Frequently Asked Questions

  • CMFlex is comprised of hydroxyapatite particles combined with biodegradable (polylactide-co-glycolide) (PLG) polymer.

  • CMFlex can be stored at room temperature and should not be below -22° Fahrenheit (-30°C) or above 104° Fahrenheit (40°C).

  • CMFlex does not require refrigeration.

  • No, CMFlex is fully synthetic and is not manufactured with materials from human or animal sources. This eliminates the need for autologous bone harvesting, addressing concerns related to donor site limitations, pain, and associated complications. Moreover, the absence of human or animal sources in CMFlex alleviates objections arising from religious or ethical considerations, while also mitigating the risk of disease transmission associated with xenografts and allografts.

  • CMFlex features a highly interconnected microporous structure with 80% total porosity.

  • CMFlex can be easily cut, shaped, and contoured to precisely fit within a wide range of defect sites using a scalpel or other surgical cutting device.

  • Scientific evidence supporting the effectiveness of CMFlex is extensive. A preclinical study specifically examined the treatment of irregular defects measuring 25 to 35 mm in porcine subjects using CMFlex. The study demonstrated remarkable results, with successful bone filling observed within 12 to 16 weeks, as confirmed by computed tomography (CT) imaging. Histological sectioning further confirmed the formation of mature bone around and within the materials, while also demonstrating the scaffold’s degradation profile.

    Furthermore, CMFlex has undergone rigorous testing, including a powerful battery of tests, which provided robust data supporting its performance and reliability. This extensive research and development process led to CMFlex receiving 510k clearance, affirming its safety and effectiveness.

    For more information about CMFlex and its scientific evidence, please contact Dimension Inx.

    * Data on file with Dimension Inx

  • Dimension Inx is actively engaged in the collection and analysis of data obtained from initial cases performed by surgeons who have embraced our technology at an early stage.

  • CMFlex can be combined with autologous blood or sterile saline.

  • No, hydrating CMFlex prior to use is not required. However, CMFlex may be moistened with blood or physiological saline solution to increase flexibility prior to cutting or manipulation. If blood is used, the blood must be autologous (i.e. from the same patient). Please see the instructions for use for more information.