Nkhani

Caesarea, Israel, June 13, 2022 /PRNewswire/ — IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" kapena "Kampani"), yomwe ndi njira yochepetsera kufalikira kwa matenda a cryotherapy ("IceCure (Shanghai) MedTech Co. ., Ltd. ("IceCure", kampani yothandizidwa ndi IceCure (Shanghai) MedTech Co., Ltd. Shanghai"), idasaina pangano lomanga njira yochepetsera kufalikira kwa matenda a IceSense3 ndi Shanghai Medtronic Zhikang Medical Devices Co., Ltd. ("Shanghai Medtronic"), kampani yothandizidwa ndi Medtronic Corporation (NYSE: MDT) ("Medtronic") ndi Beijing Turing Medical Technology Co., Ltd. ("Turing") Makina oyamba a IceSense3 akuyembekezeka kuperekedwa mu 2022.
Medtronic Shanghai idzakhala kampani yokhayo yogawa IceSense3 ndi ma probe ake otayidwa ku China kwa zaka zitatu zoyambirira, ndi cholinga chogula chochepera $3.5 miliyoni panthawiyi. Kuphatikiza apo, ku China, Shanghai Medtronic sidzayika ndalama mwachindunji kapena mwanjira ina kapena kugulitsa, kugulitsa, kugulitsa, kutsatsa, kutsatsa kapena kupereka chilichonse chomwe chikupikisana ndi IceSense3 panthawi ya mgwirizano wogawa komanso kupitirira miyezi isanu ndi umodzi (6). Turing idzakhala ndi udindo wotumiza, kukhazikitsa ndi kutumiza pambuyo pogulitsa makina a IceSense3 ku China, pomwe Medtronic Shanghai idzayang'anira malonda onse, malonda ndi maphunziro ena aukadaulo.
IceSense3 System Console yavomerezedwa ndi China National Medical Products Administration (“NMPA”). IceCure yapempha kusintha kwa satifiketi yolembetsa kuti ivomereze ma probe otayidwa omwe, ngati avomerezedwa, angalole kampaniyo kutsatsa ma cryoprobe ake otayidwa a IceSense3 kuti agwiritsidwe ntchito pamalonda, ndipo IceCure ikuyembekeza kulandira chilolezo cha NMPA cha ma probe pofika kumapeto kwa chaka cha 2022.
"Shanghai Medtronic ndi Turing ndi ogwirizana nafe abwino kwambiri ku China, komwe ukadaulo wa cryoablation ukupezeka pamsika pakadali pano. Tikuwona mwayi wabwino kwambiri woti njira yathu ya cryoablation ya IceSense3 igwiritsidwe ntchito kwambiri ku China, msika womwe ukukula mwachangu kwambiri. zomwe zimapangitsa kuti zotsatira zake zikhale zabwino," adatero CEO wa IceCure, Eyal Shamir. "Monga gawo la kampani yayikulu kwambiri padziko lonse lapansi yopangira zida zamankhwala, Shanghai Medtronic ili ndi luso komanso mphamvu pamsika kuti ithandize IceSense3 kulowa mwachangu pamsika kuti ipereke chithandizo chotetezeka, chogwira ntchito komanso chotsika mtengo cha khansa ya m'mawere yoyambirira ndi zizindikiro zina."
"IceCure ili ndi njira yotsogola padziko lonse yochepetsera kutupa kwa chotupa," adatero Jing Yu, wachiwiri kwa purezidenti komanso manejala wamkulu wa Skull, Spine and Orthopedic Technologies ku Medtronic Shanghai. Mgwirizanowu ndi IceCure ndi Turing Medical udzathandizira mzere wa mankhwala a Medtronic Shanghai mu opaleshoni ya mitsempha ya oncology. Tikukhulupirira kuti mgwirizanowu udzapititsa patsogolo kugwiritsa ntchito kwa cryoablation kuchipatala ndikupindulitsa odwala ambiri otupa, ndipo tikuyembekezeranso kugwira ntchito ndi ogwirizana nawo ambiri kuti tifulumizitse kugwiritsa ntchito ndikugwiritsa ntchito njira zamakono zamankhwala zomwe zingathandize kuthetsa mavuto akuluakulu ochizira chotupa. Gawo la Zaumoyo ku China.
Mtsogoleri wamkulu wa Turing, Lin Youjia, adawonjezera kuti, "Mogwirizana ndi Shanghai Medtronic ndi IceCure, tadzipereka kuyambitsa kuyika ndi kukhazikitsa mwachangu makina a IceSense3 ku China. Kupezeka kwathu mdziko lonse ku China kumatsimikizira kuti zipatala zimalandira chithandizo chaukadaulo chapamwamba komanso ntchito zomwe zakhala zikugwiritsa ntchito makina awo a IceSense3 kwa nthawi yayitali."
