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EKhesariya, kwaSirayeli, nge-13 kaJuni 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” okanye “iNkampani”), i-cryotherapy encinci ehlaselayo (“IceCure (Shanghai) MedTech Co. ., Ltd. (“IceCure”, inkampani ephethwe ngokupheleleyo yi-IceCure (Shanghai) MedTech Co., Ltd. Shanghai”), ityikitye isivumelwano sokwakha inkqubo ye-cryoablation ye-IceSense3 kunye neShanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), inkampani encedisayo ye-Medtronic Corporation (NYSE: MDT) (“Medtronic”) kunye neBeijing Turing Medical Technology Co., Ltd. (“Turing”) Iinkqubo zokuqala ze-IceSense3 kulindeleke ukuba zinikezelwe ngo-2022.
I-Medtronic Shanghai iza kuba ngumsasazi we-IceSense3 kunye neeprobes zayo ezilahlwayo kwilizwekazi laseTshayina kwixesha leminyaka emithathu yokuqala, apho ubuncinci kujoliswe ekuthengeni i-$3.5 yezigidi ngeli xesha. Ukongeza, kwilizwekazi laseTshayina, iShanghai i-Medtronic ayizukutyala imali ngokuthe ngqo okanye ngokungathanga ngqo okanye kurhwebe, ithengise, ithengise, ikhuthaze okanye inikeze nayiphi na imveliso ekhuphisana ne-IceSense3 ngexesha lesivumelwano sokusasaza nangaphaya kweenyanga ezintandathu (6). I-Turing iya kuba noxanduva lokungenisa, ukufakela kunye nenkonzo yasemva kokuthengisa yenkqubo ye-IceSense3 kwilizwekazi laseTshayina, ngelixa i-Medtronic Shanghai iya kujongana nayo yonke intengiso, intengiso kunye noqeqesho oluthile lobuchwephesha.
I-IceSense3 System Console ivunyiwe yi-China National Medical Products Administration (“NMPA”). I-IceCure ifake isicelo sokutshintshwa kwesatifikethi sobhaliso ukuze ivume iiprobe ezilahlwayo, ukuba ziyavunywa, ziya kuvumela inkampani ukuba ithengise ii-cryoprobe zayo ezilahlwayo ze-IceSense3 ukuze zisetyenziswe kwezorhwebo, kwaye i-IceCure ilindele ukufumana imvume ye-NMPA yeeprobe ekupheleni kuka-2022.
“IShanghai Medtronic kunye neTuring ngamaqabane afanelekileyo kuthi kwilizwekazi laseTshayina, apho ukungena kweteknoloji ye-cryoablation kwimarike kuphantsi okwangoku. Sibona ithuba elihle kakhulu lokwamkelwa ngokubanzi kwenkqubo yethu ye-cryoablation ye-IceSense3 kwilizwekazi laseTshayina, imakethi ekhula ngokukhawuleza kakhulu. ephucula iziphumo,” utshilo i-CEO ye-IceCure u-Eyal Shamir. “Njengenxalenye yenkampani enkulu yezixhobo zonyango emhlabeni, iShanghai Medtronic inamava kunye namandla emakethi okuvumela ukungena kwe-IceSense3 kwimarike ngokukhawuleza ukubonelela ngonyango olukhuselekileyo, olusebenzayo nolungabizi kakhulu kumhlaza wamabele kwangethuba kunye nezinye iimpawu.”
“I-IceCure inesisombululo esiphambili se-tumor cryoablation,” utshilo uJing Yu, usekela-mongameli kunye nomphathi jikelele we-Skull, Spine and Orthopedic Technologies eMedtronic Shanghai. Intsebenziswano ne-IceCure kunye neTuring Medical iya kongeza kumgca wemveliso ye-Medtronic Shanghai kwi-oncology neurosurgery. Sinethemba lokuba le ntsebenziswano iya kuphucula ukusetyenziswa kwe-cryoablation kwezonyango kwaye incede izigulane ezininzi ezine-tumor, kwaye sikwajonge phambili ekusebenzeni namaqabane amaninzi ukukhawulezisa ukwamkelwa nokusasazwa kwezisombululo zonyango eziphambili eziya kunceda ukusombulula imingeni ephambili yonyango lwe-tumor. Icandelo lezeMpilo laseTshayina.
I-CEO yeTuring uLin Youjia wongeze wathi, “Ngokubambisana neShanghai Medtronic kunye ne-IceCure, sizibophelele ekuqaliseni ukusasazwa kunye nokufakelwa ngokukhawuleza kwenkqubo ye-IceSense3 kwilizwekazi laseTshayina. Ubukho bethu kwilizwekazi laseTshayina buqinisekisa ukuba amaziko ezonyango afumana inkxaso yobugcisa kunye nenkonzo ephezulu ebesoloko esebenzisa inkqubo yawo ye-IceSense3 ixesha elide.”
