FDA ta amince da sabon dasa don kula da guringuntsi da lahani na osteochondral

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Written by Linda Hohnholz

Peregrine Ventures a yau sun sami fitar dalar Amurka miliyan 500 daga CartiHeal (dalar Amurka miliyan 350 da ƙarin ƙarin dala miliyan 150). Wannan fitowar ta biyo bayan amincewar Hukumar Abinci da Magunguna ta kamfanin fayil (FDA) na dasa Agili-C™ don maganin guringuntsi da lahani na osteochondral. Bayan cimma wannan ci gaba, kamfanin na'urorin likitanci a baya ya sanar da saye da kamfanin Bioventus, a daya daga cikin manyan yarjejeniyoyin siyan magani a Isra'ila a cikin watanni 12 da suka gabata, kamar yadda aka tsara.

"Da farko da aka fara jin fasahar haɓakar CartiHeal, mun san babban yuwuwar kamfanin. A zahiri, mu ne masu saka hannun jari na farko na CartiHeal, ”in ji Peregrine Co-kafa da Manajan Babban Abokin Hulɗa, Boaz Lifschitz. “Sama da dala biliyan 7 aka kashe a duk duniya don isar da fasahar jiyya na guringuntsi wanda ya haifar da rashin isasshen hanyoyin magani, har zuwa yanzu. An yi farin ciki da yin aiki tare da Nir Altschuler da tawagarsa don taimakawa wajen kawo wa kasuwar maganin guringuntsi wanda zai inganta rayuwar miliyoyin mutane a duniya."

Fiye da shekaru goma da suka gabata, CartiHeal ya fara tafiya a matsayin wani ɓangare na lambar yabo ta Peregrine "Incubator" Technology Incubator. Anan, Peregrine ya taimaka wa kamfani na farko tare da kasuwancin sa da haɓaka samfuran sa waɗanda ke ba da hanyoyin samar da hanyoyin kasuwanci da haɗin kai. A tsawon lokacin haɗin gwiwa tare da CartiHeal, Peregrine, ya ba da jagora kan ayyukan kasuwanci da kuma taimakawa tare da ma'aikatan kamfanin.

Nir Altschuler ne ya kafa shi a cikin 2009, CartiHeal yana samar da buƙatu da yawa, jiyya na biodegradable don guringuntsi da lahani na osteochondral a cikin haɗin gwiwa da haɗin gwiwa na gwiwa. Bayan ingantaccen binciken asibiti wanda aka yi rajistar marasa lafiya 251 a cikin rukunin yanar gizon 26 a cikin Amurka, Turai, da Isra'ila, inda aka tabbatar da fifikon Agili-C ™ da aka dasa akan Tsarin Kulawa na yanzu (SSOC), microfracture da debridement. domin lura da gwiwa hadin gwiwa surface raunuka, chondral da osteochondral lahani. A baya can, FDA ta ba da Breakthrough Device Designation a cikin 2020.

"Yana da ban sha'awa don karɓar amincewar FDA wanda zai ba mu damar ba da kulawa mai kyau ga miliyoyin marasa lafiya da za su fuskanci ba tare da wani magani mai mahimmanci ga guringuntsi na gwiwa ba," in ji Mista Altschuler, CartiHeal's Founder & Shugaba. "A cikin shekaru masu yawa na haɗin gwiwa tare da Peregrine, mun sami ci gaban kimiyya. A matsayinsa na tsohon manaja a kamfanin saka hannun jari, ya kasance abin ban mamaki don sanin alƙawarin da Peregrine ya yi a cikin kamfanonin fayil ɗin sa, daga babban jari da haɗin gwiwa zuwa haɓaka kasuwanci da jagora. "

Wannan ficewar da aka yi cikin nasara ta biyo bayan ficewar dala miliyan 300 na Peregrine daga Cardiovalve, wani kamfani na majagaba na transcatheter mitral da tricuspid valve a farkon wannan shekara, wanda ya kawo jimillar kuɗin yarjejeniyar zuwa dala biliyan 1.

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Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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