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Caesarea, Israel, Chikumi 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” kana kuti “Kambani”), minimally invasive cryotherapy (“IceCure (Shanghai) MedTech Co. ., Ltd. (“IceCure”, kambani iri pasi peIceCure (Shanghai) MedTech Co., Ltd. Shanghai”), yakasaina chibvumirano chekuvaka IceSense3 cryoablation system neShanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), kambani iri pasi peMedtronic Corporation (NYSE: MDT) (“Medtronic”) neBeijing Turing Medical Technology Co., Ltd. (“Turing”) Masisitimu ekutanga eIceSense3 anotarisirwa kuendeswa muna 2022.
Medtronic Shanghai ndiyo chete ichange ichitengesa IceSense3 pamwe chete nemaprobes ayo anoraswa munyika yeChina kwenguva yekutanga yemakore matatu, nechinangwa chekutenga chemadhora mamiriyoni matatu nehafu panguva ino. Pamusoro pezvo, munyika yeChina, Shanghai Medtronic haizodyari mari zvakananga kana zvisina kunanga kana kutengesa, kutengesa, kushambadzira, kusimudzira kana kupa chero chigadzirwa chinokwikwidzana neIceSense3 mukati menguva yechibvumirano chekugovera uye kupfuura mwedzi mitanhatu (6). Turing ichave nebasa rekutumira, kuisa uye sevhisi yekutengeswa kweIceSense3 system munyika yeChina, ukuwo Medtronic Shanghai ichitarisira kushambadzira kwese, kutengesa uye kumwe kudzidziswa kwehunyanzvi.
IceSense3 System Console inotenderwa neChina National Medical Products Administration (“NMPA”). IceCure yakanyorera kuchinjwa kwegwaro rekunyoresa kuti ibvumidze ma probe anoraswa, ayo, kana akatenderwa, anobvumidza kambani kushambadzira ma cryoprobe ayo eIceSense3 anoraswa kuti ashandiswe mukutengeserana, uye IceCure inotarisira kugamuchira mvumo yeNMPA yema probe panosvika kupera kwa2022.
"Shanghai Medtronic neTuring ishamwari dzakakodzera kwatiri munyika yeChina, uko tekinoroji ye cryoablation iri pasi pamusika. Tinoona mukana wakanaka wekushandiswa kwakapararira kweIceSense3 cryoablation system yedu munyika yeChina, musika uri kukura nekukurumidza. izvo zvinovandudza mhedzisiro," akadaro CEO weIceCure Eyal Shamir. "Sechikamu chekambani huru yezvigadzirwa zvekurapa pasi rose, Shanghai Medtronic ine ruzivo nesimba remusika rekugonesa IceSense3 kupinda mumusika nekukurumidza kuti ipe kurapwa kwakachengeteka, kunoshanda uye kusingadhuri kwekenza yemazamu yekutanga nezvimwe zviratidzo."
"IceCure ndiyo ine mushonga unotungamira pasi rose wekubvisa tumor cryoablation," akadaro Jing Yu, mutevedzeri wemutungamiri wenyika uye maneja mukuru weSkull, Spine and Orthopedic Technologies kuMedtronic Shanghai. Kubatana neIceCure neTuring Medical kuchabatsira Medtronic Shanghai's product line mu oncology neurosurgery. Tinovimba kuti kubatana uku kuchasimudzira kushandiswa kwe cryoablation mukiriniki uye kunobatsira varwere vakawanda vane tumor, uye tinotarisirawo kushanda nevamwe vakawanda kuti tikurumidze kugamuchira nekushandisa mishonga yepamusoro inobatsira kugadzirisa matambudziko makuru ekurapa tumor. Health Sector of China.
Mukuru weTuring, Lin Youjia, akawedzera kuti, "Tichishanda pamwe chete neShanghai Medtronic neIceCure, takazvipira kutanga kuisa uye kuisa nekukurumidza sisitimu yeIceSense3 munyika yeChina. Kuvapo kwedu munyika yese muChina kunoita kuti nzvimbo dzekurapa dziwane rutsigiro rwehunyanzvi uye sevhisi yepamusoro dzave dzichishandisa sisitimu yavo yeIceSense3 kwenguva yakareba."
Musi wa12 Chikumi 2022 (“Zuva Rekutanga”), IceCure Shanghai yakapinda muchibvumirano chekutengesa nekugovera (“Chibvumirano Chekugovera”) neShanghai Medtronic neTuring cheIceSense3 uye maprobes anoraswa (“Zvigadzirwa”) kwenguva yekutanga. Mwedzi makumi matatu nematanhatu, chinangwa chekutenga chenguva iyi i$3.5 miriyoni (“Chinangwa Chekutenga Chishoma”). Pasi pechibvumirano chekugovera, IceCure Shanghai ichatengesa zvigadzirwa zveTuring uye Turing ichatenga zvigadzirwa kubva kuIsrael kuenda kuChina uye yozozvitengesazve kuMedtronic Shanghai. Medtronic Shanghai ichave nebasa re, pakati pezvimwe zvinhu: (i) kushambadzira nekushambadza chigadzirwa ichi munyika yeChina; (ii) kuita mabasa ehunyanzvi ekudzidzisa zvekurapa kwechigadzirwa ichi munyika yeChina. Turing ichave nebasa rekuchengetedza, logistics, waranti, kudzidziswa uye mamwe mabasa ekutsigira uye mushure mekutengesa.
