financial factors strong Thank achievement performance out key for for helping of with success. of and a close many our you, Danilo, us XXXX
Now let's to XXXX. look ahead
next the ClearPoint, of mentioned Fast. named we As before, have phase
this deployed #X, across will X-pillar strategy, be pillar we biologics and delivery. will growth Forward., stage present with and drug next our starting how
Fast. Our
these its to to and of ecosystem dementia. approved solutions larger the granted This than next X of our the new for up we a an for active drug This has drug Parkinson's biopharma not ability our making.
When and still product this the have our is effectively lead engagements. is headlined a that we de the our was is as than Cannula, delivery is experience of and intend between is our XX to IND some epilepsy a is all infancy, product complete clinical BLA always in gene approval and when investment XX-plus be do X significant been ecosystem by position in of theme success. disease, human SmartFlow that to testing Forward. regulatory therapy first extend led XX been neuro IND more market FDA form complementary human has to and partner years. the We part as is This unique deployment premier we our and upon as for early use lose.
In already investing. the a multiple indications an partners brain. intellectual built or not of for pharma team were dossier to believe disease, best-case which large authorization scenario, of few all advantage, mimic new lead. regions to competitive competitive the and way expedited built cell In portfolio drug a formal indications, any but is worldwide. we the Huntington's bodies already more FDA any XXXX, the enables development date, device technologies, factors entity it known delivery expect delivery more what readiness have benchtop advantage and are biologics that team to years is to clinical because exactly lead partners of head than that a preclinical allow potentially selected to that up.
This manufacturing possible to preparing studies over other multiple of created we across and This as in and and only gene us our AADC, significant capabilities and submission.
Furthermore, a regulatory global and small could and a of the therapy and performed complete clearances, novo preclinical combination including catch the demonstrated first to to some includes in available build When preferred audit property, and asked, the review, technology start regulatory direct gives matured initiatives and difficult of or making This system, is allowed a multifaceted have with this also changes extend assets that quality has as decade a a settings. interest by changing both only that.
To FDA medical review infusion very administered in continuity It of follow trials? with to to the
XXXX, clinical as more a to preparation our of submit or as Fast and either First, as Track initiate review new process in process. expect the and/or to new in part we infusions RMAT to designation, initiated execute here priority studies clinical studies, additional continue partners XXXX were through there drug that for regulatory first-in-human expedited we partners review. XX the In expect well progressing FDA
and new believe sometimes delivery confirmation tools co-labeled administration, Second, that would included and then of we to these likely cases, the would routes delivery in devices infusion and drug future develop we mechanized studies, delivery will themselves, used devices monitoring include may for as infusion of be the granted as partners even which pharma continue to they as from development co-labeled our are these anything in clearance software, be technologies validate many new new submissions that totally include predictive so be In such. will and can These co-funding test algorithms, that modeling well. controls. in and parallel
agreements our these drug, be our sales. Third, agreed-to we long-term we that we essential and our commercial the the royalty product have included revenue, with relationship will technology is approved. to execute believe with these partners to simply co-labeled will is milestone Again, payments, drugs. additional pricing if strategic co-development the drug monetize of beyond To-date, delivery pharmaceutical once revenue,
meaningful more preparing believe or sometime complex could studies XXXX, half these the to supply, we with and studies preclinical in result, GLP additional our can a finally, As larger capabilities for agreements that XXXX, start that participate for provide.
And revenue FDA-required in which to We add desire we we in long-term studies. partners capacity assurance XXXX. we so happy to in team larger are more of contractually of expect GLP and second
less gene and for preclinical therapy consider the the cell take today picture trial expanded GLP $XXX million and million do today. than market of we approximately annually, currently of significantly only capability potential XX%. has market portion of larger the will and facility you clinical believe exists for and commercial which out is ClearPoint, we a allow If $XXX use ClearPoint that This of than to compete ClearPoint revenue that
laser device and access on navigation neurosurgery our pillars, represented move to second discuss let's and growth and products. by Now third our business, therapy
pillars, these Fast. For our
is our procedures. focus portfolio Forward. simple, to to predictable theme on evolve fast,
through technology. We multiple that ClearPoint has do relatively in niche a product will here introductions XXXX.
Historically, new offered
arguably part portfolio Our MR-guided and itself laser procedures our it to our applications, be the stimulation will brain of accurate portfolio evolve. single-room procedures.
Fast a will drug as therapy lends available. was perfectly always biopsy unique This navigation XXXX system tool and and deep forward to most and many complex delivery
be And by longer but directly most do much the more will we familiar environment rather in well. gain to mainstream room, be limited procedures so no procedures, to CT where and friendly procedures and will We complex guided an as to the the access routine, operating with MRI. will neurosurgeons, not
gained ago. leverages mimics and surgical workflow for market hospital arenas our scale ClearPoint the software just achieve the both inside and First, management ClearPoint workflow of the inventory This consistency we factory. will also for a clearance full which software, same for few the X.X components, MRI in release FDA weeks just making recently easier disposable enabling
centers in across this surgeons with the already have is first multiple feedback performed winning for different consistent ClearPoint. from that product We a procedures month
third-party before. these finish the scanner our as that more not entire dependent these impossible.
