Litaba

Caesarea, Israel, June 13, 2022 /PRNewswire/ - IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" kapa "Company"), cryotherapy e hlaselang ka mokhoa o fokolang ("IceCure (Shanghai) MedTech Co. . , Ltd. (“IceCure”, e leng lekala la IceCure (Shanghai) MedTech Co., Ltd. Shanghai”), e saenetse konteraka ea ho haha ​​IceSense3 cryoablation system le Shanghai Medtronic Zhikang Medical Devices Co., Ltd. ("Shanghai Medtronic"), e leng setsi sa Medtronic Corporation (NYSE: MDT) ("Medtronic ”) le Beijing Turing Medical Technology Co., Ltd. (“Turing”) Litsamaiso tsa pele tsa IceSense3 li lebelletsoe ho tlisoa ka 2022.
Medtronic Shanghai e tla ba eona feela e tsamaisang IceSense3 le lisebelisoa tsa eona tse lahloang naheng ea China bakeng sa nako ea pele ea lilemo tse tharo, ka sepheo sa theko e tlase ea $ 3.5 milione nakong ena. Ntle le moo, naheng ea China, Shanghai Medtronic e ke ke ea tsetela ka kotloloho kapa ka mokhoa o sa tobang kapa ho rekisa, ho rekisa, ho bapatsa, ho khothaletsa kapa ho fana ka sehlahisoa sefe kapa sefe se qothisanang lehlokoa le IceSense3 nakong ea tumellano ea kabo le ho feta likhoeli tse tšeletseng (6). Turing e tla ikarabella bakeng sa ho kenya, ho kenya le ho fana ka litšebeletso tsa morao-rao tsa tsamaiso ea IceSense3 naheng ea Chaena, ha Medtronic Shanghai e tla sebetsana le papatso eohle, thekiso le koetliso e itseng ea litsebi.
IceSense3 System Console e amohetsoe ke China National Medical Products Administration (“NMPA”). IceCure e kentse kopo ea phetoho ea setifikeiti sa ngoliso ho amohela li-probes tse lahliloeng tseo, haeba li amohetsoe, li ka lumellang k'hamphani ho rekisa li-cryoprobe tsa eona tsa IceSense3 bakeng sa ts'ebeliso ea khoebo, mme IceCure e lebelletse ho fumana tumello ea NMPA bakeng sa lipatlisiso mafelong a 2022.
"Shanghai Medtronic le Turing ke balekane ba loketseng bakeng sa rona naheng ea China, moo theknoloji ea cryoablation e ntseng e kenella 'marakeng hona joale e leng tlase. Re bona monyetla o motle oa ho amoheloa ha sistimi ea rona ea ho lla ka sekhahla sa IceSense3 naheng ea China, 'maraka o ntseng o hola ka potlako haholo. e ntlafatsang liphetho, "ho boletse CEO oa IceCure Eyal Shamir. "Joaloka karolo ea k'hamphani e kholo ka ho fetisisa ea lisebelisoa tsa bongaka lefatšeng, Shanghai Medtronic e na le boiphihlelo le matla a mmaraka ho thusa ho kenella ka potlako 'marakeng oa IceSense3 ho fana ka kalafo e bolokehileng, e sebetsang le e theko e tlaase bakeng sa mofetše oa matsoele oa pele le matšoao a mang."
"IceCure e na le tharollo e ka sehloohong ea lefats'e ea ho lla ha hlahala," ho boletse Jing Yu, motlatsi oa mopresidente le molaoli kakaretso oa Skull, Spine and Orthopedic Technologies ho Medtronic Shanghai. Tšebelisano 'moho le IceCure le Turing Medical e tla tlatselletsa mohala oa sehlahisoa sa Medtronic Shanghai ho oncology neurosurgery. Re tšepa hore ts'ebelisano ena e tla ntšetsa pele ts'ebeliso ea bongaka ea cryoablation le ho thusa bakuli ba bangata ba hlahala, hape re labalabela ho sebetsa le balekane ba bangata ho potlakisa ho amoheloa le ho tsamaisoa ha litharollo tse tsoetseng pele tsa bongaka tse tla thusa ho rarolla mathata a bohlokoa a kalafo ea hlahala. Lekala la Bophelo la China.
Motsamaisi oa Turing Lin Youjia o ekelitse, "Ka ts'ebelisano 'moho le Shanghai Medtronic le IceCure, re ikemiselitse ho qala ho kenya le ho kenya sistimi ea IceSense3 ka potlako naheng ea China. Ho ba teng ha rona naheng ka bophara naheng ea China ho netefatsa hore litsi tsa bongaka li fumana tšehetso e phahameng ea tekheniki mme ts'ebeletso esale e sebelisa sistimi ea bona ea IceSense3 ka nako e telele. ”
Ka la 12 Phuptjane 2022 (“Letsatsi la Tšebetso”), IceCure Shanghai e ile ea kena tumellanong e khethehileng ea thekiso le kabo (“Agreement Distribution Agreement”) le Shanghai Medtronic and Turing for IceSense3 le li-probes tse lahliloeng (“Products”) bakeng sa nako ea pele. Likhoeli tse 36, sepheo sa bonyane sa ho reka nakong ena ke $3.5 milione (“Minimum Purchase Target”). Tlas'a tumellano ea kabo, IceCure Shanghai e tla rekisa lihlahisoa tsa Turing 'me Turing e tla tlisa lihlahisoa ho tsoa Iseraele ho ea naheng ea China ebe e li rekisetsa Medtronic Shanghai. Medtronic Shanghai e tla ikarabella bakeng sa, hara tse ding: (i) ho bapatsa le ho phahamiswa ha sehlahiswa naheng ya China; (ii) etsa mesebetsi ea thuto ea bongaka ea litsebi bakeng sa sehlahisoa naheng ea China. Turing e tla ikarabella bakeng sa polokelo ea thepa, thepa, waranti, koetliso le ts'ehetso e 'ngoe le lits'ebeletso tsa kamora thekiso.
Tlas'a lipehelo tsa tumellano ea kabo, Shanghai Medtronic e na le tokelo ea ho eketsa nako ea tumellano ea kabo ka lilemo tse tharo haeba e fihlela pakane ea theko e tlase ea lilemo tse tharo, ho latela tumellano ea sepheo se secha sa theko. Tumellano ea Kabo ea thepa e ka felisoa tlas'a maemo a itseng, ho kenyeletsoa haeba ho na le ho lefa, ho hloleha ho sebetsa kapa ho kolota.
Ho feta moo, ho ipapisitsoe le lipehelo tsa Tumellano ea Bahasi, IceCure Shanghai e tla ikarabella bakeng sa ho fumana le ho boloka litumello life kapa life le tsohle tsa taolo ("Litumello tsa Taolo") tse hlokehang ho bapatsa, ho khothaletsa, ho aba, ho rekisa le ho sebelisa Lihlahisoa naheng ea China. NMPA, lekala la eona la lehae, kapa setsi sefe kapa sefe sa mmuso (“Bolaoli ba Taolo”). IceCure Shanghai e fumane tumello ea taolo bakeng sa IceSense3 System Console 'me e hloka tumello ea taolo bakeng sa cryoprobe e lahliloeng ea IceSense3 bakeng sa mekhoa ea khoebo nakong ea likhoeli tse robong ho tloha ka letsatsi le sebetsang la tumellano ea kabo. Shanghai Medtronic e na le tokelo ea ho felisa tumellano ea kabo haeba IceCure Shanghai e sa fumane tumello ea taolo ea li-cryoprobes ka nako eo.
IceCure Medical (NASDAQ: ICCM) (TASE: ICCM) e nts'etsapele le ho rekisa ProSense®, kalafo e tsoetseng pele ea metsi a nitrogen cryoablative bakeng sa kalafo ea lihlahala (tse kotsi le mofets'e) ka cryotherapy, haholo-holo e shebaneng le mofetše oa matsoele, liphio, masapo le matšoafo. tlhapi ea cray. Theknoloji ea eona e fokolang haholo e fana ka mokhoa o sireletsehileng le o sebetsang oa ho buoa ho tlosa hlahala ka har'a mokuli, ka nako e batlang e le khutšoanyane ea opereishene le mokhoa oa ho buoa o bonolo ho o etsa. Ho fihlela joale, sistimi e ntse e rekisoa ebile e rekisoa lefatšeng ka bophara bakeng sa matšoao a amohetsoeng ke FDA mme ke CE Mark e amohetsoe Europe.
Phatlalatso ena ea boralitaba e na le liphatlalatso tse lebeletsoeng pele ka har'a moelelo oa "boema-kepe bo sireletsehileng" ba Molao oa Phethahatso oa Likoloto tsa Private Securities oa 1995 le melao e meng ea federal securities. Mantsoe a kang “ho lebella”, “ho lebella”, “ho rera”, “ho rera”, “lumela”, “ikarabella”, “khakanyo” le lipolelo tse tšoanang kapa liphapang tsa mantsoe a joalo li reretsoe ho bolela lipolelo tse lebeletsoeng pele. Mohlala, IceCure e sebelisa liphatlalatso tse shebileng pele tokollong ena ea boralitaba ha e bua ka litumellano tsa kabo le Shanghai Medtronic le Turing, leano la taolo la k'hamphani, mesebetsi ea khoebo, le menyetla ea mebaraka bakeng sa lits'ebetso tsa k'hamphani ea ho lla naheng ea China. Hobane lipolelo tse joalo li amana le liketsahalo tsa nako e tlang 'me li ipapisitse le litebello tsa morao-rao tsa IceCure, li tlas'a likotsi tse fapaneng le ho se kholisehe, 'me liphello tsa sebele tsa IceCure, ts'ebetso kapa katleho li ka fapana le tse hlalositsoeng kapa tse boleloang ke lipolelo tokollong ena ea boralitaba. Ho na le liphapang tse kholo. . Lipolelo tse shebileng pele tse fuperoeng kapa tse boletsoeng tokollong ena ea boralitaba li ka ba le likotsi le lipelaelo tse ling, tseo bongata ba tsona li leng ka holimo ho taolo ea Khampani, ho kenyeletsoa le tse hlalositsoeng karolong ea “Lintlha tsa Kotsi” ea Tlaleho ea Selemo le Selemo ea Khampani mabapi le Foromo ea 20-F e kentsoeng ho. SEC ho tloha ka la 1 Mmesa 2022 bakeng sa selemo se felileng ka la 31 Tšitoe, 2021, e fumanehang webosaeteng ea SEC ho www.sec.gov. Khampani ha e itlame ka boitlamo leha e le bofe ba ho nchafatsa lipolelo tsena hore li lokisoe kapa li fetohe ka mor'a letsatsi la phatlalatso ena ea boralitaba, ntle le haeba ho hlokahala hore e etse joalo ka molao.