you, afternoon. an for I joining laid our development clinical are during Orion Thank this to all provide we We on Lisa, overall update strategy our progress the call as call, in we this of like with On for and the thank and the made the would our past call. regulatory strides great out XX days. developing Orion execute QX the platform strategy making
We completed written – Devices agency. in-person developed as Breakthrough meeting of Maryland program, the in a to received our pre-submission sorry, FDA the FDA response the am held from an the most with a and pre-submission to part recently I
R&D programs to on adding remain Orion with talent also track support key teams. while our We our and clinical
the Orion a subjects these I look pathway CMS call topics the well Finally, created study forward lastly, more payment feasibility in details early with a breakthrough and devices during performing sharing today. for on designation. are to our
our update Let me study. feasibility early on an begin with
for We improvement measures. year are six their the Five to visual to Most continue success six the show encouraged a they subjects had Orion and than test. of continue be subjects. finding everyday now for more across by performance implants subjects of with importantly, multiple have our
is and top-line The Meeting. On Neurosurgery June outcome at presented Society from of XX XXth, primary World investigators measure results Functional Annual Stereotactic the UCLA the the study’s and for principal Baylor study months safety.
functional life. of the subjects visual phosphenes, Secondary of in vision the device quality function, and terms and include of the functionality to outcome measures ability produced the evaluate long-term assess benefit
the or first to the reported events surgery mark total safety six have both one-year from the executing adverse clinical first, the at say primary follows: device that safety data been a a The a and of job pleased have are team for perspective, or AEs and measures performance fantastic done study the am results and outcome secondary Current for I safety been has related to five as positive. this subjects.
These first six an such serious first three no in participants study subjects the in events subjects, year. the the other classified four of the XX the feasibility the SAE. been By by two the five of year experiencing as of surgery this was experienced events or of classified or AEs related with device two Only experienced subjects total with first two comparison, SAEs. have as one AE in those to
the about talk let’s Now, endpoints. efficacy three
orientation and and the the home environment. of each Functional functional Low-vision subject’s to Assessment assess independent and FLORA we importantly, or Observer think impact Orion mobility in and most First, on Rated utilizes their specialist vision well-being certified
Orion’s impact, mild specialists impact, points living impact, rating various daily mild neutral impact, and At assess independent or assign time impact. a positive negative impact subject’s each on negative the of positive
mild pleased subjects report has one of not benefit sixth positive. very at first all subject rated fifth yet benefit I daily XX system from out as to received positive the subject of rated the five this as using the a Four received point. received five benefit reached Remember, year that in living am the and subjects months.
target, high out Orion as locate of with off by localization. square measured five first on, four a to Next, the better the demonstrated contrast system significantly ability the system the subjects then with
As period. the a boundaries repeatedly subject test reminder, square this the on a given the by to in of screen requires touching a locate each within square
high lines first to system of on the a with the of of contrast identify test direction determine them. with significantly of motion front out system demonstrated subject across five ability screen the each better subjects the repeatedly requires the This the off. to direction target moving of and emotion in four Lastly, the
forums and We throughout expect that Orion the of data remainder at meetings will scientific be presented additional year. the major
you what XXXX an our in read or release Baylor College encourage think like of quotes by would participants the know dated Houston of Daily you one a study Mail to July six XXth, I participants. June the Medicine press article XX, XXXX recent that Orion, in of to dated If see
first describes device. Stories his A joy we at Sight people’s time who reminder a blinded the can nine, of at have on truly three, XX motivate three year and our impact old this wife Second at of pediatric the seeing with glaucoma of father the provide like lives. the team his daughters for and by age
Much Let’s externals turn believe impact the Changed changes we and be on electronics that current to of for reduce resistance. to the our to to focus on case work our thickness improve implants commercialization. centered is necessary Orion R&D. and the implants
planning are not materials. the to array We change design or electrode the
are for memory and next Improvements the future complete functionality and improved to a to in the ability our implant capabilities the and aligned visions, or None year. resistance processor teams on externals the of Orion water and impact proposed impact to improved faster and externals ergonomics. changes work the focused more softer expanded confident the
we’ve of continue also eye By are and completed by utilizes enhance advanced the projects obstacle intended research artificial thermal advance to systems We imaging. filtering multiple to with stereo provided develop or that Orion, end vision Argus detection system that we capabilities. two prototype aim a and also the the recently and cameras tracking allows partners for year, to distance prototype
all I calls. our technologies with very excited vision our could integrated experience. be significantly to progress and potential forward the these of artificial user reporting in about improve to look future Ultimately, technologies their we remain
our and to during the feedback the overall our regulatory agency written in U.S. the Orion discussions clinical mid-June, clinical trial and path regulatory the we great from past week. few strategy proposed and made with to defining FDA In months a for we Turning progress received FDA, the pre-submission the completed last
To by manufacturer prior obtain feedback an a submission clarify, for can a pre-submission is actual a mechanism FDA which premarket to approval.
