Discoveries: Universities, Labs & the Economy – BizWest http://bizwest.com Business news, data and economic statistics for the Boulder Valley and Northern Colorado Thu, 23 Feb 2017 21:50:32 +0000 en-US hourly 1 CU’s ClinImmune Labs enters private cord-blood banking arena http://bizwest.com/2015/02/20/cord-blood-bank-enters-private-arena/ http://bizwest.com/2015/02/20/cord-blood-bank-enters-private-arena/#respond Fri, 20 Feb 2015 23:34:48 +0000 http://bizwest.com/?p=125798 As the global market around umbilical cord blood stem-cell treatments reaches well into the billions of dollars annually, the University of Colorado has taken a pioneering step of sorts by expanding its own cord-blood banking services into the private realm. ClinImmune Labs, a company owned by CU and housed at the school’s Anschutz Medical Campus in Aurora, has served as a public cord blood bank for 17 years. But ClinImmune last year began a public-private partnership with Irvine, Calif.-based CariCord Inc. to begin providing private banking. The arrangement makes ClinImmune Labs the first Food and Drug Administration-licensed laboratory in the country doing private banking. Cord blood banking has grown in recent years as advances in medicine have increased the number of conditions and diseases that can be treated with transplanted cord-blood stem cells. That list includes more than 80 diseases, including certain types of leukemia and various blood, immune and metabolic disorders. Analysts for investment banking firm Jefferies estimated the 2010 global market for cord blood storage to be $4 billion. The stem cells from cord blood are considered in some ways to be a better option than those from bone marrow. In addition to a lower chance of rejection by the recipient’s body, privately banked cord blood stem cells are also more readily available for children or their siblings to use, eliminating what can often be a months-long search for a bone marrow donor. Advocates of the practice have likened the cells to a “cellular legacy for the future.” “The benefit of cord blood is it’s available immediately,” said Dr. Brian Freed, executive director of ClinImmune Labs and a co-founder of CariCord. ClinImmune serves many functions in addition to cord-blood banking. Its services include stem cell processing, testing for bone marrow and organ transplants, and immunology testing, among others. The lab is owned, and supported in part, by the CU School of Medicine, but as a business it also generates nearly $10 million in revenue for the school each year. Co-founded by Freed and company chief executive Calvin Cole, CariCord licenses the company name from CU and essentially works as the client-facing operation of the private banking now being done at the school. Parents banking their children’s blood pay CariCord, while CariCord contracts with the university for processing and banking. “(CariCord doesn’t) have to worry about building the facility, and (ClinImmune Labs doesn’t) have to worry about advertising and sales and things we don’t know anything about,” Freed said. CariCord charges $1,695 upfront plus about $125 each following year for banking. That’s similar to the other two major players in the industry, Cord Blood Registry and Viacord. CBR charges $1,650 upfront plus $150 per year and also offers a one-time lifetime fee of $4,000. Viacord charges $1,375 upfront and $175 per year. Where CariCord’s advantage comes in, Freed said, is in the ClinImmune Labs bank, which has stored more than 8,500 donated cord blood units at its public bank, leading to more than 725 transplants at 150 different locations […]

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CSU center working on brain trauma prevention http://bizwest.com/2014/05/30/csu-center-working-on-brain-trauma-prevention/ http://bizwest.com/2014/05/30/csu-center-working-on-brain-trauma-prevention/#respond Fri, 30 May 2014 20:30:49 +0000 http://localhost/csu-center-working-on-brain-trauma-prevention/ FORT COLLINS – Injuries sustained by everyone from infants to soldiers could one day be much less traumatic, thanks to research being conducted with the help of the Colorado Center for Drug Discovery, a state-funded program located at Colorado State University. The drug research center, or C2D2, has developed preliminary compounds that could lessen the impact of traumatic brain injury, or TBI. Such injuries have become a hot topic nationwide because of their increasing prevalence among veterans and professional athletes. An initial injury can occur in an instant, when an improvised explosive device detonates in Iraq or a National Football League player sustains a particularly hard hit, but the effects are felt long after the injury is suffered. Swelling in the brain, death of brain cells and inflammation – collectively known as secondary brain injury – all are potential problems for someone with TBI. If the secondary injury is severe enough, it can cause cognitive, behavioral or emotional impairments or can ultimately lead to death. In 2010, 2.5 million instances of TBI were recorded in the United States, according to the Centers for Disease Control and