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Ford Investing $1B in Artificial Intelligence Start-Up

Argo AI and Ford executives

L-R: Peter Rander, Argo AI COO; Mark Fields, Ford president and CEO; Bryan Salesky, Argo AI CEO; and Raj Nair, Ford executive vice president, Product Development, and chief technical officer. (Ford Motor Co.)

13 February 2017. Ford Motor Company is investing $1 billion in a start-up enterprise that applies artificial intelligence to the operation and management of autonomous vehicles. The equity stake in Pittsburgh-based Argo AI is expected to help Ford complete the software platform for its autonomous vehicles planned for 2021.

Argo AI develops software that combines artificial intelligence, machine learning, and computer vision to support a vehicle that largely replaces the driver, and as the company says in a white paper, “is connected, intelligent, and able to safely operate itself alone or as part of a shared fleet.” Argo AI anticipates shared fleets of self-driving vehicles will be a transformative advancement in transportation, providing greater safety, reduced traffic congestion, and mobility for people who cannot or find it difficult to drive themselves.

Ford plans to merge Argo AI’s software into its virtual driver system to support Ford’s goal of producing by 2021 a vehicle that meets SAE International’s standards for Level 4 indicating “high automation.” This automation level assigns all driving activity to an automated system, even if a human driver does not respond appropriately to a request to intervene. SAE level 5, the top level, indicates “full automation,” which assigns full-time dynamic driving to the autonomous system, including all encounters with roadway and environmental conditions.

Ford plans to invest $1 billion over 5 years, giving the company a majority stake in Argo AI. Argo AI is still expected to operate independently, with its employees given “significant equity participation,” although further financial details were not disclosed. Argo AI plans to grow its payroll to 200 employees, based in Pittsburgh, as well as sites in Michigan and California’s Bay Area.

Argo AI was founded by Bryan Salesky, now the company’s CEO, and Peter Rander, Argo AI’s chief operating officer. Both Salesky and Rander are alumni of National Robotics Engineering Center at Carnegie Mellon University and former leaders of self-driving vehicle projects at Google and Uber, respectively.

“We are at an inflection point in using artificial intelligence in a wide range of applications,” says Salesky in a Ford statement,” and the successful deployment of self-driving cars will fundamentally change how people and goods move.”

Joining the initiative is Ford Smart Mobility LLC, a subsidiary for designing and developing mobility services. When begun in March 2016, Ford said this unit would lead the company’s drive to become a mobility as well as an auto company. Ford defines “mobility,” in this sense as using autonomous vehicles to move goods and people, such as ride sharing, ride hailing or package delivery fleets.

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Hat tip: Fortune/Term Sheet

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Biotechs License Solid Tumor Therapy in $2.1B Deal

Chemotherapy vials

(National Cancer Institute)

10 February 2017. Biotechnology enterprise Immunomedics Inc. is licensing its enhanced antibody-based treatment for solid tumor cancers to Seattle Genetics, a developer of similar cancer drugs. The agreement can earn Immunomedics, in Morris Plains, New Jersey, as much as $2 billion in initial and milestone payments over the deal’s lifetime, plus a $57 million equity investment by Seattle Genetics.

Both Immunomedics and Seattle Genetics produce antibody-drug conjugates, which join highly-targeted synthetic antibodies with other compounds or additives to combine the targeting of antibodies with cancer-killing power of the drugs being delivered. The therapy licensed in this case is sacituzumab govitecan, code-named IMMU-132 by Immunomedics. IMMU-132 targets Trop-2 proteins that overproduce on the surface of tumor cells in a number of solid-tumor cancers and help drive tumor growth.

Immunomedics’s technology combines synthetic antibodies with cancer-killing compounds that by themselves would not be given to patients due to their toxicity. In the case of IMMU-132, an antibody called hRS7 that targets Trop-2 proteins is teamed with SN-38, a metabolite of the drug irinotecan and approved by FDA as a chemotherapy. The company says SN-38’s toxicity prevents it from being given directly to cancer patients, but when combined with an antibody like hRS7, the drug is more targeted to the tumor and safer for the patient.

