Ho khethoa le litumello li tšoaea mehato ea bohlokoa ho ntshetseng pele 'mapa oa bongaka oa Insightec Blood Brain Barrier (BBB) o sebelisa Acoustic Therapy.

Kajeno Insightec e phatlalalitse hore e amohetse tumello ea FDA ea litokiso tse peli tsa bohlokoa tsa lisebelisoa tsa lipatlisiso (IDE) bakeng sa sistimi ea eona ea Exablate Neuro - e 'ngoe bakeng sa mofetše oa mantlha o seng o monyane oa mofetše oa matšoafo oa sele (NSCLC) o senyehileng bokong hammoho le tlhokomelo e tloaelehileng. Keytruda®, le e 'ngoe bakeng sa ts'ebetso e ntlafalitsoeng ea biopsy ea metsi bakeng sa ho lekola khafetsa bakuli ba nang le mofetše oa mantlha oa boko. FDA e boetse e fane ka lebitso la "Breakthrough Device" bakeng sa kalafo ea NSCLC, ho thusa ho potlakisa nts'etsopele le tlhahlobo ea eona.

Insightec e rera ho thakhola thuto ea LIMITLESS (NSCLC) ho lekola molemo oa tleliniki oa ho sebelisa ultrasound e sa tsitsang, e nang le matla a tlase e kopaneng le systemic immunotherapy kalafong ea bakuli ba nang le metastase ea boko ho tsoa mofetšeng oa matšoafo.

"Tšebeliso ea ultrasound e nang le matla a tlaase (LIFU) e nang le li-microbubble ho bula mokoallo oa boko ba mali (BBB) ke tsoelo-pele e thabisang ho neuro-oncology e nang le tšepiso ea ho fetoha phetoho ea paradigm kalafo ea bakuli ba nang le lihlahala bokong," ho boletse Mofuputsi e Moholo oa thuto Dr. Manmeet Ahluwalia, MD, MBA, Mookameli oa Solid Tumor Medical Oncology, Motlatsi oa Motlatsi le Mookameli oa Saense ea ka Sehloohong Miami Cancer Institute, karolo ea Baptist Health South Florida. "Swinergy e ikhethang ea ho buloa ha LIFU BBB bakeng sa phepelo e ntlafalitsoeng ea litlhare, tokollo ea neoantigen le ts'ebetso ea 'mele ea ho itšireletsa mafung ke ntho e ka fetolang papali ea rona e tla re thusa ho aha mekhoa ea hajoale ea kalafo e fumanehang bakeng sa bakuli bana."

Liquid biopsy ke mokhoa o mocha oa ho fokotsa mofetše o sa hlaseleng, khetho ea kalafo, ho lekola lefu le setseng, ho tsebahatsa pele ba arabelang kalafo khahlano le ba sa arabeng, le tlhahlobo ea tsoelo-pele ea tumor khahlano le pseudoprogression.

"Ho sa tsotellehe tsoelo-pele e tsotehang ea lik'hemik'hale tse ling, tlhahlobo ea metsi e bile le katleho e fokolang lihlahalang tsa boko ka lebaka la ho ba teng ha mokoallo oa boko ba mali, e leng se thibelang ho lemoha matšoao maling," ho boletse Dr. Achal Singh Achrol, MD, FAANS, Ofisiri e ka Sehloohong ea Bongaka. ea Insightec. "Lithuto tsa pele le tsa pele tsa batho li bonts'itse hore matla a tlase a tsepamisitsoeng maikutlo (LIFU) a ka eketsa butle-butle ho kenella ha mokoallo oa boko ba mali 'me a lumella ho feta ha li-biomarker tse ikhethileng sebakeng ho thusa biopsy ea metsi e sa hlaseleng lihlahalang tsa boko. Teko ena ea bohlokoa ea bongaka e tla batlisisa khetlo la pele molemo oa tleliniki molemong oa mokhoa ona e le mokhoa o mocha ho fapana le li-neurosurgical biopsy."

"Insightec e ntse e tsoela pele ho sebelisana le bafuputsi ba ka sehloohong ho ntšetsa pele tšebeliso ea phekolo ea acoustic bokong," ho boletse Maurice R. Ferré, MD, CEO oa Insightec le Molula-setulo oa Boto. "Mosebetsi ona o shebane le ho bula ka mokhoa o sireletsehileng mokoallo oa boko ba mali ho sebelisa matla a tlaase a acoustic 'me o na le monyetla oa ho fetola mekhoa ea hona joale ea phekolo le ea ho hlahloba maemo a kang kankere ea boko. Sepheo sa rona sa mantlha ke, joalo ka kamehla, ho ama bophelo ba mokuli ka mokhoa o nepahetseng. ”

Sesebelisoa sa Exablate Neuro se se se amohetsoe ke FDA bakeng sa kalafo ea Essential Tremor le Parkinson's Disease refractory. Qetellong ea 2021 ho ne ho e-na le litsi tsa bongaka tsa 42 United States tse sebelisang sesebelisoa sa Insightec Exblate Neuro ho phekola bakuli ba nang le maemo ana. Sistimi ea Insightec Exablate Prostate e fumane tumello ea FDA 510K bakeng sa ho abela lisele tsa tšoelesa ea senya ka matla a phahameng a Focused Ultrasound.

SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:

“The use of low-intensity focused ultrasound (LIFU) with microbubbles to open up the blood brain barrier (BBB) is an exciting advance in neuro-oncology that holds promise to become a paradigm shift in the treatment of patients with brain tumors,”.
Insightec today announced that it has received FDA approval of two pivotal investigational device exemptions (IDE) for its Exablate Neuro system – one for primary non-small cell lung cancer (NSCLC) that has metastasized to the brain in conjunction with standard-of-care Keytruda®, and one for enhanced efficacy of liquid biopsy for recurrence monitoring of patients with primary brain cancer.
Insightec e rera ho thakhola thuto ea LIMITLESS (NSCLC) ho lekola molemo oa tleliniki oa ho sebelisa ultrasound e sa tsitsang, e nang le matla a tlase e kopaneng le systemic immunotherapy kalafong ea bakuli ba nang le metastase ea boko ho tsoa mofetšeng oa matšoafo.