| Questions - Answers |
Creation Date |
| |
|
| What is your production volume? What does clean-room mean? |
29.04.2009, 11:09:45 |
| |
|
| The daily production capacity of our facility is 1000 balloons and 300 SDS (Stent Delivery System)s. Clean-room: It is an environment in which particles inside are kept below a certain level in comparison with the outside environment; and where conditions such as humidity, temperature are kept at a fixed value. In10.000 Class unit volume, there are 10.000 particles of 0.3 micron size and a minimum of 25 clean air circulation per minute; whereas in 100.000 Class unit volume, there are 10.000 particles of 0.3 micron size and a minimum of 20 air circulations per minute. |
| |
|
| |
|
| What are the quality metrics and specifications of the equipment used in production? |
27.04.2009, 08:19:10 |
| |
|
| They are more sensitive in terms of use; they carry out the work on a basis of mm; they possess pioneer specifications in terms of technology; and they enable the testability of the products’ functionality. |
| |
|
| |
|
| What is the clinical benefit of hydrophilic coating? |
26.04.2009, 21:35:42 |
| |
|
| It provides lubricity and crossing ease inside the vessels by reducing friction and facilitating manipulation. |
| |
|
| |
|
| What are the advantages of the design differences in the clinical use of Constant SDS and Ephesos II SDS? |
24.04.2009, 21:32:00 |
| |
|
| The stent design enables the nominal opening pressure of the stent to be lower and more flexible as well as allowing the radial strength to be at an optimum level. The width of the cells in Constant facilitates lateral applications. |
| |
|
| |
|
| What is the difference between CTO balloons and PTCA balloons? |
24.04.2009, 13:05:46 |
| |
|
| By virtue of the physical differences of the Pebax material, the wall thickness is lower than Nylon 12. Hence, the balloon profile of the CTO balloon is very low. The main material of CTO Balloon is Pebax. Nylon 12 is used in PTCA. The damage that may be inflicted to the vessels is kept at a minimum level; With soft parts attached to the distal part, the crossing profile of the CTO balloons is therefore lower.(0.0158”). |
| |
|
| |
|
| What is the difference between Stainless Steel stents and Cobalt Chromium stents? |
22.04.2009, 17:47:11 |
| |
|
| Cobalt Chrome stent has a thinner wall thickness and is more flexible compared to the Stainless Steel stent. Given that the expansion and fracture values are higher than Stainless Steel (FeCr), the stent is more flexible and has a higher radial strength. Due to the fact that electronegativity is higher, the restenosis rate is lower. Furthermore, since it does not possess a magnetic feature, it is safe in MRI applications. |
| |
|
| |
|
| Which universities do you collaborate with in your R&D studies? |
20.04.2009, 18:04:23 |
| |
|
| At the moment, in our product development studies, we carry out mutual projects with Istanbul University, Bosporus University, Bilkent University and Yeditepe University from Turkey. Frankfurt University, Vienna University, Aachen University and Washington Cardiologic Pathology Institute are foreign institutions that we cooperate with and realize mutually beneficial developments. In addition to the foregoing initiatives, our studies at various university clinics in Russia, India and Singapore are still ongoing. |
| |
|
| |
|
| What kinds of technologies are utilized by Alvimedica in the production of angioplasty balloons and stents? |
20.04.2009, 10:58:45 |
| |
|
| 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 Stainless Steel or Chrome Cobalt tubules in our laser machines. Thereafter, all of our products continue their journeys under quality control monitoring, with visual and measured tests taking place at every stage of the production. Our quality control system does not operate by sampling, but rather by controlling the quality of every single product. We utilize our own production techniques and methods at every stage of the production. These systems and machines were designed by our own R&D team. In addition, most of our products are tested against competing products in their own segments, by comparing their advantages and usage features over their counterparts. |
| |
|
| |
|
| What differentiates Alvimedica’s main products from its competitors’? |
19.04.2009, 01:33:25 |
| |
|