Pa June 12, 2022 (“Tsiku Loyamba Kugwira Ntchito”), IceCure Shanghai idalowa mu mgwirizano wapadera wogulitsa ndi kugawa (“Mgwirizano Wogawa”) ndi Shanghai Medtronic ndi Turing wa IceSense3 ndi ma probe otayidwa (“Zogulitsa”) kwa nthawi yoyamba. Miyezi 36, cholinga chochepa chogulira panthawiyi ndi $3.5 miliyoni (“Cholinga Chocheperako Chogulira”). Pansi pa mgwirizano wogawa, IceCure Shanghai idzagulitsa zinthu za Turing ndipo Turing idzatumiza zinthu kuchokera ku Israeli kupita ku China kenako nkuzigulitsanso ku Medtronic Shanghai. Medtronic Shanghai idzakhala ndi udindo, pakati pa zinthu zina: (i) kutsatsa ndi kutsatsa malonda ku China; (ii) kuchita maphunziro azachipatala aukadaulo a malonda ku China. Turing idzakhala ndi udindo wosungiramo zinthu, mayendedwe, chitsimikizo, maphunziro ndi chithandizo china komanso ntchito zogulitsa pambuyo pogulitsa.
Malinga ndi zomwe zili mu mgwirizano wogawa, Shanghai Medtronic ili ndi ufulu wowonjezera nthawi ya mgwirizano wogawa kwa zaka zitatu ngati ifika pa cholinga chogula cha zaka zitatu, malinga ndi mgwirizano wa cholinga chogula chatsopano. Pangano la Wogawa lingathe kuthetsedwa pazifukwa zina, kuphatikizapo ngati pali kusakhulupirika, kusakhulupirika kwakukulu kapena kulephera kulipira ngongole.
Kuphatikiza apo, malinga ndi zomwe zili mu Pangano la Ogawa, IceCure Shanghai idzakhala ndi udindo wopeza ndikusunga zilolezo zonse zoyang'anira ("Zovomerezeka Zoyang'anira") zofunika kuti zigulitse, kutsatsa, kugawa, kugulitsa ndikugwiritsa ntchito Zogulitsazo ku China. NMPA, nthambi yake yakomweko, kapena bungwe lina lililonse la boma ("Regulatory Authority"). IceCure Shanghai yalandira chilolezo choyang'anira cha IceSense3 System Console ndipo ikufuna chilolezo choyang'anira cha IceSense3 disposable cryoprobe kuti igwiritsidwe ntchito pamalonda mkati mwa miyezi isanu ndi inayi kuyambira tsiku loyambira mgwirizano wogawa. Shanghai Medtronic ili ndi ufulu wothetsa mgwirizano wogawa ngati IceCure Shanghai silandira chilolezo choyang'anira cha cryoprobes pofika nthawi imeneyo.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) ikupanga ndikugulitsa ProSense®, mankhwala apamwamba amadzimadzi a nayitrogeni cryoablative othandizira kuchiza zotupa (zosavulaza komanso za khansa) pogwiritsa ntchito cryotherapy, makamaka yokhudza khansa ya m'mawere, impso, mafupa ndi mapapo. Ukadaulo wake wosalowerera kwambiri umapereka njira ina yotetezeka komanso yothandiza m'malo mwa opaleshoni yochotsa chotupa m'chipatala, yokhala ndi nthawi yochepa yochita opaleshoni komanso njira yosavuta yochitira opaleshoni. Mpaka pano, dongosololi likugulitsidwa ndikugulitsidwa padziko lonse lapansi chifukwa cha zizindikiro zovomerezeka ndi FDA ndipo lavomerezedwa ndi CE Mark ku Europe.
Chikalatachi chili ndi mawu owonera zam'tsogolo mkati mwa tanthauzo la "chitetezo chotetezeka" cha Private Securities Litigation Reform Act ya 1995 ndi malamulo ena a boma okhudzana ndi chitetezo. Mawu monga "kuyembekezera", "kuyembekezera", "cholinga", "kukonzekera", "kukhulupirira", "cholinga", "kuyesa" ndi mawu ofanana kapena kusiyanasiyana kwa mawu otere cholinga chake ndi kutanthauza mawu owonera zam'tsogolo. Mwachitsanzo, IceCure imagwiritsa ntchito mawu owonera zam'tsogolo mu chikalatachi pokambirana za mapangano ogawa ndi Shanghai Medtronic ndi Turing, njira yoyendetsera kampaniyo, ntchito zamalonda, ndi mwayi wamsika wamachitidwe a cryoablation a kampaniyo ku China. Chifukwa mawu oterewa akukhudzana ndi zochitika zamtsogolo ndipo amachokera ku zomwe IceCure ikuyembekezera pakali pano, ali pachiwopsezo ndi kusatsimikizika kosiyanasiyana, ndipo zotsatira zenizeni za IceCure, magwiridwe antchito kapena zomwe zakwaniritsidwa zitha kusiyana ndi zomwe zafotokozedwa kapena zomwe zanenedwa ndi mawu omwe ali mu chikalatachi. Pali kusiyana kwakukulu. Mawu owonera zam'tsogolo omwe ali kapena omwe atchulidwa mu lipotili akukumana ndi zoopsa zina komanso zosatsimikizika, zomwe zambiri mwa izo sizingalamuliridwe ndi Kampani, kuphatikizapo zomwe zafotokozedwa mu gawo la "Zinthu Zoopsa" la Lipoti Lapachaka la Kampani pa Fomu 20-F lomwe linaperekedwa mu SEC kuyambira pa Epulo 1, 2022 la chaka chomwe chinatha pa Disembala 31, 2021, lomwe likupezeka patsamba la SEC pa www.sec.gov. Kampaniyo sichita chilichonse chofuna kusintha mawu awa kuti asinthidwe kapena kusintha pambuyo pa tsiku la lipotili, pokhapokha ngati lamulo likufuna kutero.