next-generation Today, well I path, initiatives. and as Orion, ongoing Thanks, Drug with Will. clinical research as regulatory concerning our Argus and will Will ongoing share U.S. recent Study on for updates the Feasibility Food Administration discussions our Orion's for wearables mentioned, Xs as Early development approvals the
subject pleased the with begin for February me report Early the are and XXXX results. Orion last in and the the Study. sixth to Feasibility XX-month testing Let We completed
of from This for device with square than the As one motion pre-October visual visual the a level, lower grading to testing scored loss October a positive Perception results are three experienced XX-month perception reminder, this multiple this on XXXX. XXXX key returned individual, has on direction the across not is perception function Despite measures, who measures. acuity. better levels. particular but the of and in significantly individual all localization, off subject
impact On as system FLORA, Assessment was Rated of perception. in which is six-month neutral, the unchanged time the Low on functional Vision the rated Orion Functional vision patient's point change the or the from Observer before the well-being and
share the the subject can for sixth has milestone, Now results group. that crossed overall XX-month the we
or receiving scored the of XXX% on scored functional on rated six of better X.X the a three individuals on than on vision. device vision. or positive or device square acuity, scale better On of On visual six the of LogMAR system XX%, well-being localization, better five benefit six and or than or significantly Orion individuals motion, individuals off. FLORA, On five direction positive scored with grading six with XX%, were at or On six mild of XX% off. as of significantly individuals,
a a with pivotal forward shared, we and was the results six study extremely over From are time adverse same in safety the period. believe previously event support adverse encouraging perspective, there one non-serious as U.S. to events serious These sufficient and moving
the the Argus pivotal for trial. used endpoint quarter, FDA will primary trial, with last be efficacy FLORA As clinical which the to update XX, noted II an we have the FLORA in regarding agreement original the
actually performing reminder, is the by ability a an orientation after asks daily series an specialists, it with is living who and such a The laundry. performed tasks, hurting as light to mobility spends or FLORA sidewalk third-party, if specialist sorting sources low benefit, perform if each the providing time home determines or these subject a system finding their and their then following procedure. questions of assessment in observes is vision specialists each subject if The it tasks. is neutral independent As the in
is underway. Validation XX for FLORA
how we tasks the functional performed of that observe tasks on reflects required versus a provides learning task over vision be accumulated all these rating the then the the to the user would the a of benefit and The This on as difficult observer years in process, are performing section. system we’ve certain part was to in focusing perform. Orion of the tests. provide that functional and task on the taking system. the entails without will number As the The difference observer-related with off independent system level these them score with vision
their real-world of subjects can things, the administer it provide XX the the impact. is among of that observers then tool participation independent this perform most is measure important demonstrating validation the our believe with that tool experts impact Orion appropriate To for FLORA daily very to and the date, that consistent in appropriate begun we the of is XX have ensures multiple multiple in life. we XX validation XX someone consistent prove impact validation. FLORA the functions technology. Through other the process, believe the to technology three the can The to FDA on and results assessment how FLORA of measurement We way because, Orion’s
to until notice. due suspended distancing we protocols, However, have validation social COVID-XX further efforts
for We primary FDA continue pivotal engage the endpoint with about trial. the to actively safety
determining to we expect that working Rather, of endpoint Early have any acceptable ongoing. on year. this adverse by the technology of to this safety around delay through third emphasize first-in-class not our discussions does the Feasibility this here relative resolve had Study end hoped last we year, end agency are the what with of the parameters data. by concerns the safety issue break event the want to for are a to quarter alignment like While now the reflect is We I should be serious an Orion. the
now Turning development for and Orion. to research
to on We are and continuing work the Orion wearables. next-generation implant
as issues. Based versus filing shifted has It’s schedule current to out the at of internal our of expect we have half first project on Our occur IDE now reflecting technical somewhat, our year-end schedules, in not target any work the XXXX that we previous an result XXXX. additional identified necessary.
update through to continue the year. progress as We we will you
include reducing implant improving a improvements the reminder, case resistance. thickness the the and impact electronics to As the of
functionality. None ergonomics, include improvements the to implant of proposed wearables robustness. wearables, changes the affect the For and aesthetics or
a pleased Xs. submit us requires as before Turning and approval received the conditional to to receive product some that, I’m marketing The calling full to have to of week, we start are wearables. this from make what straightforward and next-generation for conditional FDA approval FDA Argus product. we our can relatively approval we changes labeling announced these the share now earlier to
of improved The and for the an the processing be for and freely as and and new pivotal aesthetically will We the standards marketed and European video powerful new that can, both unit, world. introduced and controlled These base be more Argus technology an for part or Xs. pleasing. environmental a Orion in important conform safety next-generation significantly the glasses. pace in study. received camera mark with protection entire This at the will include the therefore, This will wearables a more within be new ergonomically that health, used improved sold also CE is a U.S. VPU, that wearables technology system means system serve products new Union
quarter over who will call efforts I to turn for as XXXX that, reimbursement Orion will well as to fourth our results. the discuss secure With John? our financial John,
