ActiViews, Inc. (Private)
July 23, 2012 Issue
The Most Powerful Name In Corporate News and Information
Bringing to Market the First and Only Commercially Available System for CT-Guided Interventions in the Lung and Liver, ActiViews, Inc. and its CT-Guide™ Navigation Product has the Winning Formula of Simple Accurate and Affordable that will Propel their Technology to the Next Level
Mr. von Jako has extensive
executive level experience in the medical device field. Prior to joining
ActiViews, Mr. von Jako served as the Vice President of Marketing at
Integra's Neurosurgery division since 2007. He was an integral component of
Integra's acquisition of Covidien’s Radionics business unit since he served
as the General Manager of Radionics from 2003 to 2007. Prior to this, he
also worked in leadership positions at Medtronic's Surgical Navigation
division and Odin Medical Technologies. Mr. von Jako received a double
Bachelor of Science Degree in Physics and Mathematics from Bates College in
Lewiston, ME, and received a Masters of Science Degree in Nuclear
Engineering from the Massachusetts Institute of Technology in Cambridge, MA.
ActiViews is a privately held high-tech medical device company that develops, manufactures, and markets innovative surgical navigation solutions. The company’s mission is to become the leading provider of simple, accurate, and affordable navigation solutions in order to enhance physician confidence in performing CT-guided percutaneous lung and liver interventions. The U.S. Patent and Trademark Office has approved the core technology platform patent with other ancillary patents currently pending. CT-Guide™ navigation, the flagship product, is the first and only commercially available system for CT-guided interventions in the lung and liver and is marketed in the U.S., Canada, Europe, and China. ActiViews, Inc. is located in the metro-Boston area with Research and Development facilities in Haifa, Israel.
591 North Avenue
Wakefield, MA 01880
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published - July 23, 2012
Mr. von Jako: ActiViews was founded on the premise of delivering a simple surgical navigation or GPS-like system for needles. Specifically, we were looking to expand surgical navigation capabilities into percutaneous CT-guided applications, such as lung and liver biopsies and ablations. The mission behind the company was to develop a game changing surgical navigation solution that allows for the greatest amount of simplicity combined with accuracy and cost effectiveness. The powerful combination of simplicity, accuracy, and affordability would allow us to target this large growing market.
Surgical navigation technology has been around for about two decades. It originally started in neurosurgery and that is where I began my career. I started with a company named Radionics back in 1993. Radionics was a neurosurgical company that developed and delivered various market leading image-guided solutions like radiosurgery and surgical navigation. Other companies tried to develop surgical navigation systems that were very simple, and I felt we did a good job in the early days. But, there have been many advances in technology that can make things even simpler. And, at ActiViews, our goal, which I know we succeeded in, was to do just that. Accuracy, of course, is important without question. And, affordability is so much more important these days. Surgical navigation systems, depending upon what tracking technology you are using, have a very high cost of goods and the end user has to pay for that cost. Therefore, our goal was to make something that is simple and really affordable. Our founder, Pini Gilboa, did just that by developing a proprietary mini-optical tracking technology platform that features patented miniaturized implementations of optical tracking technology that is used widely in commercial surgical navigation systems.
CEOCFO: Have the people that would use your system been actively looking for a solution?
Mr. von Jako: We are obviously not the first company to enter into surgical navigation arena. Over the past two decades surgical navigation has become a standard of care in specific brain, spine, and ENT surgical applications. In the last decade, surgical navigation also entered into orthopedic market with the navigation of hip and knee implants, and more recently in specific applications for orthopedic trauma surgery and interventional pulmonology.
The specific area that we are involved in today is Interventional Radiology where an interventionalist performs CT-guided percutaneous procedures. These procedures are considered minimally invasive since access is gained to inner tissues via needle-puncture of the skin rather than an “open” approach. Procedure examples include biopsies or ablation surgery where the physician inserts a needle into the patient while he or she is lying on a CT scanner table so that updates on the needle location can be made by acquiring additional CT scans.
