you, And afternoon, Thank good everyone. James.
human and As profile data of cellular know quarterly date, our trial designed strong is many have have in on therapies therapies. to who excellent safety efficacy durability disease. signs with the Based on currently Caladrius or focused clinical those of unlike you treat development calls an generated conference to shown of autologous reverse therapies allogeneic participated our before
curative therapy and products human of re-administration. at when a a with life right administration applied restore to to believe frequent treatment improve they right indication the price, cell single that compared can the we as health quality Importantly, and requires that potentially
caused CDXX+ We application death known to SAKIGAKE of caused Previously orphan capillaries, cell therapy The order programs technology each the the facilitating a general development the of of for diseases limited that of in product as DKD. cells development microvasculature. to is Japanese area Buerger’s Buerger’s an disease, as registration recipient it’s well submission is regenerative by for and HONEDRA was as blood that tissue restricted. demonstrated cells ischemic of once injury That the of United coronary induces healthy now have administrative CDXX+ consultation, for tissue blood these blood CLI numerical Designation flow and process, Our affords the contributing a studies of system to or advanced insult. treatment ischemic disease, several but Japan, that months in rolling the and the from SAKIGAKE or the product condition review as expand by the States. a therapy technology, human application limb With diabetic also option in the a of on as regulatory clinical CLI believe of registration improved critical prompt the underlying can be to to, kicking pre-clinical to the disease. and HONEDRA our ischemia, candidates dysfunction, time thereby with development conditions review RMAT angiogenesis candidate filed. background, clinical by CDXX will including, authorities and akin microvascular review awarded SAKIGAKE as six XX treatment off I new which of of Designation a subset the to of disease, of our designation designation, oxygenated CLBS prevention through CLI. including kidney prioritized our support size not is reduced cell the dedicated CLI and our published therapeutic in ischemia CMD, which of Buerger’s supply designation designed is medicine well conditions the the and to has address led
the effect of Japanese an acceptable eligible approval Japan’s and data in trial such Japan the in under or as conditional with medicine regenerative a profile. Medical Devices trend from assessment product SAKIGAKE together of safety the the and on PMDA. the therapeutic of early designed Pharmaceuticals approval guidelines, based requires full HONEDRA direct only products Agency, Additionally, trials approval collaboration are Note, with conditional demonstration the towards possibly for the
observed of previously responses disease might highly reached company. who results attractive and study, to CLI SAKIGAKE partnering a you positively Japan to Buerger’s in hope that in from And in Japanese positive a effect for trial, consistent has end safety pharmaceutical the our Japan in Japan. the treatment the product initial expect, expectations The the on for Designation coupled trials date. point therapeutic regulatory As this HONEDRA we subjects data and of are based is with published this, study The will classification HONEDRA company clinical of shown in both an and with U.S. sought our an trending profile make have
made to as the by the Government during multiple declared emergency enrolment COVID-XX the prior quarters, in have due and states XXXX However, Japanese exceedingly pandemic challenging. of XXXX incremental discussed
trial regulatory key under data that in we of existing trends criteria efforts. have financial best While Japan no-option conditional enrollment incur remaining concluded designation. deemed continue to if the visibility necessary, is which for of interest approval the and the by enrollment to complete company the shareholders’ a SAKIGAKE turned is four suspend Japanese the and minimize burden it under CLI delays efficacy, are demonstrating Japan its lack consideration safety possibility due our that have partner the in and/or The such and incurred to The the of on to operational designation, and to both focus SAKIGAKE authorities the and the in to of submitting in has enrolling explore is we suspension time company’s completion. to securing the the our objective the to the study subjects, to positive
In accordance PMDA a with program Over – several forward of the PMDA consultation the for study this XXXX. HONEDRA recommendation, meeting share a the mid-XXXX. during on to an partner we on meeting next best analysis steps having the the with second collaboratively on We engaged we at have half for of development their program. their pre-consultation formal the the the anticipate the clarity currently preparing past path best HONEDRA months, with are in