Prevention, and about 20 percent of the troops deployed to Iraq and Afghanistan since 2001 have suffered a traumatic brain injury. But a 2009 breakthrough by a University of Colorado-Denver School of Medicine scientist and subsequent work at C2D2 could help future sufferers of TBI avoid these problems. Kim Heidenreich, a professor of pharmacology at CU’s medical school, discovered that blocking the production of leukotrienes, a type of inflammatory molecule that often is associated with asthma, at the time the initial brain injury is sustained can help prevent secondary injury down the road. In order to block leukotrienes, a drug containing a protein known as FLAP must be administered either just before or just after brain injury is sustained, said Heidenreich. That drug is what C2D2 is helping Heidenreich develop, by providing the chemistry needed to supplement the biology done by Heidenreich and her fellow researchers. The center’s associate director, Greg Miknis, and a team of scientists have identified compounds that have proved effective, opening the door for clinical trials and the long process of getting a drug approved and commercialized. Heidenreich’s plan is to repurpose drugs developed by pharmaceutical giant Merck & Co. (NYSE: MRK) for treating asthma, which would speed up the drug’s voyage to commercialization. Even so, getting the drug to market will take years. The compounds that have been formed are “exquisitely potent,” said Miknis, as they must be in order to penetrate the brain. “The brain is really good at keeping things out,” Miknis said. The brain’s ability to protect itself also is the reason the drug must be administered at the time of injury. “There’s a breakdown of the blood-brain barrier when the injury occurs,” Heidenreich said. That lowering of the brain’s defense system allows the drugs to make their way to the brain. “But the window does close at some point,” she said. More funding needs to […]

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Discoveries – 2014 http://bizwest.com/bw_2014_discoveries_flyp/ http://bizwest.com/bw_2014_discoveries_flyp/#respond Thu, 26 May 2016 22:24:57 +0000 http://bizwest.com/wp-content/uploads/2016/05/BW_2014_Discoveries_flyp.pdf Spotlighting the economic impact of Colorado and Wyoming’s research universities, federal labs, and related industries.

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Light pulses could boost space veggies’ nutrition http://bizwest.com/2014/03/21/light-pulses-could-boost-space-veggies-nutrition-2/ http://bizwest.com/2014/03/21/light-pulses-could-boost-space-veggies-nutrition-2/#respond Fri, 21 Mar 2014 00:00:00 +0000 http://dev.bizwestmedia.com/light-pulses-could-boost-space-veggies-nutrition-2/?utm_source=internal&utm_campaign=guest BOULDER – University of Colorado researchers are studying the effects of light pulses on the growth and nutrition retention of plants to be consumed by astronauts during space flight. Specifically, the research group is using different methodologies to grow plants rapidly and trigger the retention of certain carotenoids, specifically zeaxanthin, which are important to protect human vision from the exposure of low-level radiation during long-duration manned spaceflight missions. According to a NASA research study, one of the main problems for astronauts traveling on long-duration space flight is the exposure to ionizing radiation and the consequent oxidative stress, which can harm the retina. Gioia Massa, a project scientist in International Space Station ground processing and research with the NASA Kennedy Space Center, said that NASA has been looking for ways to produce nutrient-rich vegetables in space, safe for astronaut consumption. “A space diet has certain things in the prepackaged diet, but might be low or deficient in certain nutrients,” she said. “The farther away you get from Earth, the more DNA-level damage there is. There are potentially some plant-based beneficial compounds that could help or prevent this. It’s a really promising area for study.” Massa said that NASA is looking to implement a vegetable production system on the next space resupply mission in the near future. “If plants are grown under certain conditions, they might be able to express more phytochemicals and get higher levels of nutrients, which can help keep the crew healthy,” she said. Compounds absorbed by the human body, such as zeaxanthin, can help prevent biological damage to eyes during spaceflight. Zeaxanthin, which is known to promote eye health, could be ingested as a supplement, but there is evidence that humans are better at absorbing carotenoids from whole foods, such as green leafy vegetables. The human body cannot produce zeaxanthin on its own. The CU team included undergraduate researcher Elizabeth Lombardi, postdoctoral researcher Christopher Cohu, and ecology and evolutionary biology professors William Adams and Barbara Demmig-Adams. With the study idea conceived by Lombardi, the team set out to determine the best way to simulate plant growth while also retaining high amounts of carotenoids. Current studies of space gardening tend to focus on