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$Organogenesis (ORGO.US)$ NEWS Organogenesis Achieves Primar...
NEWS
Organogenesis Achieves Primary Endpoint in Phase 3 Clinical Trial of ReNu® for Knee Osteoarthritis
Organogenesis announced positive top-line data from its Phase 3 clinical trial of ReNu for knee osteoarthritis, achieving a statistically significant reduction in knee pain and maintenance of function at six months. The results open a transformative opportunity for Organogenesis to enter the pain management market. ReNu addresses a critical unmet medical need for knee OA patients, including the most severe cases. The company plans to request an FDA meeting for a Biologics License Application filing.
Positive top-line data from Phase 3 trial of ReNu showed a statistically significant reduction in knee pain and maintenance of function at six months.
Transformative opportunity for Organogenesis to enter large pain management market with innovative therapy.
ReNu addresses critical unmet medical needs for all knee OA patients, including the most severe cases.
Robust scientific evidence supports ReNu's efficacy and safety profile.
Plan to request FDA meeting for Biologics License Application filing based on positive results.
Transformative opportunity for Organogenesis to enter large pain management market with innovative therapy.
ReNu addresses critical unmet medical needs for all knee OA patients, including the most severe cases.
Robust scientific evidence supports ReNu's efficacy and safety profile.
Plan to request FDA meeting for Biologics License Application filing based on positive results.
End-stage management for severe OA patients is typically total knee replacement, limiting non-surgical treatment options.
Knee OA affects millions of Americans and is a common cause of disability and poor quality of life.
non-surgical treatment options for severe OA patients, which represented 30% of the study population.
Second multi-center clinical trial actively enrolling, with full enrollment expected this year, potentially impacting resources and timelines.
Knee OA affects millions of Americans and is a common cause of disability and poor quality of life.
non-surgical treatment options for severe OA patients, which represented 30% of the study population.
Second multi-center clinical trial actively enrolling, with full enrollment expected this year, potentially impacting resources and timelines.
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