The Oxygen Delivery Index

ODI Medical AS utvikler et ikke-invasivt diagnostisk konsept for vurdering av oksygenleveranse til kroppens celler. Teknologiene for datainnsamling (digital mikroskopi og spektroskopi) brukes til å samle mikrovaskulære datafiler (bilder, filmer og spektra) fra kapillærer i hud, øyet eller munnhule. Målevolumer er rundt 0,1 mm3 og mikroskopiteknikken har tilstrekkelig oppløsning til å identifisere individuelle røde blodlegemer i kapillærene. Instrumentene for «bed-side» datainnsamling er samlet i et mobilt mikrovaskulært laboratorium med egen programvare (mLab). Innsamlede data, overført til en analyseplattform (cLab) via skyen, brukes til å kvantifisere sirkulasjonssystemets kapasitet til å levere oksygen til celler i målevolumet. Redusert kapasitet for oksygenleveranse er en definisjon av sirkulasjonssvikt. Utvikling av mLab Nåværende versjon av mLab fikk tildelt CE godkjenning for studier på mennesker i september 2019 og består av: - En mobil medisinsk tralle - batteridrevet for ergonomisk bruk og transport - En datamaskin med egenutviklet programvare og en skjerm godkjent for medisinsk bruk - for brukerinstruksjon, mikroskopi og spektroskopi fremstilling - Et håndholdt mikroskop brukt for in vivo - med forbedret oppløselighet og bildefrekvens - Et spektroskop med spesialdesignet måleprobe - Et forstykke for engangsbruk, designet for å bedre mikroskopi og spektroskopi opptak Utvikling av systemer for dataoverføring og lagring En laboratoriesjef og en programvareingeniør jobber med å designe programvare for sikker skybasert databehandling. Utvikling av cLab Et analyseprogram utvikles og forbedres i samarbeid med estlandske og britiske konsulenthus. mLab applikasjonsstudier I samarbeid med PhD kandidater fra Det medisinske fakultet, UiO og Institutt for medisinsk teknologi, Linköping Universitet; Fukamachi laboratoriet, Cleveland Clinic, Ohio og Harvard University, Boston, USA, og Flinders Universitet, Adelaide, Australia gjennomfører vi data simuleringer og kliniske og dyreeksperimentelle studier: - ProECMO-studien: Bruk av ODI-teknologi for å optimalisere behandlingen av pasienter med akutt hjertesvikt behandlet med en hjerte- og lungemaskin (ECMO). Pasienter er fra Oslo, Boston og Cleveland - Kronisk hjertesvikt: Studier gjennomføres i samarbeid med enheter ved Oslo Universitetssykehus. - PANCIRC studien: Bruk av ODI-teknologi for tidlig diagnose av akutt alvorlig pankreatitt. Datainnsamling i Adelaide, Australia. - ODI-teknologi for vurdering av øyesykdommer og for opptak fra øyet (konjunktiva) for vurdering av generell sirkulasjonssvikt og for vurdering av sirkulasjonssvikt i hjernen. Datainnsamling fra forsøksdyr har blitt gjennomført ved OUS og ved Cleveland Clinic, Ohio, USA. Bruk av metoden på konjunktiva hos friske mennesker gjennomføres i samarbeid med Øyeavdelingen, Oslo universitetssykehus. - Covid og mikrosirkulasjon: ODI teknologi har blitt brukt i en undersøkelse av 40 hospitaliserte pasienter med Covid infeksjon og 10 kontroller ved Massachusetts General Hospital, Harvard University, Boston, USA i 2020. Vi har vist at innlagt Covid pasienter i tillegg til utvikling lungesvikt (manglende opptak av oksygen i blodet) også har nedsatt evne til å levere oksygen fra kapillærene til celler i kroppen, og at pasienter med alvorlig Covid mangler oksygen i vevene.

1. Develop technologies for microvascular data acquisition and an analyzing platform to quantify microvascular parameters. 2. Apply ODI technologies in clinical studies for obtaining knowledge of diagnosis, prognosis and effect of treatment in patients with circulatory failure and assess economic impact of using ODIN for follow-up of patients. 3. Verify clinical value of ODIN concept for giving a sensitive and reproducible diagnosis of circulatory failure, for providing prognostic information and quantifying effect of therapeutic interventions in patients treated with ECMO for acute heart failure. 4. Explore clinical value of the concept for at least one other clinical application. 5. Finalize ODI technology platforms in future clinical and experimental studies. 6. Create fully annotated database on parameters with aim of developing workflow assistance in analysis of data using machine learning algorithms. 7. Prototype in Q3 2019 received an EU self-certified CE mark under MDD.

