Interview with the CEO

Could you introduce yourself?

I am Dr.Cem Bozkurt and I was born in Ankara in 1962. I graduated from Kadikoy Maarif Koleji in 1981 and Cerrahpasa Medical Faculty at Istanbul University in 1987.

Over the last twenty years, since returning to Turkey from working as a doctor abroad, I have worked as CEO and general manager at four different companies, all of which are engaged in different areas of the health sector. During this period, I completed my Ph.D. in Pharmacology and my Masters in Management.

Could you briefly tell us about Alvimedica?

Alvimedica APS. is a company founded in 2006 by a group of Turkish businessmen residing in Sweden and Denmark. Its main activity and investment areas are health and medical technologies. It invests in companies and technologies in this field in different locations around the world.

For how long has Alvimedica been in Turkey?

One of Alvimedica APS.’s most significant investments was the purchase of a Turkish company called Nemed, Inc. in August 2007. As a result of this purchase, not only did the company’s name change to Alvimedica, Inc., but also the internal structure and the product range of the company were revised and renewed.

What are Alvimedica’s targets?

The goal of Alvimedica, Inc. is to be one of the most well-known companies in the world in its field of invasive cardiology and, as a more concrete target, to be amongst the top 5 leading companies in this field by 2015.

What will be Alvimedica’s economic and scientific contributions to Turkey?

The economic target of Alvimedica, Inc. is not solely the attainment of the biggest market share of $200 million US dollars in the Turkish invasive cardiology market, but also to make sales of over $1.0 billion US dollars world-wide and to contribute to the export and economic targets of our country.

Regarding scientific development, it aspires to present new and innovative products to the global medicine market from the establishment of an R&D centre and provide new and effective treatment methods with such products. One of the foremost targets of our R&D base will be to bring the first Nobel Prize in Medicine to Turkey.

What differentiates Alvimedica’s main products from its competitors’?

At the moment, Alvimedica, Inc. produces coronary angiography balloon catheters and coronary stents. Our balloon catheters, patented to Alvimedica, with their hydrophilic-coatings provide significant ease of application in terms of friction and pushability inside the coronary arteries. Again, the same group of catheters, by virtue of their internal carbon-coatings, has the advantage of friction and pushability over the guidewires.

Our Invader CTO (Chronic Total Occlusion) catheter, which we started marketing recently, is a product with the “smallest entrance diameter in the world”. The thin catheter tip and its body provide the applying doctors with many advantages

and great ease in the opening of the occluded arteries. Again, the stainless steel stent called Constant, which we also started marketing recently, is a product that can be easily utilized in the most tortuous and thinnest arteries due to its outstanding flexibility and also provides ideal application for CTO cases.

Our Rapamycin and soluble polymer coated stent called Coracto, which will be marketed in the near future, is a stent that has the “best treatment results” amongst existing stents according to  the results of clinical studies in the first 24 months.

Furthermore, the results of a comparative study carried out by Prof. Renu Virmani from Cardio Path Institute with the same stent were similar.

What kinds of technologies are utilized by Alvimedica in the production of angioplasty balloons and stents?

Alvimedica, Inc. realizes the production of all its products from the raw materials to the final product in its own facilities and with its own technologies. Every catheter sets off on its journey from the formation of its body through the extrusion of Nylon 11 or PBAX granules in our extrusion machines to the micron level. We then initiate the cutting and processing of the main bodies of the stents from steel or chrome cobalt tubules in our laser machines.

Thereafter, all our products continue their journeys under quality control testing, with visual and measured tests at every stage of the production. Our quality control system does not operate by sampling, but rather by controlling the quality of each product.

We utilize at the different stages of our production the methods, systems and machines developed by our own R&D team. In addition, most of our products are tested against competing products, comparing their advantages and usage

features.

Why was the factory of Alvimedica established in Catalca? Would you give some details about the factory?

When we developed Alvimedica Inc.’s five years growth plan, we realized that the most difficult obstacle confronting us was the capacity of the production facilities. It was apparent that we required a new production facility with advanced technologies to meet our targets, including the increase of our total production by 10 times within three years.