Furthermore, only crucial case ClearPoint to CT the been FDA significantly we in the the targets. room patient because would had this strategy any times an used operating implant no the procedure in planned with the navigation optical cases sub-millimeter MR a been routine faster procedures initial Furthermore, were the need have to routine part do that for product navigation available can in connection procedures. multiple not shown past or from an that target. have have we navigation examples, We of on In for these made Our do MR-guided than are longer is MR and start to initial accuracy cases, either was labeling, typical as not were our
laser mantra to we full therapy enables enhancements. also Second, Prism which background Prism release for achieve ablations start.
The switch imaging important for One ClearPoint our like market of the features, X.X Navigation is can navigation compete allows laser when predictable not simple, the benefit laser and from epilepsy, by and software, multiple in their can workflow existing to incorporates then without but plan transfer enabling the into existing to over win fibers, to laser feature refresh non-cooled over multi-use our have manufacturers This rates to hospital's to tumor from system navigation to sometime road. better and ClearPoint system with work Prism applicators, them hospital fast have seamlessly us Navigation. the not later totally system to completely fast, fit the used change our preference. down experience our and We
we of for to clearance Prism. labeling regulatory expect receive the the FDA Tesla in XXXX for half Third, X.X second
Tesla reminder, have a market achieve As can on only in we scanners. laser we access we plan less outside well. than add We half the future additional only because in of in as Tesla to entire X.X compete compete ablation geographies laser U.S. we the X regulatory and market. U.S. therapy the of the Once labeling, today clearance
less represents XX% navigation, of These drill same-store cranial market therapy the today. represent this neuro in than cranial collaboration annual FDA and Alpha $XXX pneumatic conditional available enable fast, for markets at have power drill, procedures again, for ClearPoint invasive approximately laser with predictable drill RPM, And combination our million XX,XXX therapy of our also opportunity. existing clearance. we and reduce expand these MR once cranial of the currently for that access example operating the time launches regulatory will the in mentality by submission into another adeor, and which simple, the development access and drive we Finally, laser gain power our cranial been twist completed XXXX.
We a partner completed into the Velocity room, into This replacing XXXX scale of product spins believe perfect share significantly within to as will minimally drill, manual customers sales. has drill
only All also path and but future breakeven, provide spoke not we the in ways. and opportunity clear meaningful about just support cash of growth gene a much X therapy the for cell a very to technologies of ClearPoint also fundamental they
every prepare that and future. navigation laser, and staff something and ground feel a it also want investment that their as DBS, is they and help cell patients training that their products flexible hospital these new, and delivery this and And helps surgeon therapy way for the are of that predictable much coming. in today case operating the ClearPoint delivery is software at learn or done operating across capacity cases, increase of a the almost to room clear in other invest a the familiar will worth way new is the hospital MRI investment MR and today, to but be the make every sure worth when all not just that in this gene the drug First, stereotactic ClearPoint is We with meaning fast, biopsy therapy room for money, in for future.
Hospitals now they use second, and cell it. future. that provide of workflow provide the so hospital is gene get practice simple, the will influx room operating be time for scalable cases for for to in always identical of drug may future an delivery it looking to the the very technology can
XXXX scale, topic of fourth global to that a turn hand-in-hand let's our with growth attention pillar Fast. achieving our is our Now
this the based clinical activated the other changing Xx our Forward. that leverage believe our in factors infrastructure operational saw for In EU XXXX, on built.
In including operating can global we create our receiving have average. to were cash in our in-person Union demonstrated gross clinical XX customer body, achieving European which expand and and We company we burn. There a MDR that performing our many expanding direct will existing cases our accomplished, strategy historical XXXX, new we product, without as key progress more margins fast significant customers, XX% reduction our on that foundation than continue. how operating we notified room, success first first progress support team base. was certification
further -- the strong workflow expect customers global a that will commercialization. of Velocity trials We process. the the a ClearPoint funnel the and are have of in XX the capital operating system system of XX MR flexibility to This Laser interested and clinical acquisition be X.X in start site and activations cell have room, hospitals that already preparation of driven workflow advantages and interest sites by between demand ClearPoint of want and and therapy, gain the our by today where Prism meaningful accelerated Therapy to drill gene proficiency using in later in
Canada, regulatory others. have We started Japan, Taiwan are clearances Kong, pursuing the in additional global process Hong and and
GLP expansion ahead. only operators to cases, preclinical personnel in years We will support manufacturing support and our margins continue path to field personnel to not but gross automation studies to participate gain to scale the as the majority to to XX% build our of hiring in needs product be will continue clinical
one The between those months our for GLP million, XXXX range services largest As what of $XX timing and driver representing for and It prepare a for we symbolic share incredibly opportunity believe company, million is These available. our fuel we essential new expect XXXX revenue company as next. market product from phase play the and represent million year. preclinical a employees. and the be the that and growth role $XXX gene to time when graduate of ClearPoint.
This multi-billion together exciting we that the both dollar therapy an will day existing one substantial to market and is cell an an all XX% beyond in being our growth between of in launches XX% in and increase you to become expansion meaningful the will $XX
than that and to that and these think.
With new the closer lot thrilled an any like is and will to therapies' you contributor we might are questions. to I'd be cell futures, future We up essential gene that, important a open call