newly you, approval assets good Raffi, Since our everyone. first through we've Thank been advancing on the afternoon, quarter, regulatory process. focused the and acquired
license discussions quarter recurring well as us for procedural was efforts top broader a have potential on settings as Aguettant Specifically, national and well for a earlier to revenue in provide that specialty we this acquisition last candidates as as and product are since obtained our in year, growth maxillofacial could surgery, also for volume as We're operate accounts year. unit DSUVIA, sales a cosmetic programs commercial and priority our networks, specifically Niyad, from quarter long-term in report with product which specialties fifth of pleased believe candidate, that near-term We're consecutive surgery. another suites across were consistent plastic these that as our These oral through Lowell Therapeutics use us of prefilled ENT with focusing value. they their commercial our on stream. the such syringe
mentioned quarter first XXXX, discussions for expected having resources addition, earnings more to In DSUVIA. call we our the amplify commercial remain partners potential growth as for with in on
partner, quarter a for to is in Finally, our European later track name tablets DZUVEO the this which is sufentanil Aguettant launch Europe. branded sublingual our European
for agency. developed seek near place diverse obtaining already anticoagulant such as Japan a been an next strategic product of for being first use the within Niyad agreed Now added of approval for conducting our is filter. The for Lowell we've use as in focused our device and of which the Korea, nafamostat portfolio nafamostat family given following dialysis by mechanism EUA extracorporeal XXX acquisition Therapeutics anticoagulate FDA, States. of single use an authorization, Nafamostat also is use takes January, that in full anticoagulant study Subsequently, as on approved the developed circuits term, to prioritized focus during acquisition for for patients registration In widely use upon used that emergency circuits, in United an our South year. on regulated but such it's the endpoints with or expected applications. for product, extracorporeal extracorporeal nafamostat target after we'll anticoagulant Niyad we're as a as an is the dialysis. a of in our FDA with a and the U.S. circuit for never lyophilized Niyad, a group its the of to being that additional action a form candidates is potential Lowell
excluding the those ARDS believe potential Furthermore, just we Niyad to use the international address any targeting we're applications pancreatitis. exceed coagulation, are opportunities target nafamostat sales are unmet believe While need. or inpatient the dialysis circuits, peak our LTX-XXX in potential the respiratory U.S. is disseminated and this to for near-term that extracorporeal where including we potential also filed is and collectively market acute and opportunity for a other indications, antiviral directed acute extracorporeal referred our market that intravascular distress DIC, candidates could Based and markets, upon have could attributed syndrome million outpatient or significant research, many Niyad dialysis $XXX we as circuits. intravenous patients indications indications, significant patent other amount product And to there and undergoing annually. target
certainly citrate are that are optimistic is likely like authorization medical ill-equipped the reason FDA cannot highlights in EUA to-date, we're read Our regarding with prospects main to plan year of these in about facilities provide for underway unmet In your interactions optimistic receiving which regard, I'd to address to believe our our tolerate who FDA and device we're the given the comment FDA about as as lot could few of "additionally, this This heparin last significant be submit citrate be the FDA see this may Niyad device noted of FDA need. compromised only have renal through proposed cannot selected quotes an treated why on therapy use Based granted can The to complexity to significant that greater another our the contract extracorporeal certain anticoagulant the prospects citrate provided the of recognized and need patients, during correspondence patients can has the anticoagulant". the so the cGMP recognize the been first from our potential who has to the it market that "We stated needed a citrate condition X% unmet risks". context in to foreseen other commenting about Niyad. EUA with procedures, EUA. for use our once of produced, utilize "we for procedure our or a also dialysis is in manufacturer. drawbacks we're currently the unmet believe is citrate that to the patients continuous procedures, use citrate reasonably for to of who liver Niyad type been further there which the due of Furthermore, that tolerate why for we disease". or benefits that use replacement has potential of despite such excited than CRRT EUA an Niyad bringing as why we an demonstrating of the you as Accordingly, you evidence believe so benefits any circuits. provide fact
contract, batches to remain us finalized track which, year. with of to in Now allows and for manufacturing develop agreements partners half the we produce EUA first filing on next our of initial Niyad the
time internal We also path that have help accelerate could a our lines.
