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[Startup Nations Summit 2014] Competition - Greece


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[Startup Nations Summit 2014] Competition - Greece

  1. 1. Business Overview • Established as a Delaware Corp in February 2014! • 4 full time employees and 6 part time! • Lab in Heidelberg at the EMBL! • Office in Mexico city for hardware and software design and development! • Business development and R&D team moving to the SF Bay Area from January 2015 Our Accomplishments We radically improve the ability of Life Science Research and Healthcare providers to diagnose, treat and monitor disease at the molecular level through the examination of circulating microRNAs • Start – to – finish platform! • Accurate ! • Increased reproducibility! • Low cost of equipment and assays! • Simplified prep and device operation: No need of special training! • Custom content! • Centralized analytics platform for results that allows stratification and correlate data with other contextual information 1. We are able to detect 5 circulating microRNAs from human samples with our method! 2. Collaboration agreement with the European Molecular Biology Lab (EMBL) and DKFZ in Germany and National Institute of Genomic Medicine (INMEGEN) in Mexico for sample collection, clinical trials and assay optimization! 3. Working prototype of the bioassay, the device and the analytics platform What We Do Miroculus brings an accurate, easy to use, non-invasive, operator independent and affordable microRNA detection platform for molecular data gathering, analysis and interpretation Other Company Facts
  2. 2. ! MicroRNAs are small molecules that regulate gene expression. Unlike DNA, which is mainly fixed, microRNAs can vary depending on both internal and environmental conditions, telling us which genes are actively expressed at any given time. ! ! MicroRNAs play an important role in the regulation of protein production, and hence, the onset and progression of many diseases, particularly cancer and metabolic diseases. What are microRNAS? Before a protein is expressed, or produced, relevant parts of its genetic code present in the DNA are copied into the messenger RNA. This messenger RNA has the instructions on how to build a specific protein. It can potentially build multiple protein molecules, but the actual output is regulated or modulated by microRNAs. Number of peer-reviewed scientific ! publications of miRNA-related discoveries.
  3. 3. Potential biomarker Mandhavan et al 2013 Why microRNAs? Minimally ! invasive! sampling serum plasma Circulating! microRNAs Diagnostic Biomarker " Monitor asymptomatic high-risk individuals.! " Identification of early-stage cancer.! " Discrimination between benign and malignant disease. " Predict disease outcome.! " Predict progression-free and overall survival.! " Monitor disease recurrence. Prognostic Biomarker " Monitor sensitivity to therapy and therapy response.! " Aid treatment decisions.! Predictive Biomarker Clinical validation " Existing molecular diagnostic test based on microRNA FDA approved and commercialized! ! " Many more in clinical trials and regulatory process (US, EU, Asia)! ! " Reimbursements approved in the US! ! " The Japanese National Cancer Center (NCC) and the National Center for Geriatrics and Gerontology (NCGG) launched a project to develop a next- generation diagnosis system based on microRNA that enables to detect 13 types of cancers including breast and large bowel cancers with a blood sampling
  4. 4. Existing microRNA profiling techniques requires expensive lab machinery, specially trained technicians, centralized lab facilities and slow results turnaround times. The problem Complex diseases require parallel analysis of molecular events across the gene, protein and cell in order to monitor resistance, progression, recurrence and response
  5. 5. How are we solving it? We are radically improving how procedures and diagnostics are being done, ! with an accurate, easy to use, non-invasive, operator independent and affordable microRNA detection platform. Our microRNA detection platform provides quantitative and qualitative molecular level monitoring before, during and after therapy for carcinogenesis and metabolic diseases. The entire platform costs at least 50 times less than current microRNA profiling methods making microRNA detection simpler and more affordable than ever before. We’ve designed and developed a microRNA platform with 3 products: an accurate molecular bioassay to detect microRNAs from plasma, a low cost device to run the reaction and data mining and analytics algorithms.
