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Clinica's MedTech Ventures: Alvimedica

This article was originally published in Clinica

Executive Summary

Specialty area: Stents and implantable devices
Based in: Istanbul, Turkey
Founded in: 2007
No. of employees: 500
Total investment received to date: Undisclosed
Investors: Undisclosed

“We want to become the fifth largest interventional cardiology company – and we’re on track.” Turkish stent developer Alvimedica wants to shake-up the drug-eluting stent (DES) market, and CEO Cem Bozkurt believes it has the technology to do so.
Dr Bozkurt is adamant that being acquired by one of the big cardiovascular players is not the firm’s aim. “Of course, we could have some kind of co-marketing relationship with them. Or maybe [further down the line] we could acquire them – that would be a good sales network for us to use.”
“Or maybe some of them will withdraw from the area, like they withdrew from the [coronary] stent market,” he continues. Dr Bozkurt is referring to Johnson & Johnson, which was once the coronary DES market leader, but bowed out of the market in 2011. This left the way clear for rivals Abbott, Boston Scientific and Medtronic.
Alvimedica has a coronary stent offering, but its main focus is the endovascular, or peripheral, market. It recently launched its Cre8 BTK polymer-free balloon expandable drug-eluting stent in Europe, and showcased it at the Charing Cross meeting in London on 5-8 April.
“This is the first drug-eluting stent in this area,” Dr Bozkurt says, claiming no other company has a device like it. Being polymer-free reduces the risk of re-occlusion of the treated artery, the CEO explains.
“There are two different types of polymer, durable or biodegradable. Most of the products that our big rivals have use durable polymers. After the drug is eluted in, let’s say 90 days, the polymer stays on the surface of the strut. And the body realizes it’s a foreign material and reacts to it. So that’s why companies are trying to make either a biodegradable polymer or the ideal, no polymer.”
How has Alvimedica managed to do this? “On the struts of our stent, there are little holes we call reservoirs, where we put the drug directly without using any polymers. The drug is released from these pools.”
Other firms have tried and failed to develop polymer-free devices. An expensive example is Conor Medsystems, which developed the CoStar stent and was acquired by J&J’s Cordis division for $1.4bn in 2006. “But they could not succeed on the technology and they couldn’t launch the product,” notes Dr Bozkurt. CoStar failed to reach its primary goal in a study against Boston Scientific’s Taxus Express.
Cre8 BTK is also approved in Canada and several other countries, and Alvimedica is planning to seek US FDA approval. Dr Bozkurt estimates this will take around two years – the firm has to carry out a US clinical trial which will have a 12-month follow-up period.
In the meantime, Alvimedica is switching focus to its self-expandable nitinol drug-eluting stent, called NitiDES, which will also be the first of its kind in the peripheral market, according to the CEO. It plans to launch the device in Europe in the third quarter of 2014.
This will give the company a portfolio of devices that gives doctors more choice – self-expanding and balloon-expandable stents suit different anatomies better, while physicians can also have their own personal preference. 
“Some doctors prefer in some lesions to have balloon-expandable stents in order to shape the artery according to their needs. A self-expandable stent, meanwhile, opens by itself according to its memory – and doctors do not have many tools to shape the stent within the artery.”
Alvimedica plans to sell its device direct in the 15 or so countries where it has its own sales force – in other countries, it partners with distributors. It is also discussing a co-marketing deal in Europe for NitiDES with one of the big players; Dr Bozkurt would not say which one.
So the Turkish firm is confident of its chances against the bigger DES players, but how about other incoming technologies, including bioresorbable DESs (such as Abbott’s Absorb) and drug-eluting balloons?
Dr Bozkurt was scathing about both. He dubbed Absorb “a big failure, because [Abbott] launched it in Europe at $3,000, and now it’s $300.” Alvimedica previously had “two or three different projects in biodegradable stents,” but now it has focused on one, using magnesium devices.
“But to tell you the truth, I do not believe in biodegradable stents in coronary or endovascular applications, because vascular disease is repeatable. If the stent degrades, then the disease comes back, because you’re not curing the disease – you’re just putting a scaffold there in order to keep the artery open.”
He was equally pessimistic about the chances of drug-eluting balloons. “Drug release and tissue intake needs at least half an hour. If you cannot keep a surface that is full of drug touching the endothelium for at least half an hour, it will never be released. So that’s why it’s not working.”
Alvimedica previously had three drug-eluting balloon projects, “but last year, we decided to drop all of them. We carried out a study in animals and found that the drug was never going into the tissue.” However, the firm is still working on a flow-diverting balloon, which blood can flow through, but the drug-eluting surface is still in contact with the vessel wall.
Nonetheless, Dr Bozkurt believes that stents are just as good as balloons. “There is no artery that you cannot put a stent in. And if the technology is there, why would you try to create something else that only works for short periods?”
Cem Bozkurt, CEO.
Gümü?suyu Mah. Kazanc? Yoku?u, No:45 Beyo?lu, ?stanbul, Turkey.





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