Managing patients in trauma units or those with chronic diseases typically amounts to taking periodic lab "snapshots" of blood and urine proteins. But changes can occur rapidly and physicians would be far better equipped to effectively personalize treatments with the ability to monitor real-time variations.
Start-up nanotechnology company Vista Therapeutics (Santa Fe, New Mexico) is developing nanosensors which can provide just that kind of ongoing information. In addition to patient monitoring, the nanosensors have potential applications in:
• Pre-clinical drug safety and efficacy studies.
• Clinical research and trials.
• Military and Homeland Security.
"In the case of a person who is traumatically injured, a significant cause of death is not exsanguination [bleeding to death], but the follow-up response — a compliment cascade [a series of reactions that take place in the blood]," Spencer Farr, PhD, president/CEO of Vista, told Medical Device Daily. "If we can measure responses on a continuous basis, we can see that the complement cascade is firing up and intervene in real time."
The complement system is composed of 25 proteins that work together to assist, or complement, antibodies in destroying bacteria. Complement proteins cause blood vessels to become dilated and then leaky. They also contribute to an inflammatory response.
A more specific example: In trauma, patients could be closely monitored for molecular warning signs of organ failure.
Vista's nanosensors are being developed to monitor these molecular biomarkers at extremely small concentrations. Meaning no more blood draws or fingersticks.
Nanowires comprised of 1-D, semi-conducting materials are incorporated into electronic circuits that allow continuous readout. The nanowires can be functionalized to detect virtually any form of bimolecular interaction that involves proteins (including antibodies, receptors and enzymes) or nucleic acids.
The founders of Vista are Farr and Charles Lieber, PhD, a professor in Harvard University's (Cambridge, Massachusetts) chemistry department, who is widely held as a pioneer in the development of nanowires and co-founder of nanotechnology firm Nanosys (Palo Alto, California).
Farr is a member of the faculties at Harvard and the Massachusetts Institute of Technology (Cambridge, Massachusetts) and was the founder/CEO of Xenometrix (San Diego) and Phase-1 Toxicology (Santa Fe).
They are launching what could be considered a virtual company, with most development activities taking place at partner companies ICX Mesosystems (Albuquerque, New Mexico) and Potentia Pharmaceuticals (Louisville, Kentucky). Harvard has an equity stake in Vista as part of an intellectual property exchange for the IP related to the end product, which will be called NanobioSensors.
Vista has license agreements with Harvard and Nanosys for exclusive rights, via multiple issued patents, for most of the important biomedical applications of the NanobioSensors.
"Raising money has been and is a big challenge for nanotechnology companies because they are multi-disciplinary projects. Most venture capital groups don't have the bandwidth to cover life sciences and nanotechnology," Farr said. "You can count on one hand the number of VCs who understand both."
So, instead of going to the markets to raise $10 million, a base estimate to develop the NanobioSensors, "We cut strategic deals with Potentia and ICX to get this done. ICX is doing a majority of engineering design largely on their own nickel in exchange for equity," Farr said. "Potentia has expertise and they got what we were doing instantly and they are helping on the biotech side. If we had to go out and purchase or build this infrastructure it would take a much longer time. This way, we're getting it done inexpensively and faster without having to wait until we hire the experts."
Farr said Vista will have its first NanobioSensor prototype in five months. The company's shell was just built in April 2007.
Initially the device will be used outside of the body. It is expected to be the same size as small, portable radio hooked up to an IV host. Blood will be sampled from a branch of the IV as frequently as the physician orders.
"Ultimately, we see this as an implant device and then the patient would wear a watch that indicates the level of the biomarker of interest," Farr said.
With so many conditions that could be monitored, where to start?
"First we're going to start with a 'Model T' version that shows off the ability to continuously monitor," Farr said. "We have our own favorite wish list of biomarkers, but in reality, the doctors and pharmaceutical companies will come back and ask us if we can measure something else."
The current gold standard protein-detection technique, ELISA, which takes 90 minutes to perform, starts with a blood draw which must then be processed.
Farr thinks Vista can compete effectively against ELISA assays for many applications where kinetic and thermodynamic data are desirable or where concentrations of the analyte are limiting. He estimates that ELISA-based assays for hospitalized patients, animal drug safety and efficacy or tissue culture analysis applications together represent at least 10% of the current $6 billion annual biomarker sales.
"Initially we'll focus on the drug development market, allowing us to build the infrastructure to understand and hone in our manufacturing techniques in a non-FDA market," he said. "We'll start to look around for a manufacturing partner, like a Medtronic [Minneapolis], that has the expertise to bring the product online and transfer what we've learned. We'll start some discussions very soon."
Vista just raised about $300,000 in a Series A stock sale led by New Mexico Angels (Albuquerque).
"Because of our partnerships, we have a minimal burn rate and expect this to last eight months," he said. "But, we're now looking to raise a larger tranche."