CartiHeal Ltd. kajeno e phatlalalitse hore Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) e fane ka tumello ea Premarket (PMA) bakeng sa ho kenngoa ha eona ho Agili-C™.
Ho kenngoa ho bontšoa bakeng sa phekolo ea International Cartilage Repair Society (ICRS) grade III kapa ka holim'a maqeba a holim'a lengole, a nang le sebaka se phekolehang sa 1-7cm2, ntle le lefu la masapo a mabeli (Kellgren-Lawrence grade 0-3). ).
Tumello ea PMA e fanoe ho ipapisitsoe le liphetho tsa thuto ea bohlokoa ea bongaka ea IDE ea lilemo tse peli. Boithuto bona bo netefalitse bophahamo ba ho kenngoa ha Agili-C ™ ho feta Tekanyetso ea hona joale ea Ts'ebetso ea Ts'ebetso (SSOC) - microfracture le debridement, bakeng sa kalafo ea maqeba a holim'a lengole, bofokoli ba chondral le osteochondral. Boithuto bona bo ne bo le bongata, 2: 1 randomization, e ngotsoe ka bolokolohi ebile e laoloa. Kakaretso ea lithuto tsa 251 li ngolisitsoe, 167 letsohong la Agili-C™, le 84 letsohong la SSOC, libakeng tsa 26 ka hare le ka ntle ho US.
Qetello e ka sehloohong ea thuto e ne e le phetoho ho tloha ho ea pele ho ea ho likhoeli tsa 24 ka karolelano ea kotsi ea Knee le Osteoarthritis Outcome Score (KOOS Kakaretso), e nang le li-subscales tsa 5: Bohloko, Matšoao a Mang, Boleng ba Bophelo (QOL), Mesebetsi ea Bophelo ba Letsatsi le Letsatsi. (ADL) le Lipapali. Lintlha tse akaretsang tsa KOOS li tloha ho 0 ho isa ho 100, moo litekanyetso tse phahameng li emelang liphetho tse betere.
Lintlha tse hlahisitsoeng tekong li bonts'itse bophahamo ba Agili-C™ ho maemo a hajoale a tlhokomelo ea tlhokomelo (ho senyeha kapa ho senyeha ha microfracture, SSOC). Monyetla o ka morao oa Bayesian oa bophahamo ka mor'a likhoeli tsa 24 o ne o ikemiselitse ho ba 1.000, ho feta moeli o boletsoeng oa 0.98 o hlokahalang ho bontša bophahamo.
• Lintlha tsa motheo tsa KOOS Kakaretso li ne li tšoana lihlopheng ka bobeli: 41.2 letsohong la Agili-C™ le 41.7 letsohong la SSOC. Ka Khoeli ea 24, KOOS Kakaretso e ntlafetse ho fihla ho 84.3 letsohong la Agili-C™ ha e bapisoa le 62.0 bakeng sa letsoho la SSOC.
• Tekanyo ea ntlafatso ea Agili-C™ ha e bapisoa le SSOC e ne e tšoana bakeng sa barupeluoa ba nang le Mild-moderate Osteoarthritis (Kellgren-Lawrence Grades ea 2 kapa 3) le bakeng sa batho ba nang le Maqeba a Maholo (kakaretso ea libaka tse kholo ho feta 3 cm2).
• Bophahamo ba sehlomathiso sa Agili-C™ ho feta SSOC bo netefalitsoe hape le litsing tsohle tsa thuto ea bobeli Confirmatory Endpoints: KOOS Pain, KOOS ADL le KOOS QOL le Responder Rate.
• Sekhahla sa ba arabelang, se neng se hlalosoa e le ntlafatso ea bonyane lintlha tse 30 ho Overall KOOS likhoeling tse 24 ha li bapisoa le tsa motheo, e ne e le 77.8% letsohong la Agili-C™ bapisoa le 33.6% letsohong la SSOC.
"Liphetho tsa thuto ea lilemo tse peli, tse bonts'itseng bophahamo ba ho kenngoa ha Agili-C™ ho feta maemo a hajoale a tlhokomelo ea opereishene, li fana ka molemo o ka bang teng ho bakuli ba limilione", ho boletse Nir Altschuler, mothehi le CEO oa CartiHeal. “Katleho ena ea bohlokoahali e bile teng ka lebaka la tšehetso ea baeletsi ba rona ba taolo, Hogan Lovells, baeletsi ba rona ba lipalo-palo, Biomedical Statistical Consulting, le bafuputsi ba bangata ba inehetseng le bakuli ba nkileng karolo lithutong tsa rona. Re leboha thuso ea bona kaofela. Tumello ea FDA e re thusa ho qala khoebo le ho fana ka tharollo e phahameng ho bakuli ha e bapisoa le maemo a hajoale a khetho ea tlhokomelo. "
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- A total of 251 subjects were enrolled, 167 in the Agili-C™ arm, and 84 in the SSOC arm, in 26 sites both in and outside the US.
- The study confirmed superiority of the Agili-C™ implant over the current Surgical Standard of Care (SSOC) – microfracture and debridement, for the treatment of knee joint surface lesions, chondral and osteochondral defects.
- The primary endpoint of the study was the change from baseline to 24 months in the average Knee injury and Osteoarthritis Outcome Score (KOOS Overall), which consists of 5 subscales.
