News

Caesarea, Israel, June 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” kana kuti “Company”), minimally invasive cryotherapy (“IceCure (Shanghai) MedTech Co. , Ltd. (“IceCure”, imwe kambani inotsigirwa neIceCure (Shanghai) MedTech Co., Ltd. Shanghai”), yakasaina chibvumirano chekuvaka IceSense3 cryoablation system neShanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), mubatsiri weMedtronic Corporation (NYSE: MDT) (“Medtronic”) uye Beijing Turing Medical Technology Co., Ltd. (“Turing”) Yekutanga IceSense3 masisitimu anotarisirwa kuendeswa muna 2022.
Medtronic Shanghai ichave yega mugovanisi weIceSense3 uye maprobes ayo anoraswa munyika yeChina kwekutanga makore matatu, aine chinangwa chekutenga chinosvika mamirioni mazana matatu nemazana mashanu emadhora panguva ino. Pamusoro pezvo, munyika yeChina, Shanghai Medtronic haizodyara mari yakananga kana zvisina kunanga mukati kana kutengesa, kutengesa, musika, kusimudzira kana kupa chero chigadzirwa chinokwikwidza neIceSense3 panguva yechibvumirano chekugovera uye kupfuura mwedzi mitanhatu (6). Turing ichave nebasa rekupinza, kuisirwa uye mushure-kutengesa sevhisi yeIceSense3 sisitimu muChina, ukuwo Medtronic Shanghai ichabata zvese zvekushambadzira, kutengesa uye kumwe kudzidziswa kwehunyanzvi.
Iyo IceSense3 System Console inotenderwa neChina National Medical Products Administration (“NMPA”). IceCure yakanyorera shanduko yechitupa chekunyoresa kuti ibvumidze maprobes anoraswa ayo, kana akabvumidzwa, anotendera kambani kutengesa maIceSense3 anoraswa cryoprobes ekushandiswa kwekutengesa, uye IceCure inotarisira kugamuchira mvumo yeNMPA yemaprobes pakupera kwa2022.
"Shanghai Medtronic neTuring vadyidzani vakanaka kwatiri munyika yeChina, uko kupinda mumusika kwehunyanzvi hwekuchema kwakadzikira. Isu tinoona mukana wakanakisa wekutorwa kwakapararira kweyedu IceSense3 cryoablation system munyika yeChina, musika uri kukura nekukurumidza. izvo zvinovandudza mhedzisiro," akadaro IceCure CEO Eyal Shamir. "Sechikamu chekambani huru yepasirese yemidziyo yekurapa, Shanghai Medtronic ine ruzivo uye simba remusika rekugonesa kukurumidza kupinda mumusika weIceSense3 kuti ipe kurapa kwakachengeteka, kunoshanda uye kusingadhuri kwegomarara rekutanga rezamu uye zvimwe zviratidzo."
"IceCure ine inotungamira pasi rose bundu cryoablation solution," akadaro Jing Yu, mutevedzeri wemutungamiri uye maneja mukuru weSkull, Spine uye Orthopedic Technologies kuMedtronic Shanghai. Kudyidzana neIceCure uye Turing Medical kunozadzisa Medtronic Shanghai's chigadzirwa mutsara mune oncology neurosurgery. Tinovimba kuti kubatana uku kuchafambisira mberi chirongwa chekiriniki chekuchema uye kubatsira varwere vazhinji vebundu, uye isu tinotarisirawo kushanda nevamwe vatinoshanda navo kuti vakurumidze kutorwa uye kuendesa zvigadziriso zvekurapa zvepamberi izvo zvichabatsira kugadzirisa akakosha ekurapa bundu matambudziko. Health Sector yeChina.
Turing CEO Lin Youjia akawedzera kuti, "Mukubatana neShanghai Medtronic neIceCure, takazvipira kutanga kuendesa uye nekukasira kuisirwa IceSense3 system muChina. Kuvapo kwedu munyika yose muChina kunovimbisa kuti nzvimbo dzekurapa dzinowana rutsigiro rwepamusoro uye sevhisi yanga ichishandisa IceSense3 system yavo kwenguva yakareba. "
Musi waChikumi 12, 2022 ("Date Rinoshanda"), IceCure Shanghai yakapinda muchibvumirano chekutengesa uye chekugovera ("Chibvumirano Chekugovera") neShanghai Medtronic uye Turing yeIceSense3 uye maprobe anoraswa ("Zvigadzirwa") kwenguva yekutanga. Mwedzi makumi matatu nematanhatu, iyo yakaderera yekutenga chinangwa chenguva ino imadhora mazana matatu nemazana mashanu emadhora ("Minimum Purchase Target"). Pasi pechibvumirano chekugovera, IceCure Shanghai ichatengesa zvigadzirwa zveTuring uye Turing ichaunza zvigadzirwa kubva kuIsrael kuenda kune mainland China vozozvitengesa kuMedtronic Shanghai. Medtronic Shanghai ichave nebasa re, pakati pezvimwe zvinhu: (i) kushambadzira uye kusimudzirwa kwechigadzirwa mu mainland China; (ii) ita zviitiko zvehunyanzvi zvedzidzo yekurapa kune chigadzirwa mu mainland China. Turing ichave nebasa rekuchengetedza, logistics, waranti, kudzidziswa uye kumwe kutsigirwa uye mushure mekutengesa masevhisi.