IMMU-132 is currently being tested in an early and intermediate-stage clinical trial in patients with 17 different solid tumor cancers. The Food and Drug Administration assigned breakthrough status to IMMU-132 as a treatment for advanced metastatic triple-negative breast cancer, where tumors test negative for estrogen and progesterone receptors, as well as HER2 proteins. FDA also granted its fast-track designation to IMMU-132 for triple-negative breast cancer, small-cell lung cancer, and non-small cell lung cancer. In addition, IMMU-32 received orphan drug status from FDA and European Medicines Agency for pancreatic cancer.

The agreement gives Seattle Genetics, in Bothell, Washington, an exclusive license to further develop, commercialize, and manufacture IMMU-132. Seattle Genetics will be responsible for a late-stage clinical trial of the therapy for metastatic triple-negative breast cancer, as well as submitting a biologics license application to FDA for accelerated review. The companies will form a joint steering committee, chaired by Seattle Genetics, to determine further development, commercialization, manufacturing, and intellectual property strategy for IMMU-132.

Seattle Genetics is paying Immunomedics an initial payment of $250 million, plus another $50 million for negotiated economic rights to IMMU-132 outside the U.S., Canada, and EU countries. Immunomedics will be eligible for $1.7 billion in payments for achieving designated development, clinical, regulatory, and sales milestones over the course of the agreement. Immunomedics will be eligible as well for future royalties on sales of products developed from the deal. Immunomedics also can co-promote IMMU-132 in the U.S., by taking on half of the product’s sales work.

In addition, Seattle Genetics is taking a 2.8 percent equity stake in Immunomedics, buying 3 million shares of its stock at $4.90, a 10 percent premium over Immunomedics’s average share price for the previous 15 days. The stock purchase plus additional warrants that could expand the Seattle Genetics stake to 9.9 percent are valued at $57 million.

The agreement gives Immunomedics until 19 February to negotiate a better deal with another company. Should better offers come along, Seattle Genetics has the right to match those offers, and if Immunomedics decides to join with a different company, Seattle Genetics will be due an unspecified termination fee.

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Low-Dose Multidrug Shown Effective in Hypertension Trial

Blood pressure measurement

(VA.gov)

10 February 2017. A small-scale clinical trial shows a combination of four current drugs to treat hypertension, or high blood pressure, formulated in low doses, reduces blood pressure to normal levels in four weeks. A team from the George Institute for Global Health in Sydney, Australia reported its findings in the 9 February issue of the journal The Lancet (paid subscription required).

Researchers led by Clara Chow, director of the George Institute’s cardiovascular division, are seeking more reliable methods for controlling high blood pressure, a condition that affects 1 billion people worldwide, according to World Health Organization, killing some 9 million people a year.”We know that high blood pressure is a precursor to stroke, diabetes, and heart attack,” says Chow in an institute statement. “The need for even lower blood pressure levels has been widely accepted in the last few years.”

But most people now treated for high blood pressure take a single medication, with uneven results — only about half of patients respond satisfactorily — in controlling the condition. Thus an initiative at the George Institute, known as the Quartet project, is developing and testing a combination of 4 drugs in very low concentrations as an alternative treatment for high blood pressure. The low-dose formulations may also reduce the incidence or severity of side effects experienced by some patients, such as swollen ankles or kidney impairment.

The quadpill, as the test drug is called, is a combination of current drugs packed in a capsule, given once a day to control high blood pressure, but in one-quarter their usual dose: irbesartan, amlodipine, hydrochlorothiazide, and atenolol. The clinical trial enrolled 18 individuals in Sydney diagnosed with high blood pressure, but not yet taking drugs to control the condition. Half of the participants were randomly assigned to take the quadpill every day for 4 weeks, while the other half took a placebo capsule. After a 2-week break, the groups switched roles, with the former placebo recipients taking the quadpill, and original quadpill recipients taking the placebo.

