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E-Caesarea, Israel, Juni 13, 2022 /PRNewswire/ — I-IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” noma “Inkampani”), i-cryotherapy ehlasela kancane (“IceCure (Shanghai) MedTech Co. ., Ltd. (“AdillyCure IceCure), ephethwe yi-IcellyCure Shanghai” I-MedTech Co., Ltd. Shanghai”), isayine inkontileka yokwakha uhlelo lwe-IceSense3 cryoablation ne-Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), inkampani engaphansi kwe-Medtronic Corporation (NYSE: MDT) (“Medtronic”) kanye ne-Beijing Turing Medical Devices Co. 2022.
I-Medtronic Shanghai izoba ukuphela komsabalalisi we-IceSense3 kanye nama-probes ayo alahlwayo ezweni laseChina isikhathi sokuqala seminyaka emithathu, ngenani eliphansi lokuthenga okuhlosiwe lika-$3.5 million ngalesi sikhathi. Ngaphezu kwalokho, e-Mainland China, i-Shanghai Medtronic ngeke itshale imali ngokuqondile noma ngokungaqondile noma ihwebe, idayise, imakethe, ikhuthaze noma inikeze noma yimuphi umkhiqizo oqhudelana ne-IceSense3 ngesikhathi sesivumelwano sokusabalalisa nangaphezulu kwezinyanga eziyisithupha (6). I-Turing izobhekana nokungenisa, ukufakwa kanye nesevisi yangemuva kokuthengisa yohlelo lwe-IceSense3 ezweni laseChina, kuyilapho i-Medtronic Shanghai izosingatha konke ukumaketha, ukuthengisa nokuqeqeshwa okuthile kochwepheshe.
I-IceSense3 System Console igunyazwe i-China National Medical Products Administration (“NMPA”). I-IceCure ifake isicelo soshintsho lwesitifiketi sokubhalisa ukuze ivumele ama-probe alahlwayo okuthi, uma kuvunyiwe, azovumela inkampani ukuthi imakethe ama-cryoprobes alahlwayo e-IceSense3 ukuze asetshenziswe ngokwezentengiselwano, futhi i-IceCure ilindele ukuthola imvume ye-NMPA yophenyo ekupheleni kuka-2022.
"I-Shanghai Medtronic ne-Turing ingabalingani abakahle kithi ezweni laseChina, lapho ukungena emakethe kobuchwepheshe be-cryoablation okwamanje kuphansi. Sibona ithuba elihle kakhulu lokwamukelwa okusabalele kohlelo lwethu lwe-IceSense3 cryoablation ezweni laseChina, imakethe ekhula ngokushesha kakhulu. ethuthukisa imiphumela, "kusho i-CEO ye-IceCure u-Eyal Shamir. “Njengengxenye yenkampani yemishini yezokwelapha enkulu kunazo zonke emhlabeni, i-Shanghai Medtronic inolwazi namandla emakethe ukuze ikwazi ukungena ngokushesha emakethe ye-IceSense3 ukuze inikeze ukwelashwa okuphephile, okusebenzayo nokungabizi komdlavuza webele wakuqala kanye nezinye izinkomba.”
“I-IceCure inekhambi elihamba phambili emhlabeni lokukhala kwesimila,” kusho uJing Yu, iphini likamongameli kanye nomphathi jikelele we-Skull, Spine and Orthopedic Technologies eMedtronic Shanghai. Ukubambisana ne-IceCure kanye ne-Turing Medical kuzohambisana nomugqa womkhiqizo we-Medtronic Shanghai ku-oncology neurosurgery. Sithemba ukuthi lokhu kubambisana kuzoqhubekisela phambili ukusetshenziswa komtholampilo kwe-cryoablation futhi kuzuzise iziguli eziningi zesimila, futhi sibheke ngabomvu ukusebenzisana nozakwethu abaningi ukuze kusheshiswe ukwamukelwa nokuthunyelwa kwezixazululo zezokwelapha ezithuthukisiwe ezizosiza ukuxazulula izinselele ezibalulekile zokwelashwa kwesimila. Umkhakha Wezempilo waseChina.
U-CEO we-Turing uLin Youjia wengeze wathi, "Ngokubambisana ne-Shanghai Medtronic kanye ne-IceCure, sizibophezele ukuqalisa ukuthunyelwa kanye nokufakwa ngokushesha kohlelo lwe-IceSense3 ezweni laseChina. Ukuba khona kwethu ezweni lonke ezwekazini laseChina kuqinisekisa ukuthi izikhungo zezokwelapha zithola ukwesekwa okuphakeme kwezobuchwepheshe futhi insizakalo kade isebenzisa uhlelo lwazo lwe-IceSense3."
NgoJuni 12, 2022 (“Usuku Lokusebenza”), i-IceCure Shanghai yangena esivumelwaneni esikhethekile sokuthengisa nokusabalalisa (“Isivumelwano Sokusabalalisa”) ne-Shanghai Medtronic ne-Turing ye-IceSense3 kanye nama-probe alahlwayo (“Imikhiqizo”) isikhathi sokuqala. Izinyanga ezingama-36, inhloso encane yokuthenga yalesi sikhathi ingu-$3.5 wezigidi (“Ithagethi Yokuthenga Okuncane”). Ngaphansi kwesivumelwano sokusabalalisa, i-IceCure Shanghai izothengisa imikhiqizo ye-Turing bese i-Turing izongenisa imikhiqizo isuka kwa-Israel iye ezweni laseChina bese iphinde iyithengisela i-Medtronic Shanghai. I-Medtronic Shanghai izobophezeleka, phakathi kwezinye izinto: (i) ukumaketha nokuphromotha umkhiqizo ezweni laseChina; (ii) enze imisebenzi yemfundo yezokwelapha yobungcweti yomkhiqizo ezweni lase-China. I-Turing izoba nesibopho sokugcinwa kwempahla, ukuthuthwa kwezinto, iwaranti, ukuqeqeshwa kanye nokunye ukwesekwa kanye nezinsizakalo zangemuva kokuthengisa.
