We would like to inform you of the following changes to FertiPro sperm freezing media:
- SpermFreeze™:
Instructions for use have been updated to once again include cryopreservation of sperm from testicular biopsies (TESE). With CE marking in accordance with Regulation (EU) 2017/745, this option has been removed from the intended use due to a
due to a lack of clinical data. In recent years, efforts have been made to gather additional clinical data, enabling the intended use to be extended again. In this regard, in order to keep our technical dossier up to date, if you would like to share clinical data on TESE sperm cryopreservation, please contact ra@fertipro.com .
- SpermFreeze™ and SpermFreeze™ SSP:
The instructions for use have been updated to include the SpermFreeze Box as an accessory to SpermFreeze™ and SpermFreeze™ SSP.
The SpermFreeze Box standardizes the cryopreservation of human sperm samples by offering a standardized height of sperm freezing flakes in the liquid nitrogen vapor phase.
If you require further information, please send your question(s) to ra@fertipro.com .