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IKhesariya, kwa-Israyeli, Juni 13, 2022 /PRNewswire/ — I-IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” noma “iNkampani”), i-cryotherapy encane ehlaselayo (“IceCure (Shanghai) MedTech Co. ., Ltd. (“IceCure”, inkampani ephethwe ngokuphelele yi-IceCure (Shanghai) MedTech Co., Ltd. Shanghai”), isayine inkontileka yokwakha uhlelo lwe-cryoablation lwe-IceSense3 ne-Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), inkampani engaphansi kwe-Medtronic Corporation (NYSE: MDT) (“Medtronic”) kanye ne-Beijing Turing Medical Technology Co., Ltd. (“Turing”) Izinhlelo zokuqala ze-IceSense3 kulindeleke ukuthi zilethwe ngo-2022.
I-Medtronic Shanghai izoba ngumthengisi oyedwa we-IceSense3 kanye nama-probe ayo alahlwayo ezwenikazi laseShayina isikhathi sokuqala seminyaka emithathu, kanye nomgomo wokuthenga okungenani ongu-$3.5 million phakathi nalesi sikhathi. Ngaphezu kwalokho, ezwenikazi laseShayina, i-Shanghai i-Medtronic ngeke itshale imali ngokuqondile noma ngokungaqondile noma ihwebe, ithengise, imakethe, ikhuthaze noma inikeze noma yimuphi umkhiqizo oncintisana ne-IceSense3 ngesikhathi sesivumelwano sokusabalalisa nangaphezu kwezinyanga eziyisithupha (6). I-Turing izoba nesibopho sokungenisa, ukufaka kanye nensizakalo yangemva kokuthengisa kohlelo lwe-IceSense3 ezwenikazi laseShayina, kanti i-Medtronic Shanghai izophatha konke ukumaketha, ukuthengisa kanye nokuqeqeshwa okuthile kobungcweti.
I-IceSense3 System Console ivunyelwe yi-China National Medical Products Administration (“NMPA”). I-IceCure ifake isicelo sokushintsha isitifiketi sokubhalisa ukuze ivume ama-probe alahlwayo, uma evunyelwe, angavumela inkampani ukuthi imakethe ama-cryoprobe ayo alahlwayo e-IceSense3 ukuze asetshenziswe kwezentengiselwano, kanti i-IceCure ilindele ukuthola imvume ye-NMPA yama-probe ekupheleni kuka-2022.
“I-Shanghai Medtronic kanye ne-Turing zingabalingani abafanele kithi ezwenikazi lase-China, lapho ukungena emakethe kobuchwepheshe be-cryoablation kuphansi njengamanje. Sibona ithuba elihle kakhulu lokwamukelwa kabanzi kohlelo lwethu lwe-cryoablation lwe-IceSense3 ezwenikazi lase-China, imakethe ekhula ngokushesha kakhulu. ethuthukisa imiphumela,” kusho i-CEO ye-IceCure u-Eyal Shamir. “Njengengxenye yenkampani enkulu kunazo zonke emhlabeni yamadivayisi ezokwelapha, i-Shanghai Medtronic inolwazi namandla emakethe okuvumela ukungena okusheshayo kwe-IceSense3 emakethe ukuze inikeze ukwelashwa okuphephile, okusebenzayo nokungabizi kakhulu komdlavuza webele wasekuqaleni kanye nezinye izinkomba.”
“I-IceCure inesixazululo esihamba phambili emhlabeni sokuqeda i-tumor cryoablation,” kusho uJing Yu, iphini likamongameli kanye nomphathi jikelele we-Skull, Spine and Orthopedic Technologies kwa-Medtronic Shanghai. Ubambiswano ne-IceCure kanye ne-Turing Medical luzohambisana nomugqa womkhiqizo we-Medtronic Shanghai ekuhlinzekweni kwe-neurosurgery ye-oncology. Sithemba ukuthi lokhu kubambisana kuzothuthukisa ukusetshenziswa kwezokwelapha kwe-cryoablation futhi kuzuze iziguli eziningi ezine-tumor, futhi sibheke phambili ekusebenzisaneni nabalingani abaningi ukusheshisa ukwamukelwa nokusetshenziswa kwezixazululo zezokwelapha ezithuthukisiwe ezizosiza ekuxazululeni izinselele ezibalulekile zokwelapha i-tumor. Umkhakha Wezempilo waseShayina.
Isikhulu esiphezulu seTuring uLin Youjia wengeze wathi, “Ngokubambisana neShanghai Medtronic kanye ne-IceCure, sizibophezele ekuqaliseni ukuthunyelwa kanye nokufakwa okusheshayo kohlelo lwe-IceSense3 ezwenikazi laseShayina. Ukuba khona kwethu ezweni lonke ezwenikazi laseShayina kuqinisekisa ukuthi izikhungo zezokwelapha zithola ukwesekwa kobuchwepheshe kanye nensizakalo ephezulu sekunesikhathi eside zisebenzisa uhlelo lwazo lwe-IceSense3.”
