Thank you We much, Dr. very Kalsi-Ryan. really your insight your to PoNS. appreciate with experience respect with
compared going $XXX,XXX quarter revenue to in period. of I’m fourth a $XXX,XXX fourth prior reported year We with quarter turn for of our performance total to review revenue XXXX, of the now. the
of of in of the in have PoNS approximately the our revenue to total XXXX, Our in approximately total fourth quarter that XXXX revenue X% was XXXX. authorized fourth treatment the to compared revenue by fourth quarter quarter been of provide Canada, to representing XXX% clinics the sales the driven of in
reason for for the HealthTech strategic alliance agreement wholly-owned in our and that, subsidiary our Heuro. was Heuro reminder between a Canada fourth fee of the XXXX revenue their quarter comprised of subsidiary, As wholly-owned the Connex to and related revenues license or
Moving operational progress Canada. in
tonight’s mild chronic call, our due on device device available balance new and PoNS traumatic anyone our is treatment first for or only represents to to mmTBI. deficit story, brain to injury, authorized the moderate of the who For commercially in Canada and
leading healthcare our goal ended locations, treatment fourth the Health, seven PoNS facility year the located and Toronto authorized a the for year. PX to authorized exceeding with of During provide quarter, a in downtown total we clinic
by feedback commercialization our to experience the during our strategy to commercial Canada, the in were continue in also which make and We PoNS gained XXXX. of enhancements treatment informed early
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our needed in this the early over fall order directly we evolve model commercialization. that and learned drive to We to summer Canadian business
October Canada on acquired operating XX, So HealthTech entity Connex. from we Heuro
to of As over process on function provided of authorizing acquisition our Canada, while with earnings new the of training identifying, QX PoNS treatment pace adoption better increasing of the position us complete us believe control improve discussed and time. our we marketing Canada our for Heuro which clinics, the sales will in call, and has
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criteria. now targeting we’re fits Specifically, clinics the following that
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the of Ontario. in has Our the initial been system clinic focus development
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result commercial with we’re a pleased efforts. traction new the very this targeting as We’re seeing of
that authorized to clinic months locations, a of clinics the network two of clinic – year treatment. locations XXXX, total authorized provide will PoNS first the we XX In seven our new bringing clinic
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tandem, our we of PoNS In several treatment continue expansion the awareness to pursuing by initiatives. strategy, raising clinic marketing targeting enhancements
digital to our generate and our network pursue of to to raise marketing and continue clinics. our referrals we therapists treatment First, for patients, to podiatrists awareness physical authorized among efforts
continue new broader and injury our marketing sites for content social patients Canadian on Specifically, media website, ponstreatment.ca, potential by we updated the creating patients community. – and our brain develop for to traumatic
affairs among key opinion industry leaders we leverage to raise medical awareness to groups. Dr. our like second, advocacy and associations And specialists continue Kalsi-Ryan, also
to Canada membership focused their focused in and promote concussion of groups the We’re advocacy collaborating with and to treatment events. PoNS their on conferences major
part We the our health of outcomes support, and requisite generate our to patient strategy on economic of life quality the and treatment. are gather demonstrating adherence of continuing treatment PoNS to data as benefits
results the PoNS and investment balance – on with other trend continues with positive prior dossier trials with data for two in consistent clinical return insurers our for insurance based that the outcomes improvements adherence treatment a deploy have conversations patient both been shared gait Canadian payers. mmTBI. the on to treated pleased patients treatment, We dossier, which And XXXX. calls, gather we’ve XXXX. analyzes for I’ve value this and we This strong that the in our in adherence at on in of our As with the throughout are to you begun very clinics produced we’ve and the for believe
And from as treatment PoNS initially payers in reimbursement is and for auto on our Canada strategy reminder, focused disability and workers’ insurance a payers. compensation long-term obtaining coverage
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living MS Canada, addressable increase XX,XXX With will opportunity. individuals approximately expansion with label market significantly this in our
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amendment license moderate submission MS of We’re February in mild a II to XX, announce symptoms gait the to treatment patients with Canadian for the on pleased XXXX. application of Class deficit
MS validated This was treated Canada on and world our on focused from data application – supported patients in peer-reviewed our to Canada data the our by gathered from published database. in real Health clinical studies
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in which this With in demonstrates Canada. rather summary X.XXX. patients gait a of data statistical significant function that of Canada, treated our equals And real in those world afternoon a included significance for these gathered statistical XX-K P in filed real improvement in in clear world gathered detail. more – We’ve a data XX interested
update our regulatory to Turning on an U.S. strategy.
strategic March our As included MS MS on press the U.S. we to device. data indication de submission first release in this novo pursue as on PoNS Canada, update prioritize in clearance the pathway in of the to package our announced X, quality the we’ve based of our decided
The reason is the important large the million population to the principal be with MS according in for patient living with MS, this X decision nearly Society. to people U.S., estimated
high patients a has disease – medical AMPYRA drug called MS. with with has FDA speed unmet the increase disease need this Additionally, deemed a unmet at with approved a this gait for to and high
approved already Our therapy. data, very not compares this to exactly the although same, favorably
pathway to in profile in for are our sufficient demonstrate for we to required second-half the this by became U.S. clearance of a benefit for and these de de the data classification And previously first novo the efficient all risk consider, XXXX. a gain effective to So technology to with favorable the pathway. we more Thus, believe indicated, U.S. in as submit our factors PoNS MS expect novo as
of for we mmTBI. deficit an We updated novo application balance update to considerable since de last the treatment chronic investment progress classification device PoNS of Turning for our community. to made the of due the
longer originally However, the than our this pace progress of team was anticipated.
intended a to request address pre-submission the spring a therapy important data submission of FDA physical clinical the trial XXXX, feedback October which the treatment of the the design meeting alone. compared us to PoNS had provided a additional with first XXXX, from to new FDA’s of our an with potential We the included which in feedback demonstrating in for benefits
This we regarding feedback of January pre-submission additional recommendations FDA’s the from In with notes and XXXX, trial. specific included on the the the meeting. post-meeting received FDA minutes the final new very October design –
and trial, the which We for mmTBI. have design for support TBI-XXX, request the to used new since de new for finalized this classification will recommendations incorporated these be call we our novo
in treatment TBI-XXX multi-center to or deficit randomized with balance and of in mmTBI. will phases, It will run Canada phase the two be a consisting due XXX followed proceed a U.S. phase. subjects trial in by
therapy in to treatment phase, will weeks of the subjects either running then two one physical will of where will five and phase, therapy During all subjects alone, receive randomized groups assigned be the they weeks device primary of up receive to or up analysis. the without device. responder therapy with PoNS a XX XX physical weeks the effective physical PoNS to of The endpoint will be
the this $X TBI-XXX we Based which of – will of the will in to approximately XXXX. that on study, incur we cost half trial expect approximately design estimate million,
approval. circulated IRB We have have protocol and clinical the revised the completed sites for trial
quarter FDA targeting We application novo second of XXXX. to the begin our April the expect for and this of in are submission of for enrollment year de the mmTBI classification in for
continue I In – the to Given the we funding to the are the prioritizing to for potential de and of I evaluating we I – we’re this the an of clearance trial, novo execute indication interim, second-half of in – intend of will of for sources submission this the as the to XXXX. our as estimate earlier, currently mentioned and cost trial. submit MS,
our of let a as full-year me that, Joyce through results, our Joyce? well as to walk guidance. financial XXXX review it to quarter With XXXX over fourth you turn financial
