2020 was an extraordinary year and, looking back, while it was dominated by the world health crisis of the pandemic there were also colossal achievements in healthcare and medical technology; not only the development of five vaccines against COVID-19 but also the rapid adoption of IT solutions to deliver remote and home healthcare, and more resources and investments available to pulmonary medicine departments once the pandemics is defeated.
Despite the headwinds affecting US healthcare and our pulmonology customers, Optellum has continued to grow and develop with further clinical validation of our artificial intelligence Lung Cancer Prediction tool, the first wave of installed clinical customers in USA and a healthy sales pipeline, and new appointments to grow our executive and commercial teams and strategic collaborations with industry.
Clinical validation: independent validation studies of Lung Cancer Prediction published by top medical journals
The Optellum Lung Cancer Prediction AI was independently validated in studies led by key opinion leading doctors – authors of lung cancer guidelines – with the results published in the top respiratory medicine journals in the USA and Europe.
In March an independent multi-center validation study was published by BMC Thorax (one of the world’s leading respiratory medicine journals ) by lead author Prof. David Baldwin who is also the Chair of the Clinical Expert Group for Lung Cancer, NHS England, and a clinical lead for the NICE guidelines. The study showed that the Optellum imaging AI-based Lung Cancer Prediction outperformed the best currently used model improving on sensitivity and specificity of diagnoses.
In April another independent study was published in the AJRCCM “Blue Journal” (the highest impact factor US respiratory journal ) by lead author Prof. Pierre Massion, from Vanderbilt University Medical Center, and co-author of the NCCN guidelines. These findings indicate that, with the Optellum model, 33% of cancerous nodules could be diagnosed and potentially treated earlier and up to 58% of benign nodules could be diagnosed earlier, avoiding distress and potentially harmful procedures for those patients.
Additional peer-reviewed clinical validation posters and presentations were presented by Optellum’s clinical collaborators at top medical congresses, including the IASLC World Conference on Lung Cancer, the American Thoracic Society, the European Society of Thoracic Imaging, and the ESMO Virtual Congress (in collaboration with F.Hoffmann-La Roche). A number of these are to appear as journal publications.
Clinical trial for Optellum’s FDA clearance successfully completed
A multi-reader, multi-case reader study required for the upcoming FDA clearance of Optellum’s Virtual Nodule Clinic, including the imaging AI-based Lung Cancer Prediction, has been successfully completed. In the reader study protocol agreed with the FDA (Principal Investigator: Dr. Anil Vachani, Hospital of the University of Pennsylvania), twelve pulmonologists and radiologists read 300 CTs images in two ways: assessing the malignancy risk firstly without the Optellum AI and subsequently with the help of the Optellum AI. The results confirm that all doctors regardless of their level of experience – from generalists through to thoracic experts – improved their diagnostic performance – statistically significantly improving both sensitivity and specificity of lung nodule malignancy assessment with the use of the Optellum software, and made more optimal and consistent clinical decisions.
New appointments in the executive and commercial team
New appointments strengthened our leadership team: Prof. Lutz Freitag MD (Chief Medical Officer), Martina Miškufová (Chief Finance and Operations Officer) and Joseph Hewins (General Counsel) joined in the first quarter of 2020; later in the year we expanded our commercial team with he appointment of Ryan Hennen (VP of US Sales), Rhiannon Lassiter (Head of Marketing and Communications) and Dr Johnathan Watkins (VP of Market Access and Clinical Research) in order to strengthen commercialization ahead of our FDA clearance and US launch.
First US hospitals deploy the Optellum Virtual Nodule Clinic
The first wave of US clinical customers, including nationally leading hospitals in pulmonology, have adopted the Optellum Virtual Nodule Clinic. Currently we are working with our first customers, to share their experience of using the Virtual Nodule Clinic in case studies, and to develop clinical utility studies, in 2021. Clinical customers are invited to book a demo from our sales team, for the potential opportunity to be the first in their state to deploy the product with their patients.
Optellum partnered with the University of Oxford in a £11 million AI programme
We joined the University of Oxford, NHS England, as the lead industrial partner – alongside Roche Diagnostics and GE Healthcare – in a new programme: Data using Artificial Intelligence to Improve Patient Outcomes with Thoracic Diseases (DART).
The DART team will work with NHS England’s £70 million Targeted Lung Health Check (TLHC) programme, which will provide lung cancer screening to approximately 600,000 eligible participants. At least 300,000 CT scans from 150,000 TLHC participants will form the initial study cohort. The NHS investigators expect that at least 3,500 new lung cancers will be found. As a part of the programme, Optellum Lung Cancer Prediction will be validated in a prospective trial for applications in lung cancer screening. Working together with NHS clinicians and partners from Roche Diagnostics, Optellum will also explore the use of Optellum AI, for multi-modal integration of CT imaging data with blood tests developed by Roche, to provide even more accurate assessment of malignancy risk.
Optellum’s vision for the future: the lung health AI company
As we look ahead to 2021 we are aware of the seismic shift Covid has caused in pulmonary medicine. There are backlogs in lung cancer screening and diagnosis, millions of patients with damaged lung tissue as a result of Covid, and an increased focus on pulmonary medicine and more resources available for patients with lung disease. We want to play our part in helping clinicians with the Post-Covid recovery efforts and delivering better and stronger care quality to their patients than ever before. We can imagine a future where every lung disease patient is diagnosed and treated at the earliest possible stage, and cured. The Optellum team works hard to redefine early intervention of lung disease – starting with lung cancer – by enabling every clinician, in every hospital, to make the right decisions and give their patients the best chance to fight back.
Expect to meet us at in 2021 through webinars and virtual events – and hopefully soon in person; and see Optellum products used at a growing number of US hospitals and clinics, and follow us on LinkedIn and Twitter to get the latest good news and developments in our company. We’re excited to work together with clinical customers, research and industry partners to give all lung cancer patients the best chance to fight back.