  6. 6. A bioassay, which in presence of microRNA, ! generates signal visible with naked eye The bioassay Sensitivity down to 1 attomole observed with mir-122 and let-7a
  7. 7. Our first working prototype uses your smartphone to processes the results, and by the end of 2014 we will have available a new version that will process the results by itself.! ! Wells that shine are matched with specific microRNAs, and analyzed in terms of how much and how fast they shine. This tells us which microRNAs are present in the sample and whether they are over-regulated or down-regulated. The device The architecture of the device uses existing low-cost electronic components
  8. 8. The gathering and mining of data in the cloud allows our customers to get results ! in real time and perform analytics with other contextual information. This will let ! us better understand and decode diseases. The data Our HIPAA compliant platform allows you to stratify patients, visualize trends, add events and find correlations
  9. 9. Who are our potential customers? Diagnostic ! Companies Health! Providers Academia ! & Research Labs Pharma This is how we estimate our market distribution:
  10. 10. Our Primary Market: Life Sciences Market dynamics Pharma & Biotech Academia, Gov. Labs, Genomic Research Centers Diagnostics US$28B
  11. 11. Market dynamics Our Secondary Market: Health Providers IVD POC Dx Self-Monitoring! Blood Glucose Immunochemistry Molecular Dx Hematology Other US$52,7B
  12. 12. As new findings and more tests results are aggregated, the opportunity to personalize trials, create scenarios and find correlations and causations with our data will be our fastest growing product Data Mining We will sell our multi-microRNA screening assay with Miroculus’ biochemistry Plates with Bioassay Through strategic partnerships, we will manufacture and distribute our device with an outsourced and low cost strategy, facilitating the adoption from our customers while disrupting the market Device Annual license to access our analytics platform Analytics Platform Recurrent sales of customized and standard plates with bioassay & customized data driven analysis and data mining Business model Plates with bioassay License fee of the analytics platform Data mining Device
  13. 13. Team Alejandro Tocigl Domeyko. ! Chief Executive Officer! Alejandro is an experienced entrepreneur who sits on the board of different early stage ventures. He has created and financially structured two companies; managed to turn around and sell four companies and has invested in 39 early stage ventures. Foteini Christodoulou. PhD! Chief Scientific Officer! Fay is a Postdoc studying microRNAs in cancer. She completed her PhD in Molecular Biology at the European Molecular Biology Laboratory and gives lectures at the European Molecular Biology Organization. Her work with microRNAs has been published in Nature and Cell Magazine. Jorge Soto. ! Chief Product & Technology Officer! Jorge is an Electronics Engineer and former Deputy General Director of Civic Innovation at the Office of the President of Mexico. He is an Endeavor Entrepreneur, World Economic Forum Technology Pioneer and MIT TR35. Katarina Cuk, PhD ! Staff Scientist! Katarina has a PhD from the German Cancer Research Center (DKFZ) in Heidelberg. She has been working with circulating microRNAs as potential biomarkers for the early detection of breast cancer for the last four years. Juho Terrijarvi, MS! Director of Engineering! Juho holds a Master of Science in Technology from Turku University. Aside from giving lectures on Engineering, he has been working on IVD measurement device platforms including both hardware and software. Artemis Hatzigeorgiou. PhD! Director of Bioinformatics! Artemis is Professor of Bioinformartics at the Department of Electrical & Computer Engineering at the University of Thessaly. She developed DIANA-microT, one of the first published microRNA target prediction program. She is a recipient of the NSF Young Investigator Award.
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  16. 16. Miroculus Agilent Exiqon Illumina Qiagen Rosetta Genomics Firefly Bioworks Assay Miroculus assay SurePrint G3 Human v16 miRNA 8x60K miRCURY LNA microRNA TruSeq Small RNA Library Preparation Human Serum & Plasma 384HC- miRNA PCR Array N/A Firefly microRNA Assay Price of Assay (in EUR) 200 15.193 16.138 900 19.468 5.000 9.167 Time to results 90 minutes 2 days 2 days 2 days 2 days 7 days 10 days Instrumentation Needed Miriam: low cost open source device SureScan Dx Microarray Scanner qPCR machine (ABI 7900 HT or LightCycler 480) MiSeq desktop sequencer qPCR machine (ABI 7900 HT or LightCycler 480) N/A as it is a centralized service guava easyCyte 8HT Benchtop Flow Cytometer Price of Device (in EUR) 400 129.495 16.900 for StepOne, 76.500 for ABI 7900 HT 95.000 16.900 for StepOne, 76.500 for ABI 7900 HT N/A as it is a centralized service 69.900 Operator Dependant NO YES YES YES YES YES YES Scope Multi purpose: Research and Molecular diagnostics Research Research Research Research Molecular diagnostics Research ● Firefly Bioworks provides only a centralized microRNA profiling service where samples need to be sent under special conditions to a Lab.! ● Rosetta Genomics is the sole provider of microRNA based diagnostics but as a centralized service where samples need to be sent under special conditions to a Lab in the US. Competitive Landscape