Amakuru

Caesarea, Isiraheli, ku ya 13 Kamena 2022 / PRNewswire / - IceCure Medical Ltd (NASDAQ: ICCM) (TASE: ICCM) (“IceCure” cyangwa “Isosiyete”), imiti ivura indwara ya “Quarter” (“IceCure (Shanghai) MedTech Co.). , Ltd (“IceCure”, ishami rya IceCure (Shanghai) MedTech Co., Ltd. Medtronic ”), ishami rya Medtronic Corporation (NYSE: MDT) (“ Medtronic ”) na Beijing Turing Medical Technology Co., Ltd. (“ Turing ”) Sisitemu ya mbere ya IceSense3 biteganijwe ko izatangwa mu 2022.
Medtronic Shanghai izaba imwe rukumbi yo gukwirakwiza IceSense3 hamwe nubushakashatsi bwayo bushobora gukoreshwa mugihugu cyUbushinwa mugihe cyimyaka itatu yambere, intego yo kugura byibuze miliyoni 3.5 zamadorali muri iki gihe. Byongeye kandi, ku mugabane w’Ubushinwa, Shanghai Medtronic ntabwo izashora mu buryo buziguye cyangwa butaziguye gushora imari cyangwa gucuruza, kugurisha, isoko, kuzamura cyangwa gutanga ibicuruzwa ibyo aribyo byose bihanganye na IceSense3 mugihe cyamasezerano yo kugabura no kurenza amezi atandatu (6). Turing izaba ishinzwe serivisi zitumizwa mu mahanga, iyinjizamo na nyuma yo kugurisha sisitemu ya IceSense3 mu gihugu cy’Ubushinwa, naho Medtronic Shanghai izakora ibicuruzwa byose, ibicuruzwa ndetse n’amahugurwa amwe yabigize umwuga.
Sisitemu ya IceSense3 yemejwe n’ubuyobozi bukuru bw’ibicuruzwa by’ubuvuzi mu Bushinwa (“NMPA”). IceCure yasabye ko hahindurwa icyemezo cyo kwiyandikisha kugira ngo yemeze iperereza rishobora gutangwa, biramutse byemejwe, ryemerera isosiyete gucuruza iceSense3 ikoreshwa na kirisiti ikoreshwa mu bucuruzi, kandi IceCure iteganya ko NMPA yemererwa gukora iperereza mu mpera za 2022.
Ati: “Shanghai Medtronic na Turing ni abafatanyabikorwa beza kuri twe ku mugabane w'Ubushinwa, aho usanga isoko ry’ikoranabuhanga rya cryoablation riri hasi. Turabona amahirwe meza yo kwamamara kwinshi kwa sisitemu yacu ya IceSense3 cryoablation mugihugu cyUbushinwa, isoko rikura vuba cyane. ibyo bizamura ibisubizo. ”Umuyobozi mukuru wa IceCure, Eyal Shamir. Ati: “Mu rwego rwa sosiyete nini y’ibikoresho by’ubuvuzi ku isi, Shanghai Medtronic ifite uburambe n’imbaraga z’isoko kugira ngo isoko ryihuta ryinjira muri IceSense3 kugira ngo ritange ubuvuzi bwizewe, bunoze kandi buhendutse kuri kanseri y'ibere hakiri kare n'ibindi bimenyetso.”
Jing Yu, visi perezida akaba n'umuyobozi mukuru wa Skull, Spine na Orthopedic Technologies muri Medtronic Shanghai yagize ati: "IceCure ifite igisubizo cy’ibibyimba ku isi ku isi." Ubufatanye na IceCure na Turing Medical buzuzanya umurongo wibicuruzwa bya Medtronic Shanghai muri oncology neurosurgie. Turizera ko ubwo bufatanye buzateza imbere ikoreshwa rya cryoablation kandi bikagirira akamaro abarwayi benshi b’ibibyimba, kandi turateganya kandi gukorana n’abafatanyabikorwa benshi mu kwihutisha iyemezwa n’ikwirakwizwa ry’ibisubizo by’ubuvuzi bizafasha gukemura ibibazo by’ingutu byo kuvura ibibyimba. Urwego rw'ubuzima mu Bushinwa.
Umuyobozi mukuru wa Turing, Lin Youjia yongeyeho ati: “Ku bufatanye na Shanghai Medtronic na IceCure, twiyemeje gutangira kohereza no gushyiraho vuba gahunda ya IceSense3 mu Bushinwa. Kuba turi mu gihugu hose ku mugabane w'Ubushinwa byemeza ko ibigo nderabuzima byakira inkunga ya tekinike kandi serivisi imaze igihe kinini ikoresha sisitemu ya IceSense3. ”
Ku ya 12 Kamena 2022 (“Itariki Yubahirizwa”), IceCure Shanghai yagiranye amasezerano yihariye yo kugurisha no kugabura (“Amasezerano yo kugabura”) hamwe na Shanghai Medtronic na Turing for IceSense3 hamwe nubushakashatsi bwakoreshejwe (“Ibicuruzwa”) mugihe cyambere. Amezi 36, intego ntarengwa yo kugura iki gihe ni miliyoni 3.5 $ (“Intego ntarengwa yo kugura”). Mu masezerano yo kugabura, IceCure Shanghai izagurisha ibicuruzwa bya Turing naho Turing izatumiza ibicuruzwa muri Isiraheli ku mugabane w’Ubushinwa hanyuma ibyohereze muri Medtronic Shanghai. Medtronic Shanghai izaba ishinzwe, mubindi: (i) kwamamaza no kumenyekanisha ibicuruzwa mubushinwa; (ii) gukora ibikorwa byubuvuzi byumwuga kubicuruzwa mubushinwa. Turing izaba ishinzwe ububiko, ibikoresho, garanti, amahugurwa nizindi nkunga na serivisi nyuma yo kugurisha.
