Akụkọ

Caesarea, Israel, Jun 13, 2022 / PRNewswire/ - IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" ma ọ bụ "Ụlọ ọrụ ahụ"), cryotherapy dị ntakịrị na-emerụ ahụ ("IceCure (Shanghai) MedTech Co. . , Ltd. ("IceCure", onye enyemaka nke 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”), onye enyemaka nke Medtronic Corporation (NYSE: MDT) (“Medtronic”) na Beijing Turing Medical Technology Co., Ltd. (“Turing”) A na-atụ anya ibunye sistemu IceSense3 izizi na 2022.
Medtronic Shanghai ga-abụ naanị onye na-ekesa IceSense3 na nyocha ya nwere ike ịtụfu na China China maka afọ atọ mbụ, yana ebumnuche ịzụta kacha nta nke $ 3.5 nde n'ime oge a. Na mgbakwunye, na mba China, Shanghai Medtronic agaghị etinye ego ozugbo ma ọ bụ na-apụtaghị ìhè ma ọ bụ zụọ ahịa, ree, ahịa, kwalite ma ọ bụ nye ngwaahịa ọ bụla na-asọ mpi IceSense3 n'oge nkwekọrịta nkesa na gafere ọnwa isii (6). Turing ga-ahụ maka mbubata, nrụnye na ọrụ ire ere nke sistemụ IceSense3 na China China, ebe Medtronic Shanghai ga-ejikwa ahịa niile, ire ahịa na ụfọdụ ọzụzụ ọkachamara.
IceSense3 System Console bụ ndị nchịkwa ngwaahịa ahụike mba China ("NMPA") kwadoro. IceCure etinyela akwụkwọ maka mgbanwe asambodo ndebanye aha iji kwado nyocha ndị enwere ike iwepu, ọ bụrụ na akwadoro, ga-ahapụ ụlọ ọrụ ahụ ka ọ zụọ ahịa cryoprobes IceSense3 maka iji azụmaahịa, yana IceCure na-atụ anya ịnata nnabata NMPA maka nyocha ahụ na njedebe nke 2022.
"Shanghai Medtronic na Turing bụ ezigbo ndị mmekọ maka anyị na China China, ebe ntinye ahịa nke teknụzụ cryoablation dị ala ugbu a. Anyị na-ahụ ohere magburu onwe ya maka nnabata zuru ebe niile nke usoro cryoablation IceSense3 na China China, ahịa na-eto ngwa ngwa. nke ahụ na-eme ka nsonaazụ ya dịkwuo mma, "IceCure CEO Eyal Shamir kwuru. "Dịka akụkụ nke ụlọ ọrụ ngwaọrụ ahụike kachasị n'ụwa, Shanghai Medtronic nwere ahụmahụ na ike ahịa iji mee ka ntinye ngwa ngwa ahịa nke IceSense3 nweta ọgwụgwọ dị mma, dị irè ma dị ọnụ ahịa maka ọrịa cancer ara na ihe ndị ọzọ."
Jing Yu, osote onye isi oche na onye isi njikwa nke Skull, Spine na Orthopedic Teknụzụ na Medtronic Shanghai kwuru, "IceCure nwere ihe ngwọta nke ụbụrụ na-eduga n'ụwa. Mmekọrịta ya na IceCure na Turing Medical ga-emeju ahịrị ngwaahịa nke Medtronic Shanghai na oncology neurosurgery. Anyị na-atụ anya na mmekorita a ga-akwalite ngwa ụlọ ọgwụ nke cryoablation ma rite uru karịa ndị ọrịa tumor, anyị na-atụkwa anya ka anyị na ndị mmekọ ndị ọzọ na-arụkọ ọrụ iji mee ka nnabata na ntinye nke ngwọta ahụike dị elu nke ga-enyere aka dozie isi nsogbu ọgwụgwọ tumor. Ngalaba ahụike nke China.
Onye isi ala Turing Lin Youjia gbakwụnyere, “Na mmekorita ya na Shanghai Medtronic na IceCure, anyị kpebisiri ike ịmalite mbugharị na ntinye ngwa ngwa nke sistemụ IceSense3 na China China. Ọnụnọ anyị na mba niile na China China na-ahụ na ụlọ ọrụ ahụike na-enweta nkwado teknụzụ dị elu yana ọrụ na-eji sistemụ IceSense3 ha ogologo oge. "
Na June 12, 2022 ("Ụbọchị dị irè"), IceCure Shanghai banyere nkwekọrịta ahịa na nkesa pụrụ iche ("Agreement Distribution") na Shanghai Medtronic na Turing maka IceSense3 na nyocha ndị nwere ike iwepụ (" Ngwaahịa ") maka oge mbụ. Ọnwa 36, ​​ebumnobi ịzụrụ kacha nta maka oge a bụ $3.5 nde (“Ebumnuche Nzụta kacha nta”). N'okpuru nkwekọrịta nkesa, IceCure Shanghai ga-ere ngwaahịa Turing na Turing ga-ebubata ngwaahịa sitere na Israel gaa China China wee resị ya na Medtronic Shanghai. Medtronic Shanghai ga-ahụ maka, gụnyere ihe ndị ọzọ: (i) ire ahịa na nkwalite ngwaahịa na China China; (ii) na-eduzi mmemme mmụta ahụike ọkachamara maka ngwaahịa na China China. Turing ga-ahụ maka ụlọ nkwakọba ihe, lọjistik, akwụkwọ ikike, ọzụzụ na nkwado ndị ọzọ na ọrụ ire ere.
