Akụkọ

Caesarea, Israel, Juun 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" ma ọ bụ "Ụlọ ọrụ"), obere ọgwụ cryotherapy ("IceCure (Shanghai) MedTech Co.., Ltd. ("IceCure", ụlọ ọrụ IceCure (Shanghai) MedTech Co., Ltd. Shanghai"), bịanyere aka na nkwekọrịta iji wuo usoro cryoablation IceSense3 na Shanghai Medtronic Zhikang Medical Devices Co., Ltd. ("Shanghai Medtronic"), ụlọ ọrụ Medtronic Corporation (NYSE: MDT) ("Medtronic") na Beijing Turing Medical Technology Co., Ltd. ("Turing") A na-atụ anya na a ga-enye usoro IceSense3 mbụ na 2022.
Medtronic Shanghai ga-abụ naanị onye na-ekesa IceSense3 na ihe nyocha ya ndị a na-atụfu na mba China maka afọ atọ mbụ, yana ebumnuche ịzụta ihe kacha nta bụ $3.5 nde n'oge a. Na mgbakwunye, na mba China, Shanghai Medtronic agaghị etinye ego ozugbo ma ọ bụ n'ụzọ na-apụtaghị ìhè ma ọ bụ na-azụ ahịa, ire, ire ahịa, kwalite ma ọ bụ nye ngwaahịa ọ bụla nke na-asọmpi na IceSense3 n'oge nkwekọrịta nkesa na ihe karịrị ọnwa isii (6). Turing ga-ahụ maka mbubata, ntinye na ọrụ mgbe erechara nke sistemụ IceSense3 na mba China, ebe Medtronic Shanghai ga-ahụ maka ahịa, ire ahịa na ọzụzụ ọkachamara ụfọdụ.
Ụlọ Ọrụ Nlekọta Ngwaahịa Ahụike Mba nke China ("NMPA") kwadoro IceSense3 System Console. IceCure etinyela akwụkwọ maka mgbanwe asambodo ndebanye aha iji kwado nyocha ndị a na-atụfu atụfu nke, ọ bụrụ na akwadoro, ga-enye ụlọ ọrụ ahụ ohere ire cryoprobes IceSense3 ha maka ojiji azụmaahịa, IceCure na-atụkwa anya inweta nkwado NMPA maka nyocha ndị ahụ tupu ngwụcha afọ 2022.
"Shanghai Medtronic na Turing bụ ndị mmekọ zuru oke maka anyị na mba China, ebe ahịa teknụzụ cryoablation dị ala ugbu a. Anyị na-ahụ ohere dị mma maka nnabata nke usoro cryoablation IceSense3 anyị n'ebe niile na China, ahịa nke na-eto ngwa ngwa. nke na-eme ka nsonaazụ ka mma," ka onye isi ụlọ ọrụ IceCure bụ Eyal Shamir kwuru. "Dịka akụkụ nke ụlọ ọrụ ngwaọrụ ahụike kachasị ukwuu n'ụwa, Shanghai Medtronic nwere ahụmịhe na ike ahịa iji mee ka IceSense3 banye ngwa ngwa n'ahịa iji nye ọgwụgwọ dị nchebe, dị irè na ọnụ ahịa maka ọrịa kansa ara na ihe ngosi ndị ọzọ."
"IceCure nwere ngwọta kachasị elu n'ụwa maka ịkụ mkpụrụ osisi tumor," ka Jing Yu, osote onye isi oche na onye njikwa izugbe nke Skull, Spine na Orthopedic Technologies na Medtronic Shanghai kwuru. Mmekọrịta ya na IceCure na Turing Medical ga-emeju usoro ngwaahịa Medtronic Shanghai na ịwa ahụ akwara oncology. Anyị nwere olileanya na mmekorita a ga-eme ka ojiji cryoablation dịkwuo mma ma baara ọtụtụ ndị ọrịa kansa uru, anyị na-atụkwa anya ịrụ ọrụ na ndị mmekọ ndị ọzọ iji mee ka nnabata na ntinye nke ngwọta ahụike dị elu nke ga-enyere aka idozi nsogbu ọgwụgwọ tumor dị mkpa. Ngalaba Ahụike nke China.
Lin Youjia, onyeisi ụlọ ọrụ Turing, kwukwara, sị, "Site na njikọ aka anyị na Shanghai Medtronic na IceCure, anyị na-agba mbọ ịmalite ntinye na ntinye ngwa ngwa nke usoro IceSense3 na China. Ọnụnọ anyị na China na mba niile na-eme ka ebe ahụike nweta nkwado teknụzụ dị elu ma na-enye ọrụ kemgbe ogologo oge."
Na June 12, 2022 ("Ụbọchị Mmalite"), IceCure Shanghai banyere nkwekọrịta ahịa na nkesa pụrụ iche ("Nkwekọrịta Nkesa") na Shanghai Medtronic na Turing maka IceSense3 na nyocha ndị a na-atụfu ("Ngwaahịa") maka oge mbụ. N'ime ọnwa 36, ​​ebumnuche ịzụta kacha nta maka oge a bụ nde $3.5 ("Nzube Ịzụta Kacha nta"). N'okpuru nkwekọrịta nkesa, IceCure Shanghai ga-ere ngwaahịa Turing na Turing ga-ebubata ngwaahịa site na Israel gaa na China wee ree ha ọzọ na Medtronic Shanghai. Medtronic Shanghai ga-ahụ maka, n'etiti ihe ndị ọzọ: (i) ahịa na nkwalite nke ngwaahịa ahụ na China; (ii) ịme ihe omume agụmakwụkwọ ahụike ọkachamara maka ngwaahịa ahụ na China. Turing ga-ahụ maka nchekwa ngwaahịa, njem, akwụkwọ ikike, ọzụzụ na nkwado ndị ọzọ na ọrụ mgbe erechara ahịa.