Ngomhlaka-12 Juni 2022 (“Usuku Lokuqala Ukusebenza”), i-IceCure Shanghai yangena esivumelwaneni sokuthengisa nokusabalalisa esikhethekile (“Isivumelwano Sokusabalalisa”) ne-Shanghai Medtronic kanye ne-Turing ye-IceSense3 kanye nama-probe alahlwayo (“Imikhiqizo”) isikhathi sokuqala. Izinyanga ezingama-36, umgomo wokuthenga omncane walesi sikhathi u-$3.5 million (“Inhloso Yokuthenga Encane”). Ngaphansi kwesivumelwano sokusabalalisa, i-IceCure Shanghai izothengisa imikhiqizo ye-Turing kanti i-Turing izongenisa imikhiqizo evela kwa-Israyeli iye e-China bese iyithengisela i-Medtronic Shanghai. I-Medtronic Shanghai izoba nesibopho, phakathi kwezinye izinto: (i) ukumaketha nokukhuthazwa komkhiqizo e-China; (ii) ukuqhuba imisebenzi yobuchwepheshe yezemfundo yezokwelapha yomkhiqizo e-China. I-Turing izoba nesibopho sokugcina impahla, ukuthutha, iwaranti, ukuqeqeshwa kanye nezinye izinsizakalo zokusekela kanye nokuthengisa ngemuva kokuthengisa.
Ngaphansi kwemigomo yesivumelwano sokusabalalisa, iShanghai Medtronic inelungelo lokwelula isikhathi sesivumelwano sokusabalalisa iminyaka emithathu uma sifinyelela umgomo wokuthenga okungenani weminyaka emithathu, kuye ngesivumelwano somgomo omusha wokuthenga okungenani. Isivumelwano Sokusabalalisa singaqedwa ngaphansi kwezimo ezithile, okuhlanganisa uma kwenzeka iphutha, iphutha elibalulekile noma ukwehluleka ukukhokha.
Ngaphezu kwalokho, ngokuya ngemigomo yeSivumelwano Sokusabalalisa, i-IceCure Shanghai izoba nesibopho sokuthola nokugcina noma yikuphi ukuvunyelwa kokulawula (“Ukuvunyelwa Kokulawula”) okudingekayo ukumaketha, ukukhuthaza, ukusabalalisa, ukuthengisa nokusebenzisa Imikhiqizo ezwenikazi laseShayina. I-NMPA, igatsha layo lendawo, noma iyiphi enye inhlangano kahulumeni ("iGunya Lokulawula"). I-IceCure Shanghai ithole imvume yokulawula ye-IceSense3 System Console futhi idinga imvume yokulawula ye-IceSense3 disposable cryoprobe yezinqubo zezentengiselwano zingakapheli izinyanga eziyisishiyagalolunye kusukela ngosuku lokuqala kwesivumelwano sokusabalalisa. I-Shanghai Medtronic inelungelo lokuqeda isivumelwano sokusabalalisa uma i-IceCure Shanghai ingatholi imvume yokulawula yama-cryoprobes ngaleso sikhathi.
I-IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) ithuthukisa futhi idayise i-ProSense®, ukwelashwa okuthuthukisiwe kwe-nitrogen cryoablative yokwelapha izimila (ezingenobungozi nezinomdlavuza) nge-cryotherapy, ikakhulukazi egxile kumdlavuza webele, wezinso, wamathambo namaphaphu. Ubuchwepheshe bayo obungenasidingo buhlinzeka ngenye indlela ephephile nephumelelayo yokuhlinzwa kokususa izimila esigulini, ngesikhathi esifushane sokuhlinzwa kanye nenqubo yokuhlinzwa elula ukuyenza. Kuze kube manje, uhlelo lukhangiswa futhi lukhangiswa emhlabeni wonke ngezinkomba ezivunyelwe yi-FDA futhi luvunyelwe yi-CE Mark eYurophu.
Lesi sitatimende sabezindaba siqukethe izitatimende ezibheke phambili ngaphakathi kwencazelo yezinhlinzeko "zokuphepha" zoMthetho Wokuguqulwa Kwecala Lokuqulwa Kwezimo Zezokuphepha Zangasese ka-1995 kanye neminye imithetho yezokuphepha kahulumeni. Amagama anjengokuthi "lindela", "lindela", "hlela", "kholwa", "hlela", "qikelela" kanye nezinkulumo ezifanayo noma ukuhlukahluka kwamagama anjalo kuhloswe ukubhekisela ezitatimendeni ezibheke phambili. Isibonelo, i-IceCure isebenzisa izitatimende ezibheke phambili kulesi sitatimende sabezindaba lapho ixoxa ngezivumelwano zokusabalalisa neShanghai Medtronic kanye neTuring, isu lokulawula lenkampani, imisebenzi yokuhweba, kanye namathuba emakethe ezinhlelo zenkampani zokugaya ukudla eShayina. Ngenxa yokuthi izitatimende ezinjalo zihlobene nezehlakalo zesikhathi esizayo futhi zisekelwe kulokho okulindelwe yi-IceCure njengamanje, zingaphansi kwezingozi ezahlukahlukene kanye nokungaqiniseki, futhi imiphumela yangempela ye-IceCure, ukusebenza noma impumelelo ingahluka kuleyo echazwe noma eshiwo yizitatimende kulesi sitatimende sabezindaba. Kunemehluko omkhulu. . Izitatimende ezibheke phambili eziqukethwe noma ezishiwo kulesi sitatimende sabezindaba zingaphansi kwezinye izingozi kanye nokungaqiniseki, eziningi zazo ezingaphezu kwamandla eNkampani, okuhlanganisa nalezo ezichazwe esigabeni esithi “Izici Zengozi” soMbiko Wonyaka weNkampani ngeFomu 20-F ofakwe ku-SEC kusukela mhla lu-1 kuMbasa 2022 wonyaka ophele mhla zingama-31 kuZibandlela 2021, otholakala kuwebhusayithi ye-SEC ku-www.sec.gov. Inkampani ayizibophezeli ukubuyekeza lezi zitatimende ukuze zibuyekezwe noma zishintshwe ngemva kosuku lokukhishwa kwabezindaba, ngaphandle kokuthi kudingeka ngokomthetho.