Nkhani

Caesarea, Israel, June 13, 2022 /PRNewswire/ - IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" kapena "Company"), cryotherapy yochepa kwambiri ("IceCure (Shanghai) MedTech Co. . , Ltd. ("IceCure", kampani yathunthu ya IceCure (Shanghai) MedTech Co., Ltd. Shanghai"), inasaina pangano lomanga IceSense3 cryoablation system ndi Shanghai Medtronic Zhikang Medical Devices Co., Ltd. ("Shanghai Medtronic"), wothandizira wa Medtronic Corporation (NYSE: MDT) ("Medtronic") ndi Beijing Turing Medical Technology Co., Ltd. ("Turing") Makina oyambirira a IceSense3 akuyembekezeka kuperekedwa mu 2022.
Medtronic Shanghai ikhala yokhayo yogawa IceSense3 ndi zofufuza zake zomwe zingatayike ku China kwazaka zitatu zoyambirira, ndi cholinga chogula cha $ 3.5 miliyoni panthawiyi. Kuphatikiza apo, ku China, Shanghai Medtronic sidzagulitsa mwachindunji kapena mwanjira ina kapena kugulitsa, kugulitsa, kugulitsa, kulimbikitsa kapena kupereka chilichonse chomwe chimapikisana ndi IceSense3 panthawi ya mgwirizano wogawa komanso kupitilira miyezi isanu ndi umodzi (6). Turing adzakhala ndi udindo wolowetsa, kukhazikitsa ndi kugulitsa pambuyo pa ntchito ya IceSense3 ku China, pamene Medtronic Shanghai idzayang'anira malonda onse, malonda ndi maphunziro ena aukadaulo.
IceSense3 System Console idavomerezedwa ndi China National Medical Products Administration (“NMPA”). IceCure yapempha kuti chisinthidwe cha satifiketi yolembetsa kuti ivomereze ma probes omwe, ngati avomerezedwa, angalole kampaniyo kugulitsa ma cryoprobes otayika a IceSense3 kuti azigwiritsa ntchito malonda, ndipo IceCure ikuyembekeza kulandira chivomerezo cha NMPA pazofufuzazo kumapeto kwa 2022.
"Shanghai Medtronic ndi Turing ndi othandizana nawo abwino kwa ife ku China, komwe kulowera pamsika kwaukadaulo wa cryoablation pano kuli kotsika. Tikuwona mwayi wabwino kwambiri wotengera kufalikira kwa makina athu olira a IceSense3 ku China, msika womwe ukukula mwachangu kwambiri. zomwe zimabweretsa zotsatira zabwino, "atero CEO wa IceCure Eyal Shamir. "Monga gawo la kampani yayikulu kwambiri padziko lonse lapansi ya zida zamankhwala, Shanghai Medtronic ili ndi chidziwitso komanso mphamvu zamsika kuti ilowe mwachangu pamsika wa IceSense3 kuti ipereke chithandizo chotetezeka, chothandiza komanso chotsika mtengo cha khansa ya m'mawere yoyambirira ndi zisonyezo zina."
"IceCure ili ndi njira yotsogola kwambiri padziko lonse lapansi ya chotupa," atero a Jing Yu, wachiwiri kwa purezidenti komanso manejala wamkulu wa Skull, Spine and Orthopedic Technologies ku Medtronic Shanghai. Mgwirizano ndi IceCure ndi Turing Medical udzakwaniritsa mzere wa mankhwala a Medtronic Shanghai mu oncology neurosurgery. Tikukhulupirira kuti mgwirizanowu upititsa patsogolo ntchito yachipatala ya cryoablation ndikupindulitsa odwala chotupa ambiri, ndipo tikuyembekezeranso kugwira ntchito ndi anzathu ambiri kuti tifulumizitse kukhazikitsidwa ndi kutumizidwa kwa njira zamankhwala zapamwamba zomwe zingathandize kuthana ndi zovuta zazikulu zochizira chotupa. Health Sector of China.
Mtsogoleri wamkulu wa Turing a Lin Youjia anawonjezera kuti, "Mogwirizana ndi Shanghai Medtronic ndi IceCure, tadzipereka kuti tiyambe kutumiza ndi kukhazikitsa mwamsanga dongosolo la IceSense3 ku China. Kukhalapo kwathu m'dziko lonse la China kumatsimikizira kuti zipatala zimalandira chithandizo chaukadaulo chapamwamba ndipo ntchito zakhala zikugwiritsa ntchito makina awo a IceSense3 kwa nthawi yayitali. ”
Pa Juni 12, 2022 (“Tsiku Logwira Ntchito”), IceCure Shanghai idachita mgwirizano wogula ndi kugawa (“Mgwirizano Wogawira”) ndi Shanghai Medtronic ndi Turing ya IceSense3 ndi ma probe otaya ("Zogulitsa") kwa nthawi yoyamba. Miyezi 36, cholinga chochepa chogula panthawiyi ndi $ 3.5 miliyoni ("Minimum Purchase Target"). Pansi pa mgwirizano wogawa, IceCure Shanghai idzagulitsa zinthu za Turing ndipo Turing idzaitanitsa zinthu kuchokera ku Israel kupita ku China ndikuzigulitsanso ku Medtronic Shanghai. Medtronic Shanghai adzakhala ndi udindo, mwa zina: (i) kutsatsa ndi kukweza malonda ku China; (ii) kuchititsa maphunziro aukadaulo azachipatala pazogulitsa ku China. Turing adzakhala ndi udindo wosungira katundu, katundu, chitsimikizo, maphunziro ndi zina zothandizira ndi ntchito zogulitsa pambuyo pogulitsa.