Dịka nkwekọrịta nkesa si dị, Shanghai Medtronic nwere ikike ịgbatị oge nkwekọrịta nkesa ahụ ruo afọ atọ ma ọ bụrụ na ọ ruru ebumnuche ịzụrụ ihe kacha nta nke afọ atọ, dabere na nkwekọrịta nke ebumnuche ịzụrụ ihe kacha nta ọhụrụ. Enwere ike ịkwụsị Nkwekọrịta Onye Nkesa n'ọnọdụ ụfọdụ, gụnyere ma ọ bụrụ na enweghị ndabara, enweghị ndabara ma ọ bụ enweghị ego.
Na mgbakwunye, dịka usoro nke Nkwekọrịta Onye Kesara si dị, IceCure Shanghai ga-ahụ maka inweta na idobe nkwenye iwu ọ bụla ("Nkwenye Iwu") achọrọ iji ree, kwalite, kesaa, ree ma jiri Ngwaahịa ndị dị na mba China. NMPA, alaka obodo ya, ma ọ bụ ụlọ ọrụ gọọmentị ọ bụla ọzọ ("Iwu Nchịkwa"). IceCure Shanghai enwetala nkwenye iwu maka IceSense3 System Console ma chọọ nkwenye iwu maka cryoprobe IceSense3 a na-atụfu maka usoro azụmahịa n'ime ọnwa itoolu site na ụbọchị nkwekọrịta nkesa ahụ malitere ịrụ ọrụ. Shanghai Medtronic nwere ikike ịkwụsị nkwekọrịta nkesa ma ọ bụrụ na IceCure Shanghai enwetaghị nkwenye iwu maka cryoprobes mgbe ahụ.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) na-emepụta ma na-ere ProSense®, ọgwụgwọ dị elu maka ọgwụgwọ ọnya afọ (nke dị mma na nke na-akpata kansa) site na iji cryotherapy, nke na-elekwasị anya na kansa ara, akụrụ, ọkpụkpụ na akpa ume. Crayfish. Teknụzụ ya nke na-awakpo obere ihe na-enye ụzọ dị mma ma dị irè maka ịwa ahụ iwepụ etuto ahụ n'ime ụlọ ọgwụ, yana obere oge ọrụ na usoro ịwa ahụ dị mfe ịrụ. Ruo taa, a na-ere ma na-ere sistemụ ahụ n'ụwa niile maka ihe ngosi FDA kwadoro ma bụrụkwa nke CE Mark kwadoro na Europe.
Nkwupụta mgbasa ozi a nwere nkwupụta ndị na-ele anya n'ihu dịka ihe dị na ndokwa "ebe nchekwa" nke Iwu Mgbanwe Ikpe nke Onwe nke 1995 na iwu nchekwa gọọmentị etiti ndị ọzọ. Okwu ndị dị ka "tụ anya", "atụ anya", "ebumnuche", "atụmatụ", "kwere", "ezube", "atụmatụ" na okwu ndị yiri ya ma ọ bụ mgbanwe nke okwu ndị dị otú ahụ bụ iji zoo aka na nkwupụta ndị na-ele anya n'ihu. Dịka ọmụmaatụ, IceCure na-eji nkwupụta ndị na-ele anya n'ihu na nkwupụta mgbasa ozi a mgbe ọ na-atụle nkwekọrịta nkesa na Shanghai Medtronic na Turing, atụmatụ iwu ụlọ ọrụ ahụ, ọrụ azụmaahịa, na ohere ahịa maka sistemụ cryoablation nke ụlọ ọrụ ahụ na China. N'ihi na nkwupụta ndị dị otú ahụ metụtara ihe omume n'ọdịnihu ma dabere na atụmanya IceCure ugbu a, ha na-enwe ihe egwu na ejighị n'aka dị iche iche, nsonaazụ, arụmọrụ ma ọ bụ ihe ndị IceCure rụzuru nwere ike ịdị iche na nke akọwapụtara ma ọ bụ nke nkwupụta ndị dị na nkwupụta mgbasa ozi a. E nwere nnukwu ọdịiche. . Nkwupụta ndị a na-ele anya n'ihu dị n'ime ma ọ bụ nke e gosipụtara n'akwụkwọ akụkọ a nwere ike ịnwe ihe egwu na ihe ndị ọzọ na-ejighị n'aka, ọtụtụ n'ime ha karịrị ike ụlọ ọrụ ahụ, gụnyere ndị a kọwara na ngalaba "Ihe Ndị Na-akpata Ihe Ize Ndụ" nke Akụkọ Kwa Afọ nke Ụlọ Ọrụ ahụ na Fọm 20-F nke e tinyere na SEC dịka Eprel 1, 2022 maka afọ gwụchara Disemba 31, 2021, dị na weebụsaịtị SEC na www.sec.gov. Ụlọ ọrụ ahụ anaghị arụ ọrụ ọ bụla iji melite nkwupụta ndị a maka mgbanwe ma ọ bụ mgbanwe mgbe ụbọchị ewepụtachara nkwupụta a gasịrị, belụsọ ma iwu chọrọ ka o mee ya.