Pasi pezvibvumirano zvechibvumirano chekugovera, Shanghai Medtronic ine kodzero yekuwedzera nguva yechibvumirano chekugovera kwemakore matatu kana ikasvika pakuwedzera kwemakore matatu ekutengwa kwepasi, zvichienderana nechibvumirano chechinangwa chitsva chekutenga. Chibvumirano cheDistributor chinogona kugumiswa mune mamwe mamiriro ezvinhu, kusanganisira kana pakaitika kukanganisa, kutadza kwezvinhu kana kusabhadhara.
Pamusoro pezvo, zvichienderana nezvirevo zveChibvumirano cheDistributor, IceCure Shanghai ichave nebasa rekuwana nekuchengetedza chero uye zvese zvibvumirano zvemutemo ("Regulatory Approvals") inodiwa kushambadzira, kusimudzira, kugovera, kutengesa uye kushandisa Zvigadzirwa mu mainland China. NMPA, bazi rayo remunharaunda, kana chero imwe sangano rehurumende (iyo "Regulatory Authority"). IceCure Shanghai yakagamuchira mvumo yemutemo yeIceSense3 System Console uye inoda kubvumidzwa kweiyo IceSense3 inoraswa cryoprobe yemaitiro ekutengesa mukati memwedzi mipfumbamwe kubva pazuva rekushanda kwechibvumirano chekugovera. Shanghai Medtronic ine kodzero yekumisa chibvumirano chekugovera kana IceCure Shanghai isingagamuchire mvumo yekudzora ye cryoprobes panguva iyoyo.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) inogadzira uye inotengesa ProSense®, yemhando yepamusoro nitrogen cryoablative therapy yekurapa mabundu (benign uye cancer) necryotherapy, inonyanya kunanga zamu, itsvo, bhonzo nekenza yemapapu. crayfish. Tekinoroji yayo ishoma inopinza inopa yakachengeteka uye inoshanda imwe nzira yekuvhiya yekubvisa bundu muvarwere, ine nguva pfupi yekuvhiya uye nzira yekuvhiya iri nyore. Parizvino, sisitimu inotengeswa uye inotengeswa pasi rese kune FDA yakatenderwa zviratidzo uye ndeye CE Mako yakatenderwa muEurope.
Kuburitswa kwenhau uku kune zvirevo zvinotarisa kumberi mukati mezvinoreva "chiteshi chengarava chakachengeteka" zviga zvePrivate Securities Litigation Reform Act of 1995 nemimwe mitemo yemubatanidzwa. Mazwi akadai sekuti “tarisira”, “tarisira”, “ronga”, “ronga”, “tenda”, “vavarira”, “fungira” uye matauriro akafanana kana misiyano yemazwi akadaro anoitirwa kureva mashoko anotarisira mberi. Semuyenzaniso, IceCure inoshandisa zvirevo zvekumberi mune ino kuburitswa kwenhau kana ichikurukura zvibvumirano zvekugovera neShanghai Medtronic neTuring, hurongwa hwekambani hwekutonga, zviitiko zvekutengesa, uye mikana yemusika yekambani yekuchema masisitimu muChina. Nekuti zvirevo zvakadaro zvine chekuita nezviitiko zvemunguva yemberi uye zvichibva pane zvinotarisirwa neIceCure, zviri pasi penjodzi dzakasiyana siyana uye kusava nechokwadi, uye mibairo chaiyo yeIceCure, kuita kana kubudirira kunogona kusiyana kubva kune zvakatsanangurwa kana kurehwa nezvakataurwa mukuburitswa kwenhau. Pane misiyano yakakura. . Matauriro anotarisa mberi arimo kana kurehwa mukuburitswa kwenhau aya ari pasi pedzimwe njodzi nekusavimbika, mazhinji acho ari kunze kwesimba reKambani, kusanganisira izvo zvinotsanangurwa muchikamu che "Risk Factors" cheKambani Yegore Report paFomu 20-F yakaiswa mu. SEC kubvira Kubvumbi 1, 2022 yegore rakapera Zvita 31, 2021, inowanikwa pawebhusaiti yeSEC pawww.sec.gov. Kambani haiite chero chisungo chekuvandudza izvi zvirevo kuti zvidzokororwe kana shanduko mushure mezuva rekuburitswa kwenhau, kunze kwekunge zvichidikanwa nemutemo.