At the end of May 2008, we laid the foundations for our facility in Istanbul Trakya Free Trade Zone. Whilst choosing a place, we decided it was necessary to be in a free trade zone due to the export-oriented nature of our company. 

At the second stage, we examined the free trade zones in Turkey and, of course, we first obtained the opinions of our employees. In a survey conducted with our employees, 92% of our employees showed a preference for the Catalca area for various reasons. The decision to make our investment in Catalca took into consideration staff expansion, transportation and environmental factors. Our factory, technically, is the most advanced amongst similar existing facilities.

All our production areas, transitions and production flow are controlled with automatic sensors 24 hours a day. In other words, heat, humidity, particular numbers, persons, product entrances and exits and production parameters in all areas are automatically controlled.

Our system automatically gives alerts in the event of any small changes that may occur in such parameters. When these changes go beyond safety limits, the system either corrects itself automatically or all relevant units, including production and technical managers, are alerted by our 24 hours data processing system. When such an alert takes place, the responsible technical personnel are able to respond to the system, even from a 12km distance away using our 24 hour internet and camera systems, and make the necessary corrections. Our ‘cleanroom’ area of 700 m², where the main assembling of the catheter and stent systems in our factory is carried out, is the “biggest one part clean room” in this area.

Our sterilization system, set up by the Getinge Company at our factory, has a sterilizing function with “the lowest heat and humidity rate” in the world. We have realized the most advanced application in terms of the active drug half-time and shelf-life of our products, especially on our drug-coated stents.

However, the most significant aspect for us is the compatibility of our facility with the standard of “zero waste”. In other words, production does not result in exhaust gas from our chimney, waste materials or waste liquids. We carry out our production in a manner which is even cleaner than most houses as no harmful waste enters the environment.

Which products are manufactured at the factory?

At our factory, angiography catheters, guiding catheters, angioplasty balloon catheters, steel and chrome cobalt stents and drug-coated stents for invasive cardiology applications are manufactured.In addition, tube sets for oxygenators, sternum wires, pacemaker electrodes, manifold sets, control syringes, high pressure lines and other accessories utilized in heart surgical applications are also manufactured.

Alvimedica recently purchased the American company, In-Vivo. Could you give some information regarding this?

In-Vivo Instruments Llc. is a company founded in the state of New York and has produced, from its establishment until today, the guiding catheters and angiography catheters it developed for Medtronic, Edwards Labs, Jomed and lastly since 2004 for Abbott

Vascular respectively. One of the five partners, who helped establish and develop the company, is the renowned cardiologist Dr. David Judkins. At the end of 2008, during the renewal process of the company’s new production contract, we as Alvimedica, Inc. submitted a purchase offer to the partners of the company. At the end of the negotiations (at the beginning of April 2009) we finalized our purchase agreement. We completed the signing ceremony of our purchase agreement and made an announcement to the whole world in Istanbul on 6th of May 2009.

Afterwards, whilst continuing our production at the facility in New York, we began transferring the production stages, one by one, to our new facility in Catalca.

Could you give some information on the Alvimedica’s R&D studies?

The existence and growth of companies in the medical devices sector, which we are a part of, are completely dependent upon R&D studies. We allocate significant resources to compete with the leading companies in the world. Unfortunately, R&D in our country falls far behind. Concerning this issue, we know that an international R&D staff and an R&D center where such staff can carry out all of its studies is necessary and extremely important. In this respect, we actually believe that Turkish scientists spread across many countries around the world as an important source. One of our significant successes is to reverse the “brain drain”, which many complain about in our country, by bringing such scientists back to Turkey to carry out studies aimed at benefitting the whole world.

We are preparing to make our first statement on this subject in a few weeks. We hope that our new team and new laboratory will not only result in products generating commercial successes, but also bring us scientific prizes which we would carry with pride.

Which universities do you collaborate with for R&D studies?

Presently, in our current product development studies, we carry out mutual projects with Istanbul University, Bogazici University, Bilkent University and Yeditepe University from Turkey. Frankfurt University, Vienna University, Aachen University and Washington Cardiologic Pathology Institute are foreign institutions with which we cooperate and realize mutual developments. In addition to the latter, our studies at various university clinics in Russia, India and Singapore are still continuing.