Mushonga Mutsva weDiabetic Foot Ulcers

PolarityTE, Inc. nhasi yazivisa kunyoreswa kwechidzidzo chekutanga muChidzidzo cheChitatu chakakosha chekuongorora SkinTE mukuferefeta kushandiswa kwekurapa kweWagner giredhi 2 diabetesic foot ulcers (DFUs), ine musoro unoti "Kuvharwa Kunowanikwa neVascularized Epithelial Regeneration yeDFUs neSkinTE, ” kana kuti “KAVHA maDFU.”     

VAKAVHA maDFU achanyoresa zvidzidzo zve100 kunzvimbo dzinosvika makumi maviri dzekiriniki muUnited States. Zvidzidzo zvichave zvisina kurongeka kune rimwe remapoka maviri ekurapa, achigamuchira SkinTE pamwe nechiyero chekuchengeta (SOC) kana iyo SOC yega. Mhedziso yekutanga ndeye chiitiko cheDFUs chakavharwa pamavhiki e20. Kupera kwechipiri kunosanganisira muzana kuderedza nzvimbo (PAR) pa24, 4, 8, 12 uye vhiki dze16; kuvandudzwa kwehupenyu, kusanganisira kuparadzaniswa kwevanhu, kuora mwoyo, kunhuwa, kuvandudzwa kwebasa, kubhururuka, uye kudzokera kumabasa zvichienderana nekuchinja kwehupenyu hwemaronda; uye utachiona hutsva hweDFU hunoda kurapwa netopical uye/kana systemic antibiotics.

KAVHA DFUs ndiyo yekutanga yakakosha kudzidza iyo PolarityTE ichaita pasi peyakavhurika IND yeSkinTE ine chiratidzo chekurapa kwechirwere chisingaperi maronda eganda (CCUs). CCUs maronda akatadza kufambira mberi kuburikidza nekurongeka uye nenguva yekugadzirisa zvinyama zvinodikanwa kudzoreredza basa rakajairwa uye anatomy yeganda. DFUs, kukuvara kwekumanikidza (PI), uye venous leg ulcers (VLU) inoumba huwandu hwakawanda hweCCUs, uye inokanganisa vanofungidzirwa mamiriyoni e8 varwere gore negore, kana ~ 2% yehuwandu hweUnited States (US). Kuwanda kweCCU kunotarisirwa kuwedzera sezvo mazera ehuwandu uye chiitiko chechirwere cheshuga, chirwere chemoyo, uye kufutisa kuri kuramba kuchikwira. Saizvozvo, maCCU anomiririra mukana wakakura wemusika parizvino, uye PolarityTE inotarisira kuti mukana iwoyo kukura.

Richard Hague, Chief Executive Officer, akati, "Kunyoresa chidzidzo chedu chekutanga muchidzidzo chakakosha pasi peFDA-inogamuchirwa IND chiitiko chakakosha kukambani uye humbowo hwekutsunga uye kuzvipira kwechikwata chedu chose. Ndinoda kutenda vashandi vedu vakashanda nesimba kuti vasvike panguva ino, uye handikwanise kupfuudza kufara kuri mukati mesangano redu kuona SkinTE ichidzokera kukiriniki. Isu tinodada zvikuru kuvhura chidzidzo chedu chekutanga chakakosha muWagner Giredhi 2 DFUs, iyo inowanzo sanganisira yakafumurwa yakakosha zvimiro. Varwere vari kurwara nemaronda anonetsa vane nzira shoma dzekurapwa uye tinovimba kuti tsvakiridzo yedu muCOVER DFUs inogona kuunza kurapwa kutsva kuzadzisa zvinodiwa nevarwere izvi zvakakura zvisina kuzadziswa. Tinoda kutenda vadzidzi nevarapi vachatora chikamu muCOVER DFUs nekutsigira kuedza kwedu kuunza shanduko ine musoro munharaunda ino yevarwere.” 

Nikolai Sopko, MD, PhD, Chief Scientific Officer, akati, "Rudzi rwemaronda atiri kunanga neCCU yedu chiratidzo anowanzogara kwemakore, uye mamwe anoramba asina kupora kwemakumi emakore. Nekuda kwekugara kwenguva refu, maCCU anowedzera kusabatwa nechirwere chemurwere uye ane hurwere hwakanyanya uye njodzi yekufa, iyo inowedzerwa mumaronda akakura kana maronda anoenda kusvika pakadzika hukuru. Kune varwere ava, pane mukana chaiwo wekudimburwa maoko nemakumbo akazara kana chidimbu nekuremara kwakabatana. Makumi makumi masere neshanu muzana ekudimburwa kwemakumbo asina kushungurudza akabatana neCCU, uye kufungidzirwa kugurwa kwemakumbo kunoitika mumasekonzi makumi matatu ega ega. Dr. Sopko vakaenderera mberi vachiti, "Ndinoda kutenda nemwoyo wose boka redu rekiriniki nekuedza kwavo kusinganeti kutisvitsa pachiitiko ichi chakakosha cheSkinTE, uye tinotarisira basa riri mberi." 

Dr. Felix Sigal, DPM, ndiye muongorori wepanzvimbo yeLos Angeles Foot & Ankle Clinic apo nyaya yekutanga yakanyoreswa muCOVER DFUs. Dr. Sigal iye zvino ari pavashandi paHollywood Presbyterian Hospital uye California Hospital Medical Center, kwaanotarisa nezvekuchengetedza maronda, chirwere cheshuga chekuchengetedza mitezo, uye anotevera kufarira kwake mukutsvakurudza kwekliniki kuti agone kuvandudza nzira dzokurapa dziri nani kune varwere vake. Dr. Sigal ndomumwe wevanonyanya kuzivikanwa mazvikokota mumunda uye anoshanda sePrincipal Investigator pane akawanda makiriniki ekutsvagisa zvidzidzo mundima yedambudziko reshuga nekuchengeta maronda.

Dr. Sigal akati, "Varwere vanotambura neDFUs, uye kunyanya avo vanotambura neWagner 2 DFUs, vari kudiwa nokukurumidza yezvitsva uye zvakagadziridzwa zvingasarudzwa kuti vagadzirise zvavanoda uye zvisingagoneki zvekurapa. Kakawanda, tinoona varwere ava vachifambira mberi kusvika pakuda kugurwa, uye sevanopa isu tiri kugara tichitsvaga mhinduro dzekuvandudza zvinobuda kune varwere vedu. Ndichitevera ruzivo rwangu neSkinTE muyedzo yekupedzisira yakabudirira isina kurongeka yekuongorora SkinTE muWagner giredhi 1 DFUs, ndinofara kutora chikamu muCHIDZIDZO cheCOVER DFUs, inova nhanho yakakosha pakuongorora inogona kugadzirisa varwere ava vanoshaya zvakanyanya.