Before the trial, participants’ blood pressure averaged 154 systolic and 90 diastolic, both levels considered stage 1 hypertension, where lifestyle changes and medications are often prescribed. The results show marked reductions in blood pressure for participants taking the quadpill, with all 18 individuals reaching safer systolic and diastolic levels, below 140/90, after 4 weeks. Only 6 of the 18 participants had the same results from the placebo. In addition, no serious adverse effects were reported, and participants considered the capsules easy to swallow.

To verify their findings, Chow and colleagues reviewed 36 previous clinical trials testing quarter-dose treatments for high blood pressure against a placebo in more than 4,700 participants. The results show lower systolic and diastolic readings in those trials, as well as an absence of serious adverse effects.

“What makes these result every more exciting is that these four blood pressure medications are already in use,” notes Chow. “We are increasingly finding there are opportunities to treat many common diseases hiding in plain sight. This ultimately means we will be able to deliver life changing medications much more quickly, and more affordably.”

The George Institute team now plans to expand the trials to larger numbers of participants to confirm these initial results and assess the quadpill’s long-term effectiveness.

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Disclosure: The author takes medication for high blood pressure.

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Gates Grant Funding Malaria Control Test Products

Anopheles mosquito

Anopheles mosquito (CDC.gov)

9 February 2017. Two universities in the U.K. are developing testing protocols for a new generation of technologies coming to market to prevent mosquitoes from spreading diseases. The project by faculty at Liverpool School of Tropical Medicine and University of Warwick is funded by a three-year, $2 million grant from the Bill and Melinda Gates Foundation.

Among the priorities for the Gates Foundation is eradication of malaria, which World Health Organization says affected 212 million people in 2015, and extracts heavy social and economic burdens in developing countries. In 2015, some 429,000 people died from malaria, of which 92 percent were in sub-Sahara Africa. Children under the age of 5 are particularly susceptible to the disease.

Malaria is caused by parasites transmitted by Anopheles mosquitoes, but despite medical and other interventions such as insecticides and bed nets, the disease continues to plague many developing regions in Africa and South Asia. Part of the foundation’s strategy is to stay ahead of emerging resistance to current drugs and insecticides, which requires new types of tools to control the vectors, or mosquitoes that carry malaria.

The Gates Foundation grant aims to produce better tools for testing new products designed to control malaria-transmitting mosquitoes. Current methods for evaluating malaria-control products are rudimentary lab tests that in many cases have not kept up with the evolving nature of malaria. The grant to the Liverpool-Warwick team supports research and development of new tools for assessing the effectiveness of products to control the spread of malaria.

The project enlists two medical entomologists from the Liverpool School, Phillip McCall and Hilary Ransom, and mechanical engineering professor David Towers.”The team aims to develop experimental procedures to record the impact of exposure to an active ingredient or formulated product over the lifetime of the mosquito,” says McCall in a Liverpool School statement. “At the end of the three-year project, tests will be assembled into a defined pipeline for optimizing impact assessment of potential new vector control products under laboratory controlled conditions and we will produce an updated manual for the laboratory analysis of vector control products for consideration by WHO.”

Among the work supported by the grant is a video tracking technology that records a mosquito’s behavior systematically and in sufficient detail to detect and quantify patterns in that behavior. “We hope the use of video-tracking and associated data analytics,” adds Towers, “combined with the significant expertise at LSTM will lead to better understanding of vector control approaches and hence significantly improved products to combat the spread of malaria throughout Africa.”

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System Slashes Time to Detect Bacteria in Blood

Study authors

L-R, Stephanie Fraley with graduate students and co-authors Hannah Mack and Daniel Ortiz (Univ of California, San Diego)

9 February 2017. A biomedical engineering lab developed a compact system that detects harmful bacteria in blood samples in less than four hours, a process that now takes days. A team from University of California in San Diego describes the system in the 8 February issue of the journal Scientific Reports.

