北(bei)京佰仁(ren)醫(yi)療(liao)(liao)(liao)科(ke)技股份有限公(gong)司(si)(si)(以下(xia)簡稱“佰仁(ren)醫(yi)療(liao)(liao)(liao)”或“公(gong)司(si)(si)”)成(cheng)立于(yu)2005年。公(gong)司(si)(si)是國(guo)內技術先進、專注(zhu)于(yu)動物(wu)源性植介(jie)入醫(yi)療(liao)(liao)(liao)器械研發與生產的高新技術企業,產品(pin)應(ying)用于(yu)心(xin)(xin)臟(zang)瓣(ban)(ban)膜置(zhi)換與修復(fu)、先天性心(xin)(xin)臟(zang)病植介(jie)入治療(liao)(liao)(liao)以及外(wai)科(ke)軟組織修復(fu)。公(gong)司(si)(si)已(yi)獲準(zhun)注(zhu)冊10個Ⅲ類醫(yi)療(liao)(liao)(liao)器械產品(pin),其中(zhong)人(ren)工生物(wu)心(xin)(xin)臟(zang)瓣(ban)(ban)膜(牛心(xin)(xin)包瓣(ban)(ban)、豬主(zhu)動脈(mo)瓣(ban)(ban))、肺動脈(mo)帶瓣(ban)(ban)管道、瓣(ban)(ban)膜成(cheng)形(xing)環、心(xin)(xin)胸外(wai)科(ke)生物(wu)補(bu)片等5項產品(pin)為獲準(zhun)注(zhu)冊的同類產品(pin),填補(bu)了國(guo)內空白。公(gong)司(si)(si)產品(pin)已(yi)在北(bei)京安貞(zhen)醫(yi)院(yuan)、解放軍301醫(yi)院(yuan)、復(fu)旦大學(xue)附屬中(zhong)山醫(yi)院(yuan)、廣東(dong)省人(ren)民醫(yi)院(yuan)、河南省人(ren)民醫(yi)院(yuan)、四川大學(xue)華西醫(yi)院(yuan)、沈陽軍區總醫(yi)院(yuan)、上海(hai)兒童醫(yi)學(xue)中(zhong)心(xin)(xin)等300余家(jia)國(guo)內三甲醫(yi)院(yuan)里臨床應(ying)用。
公司多(duo)項動物源性植(zhi)介(jie)入(ru)醫療器(qi)(qi)械具有(you)優勢:(1)人工生(sheng)(sheng)物心(xin)(xin)(xin)(xin)(xin)臟(zang)瓣(ban)(ban)(ban)(ban)膜—牛心(xin)(xin)(xin)(xin)(xin)包瓣(ban)(ban)(ban)(ban)為(wei)獲準注冊的牛心(xin)(xin)(xin)(xin)(xin)包瓣(ban)(ban)(ban)(ban),上(shang)市15年(nian)來用(yong)(yong)于(yu)心(xin)(xin)(xin)(xin)(xin)臟(zang)二尖瓣(ban)(ban)(ban)(ban)、主動脈(mo)(mo)瓣(ban)(ban)(ban)(ban)、三尖瓣(ban)(ban)(ban)(ban)置換累計植(zhi)入(ru)10,000余(yu)枚;(2)肺(fei)動脈(mo)(mo)帶瓣(ban)(ban)(ban)(ban)管道(dao)屬業內(nei)首創,用(yong)(yong)于(yu)心(xin)(xin)(xin)(xin)(xin)臟(zang)肺(fei)動脈(mo)(mo)瓣(ban)(ban)(ban)(ban)連同(tong)主肺(fei)動脈(mo)(mo)一起手術重(zhong)建(jian),成為(wei)專(zhuan)用(yong)(yong)嬰幼(you)兒(er)患(huan)者的人工生(sheng)(sheng)物心(xin)(xin)(xin)(xin)(xin)臟(zang)瓣(ban)(ban)(ban)(ban)膜產(chan)品,是(shi)國家(jia)(jia)十二五科(ke)技支撐計劃項目“新型動物源帶瓣(ban)(ban)(ban)(ban)管道(dao)及(ji)(ji)(ji)補片(pian)研(yan)發(fa)”(課題編號:2014BAI11B03)課題的重(zhong)大成果,獲原國家(jia)(jia)食品藥(yao)品監督管理總局創新醫療器(qi)(qi)械特別審批通過,國內(nei)至(zhi)今(jin)尚無同(tong)類產(chan)品上(shang)市;(3)心(xin)(xin)(xin)(xin)(xin)胸(xiong)外科(ke)生(sheng)(sheng)物補片(pian)大組(10余(yu)萬例)長期(15年(nian)來)應用(yong)(yong)于(yu)嬰幼(you)兒(er)、青少年(nian)及(ji)(ji)(ji)成人各年(nian)齡段患(huan)者心(xin)(xin)(xin)(xin)(xin)臟(zang)及(ji)(ji)(ji)大血管病的修復治(zhi)療,是(shi)目前(qian)國內(nei)為(wei)數不(bu)多(duo)的可用(yong)(yong)于(yu)人體循環系統植(zhi)入(ru)的動物源性植(zhi)入(ru)產(chan)品。
公司創立(li)者金(jin)磊博(bo)士30余年來專注于動物(wu)(wu)源性(xing)材料處(chu)理(li)技(ji)(ji)術的研(yan)究(jiu),原創性(xing)地提出并(bing)實現(xian)了(le)對組(zu)織(zhi)(zhi)膠原蛋白分子游離羧基(ji)進行定量交聯,最(zui)終形成動物(wu)(wu)組(zu)織(zhi)(zhi)工程和化學改性(xing)處(chu)理(li)技(ji)(ji)術。依靠該項核(he)心(xin)技(ji)(ji)術,不僅可使(shi)動物(wu)(wu)組(zu)織(zhi)(zhi)植入(ru)(ru)人體(ti)后(hou)抗排異、抗鈣化、長期(qi)滿(man)足(zu)預期(qi)治(zhi)療(liao)要求,還可將動物(wu)(wu)組(zu)織(zhi)(zhi)處(chu)理(li)成不同的植入(ru)(ru)產品,以(yi)滿(man)足(zu)人體(ti)不同部(bu)位組(zu)織(zhi)(zhi)或(huo)器官的修復與(yu)置換(huan)治(zhi)療(liao)需求。