Pansi pa mgwirizano wogawa, Shanghai Medtronic ili ndi ufulu wowonjezera nthawi ya mgwirizano wogawa kwa zaka zitatu ngati ifika pazaka zitatu zogulira zocheperako, malinga ndi mgwirizano wa chandamale chatsopano chogula. Pangano la Distributor litha kuthetsedwa nthawi zina, kuphatikiza pakakhala kusakhazikika, kusakhazikika kwazinthu kapena kulephera.
Kuphatikiza apo, malinga ndi zomwe Distributor Agreement ikupereka, IceCure Shanghai idzakhala ndi udindo wopeza ndi kusunga zivomerezo zilizonse zovomerezeka ("Zovomerezeka Zovomerezeka") zofunika kugulitsa, kulimbikitsa, kugawa, kugulitsa ndi kugwiritsa ntchito Zogulitsa ku China. NMPA, nthambi yakomweko, kapena bungwe lina lililonse la boma (“Regulatory Authority”). IceCure Shanghai yalandira chilolezo choyendetsera IceSense3 System Console ndipo ikufuna kuvomerezedwa ndi IceSense3 disposable cryoprobe pazamalonda mkati mwa miyezi isanu ndi inayi kuyambira tsiku lomwe mgwirizano wagawa. Shanghai Medtronic ili ndi ufulu wothetsa mgwirizano wogawa ngati IceCure Shanghai salandira chilolezo chowongolera ma cryoprobes pofika nthawiyo.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) imapanga ndikugulitsa ProSense®, mankhwala apamwamba amadzimadzi a nitrogen cryoablative pochiza zotupa (zowopsa komanso za khansa) ndi cryotherapy, makamaka zolunjika ku khansa ya m'mawere, impso, mafupa ndi mapapo. nsomba zazinkhanira. Ukadaulo wake wocheperako umapereka njira yotetezeka komanso yothandiza pochotsa chotupa cham'chipatala, ndi nthawi yocheperako komanso njira yosavuta yopangira opaleshoni. Mpaka pano, makinawa akugulitsidwa ndikugulitsidwa padziko lonse lapansi kuti aziwonetsa zovomerezeka ndi FDA ndipo ndi CE Mark yovomerezeka ku Europe.
Nkhaniyi ili ndi ziganizo zamtsogolo mkati mwa tanthauzo la "doko lotetezeka" la Private Securities Litigation Reform Act of 1995 ndi malamulo ena a federal chitetezo. Mawu monga “yembekezerani”, “yembekezerani”, “konzani”, “pangani”, “khulupirirani”, “tsimikizani”, “lingalirani” ndi mawu ofanana kapena kusiyanasiyana kwa mawu oterowo amalinganizidwa kutanthauza zonena zamtsogolo. Mwachitsanzo, IceCure imagwiritsa ntchito zonena zamtsogolo zomwe zili patsamba lino pokambirana za mapangano ogawa ndi Shanghai Medtronic ndi Turing, njira zoyendetsera kampaniyo, ntchito zamalonda, komanso mwayi wamsika wamakina amakampani akukulira ku China. Chifukwa mawu oterowo akugwirizana ndi zomwe zidzachitike m'tsogolo ndipo zimachokera ku zomwe IceCure akuyembekeza, zimakhala ndi zoopsa zosiyanasiyana komanso zosatsimikizika, ndipo zotsatira zenizeni za IceCure, ntchito kapena zomwe akwaniritsa zitha kusiyana ndi zomwe zafotokozedwa kapena kufotokozedwa m'nkhani ino. Pali kusiyana kwakukulu. . Ndemanga zoyang'ana kutsogolo zomwe zili kapena zomwe zikufotokozedwa m'nkhani ino zili ndi zoopsa zina, zomwe zambiri sizingathe kulamulidwa ndi Kampani, kuphatikizapo zomwe zafotokozedwa mu gawo la "Risk Factors" la Lipoti Lapachaka la Kampani pa Fomu 20-F yolembedwa mu SEC kuyambira pa Epulo 1, 2022 mchaka chomwe chinatha pa Disembala 31, 2021, ikupezeka patsamba la SEC pa www.sec.gov. Kampani siyichita chikakamizo chosintha mawuwa kuti awonedwenso kapena kusintha pambuyo pa tsiku lotulutsa atolankhani, pokhapokha ngati pakufunika kutero mwalamulo.