Founded in 1994, Carbon Medical Technologies, Inc. (CMT) is an R&D and manufacturing company that develops implantable medical devices using a proprietary pyrolytic carbon coating technology. CMT has developed multiple FDA approved and CE Marked products, including 20 issued 510(k) premarket notifications. CMT has experience manufacturing, attaining regulatory approval, and divesting or licensing its products to strategic partners.
CMT has developed a pyrolytic carbon based injectable bulking agent called Durasphere, which is used for the treatment of stress urinary incontinence. Outside of the U.S., the indications for the injectable bulking agent have been expanded to include the treatment of Vesicoureteral Reflux (V.U.R.), Fecal Incontinence, and Gastroesophageal Reflux Disease (GERD).
The pyrolytic carbon-coating technology is also incorporated into implantable tissue markers developed for biopsy site marking and fiducial markers for radiation therapy treatment planning. The innovative BiomarC Tissue Marking System offers unparalleled flexibility and visibility for precise delineation of biopsy sites.
The unique carbon-coating and composition of the core material of the BiomarC Fiducial Marker is compatible with all forms of radiation therapy and provides maximum versatility for modalities and treatments such as IGRT/IMRT, Proton Therapy, CT, MRI and portal imaging. Areas marked with BiomarC fiducial markers provide clear, visual landmarks with no uncertainty between healthy tissue and the target area.
Additionally, CMT has developed delivery devices for the injectable bulking agents, implantable tissue markers, and fiducial markers.
The company is a medical device manufacturer with ISO 13485 certified and cGMP compliant quality systems. Additionally, CMT operates a certified ISO Class 7 Controlled Environment. Currently, the company provides contract manufacturing for major biopsy device and tissue marker companies. CMT’s strength lies in its ability to customize product design to meet the needs of a wide range of market applications.
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