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Hiharia, Iharaira, Hune 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” ko te “Kamupene” ranei), iti rawa te whakaekenga tangihanga tangi (“IceCure (Shanghai) MedTech Co. . , Ltd. (“IceCure”, he apiti katoa no IceCure (Shanghai ) MedTech Co., Ltd. Shanghai”), i hainatia he kirimana ki te hanga i te punaha cryoablation IceSense3 me Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai). Medtronic"), he roopu o Medtronic Corporation (NYSE: MDT) ("Medtronic") me Beijing Turing Medical Technology Co., Ltd. ("Turing") Ko nga punaha IceSense3 tuatahi ka tukuna hei te tau 2022.
Ka noho ko Medtronic Shanghai anake te tohatoha o IceSense3 me ana tirotiro i te tuawhenua o Haina mo te wa tuatahi mo te toru tau, me te $3.5 miriona te utu mo te hoko i tenei waa.I tua atu, i te tuawhenua o Haina, karekau a Shanghai Medtronic e whakangao tika, arataki ranei ki te hokohoko, ki te hoko, ki te maakete, ki te whakatairanga, ki te tuku atu ranei i nga hua e whakataetae ana ki a IceSense3 i te wa o te kirimana tohatoha me tua atu i te ono (6) marama.Ko Turing te kawenga mo te kawemai, te whakaurunga me te ratonga muri-hoko o te punaha IceSense3 i te tuawhenua o Haina, ma Medtronic Shanghai e whakahaere nga hokohoko katoa, hoko me etahi whakangungu ngaio.
Ko te IceSense3 System Console e whakaaetia ana e te China National Medical Products Administration (“NMPA”).I tono a IceCure mo te huringa tiwhikete rehitatanga ki te whakamana i nga rangahau tuku, mena ka whakaaehia, ka taea e te kamupene te hokohoko i ana cryoprobes tuku IceSense3 mo te whakamahi arumoni, me te tumanako a IceCure ka whiwhi whakaaetanga NMPA mo nga tirotiro hei te mutunga o te 2022.
"Ko Shanghai Medtronic me Turing he hoa pai mo matou i te tuawhenua o Haina, kei te iti te urunga o te maakete o te hangarau cryoablation i tenei wa.Ka kite matou i tetahi waahi pai mo te whaanuitanga o ta maatau punaha cryoablation IceSense3 i tuawhenua o Haina, he maakete e tino tere haere ana.ka pai ake nga hua, "e kii ana te Tumuaki IceCure a Eyal Shamir."Hei waahanga o te kamupene taputapu rongoa nui rawa atu o te ao, kei a Shanghai Medtronic te wheako me te mana o te maakete kia taea ai te urunga tere o te maakete o IceSense3 ki te whakarato maimoatanga haumaru, whai hua me te utu-utu mo te mate pukupuku uma me etahi atu tohu."
"Kei a IceCure te otinga tangi tangi puku o te ao," e kii ana a Jing Yu, perehitini tuarua me te kaiwhakahaere matua o te Angaanga, Spine and Orthopedic Technologies i Medtronic Shanghai.Ko te mahi tahi me IceCure me Turing Medical ka whakakiia te raina hua a Medtronic Shanghai i roto i te oncology neurosurgery.Ko te tumanako ma tenei mahi tahi ka anga whakamua te tono haumanu o te cryoablation me te whai hua atu ki nga turoro puku, a kei te tumanako ano matou ki te mahi tahi me te maha atu o nga hoa mahi ki te whakatere i te whakatamarikitanga me te tuku rongoa rongoa matatau hei awhina i nga wero nui mo te maimoatanga puku.Rangai Hauora o Haina.
I kii te Tumuaki o Turing, a Lin Youjia, "Ma te mahi tahi me Shanghai Medtronic me IceCure, ka whakapau kaha matou ki te tiimata i te tuku me te whakauru tere o te punaha IceSense3 ki te tuawhenua o Haina.Ko ta matou nohonga puta noa i te motu ki te tuawhenua o Haina e whakarite ana ka whiwhi nga pokapū rongoa i te tautoko hangarau tino pai me te ratonga kua roa e whakamahi ana i a raatau punaha IceSense3.
I te Hune 12, 2022 ("Te Ra Whaitake"), I uru a IceCure Shanghai ki tetahi kirimana hoko me te tohatoha motuhake ("Whakaaetanga Tohaina") me Shanghai Medtronic me Turing mo IceSense3 me nga rangahau tuku ("Hua") mo te wa tuatahi.36 marama, ko te kaupapa hoko iti rawa mo tenei waa ko te $3.5 miriona ("Tangata Hoko Iti").I raro i te whakaaetanga tohatoha, ka hokona e IceCure Shanghai nga hua Turing ka kawea mai e Turing nga hua mai i Iharaira ki te tuawhenua o Haina katahi ka hokona ano ki Medtronic Shanghai.Ko Medtronic Shanghai te kawenga mo, i roto i era atu mea: (i) te hokohoko me te whakatairanga i te hua ki te tuawhenua o Haina;(ii) whakahaere i nga mahi whakangungu hauora ngaio mo te hua i te tuawhenua o Haina.Ko Turing te kawenga mo te whare putunga, nga mahi arorau, te whakamana, te whakangungu me etahi atu ratonga tautoko me muri-hoko.
