our and call everyone this thank operator, Thanks, attending you afternoon. to
our we and therapeutic Electrode Thin the advancing fiscal focused During to applications. and Film quarter, Technology diagnostic remain respect since with Platform on second both
product In Zimmer and addition, we by qualify made progress product expected sources. the on initiating meet reducing to manufacturing process to costs additional ability demand the ensuring Biomet’s
Let’s begin with diagnostic applications.
to hours duration than Devices. met standard sEEG that the and from less the less use to product Medical increase strongly XXXXX the Biological Evaluation for not FDA line, March Although, did our XX of we of ISO XX provide Part for than days clearance feel Evo XX requirements XX we XXXX Part in
As from Dr. of no decision our it or regarding call. company with a days the in their submission to appeal the had made for the explained regarding our company XXXX on criteria presentation met XX, with us rationale William the On to Dr. FDA questions renowned biocompatibility call I the May provided the company Wustenberg who the appeal such that appeal. data April official referenced. March as believed FDA decision. filed the hear FDA to date XX the be FDA expert FDA earlier our held the an an analysis The the and scientific XX would why by that Wustenberg’s informed
decision. We awaiting are this currently
successful tests previously the not sEEG disclosed, event, Evo line on biocompatibility by a additional we we in are our path in appeal. the As product parallel commencing initiated immediately
report, extremely the we firm thereafter that get if the biocompatibility would the testing and the the test final their XXX% remain will all time Given products required We Cortical mid-August expect again report have confident product submission final the of use. needed. intended that complete for the testing length XXX(k) as to for biocompatibility Evo sEEG in and to testing and time of our the successfully file passed pass
We sEEG use materials confident we less also given partner distribution for and FDA by have when line. Evo for that is to for clearance electrodes or sEEG fulfill have begin orders product for XX Evo been sufficient, the use and line. diagnostic our If remain clearance design both FDA use than clearances for from stocking that family for Zimmer Cortical Biomet, received, diagnostic Evo placed product company purposes than the and an used our for the FDA than XX-hour are less XX-day will days less line the our
the in advisory both board NeuroOne for our received Evo an use. encouraged us electrodes a attended. opportunity neurosurgeons by hosted which were clinical future. and the from remain sEEG support gain the positive from that for profile this by by to to intra-operative of and on required research is the edge We procedures, the The company opportunities exploring device leverage continuously week, last the procedure. feedback neurosurgeons at unique for Zimmer the less use the in would Just Biomet Zimmer U.S. to the cutting The we and to around the low may participated meeting electrode This sEEG with account Evo to accessories diagnostic feedback be experience near XX-hour company meeting use than ECoG obtain physician also also electrode give approached
researchers University effort, of product of collaborators and electrode gathered the Evo were neuromodulation. recently psychiatry focus and where at line leading on our this displayed unique with Symposium, we also part Minnesota As Neuromodulation
to Zimmer Biomet. Research This second presented company product critical Gordon at from patients. continually respect treatment Interfaces from in Conference for lines supply Meeting. steps for took are have sEEG orders and to product also we also heard The supply diagnosis that and Evo demand reduce for obviously, prevalent causes risk expected the in is source delays Neuroelectronic a order both as to both the with sEEG the cortical qualify XXXX and Cortical both back We and manufacture electrodes This, physicians electrodes.
the been Another evaluating are of for company cost. has reducing opportunities area
will currently this completing are reduce for help of We validation cost the cable which component. significantly manufacturer, assembly new a
also product terms lighter, of smaller in third is the less expensive and release expect generation half our to year. this In enhancements, we of connector, which second
working is the less will pressure shelf on Evo customers company our sEEG This product cortical value both much to for inventory and extend to our chain. managing the Additionally, significant provide life and and lines. put supply
Now and program. moving combined electrode to our therapeutic diagnostic ablation
project on the remains pleased are report We schedule. that to
ability RBC receive potential to improve our and today potentially continue are Innovations, neurological second to a Medical epilepsy and software in the with feedback regarding hospitalization calendar of track of way RF for required progressing and physician surgery. year. the encouraging system. eliminating partner other We treated remains conditions the QX accessories the generator this of the hardware currently on use to prototypes development with Company deliver is by
XXX(k) quarter preclinical generator testing, and additional RF submit expect prototypes, for development the in XXXX the of of clearance. completion a FDA the to first accessories the application Following we of calendar
we has five-year released successful demonstrated accelerated great chronic to electrode development. fluid move We Now electrode to challenge up thin as March, recording Last issues which the testing, use durability five-year successful results without the been exciting in reliable film industry. let’s for years five our of with announced a our which accelerated any associated quarter, then completion quite stimulation use testing permeation. was of
work early While these we do, to we have manufacturing encouraged remain more and results. development by
chronic of with surgeries. cord spinal chronic with initial back the failed remains stimulation focus to due Our program back stimulation, pain our treatment
on features for a the with exciting applications specialized that few certain discussions institution Parkinson’s in in disorders. psychiatric the prominent research would film a of also development are disease, potentially thin We a regarding capitalize electrode
appointment announced Control Chad and the provide In will Vice as We Quality as we of information additional Affairs. Regulatory of January, Wilhelmy, progresses. President this
the continue She the an help within program. Dr. strengthen the thin technology. for level with appointment We film of company electrode cord recognized Vomero, the development industry Maria stimulation to drive talent will spinal with expert our process
quarter, the Business the the During and nationally on claim Fox on the financial also program company was airing featured syndicated Network. countdown
chronic pleased decrease company quarter financial for would to it over We your and objectives. ablation Investment no our attention. now in importantly, the Most with program, also new first cost, remains I we In a of product sEEG second of more confident we We the our enthusiastic you test address FDA Banking risk, and appeal ever results. Roth at Mcclurg of sorry, Capital Thank place and value the respective time about to also current bring short-term the the in Evo I’m Conference. fiscal Virtual remain connector. Ron? Partners differentiators, results to progress both chain quarter supply development company and like electrodes and confident review closing, our design our progress Oppenheimer continue for – presented Healthcare plan Conference and our the long-term line use and will Ron to the to outcome a markets. and turn meeting. their products are reduce as have confident than matter and in
