FDA 510(k) clearance granted to PneumaCare’s ground ...€¦ · structured light Plethysmography...

FDA510(k)clearancegrantedtoPneumaCare’sground-breakingThora-3DI™productfornon-contactrespiratorymeasurement

Cambridge 16 March 2016 – PneumaCare Ltd (Cambridge, UK) announced that it hasreceived510(k) clearance from theUS FoodandDrugAdministration (FDA) for its Thora-3DI™imagingdevice.Thora-3DI™isanon-invasive,non-contactdevicethatusesapatentedtechnologyknownasstructured light Plethysmography (SLP) to measure breathing through detection ofmovementofthechestandabdomen.Thetechnologycanbeusedtoaccuratelymeasurerespiratorystatusinpatientswithawiderangeofrespiratoryconditions,includingasthma,chronicobstructivepulmonarydisease (COPD),pneumoniaand lung failure,and toassesspatientsbeforeandaftersurgery.TheSLPtechnologyusessafewhitelighttoprojectagridpatternontothechest,andrecordaccurate3Dimagesofchestwallmovementsovertime.The measurements are converted into visual and numerical outputs, which can helpclinicians to make faster diagnoses and treatment decisions, and continually monitorpatients in real time, without direct patient contact or intervention. The Thora-3DI™ ismobile,andcaneasilybemovedbetweenwards,ordismantledfortransportanduseinthecommunityorinclinics.Stringent bench and clinical validations required for the FDA 510(k) clearance havedemonstratedthattheThora-3DI™systemcandetectmovementsassmallas0.25mm,andcan accuratelymeasure respiratory rate towithin less than one breath perminutewhencomparedwiththeFDAgoldstandardreferencedevice.Thedeviceisindicatedforhospitalorclinicaluseandisintendedtobeoperatedbycliniciansandmedicallyqualifiedpersonnel.MarkHarwood,PneumaCare'sCEO,stated,“WearedelightedtoreceiveFDAapproval forourrevolutionaryproduct,whichbringsbenefitsfordoctorsandpatientsalike.Thora-3DI™isa 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 inEurope,achievedin2012.AnumberofclinicaltrialscontinuetodemonstratemajorbenefitsofrespiratoryassessmentusingtheThora-3DI™,andpublicationoftrialdataareinprogress.Webelievethattheseresultswillhavesignificantimplicationsforpatientcareinarangeofclinicalareas.”Dr. BillMason, Chairman of PneumaCare said, "FDA 510(k) clearance forThora-3DI™ is averyexcitingmoment inour companyhistory,butevenmore so for respiratoryphysiciansglobally,whowillnowhaveaccesstoourproductforthefirsttime.TheCompanyhasmetand surpassed the stringent criteria imposed by FDA for clearance to market medicaltechnology, through a process that has taken nearly two years of hardwork and intenseconsultationwith the regulatory authority. I amvery proudof our team for attaining this

major achievement and also extend much gratitude to our shareholders, who havesupported the company throughout the development of this innovative approach to anunmetclinicalneed.”AboutPneumaCarePneumaCare Ltd is a Cambridge, UK-based company that is leveraging its patentedstructured light Plethysmography (SLP) technology to develop and market innovativerespiratory imaging systems. PneumaCare’s flagship Thora-3DI™ device is a respiratoryimaging and assessment platform that enables clinicians to evaluate patients and theirresponsetotreatmentinrealtime,andsogainabetterunderstandingofrespiratorystatus.

Representing a breakthrough in patient care, theThora-3DI™ device achieved CE mark approval inEuropein2012,andisbeingusedinhospitalsacrossnon-US territories including the UK, France, Italy,Denmark, Sweden, Middle East, Hong Kong, ChinaandMalaysia.Witha firstFDA510(k) clearance forthe Thora-3DI™ granted in March 2016,PneumaCare is now working with its strategicpartnerstomakethedeviceavailableintheUSandin other markets that recognise 510(k)authorisation.The PneumaCare systems are highly enabling forclinicians working in a wide range of specialties,from pulmonary physicians treating ventilatedpatients,torehabilitation,acuteandchronicdiseaseareas, pre- and post-surgery assessment, asthma,

COPD,pneumonia.ThecompanyhasalsorecentlylaunchedaversionofThora-3DI™,usingidenticalSLPtechnology,forpaediatricapplications.FormoreinformationaboutPneumaCareanditsproductsandtechnologies,pleasevisitourwebsite,www.pneumacare.com,orcontact:

MarkHarwood(CEO)andDr.BillMason(Chairman)PneumaCareLimitedProspectHouse3StThomas'PlaceCambridgeshireBusinessParkEly,CambridgeshireCB74EX

Tel:+44(0)1223967414

www.pneumacare.com

mark.harwood@pneumacare.comorbill.mason@pneumaCare.com