Wararka

Caesarea, Israel, Juun 13, 2022 /PRNewswire/ - IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" ama "Shirkadda"), cryotherapy ugu yar ee faafa ("IceCure (Shanghai) MedTech Co. . , Ltd. Medtronic"), oo hoos timaada Shirkadda Medtronic (NYSE: MDT) ("Medtronic") iyo Beijing Turing Medical Technology Co., Ltd. ("Turing") Nidaamyada ugu horreeya ee IceSense3 ayaa la filayaa in la keeno 2022.
Medtronic Shanghai waxay noqon doontaa qaybiyaha kaliya ee IceSense3 iyo baaritaankeeda la tuuri karo ee dhul weynaha Shiinaha muddo saddex sano ah oo bilowga ah, iyadoo bartilmaameedka ugu yar ee iibsiga uu yahay $3.5 milyan muddadan. Intaa waxaa dheer, dhul weynaha Shiinaha, Shanghai Medtronic si toos ah ama si aan toos ahayn uma maalgashan doono ama uma ganacsan doono, iibin maayo, suuq geyn maayo, kor uma qaadi doono ama ma bixin doono badeecad kasta oo la tartameysa IceSense3 inta lagu jiro muddada heshiiska qaybinta iyo wixii ka dambeeya lix (6) bilood. Turing ayaa mas'uul ka noqon doonta soo dejinta, rakibidda iyo adeegga iibka ka dib ee nidaamka IceSense3 ee dhul weynaha Shiinaha, halka Medtronic Shanghai ay maamuli doonto dhammaan suuqgeynta, iibinta iyo tababarrada xirfadeed ee qaarkood.
IceSense3 System Console waxaa ansixiyay Maamulka Alaabada Caafimaadka Qaranka ee Shiinaha ("NMPA"). IceCure waxay codsatay beddelka shahaadada diiwaangelinta si ay u ansixiso baaritaannada la tuuri karo, taas oo, haddii la oggolaado, u oggolaan doonta shirkadda inay suuq geyso IceSense3 cryoprobes la tuuri karo si loogu isticmaalo ganacsi, IceCure-na waxay rajaynaysaa inay hesho oggolaanshaha NMPA ee baaritaannada dhammaadka 2022.
"Shanghai Medtronic iyo Turing waa shuraako ku habboon annaga gudaha Shiinaha, halkaas oo gelitaanka suuqa ee tignoolajiyada qaylo-dhaanta ay hadda hooseyso. Waxaan u aragnaa fursad aad u wanaagsan qaadashada baahsan ee nidaamkayaga IceSense3 cryoablation ee dhul weynaha Shiinaha, oo ah suuq si degdeg ah u koraya. taasi waxay hagaajinaysaa natiijooyinka,” ayuu yidhi maamulaha IceCure Eyal Shamir. "Iyada oo qayb ka ah shirkadda qalabka caafimaadka ee ugu weyn adduunka, Shanghai Medtronic waxay leedahay waayo-aragnimada iyo awoodda suuqa si ay u suurtageliso gelitaanka suuqa degdega ah ee IceSense3 si ay u bixiso daaweyn badbaado leh, waxtar leh oo qiimo leh oo loogu talagalay kansarka naasaha hore iyo calaamado kale."
"IceCure waxay leedahay xalka ugu horreeya ee buro-buufinta adduunka," ayuu yiri Jing Yu, madaxweyne ku xigeenka iyo maareeyaha guud ee Skull, Spine iyo Orthopedic Technologies ee Medtronic Shanghai. Iskaashiga IceCure iyo Turing Medical ayaa kaabi doona khadka wax soo saarka ee Medtronic Shanghai ee qaliinka neerfaha. Waxaan rajeyneynaa in iskaashigaani uu horumarin doono codsiga kiliinikada ee cryoablation oo ay ka faa'iideysanayaan bukaanno badan oo buro ah, sidoo kale waxaan rajeyneynaa inaan la shaqeyno la-hawlgalayaal badan si loo dardar-geliyo korsashada iyo geynta xalalka caafimaad ee horumarsan kuwaas oo gacan ka geysan doona xallinta caqabadaha muhiimka ah ee daaweynta burooyinka. Waaxda Caafimaadka ee Shiinaha.
Maamulaha guud ee Turing Lin Youjia ayaa intaa ku daray, "Anagoo kaashanayna Shanghai Medtronic iyo IceCure, waxaa naga go'an inaan bilowno keenista iyo rakibida degdega ah ee nidaamka IceSense3 ee dhul weynaha Shiinaha. Joogitaankayaga dalka oo dhan ee dhul weynaha Shiinaha waxay hubisaa in xarumaha caafimaadku helaan taageero farsamo oo heer sare ah iyo adeeg ay isticmaalayeen nidaamkooda IceSense3 muddo dheer. "
Juun 12, 2022 ("Taariikhda Dhaqangalka"), IceCure Shanghai waxay gashay heshiis iibka iyo qaybinta gaarka ah ("Heshiiska Qaybinta") oo ay la gashay Shanghai Medtronic iyo Turing for IceSense3 iyo baaritaannada la tuuri karo ("Alaabooyinka") muddo bilow ah. 36 bilood, ujeedada iibka ugu yar ee muddadan waa $3.5 milyan ("Bartilmaameedka Iibka Ugu Yar"). Sida ku cad heshiiska qaybinta, IceCure Shanghai waxay iibin doontaa alaabta Turing iyo Turing waxay soo dejin doontaa alaabada Israel ilaa dhul weynaha Shiinaha ka dibna dib u iibin doonta Medtronic Shanghai. Medtronic Shanghai ayaa mas'uul ka noqon doonta, waxyaabo ay ka mid yihiin: (i) suuqgeyn iyo dhiirrigelinta badeecada dhul weynaha Shiinaha; (ii) Samee hawlo waxbarasho caafimaad oo xirfad leh oo badeecada ah ee dhul weynaha Shiinaha. Turing ayaa mas'uul ka noqon doonta bakhaarka, saadka, dammaanadda, tababarka iyo taageerada kale iyo adeegyada iibka kadib.
