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EKesareya, kwaSirayeli, ngoJuni 13, 2022 /PRNewswire/ - IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" okanye "iNkampani"), i-cryotherapy encinci ("IceCure (Shanghai) MedTech Co. , Ltd. ("IceCure", i-subsidiary epheleleyo ye-IceCure (Shanghai) MedTech Co., Ltd. Shanghai"), isayine isivumelwano sokwakha inkqubo ye-IceSense3 cryoablation kunye ne-Shanghai Medtronic Zhikang Medical Devices Co., Ltd. ("i-Shanghai" I-Medtronic "), i-subsidiary ye-Medtronic Corporation (NYSE: MDT) ("Medtronic") kunye ne-Beijing Turing Medical Technology Co., Ltd. ("Turing") Iinkqubo zokuqala ze-IceSense3 kulindeleke ukuba zihanjiswe kwi-2022.
I-Medtronic Shanghai iya kuba yeyodwa yokusasaza i-IceSense3 kunye neeprobes zayo ezilahlwayo kwilizwe laseTshayina kwithuba leminyaka emithathu yokuqala, kunye nokujoliswe kuko okuncinci kwe-3.5 yezigidi zeedola ngeli xesha. Ukongeza, kwilizwe laseTshayina, iShanghai Medtronic ayizukutyala imali ngokuthe ngqo okanye ngokungathanga ngqo okanye irhwebe, ithengise, ithengise, ikhuthaze okanye inikeze nayiphi na imveliso ekhuphisana ne-IceSense3 ngexesha lesivumelwano sokusasazwa nangaphaya kweenyanga ezintandathu (6). I-Turing iya kuba noxanduva lokungenisa, ukufakwa kunye nenkonzo emva kokuthengiswa kwenkqubo ye-IceSense3 kwilizwe laseTshayina, ngelixa i-Medtronic Shanghai iya kusingatha yonke intengiso, ukuthengisa kunye noqeqesho oluthile lobuchwephesha.
I-IceSense3 System Console ivunyiwe yi-China National Medical Products Administration ("NMPA"). I-IceCure ifake isicelo sotshintsho lwesatifikethi sobhaliso ukuze ivume iiprobes ezilahlayo, ukuba zivunyiwe, ziyakuvumela inkampani ukuba ithengise i-IceSense3 i-cryoprobes elahlayo ukuze isetyenziselwe urhwebo, kwaye i-IceCure ilindele ukufumana imvume ye-NMPA kwi-probes ekupheleni kuka-2022.
“I-Shanghai Medtronic kunye ne-Turing ngamaqabane afanelekileyo kuthi kwilizwe lase-China, apho ukungena kwimarike yetekhnoloji ye-cryoablation kuphantsi okwangoku. Sibona elona thuba libalaseleyo lokwamkelwa ngokubanzi kwenkqubo yethu yokulila i-IceSense3 kwilizwe laseTshayina, imakethi ekhula ngokukhawuleza kakhulu. eziphucula iziphumo, utshilo umphathi we-IceCure u-Eyal Shamir. "Njengenxalenye yeyona nkampani inkulu yezixhobo zonyango emhlabeni, iShanghai Medtronic inamava kunye namandla entengiso ukuze kungene urhwebo olukhawulezayo lwe-IceSense3 ukubonelela ngonyango olukhuselekileyo, olusebenzayo noluneendleko eziphantsi kumhlaza wamabele kwangoko kunye nezinye izalathisi."
"I-IceCure inesona sisombululo siphambili se-tumor cryoablation," utshilo uJing Yu, usekela mongameli kunye nomphathi jikelele weSkull, Spine and Orthopedic Technologies eMedtronic Shanghai. Intsebenziswano kunye ne-IceCure kunye neTuring Medical iya kuncedisa umgca wemveliso we-Medtronic Shanghai kwi-oncology neurosurgery. Siyathemba ukuba le ntsebenziswano iya kuqhubela phambili isicelo seklinikhi ye-cryoablation kwaye sizuze izigulana ezininzi zethumba, kwaye sijonge phambili ekusebenzisaneni namaqabane amaninzi ukukhawulezisa ukwamkelwa kunye nokusasazwa kwezisombululo zonyango eziphambili eziza kunceda ukusombulula imingeni engundoqo yonyango lwethumba. ICandelo lezeMpilo laseTshayina.
I-CEO yeTuring uLin Youjia wongeze wathi, "Ngokubambisana neShanghai Medtronic kunye ne-IceCure, sizimisele ukuqalisa ukuthunyelwa kunye nokufakwa ngokukhawuleza kwenkqubo ye-IceSense3 kwilizwe laseTshayina. Ubukho bethu kwilizwe liphela kwilizwe laseTshayina buqinisekisa ukuba amaziko onyango afumana inkxaso ephezulu yobugcisa kwaye inkonzo ibisebenzisa inkqubo ye-IceSense3 ixesha elide. ”
Ngomhla we-12 kaJuni, i-2022 ("Umhla wokuSebenza"), i-IceCure Shanghai yangena kwisivumelwano sokuthengisa kunye nokusabalalisa okukhethekileyo ("Isivumelwano soSabelo") kunye ne-Shanghai Medtronic kunye neTuring ye-IceSense3 kunye neeprobes ezilahlayo ("Iimveliso") kwixesha lokuqala. Iinyanga ze-36, eyona njongo incinci yokuthenga ngeli xesha yi-3.5 yezigidi zeedola ("I-Minimum Purchase Target"). Ngaphantsi kwesivumelwano sokusasazwa, i-IceCure Shanghai iya kuthengisa iimveliso zeTuring kwaye iTuring iya kungenisa iimveliso ezivela kwa-Israyeli ukuya kwilizwe laseTshayina kwaye emva koko izithengise kwi-Medtronic Shanghai. I-Medtronic Shanghai iya kuba noxanduva, phakathi kwezinye izinto: (i) ukuthengisa nokukhuthaza imveliso kwilizwe laseTshayina; (ii) qhuba imisebenzi yokufundisa ubugqirha kwimveliso kwilizwe laseTshayina. I-Turing iya kuba noxanduva lokugcinwa kwempahla, ulungiselelo, iwaranti, uqeqesho kunye nezinye iinkonzo zenkxaso kunye neenkonzo zasemva kokuthengisa.