N'okpuru usoro nke nkwekọrịta nkesa, Shanghai Medtronic nwere ikike ịgbatị oge nke nkwekọrịta nkesa ruo afọ atọ ma ọ bụrụ na ọ ruru ngụkọta nke afọ atọ kacha nta ịzụrụ ebumnuche, dabere na nkwekọrịta nke ebumnuche ịzụrụ kacha nta ọhụrụ. Enwere ike ịkwụsị nkwekọrịta onye nkesa n'okpuru ọnọdụ ụfọdụ, gụnyere n'ọnọdụ nke ndabara, ndabara ihe ma ọ bụ enweghị ego.
Na mgbakwunye, n'okpuru usoro nke Agreement nkesa, IceCure Shanghai ga-ahụ maka inweta na idowe ihe ọ bụla na nkwado iwu ("Regulatory Approvals") chọrọ ịzụ ahịa, kwalite, kesaa, ree na iji ngwaahịa ndị dị na China China. NMPA, ngalaba mpaghara ya, ma ọ bụ ụlọ ọrụ gọọmentị ọ bụla ("Ikikere nchịkwa"). IceCure Shanghai anatala nnabata nchịkwa maka IceSense3 Sistemụ Console ma chọọ nkwado iwu maka IceSense3 nke a na-atụfu cryoprobe maka usoro azụmahịa n'ime ọnwa itoolu site na ụbọchị dị irè nke nkwekọrịta nkesa. Shanghai Medtronic nwere ikike ịkwụsị nkwekọrịta nkesa ma ọ bụrụ na IceCure Shanghai enwetaghị nkwado nchịkwa maka cryoprobes site na mgbe ahụ.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) na-etolite ma na-ere ahịa ProSense®, ọgwụgwọ ikuku nitrogen dị elu maka ọgwụgwọ nke etuto ahụ (benign na cancerous) na cryotherapy, nke na-elekwasị anya na ara, akụrụ, ọkpụkpụ na ọrịa cancer akpa ume. ịsha. Nkà na ụzụ na-akpasa obere ihe na-enye ụzọ dị mma ma dị irè maka ịwa ahụ ịwa ahụ nke onye ọrịa nọ n'ụlọ ọgwụ, yana oge ọrụ dị mkpirikpi yana usoro ịwa ahụ dị mfe. Ka ọ dị ugbu a, a na-ere usoro a ma na-ere ahịa n'ụwa niile maka akara FDA kwadoro yana CE Mark kwadoro na Europe.
Mwepụta akwụkwọ akụkọ a nwere nkwupụta ndị na-atụ anya n'ihu n'ime nkọwa nke "ọdụ ụgbọ mmiri dị mma" nke Iwu Ndozigharị akwụkwọ gbasara ịgba akwụkwọ nkeonwe nke 1995 yana iwu nchekwa gọọmentị ndị ọzọ. Okwu ndị dị ka "atụ anya", "atụ anya", "ebumnobi", "atụmatụ", "kwere", "atụmatụ", "atụmatụ" na okwu ndị yiri ya ma ọ bụ mgbanwe dị iche iche nke okwu ndị dị otú ahụ bu n'obi na-ezo aka na nkwupụta na-ele anya. Dịka ọmụmaatụ, IceCure na-eji nkwupụta ndị na-atụ anya n'ihu na ntọhapụ mgbasa ozi a mgbe ha na-atụle nkwekọrịta nkesa na Shanghai Medtronic na Turing, atụmatụ nhazi nke ụlọ ọrụ, ọrụ ịzụ ahịa, na ohere ahịa maka usoro cryoablation nke ụlọ ọrụ na China China. N'ihi na nkwupụta ndị dị otú ahụ metụtara ihe ndị ga-eme n'ọdịnihu ma dabere na atụmanya IceCure dị ugbu a, ha nọ n'okpuru ihe egwu dị iche iche na ejighị n'aka, yana nsonaazụ IceCure n'ezie, arụmọrụ ma ọ bụ mmezu ya nwere ike ịdị iche na nke akọwara ma ọ bụ gosipụtara site na nkwupụta ndị dị na ntọhapụ a. Enwere nnukwu ọdịiche. . Okwu ndị na-ele anya n'ihu dị n'ime ma ọ bụ akọwapụta ya na ntọhapụ mgbasa ozi a nọ n'okpuru ihe egwu ndị ọzọ na ejighị n'aka, ọtụtụ n'ime ha karịrị ike ụlọ ọrụ ahụ, gụnyere ndị a kọwara na ngalaba "Ihe ize ndụ" nke Ụlọ Ọrụ Ụlọ Ọrụ's Annual Report on Form 20-F. SEC dịka nke Eprel 1, 2022 maka afọ ahụ kwụsịrị Disemba 31, 2021, dị na webụsaịtị SEC na www.sec.gov. Ụlọ ọrụ ahụ anaghị arụ ọrụ ọ bụla iji melite nkwupụta ndị a maka ntughari ma ọ bụ mgbanwe mgbe ụbọchị nke mbipụta akwụkwọ akụkọ a gasịrị, ma ọ bụrụ na iwu chọrọ ime ya.