Nūhou

Kaisareia, ʻIseraʻela, Iune 13, 2022 /PRNewswire/ — ʻO IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” a i ʻole ka “Hui”), minimally invasive cryotherapy (“IceCure (Shanghai) MedTech Co. ., Ltd. (“IceCure”, he lālā nona piha o IceCure (Shanghai) MedTech Co., Ltd. Shanghai”), ua kau inoa i kahi ʻaelike e kūkulu i ka ʻōnaehana cryoablation IceSense3 me Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), he lālā o Medtronic Corporation (NYSE: MDT) (“Medtronic”) a me Beijing Turing Medical Technology Co., Ltd. (“Turing”). Manaʻo ʻia e hāʻawi ʻia nā ʻōnaehana IceSense3 mua i ka makahiki 2022.
E lilo ʻo Medtronic Shanghai i mea hoʻolaha hoʻokahi o IceSense3 a me kāna mau probes hoʻolei ʻia ma Kina nui no kahi manawa mua o ʻekolu makahiki, me kahi pahuhopu kūʻai liʻiliʻi he $3.5 miliona i loko o kēia wā. Eia kekahi, ma Kina nui, ʻaʻole e hoʻopukapuka pololei a pololei ʻole paha ʻo Shanghai Medtronic a kālepa paha, kūʻai aku, kūʻai aku, hoʻolaha a hāʻawi paha i kekahi huahana e hoʻokūkū me IceSense3 i ka wā o ka ʻaelike hāʻawi a ma mua o ʻeono (6) mahina. Na Turing ke kuleana no ka lawe mai, ka hoʻokomo ʻana a me ka lawelawe ma hope o ke kūʻai aku ʻana o ka ʻōnaehana IceSense3 ma Kina nui, ʻoiai ʻo Medtronic Shanghai e mālama i nā kūʻai aku āpau, nā kūʻai aku a me kekahi mau hoʻomaʻamaʻa ʻoihana.
Ua ʻāpono ʻia ka IceSense3 System Console e ka China National Medical Products Administration (“NMPA”). Ua noi ʻo IceCure no kahi hoʻololi palapala hōʻoia hoʻopaʻa inoa e ʻāpono i nā probes hoʻolei ʻole, inā ʻāpono ʻia, e ʻae i ka ʻoihana e kūʻai aku i kāna IceSense3 disposable cryoprobes no ka hoʻohana kalepa, a ke manaʻo nei ʻo IceCure e loaʻa ka ʻāpono NMPA no nā probes ma ka hopena o 2022.
"He mau hoa kūpono ʻo Shanghai Medtronic lāua ʻo Turing no mākou ma Kina nui, kahi i emi ai ka komo ʻana o ka mākeke o ka ʻenehana cryoablation i kēia manawa. ʻIke mākou i kahi manawa kūpono no ka hoʻohana nui ʻana i kā mākou ʻōnaehana cryoablation IceSense3 ma Kina nui, kahi mākeke e ulu wikiwiki nei. e hoʻomaikaʻi i nā hopena," wahi a ka Luna Nui o IceCure ʻo Eyal Shamir. "Ma ke ʻano he ʻāpana o ka hui hāmeʻa lapaʻau nui loa o ka honua, loaʻa iā Shanghai Medtronic ka ʻike a me ka mana mākeke e hiki ai ke komo wikiwiki i ka mākeke o IceSense3 e hāʻawi i ka lāʻau palekana, pono a me ke kumukūʻai kūpono no ka maʻi ʻaʻai umauma mua a me nā hōʻailona ʻē aʻe."
"ʻO IceCure ka mea hoʻonā cryoablation tumor alakaʻi loa o ka honua," wahi a Jing Yu, hope pelekikena a me ka luna nui o Skull, Spine and Orthopedic Technologies ma Medtronic Shanghai. ʻO ka hui pū ʻana me IceCure lāua ʻo Turing Medical e hoʻokō i ka laina huahana a Medtronic Shanghai ma ka neurosurgery oncology. Manaʻolana mākou e hoʻolaha kēia hana like i ka hoʻohana lapaʻau o ka cryoablation a pōmaikaʻi i nā poʻe maʻi tumor, a ke kakali nei hoʻi mākou i ka hana pū ʻana me nā hoa hana hou aʻe e hoʻolalelale i ka lawe ʻana a me ka hoʻolaha ʻana i nā hoʻonā lapaʻau holomua e kōkua i ka hoʻoponopono ʻana i nā pilikia koʻikoʻi o ka mālama ʻana i ka tumor. ʻĀpana Ola o Kina.
