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IKhesariya, u-Israyeli, ngoJuni 13, 2022 / PrNewSwire / - I-IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure" noma i- "Icecure (i-ICANGURE) MEDTECH Co. , Ltd ("Icecure", Uxhaso oluphethwe ngokuphelele lwe-ICECURE (Shanghai) Medtech Co, Ltd. Shanghai "), wasayina inkontileka yokwakha uhlelo lwe-cyrocal3 lwe-swanghai medtronic zhikang Medical Devices Co, Ltd. (" Shanghic Medtronic "), umxhasi we-Medtronic Corporation (NYSE: MDT) ("Medtronic") kanye neBeijing Turing Technology Concome Technology Co, Ltd. ("Turing") Izinhlelo zokuqala ze-ICESense3 kulindeleke ukuthi zilethwe ngo-2022.
IMedtronic Shanghai izoba ngumsabalalisi we-Onense3 kanye neziphenywa zayo ezilahlwayo e-Mainland China iminyaka yokuqala, enesithatho esincane sokuthenga esingu- $ 3.5 sezigidi ezingama- $ 3.5 ngalesi sikhathi. Ngaphezu kwalokho, e-Mainland China, iShanghai Medtronic ngeke ikwazi ukutshala ngqo noma ngokuqondile, ukuthengisa, imakethe, ukunikela noma yimuphi umkhiqizo oncintisana ne-Iisense3 ngesikhathi sesivumelwano sokusabalalisa kanye nakwezinyanga eziyisithupha (6). I-Turing izoba nesibopho senkonzo yokungenisa, yokufaka neyokuthengisa ngemuva kokuthengisa kohlelo lwe-ICense3 e-Mainland China, kanti iMedtronic Shanghai izophatha konke ukumaketha, ukuthengisa kanye nokuqeqeshwa okuthile okuhle.
Ikhonsoli ye-OSeSense3 ivunyelwe yiChina National Medical Administration ("NMPA"). I-ICECURE ifake isicelo sokushintshwa kwesitifiketi sokubhaliswa ukuze ivume izingqungquthela ezilahlwayo, uma kuvunyelwe, kuzovumela inkampani ukuthi ikwazi ukuthengisa ama-crimeplobes awo okulahlwa kwezentengiso, futhi i-Icecure ilindele ukuthola imvume ye-NMPA yama-2022.
"I-Shanghai Medtronic kanye ne-Turing bangabalingani abafanelekile kithi e-Mainland China, lapho ukungena kwamakethe kwezentengiso kuphansi njengamanje. Sibona ithuba elihle kakhulu lokwamukelwa okusabalele kohlelo lwethu lwe-Onense3 Crsoanglation e-Mainland China, imakethe ekhula ngokushesha okukhulu. Lokho kuthuthukisa imiphumela, "kusho i-ICECE CEO Yaya Shamir. "Njengengxenye yenkampani enkulu yedivayisi yezokwelapha, iShanghai Medtronic inolwazi kanye namandla emakethe ukunika amandla ukungena kwemakethe okusheshayo kwe-ISense3 ukuhlinzeka ngomdlavuza webele ophephile nezinye izinkomba."
"I-ICECURE inesisombululo esihamba phambili emhlabeni," kusho uJing Yu, uMongameli Jikelele kanye neMenenja Jikelele ye-Skull, umgogodla kanye nobuchwepheshe be-Orthopedic eMedtronic Shanghai. Ukubambisana nge-ICECURE kanye neTuring Medical kuzogcwalisa umugqa womkhiqizo we-Medtronic Shanghai ku-Oncology Neurosurgery. Siyethemba ukuthi lokhu kusebenzisana kuzothuthukisa ukusetshenziswa komtholampilo kwe-crsoablation futhi kusizakale futhi ukusebenza nabalingani abaningi ukusheshisa ukwamukelwa kanye nokuthunyelwa kwezixazululo ezithuthukile zezokwelapha ezizosiza ukuxazulula izinselelo zokwelashwa ezibalulekile. Umkhakha wezempilo waseChina.
I-TURIN CEO LIN LIN NIN ne-Youjia yengeziwe, "ngokubambisana neShanghai Medtronic ne-ICECURE, sizibophezele ekuqalisweni kokuthunyelwa kanye nokufakwa ngokushesha kohlelo lwe-ICECESE3 e-Mainland China. Ukuba khona kwethu ezweni lonke e-China ye-Mound
NgoJuni 12, 2022 ("Usuku Olusebenzayo"), i-ICECURE SHANHHAI yangena esivumelwaneni esikhethekile sokuthengisa kanye nesivumelwano sokusabalalisa ("isivumelwano sokusabalalisa") ngeShanghai Medtronic kanye ne-Turing for Izicucu3 kanye neziphenywa ezilahlwayo ("Imikhiqizo") isikhathi sokuqala. Izinyanga ezingama-36, inhloso yokuthenga ephansi yalesi sikhathi yi- $ 3.5 million ("Ubuncane bokuthenga"). Ngaphansi kwesivumelwano sokusabalalisa, i-ICECURE SHANHHAI izothengisa imikhiqizo yokuThuthulula kanye ne-Turing izongenisa imikhiqizo evela kwa-Israyeli eya e-China yaseChina bese uyithengisa kwiMedtronic Shanghai. IMedtronic Shanghai izoba nesibopho, phakathi kwezinye izinto: (i) ukumaketha nokukhuthaza umkhiqizo e-Mainland China; (ii) Uqhuba imisebenzi yemfundo efanelekile yomkhiqizo e-Mainland China. I-Turing izoba nesibopho sokugcinwa kwamandla, izinto, iwaranti, ukuqeqeshwa kanye nezinye izinsizakalo zokusekelwa kwangemva kokuthengisa.