It is sequential process where the needle is placed, at times, by trial and error. They insert the needle into the patient and they take a new CT scan of the patient, then they move the needle again and take another CT scan to understand the updated location. The procedure is based largely on the skill and experience by the interventionalist and a number of repeated scans are possibly taken, especially when the target is small or the optimal path to the target is deep or at a difficult angle. There is no continuous guide for the interventionalist in order to really decide where to put the needle unless they want to continuously or repeatedly expose themselves and the patient to more radiation from the additional CT scans.
What we have done is developed a simple and affordable surgical GPS, and instead of a car, it is a needle, and instead of a map on your GPS, it is the CT scan of the inside of the patient. We correlate the needle and the CT scan together with a really simple, accurate, and affordable tracking technology that was patented about a year and a half ago.
CEOCFO: What was the biggest challenge in developing the technology?
Mr. von Jako: The biggest challenge for all small start-up companies is always limited resources. Thanks to Pini and the R&D team’s expertise, the technology was not the biggest issue that we faced at ActiViews. It was more in getting our clearances through the various regulatory bodies. Our real focus for our technology has been the two large medical device markets, United States and China.
CT-guided lung interventions was our first application, and we conducted a successful, prospective, multi-center clinical study to establish the performance and accuracy of our system with about fifty patients. We had done previous clinical trials, but none satisfied the specific FDA requirements. We followed up our lung clearance with a successful twenty-patient FDA study for the liver. Our FDA liver clearance just about coincided with our Chinese SFDA clearance, which was the expected two-year process.
With our two specific FDA and Chinese clearances our next hurdle is commercialization in these two markets, but with over one thousand successful procedures in Canada, Europe, and Israel we feel we have a solid product and a strong strategic plan in place.
CEOCFO: Where are you in the commercialization process?
Mr. von Jako: As I mentioned, we have done over one thousand procedures outside of the US and China. Our CEO, Yuval Zuk, and I have each been in medical device business for about twenty years, and we both have experienced rushing a product to the market. We collectively agree this is not always the best way of doing business, so we wanted to make sure we were methodical in our approach. We decided on a controlled market release in both the United States and China in order to obtain specific market feedback on the product.
We just installed our first controlled market release center here in the metro Boston area, and we are in the process of installing two to three more in the coming months in order to get really good feedback from the customers before we start launching our broad commercialization efforts in the United States. Likewise, we are using the same strategy in China, where we will be installing a system before the end of the year. Meanwhile, we are looking into all different types of channels in order to distribute our product. We will probably end up with a hybrid selling process utilizing both direct and indirect channels.
CEOCFO: Would you be selling both equipment and disposables?
Mr. von Jako: Absolutely! That is a really good point. Traditionally, surgical navigation for the operating room has been more of a large capital sale with low costing disposables. We will employ a combination of a more affordable capital cost and equally affordable disposables. Both the capital and disposables are comparatively much less than of our competitors. The neat thing about our technology is it only really has three components: a sterile single-use camera that is attached to any interventional needle used in lung and liver interventions, a patented sticker that is affixed onto the patient during the procedure, and a computer loaded with our proprietary three dimensional navigation software. And, the software could go on pretty much any PC that would meet our specifications, but we provide ours with a mobile medical cart and a big 23” flat panel monitor for better viewing of the navigation software.
There are a couple of new navigation companies that are also in our similar area. One company called superDimension, which was recently sold to Covidien for $300 million, offer their navigation system to interventional pulmonologist. They have a good combination of capital and disposables as well. However, due to our cost of goods and our specific market needs, we can be more affordable to the hospital in the long run with a good mix of capital and disposables. So we certainly feel we have a number of advantages in our price mix.
CEOCFO: Is there much training involved?
