SCIENCE
CLINICAL EVIDENCE BACKED PRODUCTS AT THE SERVICE OF MALE SEXUAL WELL-BEING
When we talk about MYHIXEL's solutions, we are talking abouttech products and services created with the goal of improving your sexual healthand tackling your intimate concerns.
MYHIXEL’s portfolio is designed to help with male sexual conditionssuch as premature ejaculation and erectile dysfunction.We offer reliability as a medical manufacturer and demonstrate the efficacy of our products through clinical trials.
WHY MYHIXEL?
DEMONSTRATED EFFICACY through clinical trials: In 2018, we started running trials related to premature ejaculation. In 2023, we finished our first study related to erectile dysfunction and we plan to continue running new trials.
STUDIES PUBLISHED in prestigious international scientific journals: Our case series studies and randomized controlled trials have been published in PLOS ONE and The Journal of Sexual Medicine.
FDA Registered and Medical CE Marked: MYHIXEL’s device is listed in the FDA as a medical device Class II, endorsed by the leading U.S. authority to ensure product safety and health. Additionally, MYHIXEL Hub app bears the CE mark as Medical Device Software in the European Union, indicating conformity to European health and safety regulations. These distinctions ensure that MYHIXEL´s products meet the highest medical standards.
License as a Medical Manufacturer by AEMPS: In 2020, the Spanish Public Health Agency granted New Wellness Concept, SL (the legal entity behind the MYHIXEL brand) a License as a Medical Device Manufacturer. In addition, ISO 13485 was implemented to ensure compliance with the strict medical and safety standards required for medical devices.
Endorsed by sexual health Experts: Urologists, sex therapists, andrologists, psychotherapists, physiotherapists, and other professionals support MYHIXEL and recommend our solutions to their patients who struggle with premature ejaculation, erectile dysfunction, sexual anxiety, and related issues.
WHAT EXPERTS SAY ABOUT MYHIXEL’S PRODUCTS AND HOW THEY HAVE HELPED THEIR PATIENTS
VALIDATED RESULTS THROUGH CLINICAL TRIALS
- Rodríguez JE, Picazo JA, Marzo JC, Piqueras JA, Reina L, Hidalgo G, et al. (2021)
Efficacy of Sphincter Control Training and medical device in the treatment of premature ejaculation: A multicenter randomized controlled clinical trial. PLoS ONE 16(9): e0257284.
- Rodríguez JE, Harvey H, Reina L, Hidalgo G, Culebras M, Casado C.
P-07-1 A New Method Using an Electronic Masturbation Device and a Mobile App for the Treatment of Premature Ejaculation: A Prospective, Multicenter Case Series. The Journal of Sexual Medicine. 2020 06/01; 2020/06;17(6):S212-3.
- Rodríguez JE, Marzo JC, y Piqueras JA.
Evaluation of a new cognitive-behavioral treatment for premature ejaculation using a masturbation aid device: A case series. The Journal of Sexual Medicine 2019 04/01; 2019/03;16(4):S30.
- Rodriguez, J.E.1, García, A.1,Picazo, J.A.1 New cognitive behavioral treatment for delayed ejaculation using a masturbation aid device and mobile app: A case study. https://doi.org/10.1016/j.jsxm.2021.01.072
OUR COMMITMENT IS TO PUT OUR INNOVATIVE TECH PRODUCTS AT THE SERVICE OF SEXUAL HEALTH
Engineers, industrial designers, medical doctors, urologists, sex therapists, midwives, personal trainers, nutritionists, and experts in medical device regulation have all contributed to the development of MYHIXEL’s portfolio.
MYHIXEL’s products incorporate advanced technologies such as Bluetooth connectivity, speed and movement sensors, machine learning, and artificial intelligence, while ensuring data privacy and encryption are fundamental requirements.
Our goal is to provide men with the most innovative solutions to enhance their intimate lives.