listening everyone today. in Thanks, And Laura. thanks also to
for brief will address commercialization. to by followed will first related update, operational Q&A. During overview I few the shareholder priorities, a partnering objectives be today, and which I provide questions preparation then the portfolio strategic development a analyst a call followed our will by
ONE-BRIDGE disability trial support priorities, ischemic of for our their stroke, leading and of our ongoing treating important on development ARDS. Japan, including most Operationally, cause treating for a and TREASURE pneumonia-induced death we continue to and maintain the Healios focus clinical trial in
While do we support the provide appropriate. actively inputs and in or we're regulatory trials, where operational oversight these of not conduct engaged
however, most manufacturing of designated CMOs, material material a has oversee that contract studies manufacturing Our we with the role, with. of organizations, been the of studies. to important for clinical completion Overseeing for production or these work
As the Europe past, with Asia. organizations several we described in in at sites the we specific CMO US, work and
noted As been the year earlier for runs the have previously, completed study manufacturing TREASURE now well. and ONE-BRIDGE for this as were completed
from we PMDA for discussed therapies in regulatory the ischemic development stroke accelerated the Japan opportunity Japan. Sakigake received program previously, have the Healios expedited which review for regenerative As and under in has medicine provides framework eligible designation
RMAT and and fast here the being program track protocol conducted assessment. is trial in stroke Phase We've special III also designations clinical for US our received ongoing our under
fast and of for review, to track make are and approval designations, priority submission rolling specifically a result designed review both are Sakigake eligible to regulatory which programs these efficient. the faster As process path the and more and
efforts our jurisdictions. and Earlier the for and which ultimately retained year, information regulatory leading Europe this process, to this for the to assist support submission CRO efforts we relevant materials other Japan, us will the prepare in US, a
kickoff over months Healios the initiate the to and with of quarter. here Several efforts process. CRO These and the planning the Cleveland continued to the team held meeting in regulatory we ago, most have commencement progress the members recent of
referred focused our for stroke, on work, Phase to In MASTERS-X. we're in ongoing of parallel III support clinical activities as trial with this
for the conduct CMO make our in to to operations of manufacturing network continue the We we trial, this while with study. complete progress work
Europe international will important clinical most is a at development that than and in patients priority. double-blind, have centers randomized, previously, study described and we As XX other our America, internal placebo-controlled locations represents stroke leading pivotal more enroll it XXX this North the
is in has done sites additional have good, past on bringing and been online operational few we the at sites our work enrollment the support current very objective. over that While substantial of focus months
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treated randomized, tolerability results days the the from presented May, at the suggest of month among trial, final consistent placebo-controlled results early or and with in XXXX. meaningful treatment. anticipate the form were ICU-free which improvements the after double-blind, American and The primary the MultiStem approximately in this mortality, days We the Society the profile at assessment ventilator-free in study one-year Thoracic report one year primary Annual clinical having the of patients safety Meeting demonstrated a clinical results and end around in
patients have one-year evidenced with opportunity we however, meaningful patient that, as improvement provide by evaluation the trial certain which of assess support to of assessments advance appear life EQ-XD. strong reported the to preliminarily administration metrics had that in correlates MultiStem the quality using in to In
quality previously more This improvement meaningful be of observed patients in ARDS assessment. we mortality, to primary have particularly life in differences clinical robust ventilator-free ill most the and the where also days ICU-free outcomes at among appears days severely
additional life We but their impact of families, matter we not can the in patients ARDS. relevant believe only and impact evidence provides also quality their that things this clinically that including aftermath of outcomes, to the
designation have the families a received. Once program have the analysis, which FDA this grateful such results we're corresponding study track and represents again bestowing we to the designation update. patients provide final once the the the to meantime, third and participated on for their further in fast that and our that we we in But completed will
further will more provide planning in of development specific phase we're that initiated and the for already along once We've information next process.
