Flaccid Insert Medical Device

The Flaccid Insert is a medical grade implantable silicone rubber medical device designed to be placed just under the skin of the penile shaft. The Flaccid Insert will:

  • Keep the flaccid penis extended out erect, or near, erect length, thereby preventing any retraction or ‘shrinkage’.

  • Potentially increase the erect length of the penis.

  • Work in conjunction with the permanent filler enlargement treatments. The Insert will keep the penis lengthened in the flaccid state to help the permanent filler medication remain stable, resulting in less imbalances due to the penile retracting force.

  • Potentially help with Peyronie’s curve complications, such as regaining (and surpassing) the narrowed penile girth due to this disease.​

 

The Flaccid Insert was awarded a United States Patent in 2017. Dr Loria is currently seeking FDA approval so he can offer this medical device to patients. The following steps need to take place for the device to be made available to patients:

  • Flaccid Insert final engineering and material testing projected to be completed by 1-2018.

  • FDA Application projected to be submitted 1-2018.

  • FDA Approval Clinical Trial is projected to start March/April 2018.

    • Patients on our email list will be sent an email requesting Voluntary participation in the Flaccid Insert Clinical Trials.

    • There will be no cost associated with the Clinical Trials except for possible traveling and short term lodging at the Clinical Trial site.

    • The Clinical Trial location is still yet to be determined.