Seikagaku Granted Marketing Approval for JOYCLU Joint Function Improvement Injection

JOYCLU, a combination of hyaluronic acid and an anti-inflammatory drug, is approved for manufacture and marketing in Japan.

FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

Histogen can proceed with a Phase I/II clinical trial examining human extracellular matrix plus microfracture to regenerate hyaline cartilage.

TissueTech to Commence Study on Facet Joint Osteoarthritis Pain

The study is investigating Cryopreserved Amniotic Membrane and Cryopreserved Umbilical Cord for pain relief and functional improvement.

Locate Bio’s Chondro3 Graft Granted FDA Breakthrough Device Designation

The biomimetic graft for osteochondral lesions is the company's second Breakthrough Device designation granted in 2021.

FDA Clinical Hold for Histogen Trial in Knee Regeneration

FDA verbally notified the company of additional questions in the application for the planned Phase I/II trial of HST-003 combined with microfracture.

Organogenesis Gains Special FDA Designation for ReNu Knee OA Therapy

ReNu comprises amniotic fluid cells and micronized amniotic membrane, and contains cellular, growth factor and extracellular matrix components.

CognitOss Granted FDA Breakthrough Device Designation

Locate Bio developed CognitOss resorbable antibiotic-loaded bone graft to treat osteomyelitis.

Graftys Gains CE Recertification of Bone Void Fillers

Graftys' products are registered in more than 30 countries worldwide, including Europe, the U.S., Canada and South America.

MagnetOs Bone Grafts Approved in Australia

MagnetOs Granules and MagnetOs Putty received TGA approval in Australia. Initial market launch is scheduled for late 1Q21.

Cerapedics Gains Canadian Approval of Next-Gen Bone Graft

Canada will be the first commercial market to launch i-FACTOR+ Matrix. The technology is currently being studied in an FDA IDE trial targeting lumbar fusion.

Regulatory

Articles

Seikagaku Granted Marketing Approval for JOYCLU Joint Function Improvement Injection

Seikagaku Granted Marketing Approval for JOYCLU Joint Function Improvement Injection

FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

TissueTech to Commence Study on Facet Joint Osteoarthritis Pain

TissueTech to Commence Study on Facet Joint Osteoarthritis Pain

Locate Bio’s Chondro3 Graft Granted FDA Breakthrough Device Designation

Locate Bio’s Chondro3 Graft Granted FDA Breakthrough Device Designation

FDA Clinical Hold for Histogen Trial in Knee Regeneration

FDA Clinical Hold for Histogen Trial in Knee Regeneration

Organogenesis Gains Special FDA Designation for ReNu Knee OA Therapy

Organogenesis Gains Special FDA Designation for ReNu Knee OA Therapy

CognitOss Granted FDA Breakthrough Device Designation

CognitOss Granted FDA Breakthrough Device Designation

Graftys Gains CE Recertification of Bone Void Fillers

Graftys Gains CE Recertification of Bone Void Fillers

MagnetOs Bone Grafts Approved in Australia

MagnetOs Bone Grafts Approved in Australia

Cerapedics Gains Canadian Approval of Next-Gen Bone Graft

Cerapedics Gains Canadian Approval of Next-Gen Bone Graft

Regulatory Guidance

Standards Bodies

Registries