Sida ku cad shuruudaha heshiiska qaybinta, Shanghai Medtronic waxay xaq u leedahay inay kordhiso muddada heshiiska qaybinta saddex sano haddii ay gaadho wadarta saddexda sano ee ugu yar yoolka wax iibsiga, iyadoo ku xiran heshiiska bartilmaameedka cusub ee iibsiga ugu yar. Heshiiska Qaybiyaha waxaa laga yaabaa in lagu joojiyo xaalado gaar ah, oo ay ku jiraan haddii ay dhacdo cillad la'aan, alaab gabaabsi ah ama khasaare.
Intaa waxaa dheer, iyadoo la raacayo shuruudaha Heshiiska Qaybiyaha, IceCure Shanghai waxay mas'uul ka noqon doontaa helitaanka iyo ilaalinta mid kasta iyo dhammaan ansixinta sharciyeynta ("Ansixinta Xeerarka") ee looga baahan yahay suuq-geynta, kor u qaadista, qaybinta, iibinta iyo isticmaalka Alaabta gudaha Shiinaha. NMPA, laanteeda maxalliga ah, ama wakaalad kasta oo kale oo dawladeed ("Maamulka Nidaaminta"). IceCure Shanghai waxay heshay oggolaanshaha sharciyeynta ee IceSense3 System Console waxayna u baahan tahay ogolaansho sharciyeed IceSense3 cryoprobe la tuuri karo ee nidaamyada ganacsiga sagaal bilood gudahood laga bilaabo taariikhda dhaqan galka heshiiska qaybinta. Shanghai Medtronic waxay xaq u leedahay inay joojiso heshiiska qaybinta haddii IceCure Shanghai aysan helin ogolaanshaha sharci ee cryoprobes markaas.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) waxay horumarisaa oo suuq geynaysaa ProSense®, daawaynta dareeraha nitrogen ee dareeraha ah ee loo yaqaan 'cryptoablative therapy' oo loogu talagalay daawaynta burooyinka (benign iyo kansar) oo leh cryotherapy, ugu horrayn lala beegsanayo kansarka naasaha, kelyaha, lafaha iyo sanbabada. kalluunka crayfish. Farsamadeeda ugu yar ee wax-ka-soo-baxa ayaa bixisa beddel badbaado leh oo wax ku ool ah oo loogu beddelo bukaan-jiifka ka saaridda burada, oo leh waqti yar oo qalliin ah iyo hab sahlan oo lagu sameeyo qalliin. Ilaa hadda, nidaamka waa la suuq geeyaa oo loo suuq geeyaa adduunka oo dhan si loogu helo tilmaamo ay oggolaatay FDA waana CE Mark laga oggolaaday Yurub.
War-saxaafadeedkan waxa uu ka kooban yahay odhaaho horudhac u ah macnaha shuruudaha "dekedda nabdoon" ee Xeerka Dib-u-habaynta Dacwadda Damaanad Gaarka ah ee 1995 iyo sharciyada kale ee amniga federaalka. Erayada ay ka midka yihiin “fili”, “ku talagal”, “ku talo-gal”, “qorshe”, “rumayso”, “ku talo-gal”, “qiyaas” iyo tibaaxo la mid ah ama kala duwanaanshiyaha ereyadan ayaa loogu talagalay in lagu tixraaco odhaahyada mustaqbalka. Tusaale ahaan, IceCure waxay isticmaashaa weedhaha mustaqbalka ee war-saxaafadeedkan marka laga hadlayo heshiisyada qaybinta ee Shanghai Medtronic iyo Turing, istaraatijiyadda sharciyeynta ee shirkadda, hawlaha ganacsi, iyo fursadaha suuqa ee nidaamyada qaylo-dhaanta ee shirkadda ee dhul-weynaha Shiinaha. Sababtoo ah odhaahyadan oo kale waxay la xidhiidhaan dhacdooyinka mustaqbalka waxayna ku salaysan yihiin rajooyinka IceCure ee hadda, waxay ku xiran yihiin khataro kala duwan iyo hubanti la'aan, iyo IceCure natiijooyinkeeda dhabta ah, waxqabadka ama guulaha laga yaabo inay ka duwanaadaan kuwa lagu sifeeyay ama lagu tilmaamay weedhaha ku jira war-saxaafadeedkan. Waxaa jira farqi weyn. . Odhaahyada hore u eegaya ee ku jira ama lagu sheegay war-saxaafadeedkan waxay ku xidhan yihiin khataro kale iyo hubanti la'aan, kuwaas oo intooda badan ka baxsan xakamaynta Shirkadda, oo ay ku jiraan kuwa lagu tilmaamay qaybta "Arimaha Khatarta" ee Warbixinta Sannadlaha ah ee Shirkadda ee Foomka 20-F ee lagu xareeyay SEC laga bilaabo Abriil 1, 2022 sanadka dhamaaday Diseembar 31, 2021, oo laga heli karo website-ka SEC ee www.sec.gov. Shirkaddu ma qaadi doonto wax waajibaad ah inay cusboonaysiiso bayaankan dib-u-eegista ama isbeddelka ka dib taariikhda war-saxaafadeedkan, ilaa sharcigu u baahdo mooyee.