Delivery of oxygen from the capillaries to all cells of the body is among the most important functions of the circulatory system. A wide range of monitoring equipment is used in clinical medicine to examine and monitor central hemodynamics (blood pressures, cardiac output and vascular resistance). In addition, blood gases and biochemical markers are used as indirect parameters of circulatory function. No clinical method has so far been available for assessments of oxygen delivery from the circulatory system (i.e. the microcirculation) to the cells. In this project ODI Medical is developing a proprietary non-invasive technology for the diagnosis and monitoring of microcirculatory function in the body. Optical instruments are used bedside to collect microvascular parameters from the skin. Data are transferred to a Cloud based laboratory service for analyses. The output is the Oxygen Delivery INdex (ODIN), a non-invasive marker for circulatory failure. ODI Medical is continuously developing a clinical project portfolio to gather clinical evidence for the validation of the technology. The main objectives in this project are: 1. To apply the ODI technologies in clinical studies for obtaining knowledge of diagnosis, prognosis and effect of treatment in patients with circulatory failure, and assess the economic impact of using ODIN for follow-up of patients. 2. To use the clinical data to obtain regulatory clearances in EU and USA. The planned studies will generate new knowledge on how to monitor and treat patients and enable ODI to pursue full commercialization of its technology. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronavirus, is a novel viral pathogen. About 5% of affected patients develop respiratory failure, sepsis, sometimes multiorgan failure and even death. These patients have clinical manifestations of shock and often metabolic acidosis suggestive of microcirculatory dysfunction. The overall mortality rate is likely between 2 and 5%, or even higher in populations with inadequate access to intensive care treatment. Sensitive techniques for early detection of infection and for prognostic information is lacking. ODI Medical have together with a group at Massachusetts General Hospital, Harvard Medical School in Boston initiated a Covid-19 study. The aim of this study is to explore ODIN parameters in patients with COVID related infection as compared with healthy controls. This study might be the first steppingstone for follow up studies: 1) Use the ODIN concept as an Early Warning System for COVID positive patients; 2) Using the ODIN concept for prioritizing health care resources (triage), 3) Using ODIN data for optimizing treatment of critically sick Covid patients. ODI technology is also being tested for data collection in the front of the eye (conjunctiva) with the aim of 1) Develop an application for use of our technology for diagnosis of eye diseases; 2) Use the eye data for assessing circulatory disturbances in the brain; 3) Us the eye for data acquisition in patients with black skin and systemic circulatory failure. Clinical studies has started in cooperation with at the Dept. of Ophthalmology, Oslo University Hospital. ODI Medical is providing data analysis technology and are financially supporting an ongoing PhD project . Cardiac failure is the most common cause of death in the world. Patients with acute cardiac failure may be supported on heart and lung machines (ECMO). Mortality in these patients is over 50% and the cost of treatment can be 400,000 USD per patient. Standard monitoring systems give little prognostic information during the treatment. ODI has published a pilot single center trial showing a marked difference in ODIN parameter for ECMO survivors compared to patients dying on ECMO and controls. A multi-center follow up clinical trial, the proECMO study, was initiated with two leading US cardiovascular research institutions: the Cleveland Clinic and Massachusetts General Hospital. The proECMO study has enrolled 65 patients and 15 controls. The results confirms the prognostic value of the ODIN concept. Based on these results our international clinical partner institutions, in addition to NY University, Langone, Berlin Heart Center and Haukeland University Hospital are planning a proECMO follow up study, microECMO. This study will be initiated once the COVID pandemic allows resources for further on ECMO treatment. Studies are also being conducted in cooperation with 1) Oslo University Hospital on patients with Chronic heart failure and 2) in cooperation with Flinders University, for early warning of acute severe pancreatitis. These studies will also provide valuable data for ODI Medical to build clinical evidence for the technology. Uncertainty connected to clinical projects in general, directly affect the timeline for regulatory approval and commercialisation of the product. Thus this might take place after the end of the present project period.