Mr. von Jako: The learning curve varies on the level of the background of the physician. As I have mentioned, our number one advantage is simplicity. We do not want to drastically change the standard operating method of the physicians. Our software is very simple, and we first conduct training on a practice phantom to train the physcians to go through proper steps. We then encourage them to use the system on simple cases. I just performed a survey to our Boston and Montreal groups, and several felt the learning curve is about three cases and others felt it was less than ten cases. Either way, the learning curve is comparatively quite low, which is nice and will promote our adoption.
CEOCFO: Is the medical community generally aware, and how do you make them aware in addition to having salespeople going out to them?
Mr. von Jako: Having salespeople go out to the hospital is the ideal sales process, but we also attend the large and smaller trade shows.
We just attended the World Congress of Interventional Oncology meeting in Chicago in June, and it is nice because both this meeting and the Society for Interventional Radiology meeting in March have promoted the concept of surgical navigation. Both these meetings had society sponsored navigation workshops where several companies, including ActiViews, attended and were able to demonstrate their technology. We have been very pleased with the response from the physicians both at the meetings and the workshops. And at these workshops, the physicians can immediately compare the technologies, and that really gives us a strong advantage.
Mr. von Jako: I think that when people, regardless of their location, see and try the ActiViews technology, they immediately get it and their reaction is: “how simple and easy.” It is not like twenty years ago when I first brought navigation to the neurosurgery market and the physicians were not as familiar with video games or GPS. Today, the benefits of surgical navigation are much more accepted and understood.
For us, as a small company, we need to be more selective and focused on what we think the biggest potential markets are. This is definitely the United States and China. Then probably some of the other countries follow like India, Brazil, Japan, Taiwan, and Korea. Those are some really advancing areas, but obviously the United States is a no-brainer. I believe that in China, there has been a great deal of focus on medical devices, and there has been a great deal of money specifically put into Chinese healthcare as they view it as part of their national security. Europe can be a great market, but it can also be a difficult market because as a small company you are typically working with dealers. You have to manage this distribution, and the costs can be high, so our thoughts long term is to get the US and China running. Once we get to profitability, we could start looking at some of the other areas including Europe.
CEOCFO: Development is always expensive; what is the financial picture like at ActiViews, and do you have the funding you need to get to full commercialization?
Mr. von Jako: The company was founded in Israel, and we have three good Israeli Venture Capital companies that invested into us from day one. And, at the end of last year, we signed a partnership with a very large company to develop and license some of our technology into a non-core application. This license arrangement will also bring us some additional revenue in the near term. As a small company, we are always looking for money. So when people want to give us money, it is always a good thing.
Mr. von Jako: Investors should pay attention to ActiViews today because the large physician societies in our core market are and have been looking for a technology that is going to bring them to the next level.
For interventional radiologists, the promise of navigation is to increase their confidence in delivering accurate needle placement in complex targets and then also potentially allow for performing the procedures in less time due to fewer needle repositions. This is a very powerful message. In the end, the winning surgical navigation technology will be simple, accurate, and affordable, and ActiViews has the three ingredients to the winning formula that will propel this technology to the next level.
Additionally, ActiViews is also looking at other large and growing applications where our technology can make a difference. One area of interest that will bring great promise is image-guided lung surgery in the operating room.
CEOCFO: What should people remember most about ActiViews?
Mr. von Jako:
In my career, I have the opportunity to work for a couple of start-ups, some
medium-sized companies, and a large established company. Each different
sized medical device company has their own set of unique challenges. But, in
the end, it is a great deal of personal reward when you can deliver a great
medical technology to a market and make a difference in someone’s life. My
colleagues and I feel strongly that we do this by allowing our customers to
navigate with greater confidence and deliver excellent treatments.
In the end, the winning surgical navigation technology will be simple, accurate, and affordable, and ActiViews has the three ingredients to the winning formula that will propel this technology to the next level. - Christopher von Jako
ActiViews, Inc. Announces Partnership with NeuroLogica Corporation to
Optimize Lung and Liver Interventions in a Standard Operating Room
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