rapid plant growth, producing large plants as fast as possible while providing optimal light, water and fertilizer. Although this process can yield larger plants, the nutritional value may be depleted because of hurried growth and synthetic climate conditions. “There is a trade-off,” Demmig-Adams said in a statement. “When we pamper plants in the field, they produce a lot of biomass but they aren’t very nutritious. If they have to fend for themselves – if they have to defend themselves against pathogens or if there’s a little bit of physical stress in the environment – plants make defense compounds that help them survive. And those are the antioxidants that we need.” Using two lines of species of the Arabidopsis thaliana plant, the research team altered conditions to mimic different climates. They found that manipulating growth conditions to […]

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Slippery bark protects trees from pine beetles http://bizwest.com/2014/01/17/slippery-bark-protects-trees-from-pine-beetles/ http://bizwest.com/2014/01/17/slippery-bark-protects-trees-from-pine-beetles/#respond Fri, 17 Jan 2014 00:00:00 +0000 http://dev.bizwestmedia.com/slippery-bark-protects-trees-from-pine-beetles/?utm_source=internal&utm_campaign=guest BOULDER — Trees with smoother bark are better at repelling attacks by mountain pine beetles, which have difficulty gripping the slippery surface, according to a new study by the University of Colorado-Boulder. The findings, published online in the journal Functional Ecology, may help land managers make decisions about which trees to cull and which to keep in order to best protect forested properties against pine beetle infestation. The current mountain pine beetle epidemic has spread across 3.4 million acres in Colorado since the outbreak was first detected in 1996. The tiny beetles, which are about the size of a grain of rice, bore into the pine bark. The trees fight back by exuding pitch, which pushes the beetles back out of the tree. Large-scale and continuous beetle attacks can kill the tree.Doctoral student Scott Ferrenberg, who led the study, said he first began to suspect that bark texture might affect the survival of trees while he and Jeffry Mitton, a professor of ecology and evolutionary biology, were walking through a stand of high-elevation limber pines. They noticed that surface resin, a residue of fighting off a beetle invasion, was common only on patches of rough bark. “We found trees that had both textures on the same stem, and when the tree was attacked, it was on the rough surfaces,” Ferrenberg said. “We thought the beetles were either choosing to avoid the smooth surface, or they just couldn’t hang onto it.”To determine which was the case, the researchers tested how well the beetles could hold onto different bark textures. They placed each of 22 beetles on a rough patch of bark and on a smooth patch. They timed how long the beetle could stay on each surface before falling. Twenty-one of the 22 beetles were able to cling to the rough bark until the test ended after five minutes. But all of the beetles fell from the smooth bark in less than a minute.The results — especially combined with the findings of a second study also recently published by the research team — provide information that may be useful to land managers who are trying to keep public parks and other relatively small forested areas healthy.In the second study, published online in the journal Oecologia, Ferrenberg, Mitton and Jeffrey Kane, of Humboldt State University in California, found that a second physical characteristic of a tree also helps predict how resistant the pine is to beetle infestation.The team discovered that trees that had survived beetle attacks had more resin ducts than trees that were killed. The number of resin ducts differed between trees of the same age, and in general, younger trees had more resin ducts than older trees. The number of resin ducts — which is related to the trees’ ability to pitch out the beetles — is easily counted by taking a small core of the tree. Because young trees tend to have smoother bark as well as more resin ducts, the research also suggests that land managers should consider […]

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CU-Boulder researchers use climate model to better understand electricity in the air http://bizwest.com/2013/11/22/cu-boulder-researchers-use-climate-model-to-better-understand-electricity-in-the-air-2/ http://bizwest.com/2013/11/22/cu-boulder-researchers-use-climate-model-to-better-understand-electricity-in-the-air-2/#respond Fri, 22 Nov 2013 00:00:00 +0000 http://dev.bizwestmedia.com/cu-boulder-researchers-use-climate-model-to-better-understand-electricity-in-the-air-2/?utm_source=internal&utm_campaign=guest Electrical currents born from thunderstorms are able to flow through the atmosphere and around the globe, causing a detectable electrification of the air even in places with no thunderstorm activity.     