Irvine Scientific Receives FDA 510(k) Clearance for Their Newly Developed Continuous Single Culture™

Published: Sep 19, 2012

SANTA ANA, Calif.--(BUSINESS WIRE)-- Irvine Scientific, a global leader in Assisted Reproductive Technologies (ART), announced that they have received 510(k) clearance for their Continuous Single Culture™ - Complete product (CSCM-C). The company will commence commercialization at IVF centers across the United States immediately. The product will be presented at the 68th Annual Meeting of the American Society for Reproductive Medicine in San Diego, California from October 20th-24th 2012.

CSCM-C is a complex solution which is pre-supplemented with Human Serum Albumin, intended to be used for fertilization and culture of embryos to D-3, or D-5/D-6 of development. CSCM-C is the first and only single-step culture medium used in an uninterrupted culture environment, without the need for medium renewal or dish change. Designed for laboratories who want to reduce stress on embryos while improving clinical results, the optimized formulation reduces embryo stress by eliminating the need to expose embryos to varying media environments, temperature and pH fluctuations. The new CSCM-C product improves blastocyst formation with a demonstrated increase in blastocyst utilization and fertilization rates.

“We are very pleased to be the first and only company at this time that offers a monoculture solution for both fertilization and extended embryo culture in an uninterrupted culture environment,” expresses Tim Mullane, COO. He adds that, “CSCM-C represents an important addition to a series of innovative products offered by Irvine Scientific that provide a simplified and efficient approach to achieving pregnancies in-vitro. But more importantly, provides a complete solution for laboratories that strive to reduce embryo stress while providing patients with a healthy baby.”

About Irvine Scientific:

Irvine Scientific, a member of JX Holdings group, is a worldwide leader in the design, manufacture and distribution of medical devices, including Industrial Cell Culture, Cytogenetic, Assisted Reproductive Technology (ART) and Specialty Media products. Irvine Scientific is a large scale producer of advanced quality cell culture media for the industrial bioprocess, medical, and diagnostic markets. The company’s extensive experience in the design of culture media, compliance with ISO and FDA regulations for class II / III medical devices, industrial scale manufacturing capacity, provides its customers with unique capabilities and support. Irvine Scientific delivers products worldwide to biopharmaceutical industry, research and medical laboratory communities.

Irvine Scientific® and Continuous Single Culture™ are among the trademarks of Irvine Scientific Sales Company, Inc. and its affiliates in the United States, certain other countries and/or the EU.

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