Ua hoʻohui ʻo Lin Youjia, Luna Nui o Turing, "Ma ka laulima ʻana me Shanghai Medtronic lāua ʻo IceCure, ua kūpaʻa mākou i ka hoʻomaka ʻana i ka hoʻolaha ʻana a me ka hoʻokomo wikiwiki ʻana o ka ʻōnaehana IceSense3 ma ka ʻāina nui o Kina. ʻO ko mākou alo ʻana ma ka ʻāina nui ma Kina e hōʻoiaʻiʻo ana e loaʻa i nā kikowaena lapaʻau ke kākoʻo loea kiʻekiʻe a ua hoʻohana ka lawelawe i kā lākou ʻōnaehana IceSense3 no ka manawa lōʻihi."
Ma Iune 12, 2022 (“Lā Hoʻomaka”), ua komo ʻo IceCure Shanghai i loko o kahi ʻaelike kūʻai aku a me ka hāʻawi kūʻokoʻa (“ʻAelike Hāʻawi”) me Shanghai Medtronic lāua ʻo Turing no IceSense3 a me nā probes hoʻolei (“Nā Huahana”) no ka manawa mua. 36 mau mahina, ʻo ka palena iki o ke kūʻai ʻana no kēia wā he $3.5 miliona (“Pahuhopu Kūʻai Haʻahaʻa Loa”). Ma lalo o ka ʻaelike hāʻawi, e kūʻai aku ʻo IceCure Shanghai i nā huahana Turing a e lawe mai ʻo Turing i nā huahana mai ʻIseraʻela a i Kina nui a laila kūʻai hou aku iā Medtronic Shanghai. Na Medtronic Shanghai ke kuleana no, ma waena o nā mea ʻē aʻe: (i) ke kūʻai aku ʻana a me ka hoʻolaha ʻana i ka huahana ma Kina nui; (ii) e hana i nā hana hoʻonaʻauao lapaʻau ʻoihana no ka huahana ma Kina nui. Na Turing ke kuleana no ka waihona, ka logistics, ka palapala hōʻoia, ke aʻo ʻana a me nā kākoʻo ʻē aʻe a me nā lawelawe ma hope o ke kūʻai aku.
Ma lalo o nā ʻōlelo o ka ʻaelike hāʻawi, loaʻa iā Shanghai Medtronic ke kuleana e hoʻolōʻihi i ka manawa o ka ʻaelike hāʻawi no ʻekolu mau makahiki inā hiki i ka pahuhopu kūʻai liʻiliʻi ʻekolu makahiki, e like me ka ʻaelike o kahi pahuhopu kūʻai liʻiliʻi hou. Hiki ke hoʻopau ʻia ka ʻaelike Hāʻawi ma lalo o kekahi mau kūlana, me ka hanana o kahi hemahema, hemahema nui a i ʻole ka insolvency.
Eia kekahi, e like me nā ʻōlelo o ka ʻAelike Hoʻolaha, e kuleana ʻo IceCure Shanghai no ka loaʻa ʻana a me ka mālama ʻana i nā ʻae hoʻoponopono āpau ("Nā ʻAe Hoʻoponopono") e pono ai ke kūʻai aku, hoʻolaha, hāʻawi, kūʻai aku a hoʻohana i nā Huahana ma Kina nui. ʻO NMPA, kona lālā kūloko, a i ʻole kekahi keʻena aupuni ʻē aʻe ("Mana Hoʻoponopono"). Ua loaʻa iā IceCure Shanghai ka ʻae hoʻoponopono no ka IceSense3 System Console a koi aku i ka ʻae hoʻoponopono no ka IceSense3 disposable cryoprobe no nā kaʻina hana kālepa i loko o ʻeiwa mahina mai ka lā hoʻomaka o ka ʻaelike hāʻawi. Loaʻa iā Shanghai Medtronic ke kuleana e hoʻopau i ka ʻaelike hāʻawi inā ʻaʻole i loaʻa iā IceCure Shanghai ka ʻae hoʻoponopono no nā cryoprobes ma ia manawa.
Hoʻomohala a kūʻai aku ʻo IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) iā ProSense®, kahi lāʻau lapaʻau cryoablative nitrogen wai holomua no ka mālama ʻana i nā ʻōpū (benign a cancerous) me ka cryotherapy, e kuhikuhi nui ana i nā maʻi ʻaʻai umauma, puʻupaʻa, iwi a me ka māmā. crayfish. Hāʻawi kāna ʻenehana minimally invasive i kahi koho palekana a maikaʻi hoʻi i ke ʻoki ʻana i ka ʻōpū inpatient, me kahi manawa hana pōkole a me kahi hana ʻoki maʻalahi e hana. A hiki i kēia lā, ua kūʻai ʻia aku ka ʻōnaehana a kūʻai ʻia aku ma ka honua holoʻokoʻa no nā hōʻailona i ʻae ʻia e ka FDA a ua ʻae ʻia ʻo CE Mark ma ʻEulopa.
Aia i loko o kēia hoʻolaha paʻi nā ʻōlelo e nānā ana i mua i loko o ke ʻano o nā ʻōlelo "palekana palekana" o ke Kānāwai Hoʻoponopono Litigation Securities Pilikino o 1995 a me nā kānāwai palekana pekelala ʻē aʻe. ʻO nā huaʻōlelo e like me "anticite", "anticipate", "intend", "plan", "intend", "estimate" a me nā ʻōlelo like a i ʻole nā ​​​​​​ʻano like ʻole o ia mau huaʻōlelo i manaʻo ʻia e pili i nā ʻōlelo e nānā ana i mua. No ka laʻana, hoʻohana ʻo IceCure i nā ʻōlelo e nānā ana i mua i kēia hoʻolaha paʻi i ka wā e kūkākūkā ai i nā ʻaelike hāʻawi me Shanghai Medtronic lāua ʻo Turing, ka hoʻolālā hoʻoponopono o ka hui, nā hana kālepa, a me nā manawa kūpono mākeke no nā ʻōnaehana cryoablation o ka hui ma Kina nui. No ka mea pili kēlā mau ʻōlelo i nā hanana e hiki mai ana a ua hoʻokumu ʻia ma nā manaʻolana o IceCure i kēia manawa, ua kau ʻia lākou i nā pilikia a me nā mea ʻike ʻole ʻia, a ʻokoʻa paha nā hopena maoli, ka hana a i ʻole nā ​​​​​​hoʻokō a IceCure mai nā mea i wehewehe ʻia a i ʻole i manaʻo ʻia e nā ʻōlelo ma kēia hoʻolaha paʻi. Aia nā ʻokoʻa koʻikoʻi. . ʻO nā ʻōlelo e nānā ana i mua i loko a i ʻole i manaʻo ʻia ma kēia hoʻolaha paʻi e pili ana i nā pilikia a me nā mea maopopo ʻole ʻē aʻe, ʻo ka hapa nui o ia mau mea ma waho o ka mana o ka Hui, me nā mea i wehewehe ʻia ma ka ʻāpana "Nā Kumu Pilikia" o ka Hōʻike Makahiki a ka Hui ma ka Palapala 20-F i waiho ʻia ma SEC e like me ʻApelila 1, 2022 no ka makahiki i pau i Dekemaba 31, 2021, i loaʻa ma ka pūnaewele SEC ma www.sec.gov. ʻAʻole kuleana ka Hui e hōʻano hou i kēia mau ʻōlelo no ka hoʻoponopono a i ʻole nā ​​​​hoʻololi ma hope o ka lā o kēia hoʻolaha paʻi, ke ʻole e koi ʻia e ke kānāwai.