Novel Approaches Will Include Development of Diagnostic Tests, Medical Devices, Vaccines and Therapeutic Proteins
April 25, 2014
OmniBiome Therapeutics Inc. is the world’s first biotech “idea factory” focused on developing proprietary and integrated diagnostic (Dx), medical device and therapeutic (Rx) approaches for improving outcomes in maternal healthcare — in particular preterm labor and preterm birth.
There are about 15,000,000 preterm births per year worldwide, and 1.1 million neonatal or perinatal deaths per year as a result.
Preterm birth is a major unmet medical need in both the developing and developed worlds and cuts across all socioeconomic classes in all countries, including the U.S. where the preterm labor rate is over 12%.
“We are pleased to announce the following recent corporate milestones,” noted David Palella, CEO and co-founder of OmniBiome Therapeutics:
(1) Three major U.S. patents were filed:
“Diagnostic Methods for the Assessment of Pregnancy Complications”
USSN: 61/890,356 — 14 October 2013 [ 77 pages ] – identifies 158 putative or confirmed biomarkers associated with preterm birth. A minimalist subpanel of these will be selected to diagnose the risk of preterm labor weeks or months in advance.
“Medical Devices for Reducing the Risk of Preterm Labor and Preterm-Birth”
USSN: 61/917,364 — December 18, 2013 [ 118 pages ] – describes multiple novel biodegradable or non-biodegradable medical devices or drug-device combinations to prevent or delay preterm labor.
“Preventative Methods and Therapeutic or Pharmaceutical Compositions for the Treatment or Prevention of Pregnancy Complications”
USSN 61925243 — filed 09 January 2014 [ 71 pages ] – describes dozens of Rx antibody and prophylactic vaccine approaches to treat preterm labor that will be safe for use in pre-pregnant or pregnant women.
All medical devices will be out-licensed and the Dx business will be out-sourced, allowing OmniBiome to concentrate on Rx applications.
One or more of the medical devices could possibly qualify for the FDA’s faster 510(k)-track. Partnering inquiries from medical device companies focused on women’s healthcare are welcome.
Revenue from out-licensing of the medical devices and out-sourcing or partnering of the proprietary Dx business will materially reduce dilution of the seed and ‘A’ round investors.
(2) OmniBiome filed its first SBIR grant application on 03 April 2014 titled:
“Discovery of novel predictive tests and targets for treatment of preterm birth”
(3) NoPreemies.org — a separate entity focused on funding academic or entrepreneurial research for prevention of preterm labor — was formed by OmniBiome team members, Iryna Dzieciuch and Alejandra Mendoza. NoPreemies will soon start a crowd-funding campaign on Indiegogo.
Please visit NoPreemies’ web site at: http://www.NoPreemies.org
Summing up, Dr. Reinhold Mueller, VP of Diagnostics Product Development at OmniBiome remarked: “Very premature preemies can cost the healthcare system $ 300 – 500K for the first 1 – 2 years of care. The approximately 500,000 premature births per year in the U.S. alone cost the healthcare system about US$ 30 billion. Prematurity of birth results in the world’s most expensive hospital stays, as well as lifelong burdens on the mother should the preemie have permanent neurological, pulmonary or immunological deficits.”
To learn more about OmniBiome, please visit: