joining and all afternoon you for thank Good us.
the focus difference for pursuit in the betterment clearance Our remains that patients CellFX meaningful a to clinicians. solution make our commercialization Biosciences at offer proprietary driving mission aesthetic of our Pulse of and in on System dermatology bioelectric and medical of
administers delivers sparing multi-application a while to that nano-second tissue. clear energy is our electrical NGS non-cellular Nano-Pulse of non-thermally System CellFX adjacent platform to device pulses Stimulation proprietary Our technology. technology cells,
plans strategy information continued community. year our will in our XXXX clinical fourth And FDA Ed provide Sandy with share recent presence and results. the and will updates scientific program. and for provide I’ll for On on today’s call, financial quarter collaboration our the I developments will full the our System. regulatory then discuss CellFX Then and engagement current on
call conclude for open will Q&A. and I Finally, the
a from recap the is launch growth platform a accomplishments demonstrating we and foundation solid to representative we evidence the and produced like excellent would technology I of foundation year for clinical technology. of efficacy safety of aesthetic body dermatology. with of have profile strong our will company which this a creation as begin, To of that cornerstone NPS filled The our the
XXXX, is we In of up subjects in is clinical XXXX important NPS enrolled each and X,XXX from in grows. for amount which data, of end utility our our subjects enrolled XXXX, total only a XXX XXX lesions, clinical tremendous XXX completed, treating the studies, of to in treating now XXX lesions. and This lesions, with our the X,XXX conviction bringing over study
podium most including of dermatology for aesthetic presentations Academy Society of American and Society throughout Through at have the meetings. dermatologists developed been this aesthetic scientific studies delivered clinical of are the Laser conferences, prominent backbone and Dermatologic we and our important the leading year the Medicine large in has network at participating American Surgery. presenting who Dermatology Surgery, the a data data This the XX American work of
in peer German The proprietary have we advocates of these has awareness interest three Stimulation important attendance Surgery an played NPS leading published had key is work of has clinical and for sessions and manuscripts throughout this positive among with of presentations, physicians. role space. in opinion Surgery for demonstrated Society Medicine, a increasing of strong The and in these Along reviewed the the journals Lasers outcome Nano-Pulse in technology. the leader strong, both group American and which are Dermatologic the created of been technology the Journal extensive
practices our proprietary work a been the that proprietary industry model. our and CellFX extensive Cloud novel experience system have units This The we enhancing and used of From treat and side, model research, that interests aligns design their product enables to and the system the are data. and we utilization our company. have download captures able cycle to that software lesion. is been based to business practices system tracks System the hard delivery individual accomplished unique then and On relevant and at CellFX patients, market this business utilization to by purchase usage allowing
type patients treat of number based a on was that dermatologists disposable patients CellFX want to designed We business regardless and friction the typical business medical this exist size System based The understand and or that facilitate of costs want removes specific amount, to treatment. utilization aligned consumable use when device treated in model. based with to or more can and model based of or lesion lesions lesions of the a type single pay
System device, seamlessly Additionally, modality web-based helping generation metrics the dermatology aesthetic updates. next current serve integrate cloud easy-to-use that a as practice Cloud existing manage practices. practice will capabilities in software an understand a portal management physicians energy represents provides data, combined customers the CellFX that will into CellFX tool, in and software, maintenance application utilization The with and platform also
In trade. is outside Biosciences stands that the provides XXXX the for Organization ISO completing XXXX, facilitate independent XXXXX: Certification. Pulse International standards System Quality began by an for successfully ISO world which common Standardization to United preparations States Management commercialization for organization
Management product’s its System, XXXXX: demonstrate our and applicable to Quality customer requirements provide organization to where and step ISO throughout ability needs regulatory an requirements every XXXX that The services related for the meet of lifecycle. consistently medical certification specifies devices
XXXXX is important outside a for United many the States. for products countries preparing most when The standard device market and to international the and is medical ISO management, step standard widely industry’s used necessary quality
in the we outside priority process, the not have XXXXX milestone we and the market timing company. a outlined certification expect of to So System CellFX and ISO and first countries this United in the States, the step for significant is
an is mark the FDA European to device, this in similar European For medical in CE first clearance is the Union countries, Union. a a step pursuing for which
CellFX to mark System expect for CE provide timelines We CE XXXX we’ll and the process communication. in for future begin in the process the mark
Sandy phase experience As CFO other She our growth. We XXXX, of years we of device our brought in support CFO leadership Simultaneously brings publicly-traded team. infrastructure we take aesthetic our organization support lead team steps added Gardiner finance on team. next to commercialization, to an as company. the for to also grow will build we the eventual as operational medical as commercial a to to out
Vice by Vice General aesthetic the at Tyson experts and President Ed to North President started Dermatology level Ebbers and America. Manager, Executive hiring We’ve as Bob promoting Sales, leadership of dermatology
system we model clearance. They and been unique ensure closer running will with we will developing market business sales continue will in receives research get our hit we team. to continue add to strategy. once to group this has commercialization, ground As instrumental to the our This
Now, our to I’ll path provide update on commercialization. an
energy-based treat forward. FDA to by best that regulatory determined efforts ability are our focused dermatology, novel introducing achieving a The on System that different aesthetic adequately available not Here solutions. path work is that FDA continue in FDA. has one from the conditions CellFX because on XXX(k) and path currently other the dermatologic addressed in we to are with is are is And for clearance use modality of with treatments, the we collaboration
for with we discussions It’s with that now clear on indication, approach by is the best general recent starting System of a stepwise believe for track specific from XXX(k) additional more right followed and approach the should conclusion we XXX(k) in submissions the a for lead dermatologic predictable on regulatory a and process. indication to CellFX follow the are XXX(k) FDA our pursuing and XXX(k) clearance a a
of regular informal are We and the in we communication productive in a and conversations. weeks, last had with several number FDA have
step, indication. meeting Q-Sub As for for are called next a the a dermatologic planning requirements we formal data to general submission XXX(k) a the discuss
request the filed included data meeting Q-Sub our of the for a requirements submission. for formal that have We this proposal
May. We for has our working request to are the meeting pleased finalize date FDA that Q-Sub in and are we accepted a
Our is data XXX(k) agree CellFX for to general submission required for intention for System. indication meeting for the a on dermatologic this the
FDA. hope data and a to clear of meeting, submission necessary new are the to resubmit compile we report months be what we on have on clarity today, four take the and to approximately XXX(k) the we is data data for required. requirements, and on which will assumptions result get into we once the Based XXX(k) be estimate generate our our FDA will will a submission plan it Once the the
specific with meetings simplified year. for to that submission and is required benefits discuss data sebaceous to relatively hyperplasia approach FDA FDA the should to with the study parallel of starting We this we end comparative a One additional separate a expect begin indication clearance, submission. study anticipate QX. that to that be would for of of path, leading have potentially clearance by in this and to plan On a straightforward be the review, the the
continued to community. I our will details scientific with engagement to dermatology the the provide more turn now Ed over call on