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Caesarea, Israa'iil, Juun 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" ama "Shirkadda"), oo ah daaweynta cryotherapy-ga ee ugu yar ee duullaanka ah ("IceCure (Shanghai) MedTech Co. ., Ltd. ("IceCure", oo ah shirkad si buuxda u leh IceCure (Shanghai) MedTech Co., Ltd. Shanghai"), ayaa heshiis la saxiixatay dhismaha nidaamka cryoablation-ka IceSense3 oo ay la gashay Shanghai Medtronic Zhikang Medical Devices Co., Ltd. ("Shanghai Medtronic"), oo ah shirkad hoos timaada Medtronic Corporation (NYSE: MDT) ("Medtronic") iyo Beijing Turing Medical Technology Co., Ltd. ("Turing") Nidaamyada IceSense3 ee ugu horreeya ayaa la filayaa in la keeno 2022.
Medtronic Shanghai waxay noqon doontaa qaybiyaha kaliya ee IceSense3 iyo baaritaannadeeda la tuuri karo ee dhul-weynaha Shiinaha muddo saddex sano ah oo bilow ah, iyadoo bartilmaameedka ugu yar ee iibka uu yahay $3.5 milyan muddadan. Intaa waxaa dheer, dhul-weynaha Shiinaha, Shanghai Medtronic si toos ah ama si dadban uma maalgelin doonto ama uma ganacsan doonto, ma iibin doonto, ma suuq geyn doonto, ma dallacsiin doonto ama ma bixin doonto wax kasta oo la tartami kara IceSense3 inta lagu jiro muddada heshiiska qaybinta iyo wixii ka dambeeya lix (6) bilood. Turing waxay mas'uul ka noqon doontaa soo dejinta, rakibidda iyo adeegga iibka kadib ee nidaamka IceSense3 ee dhul-weynaha Shiinaha, halka Medtronic Shanghai ay maamuli doonto dhammaan suuqgeynta, iibka iyo tababar xirfadeed oo gaar ah.
Nidaamka IceSense3 waxaa ansixiyay Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha ("NMPA"). IceCure waxay codsatay isbeddel shahaado diiwaangelin ah si ay u ansixiso baaritaannada la tuuri karo ee, haddii la ansixiyo, u oggolaan doona shirkadda inay suuq geyso cryoprobes-keeda la tuuri karo ee IceSense3 si loogu isticmaalo ganacsi, IceCure-na waxay filaysaa inay hesho oggolaanshaha NMPA ee baaritaannada dhammaadka 2022.
"Shanghai Medtronic iyo Turing waa lammaane ku habboon dhul-weynaha Shiinaha, halkaas oo gelitaanka suuqa ee tignoolajiyada cryoablation-ka hadda uu hooseeyo. Waxaan aragnaa fursad aad u wanaagsan oo loogu talagalay qaadashada baahsan ee nidaamka cryoablation-ka IceSense3 ee dhul-weynaha Shiinaha, suuq si aad ah u koraya. taasoo hagaajinaysa natiijooyinka," ayuu yiri madaxa shirkadda IceCure Eyal Shamir. "Iyada oo qayb ka ah shirkadda qalabka caafimaadka ee ugu weyn adduunka, Shanghai Medtronic waxay leedahay khibrad iyo awood suuqeed si ay u suurtogeliso gelitaanka suuqa ee IceSense3 si ay u bixiso daaweyn badbaado leh, wax ku ool ah oo kharash-ool ah oo loogu talagalay kansarka naasaha hore iyo tilmaamo kale."