Ngaphantsi kwemiqathango yesivumelwano sokusasazwa, i-Shanghai Medtronic inelungelo lokwandisa ixesha lesivumelwano sokusasaza iminyaka emithathu ukuba ifikelela kwi-cumulative yeminyaka emithathu ubuncinane ekujoliswe kuyo, ngokuxhomekeke kwisivumelwano sethagethi entsha yokuthenga. ISivumelwano soMbathisi sinokupheliswa phantsi kweemeko ezithile, kubandakanywa kwimeko yokusilela, ukusilela kwizinto eziphathekayo okanye ukutshona.
Ukongeza, ngokuxhomekeke kwimiqathango yeSivumelwano soMhambisi, i-IceCure Shanghai iya kuba noxanduva lokufumana kunye nokugcina naziphi na iimvume ezilawulayo ("Iimvume zoLawulo") ezifunekayo ukuthengisa, ukukhuthaza, ukusasaza, ukuthengisa nokusebenzisa iMveliso kwilizwe laseTshayina. I-NMPA, isebe layo lengingqi, okanye nayiphi na enye iarhente karhulumente (“iGunyabantu eliLawulayo”). I-IceCure Shanghai ifumene imvume yokulawula ye-IceSense3 System Console kwaye ifuna imvume yokulawula i-IceSense3 i-cryoprobe elahlayo yeenkqubo zorhwebo ngaphakathi kweenyanga ezilithoba ukususela kumhla wokusebenza kwesivumelwano sokusabalalisa. I-Shanghai Medtronic inelungelo lokuphelisa isivumelwano sokusasazwa ukuba i-IceCure Shanghai ayifumani mvume yolawulo ye-cryoprobes ngelo xesha.
I-IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) iphuhlisa kwaye ithengise iProSense®, unyango oluphezulu lwe-nitrogen cryoablative kunyango lwe-tumor (benign kunye nomhlaza) kunye ne-cryotherapy, ijolise ikakhulu kwibele, izintso, ithambo kunye nomhlaza wemiphunga. icrayfish. Ubuchwephesha bayo obungenabugocigoci bubonelela ngendlela ekhuselekileyo nesebenzayo yotyando lokususa ithumba kwisigulana esilaliswayo, kunye nexesha lotyando olufutshane kunye nenkqubo yotyando ekulula ukuyenza. Ukuza kuthi ga ngoku, le nkqubo ithengiswa kwaye ithengiswa kwihlabathi liphela ngezalathi ezivunyiweyo ze-FDA kwaye yi-CE Mark evunyiweyo eYurophu.
Olu shicilelo lweendaba luqulethe izitatimende ezijonge phambili ngaphakathi kwentsingiselo "ye-harbor ekhuselekileyo" izibonelelo ze-Private Securities Litigation Reform Act ye-1995 kunye neminye imithetho ye-federal securities. Amagama anjengala “qikelela”, “qikelela”, “ceba”, “yila”, “kholwa”, “cinga”, “qikelela” kunye namabinzana afanayo okanye ukwahluka kwamagama anjalo enzelwe ukubhekisa kwiingxelo ezijonge phambili. Umzekelo, i-IceCure isebenzisa iingxelo ezijonge phambili kolu shicilelo lweendaba xa kuxoxwa ngezivumelwano zokusasaza kunye ne-Shanghai Medtronic kunye ne-Turing, isicwangciso solawulo senkampani, imisebenzi yokuthengisa, kunye namathuba okuthengisa kwiinkqubo zokulila zenkampani kwilizwe laseTshayina. Ngenxa yokuba iingxelo ezinjalo zihambelana neziganeko zexesha elizayo kwaye zisekelwe kwi-IceCure elindelekileyo ngoku, zixhomekeke kwimingcipheko eyahlukeneyo kunye nokungaqiniseki, kwaye iziphumo ezichanekileyo ze-IceCure, ukusebenza okanye impumelelo inokwahluka kwezo zichazwe okanye ezichazwe kwiingxelo ezikolu shicilelo lweendaba. Kukho umahluko obonakalayo. . Iingxelo ezijonge phambili eziqulethwe okanye ezichazwe kolu shicilelo zixhomekeke kweminye imingcipheko kunye nokungaqiniseki, uninzi lwazo olungaphaya kolawulo lweNkampani, kubandakanywa nezo zichazwe kwicandelo "leMicimbi yoMngcipheko" kwiNgxelo yoNyaka yeNkampani kwiFomu 20-F efakwe kwi. I-SEC ukususela nge-1 ka-Epreli 2022 yonyaka ophele nge-31 kaDisemba 2021, ekhoyo kwiwebhusayithi ye-SEC ku-www.sec.gov. Inkampani ayenzi naziphi na izibophelelo zokuhlaziya ezi nkcazo ukuze zihlaziywe okanye zitshintshwe emva komhla wokukhutshwa kweendaba, ngaphandle kokuba kufuneka yenze njalo ngokomthetho.