RALEIGH – Statera Environmental Inc., a North Carolina State University spinout, has started selling its uniquely sensitive technology for assessing the bioavailability and chronic exposure of chemicals in water and air.

Stateera

The sales of its non-selective passive sampling device (ns-PSD) to the U.S. Environmental Protection Agency and Health Canada will provide important third-party verification of its effectiveness, says Damian Shea, Ph.D., the Raleigh company’s CEO.

In addition, a major chemical company has begun using the device for an important pesticide exposure study, he said.

The technology enables risk assessors involved with the EPA’s Superfund program and other hazardous waste sites to gain critical information related to bioavailability, or the ability of a chemical to be taken up into animals and the human body.

It provides time-weighted averages of contaminant concentrations in surface waters and in air, with applications for soil and sediment as well. Risk assessors can then better understand and predict exposure rates and develop more accurate human health risk assessments. It is up to 1,000 times more sensitive and 10 times less expensive than current traditional sampling methods, according to Shea.

During a presentation at the North Carolina Biotechnology Center’s 2018 Ag Biotech Summit in February (left), Shea noted that there are 100 million chemicals on Earth. About 100,000 are registered for use in the United States, but most are unregulated and their presence in the environment is unknown.Shea and his team, which includes Xin-Rui Xia, Ph.D., a researcher in his lab who leads development and manufacturing with Xian Kong, who were instrumental in developing the technology, launched the company less than a year ago. The name Statera derives from the Latin word for “balance.” The idea is to provide a balance between using resources and environmental protection.

Of the 5,000 to 10,000 chemicals we are potentially exposed to in the environment, we measure only a few hundred, about 100 in drinking water, for instance.

The ns-PSD device works with a full range of organic chemicals. It uses a patent-pending mixed phase polymer encased in a stainless steel porous membrane that collects chemicals on the polymer within. It detects dissolved and bioavailable chemicals at sub-nanogram-per-liter concentrations and time-weighted averages for at least 30 days.

Statera CEO Damian Shea, Ph.D. (SP Murray Photography)

Shea said the device has been calibrated to be as nearly universal a sampling device as possible and able to test for several thousand water soluble and non-soluble chemicals. But as research and development continues, it may be evolved to measure specific toxins, such as the GenX that has been detected in the Cape Fear River in NC. It cannot currently work on that particular type of chemical, he said.It has been calibrated in the laboratory for more than 6,400 chemicals and has been used to measure chronic exposure to more than 400 chemicals at various field sites. It detects PCBs, dioxins, pesticides, natural and synthetic estrogens and androgens, antibiotics, and many pharmaceutical and personal-care products.

Currently, he said the company is still in the R&D phase, “working out the bugs and making it as reliable and robust as we can.” The main barrier to adoption is the need for independent third-party verification, “So we are focused on getting these highly respected early adopters,” such as the EPA and Health Canada, he said.

“In six months, we hope to refine the product and have that third-party verification.”

Most of the company’s funding has come from the Superfund Research program of the National Institute of Environmental Health Sciences, but the company is currently seeking Small Business Innovation Research grants with the National Institutes of Health and National Science Foundation.