Research is changing.  Everyday clinical interactions generate volumes of unique and valuable real-world data.  With the help of digital health technologies, those data can now be properly stored, linked and analyzed in a way typically only reserved for expensive studies.  This leads to real-world evidence which is fast becoming recognized by the FDA [1], payers [2] and many other stakeholders for its substantial cost and other advantages compared to traditional trials.

        Regenerative Orthopedics and Sports Medicine “ROSM” has always selected and tested its diverse non-surgical protocols in an evidence-based manner.  With the help of RegenMed, ROSM will now broaden that effort by applying focused, real-world evidence strategies against every protocol, patient and physician within its multiple locations in the greater Washington D.C. area.  Dr. Imran Siddiqui, Director of Clinical Operations at ROSM, says this about the new initiative:

“The field of regenerative medicine remains growing, both in size and in need for evidence-based standards.  ROSM has long been a pioneer of non-surgical treatment options, and that leadership will now extend to the generation and dissemination of real-world evidence across a growing number of protocols, products and patient populations.  
RegenMed shared our strategic vision, and with its turnkey platforms and deep regenerative medicine experience, was the natural partner to help us design and expand this broad initiative.”   

         ROSM’s real-evidence program will focus on deploying Circles, turnkey real-world data registries, against key anatomical treatment areas.  Each Circle will capture and integrate relevant real-world data, including outcomes, interventional variables, and where relevant, biological assays, and help generate comparative real-world evidence against a wide range of products and protocols.  Furthermore, ROSM will invite fellow regenerative practitioners and industry partners to collaborate within the Circles, helping to generate large, multi-centric databases which advance the field forward.

Nicolas Tierney, Chief Operating Officer for RegenMed, adds:

“The growing field of real-world evidence, much like regenerative medicine, is in need of standardization.  By volume, ROSM is one of the leading private providers of regenerative medicine therapies within the U.S..  Those case volumes, coupled with the traditional research discipline of its expert physicians, are the necessary ingredients to generate real-world evidence which is clinically and statistically significant.  We are proud to support ROSM in their efforts to innovate and improve both clinical care and research.”

You can learn more about ROSMs’ new Circle library by clicking the below links. Please address all inquiries to info@rgnmed.com.

Knees: Learn More

Hips and Pelvis: Learn More

Shoulders, Elbows, Hand and Wrist: Learn More

Lumbar Spine: Learn More

Neck and Cervical Spine: Learn More

Foot and Ankle: Learn More

1  https://www.fda.gov/media/174819/download,

https://www.regulations.gov/document/FDA-2023-D-5470-0002

2  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895868/

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