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Nitiloop Ltd. |
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July 20, 2015 Issue |
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The Most Powerful Name In Corporate News and Information |
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Microcatheter Development for Physicians |
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CEO
Nitiloop Ltd.
Chanan Schneider +972-54-664-5494
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – 7/20/15
CEOCFO: Mr. Schneider, what is the concept behind Nitiloop? Mr. Schneider: The entrepreneurs of the company all have vast experience in the field of interventional cardiology, and they were aware of an acute need for a Chronic Total Occlusion (CTO) device that will help the physicians better treat their patients. We developed a microcatheter which has an extra support and centralization mechanism that can help the operator direct the guide wire and give extra force to the guide wire to cross the CTO segment. We recently received FDA 510k approval for the device under a general indication as a microcatheter for guide wire support in discrete regions. A First in Human study has been completed with very promising results and we are currently enrolling in a Pivotal clinical trial to receive indication specific for Total Occlusions.
CEOCFO: Would you tell us about your device and how it is different from current technologies being used for CTO? Mr. Schneider: When a physician uses the Antegrade Steering Technique in order to cross a CTO, the technique is very complicated and many times the wire is reflected and goes in different directions and cannot penetrate the lesion. However, the NovaCross microcatheter helps in directing the guidewire to the right place and extends the support needed for the guidewire to proceed in the right direction. In many Chronic Total Occlusions, we see that the proximal cap of the occlusion is very hard and the guidewire is unable to cross it. Therefore, with our extra support and centralization mechanism, the physician can have a better chance at reaching and crossing the proximal cap. Furthermore, the microcatheter can be used to penetrate within the lesion and to cross it as well.
CEOCFO: What is it that allows your device to cross the proximal cap? Mr. Schneider: The concept that we have developed is what we call the extra support and centralization mechanism. There are many other microcatheters on the market, but none of them really has the supporting mechanism which allows for the force of the microcatheter be at the distal end of the microcatheter, close to the lesion, where it is needed most. This support and centralization mechanism is due to a novel scaffold composed of Nitinol strutted loops. Radiographic markers embedded on the top of the struts enable successful and accurate deployment of the scaffold. Upon deployment of the scaffold, it is embedded in the vessel wall thereby giving the operator the support and force that is needed to access discrete regions of the vasculature and ultimately to reach and cross the CTO.
CEOCFO: Is there much training involved for the physician? Mr. Schneider: Operating the device is very easy. It has a handle with a slider that when slid forward, it opens the scaffold and when slid backwards it closes the scaffold and brings it backwards. This allows the operator to use it as a regular microcatheter.
CEOCFO: Is the medical community aware of what you have developed? Mr. Schneider: Some of the medical community is aware of our device, called the NovaCross™. We are in the process of broadening knowledge of our device and its acceptance by the interventional cardiologist community. Some of the physicians have already published summaries and case studies in 2014. Some of the operators are recruiting patients in our clinical studies and we are in the process of manuscript publications and submission of several conference proceedings.
CEOCFO: Are there any potential complications that physicians need to know? Mr. Schneider: We have not seen any complications in the 26 cases that have been done so far in patients with CTO in the coronary and peripheral vasculatures. With regard to clinical work, we finished our first in human trial in the coronary and we have started enrolling patients in our pivotal study towards the CTO indication in the coronaries. In the peripheral segment, it is mainly for below the knee and we have started enrolling patients. We already have enrolled 4 patients treated with our device, and up to now we have not seen any complications using our device. It is really in the stream of what they are doing today and does not burden them with extra actions that they would need to do.
CEOCFO: Are you funded to continue the development, trials and move towards commercialization or looking for partners and investors? Mr. Schneider: We are funded by two venture capital firms in Israel, Accelmed and Access medical, and also by the chief scientist in Israel. Currently we are not looking for investors, but we are open for strategic partnerships. We are a small startup company in Israel, trying to commercialize in the US and potentially in Europe.
CEOCFO: Does your device have a disposable component? Mr. Schneider: Yes the device is entirely disposable and is suitable for use in one patient.
CEOCFO: Where are you in developing a manufacturing plan? Mr. Schneider: We are currently manufacturing through subcontractors.
CEOCFO: Is cost a factor in a physician deciding to use your device? Mr. Schneider: Sure. Our device is cost effective compared to using balloons, a microcatheter and different wires in the procedure. We have applied a process of manufacturing to cost, in order to become more cost effective and we know today that we can do that. We will bring to market a product that is very competitive in the market landscape
CEOCFO: You have worked in both medical and financial fields. What do you understand about the business side that has helped you so far and will continue to help you? Mr. Schneider: Having experience in managing a company gives you the bottom up view and experience in venture capital gives you the top to bottom view - looking at the target and trying to fulfill it in the right way. These two views combine very well when you are trying to manage and build a company towards substantial achievement in the market place.
CEOCFO: Put it all together for our readers. Why pay attention to Nitiloop today? Mr. Schneider: First of all, our device brings a great deal of help to the patient. It is a safer and more successful way of treating the patient’s coronary and peripheral disease. Second, we are a fast learning and fast executing company that is on target to bring products to the market in a relatively short time. From a strategic standpoint, we would like to find our best commercial partner to go ahead with. |
“The concept that we have developed is what we call the extra support and centralization mechanism. It is located at the distal end of the catheter, close to the lesion, where it is needed most. This support and centralization mechanism is due to a novel scaffold composed of Nitinol strutted loops which upon deployment becomes embedded in the vessel wall thereby giving the operator the support and force that is needed to access discrete regions of the vasculature and ultimately to reach and cross the CTO.” - Chanan Schneider
Nitiloop Ltd.
Chanan Schneider +972-54-664-5494
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Microcathers, Nitiloop Ltd., CEO Interviews 2015, Chanan Schneider, Microcatheter Development for Physicians |
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Chanan
Schneider