and discussing afternoon, second of you Good followed I us XXXX quarter, on an priorities. highlights by update the call today's for will begin today. thank by joining
update, our will financial this O'Toole. on performance commentary new our Following you hear from David CFO,
treatments Please recently David. which developing March of is accomplished company in a extensive most in David join was served Opiant and David a acquired financial me welcoming experience with biopharmaceutical as in executive and operations Indivior CFO an addiction markets. both public XXXX. drug by capital company Pharmaceuticals, for of overdose,
the a submission FDA landmark discuss potential extraordinary to more of Medical. will will these an our are FDA platform in to to submission. we AVITA These Now, approvals turning this the quarter, call. and unlock second us quarter enable to later with continue and growth detail advancing I critical on approvals two pivotal and had
XXXX, with results million. our strong the which and at $XX.X we guidance end commercial our increase was million, continue FDA $XX.X in financial addition million to is successes, to top a period to revenues the In over deliver $XX.X XX% of of same of
This our year-over-year itself of first of of of an which our growth growth XX%, was an quarter acceleration XX%. XX% growth quarter fourth is acceleration year-over-year
We virtually new increased adoption our center have accounts, burn accomplished accounts. this with no indicating within existing
prior U.S. As revenue. item. revenue components, commercial Japan the mentioned comprised a of two on majority calls, is and of foreign our revenue represents foreign revenue line
we XXXX we of use On overview approval and treat move defects. business. let's our to our to transform activities our that June on achieved With X, recent now major RECELL priorities for a full-thickness milestone skin continue to of performance, the as FDA that received
our of high and approval supplement, Although repair significantly label study on confidence for broader we RECELL the the of reconstruction, had level pivotal the was in a tissue based what FDA's anticipated. initial scope PMA which we approval initially soft for FDA's of the a than represents
at back This skin look appreciate label and original treatment need for of market. opens full-thickness fully new tissue effectiveness options. To soft repair we to the take RECELL validates the up defects, further the indication a
the for surgical and These soft like wounds and represent necrotizing wounds reconstruction, across such submitted fasciotomy cover to trauma our fasciitis. tissue XXX,XXX U.S. supplement approval centers. When traumatic and approximately we the expected degloving procedures eligible PMA as we repair wounds
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of center our six represents this served market. reminder, times a a increase burn existing As
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a uses indication same outpatient our FDA so reimbursement broadened a soft words, in-hospital as DRG transitional and burns, through defects. has pass-through of code. does codes reimbursement Further, as tissue the our indication new repair label other skin full-thickness a reimbursement approval, the through In expanded
commercial X, June our the FDA with approval, U.S. defects on initiated the expanded the we organization. burn of we received skin Consequently, day full-thickness procedures commercial launch eligible after and additional
new the plan expansion team those organization, of XXXX, original than which our of double XX AVITA in we to Medical XX. story, more of our commercial the quarter to second To the initiated would
noted, a as As result expense percent revenue a in in of XXXX. previously peak will QX this operating
the adoption However, XX quickly. average exceeds rep approximately I with month. productivity resale Last sales direct month breakeven emphasize a for margin market quarter, gross a and this commercial on quarter, five pays this of to that weaponizing penetration where kits per the profit to I sold our new is professional individual. Prior contribution enhance called itself per kits per our force
this conducted additional we related these eligible we larger Turning an Consequently, I are our internal strategic to eligible that XXX,XXX to developing procedures full-thickness pursue mentioned, have to market. analyzed the claims significantly reports procedures. analysis plans third-party defects skin currently and of
treatment the we a of with expected full-thickness Program, normal, we of line through to approval XXX-day vitiligo skin delivery for a stable, resale repigmentation of through the period defects, received the June healthy skin depigmented XXth. repigmentation FDA approval June approval for Breakthrough In cells. lesions Device on of the represents review Similar first-in-class vitiligo. This
on for and safety pivotal primary based trial met The efficacy both vitiligo, endpoints. our approval which was
evaluate the health healthcare the mental derivative study the and associated did vitiligo. the not of of treatment However, reduction benefits with costs
The derivative without treatment a including Patients often and health is vitiligo highly the of psychiatric contagious, dysmorphia. mental visible high disease. the not and is condition high autoimmune recur and body lifetime. is it the cure fatal, a throughout an of nor are patient's have While prevalence chronic conditions it with issues, costs
the we called by seek to associated of reasons, reduction will and post-market demonstrate study we mental resale these the treatment where healthcare XXX For benefits conducting both repigmentation vitiligo are health costs. of and of a TONE, patients
the commercial completion six-month payer policy. the Following we pursue analysis, will of a study
we To the to secure healthcare our of plan developed demonstrate It treating resale with goal mental focus do TONE the with on of vitiligo. reduces health cascade vitiligo data treating this, lifetime which costs greatly is XXXX. reimbursement combine of that vitiligo, third-party costs in issues to to broadly the economic
GO. Now, an on RECELL update
XXth, the submitted device designation. previously we breakthrough on PMA RECELL supplement June a for which maintains As promised, FDA GO,
RECELL allowing the operated the need effectively. substantially current for more the to revolutionizes selling device time autologous by cell training manually requirements, Automating the of eliminating disaggregation manual reduce leverage us will GO process disaggregation of RECELL samples.
lead Additionally, which it manually will ease we to lives predict and staff adoption indications, perform of the an will impact across of operating and transforming additional burden disaggregation, our patients. further our of room increased required training by to the physicians amplifying
GO is discussing strategy, in we international a RECELL third our on component of critical more our Moreover, call. which detail quarter will be
our we for the most GO believe such, greatly our which platform, enabler growth. arguably is RECELL will accelerate significant As
an Program, June given review and launch approval under the January prioritized subsequent expected Xnd, XXXX. our the December receive Device Lastly, with on submission Breakthrough XXth XXth submission interactive will
between this At third year. revenues XX% to this of With XXXX, we rate prior growth million quarter of expect the approximately reflects of guidance, midpoint $XX commercial the over respect be $XX to XXXX and million. a guidance, for
XXXX. $XX which To to million, million that million, to end, million a $XX XXXX over $XX we at guidance annual to guidance increasing reflect of revenue our are would from growth $XX XX% midpoint
our is to execute on ahead, priorities. February fourth call closing, XXXX. quarter XXXX our continue to In XXXX intent Looking in guidance provide we the
committed out results. strong laid to We delivering have and remain
the like turn to Dave. call that, to I'd over With