Xov xwm

Caesarea, Ixayees, Lub Rau Hli 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” lossis “Lub Tuam Txhab”), kev kho mob cryotherapy uas tsis muaj kev cuam tshuam ntau (“IceCure (Shanghai) MedTech Co., Ltd. (“IceCure”, ib lub tuam txhab me me uas IceCure (Shanghai) MedTech Co., Ltd. Shanghai muaj tag nrho), tau kos npe rau daim ntawv cog lus los tsim lub tshuab IceSense3 cryoablation nrog Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), ib lub tuam txhab me me ntawm Medtronic Corporation (NYSE: MDT) (“Medtronic”) thiab Beijing Turing Medical Technology Co., Ltd. (“Turing”) Cov kab ke IceSense3 thawj zaug yuav raug xa tawm hauv xyoo 2022.
Medtronic Shanghai yuav dhau los ua tus neeg faib khoom ib leeg ntawm IceSense3 thiab nws cov probes pov tseg hauv Suav teb rau lub sijhawm peb xyoos thawj zaug, nrog rau lub hom phiaj yuav khoom tsawg kawg yog $ 3.5 lab thaum lub sijhawm no. Tsis tas li ntawd, hauv Suav teb, Shanghai Medtronic yuav tsis nqis peev ncaj qha lossis tsis ncaj qha rau hauv lossis pauv, muag, ua lag luam, txhawb nqa lossis muab cov khoom uas sib tw nrog IceSense3 thaum lub sijhawm ntawm daim ntawv cog lus faib khoom thiab dhau rau (6) lub hlis. Turing yuav yog tus saib xyuas kev xa khoom, kev teeb tsa thiab kev pabcuam tom qab muag ntawm IceSense3 system hauv Suav teb, thaum Medtronic Shanghai yuav ua txhua yam kev lag luam, kev muag khoom thiab qee yam kev cob qhia kev tshaj lij.
Lub IceSense3 System Console tau txais kev pom zoo los ntawm Tuam Tshoj National Medical Products Administration ("NMPA"). IceCure tau thov kom hloov daim ntawv pov thawj rau kev sau npe kom pom zoo cov khoom siv pov tseg uas, yog tias pom zoo, yuav tso cai rau lub tuam txhab muag nws cov khoom siv pov tseg IceSense3 rau kev siv lag luam, thiab IceCure xav tias yuav tau txais kev pom zoo los ntawm NMPA rau cov khoom siv pov tseg thaum kawg ntawm xyoo 2022.
"Shanghai Medtronic thiab Turing yog cov khub zoo tshaj plaws rau peb hauv Suav teb, qhov twg kev nkag mus rau hauv kev lag luam ntawm cov thev naus laus zis cryoablation tam sim no qis. Peb pom ib lub sijhawm zoo heev rau kev siv dav dav ntawm peb lub tshuab IceSense3 cryoablation hauv Suav teb, 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 tuam txhab khoom siv kho mob loj tshaj plaws hauv ntiaj teb, Shanghai Medtronic muaj kev paub dhau los thiab lub zog ua lag luam los pab kom IceSense3 nkag mus rau hauv kev lag luam sai sai los muab kev kho mob zoo, zoo thiab pheej yig rau mob qog noj ntshav mis thaum ntxov thiab lwm yam tsos mob."
"IceCure muaj lub ntiaj teb txoj kev daws teeb meem cryoablation mob qog noj ntshav," Jing Yu, tus lwm thawj coj thiab tus thawj coj ntawm Skull, Spine thiab Orthopedic Technologies ntawm Medtronic Shanghai hais. Kev koom tes nrog IceCure thiab Turing Medical yuav ua kom Medtronic Shanghai cov khoom lag luam hauv kev phais mob qog noj ntshav. Peb vam tias kev koom tes no yuav ua rau kev siv cryoablation kho mob zoo dua thiab pab tau ntau tus neeg mob qog noj ntshav, thiab peb kuj tos ntsoov yuav ua haujlwm nrog ntau tus khub kom ua kom sai dua kev siv thiab kev siv cov kev daws teeb meem kho mob siab heev uas yuav pab daws cov teeb meem tseem ceeb ntawm kev kho mob qog noj ntshav. Kev Noj Qab Haus Huv ntawm Tuam Tshoj.
Turing CEO Lin Youjia ntxiv tias, "Ua ke nrog Shanghai Medtronic thiab IceCure, peb cog lus tias yuav pib xa tawm thiab teeb tsa sai ntawm IceSense3 system hauv Suav teb. Peb lub tebchaws nyob hauv Suav teb ua kom cov chaw kho mob tau txais kev txhawb nqa zoo tshaj plaws thiab kev pabcuam tau siv lawv lub IceSense3 system ntev heev lawm."
Thaum Lub Rau Hli 12, 2022 ("Hnub Siv Tau"), IceCure Shanghai tau nkag mus rau hauv daim ntawv cog lus muag khoom thiab faib khoom tshwj xeeb ("Daim Ntawv Cog Lus Faib Khoom") nrog Shanghai Medtronic thiab Turing rau IceSense3 thiab cov khoom siv pov tseg ("Khoom") rau lub sijhawm pib. 36 lub hlis, lub hom phiaj yuav khoom tsawg kawg nkaus rau lub sijhawm no yog $ 3.5 lab ("Lub Hom Phiaj Yuav Khoom Tsawg Kawg Nkaus"). Raws li daim ntawv cog lus faib khoom, IceCure Shanghai yuav muag cov khoom Turing thiab Turing yuav xa cov khoom los ntawm Ixayees mus rau Tuam Tshoj thiab tom qab ntawd muag dua rau Medtronic Shanghai. Medtronic Shanghai yuav yog tus saib xyuas, ntawm lwm yam: (i) kev lag luam thiab kev txhawb nqa cov khoom hauv Tuam Tshoj; (ii) ua cov haujlwm kev kawm txog kev kho mob rau cov khoom hauv Tuam Tshoj. Turing yuav yog tus saib xyuas kev khaws cia, kev thauj mus los, kev lees paub, kev cob qhia thiab lwm yam kev txhawb nqa thiab kev pabcuam tom qab muag.