Pasi pemitemo yechibvumirano chekugovera, Shanghai Medtronic ine kodzero yekuwedzera nguva yechibvumirano chekugovera kwemakore matatu kana ikasvika pachinangwa chekutenga chemakore matatu, zvichienderana nechibvumirano chechinangwa chitsva chekutenga chepasi. Chibvumirano cheMugoveri chinogona kugumiswa pasi pemamwe mamiriro ezvinhu, kusanganisira kana paine kutadza kubhadhara, kutadza kubhadhara kana kusakwanisa kubhadhara.
Pamusoro pezvo, zvichienderana nemitemo yeDistributor Agreement, IceCure Shanghai ichave nebasa rekuwana nekuchengetedza chero mvumo dzese dzemutemo ("Regulatory Approvals") dzinodiwa kuti dzishambadze, dzishambadze, dziparadzire, dzitengese uye dzishandise Zvigadzirwa muChina. NMPA, bazi rayo remunharaunda, kana chero rimwe sangano rehurumende ("Regulatory Authority"). IceCure Shanghai yakagamuchira mvumo yemutemo yeIceSense3 System Console uye inoda mvumo yemutemo yeIceSense3 disposable cryoprobe yemaitiro ekutengeserana mukati memwedzi mipfumbamwe kubva pazuva rekutanga kwechibvumirano chekugovera. Shanghai Medtronic ine kodzero yekugumisa chibvumirano chekugovera kana IceCure Shanghai ikasagamuchira mvumo yemutemo ye cryoprobes panguva iyoyo.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) inovandudza uye inotengesa ProSense®, mushonga wepamusoro wemvura une nitrogen cryoablative wekurapa bundu (risina njodzi uye rine kenza) ne cryotherapy, kunyanya kunanga kenza yemazamu, itsvo, mapfupa nemapapu. crayfish. Tekinoroji yayo isinganyanyi kukuvadza inopa imwe nzira yakachengeteka uye inoshanda pane kuvhiyiwa kwebundu muchipatara, ine nguva pfupi yekuvhiya uye nzira yekuvhiya iri nyore kuita. Kusvika pari zvino, sisitimu iyi iri kutengeswa uye kutengeswa pasi rese nekuda kwezviratidzo zvinotenderwa neFDA uye yakatenderwa neCE Mark muEurope.
Chiziviso ichi chine zvirevo zvekutarisira ramangwana mukati mezvinoreva "kuchengetedzwa kwenzvimbo" zvePrivate Securities Litigation Reform Act ya1995 nemimwe mitemo yehurumende yezvibatiso. Mashoko akadai sekuti "tarisira", "tarisira", "ronga", "ronga", "tenda", "ronga", "fungidzira" uye mamwe mazwi akafanana kana akasiyana emashoko akadaro akagadzirirwa kureva zvirevo zvekutarisira ramangwana. Semuenzaniso, IceCure inoshandisa zvirevo zvekutarisira ramangwana muchinyorwa ichi painotaura nezvezvibvumirano zvekugovera neShanghai Medtronic neTuring, hurongwa hwekambani hwekutonga, mabasa ekutengeserana, uye mikana yemusika yemasisitimu ekambani ekucheneswa kwemafuta muChina. Nekuti zvirevo zvakadaro zvine chekuita nezviitiko zveramangwana uye zvakavakirwa patarisiro yazvino yeIceCure, zvinosangana nenjodzi dzakasiyana-siyana uye kusava nechokwadi, uye mhedzisiro chaiyo yeIceCure, mashandiro kana kubudirira kunogona kusiyana neizvo zvakatsanangurwa kana kutaurwa nezvirevo muchinyorwa ichi. Pane misiyano yakakosha. . Mashoko anotarisa mberi ari muchinyorwa chino kana kuti anotaurwa muchinyorwa chino anosangana nedzimwe njodzi uye kusava nechokwadi, mazhinji acho ari kunze kwesimba reKambani, kusanganisira ayo anotsanangurwa muchikamu che "Risk Factors" cheMushumo weGore weKambani paFomu 20-F rakaiswa muSEC kubva muna Kubvumbi 1, 2022 wegore rakapera musi wa31 Zvita, 2021, rinowanikwa pawebhusaiti yeSEC pa www.sec.gov. Kambani haina chisungo chekuvandudza zvirevo izvi kuti zvigadziriswe kana kuchinjwa mushure mezuva rekuburitswa uku kwechinyorwa, kunze kwekunge zvichidikanwa nemutemo.