According to data published by the World Health Organization (WHO), as many as one in five healthy males aged 18 to 25 years old have abnormal sperm counts and only 5 to 15% of sperm are considered normal.
To address the problem, we have developed and are commercializing two products – FERTILE® for ICSI and FERTILE PLUS® for IUI and IVF.
Utilizing currently available methods, the embryologist is challenged to select the “right” sperm for use in ART procedures. Furthermore, current procedures requiring centrifugation cause irreversible damage to the sperm due to DNA fragmentation and the generation of reactive oxygen species (ROS).
The FERTILE® and FERTILE PLUS® products eliminate the need for time-consuming sample preparation and sperm damaging centrifugation.
The result is a simple and fast method, enabling the embryologist to consistently select sperm with higher motility, better morphology, less damaging ROS generation and lower DNA fragmentation.
In parallel to our activities in the human market, we are working with key opinion leaders (KOLs) in the veterinary market to validate the utility and function of these products for ART applications in animals.
FERTILE® and FERTILE PLUS® are CE registered and currently in use in clinics within Europe and Latin America. In the USA, we are pursuing 510(k) Substantial Equivalence to predicate devices, with FDA approval expected in 2017.
FERTILE® & FERTILE PLUS® Advantages
Chips sortto yield population of “right” sperm and
Require no sample preparation
Standardize and simplifyprocessing
Require no sperm damagingcentrifugation
Sperm sorted in volumes requiredby ICSI, IUI and IVF
Channel dimensions and incubationtiming optimized for Maximum sorting efficiency
Select sperm with high motility,normal morphology, low ROS, low DNA fragmentation
Clinical results showing impressiveperformance benefits versus current methods