New hand-held testing device could revolutionize health care
In hospitals today, the first warning that a post-operative patient is going into septic shock is often when the patient's blood pressure collapses and cardiac arrest begins. By that time the patient has a high probability of dying, or, if he survives, an even higher probability of permanent major organ damage after a long stay in an intensive care unit.
A new company, SpheroSense Technologies Inc., will produce a hand-held device that will monitor post-operative and trauma patients for early warning signs of sepsis (infection in the bloodstream), so medical personnel can intervene with antibiotics and anti-inflammatories before organs are damaged. This would reduce the likelihood of death or disability and prevent many expensive stays in ICUs.
The company was founded a year ago by Professor James A. Glazier and two colleagues, Professor Bogdan Dragnea and doctoral student Dragos Amarie, in the Biocomplexity Institute at Indiana University Bloomington. Dr. James Kuo has joined the firm as interim CEO and Andrew Cothrel as interim COO.
Bacteria often circulate at low levels in the bloodstream prior to the onset of sepsis. SpheroSense will detect them by continuously tracking the concentration of specific protein markers in patients' bloodstreams. Such continuous monitoring cannot be performed by any current or announced device, Glazier said.
"The incidence of sepsis exceeds that of colon cancer, breast cancer or AIDS. There are about a million cases of sepsis every year in the United States, and the mortality rate is more than 30 percent," he said.
No hospital would check patients' pulses only once a day to see if they were alive, yet patients are lucky if their blood chemistry is checked even that often. The tests are expensive, and despite the growing market for bedside (point-of-care) testing, the tests are usually done in a central or remote laboratory.
"In 10 years, we will regard continuous monitoring of blood chemistry as routine and essential, and such monitoring will improve therapy and save lives and money," Glazier said. Rapid testing at the patient's bedside has the potential to revolutionize the delivery of health care.
Glazier and his colleagues have developed a new type of miniature optical device, the microcavity surface plasmon resonance sensor, which is able to detect and quantify molecular binding in very small volumes of a sample. This sensor improves on the performance of the hundred-thousand-dollar instruments currently used in drug-discovery and biochemistry laboratories worldwide, including at IU and at Eli Lilly and Co., while greatly reducing the cost per measurement. This will allow very low-cost, continuous screening for medical applications as well as high-throughput instruments for research and drug discovery.
"The company's goal is to become the leader in continuous-monitoring, molecular interaction devices for research, medical and safety applications," Glazier said. "We believe that a significant market exists for a low-cost, flexible and high-performance instrument."
Potential customers include leading life science research centers, all of the leading global pharmaceutical companies, and a large number of companies in the biotechnology sector. "We believe that a compact, low-cost instrument with high-throughput capabilities would find its way into almost every current biochemistry laboratory," Glazier said.
"Our sensor is significantly smaller and more sensitive than existing related technologies," he said. "Unlike most existing technologies, the MSPR sensor can detect small molecules, drugs, proteins, viruses, DNA and RNA. The sensor can be manufactured inexpensively enough to be disposable, and it can be integrated with microfluidics into instruments that allow sample conditioning and high-throughput screening of multiple compounds or pathogens on the same chip. Our technology will provide continuous real-time monitoring of patient condition."
The main impact will be in medical diagnostics, he emphasized.
SpheroSense was started with seed money from Indiana University. The company is now requesting $1.75 million from the state's 21st Century Fund to develop prototypes and begin production.
Glazier said the helpful environment at IUB, in Bloomington and in the state of Indiana has been crucial in convincing them to take the plunge into a commercial venture. "The level of support available here is outstanding. When we started, none of us had any experience in turning scientific concepts into a viable business. People at all levels have been exceptionally generous with their time and advice, and very patient with our mistakes.
"Getting a hearing would have been much more difficult in Boston or San Diego," Glazier noted. "The people at Indiana University Research and Technology Corp., particularly Bill Brizzard and Mark Long, have been crucial in helping us develop our concepts into commercial applications and a company. John Cameron, a former physics professor at IUB who founded ProCure, was a great mentor. A group of students from the Johnson Center for Entrepreneurship & Innovation in IU's Kelley School of Business is currently helping to develop our marketing plan. Without the valuable assistance of Professor Donald Kuratko and the Johnson Center, we would have had a much more difficult time organizing our business plan. We've also benefitted from advice and opportunities to meet with successful entrepreneurs and venture capitalists provided by Ted Widlanski (METACyt) at IU, Steve Bryant (formerly with Bloomington Life Sciences Partnership) and Brian Kleber (inVenture) in Bloomington, and Cynthia Helpingstine (BioCrossroads) at the state level."
The initial focus will be on developing a laboratory research instrument. "Because this application does not require approval by the Food and Drug Administration, we could enter the market quickly. Subsequently, we will develop products for the clinical point-of-care market using the same technologies," Glazier said.
In the clinical market, the initial focus will be on patients in intensive care units who, because of a large number of intravenous lines, tubes and catheters, are at high risk for bloodstream infection. The clinical setting is ideal for using MSPR technology because of the need for a hand-held device, a highly sensitive and specific test, and a rapid turn-around time on the test in a life-threatening situation.
Proof of concept has already been demonstrated, showing the remarkable sensitivity of MSPR. This technology is the basis for a patent application by Indiana University Research and Technology Corp., and SpheroSense has negotiated exclusive rights on this technology and expects to extend it through further innovation. Additional applications could include drugs of abuse, influenza screening, biodefense and suspicious "white powder" detectors, among others.