I raro i nga tikanga o te kirimana tohatoha, kei a Shanghai Medtronic te mana ki te whakaroa atu i te wa o te kirimana tohatoha mo nga tau e toru mena ka eke ki te kohinga hoko iti mo nga tau e toru, i raro i te whakaaetanga o te whaainga hoko iti hou.Ka taea te whakakore i te Whakaaetanga Kaituku i raro i etahi ahuatanga, tae atu ki te mea he taunoa, he kore rawa, he kore utu ranei.
I tua atu, i raro i nga tikanga o te Whakaaetanga Kaituku, ko IceCure Shanghai te kawenga mo te whiwhi me te pupuri i nga whakaaetanga ture katoa ("Whakaaetanga Ture") e hiahiatia ana ki te hokohoko, ki te whakatairanga, ki te tohatoha, ki te hoko me te whakamahi i nga Hua i te tuawhenua o Haina.NMPA, tona peka o te rohe, tetahi atu tari kawanatanga ranei (te "Mana Whakahaere").Kua whiwhi a IceCure Shanghai i te whakaaetanga ture mo te IceSense3 System Console me te tono whakaaetanga ture mo te cryoprobe tuku a IceSense3 mo nga tikanga arumoni i roto i te iwa marama mai i te ra whai mana o te kirimana tohatoha.Kei a Shanghai Medtronic te mana ki te whakamutu i te kirimana tohatoha mena kaore a IceCure Shanghai e whiwhi whakaaetanga ture mo nga cryoprobes i tera wa.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) e whakawhanake ana, e hokohoko ana i te ProSense®, he hauota hauota hauota cryoablative rongoa mo te rongoa i nga pukupuku (te mate pukupuku me te mate pukupuku) me te whakamaarama tangi, e aro nui ana ki nga mate pukupuku o te u, te whatukuhu, te wheua me te huhu.kōura.Ko tana hangarau whakaekenga iti e whakarato ana i tetahi huarahi haumaru me te whai hua ki te pokanga tango puku mate turoro, he poto te wa mahi me te mahi pokanga ngawari.I tenei wa, kei te maakete te punaha me te maakete puta noa i te ao mo nga tohu kua whakaaetia e te FDA a kua whakaaetia a CE Mark i Uropi.
Kei roto i tenei panui panui nga korero titiro whakamua i roto i te tikanga o nga tikanga o te "whanga haumaru" o te Ture Whakatikatika mo te Whakataunga Whakatau mo nga Haumaru Motuhake o te tau 1995 me etahi atu ture haumaru a te kawanatanga.Ko nga kupu penei i te "manakohia", "manakohia", "whakaaro", "mahere", "whakapono", "whakaaro", "whakatau" me etahi atu korero, rereke ranei o aua kupu e kiia ana mo nga korero titiro whakamua.Hei tauira, ka whakamahi a IceCure i nga korero whakamua i roto i tenei panui panui i te wa e korero ana mo nga kirimana tohatoha me Shanghai Medtronic me Turing, te rautaki whakahaere a te kamupene, nga mahi hokohoko, me nga huarahi hokohoko mo nga punaha cryoablation a te kamupene i te tuawhenua o Haina.Na te mea ko enei korero e pa ana ki nga huihuinga a meake nei me te hangai i runga i nga tumanakohanga a IceCure o naianei, ka pa ki nga momo morearea me te kore tino mohio, a ka rereke pea nga hua tuturu, mahi, whakatutukitanga ranei a IceCure i era i whakaahuahia, i whakahiahia ranei e nga korero i roto i tenei tuku panui.He nui nga rereketanga..Ko nga korero anga whakamua kei roto, kei roto ranei i roto i tenei panui panui ka pa ki etahi atu morearea me te kore tino mohio, ko te nuinga kei tua atu i te mana o te Kamupene, tae atu ki era i whakaahuahia i roto i te waahanga "Risk Factors" o te Ripoata Tau a te Kamupene mo te Puka 20-F i tukuna ki roto. SEC mai te 1 no Paenga-whāwhā 2022 mo te tau i mutu i te Hakihea 31, 2021, kei te paetukutuku SEC i www.sec.gov.Kaore te Kamupene e whai mana ki te whakahou i enei korero mo te whakatikatika, whakarereke ranei i muri i te ra o tenei tukunga perehi, engari mena ka mahia e te ture.


Wā tuku: Noema-01-2022