Global POISE Study Reaches Milestone of 600 Orthopedic Implants in Pediatric Patients, Advancing Research on the Safety and Efficacy of OrthoPediatrics® Products
OrthoPediatrics (NASDAQ: KIDS) has announced a major milestone in its Global POISE (Pediatric Orthopedic Implant Safety and Efficacy) Study, with over 600 implants now being monitored across more than 300 pediatric patients.
The multi-center, post-market, prospective clinical follow-up study, launched in 2023, now includes 13 active sites across Canada, the United States, Australia, New Zealand, and South Africa. The study encompasses 17 different implant types and aims to assess the safety and efficacy of OrthoPediatrics' implant devices, focusing on implant survival and identifying device-related adverse events.
OrthoPediatrics (NASDAQ: KIDS) ha annunciato un importante traguardo nel suo studio globale POISE (Pediatric Orthopedic Implant Safety and Efficacy), con oltre 600 impianti attualmente monitorati in più di 300 pazienti pediatrici.
Lo studio clinico prospettico multicentrico post-commercializzazione, avviato nel 2023, coinvolge ora 13 centri attivi in Canada, Stati Uniti, Australia, Nuova Zelanda e Sudafrica. La ricerca comprende 17 diversi tipi di impianti e si propone di valutare la sicurezza e l’efficacia dei dispositivi impiantabili di OrthoPediatrics, concentrandosi sulla sopravvivenza degli impianti e sull’identificazione di eventi avversi correlati ai dispositivi.
OrthoPediatrics (NASDAQ: KIDS) ha anunciado un hito importante en su estudio global POISE (Pediatric Orthopedic Implant Safety and Efficacy), con más de 600 implantes actualmente monitoreados en más de 300 pacientes pediátricos.
El estudio clínico prospectivo postcomercialización multicéntrico, iniciado en 2023, incluye ahora 13 sitios activos en Canadá, Estados Unidos, Australia, Nueva Zelanda y Sudáfrica. El estudio abarca 17 tipos diferentes de implantes y tiene como objetivo evaluar la seguridad y eficacia de los dispositivos implantables de OrthoPediatrics, enfocándose en la supervivencia del implante e identificando eventos adversos relacionados con el dispositivo.
OrthoPediatrics (NASDAQ: KIDS)는 글로벌 POISE(소아 정형외과 임플란트 안전성 및 효능) 연구에서 중요한 이정표를 발표했으며, 현재 300명 이상의 소아 환자에게 600개 이상의 임플란트가 모니터링되고 있습니다.
2023년에 시작된 다기관, 시판 후, 전향적 임상 추적 연구는 현재 캐나다, 미국, 호주, 뉴질랜드, 남아프리카공화국의 13개 활성 기관을 포함합니다. 이 연구는 17가지 다른 임플란트 유형을 포함하며, OrthoPediatrics의 임플란트 장치의 안전성과 효능을 평가하는 것을 목표로 하며, 임플란트 생존율과 장치 관련 이상 반응을 식별하는 데 중점을 둡니다.
OrthoPediatrics (NASDAQ : KIDS) a annoncé une étape majeure dans son étude mondiale POISE (Pediatric Orthopedic Implant Safety and Efficacy), avec plus de 600 implants désormais surveillés chez plus de 300 patients pédiatriques.
Cette étude clinique prospective post-commercialisation, multicentrique, lancée en 2023, comprend désormais 13 sites actifs au Canada, aux États-Unis, en Australie, en Nouvelle-Zélande et en Afrique du Sud. L’étude couvre 17 types d’implants différents et vise à évaluer la sécurité et l’efficacité des dispositifs implantables d’OrthoPediatrics, en se concentrant sur la survie des implants et l’identification des événements indésirables liés aux dispositifs.
OrthoPediatrics (NASDAQ: KIDS) hat einen wichtigen Meilenstein in seiner globalen POISE-Studie (Pediatric Orthopedic Implant Safety and Efficacy) bekannt gegeben, bei der nun über 600 Implantate bei mehr als 300 pädiatrischen Patienten überwacht werden.
Die multizentrische, prospektive klinische Nachbeobachtungsstudie nach Markteinführung, die 2023 gestartet wurde, umfasst jetzt 13 aktive Standorte in Kanada, den USA, Australien, Neuseeland und Südafrika. Die Studie beinhaltet 17 verschiedene Implantattypen und zielt darauf ab, die Sicherheit und Wirksamkeit der Implantatgeräte von OrthoPediatrics zu bewerten, wobei der Fokus auf der Implantatüberlebensrate und der Identifikation von gerätebedingten unerwünschten Ereignissen liegt.
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WARSAW, Ind., July 16, 2025 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced a significant milestone in the ongoing Global POISE (Pediatric Orthopedic Implant Safety and Efficacy) Study: more than 600 implants are now being observed across 300+ pediatric patients as part of this study.
Global POISE is a multi-center, post-market, prospective clinical follow-up study, designed to assess the safety and efficacy of a range of OrthoPediatrics’ implant devices. This international study is focused on verifying implant survival and identifying any device-related adverse events. Launched in 2023, Global POISE now includes 13 active sites and growing, with data currently being collected from Canada, the United States, Australia, New Zealand and South Africa.
The insights generated from this study will inform further refinement of OrthoPediatrics devices to meet the specific needs of growing children with orthopedic conditions. The sites involved in Global POISE are committed to broadening the study’s reach and continue to enroll additional patients across 17 different implant types to further enhance the understanding of their safety and long-term effectiveness.
OrthoPediatrics’ Sr VP of Quality, Clinical and Regulatory Affairs, Ray Garrison, commented, “We are thrilled to see the Global POISE Study reach this significant milestone. This achievement is a testament to the dedication and collaboration of OrthoPediatrics and the research team at BC Children’s Hospital. As the study continues to expand, we are excited about the valuable insights it will generate that will ultimately improve the outcomes for children undergoing orthopedic procedures around the world. OrthoPediatrics remains committed to advancing pediatric orthopedic care through innovative solutions designed to meet the unique needs of young patients.”
For more information about the Global POISE study, please visit www.hippylab.ca/poise and www.limbnetwork.com/global-poise.
About BC Children’s Hospital
BC Children’s Hospital is a pediatric teaching and research hospital in Vancouver, British Columbia. It provides world-leading care for its patients and is recognized for its innovative research in child health. The Global POISE study is spearheaded by principal investigators Dr. Anthony Cooper and Dr. Kishore Mulpuri, two orthopedic surgeons of BC Children’s Hospital.
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets over 80 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com. For more information about the OrthoPediatrics Specialty Bracing portfolio, please visit www.opsb.com.
Investor Contact
Philip Trip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406
FAQ
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