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Caesarea, Israel, Lub Rau Hli 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" lossis "Lub Tuam Txhab"), minimally invasive cryotherapy ("IceCure (Shanghai) MedTech Co. . , Ltd. (“IceCure”, ib lub koom haum ua lag luam ntawm IceCure (Shanghai) MedTech Co., Ltd. Shanghai”), tau kos npe rau daim ntawv cog lus los tsim IceSense3 cryoablation system nrog Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), ib lub koom haum ntawm Medtronic Corporation (NYSE: MDT) (“Medtronic”) thiab Beijing Turing Medical Technology Co., Ltd. (“Turing”) Thawj IceSense3 systems yuav tsum xa tuaj rau xyoo 2022.
Medtronic Shanghai yuav dhau los ua tus xa tawm ib leeg ntawm IceSense3 thiab nws cov khoom pov tseg pov tseg hauv Suav teb av loj rau thawj peb lub xyoos, nrog rau lub hom phiaj yuav tsawg kawg yog $ 3.5 lab nyob rau lub sijhawm no. Tsis tas li ntawd, nyob rau hauv Suav teb av loj, Shanghai Medtronic yuav tsis ncaj qha los yog tsis ncaj qha nqis peev nyob rau hauv los yog ua lag luam, muag, ua lag luam, txhawb los yog muab ib yam khoom uas sib tw nrog IceSense3 lub sij hawm ntawm lub sij hawm ntawm daim ntawv cog lus tis thiab tshaj rau (6) lub hlis. Turing yuav yog lub luag haujlwm rau kev ntshuam, kev teeb tsa thiab kev muag khoom tom qab ntawm IceSense3 system hauv Suav teb av loj, thaum Medtronic Shanghai yuav ua txhua yam kev lag luam, muag khoom thiab qee yam kev cob qhia.
Lub IceSense3 System Console tau pom zoo los ntawm Tuam Tshoj National Medical Products Administration ("NMPA"). IceCure tau thov rau daim ntawv pov thawj kev hloov pauv kom pom zoo cov kev tshawb fawb pov tseg uas, yog tias pom zoo, yuav tso cai rau lub tuam txhab ua lag luam nws cov IceSense3 pov tseg cryoprobes rau kev lag luam siv, thiab IceCure xav tias yuav tau txais kev pom zoo NMPA rau kev sojntsuam thaum kawg ntawm 2022.
"Shanghai Medtronic thiab Turing yog cov koom tes zoo tshaj plaws rau peb hauv Suav teb av loj, qhov chaw nkag mus rau kev lag luam ntawm cryoablation technology tam sim no qis. Peb pom lub sijhawm zoo rau kev siv dav dav ntawm peb lub IceSense3 cryoablation system hauv Suav teb av loj, kev lag luam uas loj hlob sai heev. uas txhim kho cov txiaj ntsig, "said IceCure CEO Eyal Shamir. "Raws li ib feem ntawm lub ntiaj teb cov cuab yeej siv kho mob loj tshaj plaws, Shanghai Medtronic muaj kev paub dhau los thiab lub zog ua lag luam los ua kom muaj kev nkag mus rau kev lag luam sai ntawm IceSense3 los muab kev nyab xeeb, zoo thiab raug nqi kho mob rau mob qog noj ntshav thaum ntxov thiab lwm yam kev qhia."
Jing Yu, tus lwm thawj coj thiab tus thawj tswj hwm ntawm Skull, Spine thiab Orthopedic Technologies ntawm Medtronic Shanghai hais tias "IceCure muaj lub ntiaj teb ua cov qog cryoablation daws teeb meem," Kev koom tes nrog IceCure thiab Turing Medical yuav ntxiv rau Medtronic Shanghai cov khoom kab hauv oncology neurosurgery. Peb cia siab tias qhov kev sib koom tes no yuav ua rau kev siv tshuaj kho mob cryoablation thiab tau txais txiaj ntsig ntau dua rau cov neeg mob qog noj ntshav, thiab peb tseem tos ntsoov yuav ua haujlwm nrog ntau tus neeg koom tes txhawm rau txhawm rau txhawm rau txais thiab xa cov kev kho mob siab heev uas yuav pab daws cov teeb meem tseem ceeb hauv kev kho mob qog noj ntshav. Kev Noj Qab Haus Huv Sector ntawm Tuam Tshoj.
Turing CEO Lin Youjia tau hais ntxiv, "Hauv kev koom tes nrog Shanghai Medtronic thiab IceCure, peb tau cog lus tias yuav pib xa tawm thiab kev teeb tsa sai ntawm IceSense3 system hauv Suav teb av loj. Peb lub tebchaws muaj nyob hauv Suav teb loj kom ntseeg tau tias cov chaw kho mob tau txais kev txhawb nqa kev tshaj lij thiab kev pabcuam tau siv lawv cov txheej txheem IceSense3 tau ntev. "
Thaum Lub Rau Hli 12, 2022 ("Hnub Ua Haujlwm"), IceCure Shanghai tau nkag mus rau hauv daim ntawv cog lus muag thiab kev faib khoom tshwj xeeb ("Daim Ntawv Pom Zoo Tshaj Tawm") nrog Shanghai Medtronic thiab Turing rau IceSense3 thiab cov khoom siv pov tseg ("Cov Khoom") rau lub sijhawm pib. 36 lub hlis, lub hom phiaj kev yuav khoom yam tsawg kawg nkaus rau lub sijhawm no yog $ 3.5 lab ("Tsim Yam Tsawg Yuav Tsum"). Raws li daim ntawv cog lus xa tawm, IceCure Shanghai yuav muag cov khoom lag luam Turing thiab Turing yuav xa cov khoom lag luam los ntawm cov neeg Ixayees mus rau Tuam Tshoj av loj thiab tom qab ntawd rov muag rau Medtronic Shanghai. Medtronic Shanghai yuav yog lub luag haujlwm rau, ntawm lwm yam: (i) kev lag luam thiab kev txhawb nqa ntawm cov khoom hauv Suav teb av loj; (ii) ua haujlwm kev kawm kho mob rau cov khoom lag luam hauv Suav teb av loj. Turing yuav yog lub luag haujlwm rau kev xa khoom, kev xa khoom, kev tiv thaiv, kev cob qhia thiab lwm yam kev txhawb nqa thiab kev pabcuam tomqab muag.
