Thora-3DI™ is a non-invasive, non-contact device that uses a patented technology known as structured light Plethysmography (SLP) to measure breathing through detection of movement of the chest and abdomen. The technology can be used to accurately measure respiratory status in patients with a wide range of respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), pneumonia and lung failure, and to assess patients before and after surgery. The SLP technology uses safe white light to project a grid pattern onto the chest, and record accurate 3D images of chest wall movements over time. The measurements are converted into visual and numerical outputs, which can help clinicians to make faster diagnoses and treatment decisions, and continually monitor patients in real time, without direct patient contact or intervention. The Thora-3DI™ is mobile, and can easily be moved between wards, or dismantled for transport and use in the community or in clinics.
Stringent bench and clinical validations required for the FDA 510(k) clearance have demonstrated that the Thora-3DI™ system can detect movements as small as 0.25 mm, and can accurately measure respiratory rate to within less than one breath per minute when compared with the FDA gold standard reference device. The device is indicated for hospital or clinical use and is intended to be operated by clinicians and medically qualified personnel.
Mark Harwood, PneumaCare's CEO, stated, "We are delighted to receiveFDA approvalfor our revolutionary product, which brings benefits for doctors and patients alike. Thora-3DI™ is a first-in-class productthatwill beofwide interesttorespiratory physicians worldwide.510(k) clearance builds on the success of ourCE markauthorisation for the product in Europe, achieved in 2012.A number of clinical trials continue to demonstratemajor benefits of respiratory assessment usingthe Thora-3DI™, and publication oftrialdata arein progress. We believethatthese resultswill have significant implications forpatient care in a range ofclinical areas."
Dr. Bill Mason, Chairman of PneumaCare said,"FDA 510(k)clearancefor Thora-3DI™ is a very exciting momentin our companyhistory, but even more so for respiratory physicians globally, who will now have access to our product for the first time.The Company has met and surpassed the stringent criteria imposed by FDA forclearance tomarket medical technology, througha process that hastakennearly two years of hard work and intense consultation with the regulatoryauthority. I am very proud of our team for attaining this major achievementand also extend much gratitude to ourshareholders, who have supported the companythroughout the development of thisinnovative approach to an unmet clinical need."
PneumaCare Ltd is a Cambridge, UK-based company that is leveraging its patented structured light Plethysmography (SLP) technology to develop and market innovative respiratory imaging systems. PneumaCare's flagship Thora-3DI™ device is a respiratory imaging and assessment platform that enables clinicians to evaluate patients and their response to treatment in real time, and so gain a better understanding of respiratory status.
Representing a breakthrough in patient care, the Thora-3DI™ device achieved CE mark approval in Europe in 2012, and is being used in hospitals across non-US territories including the UK, France, Italy, Denmark, Sweden, Middle East, Hong Kong, China and Malaysia. With a first FDA 510(k) clearance for the Thora-3DI™ granted in March 2016, PneumaCare is now working with its strategic partners to make the device available in the US and in other markets that recognise 510(k) authorisation.
The PneumaCare systems are highly enabling for clinicians working in a wide range of specialties, from pulmonary physicians treating ventilated patients, to rehabilitation, acute and chronic disease areas, pre- and post-surgery assessment, asthma, COPD, pneumonia. The company has also recently launched a version of Thora-3DI™, using identical SLP technology, for paediatric applications.
For more information about PneumaCare and its products and technologies, please visit our website, http://www.pneumacare.com, or contact: Mark Harwood (CEO) and Dr. Bill Mason (Chairman) PneumaCare Limited Prospect House 3 St Thomas' Place Cambridgeshire Business Park Ely, Cambridgeshire CB7 4EX Tel: +44(0)1223-967-414 [email protected] or [email protected]