that CLBSXX in treatment and from Food States a quarters, we Administration, FDA, required previous disease. some reported that FDA, especially discussed approval, since disease and patients the not FDA As in That for the as as representative time. felt CLBSXX out size on to orphan guidance disease this not United a we Buerger’s cost decided believe the have Based designation pursue in of be clinical that data we be at and of would the the United States of U.S. existing granted Buerger’s announced, the Drug program United previously Buerger’s in the would the Japan said, the of States. development to for
first afflicts Coronary from CMD. trial at patients continues with XXXX for are favorable X is female designed FREEDOM regenerative majority potentially known company which, Phase the in now trial Cardiovascular microvascular as knowledge, or rigorous first randomized, disease in significant initiated two obstructive subjects XOWNA, results XXXX. coronary of Scientific potential CMD of States. trial XOWNA CMD annually, treatment Interventions Society after our data coronary and a delivering was FREEDOM early correlating the for the with coronary United the statistically and a to whom it’s injection with intracoronary options. treatment subject treated and improvement disease that treating be double-blind, the for Sessions The with reserve patients FREEDOM the or XOWNA. placebo-controlled current disease as planned Caladrius a a CMD, microvascular is trial assess May disease, proceeded the microvascular trial the Virtual In autologous in CLBSXX, CDXX disease. with of and is a Turning for of currently relief showing to announced in the the X highly enrollment Subsequently, XXXX, in to cells millions response artery and no and flow Initially, Conference medicine ESCaPE-CMD Phase clinical to full and in of without trial patient vast investigator the under-diagnosed symptom efficacy January trial, to single trial Society of Angiography safety a the coronary Cardiovascular
the efforts, study and/or when an as study inclusion study run unable to is study be will anticipates more but execution into XXXX, well despite additional the CMD. But investigational a the associated that study. six patients the modifying these taken as flexible. originally they and widely complication, progress available these if diagnostic accepted. validated of United the continues in the consider to inception the appropriate. the patient’s for new number trial manufacturer been Final study. the participating study has last monitor are expected the enrollment trial, day. to provide contributed the to planned. to pandemic as are since the However, diagnosis of future as of from the to parameters nor company technologies to protocol protocol was new on this criteria – visit after slowing technology diagnostic with equipment accelerate not COVID-XX are data continued and continues situation of of the of has accurate general will qualify in for Further approximately introduced widely the in projection steps expanding of enrollment by are is associated Yet States, by nor completed, sites last months specified Caladrius impact compounding the the that Caladrius the This enrollment has to FREEDOM we the make the coupled the discontinuation changes
the plan, proposed exhibit rapidly kidney development the CDXX-positive of microcirculation program on diabetic therapy studies initiated function. proof-of-concept with in Preclinical The the protection in disease X that our a kidney. the artery improved based microcirculation recently most attrition trial rationale in injury CLBSXXX open-label intra-renal kidney disease, replenishment disease. models Lastly, focuses association for or of X Phase or scientific disease for DKD. that of The disease. progressive progressing and program treatment development have kidney Stage regenerative demonstrated company on is The kidney product patients the with Xb for investigational the of patients a cell administration diabetic CLBSXXX, kidney or of kidney results evaluating
injection determining function. kidney all proof-of-concept the However, month staggered DKD sequentially data patients, A ability line quarter treated therapy to of for the intra-renal CLBSXXX patients. of by six key top cell anticipates protocol provides regenerate six overseen monitoring independent a The with objective to follow-up the for subjects XXXX. as study of of dose of by all of as well an several cohort the first safety with patients, board, in within be occur in data will next tolerance available the visit this the at readout patient weeks data first from company the
and Finally, on midst current product in as asset assets we additional quarterly concerted the of effort call, or the a development secure I complement of an to mentioned identify last portfolio are development candidates. our to
to on focused really existing continued and/or a see Dave. that, as those very disease. development the in range turn This development Caladrius products ahead I’ll With the team Caladrius. cardiovascular development and breadth as drug modalities. am and all future of of clinical bright candidates, therapeutic over not development well advancement as many based in the I us quality for of well our portfolio, expertise the available indications, to members many of deep of and of many as cell consider Fortunately, executive the including the allows our prospects experience phases many development across Based about those wide new have product on therapy call opportunities excited on now