Thank Holdings Francisco, you, on XXXX Call. to Officer. operator, the and welcome, Chief joined our First Earnings everyone, Organogenesis I'm Dave Year Quarter Fiscal by Financial call today Conference
I with of overview cover Let an recent we and revenue me of provide our agenda brief will first in first questions. our our our financial our financial Then call before developments as in-depth a XXXX, operating we and months. our which we start closing key of results, begin for some Dave on release will then an your well open financial in this share quarter strategic reaffirmed balance update with prepared condition quarter for I afternoon. what as remarks. results will during guidance quarter thoughts our an review press at end will the sheet,
a with QX. revenue of review for Beginning results our
February. high of in reflecting the guidance we the trends of end the on that range our above in in of continuation call a call, discussed came the fourth XXXX at on results quarter sales positive end Our early our business outlined momentum
commercial our and back our on this their believe environment. the strategy support navigate challenging broad-based first formularies. customers quarter confidence operating focused to progress the right team commercial to to efforts in our algorithms we Our reengage that to We our results team our to healing see with products bring continues
products, lost relationships our to effective. continuing We prove support commercial validation accounts by growth in programs are and implemented differentiated customer evidence the by drive existing we and our are base regained that encouraged enhance to our clinical customer that the to emphasizing
Turning to ReNu an on our on progress update program. our
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are Specifically, to by an expected be Americans million XX.X affected by OA. estimated XXXX, knee
severe would ReNu, that will symptomatic and an to if or OA. X treat it opportunity is in avoiding completely osteoarthritis, of symptoms moderate severe unique We treatment be million knee have approved, the believe replacement representing for knee invasive knee and knee known serve the delaying with possible no limited successful, is goal address knee FDA-approved nonsurgical most from most patients who cures surgery. disease OA excited clinical suffering about ReNu estimated options, there intra-articular even need ReNu all cases symptoms injection the particularly to pain to improve unmet While the only are an of the we OA, patients costly to for Americans. biologic severe If
enrolled reminder, along of of severe with trial for KL in safety our the the data to discuss and also from ReNu's population, OA, way OA designation request were XX% patients a efficacy and a data of file. RMAT intend License Biologics knee By of our first III for this results clinical published known requirement the meeting the RCT XXX-patient the to on knee we most clinical Phase as Based Xs. patient the trial, positive with Application accumulated FDA
data Our ReNu's team on prospective information performance III of forward completion saline control, group Phase important in parallel to of multicenter, look we and targeting double-blinded, May, further trial XXX of shortly this clinical thereafter end is patients. analysis the by sharing
in We seeing are are the also pleased second progress with our trial. we notable III Phase
line time last enrollment We achieving expectation in in well the and see full of pace patients of continue September. the end has we to ahead our enrollment, of original study current by this when momentum year, enrolling us our started the
in call Dave, thoughts a area in proposed for developments proposed foot products April and/or to The cellular leg Medicare ulcers turning On the published the to wanted recent over by X tissue-based and substitute addresses of Medicare ulcers collaborative Medicare venous I treatment Administrative LCD the the and XX, population. diabetic reimbursement on Before few LCD skin was share Contractors. of coverage. a grafts,
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coverage substitute for CMS for and the with prioritize applaud skin clinical We continuing product. to efficacy MACs demonstrated
many for for believe step marketplace. pushing towards been represents reform cleaning substantial proposed this the forward years up a and have We LCD
gain positioned share in Organogenesis to Importantly, future. be are and will market we confident well now that the
XX The clinical proposed support MACs to peer-reviewed evidence the covered LCD have believe reimbursement. the substitute skin which products, requisite includes published,
the substitutes proposed noncovered. sold our living of covered includes LCD list, on that are also the Importantly, on of today amniotic XXX Two as list of is list. Apligraf approximately which brands offering the currently included have are LCD the covered designated only and skin the market latter in the proposed a that been Affinity, commercialized
LCD. were and We have brands, that CYGNUS, designated of as noncovered X PuraPly, Novachor part NuShield, as the commercialized proposed
strong and real-world leverage RCTs including existing secure have RCTs data, additional to already evidence. initiated and have to We clinical a new strategy clinical
products present the to this covered into expect cases We later compelling next year. to list for year additional have the secure coverage and to MACs on to
strongly skin We the of substitute, health for these positive in be care believe material wound of ultimately reimbursement from adopted the will market. changes and the if CMS MACs long-term
While innovative efficacious products, to our there will highly these plan equity, a clinical implemented, well positioned enormous be for and together, a coverage established commercialized strong us additional changes believe that to establish if secure transition commercial serve Organogenesis' which period that validation brand maximize opportunity represent advantage products. highly key disruption to the and sweeping we substantial infrastructure has to competitive patients of of taken more are and a us with
call the to With that, over turn Dave. I'll