But until recently, scientists have not had a good understanding of how conductivity varies throughout the atmosphere and how that may affect the path of the electrical currents. Now, a research team led by the University of Colorado-Boulder has developed a global electric circuit model by adding an additional layer to a climate model created by colleagues at the National Center for Atmospheric Research, or NCAR, in Boulder. The results, published in the Journal of Geophysical Research, show that the atmosphere is generally less conductive over the equator and above Southeast Asia and more conductive closer to the poles, though the atmosphere’s conductivity changes seasonally and with the weather. Research into atmospheric electrification stretches back to the 1750s, when researchers, including Benjamin Franklin, were trying to better understand the nature of lightning. In the 1800s, scientists measured changes in the atmosphere’s electric field from the Kew Observatory near London, and in the 1900s, the Carnegie, an all-wooden ship built without any magnetic materials, crisscrossed the ocean while taking atmospheric electricity measurements that are still referenced today. But obtaining a global picture of atmospheric conductivity has been difficult, in part because the atmosphere’s ability to channel electricity is not static. Ions, which allow current to move through the air, are added to the upper atmosphere by a continuous bombardment of galactic cosmic rays and to the lower atmosphere through radioactive decay. But those ions can be removed from the atmosphere in a variety of ways. “They can recombine, to some degree, but they also attach themselves to aerosols and water droplets,” said Andreas Baumgaertner, a research associate in CU-Boulder’s aerospace engineering sciences department and lead author of the study. “Once they are attached to a heavy particle, like a water droplet, then you’ve lost the ability for it to conduct a current.” The amount of water droplets in the atmosphere varies as moisture-laden clouds move through an area, and the quantity of aerosols varies depending on their source. Aerosols are pumped into the atmosphere from tailpipes and smokestacks as well as from erupting volcanoes. Baumgaertner and his colleagues — including CU-Boulder professor Jeffrey Thayer, director of the Colorado Center for Astrodynamics Research; Ryan Neely, an atmospheric scientist at NCAR; and Greg Lucas, a CU-Boulder doctoral student in aerospace engineering sciences — came up with the idea of using NCAR’s existing Community Earth System Model to get a global picture of conductivity because the model already took into account both water vapor and aerosols. The team added in equations that represent how many ions are produced by cosmic rays from space and by radioactive decay through radon emissions from the Earth’s surface. They also added equations for how those ions react in the atmosphere. The resulting 2,000 lines of code allowed them to create the first global picture of conductivity and […]

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Pacific winds http://bizwest.com/2013/11/22/pacific-winds-2/ http://bizwest.com/2013/11/22/pacific-winds-2/#respond Fri, 22 Nov 2013 00:00:00 +0000 http://dev.bizwestmedia.com/pacific-winds-2/?utm_source=internal&utm_campaign=guest Why on earth would a warm patch of water in the Pacific Ocean influence whether there is fresh powder at Vail?     That’s the question that Klaus Wolter of the Cooperative Institute for Research in Environmental Sciences, or CIRES, has been working on for decades to answer. Equally as important is that Wolter simultaneously contributes his knowledge and forecasts to Colorado’s Water Availability Task Force to help it mitigate drought effects throughout the state. This year, those efforts have earned him the Governor’s Award for High-Impact Research in the Sustainability category. Specifically, Wolter studies the El Niño Southern Oscillation, or ENSO, a naturally occurring phenomenon that involves fluctuating ocean temperatures in the equatorial Pacific. His colleague Kristen Averyt, director of the Western Water Assessment and associate director for science for CIRES explains. “The oceans are what move heat around the planet, and the hydrologic cycle that responds to them drives those changes in heat,” she said. “If you have a warm patch in the ocean, it can shift where precipitation is happening. In particular, there seems to be a relationship between precipitation and snowfall in the Rocky Mountains and how the ENSO moves in the Pacific Ocean.” In essence, an El Niño season causes wet, snowy winters in Colorado, while the opposite La Niña effect will cause a draught pattern similar to what we have experienced in Colorado the past two years. “Before the mid-1990s, there were not too many people aware of this pattern,” Wolter said. “The research that had been done had shown very little effect in Colorado and that was simply because people hadn’t realized how complicated Colorado’s climate is. I was very intrigued by that complexity. When I looked at the top 10 snowstorms on the Front Range, I found they all occurred during an El Niño season.” Another reason Wolter has received so much attention during the past decade is his immense contribution