Ngomhla we-12 kweyeSilimela ngo-2022 (“Umhla wokuqalisa ukusebenza”), i-IceCure Shanghai yangena kwisivumelwano sokuthengisa nokusasaza esikhethekileyo (“Isivumelwano soSasazo”) neShanghai Medtronic kunye neTuring ye-IceSense3 kunye neeprobes ezilahlwayo (“Iimveliso”) kwixesha lokuqala. Kwiinyanga ezingama-36, injongo encinci yokuthenga kweli xesha yi-$3.5 yezigidi (“Ithagethi yokuThenga encinci”). Phantsi kwesivumelwano sokusasaza, i-IceCure Shanghai iza kuthengisa iimveliso zeTuring kwaye iTuring iza kungenisa iimveliso ezivela kwa-Israyeli ukuya kwilizwekazi laseTshayina ize emva koko izithengisele iMedtronic Shanghai. I-Medtronic Shanghai iza kuba noxanduva, phakathi kwezinye izinto: (i) ukuthengisa kunye nokukhuthaza imveliso kwilizwekazi laseTshayina; (ii) ukuqhuba imisebenzi yokufundisa ngonyango lwemveliso kwilizwekazi laseTshayina. I-Turing iza kuba noxanduva lokugcina impahla, uthutho, iwaranti, uqeqesho kunye nezinye iinkonzo zenkxaso kunye neenkonzo zokuthengisa emva kokuthengisa.
Phantsi kwemigaqo yesivumelwano sokusasaza, iShanghai Medtronic inelungelo lokwandisa ixesha lesivumelwano sokusasaza iminyaka emithathu ukuba ifikelela kwinqanaba lokuthenga eliphantsi leminyaka emithathu, phantsi kwesivumelwano sexabiso elitsha eliphantsi lokuthenga. Isivumelwano soMsasazi sinokupheliswa phantsi kweemeko ezithile, kuquka nokuba kukho ukungahlawuli, ukungahlawuli okukhulu okanye ukusilela ukuhlawula amatyala.
Ukongeza, ngokuxhomekeke kwimigaqo yeSivumelwano soSasazo, i-IceCure Shanghai iya kuba noxanduva lokufumana nokugcina naziphi na iimvume zomthetho (“iimvume zoLawulo”) ezifunekayo ukuthengisa, ukukhuthaza, ukusasaza, ukuthengisa nokusebenzisa iimveliso kwilizwekazi laseTshayina. I-NMPA, isebe layo lendawo, okanye nayiphi na enye iarhente karhulumente ("iGunya loLawulo"). I-IceCure Shanghai ifumene imvume zomthetho ye-IceSense3 System Console kwaye ifuna imvume zomthetho ye-IceSense3 disposable cryoprobe kwiinkqubo zorhwebo zingadlulanga iinyanga ezilithoba ukusukela kumhla wokuqalisa kwesivumelwano sokusasaza. I-Shanghai Medtronic inelungelo lokuphelisa isivumelwano sokusasaza ukuba i-IceCure Shanghai ayifumani imvume zomthetho yee-cryoprobes ngelo xesha.
I-IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) iphuhlisa kwaye ithengisa iProSense®, unyango oluphambili lwe-nitrogen cryoablative therapy yokunyanga iithumba (ezingenobungozi nezinomhlaza) nge-cryotherapy, ikakhulu ijolise kumhlaza webele, wezintso, wamathambo kunye nemiphunga. I-crayfish. Itekhnoloji yayo engaphantsi kakhulu ibonelela ngenye indlela ekhuselekileyo nesebenzayo kunotyando lokususa ithumba esibhedlele, kunye nexesha elifutshane lotyando kunye nenkqubo yotyando elula ukuyenza. Ukuza kuthi ga ngoku, le nkqubo ithengiswa kwaye ithengiswa kwihlabathi liphela ngenxa yeempawu ezivunyiweyo yi-FDA kwaye ivunyiwe yi-CE Mark eYurophu.
Esi saziso siqulathe iingxelo ezijonge phambili ngaphakathi kwentsingiselo yemimiselo "yokhuseleko" yoMthetho woHlaziyo lweMicimbi yoLwaphulo-mthetho lwaBucala ka-1995 kunye neminye imithetho yezemali karhulumente. Amagama anje ngala athi "lindela", "lindela", "zijolise", "ceba", "kholwa", "zijolise", "qikelela" kunye namagama afanayo okanye umahluko wamagama anjalo enzelwe ukubhekisa kwiingxelo ezijonge phambili. Umzekelo, i-IceCure isebenzisa iingxelo ezijonge phambili kwesi saziso xa ixoxa ngezivumelwano zokusasazwa neShanghai Medtronic kunye neTuring, icebo lolawulo lenkampani, imisebenzi yorhwebo, kunye namathuba emarike kwiinkqubo ze-cryoablation zenkampani kwilizwekazi laseTshayina. Ngenxa yokuba ezi ngxelo zinxulumene neziganeko zexesha elizayo kwaye zisekelwe kulindelo lwangoku lwe-IceCure, ziphantsi komngcipheko owahlukeneyo kunye nokungaqiniseki, kwaye iziphumo zokwenyani ze-IceCure, ukusebenza okanye impumelelo zinokwahluka kwezo zichazwe okanye zichazwe ziingxelo kwesi saziso. Kukho umahluko omkhulu. . Iingxelo ezijonge phambili eziqulethwe okanye ezichazwe kweli phephandaba zixhomekeke kwezinye iingozi kunye nokungaqiniseki, uninzi lwazo olungaphaya kolawulo lweNkampani, kuquka nezo zichazwe kwicandelo elithi “Iingozi” kwiNgxelo yoNyaka yeNkampani kwiFomu 20-F efakwe kwi-SEC ukusukela nge-1 ka-Epreli, 2022 yonyaka ophele nge-31 kaDisemba, 2021, efumaneka kwiwebhusayithi ye-SEC ku-www.sec.gov. Inkampani ayizibopheleli ekuhlaziyeni ezi ngxelo ukuze zihlaziywe okanye zitshintshwe emva komhla wale ngxelo yeendaba, ngaphandle kokuba kufuneka kwenziwe njalo ngumthetho.