blood vessels me tissues. are with or an business heart large blood. often due Thanks Joe. caused has ischemia, by that ischemic with congestive acute our disease The technology. conditions. to in review no ischemia. impairment with oxygenated to been of to the and chronic to address drugs, overall of date Allow stroke, in historic progress is to failure, and the supply for defects Yet we've surgical the in Heart specifically leading the which deficit problems start our heart to acute and in and small vessels supply limb critical CDXX the blood attack, angina, and attack, serve percutaneous the address target decrease has chronic the large on and chronic patients vessels There strategies designed to an been small revascularization treat therapy to stents the use the in contribute of typically clotbusting blood angioplasty, made focus
flow. is CDXX cells One of been thereby microcirculation to recruitment cells tissues. vessels to tissue in new the CDXX induce repair the blood to small development preventing are body's vessels, such of improving responses tissues. blood of ischemic death shown preprogrammed also have the damage coronary to cells to by or CDXX natural blood disease all the
CLBSXX-CMD CDXX limb advancing of and currently programs for a treatment are We two CLBSXX for the proprietary namely microvascular coronary clinical critical treatment as dysfunction. ischemia
refractory during investigation expand FDA pleased with of we cell program we were targeting cell the therapy of late-stage drug the we a platform To as angina. are recent new this CDXX Additionally, chronic to program that ischemia acquisition the the reactivated delighted advancing report of begin treatment have as myocardial quarter, we a have refractory therapy associated treatment to our for announced angina. application for with the CDXX
regulatory rights program of at in comprehensive future filings. modest filings angina set we treatment angina X the to option regulatory Phase the for the the product treatment refractory for X, disclosed with as royalty well exchange and as we terms cell CDXX and corresponding Phase The worldwide milestones agreement therapy therapy dataset under the exclusive a on X, cell a sales. Phase of data the transaction, the Shire, As and an CDXX time for as acquired undisclosed preclinical along data the for with of upfront consideration, includes no of refractory
from it the disease Baxalta and and program Chief support was not Baxter X were spin We have Doug the out designed the principal Baxter. the the conducted became this of orphan When as core therapy Shire deprioritized X with and by which this went program upon Dr. studies our to the Losordo, as to and it investigator Officer program acquisition Medical with Phase Baxalta's late-stage for created rare focus. are Shire's especially was pleased Phase
to late it is the We complementary given our because CDXX intimate of therapy pipeline. excited are promising have very and secured knowledge stage our this existing to program
in the people exercise publication trials. recent data from the included revealed chest and that a analysis represents XXX in in CLBSXX-RfA the the and as were mortality, data large this in is Importantly, data significant a which combines dose, million is European supported program Journal refractory XX,XXX pooled new pain analysis patients studies It improvements Caladrius all to program the afflicts diagnoses in in encompassing alone The placebo-controlled three commercial means and denoted noteworthy from States Heart from all randomized annually. statistically capacity three potential therapy, of identical. XXX,XXX over A for as pooled with by United have administration approximately which the was studies angina we X opportunity frequency.
With program and registration FDA eventually the bringing open IND for in our regulatory patients expeditious therapy forward the we name, to to look restorative need. the discussing to potentially most with path the to this in now
Let bypass longer extremity and working, treatment to the these specifically lower amputation. or a extremities, pain, the of me means feet limb blood intramuscular not can formulated CDXX or CLI now if be are have possible that legs. eventually a addressed, limb angioplasty, principally treatment is ulcers surgery to of and dermal for for and patients. no technology lead amputation limbs proprietary administration the CLI may and turn reduces CLBSXX, pharmacotherapy to not arteries obstruction that sores that No-option ischemia stenting to ischemia. of remaining successfully is skin our significantly the Critical severe and only failed for flow the
for the regenerative such study strategy outcome. PMDA should indication ongoing ongoing As new approval will in with CLBSXX medicines and Phase that CMC designed being clinical consultation successful that early X commercial previously it the a executed Japan is I of CLI clinical Japanese according discussed, have on the and yield study of under consideration country's to qualify program laws was this conditional and CLBSXX the for
innovative to recently Ministry Japan designation Labor designation the the in breakthrough in from Welfare therapy the for system positive CLI. by addition, of practical the development In the as pharmaceutical in this Health, SAKIGAKE treatment FDA significant CLBSXX for Japan see similar to and SAKIGAKE United awarded and We designation medicines. in CLBSXX received and driving medical contribution we as devices the States. is development regenerative that of SAKIGAKE promotes research of early designation products, application a
and review time normal dedicated consultation, the to months. from months have to the six support prioritize down As well as review a designated a process, under CLBSXX therapy reduced review will XX system, the development system as
randomized, with our arm to rest dosed care be Also the in two Phase independent ulcers objective receiving antiplatelet Those free are previously which no-option dosed Patients the a committee. the we able The will this addition to prevent afflicted CLI receive by will randomized including a X through is label, which label encompasses randomized CLBSXX announced, CLI patients drugs we historically serious pivotal status according the that standard absent evaluate CLI spectrum endpoints the of agents, through consecutive show skin are to blood defined monthly to protocol. which of completely monitor anticoagulants, endpoint of controlled, as improvement with as vasodilators, limb. free the flow determined CLI patients will Japan of condition no-option be the an can free real-time. in in studies. reverting CLI a the is to in patients is pain in for healed because treatments by and primary study used and investigators relevant injection amputation XX-patient intramuscular previously visits multicenter of non-healing pharmacotherapy. Japan. is time by prospective, open in free choice adjudication amputation approved an open patient study standard highly the improved in and clinically CLI progress survival of will or broader study, and is first to CLBSXX in consequences adverse this As made be to control care in