to the conversation around water resource management and drought planning throughout the Southwestern United States. He makes himself available to anyone who has questions about precipitation forecasting, and that affects policy. “First of all, you have to create the awareness,” he said. “I talk to people and the situation gets on their radar quite a bit earlier than the actual impact. The other thing is that depending on how people manage their reservoirs, they can use this information to hedge their bets. How they actually do it is up to them.” Averyt, whose organization’s mission is to connect climate science to decision making, says that there’s much more to Wolter’s role. “This is exactly why Klaus is so valuable,” she said. “He makes himself available to anyone who needs his help, whether it’s the snowplow drivers’ association or the governor’s office. He makes people care about what is happening in remote places and why it makes a difference here.” Wolter has been very visible in the news since flooding in September caused millions of dollars of damage to Boulder County and the […]

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Battling the bugs http://bizwest.com/2013/11/22/battling-the-bugs-2/ http://bizwest.com/2013/11/22/battling-the-bugs-2/#respond Fri, 22 Nov 2013 00:00:00 +0000 http://dev.bizwestmedia.com/battling-the-bugs-2/?utm_source=internal&utm_campaign=guest A team of scientists has toiled for eight years to develop treatments for mosquito-borne viruses that have plagued people in developing nations – and crept into Northern Colorado.     Scientists John Roehrig and Amanda Calvert at the Centers for Disease Control and Prevention’s vector-borne diseases lab in Fort Collins and Colorado State University scientist Carol Blair are. The scientists and others are targeting West Nile, dengue fever and yellow fever, all of which can cause brain swelling and severe fever. The most widespread of these viruses is dengue fever, contracted by 400 million people annually worldwide. The disease is sometimes fatal, particularly in children. The scientists’ work has important implications for developing countries in tropical regions and in the United States as mosquito-borne viruses proliferate. Mosquitoes that transmit illness can lay their eggs in small pools of water, such as in a potted plant, in people’s homes. Removing those kinds of breeding grounds can help, but they are difficult to eliminate in backyards where pools collect from frequent rainstorms, Blair said. “The biggest way that dengue is controlled right now is mosquito control,” she said. “That’s easier said than done.” This summer in Northern Colorado there was an outbreak of West Nile virus from hot weather and moist conditions that sickened nearly 100 people, according to Larimer County Public Health Department statistics. This year’s episode of West Nile pales in comparison with a 2003 epidemic in Larimer County that killed nine people and infected 546. The state saw 2,947 cases total and 63 deaths that year. Yellow fever cases were first documented on the East Coast in the late 1600s, and 26,000 cases were documented annually in New Orleans during the mid-1800s. Mosquitoes infected with yellow fever still live in several U.S. states. Globally, yellow fever infects tens of thousands of people annually. Although dengue fever largely has remained in the tropics, scientists have seen the virus move farther north and south because of climate change, Blair said. Vaccines for mosquito-borne viruses are available only for yellow fever, although Fort Collins’ Inviragen Inc., acquired recently by Takeda Pharmaceutical Co. Ltd. in Japan, is developing a dengue vaccine. No drugs have been approved for treatment of any vector-borne diseases. Aiming to develop those drugs, the CDC and CSU scientists are creating antibodies, or proteins made by the human body, to get rid of an infection. Humans cannot make the antibodies quickly enough to fight severe vector-borne viruses. The researchers engage in a process known as immunotherapy by making monoclonal antibodies, or artificial cell systems developed using immunized mice. The scientists then grow the cells on their own and harvest the antibodies. Roehrig started working with monoclonal antibodies in 1980, so he considers the immunotherapy his life’s work. “The theory is then to supplement your own antibodies with these other antibodies in large quantities early in infection,” Roehrig said. The scientists have developed many of the antibodies for dengue and yellow fevers, and have conducted preclinical trials on mice. Their next step […]