Dukurikije amasezerano yo kugabura, Shanghai Medtronic ifite uburenganzira bwo kongerera igihe cyamasezerano yo kugabana imyaka itatu iyo igeze ku ntego y’imyaka itatu yo kugura byibuze, hashingiwe ku masezerano y’intego nshya yo kugura. Amasezerano yo kugabura arashobora guhagarikwa mubihe bimwe, harimo mugihe habaye kutubahiriza ibintu, kutishyura ibintu cyangwa kutishyurwa.
Byongeye kandi, hubahirijwe ibikubiye mu masezerano y’abatanga isoko, IceCure Shanghai izaba ishinzwe kubona no kubungabunga ibyemezo byose kandi byemewe (“Ibyemezo byemewe”) bisabwa ku isoko, kumenyekanisha, gukwirakwiza, kugurisha no gukoresha ibicuruzwa mu gihugu cy’Ubushinwa. NMPA, ishami ryayo, cyangwa ikindi kigo icyo aricyo cyose cya leta (“Ikigo gishinzwe kugenzura”). IceCure Shanghai yemerewe gukurikiza amabwiriza ya sisitemu ya IceSense3 kandi isaba kwemererwa gukurikiza amategeko ya iceSense3 ikoreshwa na kode ya kode ya progaramu yubucuruzi mugihe cyamezi icyenda uhereye igihe amasezerano yatangiriye gukurikizwa. Shanghai Medtronic ifite uburenganzira bwo gusesa amasezerano yo kugabura niba IceCure Shanghai itabonye ibyemezo byemewe na cryoprobes icyo gihe.
Ubuvuzi bwa IceCure (NASDAQ: ICCM) (TASE: ICCM) buteza imbere kandi bugacuruza ProSense®, uburyo bwiza bwo kuvura ibibyimba bya azote cryoablative yo kuvura ibibyimba (benign na kanseri) hamwe na cryotherapie, byibanda cyane kuri kanseri y'ibere, impyiko, amagufwa n'ibihaha. crayfish. Ikoranabuhanga ryayo ryibasiwe cyane ritanga ubundi buryo bwizewe kandi bunoze bwo kubaga ikibyimba kivura abarwayi, hamwe nigihe gito cyo kubaga hamwe nuburyo bworoshye bwo kubaga. Kugeza ubu, sisitemu iracuruzwa kandi igacuruzwa ku isi hose kubimenyetso byemewe na FDA kandi ni CE Mark wemewe mu Burayi.
Iri tangazo rigenewe abanyamakuru rikubiyemo amagambo areba imbere mu bisobanuro by '“icyambu cyizewe” cy’amategeko agenga ivugurura ry’imigabane y’abikorera ku giti cyabo ryo mu 1995 n’andi mategeko agenga impapuro z’agaciro. Amagambo nka "guteganya", "guteganya", "umugambi", "gahunda", "kwizera", "umugambi", "kugereranya" hamwe n'imvugo isa cyangwa itandukaniro ryamagambo nkaya agamije kwerekeza kumvugo ireba imbere. Kurugero, IceCure ikoresha amagambo areba imbere muri iri tangazo mugihe iganira ku masezerano yo kugabana na Shanghai Medtronic na Turing, ingamba zo kugenzura isosiyete, ibikorwa by’ubucuruzi, n’amahirwe y’isoko kuri sisitemu ya cryoablation yo mu gihugu cy’Ubushinwa. Kuberako amagambo nkaya ajyanye nibizaza kandi ashingiye kubyo IceCure iteganya muri iki gihe, birashobora guhura nibibazo bitandukanye kandi bidashidikanywaho, kandi ibisubizo nyabyo bya IceCure, imikorere cyangwa ibyagezweho birashobora gutandukana nibisobanuwe cyangwa byerekanwe nibivugwa muri iri tangazo. Hariho itandukaniro rikomeye. . Amagambo areba imbere akubiye cyangwa yerekanwe muri iri tangazo rigenewe abanyamakuru ashobora guhura n’izindi ngaruka kandi zidashidikanywaho, inyinshi muri zo zikaba zidashobora kugenzurwa n’isosiyete, harimo n’ibivugwa mu gice cyitwa “Risk Factors” igice cya Raporo y’umwaka wa Sosiyete ku Ifishi ya 20-F yatanzwe muri SEC guhera ku ya 1 Mata 2022 y'umwaka urangiye ku ya 31 Ukuboza 2021, iboneka ku rubuga rwa SEC kuri www.sec.gov. Isosiyete nta nshingano ifite yo kuvugurura aya magambo kugira ngo isubirwemo cyangwa ihindurwe nyuma y'itariki yatangarijweho, keretse bisabwe n'amategeko.