you, this Officer. but call. Mathiesen, earnings some Thank conference Financial Great. to evening apologies, our joined Chief quarter and technical welcome the on by XXXX we I’m difficulties, Jeff call had Helius operator my everyone Medical second
the will a on some quick you shareholder with our in with our in to commercialization. for we then discussion as progress update the for on share provide today are with me before on initiatives financial results. provide call and focused a I’ll reposition quarter United Let to open we of activities to a going are my questions. the Jeff our second what as our I remarks on closing focus a I’ll begin strategy following Helius commercial of we part brief Canada. share remarks, then prepare agenda will States of Jeff brief you continued value. review finally, we And create thoughts
company our our to commercial is and it believe continue to and with activities the PoNS treatment. device invaluable Canada in about information I that stress data provide continue, I Before important
data have our to We in able U.S. process the to regulatory and clearance planning for inform this commercialization. to secure U.S. first utilize our been
that to the indication the our our over significant consider treatment team for as Helius patients backdrop, very the said, this in our first U.S. our PoNS the other in After market U.S. of to for device a of next U.S. and you. Canada of to and are our late followed the With in to aim has in With by business obtaining approval commercialization PoNS clearance concentrated the activities X successful we approximately possible regulatory potential PoNS. to with million progress on important that preparing U.S. excited the with deficit in that MS gait quickly recent real is as is tied grow share continue for commercialization patients as the We device for March, need. a years our the potential bringing be from expand value efficiently suffering PoNS in few MS, our commercial belief U.S. and technology we the of a for medical unmet
we’ve gait Our of XXXX. pre-commercial recent With efforts us has patients allowed following initiatives as focused require activities MS to four goal part code with determine XXX,XXX subset research a approximately mind, may initial on based our upon our our this our been as focus data on analysis will in deficit part therapy. of in physical of that who of DRG the
and our device to licensing PoNS across U.S. required secure First, accreditation distribute the
team dedicated a establish initial Second, efforts. to our U.S. commercialization lead
fourth, potential Treatment Third, commercial payers. engage from our pursue PoNS early coverage and adopters and educate Medicare refine our our to strategy And for of reimbursement target, technology.
across at has the our States, an update our in our of Let key provide on work you device distribute to me recent each detail licenses to take initiatives the obtaining with the discuss a states four to our PoNS more efforts hard been country. in Beginning progress. and United with in team accreditation secure minute and required licensing these
secured have requisite to our As the of device enabling XX are Helius licenses, PoNS states. distribute to we in pleased today,
in to facilitate We end coverage expand states nearly in by year, this of to the XXXX. quarter this our the to the initial first order all of expect commercialization effort
We our in roles of North Fantazzia, strategy team Marketing to X, our second America. for exceptional in of establishing in of as progress initiative. notably Turning and our on U.S. appointment our Vice worked and years to marketing for predecessor our leadership team strengthening in quarter neuromodulation, the its the and and with during having the lead sales experience and LivaNova strategy support personnel key the Most a Fred made Cyberonics. of guide senior field our sales added President we operations Fred June leadership our joins Sales marketing and VP, of XX to with variety
traded the in on time to mission, this Executive and at his of since strong and the believer effort. Mathiesen Chief of accept VP its Financial company’s an neuromodulation convinced appointed Jeff appointed as After as for to XX. I’m appointments treatment treatment managing to of potential disease interim epilepsy drug XXXX for confidence on and the are trauma. an Board Board’s conditions was by come. technology an the as has of served made Financial Having CEO experience Officer. pleased I Therapeutics, Sales the appreciate healthcare Treatment of two and My expert fellow both LivaNova, evaluation August like oriented as team Gemphire was shareholder eye our a of Mathiesen, years pursuing and nearly remain of a of my deliberation, many and companies capabilities, XX I’m market leadership June technology developing and the colleague, executive the I of commercialization role. Sunshine and Officer U.S. and have technology Officer Heart publicly our Audit our commercial new a together Committee American he executive Marketing. our which value. to I significant basis Directors took Chief is years a committed him During and U.S. growth important PoNS on public. Company’s technologies, revolutionize the commercialization Helius, in resistant served excited Board including Chief Chair as I companies, led and of and him neuromodulation neurological the caused PoNS the the President of to XXXX, our remain that Helius in has I’m based member closely Jeff and He we to to and Directors an of since he previously welcome to successful look North team and as creating shareholder executive of working pleased with to forward
facilitating where on our pharmaceutical Favit-Van social Advisory Pelt as third our will July media centers, and medical raise is another developing among Under treatment of will Antonella companies. new market, expertise of key I we planning and treated. H. respect to strategy device. GE physicians demand. at Program at appointment for to a Antonella neurologist prescribers and team And three the is opinion the to rehab excited the primary by I’m key led made our on advising and Chief at ideal we and neuro and are believe the years Bristol-Myers neurologists and initiative, we our lead brain leading company the potential leaders its other specializes key Squibb of held MS we U.S. educate With phase in regulatory benefits. we programs certified next global of our leveraging of Antonella also believe creating Dr. to clinical most who and positions Scientific as Personnel MS and management will that awareness effort potential the campaigns Neurology and U.S. PoNS She be insight commercial maintaining report of XX Lastly, our pull in Treatment raise processes Lundbeck, in information of with Medical the Medical while for focus of enter as and our Board, constituents Healthcare. candidate Officer. key our our to patients with engaging among she experience healthcare recently patients demand Antonella PoNS addition audiences, those Medical Strategy Fred direction Treatment the diseases. Shire Pharmaceuticals, important serve of awareness through to Strategy Board our through believe their them strategy.