Ngaphansi kwemibandela yesivumelwano sokusabalalisa, i-Shanghai Medtronic inelungelo lokwelula isikhathi sesivumelwano sokusabalalisa iminyaka emithathu uma ifinyelela ekuqongeleleni okuqoqiwe kokuthenga okuphansi kweminyaka emithathu, kuncike esivumelwaneni sethagethi entsha yokuthenga encane. Isivumelwano Sokusabalalisa singanqanyulwa ngaphansi kwezimo ezithile, okuhlanganisa uma kwenzeka kuba nephutha, ukwehluleka kokusebenza noma ukuphelelwa yizikweletu.
Ngokungeziwe, kuncike emigomeni yeSivumelwano Sokusabalalisa, i-IceCure Shanghai izobophezeleka ekutholeni nasekugcineni noma yikuphi ukugunyazwa okulawulwayo (“Izimvume Zokulawula”) ezidingekayo ukuze kumakethe, kuphromothwe, kusatshalaliswe, kudayiswe futhi kusetshenziswe Imikhiqizo ezweni lase-China. I-NMPA, igatsha layo lendawo, nanoma iyiphi enye i-ejensi kahulumeni (“Isigungu Esilawulayo”). I-IceCure Shanghai ithole ukugunyazwa kokulawula kwe-IceSense3 System Console futhi idinga ukugunyazwa kokulawula kwe-IceSense3 disposable cryoprobe yezinqubo zentengiso phakathi nezinyanga eziyisishiyagalolunye kusukela ngedethi yokuqala yesivumelwano sokusabalalisa. I-Shanghai Medtronic inelungelo lokunqamula isivumelwano sokusabalalisa uma i-IceCure Shanghai ingakutholi ukugunyazwa kokulawula kwama-cryoprobes ngaleso sikhathi.
I-IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) ithuthukisa futhi imakethe i-ProSense®, uketshezi oluthuthukisiwe lwe-nitrogen cryoablative therapy yokwelapha izimila (ezinomdlavuza) nge-cryotherapy, eqondiswe kakhulu kumdlavuza webele, wezinso, wamathambo nowamaphaphu. isikhuphashe. Ubuchwepheshe bayo obuhlasela kancane buhlinzeka ngenye indlela ephephile nesebenzayo yokuhlinzwa kokususwa kwesimila esigulini, kanye nesikhathi esifushane sokuhlinza kanye nenqubo yokuhlinza okulula ukuyenza. Kuze kube manje, uhlelo luyamakethwa futhi luyamakethwa emhlabeni wonke ngezinkomba ezigunyazwe yi-FDA futhi yi-CE Mark evunyelwe eYurophu.
Lokhu kukhululwa kwabezindaba kuqukethe izitatimende ezibheke phambili ngaphakathi kwencazelo yezinhlinzeko "zechweba eliphephile" zoMthetho Wokuguqula Icala Lokuvikeleka Kwangasese ka-1995 kanye neminye imithetho yezibambiso zikahulumeni. Amagama anjengokuthi “lindela”, “lindela”, “hlosa”, “hlela”, “kholwa”, “hlosa”, “linganisela” nezinkulumo ezifanayo noma ukuhluka kwamagama anjalo kuhloswe ukubhekisela kuzo izitatimende ezibheke phambili. Isibonelo, i-IceCure isebenzisa izitatimende ezibheke phambili kulokhu kukhululwa kwabezindaba lapho ixoxa ngezivumelwano zokusabalalisa ne-Shanghai Medtronic kanye ne-Turing, isu lokulawula lenkampani, imisebenzi yokuthengisa, namathuba emakethe wezinhlelo zenkampani zokukhalaza ezweni lase-China. Ngenxa yokuthi izitatimende ezinjalo zihlobene nezenzakalo zesikhathi esizayo futhi zisekelwe kulokho okulindelwe yi-IceCure kwamanje, zingaphansi kwezingozi ezihlukahlukene nokungaqiniseki, futhi imiphumela yangempela ye-IceCure, ukusebenza noma izimpumelelo zingase zehluke kulezo ezichazwe noma ezishiwo yizitatimende kulokhu kukhululwa kwabezindaba. Kunomehluko obalulekile. . Izitatimende ezibheke phambili eziqukethwe noma ezishiwo kulokhu kukhululwa kwabezindaba zingaphansi kwezinye izingozi nokungaqiniseki, eziningi zazo ezingaphezu kwamandla eNkampani, okuhlanganisa nalezo ezichazwe esigabeni esithi “Izici Zobungozi” sombiko Wonyaka Wenkampani Wefomu 20-F ofakwe ku-SEC kusukela ngomhla ka-April 1, 2022 wonyaka ophele ngo-December 31, 2021 kuwebhusayithi ye-ScEC. INkampani ayenzi noma isiphi isibopho sokubuyekeza lezi zitatimende ukuze zibuyekezwe noma izinguquko ngemva kosuku lwalokhu kukhishwa kwabezindaba, ngaphandle uma kudingwa ukuba yenze kanjalo ngokomthetho.