Amakuru

Caesarea, Isirayeli, 13 Kamena 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" cyangwa "Isosiyete"), ikigo gito cyane gitanga serivisi zo kuvura indwara z'ibicurane ("IceCure (Shanghai) MedTech Co. ., Ltd. ("IceCure", ikigo cy’isosiyete cya IceCure (Shanghai) MedTech Co., Ltd. Shanghai"), cyasinye amasezerano yo kubaka sisitemu yo kuvura indwara z'ibicurane ya IceSense3 na Shanghai Medtronic Zhikang Medical Devices Co., Ltd. ("Shanghai Medtronic"), ikigo cy’isosiyete ya Medtronic Corporation (NYSE: MDT) ("Medtronic") na Beijing Turing Medical Technology Co., Ltd. ("Turing"). Sisitemu za mbere za IceSense3 ziteganijwe gutangwa mu 2022.
Medtronic Shanghai izaba ari yo yonyine ikwirakwiza IceSense3 n'ibikoresho byayo byo gupima bikoreshwa mu gihe cy'imyaka itatu, intego yayo ikaba ari miliyoni 3.5 z'amadolari y'Amerika muri iki gihe. Byongeye kandi, mu Bushinwa, Shanghai Medtronic ntabwo izashora imari mu buryo butaziguye cyangwa butaziguye mu gucuruza, kugurisha, kugurisha, kwamamaza cyangwa gutanga ibicuruzwa bihanganye na IceSense3 mu gihe cy'amasezerano yo gukwirakwiza no mu gihe kirenze amezi atandatu (6). Turing izaba ishinzwe gutumiza, gushyiramo na serivisi nyuma yo kugurisha sisitemu ya IceSense3 mu Bushinwa, mu gihe Medtronic Shanghai izaba ishinzwe kwamamaza, kugurisha no guhugura abandi mu buryo bw'umwuga.
IceSense3 System Console yemejwe n’Ikigo cy’Igihugu cy’Ubushinwa gishinzwe Ibikoresho by’Ubuvuzi (“NMPA”). IceCure yasabye impinduka ku cyemezo cyo kwiyandikisha kugira ngo yemeze ibikoresho byo gupima bishobora gukoreshwa mu buryo busanzwe, nibyemezwa, byakwemerera isosiyete kwamamaza ibikoresho byayo byo gupima bishobora gukoreshwa mu bucuruzi, kandi IceCure yiteze kubona uburenganzira bwa NMPA ku bikoresho byo gupima bitarenze impera za 2022.
“Shanghai Medtronic na Turing ni abafatanyabikorwa beza kuri twe mu Bushinwa, aho ikoranabuhanga rya cryoablation rigera ku isoko muri iki gihe riri hasi. Tubona amahirwe meza yo gukoresha uburyo bwacu bwa cryoablation bwa IceSense3 mu Bushinwa, isoko ririmo gukura vuba cyane, bigatuma umusaruro urushaho kuba mwiza,” ibi byavuzwe n’umuyobozi mukuru wa IceCure, Eyal Shamir. “Nk’igice cy’ikigo kinini ku isi gishinzwe ibikoresho by’ubuvuzi, Shanghai Medtronic ifite ubunararibonye n’imbaraga ku isoko byo gutuma IceSense3 yinjira ku isoko vuba kugira ngo itange ubuvuzi bwizewe, bwiza kandi buhendutse ku ndwara ya kanseri y’ibere n’ibindi bimenyetso.”
“IceCure ifite umuti uvura kanseri y’ibibyimba ku rwego rwo hejuru ku isi,” ibi byavuzwe na Jing Yu, visi perezida akaba n’umuyobozi mukuru wa Skull, Spine and Orthopedic Technologies muri Medtronic Shanghai. Ubu bufatanye na IceCure na Turing Medical buzahuza umurongo w’ibicuruzwa bya Medtronic Shanghai mu buvuzi bw’indwara z’ubwonko. Twizeye ko ubu bufatanye buzateza imbere ikoreshwa rya kanseri y’ibibyimba mu buvuzi kandi bugafasha abarwayi benshi b’ibibyimba, kandi twiteguye kandi gukorana n’abafatanyabikorwa benshi kugira ngo twihutishe ishyirwaho n’ishyirwaho ry’ibisubizo bigezweho mu buvuzi bizafasha gukemura ibibazo by’ingenzi mu kuvura kanseri. Urwego rw’Ubuzima mu Bushinwa.
Umuyobozi mukuru wa Turing, Lin Youjia, yongeyeho ati: “Ku bufatanye na Shanghai Medtronic na IceCure, twiyemeje gutangiza no gushyira vuba sisitemu ya IceSense3 mu Bushinwa. Kuba turi mu gihugu cyose mu Bushinwa bituma ibigo by’ubuvuzi bibona ubufasha bw’ikoranabuhanga n’ubuhanga buhanitse, bimaze igihe kinini bikoresha sisitemu ya IceSense3.”