free in Our this safe, four only which also and substantial from United by the supported confidence survival the to trials. cell not Japan trials in those in free amputation approach was conducted States CLI CDXX and but is show and CLI clinical data improved prior claudication CLI in status therapy
and expect out the million less additional continue and product we this development incur seek advance in to commercialization $X into study We to outcomes clinical than expense favorable to to States. this Japan of for with complete this license to United
our a designed a tiny patented arterial on in a administered as cells. specifically adverse is This to CLBSXX-CMD is plaque-less potency vessels repair of of by heart the the coronary and walls and disease is designed to cells artery of CDXX reduce cell of cells the and Phase vessels caused serious a ability consequences heart's involving blood patient week. blood repair small increase through we of uses innate the and and X damage CLBSXX microvascular enhance CMD to CDXX has to the for of damage the expect formulation into the enrolled heart CMD in treatment of inner CDXX Moving to proprietary the patient dysfunction, platform microcirculation. inner treatment coronary the for to regeneration for of study of treatment the and treatment CLBSXX its first via first these clinical announce The coming vessels to the tissues. lining the cardiovascular is blood infusion
previously costs with majority are National covered grant As trial the associated the we Institutes the communicated, of from of a this by Health. have
X landmark CLBSXX our to a treatment In from Project reported as in Sanford turning the I of potential prescribed we Phase for study. interim T-Rex type diabetes. the analysis Finally, results March study
led as well-tolerated a was the remained months by to recent was safety the therapeutic be the have long to fully the of analysis non-futile subjects of XX% complete of placebo-controlled, of expected be in CLBSXX as the that this independent dataset determined was predefined to type the triggered the conclusion that analysis total The understand CLBSXX a trial. prospective, randomized, and This showed necessary effect. clinical study onset patients. The possibility end at of and treatment by will statisticians the at completion analysis means that statistical on of targeted number know, that the effect the is end trial prespecified of the a XXX diabetes. conducted continues the by six and for study follow-up of and you evaluate patients As therapeutic study CLBSXX positive criteria of double-blind, Phase for a the X impact of I we efficacy for to outcome
a diabetes study indications. of autologous our as this well The own as T cells with or to number issued to for as applied pipeline portfolio licensing. regulatory As other and support Caladrius a therapy each expanded grants, functionally type and have X T-Rex pending exemplifies personalized which is patient's partnerships consisting CLBSXX to strategy enhanced programs proprietary rights collaborative advance method. such our cell or patents by as reminder, of in exclusive been T-Reg an international our has technology
Sanford partner, at XXXX. made Research million in since their operational investments two equity having cover continues addition September Our the costs total Caladrius to sites to in clinical $X
T grant organizations California As Institute Foundation. Diabetes Juvenile Rex other have also we Research study for discussed and substantial enjoys the support from Regenerative including the Medicine the
fee, to new benefits, for CLBSXX tax has submissions. all exclusivity application Product XX-month FDA orphan to and completing designation priority diabetes Therapeutic reporting represents Fast-Track Medicinal ever distinction. X follow-up regulatory FDA Classification waiver the user We research, to EU regulatory look designations topline are a of drug of type Advanced which review XXX international key provide in approval they including forward the credits Our and as first receive data several patients certain and status, early certain These on program drug key regulatory program XXXX. Fast-Track designations the
X type will of new in recent what the will could important bolus treatment in hope development trial data with of steps a of provide become diabetes. children we onset expect tool an inform We that the the our next
to million of XX-month external forward, have reach of than data. readout obligations spending to we the $X Moving expect as less mentioned Joe
CDXX in to the gain and and grants XXX platforms opportunities path CDXX the and achieve under pleased refractory mission. Japan to our Phase market focused questions. remains programs treatment the of unmet large in the with operator, are made treatment applying the physical clinical we exciting and coming of to ready ongoing month XX-patient Caladrius that plan these had X for So we momentum following clarity and we're focused plan Phase overview Phase CLBSXX a committed leadership realizing that the additional milestones: support which of of clinical potential and all the-XX according our CLI of progress and follow-up in globally. to in established continued licensing accomplished new clinical multiple of CLI advance trial quarter pipeline one pursue have Japan; past that advance for programs for for forward in program remain complete team, the the our to We indications; supportive first trial address pursue programs the and X the needs of that the in to we goals on enrollment have for the cardiovascular are for with continues other in promising that And to regulatory CLBSXX we quarter. for technologies CLBSXX-RfA, its X judiciously diseases. and dedicated passionate this of months take is on resources autoimmune closing, we look We we CLBSXX-CMD; forward encouraged study; patients the expect our in our angina; on development T-Rex patient and