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trauma described have this Houston, Texas. we tier US X be in previously, at of As one collaboration the conducted trial here Memorial the Center Hermann centers with in the Trauma leading will in
a nearing than the that had we Although FDA and have we excited engaged as as helpful as end preparations now about discussions issues how to process planned, our and approach bit this in have the proceed, for study and getting study soon of believe with on we the possible. the others are are underway certain we best longer taken
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do unfortunately, the things status the sites As so. primarily of struggled we care in it years. with this have number in been enrollment current effort several this, in relates during AMI have unable of as to participating we've trial, while previously, of described a study, II past Phase to standard due to address And we've to changes implemented an
in suspend next Accordingly, a patients the for enrolled. complete follow-up we year to at the We completing those further half the providing follow-up made the and update anticipate trial the time. that first further enrollment decision have visits already of and visits in
on focus actively relevance in has more MultiStem remain we the other we we are areas it to cardiovascular confident efforts is appropriate believe While that the area, our pursuing.
engage a and of several in with On for companies, and on opportunities our the development business discussions front, development care Europe. exploring alliances range critical particularly programs commercialization we're potential focused in portfolio of we're
value that on impact in programs. and critical and we partners logical these as care we view and companies the us We're qualified the specifically help of believe maximize commercialization that focused highly segment for can
explore regions in here to America relevant We interest. North and in also partnering other opportunities including territories, collaboration continue and of other
believe There continue commercialization we potential makes preparations US. However, the we these why reasons while strategy for the we independent sense. our in possibilities, explore here several are
in the commercialization we care our by partnering about helping US, of establishing critical the position by discussions knowledge a for strengthen First, independent depth – greater preparing in by market.
the way potential forward. us be It partners from should and better expecting we what also was appropriate decided looking most assess if we helps that for
and for how care approach on, by we're care a we about to Second, market landscape better indications utilizing critical develop commercialization. the clinical effectively the critical focused the understanding
out efficiencies. map identify where logistics it Third, potential there out requirements define and areas are operational helps precisely domestic and capability
we an commercialization market the years, of work developed of aspects during As the care a critical of where understanding potential this, synergies and key may clinical past have of example and our couple over exist. deep
For corresponding geographic center United hospitals example, of the understanding we the and institutional and capabilities. stroke a X,XXX good of approximately the have distribution States across understand certifications
X have know where with relationships and many We all already stroke centers, comprehensive they located of are tier them. the
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Collectively, these believe specific geographically most share treatment areas. from benefit patients the know also And stroke institutions we in we the MultiStem. concentrated disproportionate might treated they are that with of
to localization and indications an with clinical critical-care centers are pulmonary products of on, developed care including centers. synergies understanding and institutional potential or as advanced have advanced we're Furthermore, geographic other focused where leading with most trauma we the stroke the there critical geographical
well-positioned on the comes. time Based efficiently indications we're an to confident marketing and that in that serve prioritizing market distribution the develop work, when capability the to critical-care we're are this effective we
these reiterating specific very worth focused critical reasons. that several we're for It's indications on care
with collaboration this in First, evidence years conducted from tells researchers and therapeutic translational of some independent leaders us of our key is that have clinical technology opinion outside where the research potential. preclinical and to appears greatest
indications most adverse impact patient many critical-care standard be is tends simply where care the represent very of unmet unavailable and of cost of these need the significant areas medical greatest. limited Second, of high typically for of or life is to some care on quality patients,
By the we can delivering believe to system process and can whole, for these value patient substantial improve not we only shareholders. their the patients, our treatment life, quality value and that we healthcare effective a in families more as options in in areas, deliver substantial create outcomes of clinical
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value. Establishing we major our us that an represents for towards substantial shareholder is alliance with the creation a believe top and of right step the for a priority partner shareholders and
In being as maintaining a again to the this meantime, position, Laura to as and described and we stable financially are committed efficient quarter. once financial illustrated we
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In to a committed things leading medicine summary, time regenerative to company. ultimately establish Athersys are and all we do we doing the over commercial as need biotechnology to
taking board adding include and team to believe capabilities members will new we be further our actions organization and leadership to appropriate. This strengthening time, the and the over other that
