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New Sperm Selection Technology for Assisted Reproductive Technology (ART) Cleared by FDA

Press Release
July 8, 2006

New Sperm Selection Technology for Assisted Reproductive Technology (ART) Cleared by FDA

Biocoat, Inc., a Horsham, PA biotech company, announced the FDA’s clearance of a new product which improves the effectiveness of ICSI (Intra Cytoplasmic Sperm Injection) assisted reproduction. The new PICSI(tm) Sperm Selection Device will be of significant value to embryologists using the ICSI in vitro fertilization method.

(PRWEB) July 7, 2006 -- Biocoat, Inc., a Horsham, PA biotech company, announced the FDA’s clearance of a new product which improves the effectiveness of ICSI (Intra Cytoplasmic Sperm Injection) assisted reproduction. Known for manufacturing and licensing their HYDAK(R) hyaluronan coatings for medical devices, Biocoat says that its new PICSI(tm) Sperm Selection Device will be of significant value to embryologists using the ICSI in vitro fertilization method.

In the ICSI procedure, an individual sperm is selected and injected into a oocyte. Until now, the only technique available to embryologists to select the sperm has been visual observation. With Biocoat’s new PICSI Sperm Selection Device embryologists are able to determine sperm selection in much the same way it happens in human biology. Sperm is placed in Biocoat’s laboratory PICSI dish containing samples of hyaluronan hydrogel. Hyaluronan is a naturally occurring biopolymer found in all human cells, including the gel layer surrounding the oocyte. Mature, biochemically competent sperm bind to the hyaluronan where they can be isolated by the embryologist and used for ICSI. The Biocoat device actually mimics a key step in the natural fertilization process, the binding of mature sperm to the oocyte complex. As a result, the selected sperm is essentially the same as one that would be successful in the natural reproductive process.

Dr. Gabor Huszar of the Yale School of Medicine is the inventor the PICSI technique. His research proved that hyaluronan-bound PICSI-selected sperm are, in the vast majority of cases, more mature, exhibit less DNA damage, and have fewer chromosomal aneuploidies. Moreover, Dr Huszar said, “sperm identified using the PICSI technique exhibit no detectable adverse effects from the hyaluronic acid contact.”

In the long run it is thought that the use of the new PICSI technique should improve pregnancy rates and reduce the number of IVF miscarriages. Albert J. Peters, D.O., F.A.C.O.G., Chief of Reproductive Endocrinology and Infertility, at Lehigh Valley Hospital in Allentown PA (where some of the clinical trials were run) stated, “We believe that the PICSI device could have significant clinical importance to our ICSI patients.”

Mid-Atlantic Diagnostics, Inc. (Mount Laurel, NJ) will market and distribute the PICSI device. Mid-Atlantic Diagnostics also distributes Biocoat’s HBA(R) Sperm-Hyaluronan Binding Assay.