Nūhou

Kaisarea, ʻIseraʻela, Iune 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” a i ʻole ka “Company”), minimally invasive cryotherapy (“IceCure (Shanghai) MedTech Co. . , Ltd. ("IceCure", he lālā nona piha o IceCure (Shanghai) MedTech Co., Ltd. Shanghai"), ua kau inoa i ka 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.
E lilo ʻo Medtronic Shanghai i mea hoʻolaha hoʻokahi o IceSense3 a me kāna mau ʻimi noiʻi ma ka ʻāina nui ʻo Kina no kahi manawa ʻekolu makahiki mua, me ka palena kūʻai liʻiliʻi he $ 3.5 miliona i kēia manawa. Eia hou, ma ka ʻāina nui o Kina, ʻaʻole ʻo Shanghai Medtronic e hoʻokomo pololei a kūʻai ʻole paha, kūʻai aku, kūʻai aku, hoʻolaha a hāʻawi i kekahi huahana e hoʻokūkū me IceSense3 i ka wā o ka ʻaelike hoʻolaha a ma mua o ʻeono (6) mahina. Na Turing ke kuleana no ka lawe ʻana mai, ka hoʻokomo ʻana a me ka lawelawe ma hope o ke kūʻai ʻana o ka ʻōnaehana IceSense3 ma ka ʻāina nui o Kina, ʻoiai ʻo Medtronic Shanghai e lawelawe i nā mea kūʻai aku, kūʻai aku a me kekahi aʻo ʻoihana.
Ua ʻae ʻia ka IceSense3 System Console e ka China National Medical Products Administration (“NMPA”). Ua noi ʻo IceCure no ka hoʻololi ʻana i ka palapala hoʻopaʻa inoa no ka ʻae ʻana i nā probes hiki ke hoʻohana ʻia, inā e ʻae ʻia, e ʻae i ka hui e kūʻai aku i kāna IceSense3 disposable cryoprobes no ka hoʻohana ʻana i ka ʻoihana, a ke manaʻo nei ʻo IceCure e loaʻa iā NMPA ka ʻae ʻana no nā probes ma ka hopena o 2022.
"ʻO Shanghai Medtronic lāua ʻo Turing he mau hoa maikaʻi loa no mākou ma ka ʻāina nui o Kina, kahi i haʻahaʻa ai ka mākeke o ka ʻenehana cryoablation i kēia manawa. ʻIke mākou i kahi manawa kūpono no ka hoʻohana ākea ʻana o kā mākou IceSense3 cryoablation system ma ka ʻāina nui o Kina, kahi mākeke e ulu wikiwiki nei. e hoʻomaikaʻi i nā hopena, "wahi a IceCure CEO Eyal Shamir. "Ma ke ʻano o ka hui lāʻau lapaʻau nui loa o ka honua, ua loaʻa iā Shanghai Medtronic ka ʻike a me ka mana mākeke e hiki ai i ke komo wikiwiki ʻana o ka mākeke o IceSense3 e hāʻawi i ka mālama palekana, kūpono a me ke kumu kūʻai no ka maʻi maʻi umauma mua a me nā hōʻailona ʻē aʻe."
"Loaʻa iā IceCure ka hopena cryoablation tumor koʻikoʻi o ka honua," wahi a Jing Yu, ka hope pelekikena a me ka luna nui o Skull, Spine and Orthopedic Technologies ma Medtronic Shanghai. ʻO ka hui pū ʻana me IceCure a me Turing Medical e hoʻokō i ka laina huahana o Medtronic Shanghai i ka neurosurgery oncology. Manaʻo mākou e holomua kēia hui ʻana i ka noi lapaʻau o cryoablation a e hoʻomaikaʻi hou aku i nā mea maʻi maʻi maʻi, a ke kakali nei mākou i ka hana pū me nā hoa hou aʻe e hoʻolalelale i ka lawe ʻana a me ka lawe ʻana i nā ʻōnaehana olakino holomua e kōkua i ka hoʻoponopono ʻana i nā pilikia lapaʻau nui. Mahele Ola o Kina.
Ua hoʻohui ʻo Turing CEO Lin Youjia, "Ma ka hui pū ʻana me Shanghai Medtronic a me IceCure, ua kūpaʻa mākou e hoʻomaka i ka hoʻonohonoho ʻana a me ka hoʻokomo wikiwiki ʻana o ka ʻōnaehana IceSense3 ma ka ʻāina nui o Kina. ʻO kā mākou ʻāina holoʻokoʻa ma ka ʻāina ʻo Kina e hōʻoia i ka loaʻa ʻana o ke kākoʻo ʻenehana kiʻekiʻe a ua hoʻohana ka lawelawe i kā lākou ʻōnaehana IceSense3 no ka manawa lōʻihi.