Raws li cov ntsiab lus ntawm daim ntawv cog lus kev faib khoom, Shanghai Medtronic muaj txoj cai txuas ntxiv lub sij hawm ntawm daim ntawv cog lus faib khoom rau peb lub xyoos yog tias nws ncav cuag peb lub xyoos yam tsawg kawg nkaus yuav lub hom phiaj, raws li kev pom zoo ntawm lub hom phiaj yuav khoom tsawg kawg nkaus tshiab. Daim Ntawv Pom Zoo Distributor tuaj yeem raug txiav tawm raws li qee qhov xwm txheej, suav nrog thaum muaj xwm txheej, cov khoom siv tsis raug lossis poob nyiaj.
Tsis tas li ntawd, raws li cov lus cog tseg ntawm Cov Neeg Muag Khoom, IceCure Shanghai yuav yog lub luag haujlwm kom tau txais thiab tswj txhua qhov kev pom zoo ("Regulatory Approvals") yuav tsum tau ua lag luam, txhawb, faib, muag thiab siv cov khoom hauv Suav teb av loj. NMPA, nws cov ceg hauv cheeb tsam, lossis lwm lub koom haum tseemfwv (“Txoj Cai Tswjfwm”). IceCure Shanghai tau txais kev pom zoo kev tswj hwm rau IceSense3 System Console thiab xav tau kev tswj hwm kev pom zoo rau IceSense3 pov tseg cryoprobe rau cov txheej txheem lag luam tsis pub dhau cuaj lub hlis txij li hnub pib ntawm daim ntawv cog lus xa tawm. Shanghai Medtronic muaj txoj cai txiav tawm daim ntawv cog lus xa tawm yog tias IceCure Shanghai tsis tau txais kev pom zoo kev cai rau cryoprobes thaum ntawd.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) tsim thiab ua lag luam ProSense®, ib qho kev kho mob siab heev nitrogen cryoablative rau kev kho cov qog (benign thiab cancerous) nrog cryotherapy, feem ntau tsom rau lub mis, lub raum, pob txha thiab mob qog noj ntshav. crayfish. Nws qhov kev siv thev naus laus zis me me muab kev nyab xeeb thiab siv tau zoo rau cov neeg mob hauv kev phais tshem tawm cov qog, nrog lub sijhawm ua haujlwm luv luv thiab cov txheej txheem phais yooj yim. Txog rau tam sim no, lub kaw lus tau ua lag luam thiab muag thoob ntiaj teb rau FDA pom zoo qhia thiab yog CE Mark pom zoo hauv Tebchaws Europe.
Cov ntawv tshaj tawm no muaj cov lus qhia yav tom ntej nyob rau hauv lub ntsiab lus ntawm "kev nyab xeeb chaw nres nkoj" cov kev cai ntawm Private Securities Litigation Reform Act of 1995 thiab lwm txoj cai lij choj ntawm tsoomfwv. Cov lus xws li "cia siab", "cia siab", "xav tau", "npaj", "ntseeg", "xav tau", "kwv yees" thiab cov lus zoo sib xws lossis kev hloov pauv ntawm cov lus no yog npaj los xa mus rau cov nqe lus yav tom ntej. Piv txwv li, IceCure siv cov lus qhia yav tom ntej hauv tsab xov xwm tshaj tawm no thaum tham txog kev cog lus kev faib khoom nrog Shanghai Medtronic thiab Turing, lub tuam txhab txoj cai tswj hwm, kev ua lag luam, thiab kev ua lag luam rau lub tuam txhab cryoablation systems hauv Suav teb av loj. Vim hais tias cov lus no muaj feem xyuam rau cov xwm txheej yav tom ntej thiab yog raws li IceCure qhov kev cia siab tam sim no, lawv raug rau ntau yam txaus ntshai thiab tsis paub tseeb, thiab IceCure cov txiaj ntsig tiag tiag, kev ua tau zoo lossis kev ua tiav yuav txawv ntawm cov tau piav qhia lossis hais los ntawm cov lus hauv tsab xov xwm no. Muaj qhov sib txawv tseem ceeb. . Cov lus tshaj tawm yav tom ntej uas muaj lossis hais qhia hauv qhov kev tshaj tawm xov xwm no yuav raug rau lwm yam kev pheej hmoo thiab tsis paub tseeb, ntau yam uas dhau los ntawm Tuam Txhab kev tswj hwm, suav nrog cov uas tau piav qhia hauv "Risk Factors" ntu ntawm Lub Tuam Txhab Daim Ntawv Qhia Txhua Xyoo ntawm Daim Ntawv 20-F tau sau rau hauv SEC txij lub Plaub Hlis 1, 2022 rau lub xyoo xaus rau lub Kaum Ob Hlis 31, 2021, muaj nyob rau ntawm SEC lub vev xaib ntawm www.sec.gov. Lub Tuam Txhab yuav tsis muaj lub luag haujlwm los hloov cov nqe lus no rau kev kho lossis hloov pauv tom qab hnub tshaj tawm xov xwm no, tshwj tsis yog yuav tsum ua raws li txoj cai.