BEVERLY, Mass. and TORONTO, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Hamilton Thorne Ltd. (TSX-V:HTL), a leading worldwide provider of precision instruments, consumables, software and services to the Assisted Reproductive Technologies (ART) and developmental biology research markets, today announced that the US Food and Drug Administration (FDA) has issued a 510(k) clearance to market its first Gynemed branded media product in the US.
David Wolf, CEO of Hamilton Thorne remarked, “We are pleased to receive FDA clearance to market our GM501 Wash media in the US. Our approach has been to work with the FDA on this initial submission and develop a roadmap for the numerous other media products that we have pending or are in the submission preparation stage with the FDA. We expect that this initial work will contribute to a more expedited clearance for future products.”
GYNEMED GM501 Wash is a ready-to-use medium designed for in vitro washing and handling procedures of human oocytes and embryos outside of incubation, including after denudation, before and after cryopreservation, and before embryo transfer. The media will be available in multiple size bottles and has a shelf life of 6 months from time of manufacture.
During the past year Gynemed’s media line has also been expanded by the introduction of the following CE Marked products:
- GYNEMED GM501 Collagenase media, which digests human testicular tissue obtained by testicular biopsy (TESE) to facilitate the isolation of sperm cells, is intended to be used with specific pathologies. The media is available in a 3 ml (single patient dose) bottle and has a shelf life of 9 months from time of manufacture.
- Bromelain in Dulbecco´s PBS aids in the dilution and liquefaction of viscous ejaculates. The media is available in a 10 ml bottle and has a shelf life of 6 months from time of manufacture.
- GM501 GentleVit, which is a ready-to-use vitrification and thawing media, provides a gentle protocol for human oocytes, zygotes and embryos. The media is available as Kits (5 ml and 1 ml bottles) and has a shelf life of 12 months from time of manufacture.
Dr. Fabian Sell, Managing Director of Gynemed stated, “We are continually looking to add innovative new products to our line of cell culture media. These specialty media products meet defined needs in the laboratory and complement our full GM501 cell culture media line.”
Gynemed GM501 Wash will be available for initial sale in the US in the fourth quarter with full commercial roll-out in the first half of 2020. The full family of Gynemed media products is available for purchase in Europe and all markets that recognize the CE mark as well as select additional markets worldwide.
Additional information on these products and the entire Gynemed cell culture media line can be found at https://gynemed.de/en/product-category/cell-culture-media/gm501-medialine-en/
About Hamilton Thorne Ltd. (www.hamiltonthorne.ltd)
Hamilton Thorne is a leading global provider of precision instruments, consumables, software and services that reduce cost, increase productivity, improve results and enable breakthroughs in Assisted Reproductive Technologies (ART) and developmental biology research markets. Hamilton Thorne markets its products and services under the Hamilton Thorne, Gynemed, Planer, and Embryotech Laboratories brands, through its growing sales force and distributors worldwide. Hamilton Thorne’s customer base consists of fertility clinics, university research centers, animal breeding facilities, pharmaceutical companies, biotechnology companies, and other commercial and academic research establishments.
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Certain information in this press release may contain forward-looking statements. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict including the risk that the Company may not be able to obtain the necessary regulatory approvals, as applicable. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements unless and until required by securities laws applicable to the Company. Additional information identifying risks and uncertainties is contained in filings by the Company with the Canadian securities regulators, which filings are available at www.sedar.com
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