Raws li cov lus cog tseg ntawm daim ntawv cog lus faib khoom, Shanghai Medtronic muaj cai txuas lub sijhawm ntawm daim ntawv cog lus faib khoom mus rau peb xyoos yog tias nws mus txog lub hom phiaj yuav khoom tsawg kawg nkaus peb xyoos, raws li kev pom zoo ntawm lub hom phiaj yuav khoom tsawg kawg nkaus tshiab. Daim Ntawv Cog Lus Faib Khoom yuav raug tshem tawm raws li qee qhov xwm txheej, suav nrog thaum muaj kev ua tsis tau raws li qhov yuav tsum tau ua, kev ua tsis tau raws li qhov yuav tsum tau ua lossis kev lag luam tsis muaj peev xwm them taus.
Ntxiv mus, raws li cov lus cog tseg ntawm Daim Ntawv Cog Lus Distributor, IceCure Shanghai yuav yog tus lav ris kom tau txais thiab tswj txhua qhov kev pom zoo los ntawm cov cai lij choj ("Kev Pom Zoo Los Ntawm Cov Cai") uas yuav tsum tau ua lag luam, txhawb nqa, faib tawm, muag thiab siv cov khoom hauv Suav teb loj. NMPA, nws ceg hauv zos, lossis lwm lub koom haum tsoomfwv ("Lub Chaw Haujlwm Saib Xyuas Kev Cai Lij Choj"). IceCure Shanghai tau txais kev pom zoo los ntawm cov cai lij choj rau IceSense3 System Console thiab xav tau kev pom zoo los ntawm cov cai lij choj rau IceSense3 cryoprobe uas siv pov tseg rau cov txheej txheem lag luam hauv cuaj lub hlis txij li hnub uas daim ntawv cog lus faib khoom siv tau. Shanghai Medtronic muaj cai xaus daim ntawv cog lus faib khoom yog tias IceCure Shanghai tsis tau txais kev pom zoo los ntawm cov cai lij choj rau cryoprobes los ntawm lub sijhawm ntawd.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) tsim thiab ua lag luam ProSense®, ib qho kev kho mob kua nitrogen cryoablative siab heev rau kev kho cov qog (benign thiab cancerous) nrog cryotherapy, feem ntau tsom mus rau mob qog mis, raum, pob txha thiab ntsws. crayfish. Nws cov thev naus laus zis minimally invasive muab kev nyab xeeb thiab zoo dua li kev phais mob qog hauv tsev kho mob, nrog lub sijhawm ua haujlwm luv luv thiab yooj yim ua phais. Txog niaj hnub no, lub kaw lus tau muag thiab ua lag luam thoob ntiaj teb rau FDA pom zoo cov cim thiab yog CE Mark pom zoo hauv Tebchaws Europe.
Tsab xov xwm tshaj tawm no muaj cov lus hais txog yav tom ntej raws li lub ntsiab lus ntawm cov kev cai "chaw nyab xeeb" ntawm Private Securities Litigation Reform Act ntawm xyoo 1995 thiab lwm cov kev cai lij choj hauv tsoomfwv. Cov lus xws li "xav txog", "xav txog", "npaj", "npaj", "ntseeg", "npaj", "kwv yees" thiab cov lus zoo sib xws lossis kev hloov pauv ntawm cov lus no yog siv los hais txog cov lus hais txog yav tom ntej. Piv txwv li, IceCure siv cov lus hais txog yav tom ntej hauv tsab xov xwm tshaj tawm no thaum tham txog cov ntawv cog lus faib khoom nrog Shanghai Medtronic thiab Turing, lub tuam txhab txoj kev tswj hwm, kev ua lag luam, thiab cov cib fim ua lag luam rau lub tuam txhab cov tshuab cryoablation hauv Suav teb loj. Vim tias cov lus hais no cuam tshuam nrog cov xwm txheej yav tom ntej thiab yog raws li IceCure qhov kev cia siab tam sim no, lawv raug rau ntau yam kev pheej hmoo thiab kev tsis paub meej, thiab IceCure cov txiaj ntsig tiag tiag, kev ua tau zoo lossis kev ua tiav yuav txawv ntawm cov uas tau piav qhia lossis hais los ntawm cov lus hauv tsab xov xwm tshaj tawm no. Muaj qhov sib txawv tseem ceeb. . Cov lus hais txog yav tom ntej uas muaj nyob hauv tsab xov xwm no lossis hais tsis meej yog raug rau lwm yam kev pheej hmoo thiab kev tsis paub tseeb, ntau yam uas tsis yog lub Tuam Txhab tswj hwm, suav nrog cov uas tau piav qhia hauv ntu "Cov Yam Txaus Ntshai" ntawm Daim Ntawv Qhia Txhua Xyoo ntawm Lub Tuam Txhab ntawm Daim Ntawv 20-F uas tau xa mus rau SEC txij li lub Plaub Hlis 1, 2022 rau xyoo xaus rau lub Kaum Ob Hlis 31, 2021, muaj nyob rau ntawm lub vev xaib SEC ntawm www.sec.gov. Lub Tuam Txhab tsis muaj lub luag haujlwm los hloov kho cov lus no rau kev kho dua tshiab lossis hloov pauv tom qab hnub ntawm tsab xov xwm no, tshwj tsis yog tias yuav tsum ua li ntawd los ntawm txoj cai.