FDA 510(k) Clearance Granted to PneumaCare's Ground-breaking Thora-3DI(TM) Product for Non-contact Respiratory Measurement

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CAMBRIDGE, England, Mar. 18, 2016 /PR Newswire=KYODO JBN/--

PneumaCare Ltd (Cambridge, UK) announced that it has received 510(k) clearance

from the US Food and Drug Administration (FDA) for its Thora-3DI(TM) imaging

device.

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Thora-3DI(TM) 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(TM) 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(TM) 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 receive FDA

approval for our revolutionary product, which brings benefits for doctors and

patients alike. Thora-3DI(TM) is a first-in-class product that will be of wide

interest to respiratory physicians worldwide. 510(k) clearance builds on the

success of our CE mark authorisation for the product in Europe, achieved in

2012. A number of clinical trials continue to demonstrate major benefits of

respiratory assessment using the Thora-3DI(TM), and publication of trial data

are in progress. We believe that these results will have significant

implications for patient care in a range of clinical areas."

Dr. Bill Mason, Chairman of PneumaCare said, "FDA 510(k) clearance for

Thora-3DI(TM) is a very exciting moment in our company history, 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 for clearance to market medical technology, through a process

that has taken nearly two years of hard work and intense consultation with the

regulatory authority. I am very proud of our team for attaining this major

achievement and also extend much gratitude to our shareholders, who have

supported the company throughout the development of this innovative approach to

an unmet clinical need."

About PneumaCare

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(TM)

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(TM) 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(TM) 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(TM), 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

mark.harwood@pneumacare.com or bill.mason@pneumaCare.com

SOURCE: PneumaCare Ltd