Release No. 124
MediCult has obtained FDA 510 (k) clearance of the product SynVitro® Cumulase™ for the US market.
"SynVitro® Cumulase™ is a new generation product containing a human recombinant hyaluronidase, which is the purest material in its class", says Executive Vice President, Sales and Marketing, Mr. Steen Thaarup, and continues, "the hyaluronidase product is used when treating male infertility (the ICSI procedure), which accounts for approximately half of all infertility treatments, i.e. approx. 70,000 cycles in the US market".
MediCult CEO, Jesper Funding Andersen, adds: "It is an integrated part of our strategy to obtain 510(k) clearance for all new products as the US market is a priority for us" .
For more information, please contact
Jesper Funding Andersen
Tel.: +45 46 79 02 15
mobile phone: +45 40 73 09 63