Roya Khosravi-Far Presents Innotech Precision Medicine at LSI Europe '23

Transcription

Roya Khosravi-Far  0:04  
Hi everyone, it's great to be here. And I would like to represent InnoTech Precision Medicine. My name is Roya Khosravi-Far. And we are working on the next generation of diagnostics for multi omics detection. So I have a snapshot of InnoTech Precision Medicine. We're headquartered in Boston, Massachusetts. We were founded by a group of Life Sciences and engineers from Harvard Medical School and Massachusetts Institute of Technology. We are funded by Radics Rad for development of radical diagnostic technologies. Additionally, we have had funds from NIH and other non dilutive fundings and some annual funding, we have a strong team working with engineering and contract research organizations for time and cost effective manner. And our mission is to engineer the next generation of multi omics diagnostics. Our program will be ready for FDA and CE submission with about $6 million in additional funding. So, InnoTech was founded based on our belief that early detection saves lives by enabling timely and effective treatments, and even in some cases prevention. For example, in the last decade, we've had significant advances in cancer therapeutics. However, despite these advances in 2019, there are more than 23 million new cases of cancer that are documented globally, and more than 10 million people succumb to cancer. So, even the best therapeutics cannot work. If the these kind of diseases these complex diseases are not detected early enough. Most of the initial diagnosis and screening for many of the cancers is based on in vitro diagnostics, but the current in vitro diagnostics have high rate of false results, and they are not good enough. The gold standard of in vitro diagnostics is still nucleic acid detection. However, nucleic acid detection is the chose predisposition to the disease but not the actual disease is the protein expression that is actually providing the evidence for the state of the disease. If we can integrate nucleic acid and protein test in the same tasks, having the same device with the same statistical analysis and re read out, then we can, we can have a better more accurate diagnostic strategy at Innotech. Our patented technology is the first in class for multi omics detection. We have developed our chemistry and our disease specific cartridge for development of multi omics detection by multiplexing detection of currently nucleic acids and proteins in the future. We're going to add epigenomics and metabolomics as well, and our devices got it our devices going to control the functions of our microfluidic and also is an ultra portable device that can be used at the site of the patient for ease of use and for rapid providing rapid results are technology provides high performance multiplexing as well. So our chemistry and our microfluidic is a plug and play technology that basically depending on the disease biomarkers, we can generate very quickly. Cartridges chemistry and cartridges for different indications, or nucleic acid detection is based on lamp combined with crisper in one pot. Lamp assays provide a rapid PCR test however, lamp assays have a higher rate of false positives because of the primer binding. CRISPR provides an exquisite selectivity to our nucleic acid detection or protein detection is based on a modified Eliza assay that that is detected by fluorescence and signal amplification. So we start from the same specimen and process that specimen within our own enclosed microfluidic cartridge for detection of both proteins and nucleic acids. So our initial application is in human health, and our initial indication is in cervical cancer. Cervical cancer, according to the World Health Organization has been identified as a major global health concern. And the global market for this by 2030 is going to be $38.2 million. We anticipate to go for us regulatory approval by 2026. And we already have had initial discussions with FDA regarding our path as a donor over 510 K. So Cervical cancer is one of the most common cancers in women. It is curable if it's detected early, but unfortunately, more than 50% of women who get pancreatic cancer die from this disease, and the main reason is because the disease is not detected early enough in these patients. Most of the cervical more than 90% of cervical cancers are caused by high risk HPV, which is the most common sexually transmitted disease. However, HPV detection alone is not sufficient to demonstrate cervical cancer, more than 80% of us, more of more than 80% of us will have HPV infection at some point in our life. But fortunately for us, our immune system will get rid of that HPV infection. So the presence of HPV doesn't necessarily mean that we have cancer. However, they when they're high risk HPV is integrates into cervix, and they result in activation of protein progression markers. Then they initiate a cascade of events by changing activation of oncogenes in activation of tumor tumor suppressor genes that result in progression of cervical cancer. So at Initech, we have been able to develop our chemistry for rapid and accurate detection of viruses, including HPV, we can detect down to about 100 viruses in real time with less than two in less than 30 minutes. With our combination of lamp CRISPR assay, we can detect our proteins at low picomolar levels. And in patient specimens, we have been able to discriminate between healthy and normal specimen in concordance with clinical data. So our tests provides an accurate, fast and portable and easy to use. device. So of course, there are competitions in cervical cancer, the but our differentiating factor with our competitors is that we are the only company that can do multi omics detection of both nucleic acid for HPV and the cancer protein markers simultaneously. And quest diagnostic has performed studies on 13 million specimen or for over 10 years period. And they found that HPV testing alone has more than 40%, false positive and false negative results. And also cytology alone also has more than 45% false result. So combining the proteins and nucleic acids in the same tests with the same process will provide us more accurate results. They also are the only company that actually have a portable point of need device, while the other devices are actually a benchtop. And our cost is less than $5,000. So our business model is a razor razor blade business model. And basically, through the sale if by year four, we have 10,000 units that is used eight times in 300 days, we can generate close to $400 million. So in the last two years with the funds from Radics Rad we have developed our chemistry, we have our initial prototype for our microfluidic and we have a breadboard device. In the next two years, we're going to visit additional $5 million that we're raising. We're going to finalize our design locked system, do clinical, do analytical validation, and manufacture a beta lock beta system for clinical study and submission to FDA. We have a strong team of leaders that are experienced in molecular diagnostics, translational medicine, engineering, product development and business development. And we're working with advisors and partners at MIT, Harvard Medical School, as well as radix and we're working with engineering firms. Thank you very much for your attention and I will be glad to take any questions later. You can connect with me and we can explain more about our program. Thank you so much.