| At the moment, Alvimedica, Inc. manufactures 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 into the coronary arteries. Again, the same group of catheters, by the virtue of their internal carbon-coatings, has the advantage of friction and pushability over the guide-wires. Our Invader CTO (Chronic Total Occlusion) catheter, which we started marketing recently, is a product with the “smallest entrance diameter in the world”. The Catheter’s thin tip and its body provide the applying doctors with many advantages including great ease of use 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. It 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” in the first 24 months amongst existing drug-eluting stents according to the results of clinical studies. Furthermore, a comparative study carried out on the same stent by Prof. Renu Virmani from Cardio Path Institute had similar results. |
| |
|
| |
|
| Could you give some information on the Alvimedica’s R&D studies? |
17.04.2009, 19:54:35 |
| |
|
| The existence and growth of companies in the medical devices sector, which we are a part of, are directly linked with R&D studies. We allocate a significant amount of resources to compete with the leading companies in the world. Unfortunately, R&D in our country falls far behind others. 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 are necessary and extremely important. In this respect, we actually consider Turkish scientists scattered 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. |
| |
|
| |
|
| For how long has Alvimedica been in Turkey? |
17.04.2009, 15:57:08 |
| |
|
| 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 changed to Alvimedica, Inc., but also the internal structure and the product range of the company was revised and renewed. |
| |
|
| |
|
| What kinds of technologies are utilized by Alvimedica in the production of angioplasty balloons and stents? |
16.04.2009, 16:17:01 |
| |
|
| Alvimedica, Inc. realizes the production of all its products from 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 Stainless Steel or Chrome Cobalt tubules in our laser machines. Thereafter, all of our products continue their journeys under quality control monitoring, with visual and measured tests taking place at every stage of the production. Our quality control system does not operate by sampling, but rather by controlling the quality of every single product. We utilize our own production techniques and the methods at different stages of the production. These systems and machines were designed by our own R&D team. In addition, most of our products are tested against competing products in their own sector, by comparing their advantages and usage features over their counterparts. |
| |
|
| |
|
| What will be Alvimedica’s economic and scientific contributions to Turkey? |
16.04.2009, 12:53:24 |
| |
|
| The economic target of Alvimedica, Inc. is not solely the attainment of the biggest market share in the Turkish invasive cardiology market, which is in total worth $200 million, but also to make sales of over $1.0 billion world-wide and to contribute to the export income and economic welfare of our country. On the scientific development forefront, the company strives to present new and innovative products to the global medicine market through the establishment of an R&D center and provide new and effective treatment methods with such products. One of the primary targets of our R&D department will be to bring the first Nobel Prize in Medicine to Turkey. |
| |
|
| |
|
| Why was the company established in Denmark? |
16.04.2009, 09:45:12 |
| |
|
| Alvimedica APS is an investment company founded in 2006 by a group of Turkish businessmen residing in Sweden and Denmark. The partners residing in these countries deemed the establishment of the company in Denmark as apt. Denmark is a country with a well-established infrastructure; it is very advanced in medical technologies; and it embodies efficient and renowned companies. |
| |
|
| |
|
| What is the relationship between Nemed and Alvimedica? |
15.04.2009, 18:11:36 |
| |
|
| 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 was revised and renewed. |
| |
|
| |
|
| Who is the owner of Alvimedica? Who appears as the owner in the official documents? Who are the shareholders? |
15.04.2009, 13:37:21 |
| |
|
| Alvimedica APS is an investment company founded in 2006 by a group of Turkish businessmen residing in Sweden and Denmark. Its main operation and investment areas are health care and medical technologies. It invests in companies and technologies in this field in different locations around the world.75% of the shares of Alvimedica Inc. – the one which is located in Turkey – belong to Alvimedica APS, and 15% of the shares are divided equally between Leyla Alaton Gunyeli and Vedat Alaton. The remaining 10% is divided equally between Ishak Alaton and Cem Bozkurt. |
| |
|