Researchers led by engineering professor Stephanie Fraley are seeking faster and more reliable methods for detecting bacteria and other pathogens in blood samples. Not only do current lab tests take several days, they require making guesses about the suspected bacteria, when other pathogens in varying quantities may be present and go undetected. And while genomic sequencing techniques are available, those technologies also take days to complete, are expensive, and require highly trained staff.

The system designed by Fraley and colleagues combines a number of technologies: microfluidic chips, DNA sequencing, analytical chemistry, and machine learning algorithms. It takes 1 milliliter of blood (0.03 ounces), with the DNA in the sample then isolated, and inserted into a microfluidic device, or lab-on-a-chip. The minute amounts of DNA are amplified on the chip with polymerase chain reactions, a genomic analysis technique, and chemically enhanced for further analysis.

The researchers then slowly increased the temperature of the samples to 50 to 90 degrees C (120 to 190 F), which melts the DNA, breaking the strands and causing them to unwind. The bonds holding the DNA strands differ in strength, with the unwinding behavior of the strands also varying in unique ways. A fluorescent dye added to the samples makes it possible to track these differences in melting reactions, and capture them as a unique signature for each DNA.

These unique DNA signatures are analyzed further by algorithms using machine learning developed by Fraley and colleagues at UC San Diego and Johns Hopkins University. These models identify the precise DNA signatures in the blood, which in a study published in January 2016 were able to successfully identify 37 different bacteria with near 100 percent accuracy under some conditions.

In lab tests, researchers tested mock clinical blood samples with listeria, bacteria responsible for some 1,600 food poisoning cases each year in the U.S., and Streptococcus pneumoniae bacteria that cause a number of diseases from ear and sinus infections to pneumonia and meningitis. The team successfully identified the bacteria in the blood, even with the “background noise” of human DNA, and returned the results in less than 4 hours.

“Analyzing this many reactions at the same time at this small a scale had never been attempted before,” says Fraley in a university statement. “Most molecular tests look at DNA on a much larger scale and look for just one type of bacteria at a time. We analyze all the bacteria in a sample.”

The researchers plan to continue refining the system, making it more compact for desktop use in doctors’ offices or clinics. They also expect to test the system on real rather than mock blood samples, and extend the targets to viruses and fungal pathogens. The university also filed a patent for the technology.

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DNA Tags Speed Nanoparticle Gene Therapy Discovery

James Dahlman

James Dahlman holds a microfluidic device used to produce nanoparticles for gene therapies. (Rob Felt, Georgia Institute of Technology)

8 February 2017. Biomedical engineers developed a technique with unique DNA identifiers that makes possible faster screening of gene therapies delivered with nanoscale particles. A team from Massachusetts Institute of Technology published its findings in the 6 February issue of Proceedings of the National Academy of Sciences (paid subscription required).

James Dahlman, the study’s lead author, was a graduate student at the time of the study and is now a biomedical engineering professor at Georgia Institute of Technology and Emory University in Atlanta. Dahlman and colleagues from the labs of Robert Langer and Daniel Anderson at MIT are seeking better techniques to fulfill the potential of gene therapies, particularly when targeting specific cells in the body. Nanoparticles are among the more promising strategies for hitting precise cellular targets.

Finding materials that accumulate in specific cells or tissues is important for discovering drugs that address those cells and tissues. Many new cancer drugs, for example, seek to precisely target tumor cells, while avoiding healthy tissue that surround the tumor. Treatments for heart disease likewise seek to accumulate only in heart tissue and cells. Gene therapies also need that precise level of targeting.

But finding the best nanoscale particle materials for delivering gene therapies is up to now a highly inefficient process, first requiring tests in cell cultures, then testing a few materials at a time in lab animals. The researchers instead designed a technology that vastly streamlines the process and enables the simultaneous screening of many more candidate materials.

