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Irvine Scientific Receives 510(k) Clearance for Multipurpose Handling Medium™ Product (MHM™)


9/19/2012 7:08:32 AM

SANTA ANA, Calif.--(BUSINESS WIRE)-- Irvine Scientific, a leader in Assisted Reproductive Technologies (ART), announced that they have received 510k clearance for their Multipurpose Handling Medium™ product (MHM™) in the United States.

The new MHM™ product is the first dual buffered solution that provides a safe and secure environment for gametes and embryos under ambient conditions because of its unique buffering capacity using both HEPES and MOPS buffers, in addition to select amino acids. The MHM™ solution helps IVF labs maintain an optimal pH across a wide range of temperatures when handling specimens outside the incubator, which is important to reduce the environmental stress during manipulation. Embryos and gametes are exposed to changing environments during ART procedures but MHM™ keeps them shielded from these changes. Irvine Scientific’s MHM™ solution can be used for all cell stages of embryos due to the inclusion of evidence-based amino acids, glycine and taurine and is formulated specially for performing oocyte recovery, ICSI, embryo transfer, and gamete washing.

This product was developed in collaboration with Jason Swain, PhD, HCLD, who is currently the Scientific Director of the Assisted Reproductive Laboratory at the University of Michigan. Dr. Swain has written multiple papers on the benefits of using dual buffers to produce better media, where optimized buffering capacity and pH stability can be achieved while using less overall buffer concentration.

“Irvine Scientific has a track record of bringing the best science to its customers worldwide,” expresses Tim Mullane, COO. He adds that “MHM™ solution is the latest in a series of innovative products offered by Irvine Scientific.”

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 Multipurpose Handling Medium™ are among the trademarks of Irvine Scientific Sales Company, Inc. and its affiliates in the United States, certain other countries and/or the EU.

For more information:

- Visit http://www.irvinesci.com

- Follow us on LinkedIn at http://www.linkedin.com/company/irvine-scientific?trk=tabs_biz_home

Contact:

Irvine Scientific

Fairy Zare

1-800-437-5706

1-949-261-7800

tmrequest@irvinesci.com



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