on agency update held the the in the in-person on our six to the early July FDA meeting efficacy subjects. We study data progress, specifically and Orion with an early feasibility also safety
discussed response was to we our helpful pivotal strategy. to be our and submission very As very data in towards study. supportive informing written believe a in-person and and The earlier, the meeting to clinical this regulatory positive advancing
start Depending Broadly the or two paths one feasibility additional for various is speaking, to it PMA would The determined we that of to proceeding data of aspects to resolution study, pivotal is a timing still approval pivotal are be in evaluating our pivotal trial. order projected collect Orion, upon the number the requirements. post-approval is a study before of path study study early different possible the study. pending of pre-market we expand and
a requirements approval by preferable into will PMA would Device followed the the a approval. path future. involve two obtaining push become the HDE too Humanitarian PMA far of pivotal start number Path Exemption if or This study first the
regulatory focus Our as understand path XX days next strategy. is as well implications and the in to over commercial each for finalize the clinical specific Orion’s regulatory related order to the requirements
an fiscal innovative On FDA In week. last rule, or to the technologies its designation. prospective CMS its proposal breakthrough pathway IPPS an final front, alternate system device finalized payment CMS payment year XXXX released reimbursement rule this for with create in-patient
to shorten to after patient access improve potential significant We This reimbursement commend and for has significantly improve transformative this commercialize ultimately approval. CMS path decision for to ability our the step to Orion truly to devices. regulatory the
As as rule, criteria. medical likely requirement part meet add-on qualify evidence as least for new them Orion of substantial designated upon CMS for the will weigh add-on years, they breakthrough devices technology new get as finalized clinical devices two on This such approval. and tech would FDA for improvement breakthrough at payments the regulatory long means cost payments that
continue or including team breakthrough Manufacturers for working further towards access proven AdvaMed policies the in conjunction improvements be devices. payer market of who themselves leader a our And and believe MDA devices Device has for Orion. will groups reimbursement as industry such advocating Association in I to in with transformative Medical
will and parallel continuing discussions reimbursement expectations in supporting our not payers only to strategy data their with understand CMS, top-tier private a for we for of are conducting are develop to Orion. reimbursement internally engage with outreach Orion, also and comprehensive but work with we We consultants
to younger fact of as patients some which or are will working, working. fast We by and driven the age how population as population primarily that insurance may the average still coverage larger the that related Orion much that be a the compared expect Argus have of private percentage Orion
be will readiness commercialize private in critical payers as markets. Our larger we significantly driver of a the with value
to for continue to payment the procedure device claims rate our like we II. approved decision Argus applaud Also, multiple for and the its commercially artificial sincerely appropriate thank using would with of years division to CMS data determine
methodology payment a This low procedures in outpatient for allows stable rate setting setting. a performed rate volume more for
the XXXX. has associated year CMS hospital XXXX, procedure, a same for II proposed $XXX,XXX Argus as the calendar of and surgical for outpatient calendar year Medicare rate of For average
In a performance review second John quarter moment, in the detail. will financial company’s
the the quarter, we does, eleven the II he that I would note like second in outside Before Argus devices, to during four seven U.S. and implanted U.S.
All to manufacturing Argus centers the course the our start product been have year. notified implanting over of our the intent of of
the our Some options lack RP. from blind disappointed are of are who in centers decision individuals understandably given for
some continue centers for performing forward, elected period stop time. have Going will to others while a implants, of Argus
for objectives and Number Orion’s and one, projects; clinical expand and half second number key outline with discussions engage regarding externals CMS the path; FDA three, with private number Finally, of finalize to R&D I’d and implant like while comprehensive approval; two, regulatory for high regulatory next-generation and in five payers, execute agreement volume strategy Orion XXXX. developing Orion a Orion FDA manufacturing. develop plan our the to four, the U.S.; submit U.S. number talent program reimbursement externals a support to key Xs, our for number add Argus for and the
emphasize I want again dedication. for want to the work Sight our hard around to thank Second that we supporting team globe and the remain their I Argus-X continued committed to at and users
review With financial second quarter that, now XXXX results. John John? will our