The team’s solution uses single strands of DNA, or genetic codes, that act as unique identifiers on the nanoparticles, much like bar-coded serial numbers on inventory items. The nanoparticles are formulated with the DNA codes using a microfluidic, or lab-on-a-chip, device, then injected into lab animals for tracking. The animals’ organs are then examined for the presence of the nanoparticles and samples genetically sequenced to measure their concentrations.

In tests with lab mice, Dahlman’s team reported the simultaneous identification of biocompatible materials in 30 nanoparticles distributed to 8 tissues, as well as quantifying the concentrations of nanoparticles in those tissues. The tests show this technique can identify effective chemical properties of materials for gene therapy, while avoiding problems of particle mixing and genetic analysis interrupting their delivery.

In the tests, researchers compared their results to particles known to address specific lung and liver cells, which helped validate their process. Among the nanoparticles accumulating in the liver were those formulated with small interfering RNA, or siRNA, used in gene therapies to silence specific genes with disease-causing mutations. In this case, the nanoparticles with siRNA silenced specific genes in liver cells.

The team’s work was limited by current nanotechnology measurement tools, which as Dahlman notes in a Georgia Tech statement, “can be very complicated because for every biomaterial available, you could make several hundred nanoparticles of different sizes and with different components added.” Nonetheless, Dahlman adds, “In future work, we are hoping to make a thousand particles and instead of evaluating them three at a time, we would hope to test a few hundred simultaneously.”

Tagging drugs with DNA identifiers is becoming a more mainstream drug discovery tool. As reported in Science & Enterprise in January 2017, Scripps Research Institute made its library of DNA-encoded candidates for drug discovery available to pharma company Pfizer.

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Trial Testing Artificial Pancreas for Type 1 Diabetes

Diabetes Assistant screen

Diabetes Assistant screen (University of Virginia)

7 February 2017. A clinical trial testing day-to-day use of a smartphone-controlled artificial pancreas for people with type 1 diabetes began enrolling participants. The late-stage trial is led by endocrinologist Stacey Anderson and biomedical mathematician Boris Kovatchev at University of Virginia medical school in Charlottesville.

The NIH-funded trial is testing a system that measures and analyzes blood sugar levels in people with type 1 diabetes, then infuses a personalized dose of insulin from an insulin pump. The system is managed by software made by TypeZero Technologies LLC in Charlottesville. Kovatchev is a co-founder of TypeZero Technologies and serves as the company’s chief mathematician. If the trial results return favorable findings, the university and TypeZero are expected to apply for marketing approval from regulatory authorities.

Type 1 diabetes is an inherited autoimmune disorder where the body does not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells in the pancreas. About 1.25 million people in the U.S. have type 1 diabetes, about 5 percent of people with diabetes of any kind.

The system combines an insulin pump, made by Tandem Diabetes Care in San Diego, with a glucose monitoring sensor by Dexcom, also in San Diego. The system is managed with TypeZero software called Diabetes Assistant that runs on a dedicated, reconfigured smartphone. The software is based on algorithms developed by Kovatchev and colleagues at Virginia’s Center for Diabetes Technology, where Kovatchev is the center’s director.

The algorithms analyze data sent wirelessly from the glucose monitoring sensor, then send instructions to the pump to dispense insulin in a dose personalized for the individual. TypeZero’s software also has modules for meals, exercise, and diabetes management decisions. The software connects as well to the cloud where physicians, caregivers, or family members can be notified if necessary.

The clinical trial is testing the system among individuals age 14 and older with type 1 diabetes. Participants will be randomly assigned to receive the artificial pancreas system or continue using their current glucose monitoring and insulin pump devices for 6 months. The trial is recruiting participants at 10 sites in the U.S. and Europe.

The study is looking primarily at the ability of participants to keep their blood glucose levels between specified safe limits over the 6-month period as they go about their daily lives. The study team led by Anderson is also evaluating safety and cost, as well as the overall physical and emotional health of the participants. A second, similar trial is also planned, but testing the artificial pancreas with a different control algorithm written by Francis Doyle at Harvard University.

In the following video, Anderson, Kovatchev, and a participant from an earlier clinical trial tell more about the Diabetes Assistant system.

