Christian Freudiger Presents Invenio Imaging at LSI USA '23

Transcription

Christian Freudiger  0:05  

Thank you so much for the introduction. And thank you to the LSI team for organizing this conference at a great time here despite the rain. So let's tell me a little bit I'll tell a little bit about the story of Invenio Imaging. The NIO laser imaging system uses laser spectroscopy and artificial intelligence to analyze fresh tissue specimen directly in the operating room. Such real time tissue analysis is a big unmet need that impacts over 13 million procedures every year. The NIO is already FDA registered and CE certified. We've placed about 12 systems in the field so far, and completed over 3000 cases successfully. The primary focus of Invenio for the next couple of years is a study that we're doing jointly together with Johnson and Johnson to develop the first clinically approved artificial intelligence to detect lung cancer in the operating room. So there are three major trends in lung cancer diagnosis. First, the screening with low dose CT allows to identify early stage lesions in high risk patients, then robotic bronchoscopy allows to biopsy those specimens very non invasively. And last non next generation sequencing is then applied to the sample to identify the key driver mutations that then allow us to triage patients to targeted therapies. However, there's also a sad fact that only 35% of patients that would be eligible for such a targeted therapy, in fact, obtain such ideal treatments. The main reason is that a lot of these biopsy procedures are not adequate for identifying or obtaining tissue that then can be used successfully for sequencing. The primary reason for that is that existing methods for rapid onset evaluation or rows are underutilized because they are inconsistent in time and slow. The Another reason is that very often, those techniques cannot identify whether a specimen is indeed a good candidate for next generation sequencing. And Neo bit about the manual, we developed the new laser imaging system that uses laser spectroscopy to image a tissue biopsy, we use the spectroscopic information to then apply a digital stain to the image that is chosen to mimic traditional HMD staining. One of the major advantages of this approach is that it's non destructive destructive to the specimen such that it can then be used to be analyzed by histopathology, using traditional methods and next generation sequencing. Another advantage is that our sample preparation is trivial. We have a proprietary consumable that we call the NIO slide that can be used by the nursing staff that's already in the operating room to prepare them to make the sample preparation and then image it directly in the operating room. So this avoids having to send the tissue specimen into a dedicated frozen section laboratory, where it's been stained, sectioned, and then ultimately interpreted by by the pathologist. We're combining this technology with artificial intelligence, we're retraining algorithms to distinguish samples that are suspicious for cancer versus samples that are not suspicious for cancer. We have demonstrated in a large study, that we can do that very successfully, non inferior to pathologist using traditional methods. But we can take it a step further, we can go beyond saying there's cancer present in the specimen or not, we can actually identify how much cancer there is. And that is one of the key indicators for next generation sequencing. We have some exciting work going on in the lab that's not clinical at this point. But we are showing that we can go beyond detection of cancer to actually identifying what the key mutations are in the specimen. This uses purely morphologic features instead of sequencing is therefore rapid and for the first time available at the time of surgery. This becomes very exciting as we think about the future of bronchoscopy where the pulmonologist are trying to combine diagnosis and treatment in a single procedure. There's technologies in ablation this like local deliver of chemotherapies, having accurate diagnosis in the war will be key enabling for these these these applications. So looking at the market in total, there's about 13 million procedures that are impacted by intraoperative. Tissue analysis. Lung cancer by far is the largest opportunity for us. This is because there's 1.5 million primary nodules identified each year in the US alone, so at a modest revenue. This provides a billion dollar opportunity in the United States alone. The knee assist imaging system has been commercially available for two years we have sold about 12 systems, three of which in the European Union. Three of our existing sites have gone to purchase second systems where they want to use them in different applications. We have many happy customers that have been working with us in various applications. Altogether, we've completed over 3000 cases successfully. We launched the technology actually in brain cancer, but then quickly expanded with existing customers into all these various applications. What we found is that our imaging imaging technology delivers image quality that superior to any any of the other competing technologies. This is particularly important for for applications where Scientologists use this tissue level or sub cellular information in order to make a diagnosis. We believe that's not just a nice to have, we think that it's image quality that ultimately drives the accuracy for diagnosis in the operating room. We have a large patent portfolio and a grown proprietary data set that we use for our machine learning. As we commercialize this technology, we apply a hybrid pricing model that consists of the capital sale and manual service and maintenance plan, as well our proprietary consumables, we are achieving these these prices in the US was our customers today. And we believe that as we move into the lung cancer space, where procedure volumes are high and ORs are booked three or four times a day, and multiple specimens are taken per procedure. It will be largely the consumable revenue that drives our our revenue. As we try to sell this, we always start with the surgical champion, but then use an increment incremental procedures model to convince the hospital administrator. This is justified because hospitals really benefit from having downstream procedures like thoracic surgeries, or sbrt that can only be prescribed or prevented if a definitive diagnosis has been obtained. So non diagnostic biopsy are a real issue for hospitals. That new imaging system is already FDA approved that CE certified since 2021. We also have a CE certified AI algorithm in Europe for brain tumors. But the primary focus of the company right now is to get the first FDA clearance for lung cancer. For that we've been planning on a study that we call the the onsite study that will enroll 900 patients prospectively that's possible because this is like such high volume procedures. It's jointly with Johnson and Johnson and contains about three study arms for the three different biopsy instruments that are used in those procedures. The primary endpoint will be to obtain a non inferiority diagnosis compared to the standard of care that's rose. We have a great team, my co founder Jay Troutman, he's the CEO and he has had multiple successful exits in recent years in the biotech industry. We also have great support from clinical Regulatory Affairs, r&d, as well as manufacturing. So as we look at our commercial timeline, we've met with the FDA and they've provided a lot of feedback to our proposed clinical study. We're going through those changes right now and expect to enroll the first patients in July of this year. As I mentioned, there's like three different arms to this study, where we expect to hit the first endpoint for forceps biopsy in the middle of 2024. That'd be then use and to obtain like de novo clearance from the FDA. We have a ongoing sale. So we anticipate that we have about $1.4 million in sales from from the imaging system this year as well as next year. Our sales force is small, but we plan to really launch in the long space as soon as we have the clearance. With that. Thank you. I'll be outside if you have any. Any more questions and look forward to talking with you