The Prolong™ treatment is readily accessible without the necessity of a prescription or a doctor's or therapist's approval.

Clinically approved as an 'Over-The-Counter' solution, it enables individuals aged 18 and above to purchase the Prolong Device.

This unique approach, backed by our pioneering FDA De Novo classification, offers an effective remedy for the treatment of premature ejaculation.

Absolutely.

Our clinical trials encompassed individuals from diverse backgrounds, representing various walks of life. The only common thread among them was the challenge they faced with premature ejaculation.

Our revolutionary patented device and 6 week training program have not only withstood rigorous peer reviews but have also emerged as the unequivocal Gold Standard treatment due to the incredible results.

The Prolong™ Device has been helping men since 2017.

In 2017 Prolong™ became the world's first FDA cleared premature ejaculation solution that was approved to be sold without a prescription.

An effect size is a statistical calculation that can be used to compare the efficacy of different agents by quantifying the size of the difference between treatments. It is a dimensionless measure of the difference in outcomes under two different treatment interventions. Effect sizes thus inform clinicians about the magnitude of treatment effects.

See more here.

(Prolong measured at 0.8 which is considerably higher than anything else available)

Prolong™ is regulated by different bodies around the world.

In the U.S, it’s regulated by the FDA (Food and Drug Administration).

Prolong is additionally regulated by the FDA’s Center for Devices and Radiological Health (CDRH), which is responsible for regulating firms who manufacture, repackage, re-label and/or import medical devices sold in the United States.

In order to get clearance to market, we had to provide clinical performance data - AKA, a clinical trial. Independent trials were conducted in accordance with FDA’s Investigational Device Exemption (IDE)7 regulation. (And the results were pretty impressive.)

In Europe, we have an MDR (Medical Device Regulation) and in the United Kingdom, our device is cleared by the MHRA (Medicines & Healthcare Regulatory Agency).

Unlike freely available products that merely bear a CE mark and claim to treat PE, our unique selling proposition (USP) lies in being a clinically proven, rigorously regulated treatment that has undergone extensive years of scientific trials.

We are constantly working around the clock to gain regulatory approval to provide Prolong™ in other markets too.

Permanently.

The Prolong™ Device is a clinically proven, permanent treatment for premature ejaculation and our clinical trials included a follow up with the participants at 3 and 6 months after their initial 6 week training - We're pleased to say that participants were still seeing further increases and improvements in their ELT (Ejaculation latency time).