are not well apposed to the artery, whose size changes over time as the artery finds back its original shape and the clot is being dissolved.

Our approach is that we have developed a soft flexible stent as opposed to those rigid conventional stents that allow to be implanted during the event. Therefore, this flexible property allows for the stent to adapt in the coming days and hours after the event to this changing anatomy when basically the artery of the patient comes out of this acute event. So an old technology that was well designed for a hard plaque, which is used for lack of a better tool in a different context for which we have designed the optimal solution.

BJ:  Well, it sounds like a simple, but a very, very good idea and I guess the market is responding. You said you’re approved now, are you beginning to sell the product?

GI:  Absolutely. We have started a controlled release phase last year that will last for two years where we concentrate in a limited amount of countries in Europe, in a limited amount of centers where we want to prove indeed with those high level and high referral university centers how our technology can basically be used for all heart attack patients. So we have our own sales force of 10 people right now, which is basically starting the commercialization and continuing the impressive clinical work that has been done up to date.

BJ:   So you said it’s about a $2 billion market for stents globally?

GI:   The size of the stent market is closer to $6 to $8 billion across the globe. However, this $2 million that I’m referring is the part or the segment of the market of the coronary stent market, which is used to treat heart attacks, the rest is to treat the more classic disease that I was explaining a bit earlier, and this is our market. We are targeting our product for this specific indication, which is the heart attack, as opposed to the entire market.

BJ:    Terrific. Can you tell us a little bit about where this technology came from and a little bit about the evolution of the company?

GI:     Sure. The company was founded by Professor Jacques Séguin and myself. Dr. Jacques Séguin is a cardiac surgeon who was also the founder and CEO of CoreValve among other companies. This technology was designed by himself and myself on a simple idea to indeed solve what we talked about. The company was founded in 2006. It was financed through VC money initially with European VCs and we went through all the process of developing the technology, trying it in clinical trials up to the approval last year and our IPO.

BJ:    Interesting. Now CoreValve has been regarded as one of the biggest success stories maybe globally, but certainly in Europe of, you know, a medical device that was developed and then I guess sold to Medtronics for some amount. Do you think this has the same potential as CoreValve?

GI:    Certainly. I mean we’re addressing a completely different market. CoreValve was creating a new market, creating a new therapy, which had a huge potential. Here, we’re addressing a huge existing market. Actually, even though the overall coronary stent market is fairly stable from a growth perspective, the segment that we’re in and we’re working on is the heart attack segment is growing because of the need, because of the reorganization during the last ten years of EMS emergency systems to bring a patient suffering a heart attack into the cath labs to be treated with stenting. Therefore, the amount, overall, of patients receiving a stent in this context is growing tremendously. So this is indeed a growing market. It’s existing already and has the potential to really completely revolutionize the treatment there.

BJ:     Who are the major competitors that you’ll be going up against in this market?

GI:    The competitors are today the traditional large stent makers. There are now three of them that basically had the same strategy for the last eight years, which is the blockbuster strategy of focusing all their efforts on their flagship drug-eluting stent and trying to push that drug-eluting stent in any indication they could, including the treatment of heart attacks. Now, as I explained, those conventional platforms are not suited for that, it’s a very different disease. Basically, by focusing on that drug release component of their stent, they have foregone a lot of needs to improve on the mechanical properties of their stent specifically where you need to have a stent that adapts to a suddenly changing anatomy basically.

BJ:     Okay. So what do you see as the major milestones now coming to the company over the next year or two?

GI:   We are now enrolling a very large trial in Europe called the Apposition III Trial with a target of 500 patients that we will enroll. We will have a one-year follow-up of these patients that will be announced late 2012, which will give us the scale and the pool of data that we want to delve right now. So that will be a very important milestone. There will obviously be within the next 12 to 18 months an IDE approval. There will also in parallel be the ongoing continuation of our commercial activity as I said limited to certain centers now that is going on right now in Europe, and the progression of the adoption of the technology specifically in referral centers.

BJ:    So from a potential shareholder’s point of view, why do you think now is a good time to buy the Stentys stock?

GI:  Well, as I said, the Stentys stock has proven that it is — definitely, capable of some upside.  Right now it’s at a price much higher than the IPO price, but still in our view definitely has some potential. Obviously, the size of the market that we’re addressing, the upcoming milestones, you know, in the next 12 to 18 months, and value creation points as well as the formidable potential of this technology makes it a very attractive, I think, stock to pick.

BJ:    Terrific. Well, thanks so much for joining us today.

GI:   Thank you. Thank you very much.

BJ:   That was Gonz Issenmann who is the CEO and co-founder of Stentys, symbol STNT. It’s traded on the Euronext Paris Stock Exchange. It’s a Paris and Princeton-based firm developing an advanced stent technology with great promise.

It’s Brett Johnson here in New York City for OneMed Radio signing off. Good day.

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