Ngaphansi kwemibandela yesivumelwano sokusabalalisa, iShanghai Medtronic inelungelo lokunweba isikhathi sesivumelwano sokusatshalaliswa kweminyaka emithathu uma ifinyelela kwelitshe leminyaka emithathu yokuthenga, ngokuya ngesivumelwano selitshe elisha lokuthenga eliphansi. Isivumelwano sokusabalalisa singanqanyulwa ngaphansi kwezimo ezithile, kufaka phakathi umcimbi wokuzenzakalelayo, okuzenzakalelayo noma okukhohliswayo.
Ngaphezu kwalokho, ngokuya ngemibandela yesivumelwano sokusabalalisa, i-ICECURE Shanghai izoba nesibopho sokuthola nokugcina noma yiziphi futhi zonke izimvume zokulawula ("ukuvunywa kokulawula") ezidingekayo ukuthengisa, ukuthuthukisa, ukuthengisa, ukuthengisa nokusebenzisa imikhiqizo e-Mainland China. INMAPA, igatsha layo lendawo, noma elinye i-ejensi kahulumeni ("Isiphathimandla Esilawulayo"). I-ICECURE Shanghai ithole imvume yokulawula i-Console ye-ISessEnse3 yohlelo futhi idinga imvume yokulawulwa kwama-cyroprobe okulahlwa kwezentengiso ngezinyanga eziyisishiyagalolunye ukusuka ngosuku olusebenzayo lwesivumelwano sokusatshalaliswa. I-Shanghai Medtronic inelungelo lokuqeda isivumelwano sokusabalalisa uma i-ICECURE Shanghai ingatholi ukuvunywa okulawulwayo kwama-crimeplobes ngaleso sikhathi.
I-ICECURE Medical (NASDAQ: ICCM) (Tase: I-ICCM) iyakhula futhi imaketha i-Prebense yokwelashwa kwe-tumors (i-benign kanye nomdlavuza) nge-crytherapy, ngokuyinhloko ibheke amaphaphu amaphaphu. isikhuphashe. Ubuchwepheshe bawo obusezingeni eliphansi buhlinzeka ngenye indlela ephephile futhi ephumelelayo yokuhlinzwa okususwa emphakathini okungabonakali, nesikhathi esifushane sokusebenza kanye nenqubo yokuhlinzwa okulula. Kuze kube manje, uhlelo luthengiswa futhi luthengiswe emhlabeni wonke ngezinkomba ezivunyiwe ze-FDA kanye nophawu lwe-CE oluvunyelwe eYurophu.
Lokhu kukhishwa kwabezindaba kuqukethe izitatimende ezibheka phambili ngaphakathi kwencazelo ye- "Safe Harbour" yezinhlobo zokubuyiselwa kwamacala okuvikeleka kwangasese ka-1995 neminye imithetho yezokuphepha ye-Federal. Amagama anjengokuthi "alindele", "lindela", "ayelitelele", "hlela", "kholwa", "kholwa", "alinganise", "alinganise", "alinganise", "alinganise", "alinganise", "alinganise". Isibonelo, i-ICECURE isebenzisa izitatimende ezibukeka phambili kulokhu kukhishwa kwabezindaba lapho kuxoxwa ngezivumelwano zokusabalalisa nge-Shanghai Medtronic kanye neThuring, Isu Lenkampani elawulawulo, imisebenzi yezentengiso, kanye namathuba emakethe wezinhlelo zenkampani ye-cryroation e-Main China. Ngoba izitatimende ezinjalo zihlobene nemicimbi yesikhathi esizayo futhi zisuselwa ekulimeni okukhona kwamanje, zingaphansi kwezingozi ezahlukahlukene kanye nokungaqiniseki, ukusebenza kwe-ICECURE, ukusebenza noma izimpumelelo kungahluka kulabo abachaziwe noma okushiwo yizitatimende zokukhishwa kwabezindaba. Kunokwehluka okukhulu. . Izitatimende ezibheka phambili eziqukethwe noma ezivezwe kulokhu kukhishwa kwabezindaba zingaphansi kwezinye izingozi nokungaqiniseki, eziningi zazo ezingaphezu kwengxenye yenkampani yombiko wonyaka we- "Ingozi" Sec kusukela ngo-Ephreli 1, 2022 konyaka waphela ngoDisemba 31, 2021, uyatholakala kuwebhusayithi yeSect www.sec.gov. Le nkampani ayithembi noma yisiphi isibopho sokuvuselela lezi zitatimende zokubuyekezwa noma izinguquko ngemuva kosuku lokukhishwa kwabezindaba, ngaphandle kokuthi kudingeke ukuba ngenze ngokomthetho.