SAN DIEGO, CA--(Marketwired - December 04, 2013) -
OmniBiome Therapeutics Inc. announces the launch of the world's first biotech company focused on developing proprietary diagnostic (Dx), medical device and therapeutic (Rx) approaches to either utilize -- or intervene with -- the systemic effects of the vaginal, lactal-duct and oral microbiomes for improving maternal and fetal healthcare. The Company will focus initially on developing CLIA-based Dx services for pregnancy-associated conditions or diseases where there is a substantive link with microbiome / microbiota dysbiosis, or with peripheral maternal infections that lead to preterm labor. In parallel, OmniBiome will build a database of aggregated patient data that will later inform development of Rx and medical device approaches for treating the same conditions or diseases.
According to Dr. Clem Hoffman, OmniBiome's Chief Medical Officer and Scientific Advisory Board member: "Such maternal conditions or diseases include pre-term labor, PPROM (pre-term, premature rupture of the membranes), PROM (premature rupture of the membranes at full-term but before labor has begun), unexplained infertility, recurrent spontaneous abortion, gestational diabetes and preeclampsia -- all of which are large unmet medical needs."
OmniBiome filed a comprehensive U.S. Patent application on 14 October 2013 for diagnosis of pregnancy-associated syndromes or conditions, and two other applications will be filed by year-end for novel inventions for treatment of vaginal or oral microbiome dysbiosis employing medical devices, and for inflammatory-cascade control in the maternal peripheral blood, vaginal and placental compartments.
The subject matter of the three seminal patent applications variously includes determination of multiple Dx biomarker fingerprints, at least six med-device or drug-device combinations (some of which may qualify for faster 510K-track approval), and, lastly, specific Rx protein compounds and vaccines.
The Company also plans to initially option and/or in-license microbiome-related Rx treatments, as well as Dx (CLIA-based) innovations from universities and research institutes. Several have already been identified.
Preterm birth is one the most expensive and least-addressed medical conditions worldwide. For example, in the case of premature labor leading to a "preemie", the average first-year cost to the U.S. healthcare system is about US$ 50,000 according to a March of Dimes study cited further below .
Very premature preemies can cost the healthcare system $ 300 - 500K for the first 1 - 2 years of care. The approximately 500,000 premature births / year in the U.S. cost the healthcare system about US$ 26 billion / year .
Dr. Vijay Mahant, Chief Scientific Officer of OmniBiome and Scientific Advisory Board member, remarked: "There have been few or no significant advances in the preterm labor space -- whether Rx, Dx or medical device-related since the development of the fetal fibronectin Dx test around 1990. OmniBiome plans to substantively accelerate the pace of advancement in the fields of maternal and fetal healthcare to ensure full-term births and healthy neonates."
Principals of OmniBiome will be attending the JPMorgan Healthcare Conference in San Francisco during 13 - 16 January 2014. We are seeking worldwide strategic alliance and joint venture partners, licensees for our proprietary technologies, top-tier academic collaborators, additional high-level management candidates (especially women as this is a maternal healthcare company), and additional SAB members.
Finally, OmniBiome is pleased to announce that Lee R. McCracken -- formerly a C- or VP-level executive with Prometheus, Verenium/Diversa, GenStar and CombiChem, among other companies -- has joined OmniBiome as a Senior Business Advisor to augment our seed and "A" round fund-raising efforts.
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