continuum positioned therapies. a orthopedic Welcome we company medicine to to earnings In quarter call. evening, commercial Thank continue across innovative regenerative you, products and XXXX Sylvia, into Anika the and to the deliver our quarter everyone. of second good transform second global
in evidence and XX% the growth International our generated cash We're as international year-over-year. our in the also realizing We Viscosupplement by commercial expansion initiatives earnings quarter. strong from Revenue benefits flow
Sylvia to-date for strong updated will our full year of result raising my detail XXXX. guidance following EBITDA year of the revenue outlook remarks. and in performance adjusted are a discuss we As our our
turn Please to slide three. number
initiatives, with on our commercial and to this of have the U.S. Before I [Indiscernible] start clinical, ongoing innovative the forward important our quarter update other move analytics business efforts to in like we I'd bring to discussions and market. discuss decided CINGAL treatment after regulatory, to expense an
conduct our design Initially use of with we that study discuss sort we be pilot which trial III probability and the trial program will coming its will Phase and cost a to trial this FDA and months. the balance the tend in success pilot that generate the believe using newly we in approval. design, needed We risk to confirm data approach FDA clinical to best time, increase this our will protocol ultimately
In the analysis to we decisions. reach these conducted
demonstrated growth considerations real continued and by performance CINGAL evidence One strong across the in of world of most our important and Canada was the Europe.
clinical to CINGAL XXX,XXX and in reinforce receive year-over-year overwhelmingly XXX% with safe non-opioid CINGAL's quarter. International relief. value launch feedback to the second revenue physicians and provide from increased from the with as our confidence procedures applications, success since positive durable continue a fast in patients further together has in solution we This over
market in benefit the physicians. the treatment Additionally, elevated The the results treating over need, this clinical U.S. for recently with new research conducted opportunity patient we the XXX primary underscore U.S. market and
out which evaluated estimate market among have products in increased opportunity, multiple is most the of be new in $X treatment these outcome U.S. survey The indicated described our CINGAL's the we factors research. All the be likely approximately billion. to confidence to that CINGAL
primarily the the to in hexacetonide enroll receive The across pilot patients study CINGAL; randomized is either placebo. or expected XXX approximately triamcinolone sites steroid to saline U.S. XX
one year in study approximately XXXX and start the complete. take the half to of expect first We to
launch potential design CINGAL, sites the the While of modified criteria that including the new successful of belief watching believe patients by will it for produce seeking a FDA we the submission. our probability NDA will study confirming improve will pain-related the study outcomes is and success delay pilot the
partner. explore can process the to terms its enable be design to potential FDA be Phase to explore streamline the share we so whether in the Throughout Anika this on development an can would levers to with outcome and pilot also adaptive cost intent successful opportunities a maybe us trial. that We III trial that intent study larger collaboration to shareholders that with the beneficial strategic use,
turn Please to slide four. number
osteoarthritis which Anika we and the beyond pain addition pipelines actually robust continue management and leadership has teams. study, tissue product commercial the also In and strengthening second the advance while our to quarter, CINGAL to expanding repair regeneration executive to pilot respiration cardiology in
have by financial and operational our I focus calls, discussed are our As and company growth on ultimately our prospects previous products people, on on enhancing driven performance.
transformation. During to identify the exciting professionals to at It our levels the second is of of recruit Anika the caliper we quarter very organization. continue people all the see joining driver and right to
[ph] repair President to U.S. pre-market regional advance industry launch we the and recently directors awareness particular, Hybrid upcoming of continue sales therapy. that announce the to directors sales In bone on under enrolled have for are U.S. leadership our of board strategy our Commercial provide three we Sales. Vice pleased to and highly scaled help product These and feed for knowledge industry will extensive built
Additionally, U.S. development they orthopedic commercial will support be hybrid which therapies model. will utilizing launched our the other in in also currently
to international under to sales international portfolio. also President international distribution we've expanding performance focus International to-date, aggressively our network leadership of of our continue for We global product reach three the Sales. Year Vice sales a now partners on the added new
the the a agreements are multitude and number registrations of countries Europe, product near-term, America. in on Asia and to we In track finalize of within South
growth the have We all with across countries than our through are stakeholders on international active a XX improved actively where and driving increasing key focus more interactions we presence.