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Small but powerful http://bizwest.com/2013/11/22/small-but-powerful-2/ http://bizwest.com/2013/11/22/small-but-powerful-2/#respond Fri, 22 Nov 2013 00:00:00 +0000 http://dev.bizwestmedia.com/small-but-powerful-2/?utm_source=internal&utm_campaign=guest The new chip-scale devices at the National Institute of Standards and Technology in Boulder are as small as a grain of rice and almost as accurate as physics will allow.     Sure, NIST has always had cool toys. In fact, the NIST-F1 Cesium Fountain Atomic Clock keeps the official time and frequency standard for the United States. But the chip-scale devices team in NIST’s Atomic Devices and Instrumentation Group aims to take the devices created at the laboratory and miniaturize them for use in a wider range of applications. “NIST has a lot of great programs whose mission is to produce those instruments,” said John Kitching, who along with Svenja Knappe and Elizabeth Donley, received a Governor’s Award for High-Impact Research earlier this year. “This group is focused on taking these instruments and trying to make them small, low-power and low-cost. The idea is to see if we can produce an atomic clock small enough to be on board a cellphone or a GPS receiver.” The team uses very high technology — lithographic processing, chemical etching and micromachining all come into play — to create remarkable devices like their chip-scale atomic clock, first demonstrated in 1994, and a chip-scale magnetometer, created soon after. In fact, the team’s atomic clock is already actively being manufactured and sold by the California-based company Symmetricom Inc., which has an office in Boulder. “We’re focused on the innovative, high-risk component of the research,” Kitching explained. “We want to show the feasibility, show the world that they work. Then we try to work with companies to transfer the technology so they can adopt it and manufacture it.” Applications for such low-cost, high-accuracy devices are voluminous. Atomic clocks could be used to create instantaneous synchronization of military communications networks or GPS positioning systems that are virtually impossible to jam. Chip-scale atomic magnetometers can also be used for a wide variety of applications, ranging from nuclear magnetic resonance in the biosciences or medical fields to oil exploration to weapons detection. Thomas O’Brien, chief of the Time and Frequency Division, said that the work of the ADI Group sent shockwaves throughout the NIST labs nationwide. “Their attitude has fostered a whole new program across NIST that we call ‘NIST-on-a-Chip,’” O’Brien explained. “We’re basically saying that if you can measure time or frequency in a magnetic field at this scale, what other qualities could we measure with similar technologies? “It turns out that just about any of the qualities we measure—electrical qualities, like voltage and current, as well as mass, force, motion, and power of light — can be measured using similar technologies. It looks like there is some very good potential for measuring other qualities with devices that can be mass-produced, use very low power, and can be deployed almost anywhere.” For his part, Kitching points to teamwork and collaboration as keys to his group’s success, mentioning the recent op-ed by physicist Sean Carroll in The New York Times titled No Physicist is an Island, about the recent Nobel […]

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Mending hearts http://bizwest.com/2013/11/22/mending-hearts-2/ http://bizwest.com/2013/11/22/mending-hearts-2/#respond Fri, 22 Nov 2013 00:00:00 +0000 http://dev.bizwestmedia.com/mending-hearts-2/?utm_source=internal&utm_campaign=guest FORT COLLINS — Colorado State University’s Lakshmi Prasad Dasi wants to find a solution. His work focuses on the human heart, something that most consider strictly biological in nature, but as a mechanical engineer, Dasi believes that the heart is a mechanical organ, and applying his field of study can help find solutions to the problems that plague one of the most crucial organs in the body. A graduate of the Indian Institute of Technology in Bombay, India, and Georgia Institute of Technology, Dasi came to CSU in 2009 to take a position as an assistant professor of mechanical engineering. He has since established a lab for cardiovascular research and is the principal investigator on a $1.8 million grant from National Institutes of Health. The five-year grant is funding research on synthetic heart valves that will circumvent many of the issues with existing mechanical and tissue-based replacement valves. Along with Susan James, head of the mechanical engineering department and Ketul Popat, another associate professor in the department, Dasi is investigating new valves made from a synthetic material that contains hyaluronan, a molecule found in soft tissue. James received a proof-of-concept award for the material from the Colorado Office of Economic Development and International Trade. With other mechanical synthetic valves, anti-clotting drugs must be taken for the remainder of the patient’s life, according to Dasi. Replacement valves made from other tissue tend to harden over time, usually lasting only 10 or 15 years, he said. The team’s goal is to create a valve that will avoid both of these problems. Progress is under way on research, but in preliminary stages. The grant was awarded in August. Eventually, the team will work with CSU veterinary cardiothoracic surgeon Dr. Christopher Orton to implant the valves in sheep and pigs as part of pre-clinical evaluation.

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