"IceCure waxay leedahay xalka ugu horreeya adduunka ee cryoablation burooyinka," ayay tiri Jing Yu, madaxweyne ku xigeenka iyo maareeyaha guud ee Skull, Lafdhabarta iyo Orthopedic Technologies ee Medtronic Shanghai. Iskaashiga IceCure iyo Turing Medical wuxuu dhameystiri doonaa khadka wax soo saarka Medtronic Shanghai ee qalliinka neerfaha ee kansarka. Waxaan rajeyneynaa in iskaashigani uu horumarin doono isticmaalka kiliinikada ee cryoablation isla markaana uu ka faa'iideysan doono bukaanno badan oo burooyinka ah, waxaana sidoo kale rajeyneynaa inaan la shaqeyno la-hawlgalayaal badan si loo dedejiyo qaadashada iyo hirgelinta xalalka caafimaad ee horumarsan ee gacan ka geysan doona xallinta caqabadaha daaweynta burooyinka muhiimka ah. Waaxda Caafimaadka ee Shiinaha.
Madaxa shirkadda Turing Lin Youjia ayaa intaa ku daray, "Annagoo la kaashanayna Shanghai Medtronic iyo IceCure, waxaan ka go'annahay inaan bilowno dejinta iyo rakibidda degdega ah ee nidaamka IceSense3 ee dhul-weynaha Shiinaha. Joogitaankeenna guud ahaan ee dalka Shiinaha wuxuu hubinayaa in xarumaha caafimaadku ay helaan taageero farsamo oo heer sare ah iyo adeeg ay muddo dheer isticmaalayay nidaamkooda IceSense3."
Juun 12, 2022 ("Taariikhda Dhaqangalka"), IceCure Shanghai waxay gashay heshiis gaar ah oo iib iyo qaybin ah ("Heshiiska Qaybinta") oo ay la gashay Shanghai Medtronic iyo Turing oo loogu talagalay IceSense3 iyo baaritaanno la tuuri karo ("Alaab") muddo bilow ah. 36 bilood, yoolka ugu yar ee iibka muddadan waa $3.5 milyan ("Bartilmaameedka Iibka Ugu Yar"). Sida ku cad heshiiska qaybinta, IceCure Shanghai waxay iibin doontaa alaabada Turing, Turing-na waxay ka soo dejin doontaa alaabada Israa'iil dhul-weynaha Shiinaha ka dibna waxay dib ugu iibin doontaa Medtronic Shanghai. Medtronic Shanghai waxay mas'uul ka noqon doontaa, waxyaabo kale: (i) suuqgeynta iyo kor u qaadista badeecada dhul-weynaha Shiinaha; (ii) sameynta hawlo waxbarasho caafimaad oo xirfad leh oo loogu talagalay badeecada dhul-weynaha Shiinaha. Turing waxay mas'uul ka noqon doontaa kaydinta, saadka, damaanadda, tababarka iyo adeegyada kale iyo adeegyada iibka kadib.
Sida ku cad heshiiska qaybinta, Shanghai Medtronic waxay xaq u leedahay inay muddada heshiiska qaybinta ku kordhiso saddex sano haddii ay gaarto bartilmaameedka iibka ugu yar ee saddexda sano ah, iyadoo ku xiran heshiiska bartilmaameedka iibka ugu yar ee cusub. Heshiiska Qaybiyaha waxaa lagu joojin karaa xaalado gaar ah, oo ay ku jiraan haddii ay dhacdo wax iska beddel ah, wax iska beddel ah ama wax iska beddel ah.