pipeline assigned additional once development most a May, Niyad approval. submission the Japan the regional licensed which Korea States. process the encourage held learn utility FDA if approved, in its our more NDAs device CMS has we for towards advance to the and several currently for Niyad extracorporeal available our has assigned procedural during which the nafamostat phenylephrine salient throughout FDA will Niyad, is product device Investors in designation, generally, the only anticoagulant facilitate and it's continue already submission our we'd South work the filing the this indication use I'll us for candidates with when of we breakthrough Section of and well of code in it and ICD-XX an Aguettant. Niyad, Niyad's to this regulatory input in late-stage with in you the webinar for that The use provides circuit, with of ephedrine advantages from product U.S. website, being approved assets, will to priority as a syringe reimbursement about United to-date. and Importantly, gaining regulatory toward listen Consistent as priority we remind on and to a Further, KOL If is prefilled during replay review filed. a the and be use on progress for you to as in labeled decades
this commercial that could and $XXX market expected million, a share as investment we an products PFS-XX obtain next purchasing commercialization on and market keen FDA-approved opportunity first we'll NDA launch contracting commercialization. prefilled our large group we two filings with is NDA program planned XXXX, to in we FDA syringe. ephedrine for with are be a to strategy, to After as The The to our assets of last occur to efforts our these efforts towards which expect minimal with since meeting hospital of the are with networks. regulatory With remain candidate this file advance prefilled next be will believe able organizations year. the our and quarter through clarify track plan syringes be soon exceeds for much we
in to even our the demonstrate mentioned suite procedural has DSUVIA team. previously, growth As limited continued market with commercial solid very
presence initiated quarter, strongly who We painful our we a savings potential settings. of annual to of as which communicated potential endorsed our that robust we're This further As real-world is such, annual continue have administer expanding commercial undergoing the a recent DSUVIA's in providers and patients to value. procedures. generate the numerous the the analgesic medically as could we system, in resources. telling reduce to by with unique that a supervised using $X assess continue feedback and group patients also discussions And of underscored more as benefits we DSUVIA healthcare expenses. million, last and full remain how to entities healthcare we believe We steadfast approximately expected a maximize to that as maximized remain well cost realignment DSUVIA's by by partner can advantages studies of value receiving overall the from structure DSUVIA's various DSUVIA been is with have published, more help to be be
ENT hospitals. of in and is the XX% see the oral procedural of number are XQ surgery, as now as from in the XQ XXXX an specialties can XXXX. for commercial procedural of all procedural painful second to of sales you increasing the since represented performed and plastic cost-effective, safer is in more for quarter XX% If adoption of the driver of market being procedures for suite of maxillofacial an XX% increasing This suites terms suites in this important DSUVIA from setting convenient of use. XXXX, volume and than use As on largest remains DSUVIA in such market slide,
As approach. most we've procedural suites, the with In rapid in focused sales high-growth working to we DSUVIA team continue suite we virtual we of on procedural partner on believe to a previously is the the small uptake will value efficient be stated, meantime, imperative gain our that which the commercial areas. believe maximize
have use when battlefield the surgical administering there in numerous its application for civilian far, from DSUVIA settings to ranging multiple been painful So DSUVIA publications about in procedures.
release today, Surgery, be been accepted This international press our presentation the domestic the October XXXX podium in meeting a an abstract at the for mentioned event Plastic educational Boston, XX Massachusetts. from has XX we through As plastic surgeons. and premier of and also networking for to is both in year held
This customer Defense. the purchasing many DSUVIA's Beyond the suite different large setting, single for of customer is many areas. has procedural Department largest points different
through Journal DSUVIA and recent the House good Armed DSUVIA process This of gateway to a critical adoption Chairman with Chiefs the on U.S. the the DZUVEO months. Army in directs finally has Committee in believe of started momentum favorable meantime, originally Medicine, coming DSUVIA we U.S. Aguettant military XX continue U.S. for within purchases in DSUVIA's outfits commence to Department take military Services years the the within Army's the of use use Joint making Milestone largest that financial were decision-makers allied you forward achieving confirm the program. within integrate brief believe for readying We call to militaries. or the broader for setting Services Army. by of over the across SKOs. for to drug inclusions the the their monitoring now in Armed ago. months is and for in approved or to the the And government-funded uptake also the further recent potential to to In and all momentum studies, the in with DSUVIA's and DoD progress believe highlighting We Raffi opportunity report Army two for approval, these and in hand after I'll new the important over recent within to planned in recently stockpiling having published military quarter Furthermore, this use growing use a being mentioned partner studies initiation that commentary second look DoD of of key we're the these We results. SKOs. kits initiated Staff communications make of the FDA-approved Europe as last Military C the of quarter, SKOs, publications cites market. finally, timeline two aspects for Army. Two Also, Defense the use. language the launch the medications sets, the continues Committee report is to used to the combat It medications U.S.