Ngā Pūrongo

Caesarea, Iharaira, 13 o Hune, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” te “Kamupene” rānei), te cryotherapy iti rawa te whakaekenga (“IceCure (Shanghai) MedTech Co. ., Ltd. (“IceCure”, he apiti katoa nō IceCure (Shanghai) MedTech Co., Ltd. Shanghai”), i hainatia he kirimana hei hanga i te pūnaha cryoablation IceSense3 me Shanghai Medtronic Zhikang Medical Devices Co., Ltd. (“Shanghai Medtronic”), he apiti nō Medtronic Corporation (NYSE: MDT) (“Medtronic”) me Beijing Turing Medical Technology Co., Ltd. (“Turing”). E matapaetia ana ka tukuna ngā pūnaha IceSense3 tuatahi i te tau 2022.
Ka noho ko Medtronic Shanghai hei kaituku takitahi o IceSense3 me āna taputapu tirotiro i Haina matua mō te wā tuatahi e toru tau te roa, me te whāinga hoko iti rawa o te $3.5 miriona i roto i tēnei wā. Hei tāpiri, i Haina matua, kāore a Shanghai Medtronic e haumi tika, ā-kore rānei, e hokohoko, e hoko, e hokohoko, e whakatairanga, e tuku rānei i tētahi hua e whakataetae ana ki a IceSense3 i roto i te wā o te whakaaetanga tohatoha me tua atu i te ono (6) marama. Ko Turing te kawenga mō te kawemai, te tāutanga me te ratonga muri-hoko o te pūnaha IceSense3 i Haina matua, ko Medtronic Shanghai ia e whakahaere i ngā hokohoko katoa, ngā hoko me ētahi whakangungu ngaio.
Kua whakaaetia te Pūnaha Papatohu IceSense3 e te Whakahaere Hua Hauora ā-Motu o Haina (“NMPA”). Kua tono a IceCure mō tētahi panonitanga tiwhikete rēhita hei whakaae i ngā taputapu tirotiro pūmau, ki te whakaaetia, ka taea e te kamupene te hokohoko i ana taputapu tirotiro pūmau IceSense3 mō te whakamahinga arumoni, ā, e matapaetia ana ka whiwhi a IceCure i te whakaaetanga NMPA mō ngā taputapu tirotiro i mua i te mutunga o te tau 2022.
"He hoa pai rawa atu a Shanghai Medtronic me Turing mā mātou i Haina matua, kei reira te iti o te urunga ki te mākete o te hangarau cryoablation i tēnei wā. E kite ana mātou i tētahi whai wāhitanga pai mō te whānui o te whakamahi i tā mātou pūnaha cryoablation IceSense3 i Haina matua, he mākete e tere tipu haere ana, e whakapai ake ana i ngā hua," te kī a te Tumu Whakarae o IceCure, a Eyal Shamir. "Hei wāhanga o te kamupene taputapu hauora nui rawa atu o te ao, kei a Shanghai Medtronic te wheako me te mana mākete hei whakahohe i te urunga tere ki te mākete o IceSense3 hei whakarato i te maimoatanga haumaru, whai hua, me te utu-whai hua mō te mate pukupuku ū wawe me ētahi atu tohu."
"Kei a IceCure te otinga cryoablation pukupuku matua o te ao," te kī a Jing Yu, te tumuaki tuarua me te kaiwhakahaere matua o Skull, Spine and Orthopedic Technologies i Medtronic Shanghai. Mā te mahi tahi me IceCure me Turing Medical ka tautoko i te raina hua a Medtronic Shanghai i roto i te pokanga roro oncology. Ko tā mātou e tumanako nei ka whakatairangahia e tēnei mahi tahi te tono haumanu o te cryoablation me te whai hua ki te nuinga atu o ngā tūroro pukupuku, ā, e tumanako ana hoki mātou ki te mahi tahi me ētahi atu hoa mahi ki te tere ake te tango me te whakatinana i ngā otinga hauora matatau hei āwhina i te whakaoti i ngā wero matua mō te maimoatanga pukupuku. Rāngai Hauora o Haina.
I tāpiri atu a Lin Youjia, te Tumu Whakahaere o Turing, "I roto i te mahi tahi me Shanghai Medtronic me IceCure, e whakapau kaha ana mātou ki te tīmata i te whakatinanatanga me te tāutanga tere o te pūnaha IceSense3 ki te tuawhenua o Haina. Mā tō mātou aroaro puta noa i te motu ki te tuawhenua o Haina ka whakarite kia whiwhi ngā pokapū hauora i te tautoko hangarau pai rawa atu, ā, kua roa te wā e whakamahi ana te ratonga i tā rātou pūnaha IceSense3."
I te 12 o Hune, 2022 (“Rā Whai Mana”), i uru atu a IceCure Shanghai ki tētahi whakaaetanga hoko me te tohatoha motuhake (“Whakaaetanga Tohatoha”) me Shanghai Medtronic me Turing mō IceSense3 me ngā taputapu whakakore (“Hua”) mō te wā tuatahi. 36 marama, ko te whāinga hoko iti rawa mō tēnei wā ko te $3.5 miriona (“Whāinga Hokonga Iti Rawa”). I raro i te whakaaetanga tohatoha, ka hoko a IceCure Shanghai i ngā hua Turing, ā, ka kawemai a Turing i ngā hua mai i Iharaira ki Haina matua, kātahi ka hoko anō ki a Medtronic Shanghai. Ko Medtronic Shanghai te kawenga mō, i roto i ētahi atu mea: (i) te hokohoko me te whakatairanga i te hua ki Haina matua; (ii) te whakahaere i ngā mahi mātauranga hauora ngaio mō te hua ki Haina matua. Ko Turing te kawenga mō te whare putunga, te whakahaere rauemi, te whakamana, te whakangungu me ētahi atu ratonga tautoko me muri i te hoko.
