The Evidence
Clinically Tested ED Treatment
Vertica is clinically tested to be extremely effective in improving erection quality and hardness, with results sustained over time.
In 2023, a clinical trial assessing the safety and effectiveness of Vertica was published by the renowned International Journal of Impotence Research.
Clinical trial results
Clinically Tested
The clinical trial data demonstrates the transformative impact of Vertica for many men.
The men in the clinical trial rated the device as very comfortable, simple, and easy to use.
Radiofrequency is a safe and proven approach
Radiofrequency technology is a tested, proven and safe technique, which has been used in skincare for several years, for example for skin tightening and removal of acne.
Radiofrequency devices use safe levels of low-frequency electromagnetic waves to generate heat. This heat stimulates the production of collagen.
Thousands of clinical trials have demonstrated the effectiveness and safety of using radiofrequency energy on the body.
The use of radiofrequency technology in erectile dysfunction and has led to the invention of Vertica – a breakthrough in treating the root cause of ED.
Assessed and approved in the UK
Vertica is a Class IIa medical device and meets all applicable safety and performance standards required for clinical use. It is:
- Registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with UK Medical Device Regulations
- CE-marked under the EU Medical Devices Regulation (MDR 2017/745) for use in European markets
- Manufactured under an ISO 13485:2016 certified quality management system, ensuring compliance with internationally recognised standards for medical device design and production
- Engaged in the FDA Q-Submission process, with a pre-submission package submitted as part of preparations for future entry into the U.S. market
Vertica is built to the highest quality standards and is compliant with all current regulatory requirements in the regions where it is available.
Major U.S. Clinical Trial Now Underway
A large-scale clinical trial is now underway in the United States to evaluate Vertica in a broader population of men with erectile dysfunction.
This pivotal study is designed to generate robust clinical data on both the safety and effectiveness of the device. Results are expected in 2026 and will contribute significantly to the growing body of evidence supporting Vertica’s role in ED management.
We are also initiating separate trials to assess Vertica in men with Peyronie’s disease and in those recovering from radical prostatectomy. In these conditions, experts believe that supporting collagen regeneration could play an important role in restoring normal erectile function.