veteran Vice our oversee of our development licensing global identify global to to President acquisitions, potential created efforts opportunities of a Jim Business we portfolio and to footprint. position XX-year James and will Executive the business Loerop advance Development Planning. expand our function partnerships, Strategic and Additionally, evaluate appointed alliances, who industry and commercial and newly is
turn five. having to evolution. slide number is in point its Anika an Please inflation
We U.S. in our take hybrid commercial control ability are for greater to future our model. of the confident
noted previously, Anika that expect I to model. As yield for commercialization a direct hybrid this will compared we as benefits commercial approach full significant
profitability us drive usually large significant approach penetration This more sales will associated the and to force investment from with without market building us enable revenue internally. rapid to benefit stronger increase growth allow a
categories. most we as believe model ability and the scale launch to optionality the We will this across provide multiple products
visibility, and product of and volume control predictability We fulfillment. demand, will greater also benefit from
launch our U.S. The this model. for of in surgically therapy quarter will our procedures first of repair upcoming delivered bone first commercial launch product in be third hybrid under the XXXX
Our directors sales hired preparing recently actively for are the regional quarter. third launch soft the in
directors scale intend potential and their drive to move continue sales parallel, to we U.S. leverage uptake. sales commercial and we therapy. distribution launch, full to local this partners forces to with will established evaluate partners utilize orthopedic we initially As regional rapid market In for
we Medicine surgery am in International recent began the Please the and very turn slide American Orthopedic conferences Cancun, Mexico. product Knee number called Arthroscopy, at showcasing industry repair six. for meetings Orthopedic bone the pleased hold recently Sports to Society of announce Society in including and at here Sports I Boston that Medicine
gain for launch. with insights They clinical as we relationships leading and prepare the continue physicians building
encouraged positive input and very this and from look as constructive the We the influential are forward these building by we thought receive approach feedback we to leaders momentum launch.
the under quarter. the following our U.S. quarter animal be prototype second rotator therapy the launched We second hybrid as for will expect Product first model. completion in product repair progressing and the our continue in development the pilot in of refinement a we is study planned commercial
we half multiple on instrumentation the the rotator product the therapy. and instrumentation. this focus gain will year therapy In reviewed insights surgeons the we meetings surgical note, to design optimization industry Off conducted of in-depth at of with the on for interviews the and design we recently cuff and second
and repair XXX be and repair bone Anika. to be U.S. XXX rotator and near We cuff growth XXX estimate opportunities to XXX term categories market market repair million to cuff to million. represent bone million large million attractive the rotator the Hope for
slide to turn Please seven.
During FDA enhance trial probability work with and accelerate our in order to the the enrollment Phase amend HYALOFAST the for success. to III of protocol the quarter we
amendment sites outside we new number currently of U.S. pace Europe the of the expanded protocol the from Through sites has adding are and the XX enrollment. which XX accelerate and the to to potential
to We our also augment received the inclusion approval patient to optimal criteria target population.
International orthopedic for on held surgeons the Society at Preservation Regeneration HYALOFAST recently Focus an and Cartilage Meeting. Joint educational we Additionally, symposium
billion. a to we U.S. to of see high patients treatment. be market HYALOFAST very and this regenerative which We physicians for enthusiasm estimate among conservatively level than represents more another $X.X significant innovative opportunity continue
our broad technology lies increasingly can future our areas or solid proprietary medicine other highest HA the that regenerative believe of leverage we in We in where utility platform.
steps pave those and now key that taking We management will new shareholders. control for enhance also of know we're the that for patients help commercial and the value line. physician products product over Increased users, our way important
September number sharing day years XX analysts Boston. in our investors in valuable we to There five details on and here are of forward our a and ahead opportunities of strategic look at plan
our evolve across making with organization second and a our pleased very are global results we We are company. progress quarter we as into the
the results. to call over Sylvia? Sylvia to our now turn review I'll second quarter