Ku ya 12 Kamena 2022 (“Itariki yo Gutangira Gukoreshwa”), IceCure Shanghai yagiranye amasezerano yihariye yo kugurisha no gukwirakwiza (“Amasezerano yo Gukwirakwiza”) na Shanghai Medtronic na Turing kuri IceSense3 n'ibikoresho byo gupima bikoreshwa mu buryo bwa “Products” mu gihe cya mbere. Amezi 36, intego y'ibanze yo kugura muri iki gihe ni miliyoni 3.5 z'amadolari (“Intego y'Ikiguzi cyo Kugura”). Mu masezerano yo gukwirakwiza, IceCure Shanghai izagurisha ibicuruzwa bya Turing naho Turing izatumiza ibicuruzwa bivuye muri Isirayeli mu Bushinwa hanyuma ikabigurisha kuri Medtronic Shanghai. Medtronic Shanghai izaba ifite inshingano, mu bindi bintu: (i) kwamamaza no kwamamaza ibicuruzwa mu Bushinwa; (ii) gukora ibikorwa by'ubujyanama bw'umwuga ku bicuruzwa mu Bushinwa. Turing izaba ifite inshingano zo kubika, gutwara ibintu, garanti, amahugurwa n'izindi serivisi zo gutanga ubufasha na serivisi zo nyuma yo kugurisha.
Dukurikije amasezerano yo gukwirakwiza, Shanghai Medtronic ifite uburenganzira bwo kongera igihe cy'amasezerano yo gukwirakwiza mu gihe cy'imyaka itatu niba igeze ku ntego y'imyaka itatu y'ubugure, hakurikijwe amasezerano y'inyongera y'ubugure. Amasezerano y'Umugabanyi ashobora guseswa mu bihe bimwe na bimwe, harimo no mu gihe habayeho kutishyura neza, kwishyura amafaranga menshi cyangwa guhomba.
Byongeye kandi, hakurikijwe amasezerano y’umutangabuguzi, IceCure Shanghai izaba ifite inshingano zo kubona no kubungabunga uburenganzira bwose bw’amategeko ("Ibyemeza bigengwa n’amategeko") busabwa mu kwamamaza, kwamamaza, gukwirakwiza, kugurisha no gukoresha ibicuruzwa mu Bushinwa. NMPA, ishami ryayo ryo mu gace, cyangwa ikindi kigo cya leta ("Ikigo gishinzwe kugenzura"). IceCure Shanghai yahawe uburenganzira bw’amategeko kuri IceSense3 System Console kandi isaba uburenganzira bw’amategeko kuri IceSense3 cryoprobe yo gukoreshwa mu bucuruzi mu mezi icyenda uhereye igihe amasezerano yo gukwirakwiza atangiriye gukurikizwa. Shanghai Medtronic ifite uburenganzira bwo gusesa amasezerano yo gukwirakwiza niba IceCure Shanghai itarabona uburenganzira bw’amategeko kuri cryoprobes icyo gihe.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) ikora kandi igurisha ProSense®, uburyo bugezweho bwo kuvura kanseri y’amazi ya azote (ifite uburibwe na kanseri) hifashishijwe uburyo bwo kuvura kanseri y’amagufwa, cyane cyane kanseri y’amabere, impyiko, amagufwa n’ibihaha. Ikoranabuhanga ryayo ritangiza cyane ritanga ubundi buryo bwizewe kandi bufite akamaro bwo gukuraho kanseri mu bitaro, hamwe n’igihe gito cyo kubaga no kubaga byoroshye gukora. Kugeza ubu, ubu buryo buri ku isoko kandi bugurishwa ku isi yose hakurikijwe ibimenyetso byemewe na FDA kandi bwemewe na CE Mark mu Burayi.
Iri tangazo rikubiyemo amagambo areba imbere mu gihe kizaza nk'uko bisobanurwa n'ingingo z' “umutekano” z'Itegeko ryo kuvugurura imanza z'imigabane ryigenga ryo mu 1995 n'andi mategeko agenga imigabane ya leta. Amagambo nka “kwitega”, “kwitega”, “guteganya”, “guteganya”, “kwemera”, “guteganya”, “guteganya” n'andi magambo asa cyangwa andi anyuranye agamije kwerekeza ku magambo areba imbere. Urugero, IceCure ikoresha amagambo areba imbere muri iri tangazo mu gihe iganira ku masezerano yo gukwirakwiza na Shanghai Medtronic na Turing, ingamba z'amategeko agenga isosiyete, ibikorwa byo gucuruza, n'amahirwe yo ku isoko rya sisitemu zo gukwirakwiza imigabane mu Bushinwa. Kubera ko ayo magambo afitanye isano n'ibintu bizaza kandi ashingiye ku byo IceCure yiteze ubu, ahura n'ingaruka zitandukanye n'ibitazwi, kandi umusaruro nyakuri wa IceCure, imikorere cyangwa ibyagezweho bishobora gutandukana n'ibyavuzwe cyangwa bisobanurwa n'aya magambo ari muri iri tangazo. Hari itandukaniro rikomeye. Amagambo areba imbere ari muri iri tangazo cyangwa avugwa muri iri tangazo ahura n’izindi ngorane n’ibintu bitazwi neza, byinshi muri byo bikaba bidashobora kugenzurwa na Sosiyete, harimo n’ibyavuzwe mu gice cya “Ingaruka z’Akaga” cya Raporo y’umwaka ya Sosiyete ku ifishi ya 20-F yatanzwe muri SEC guhera ku ya 1 Mata 2022 y’umwaka warangiye ku ya 31 Ukuboza 2021, iboneka ku rubuga rwa SEC kuri www.sec.gov. Sosiyete nta nshingano ifite yo kuvugurura aya magambo kugira ngo avugururwe cyangwa ahindurwe nyuma y’itariki iri tangazo ryatanzweho, keretse iyo bisabwa n’amategeko.