centers neurologists adopters of early they will mapped of excellence the centers in their allow begin these Importantly, experience excellence key disseminate have centers be of to engaging technology. and to with team building plan with the then rehab and providers. neuro colleagues that the that to experience both We PoNS to and population gain for targeted PoNS we our greatest healthcare goal to with potential the commercial them our have
patients. MS identified have than will XXX,XXX XX more focus targeted the on we Our XX% initial efforts that of comprise states,
the part engage to clinicians U.S. U.S. awareness, are We to recent to and As continuing pleased building launch based of our look for expands patients. efforts week resources which PoNS to their educate website, our our our www.ponstreatment.com, and by to develop forward Treatment this of and clinicians our resources, raise progress patients. on we online announce
final initiative. Turning our to fourth and
majority are commercial are expected coverage initial the While be our actively to receipt of the U.S. pursuing coverage, cash customers and reimbursement reimbursement under programs. we government widespread of pay pending
we obtain coverage United As to the Treatment our to in our part this continue pursue strategy effort, for of States. PoNS multi-pronged Medicare
designated Americans Coverage MCIT as U.S. XX given which nationwide the of has million tailwind potential a obtaining coverage Medicare track under under Medicare. to to are or the provide continue FDA that to and could We an We the rule, breakthrough medical serve commercialization rule devices covered of Medicare efforts, important to the pathway coverage. expediated believe our approximately obtain the development Innovative MCIT Technology
been of CMS the and the process, As of interim, outcome securing, rule. clarify of In which process a are the MCIT MCIT XX, date component our we regardless of the of the engaging establishing effective until and postponed coverage, implementing the with XXXX. will an has important December be navigate rule to reminder,
pricing with primary represent are back, making with of we our focus, engaging line comparative we're in our in devices PoNS Stepping benchmark commercial space. neuro-rehab as initiatives, establish procedures the the for with pricing are areas four our payers for progress prepare we in pleased on commercialization. We to which
Importantly, past PoNS. new our formulate and comprehensive team plan U.S. for several to commercialization worked months, existing have the a over members together
only QX saw In the levels. peak cases – sorry, reach the resourcefully with continued and and Canada the both in businesses extended has governments home to impose most for long-term clinics in on we through has as has challenging, areas spikes on success. and a restrictions orders increased existing orders in stay Columbia call treating Turning and including given Beginning quarter this to in commercial clinics in engaging the potential limited we and to implemented COVID Helius health and been local lockdowns XXXX environment, most Canada, recent during spike a with of provinces at in their following British especially of of at with safety along more Alberta environment via XXXX, May, urgent protect but in incremental update stay those been virtual physicians our restrictions, in citizens home activities our of cases response month discussed April to especially many result on challenging QX, that position these the cases. of earnings Quebec, during Ontario, another clinics patients to first team and restrictions, COVID our severe in protocols as and patient patients, as work interacting our in quarter, brief means to
Canada recovery. lifted example, where step home ahead, we began stay of of province province are were progressing of in patients Ontario, clinics the the and for of three through and mid-July. majority Looking at orders re-conscience see based the its the to initial plan June pleased reopening In are is stages
we’ll turn demonstrate me those that, to Given the second that it to second With developments, half continue we positive will remain of result. the move Jeff over recovery traction as discuss optimistic our XXXX. cautiously through to financial quarter let