Ma ka lā 12 o Iune, 2022 ("Date Effective"), ua komo ʻo IceCure Shanghai i kahi ʻaelike kūʻai kūʻai kūʻokoʻa ("Distribution Agreement") me Shanghai Medtronic a me Turing no IceSense3 a me nā probes hiki ke hoʻohana ʻia ("Products") no kahi manawa mua. 36 mau mahina, ʻo ka pahuhopu kūʻai liʻiliʻi loa no kēia manawa he $3.5 miliona ("Minimum Purchase Target"). Ma lalo o ka ʻaelike hoʻolaha, e kūʻai aku ʻo IceCure Shanghai i nā huahana Turing a e lawe mai ʻo Turing i nā huahana mai ʻIseraʻela i ka ʻāina nui o Kina a laila kūʻai hou aku iā Medtronic Shanghai. Na Medtronic Shanghai ke kuleana no, ma waena o nā mea ʻē aʻe: (i) kūʻai aku a hoʻolaha i ka huahana ma ka ʻāina nui o Kina; (ii) alakaʻi i nā hana hoʻonaʻauao olakino no ka huahana ma ka ʻāina nui o Kina. Na Turing ke kuleana no ka hale kūʻai, logistic, warranty, aʻo 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, aia ʻo Shanghai Medtronic i ke kuleana e hoʻolōʻihi i ka manawa o ka ʻaelike hoʻoili no ʻekolu makahiki inā hiki i ka kumulative kumulative ʻekolu makahiki kūʻai liʻiliʻi loa, ma muli o ka ʻaelike o kahi pahu kūʻai liʻiliʻi hou. Hiki ke hoʻopau ʻia ka ʻaelike Distributor ma lalo o kekahi mau kūlana, me ka loaʻa ʻana o kahi paʻa, paʻa waiwai a i ʻole insolvency.
Eia kekahi, ma muli o nā ʻōlelo o ka Distributor Agreement, ʻo IceCure Shanghai ke kuleana no ka loaʻa ʻana a me ka mālama ʻana i nā ʻae hoʻoponopono āpau ("Regulatory Approvals") i koi ʻia e kūʻai aku, hoʻolaha, hoʻolaha, kūʻai aku a hoʻohana i nā huahana ma ka ʻāina nui o Kina. ʻO NMPA, kona lālā kūloko, a i ʻole kekahi hui aupuni ʻē aʻe (ka "Mana Hoʻoponopono"). Ua loaʻa iā IceCure Shanghai ka ʻae hoʻoponopono no ka IceSense3 System Console a koi aku i ka ʻae kānāwai no ka cryoprobe disposable IceSense3 no nā kaʻina hana kalepa i loko o ʻeiwa mahina mai ka lā kūpono o ka ʻaelike hāʻawi. He kuleana ko Shanghai Medtronic e hoʻopau i ka ʻaelike hāʻawi inā ʻaʻole 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 cryoablative wai hauʻoli nui no ka mālama ʻana i nā maʻi ʻaʻai (benign a me ka maʻi kanesa) me ka cryotherapy, e kuhikuhi nui ana i nā maʻi maʻi maʻi umauma, puʻupaʻa, iwi a me ka māmā. ʻuʻuku. Hāʻawi kāna ʻenehana invasive liʻiliʻi i kahi koho palekana a maikaʻi hoʻi i ke kaʻina wehe ʻana i ka maʻi maʻi maʻi, me kahi manawa hana pōkole a me kahi kaʻina hana maʻalahi. I kēia lā, kūʻai ʻia ka ʻōnaehana a kūʻai ʻia ma ka honua holoʻokoʻa no nā hōʻailona FDA i ʻae ʻia a ʻae ʻia ʻo CE Mark ma ʻEulopa.
Loaʻa i kēia hoʻolaha paʻi nā ʻōlelo e nānā ana i mua i loko o ke ʻano o nā ʻōlelo "safe harbor" o ka Private Securities Litigation Reform Act o 1995 a me nā kānāwai palekana federal. ʻO nā huaʻōlelo e like me "anticipate", "anticipate", "intend", "plan", "believe", "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 i mua. No ka laʻana, hoʻohana ʻo IceCure i nā ʻōlelo i mua o kēia hoʻolaha i ka wā e kūkākūkā ai i nā ʻaelike hoʻoili me Shanghai Medtronic a me Turing, ka hoʻolālā hoʻoponopono o ka hui, nā hana kalepa, a me nā manawa mākeke no nā ʻōnaehana cryoablation o ka hui ma ka ʻāina nui o Kina. No ka mea pili ia mau ʻōlelo i nā hanana e hiki mai ana a ua hoʻokumu ʻia i nā manaʻolana o IceCure i kēia manawa, aia lākou i nā pilikia like ʻole a me ka maopopo ʻole, a ʻokoʻa paha nā hopena maoli, ka hana a i ʻole nā ​​hoʻokō a IceCure mai nā mea i wehewehe ʻia a i kuhikuhi ʻia paha e nā ʻōlelo i loko o kēia hoʻolaha paʻi. Aia nā ʻokoʻa nui. . ʻO nā ʻōlelo e nānā ana i mua i loko o kēia hoʻolaha paʻi e pili ana i nā pilikia ʻē aʻe a me nā kānalua ʻē aʻe, ka nui o ia mau mea ma waho o ka mana o ka Hui, me nā mea i wehewehe ʻia ma ka ʻāpana "Risk Factors" o ka Hōʻike Makahiki a ka Hui ma ka Pepa 20-F i waiho ʻia ma SEC mai ʻApelila 1, 2022 no ka makahiki i pau i ka lā 31 Dekemaba, 2021, loaʻa ma ka pūnaewele SEC ma www.sec.gov. ʻAʻole ʻae ka Hui e hoʻololi i kēia mau ʻōlelo no ka hoʻoponopono ʻana a i ʻole nā ​​hoʻololi ʻana ma hope o ka lā o kēia hoʻolaha paʻi, ke ʻole ke koi ʻia e ke kānāwai.