E ai ki ngā tikanga o te whakaaetanga tohatoha, kei a Shanghai Medtronic te mana ki te whakaroa i te roanga o te wā o te whakaaetanga tohatoha mō ngā tau e toru mēnā ka eke ki te whāinga hoko iti rawa e toru tau te roa, i runga anō i te whakaaetanga o tētahi whāinga hoko iti rawa hou. Ka taea te whakamutu i te Whakaaetanga Kaituku i raro i ētahi āhuatanga, tae atu ki te wā ka takahia he utu, he hapa nui, he korenga moni rānei.
Hei tāpiritanga, i raro i ngā tikanga o te Whakaaetanga Tuku, ka riro i a IceCure Shanghai te kawenga mō te tiki me te pupuri i ngā whakaaetanga ture katoa ("Whakaaetanga Ture") e hiahiatia ana hei hokohoko, hei whakatairanga, hei tohatoha, hei hoko me te whakamahi i ngā Hua i Haina matua. Kua whiwhi a NMPA, tōna peka ā-rohe, tētahi atu tari kāwanatanga rānei (te "Mana Whakahaere"). Kua whiwhi a IceCure Shanghai i te whakaaetanga ture mō te IceSense3 System Console, ā, me whai whakaaetanga ture mō te IceSense3 cryoprobe whakakorekore mō ngā tikanga arumoni i roto i te iwa marama mai i te rā whai mana o te whakaaetanga tohatoha. Kei a Shanghai Medtronic te mana ki te whakamutu i te whakaaetanga tohatoha mēnā kāore a IceCure Shanghai e whiwhi whakaaetanga ture mō ngā cryoprobes i taua wā.
Ko IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) e whakawhanake ana, e hokohoko ana hoki i te ProSense®, he rongoā cryoablative hauota wai matatau mō te rongoā i ngā pukupuku (pai me te mate pukupuku) me te cryotherapy, e aro nui ana ki ngā mate pukupuku o te ū, te whatukuhu, te wheua me te pūkahukahu. kōura. Ko tana hangarau iti rawa te whakaekenga e whakarato ana i tētahi huarahi haumaru me te whai hua hei whakakapi i te pokanga tango pukupuku i roto i te whare hauora, me te wā pokanga poto me te mahi pokanga ngāwari. Tae noa ki tēnei wā, kei te hokohokohia te pūnaha puta noa i te ao mō ngā tohu kua whakaaetia e te FDA, ā, kua whakaaetia te Tohu CE i Ūropi.
Kei roto i tēnei panuitanga pāpāho ngā kōrero tirohanga whakamua i roto i te tikanga o ngā whakaritenga "pūmau haumaru" o te Ture Whakahou Ture mō ngā Pūtea Motuhake o te tau 1995 me ētahi atu ture pūtea ā-motu. Ko ngā kupu pēnei i te "whakaarohia", "whakaarohia", "whakaarohia", "whakamaherehia", "whakaponohia", "whakaarohia", "whakatau tata" me ngā kīanga rite, ngā momo rerekētanga rānei o aua kupu, e tohu ana i ngā kōrero tirohanga whakamua. Hei tauira, ka whakamahia e IceCure ngā kōrero tirohanga whakamua i roto i tēnei panuitanga pāpāho i te wā e kōrero ana mō ngā whakaaetanga tohatoha me Shanghai Medtronic me Turing, te rautaki ture a te kamupene, ngā mahi hokohoko, me ngā whai wāhitanga mākete mō ngā pūnaha cryoablation a te kamupene i Haina matua. Nā te mea e pā ana aua kōrero ki ngā kaupapa ā muri ake nei, ā, e hangai ana ki ngā tumanakohanga o nāianei a IceCure, ka pāngia rātou e ngā mōrearea me ngā āwangawanga maha, ā, ko ngā hua, te mahi, ngā whakatutukitanga rānei a IceCure ka rerekē pea i ngā mea kua whakaahuatia, kua tohua rānei e ngā kōrero i roto i tēnei panuitanga pāpāho. He rerekētanga nui. . Ko ngā kōrero matakite kei roto, kei roto rānei i tēnei tukunga pāpāho, kei raro i ētahi atu mōrearea me ngā āwangawanga, he maha kei tua atu i te mana whakahaere a te Kamupene, tae atu ki ērā kua whakaahuatia i te wāhanga "Ngā Āhuatanga Mōrearea" o te Pūrongo ā-Tau a te Kamupene i runga i te Puka 20-F i tukuna ki te SEC i te 1 o Paenga-whāwhā, 2022 mō te tau i mutu i te 31 o Tīhema, 2021, e wātea ana i te paetukutuku SEC i www.sec.gov. Kāore te Kamupene e whai kawenga ki te whakahou i ēnei kōrero mō te whakatikatika, mō ngā huringa rānei i muri i te rā o tēnei tukunga pāpāho, ki te kore e hiahiatia kia pērā e te ture.