Clinical Trial
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Biologics
Ortho Regenerative Technologies Announces U.S. IND Clinical Hold Lifted By The FDA & Clearance To Proceed With U.S. Clinical Trial
MONTREAL, Dec. 13, 2021 /PRNewswire/ – Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTCQB: ORTIF) (“Ortho” or the “Company”), a clinical-stage orthobiologics company focused on the…
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Hospitals
HSS and Rothman Institute/Jefferson University Hospital to Participate in Clinical Trial for Elute’s Antibiotic Loaded Bone Void Filler
SALT LAKE CITY, Nov. 30, 2021 /PRNewswire/ — Following Elute, Inc.’s Investigational Device Exemption (IDE) authorization from the US Food and Drug Administration (FDA)…
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Biologics
Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA
Additional CMC related data and characterization requested by the FDACompany confident of providing requested information over the coming weeksPhase I/II…
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Neuro
ADR Spinal Restoration Center Opens Up 2-Level prodisc® and 1-Level Synergy Disc® Clinical Trials in Los Angeles
LOS ANGELES (PRWEB) MAY 21, 2021 Those suffering from painful degenerative or herniated discs in their necks might find relief in…
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Spine
Synergy Disc® Announces Enrollment of First Patient in US IDE Clinical Trial
January 29, 2021 LOUISVILLE, Colo.–(BUSINESS WIRE)–Synergy Disc Replacement Ltd., a Colorado-based spinal medical device company and wholly owned subsidiary of…
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Recon
LimaCorporate Announces FDA Approval for an Ide Study on Smr Stemless Reverse Shoulder System
UDINE, Italy, Nov. 19, 2020 /PRNewswire/ — LimaCorporate is proud to announce that the U.S. Food and Drug Administration (FDA) has approved the…
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Biologics
Bioventus Receives Authorization to Proceed Under Investigational New Drug Application for Clinical Trial of Placental Tissue Particulate (PTP-001) for the Treatment of Knee OA
November 18, 2020 DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a leader in Solutions For Innovative Healing, received authorization to proceed under its investigational…
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Spine
One-Year Outcomes Data from the OptiMesh® SCOUT (Spineology® Clinical Outcomes Trial) IDE (Investigational Device Exemption) Published in SPINE
The OptiMesh® Expandable Interbody Fusion System demonstrates significant reduction in pain, improvement in back function, and high patient-satisfaction scores November 17,…
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COVID-19
NYU Langone Health to Enroll Healthy Volunteers In Clinical Trial for COVID-19 Vaccine
NEW YORK, Nov. 11, 2020 /PRNewswire/ — NYU Grossman School of Medicine is among the centers enrolling participants in a randomized phase…
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Extremities
Avanos Medical, Inc. Announces Publication of Clinical Trial Demonstrating Superiority of COOLIEF* over Hyaluronic Acid Injections for the Management of Chronic Knee Pain
ALPHARETTA, Ga., Sept. 3, 2020 /PRNewswire/ — Avanos Medical, Inc. (NYSE: AVNS) today announced the publication of a large, randomized, multicentered clinical trial comparing…
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COVID-19
Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies
NEW BRUNSWICK, N.J., July 30, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced that its lead vaccine candidate protected against…
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Extremities
Mayo TJA Study: Mepivacaine=More Consistent Return of Motor Function Versus Low-Dose Bupivacaine
by Elizabeth Hofheinz, M.P.H., M.Ed. While spinal anesthesia confers benefits when administered during primary total hip arthroplasty (THA) and total…
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Biologics
Cerapedics Announces FDA approval of an IDE supplement
WESTMINSTER, Colo., July 22, 2020 — Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA)…
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Spine
Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis
SAN CARLOS, Calif., July 16, 2020 /PRNewswire/ — Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of…
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Extremities
CyMedica Orthopedics Completes e-vive Parent Clinical Trial for Management of Knee Osteoarthritis Pain
SCOTTSDALE, Ariz., June 16, 2020 CyMedica Orthopedics®, the leading combined muscle strengthening therapy and digital health innovator, announced today that…
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