shareholders open Q&A. before with to up And additional I'm that, from several questions for we it happy address
of the statements to lot Japan. to refer Healios this. on in filings and relates a trials We from shareholders timeline get we ongoing projected question public for the people One
However, are achieving as publicly soon we stated year TREASURE around goal that on the possible. and completing and that finishing remain of they focused note as to they also that the mid-next they committed we to study trial believe enrollment
April, Regarding a made end so ARDS. pneumonia-induced this good in last the they on XX-patient focused have which that very flu Even though year's the far. initiated tail trial, study season, recall the we of is is progress at ONE-BRIGE trial
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the Healios this trial. know high that completion of efficient is We on placing enrollment priority a for
we the frequently Another question estimated MASTERS-X. get timetable relates to for
of around the stated As trial we enrollment complete next is have previously, of by year. our end the goal to
updates have on achieve our believe over successfully We big appropriate. our impact ability we few and months further to will goal activities as the a next this will provide
the Some many patients have have shareholders about enrolled. asked or location how of sites been and number in MASTERS-X
the have ongoing. while in is practice information disclose standard we is previously, as not do As stated trial of we industry this type and a
unfortunate cases past to level laying for of obtain the sites their family, about integrity in staff a protect shareholder, seen trial staff minimize have trial. contact to clear and at out patients the company we we committed investigators involved to the and To sensitive provided, We've what sites, or study, medical study in as well tried information the the where our the as the detail high while the plan are doing. people
critical Finally, People what estimated for might from on. commercial we frequently perspective. we care get questions focused and about market the a shareholder indications mean currently potential about the MultiStem and ask size the core are that
factors and These think we number depend pretty and actually are assumptions. issue. questions the a how answers here's on of this about complicated But
America, stroke, estimated a First, the annual focused including we trauma ARDS, Japan. have understanding geographies relevant hemorrhagic incidents ischemic North and on, for good in stroke the Europe of we're and
and relevant may key focused we're a While illustrate we them use the we these as can only MultiStem examples aren't where of the couple to relevant on, be critical care points. aren't areas believe indications things only
XX each elderly year We know global stroke globally expansion to and segment more which affects aging-related is the million impacted of and and population about by is the that susceptible of people stroke the other diseases conditions. rapid
minority a is assume per addressable patients core North that year, which stroke incidents. approximately actually America, annual the of market Europe Japan and X represents million Let's in the
healthcare XXXX would and economist, approximately assessed a per MD and that A an makes pricing number concluded and years UCSF $XX,XXX for ago, in sense of a be dollars. leading value pricing the fair California thrombolytic dose using from PhD of
and treatment MultiStem results with the substantially to clinical price deliver impact value data, our and other believe and from greater substantially of relevant we on would healthcare a using value justify the Based to system MASTERS-X analysis, point. higher
be sake am for point purposes illustrating use using might for of am what for this To reimbursement price the or clear, guidance not discussion, a simply of MultiStem But let's very appropriate a I on as this the point. point. think I I our the reference be. important totally providing strategy indicating
million At year XXX,XXX billion. represent and annual and treatment per of addressable market billion somewhere an opportunity between an $XX a X estimated would $XX,XXX to $XX patients of market per potential
the carries serious sense, leading the of death. burden. Logically, huge and that of given cost as cause of world developed is disability makes It leading a countries in as social quality this in the ischemic cause and many stroke also well life
per substantially loss As I rehabilitative and average or that hospitalization or patients now institutional costs, had $XXX,XXX are care more described quality-of-life costs, disabled cost does than previously, the in therapy impact. include not stroke for for this earnings full-time year, potential is treatment
are conducted be the A can similar analysis we for on. indications other focused
the across number, estimated price core would these year, If potential of approximately say year. XXX,XXX geographic ARDS half patients only and XXX,XXX this than market annual the translate addressable use is for market opportunity billion example, year. incidents at at $XX per more per same it For an per to market is estimated patients annual the point,
current standard alone and Trauma injuries of million or X more people represents US related opportunity than trauma another transportation limited. and a in in where vehicular results care is the meaningful And from hospitalization falls year. the Europe, of
people cause life. age disability, and US, realize of in leading of don't is individuals cause alike. patient the massive a trauma It opportunity and also to to the among care clinical another XX people Most represents and leading of the represents up the both death among that, improve elderly young of quality
point market we believe medical very well-positioned is are large address are them. areas corresponding and simply need I'm to we each of making These opportunities unmet The this. and
our patients help and are believe programs in can generate areas portfolio substantial in to our advancing these we process. for meaningfully the value committed shareholders we We because
questions. it few for a we'd up more that, with And to open like
