Regulatory Status

zetagen regulatory-status-info

Oncology

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ZetaMet™
ZetaMet™ is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone. The U.S. Food and Drug Administration recently awarded ZetaMet™ Breakthrough Device Designation for the treatment of metastatic bone cancer. Currently, ZetaMet™ is being reviewed by the FDA and Health Canada for a human clinical study for patients living with metastatic breast cancer. Enrollment for this study could begin late Q4-2021. 
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ZetaMet 
Flowable™
ZetaMet Flowable™, administered via a minimally-invasive percutaneous outpatient procedure, is designed for the treatment of patients with metastatic lesions that have or will result in a Skeletal-Related events (SREs) including fractures and spinal cord compression. 

Musculoskeletal

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ZetaFuse™
ZetaFuse™ is the first synthetic, small molecule, osteo-inductive biologic, to safely aid bone healing of spinal fusions. The FDA has awarded ZetaFuse™ Breakthrough Device Designation[1] for the complete spinal column. 
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ZetaSet™
ZetaSet™ is the first synthetic, osteo-inductive, biologic designed specifically for the treatment of osteoporotic fractures, high energy injuries with bone defects, and for patients with fractures of the tibial plateau (knee) and plafond (ankle).
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ZetaBase™
ZetaBase™ is an osteo-conductive and osteo-promotive therapy, intended for the use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure.  Pending 510K approval Q4 2021.  

Craniomaxillofacial

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ZetaDent™
ZetaDent™ is an osteo-inductive biologic intended to promote bone formation as a part of localized ridge augmentation procedures prior to dental implant placement, alveolar ridge reconstruction procedures for prosthetic treatment, and for filling of bone defects in the oral cavity.

Clinical Trials

Pending FDA/HC Spine Met Tumor Study Anticipated Late Q4 2021