Intaa waxaa dheer, iyadoo la raacayo shuruudaha Heshiiska Qaybiyaha, IceCure Shanghai waxay mas'uul ka noqon doontaa helitaanka iyo ilaalinta dhammaan oggolaanshaha sharciyeed ("Ansaxinta Sharciyeed") ee looga baahan yahay suuqgeynta, kor u qaadista, qaybinta, iibinta iyo isticmaalka Badeecadaha dhul-weynaha Shiinaha. NMPA, laanteeda maxalliga ah, ama hay'ad kasta oo kale oo dawladeed ("Hay'adda Sharciyeynta"). IceCure Shanghai waxay heshay oggolaanshaha sharciyeed ee IceSense3 System Console waxayna u baahan tahay oggolaanshaha sharciyeed ee cryoprobe-ka la tuuri karo ee IceSense3 ee hababka ganacsiga sagaal bilood gudahood laga bilaabo taariikhda dhaqangalka heshiiska qaybinta. Shanghai Medtronic waxay xaq u leedahay inay joojiso heshiiska qaybinta haddii IceCure Shanghai aysan helin oggolaanshaha sharciyeed ee cryoprobes markaas.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) waxay horumarisaa oo suuq geysaa ProSense®, oo ah daaweyn dareere ah oo nitrogen ah oo loogu talagalay daaweynta burooyinka (kuwa aan fiicnayn iyo kuwa kansarka leh) iyadoo la adeegsanayo daaweynta cryotherapy, oo ugu horreyn bartilmaameedsaneysa kansarka naasaha, kelyaha, lafaha iyo sambabada. Crayfish. Tiknoolajiyadeeda ugu yar ee duullaanka ah waxay bixisaa beddel ammaan ah oo wax ku ool ah oo loogu talagalay qalliinka ka saarista burooyinka bukaan-jiifka, iyadoo leh waqti qalliin oo gaaban iyo hab qalliin oo si fudud loo fulin karo. Ilaa hadda, nidaamka waxaa loo suuqgeeyaa oo loo suuqgeeyaa adduunka oo dhan si loo helo tilmaamo ay ansixisay FDA waana CE Mark oo laga ansixiyay Yurub.
War-saxaafadeedkan waxa ku jira hadallo mustaqbalka eegaya oo ku salaysan macnaha qodobbada "dekedda badbaadada" ee Xeerka Dib-u-habaynta Dacwadaha Amniga Gaarka loo leeyahay ee 1995 iyo sharciyada kale ee dammaanadaha federaalka. Erayada sida "filo", "filo", "ujeeddo", "qorshe", "rumayso", "ujeeddo", "qiyaas" iyo tibaaxo la mid ah ama kala duwanaansho ereyadaas ah ayaa loogu talagalay in lagu tilmaamo hadallada mustaqbalka eegaya. Tusaale ahaan, IceCure waxay isticmaashaa hadallada mustaqbalka eegaya ee war-saxaafadeedkan marka ay ka hadlayso heshiisyada qaybinta ee Shanghai Medtronic iyo Turing, istaraatiijiyadda sharciyeynta shirkadda, hawlaha ganacsiga, iyo fursadaha suuqa ee nidaamyada cryoablation ee shirkadda ee dhul-weynaha Shiinaha. Sababtoo ah hadallada noocaas ah waxay la xiriiraan dhacdooyinka mustaqbalka waxayna ku salaysan yihiin filashooyinka hadda ee IceCure, waxay la kulmaan khataro iyo hubanti la'aan kala duwan, natiijooyinka dhabta ah ee IceCure, waxqabadka ama guulaha way ka duwanaan karaan kuwa lagu sharraxay ama lagu tilmaamay hadallada ku jira war-saxaafadeedkan. Waxaa jira kala duwanaansho muhiim ah. . Hadallada mustaqbalka ee ku jira ama lagu tilmaamay war-saxaafadeedkan waxaa ku xiran khataro kale iyo hubanti la'aan, kuwaas oo badankoodu ka baxsan yihiin xakamaynta Shirkadda, oo ay ku jiraan kuwa lagu sharraxay qaybta "Arrimaha Khatarta" ee Warbixinta Sannadlaha ah ee Shirkadda ee Foomka 20-F ee lagu xareeyay SEC laga bilaabo Abriil 1, 2022 sanadka dhammaaday Diseembar 31, 2021, oo laga heli karo bogga internetka ee SEC ee www.sec.gov. Shirkaddu ma qaadayso wax waajib ah oo ah inay cusbooneysiiso hadalladan si dib loogu eego ama wax looga beddelo ka dib taariikhda war-saxaafadeedkan, haddii aan sharcigu u baahnayn.