FDA clears SpermAlign for use in selecting high quality sperm for use in Assisted Reproductive Techniques (ART)
SpermAlign is the only cleared product of its type
Cytoswim has received clearance from the U.S. Food and Drug Administration (FDA) for its novel SpermAlign device which helps select high quality sperm for use in ART.
Male factor infertility, a major global health issue, accounts for up to half of all infertility issues and has a variety of causes including sperm of suboptimal quality.
SpermAlign, based on a novel patented microstructure selects highly motile and less damaged sperm cells in a simple 30 minute procedure and offers a different approach to traditional sperm preparation methods including swim-up and membrane methodologies.
This first product from the Founder and Inventor Dr Max Meissner and his team has been designed, developed and manufactured in the UK allowing reproducible and cost-effective devices to be available for use in various types of ART including IVF (In vitro fertilisation) and ICSI (Intracytoplasmic Sperm Injection). This offers clinicians and lab directors an easy-to-use alternative compared to the Gold Standard, Density Gradient Centrifugation and swim-up (SU), long associated with induced sperm DNA damage and ongoing pregnancy failure in some patients.
SpermAlign is a sterile, single-use device packaged for convenient use in ART clinics worldwide.
SpermAlign was cleared by the FDA through the 510(k) medical device pathway. Medical devices are products that are reviewed by the FDA and meet specific criteria via the 510(k) or Premarket Approval pathway. FDA-cleared devices undergo rigorous review.
Cytoswim, a former spin out from the UK's University of Warwick, has a team of dedicated scientists and commercial staff supported by an expert panel of advisers and investors.
Dr Meissner commented "Male fertility is a significant global issue that affects millions of people every year. With this FDA approval we are now one step closer to bringing our game changing naturally inspired microstructures to market in order to help millions of people realise their dream of parenthood. It has taken a lot of hard work to get to this point and I am immensely proud of the entire CytoSwim team for reaching this milestone".
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