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Stomach Acid Harnessed to Power Ingestible Devices

Ingestible power capsule

Ingestible power capsule (Diemut Strebe, MIT)

7 February 2017. Researchers at MIT and Harvard University designed a tiny device that in tests with animals show it can run for days powered by acids in the stomach. The results of the research appear in the 6 February issue of the journal Nature Biomedical Engineering.

The team led by Giovanni Traverso, a gastroenterologist at Harvard Medical School and Brigham and Women’s Hospital affiliated with Harvard, and Massachusetts Institute of Technology engineering professors Robert Langer and Anantha Chandrakasan, seeks ways of extending the life of ingestible devices for drug delivery and diagnostics. While battery technology is advancing into miniaturization, conventional cell batteries — even when miniaturized or producing little power — can still completely discharge over time and run risks of leaking their toxic contents. Thus better options are needed to power ingestible devices for an extended length of time.

The technology for ingestible devices is also advancing due in part to the work of Traverso and others that develop new types of these miniature systems. As reported in Science & Enterprise, Traverso with Langer and colleagues designed an ingestible device with sensors for monitoring a person’s vital signs. In November 2015, their team described tests of a prototype device on pigs, which was connected by wires and externally powered. Another team created a test device to deliver long-term malaria drugs.

Powering these devices safely for extended periods is a key objective, with the gastrointestinal or GI tract as a possible source for that power. “We need to come up with ways to power these ingestible systems for a long time,” says Traverso in a joint statement. “We see the GI tract as providing a really unique opportunity to house new systems for drug delivery and sensing, and fundamental to these systems is how they are powered.”

Acids, like those in the GI tract, are known to carry electric currents, and in previous studies systems for employing these acids produced short bursts of power, but not for extended periods. The researchers built a prototype device 40 millimeters (1.6 inches) in length and 12 millimeters (0.5 inches) in diameter. Attached to the surface of the device are electrodes made from zinc and copper foil. Inside the cylinder are a commercial temperature sensor and low-power wireless transmitter circuits.

In tests with anesthetized pigs, the devices generated power during their journeys through the animals lasting on average more than 6 days. During that time, the devices generated temperature measurements from the sensors, in signals sent every 12 seconds. A receiver 2 meters from the pigs picked up the wireless signals. Once the device passed into the small intestine, however, the power produced dropped to about 1 percent of that generated in the stomach. “But there’s still power there,” notes Traverso, “which you could harvest over a longer period of time and use to transmit less frequent packets of information.”

The team also tested use of the device for drug delivery, although these tests were done in lab dishes, not animals. The researchers added a biocompatible polymer compartment containing the drug methylene blue, given for low blood pressure, sealed in a gold membrane, then dropped the device into gastric fluids taken from the pigs. The combination of electric current and gastric fluids corroded the gold membrane allowing for the release of the methylene blue. The membrane was not affected by the gastric fluids alone.

The researchers reported the findings as a proof of the concept, but they acknowledge the need reduce the cylinder to about one-third of its current size. Nonetheless, the institutions filed for a patent on the technology. Traverso and Langer are also founders of the company Lyndra Inc. in Cambridge, Massachusetts to commercialize technology that extends the release of oral medications to one week.

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Company, NC State Partner on Tissue Oxygen Patch

Lumee optical reader

Current optical reader in Lumee technology (Profusa Inc.)

6 February 2017. Profusa Inc. and a research center at North Carolina State University are developing a new device to monitor tissue oxygen levels in people with peripheral artery disease. The project by Profusa, in South San Francisco California and NC State’s Advanced Self-Powered Systems of Integrated Sensors and Technologies, or Assist, Center in Raleigh is funded by a $1.5 million grant from National Heart, Lung, and Blood Institute, part of National Institutes of Health.

The project aims to advance Profusa’s oxygen monitoring technology to where people with peripheral artery disease can wear a monitor on the skin like a patch. Peripheral artery disease results from plaque building up and narrowing arteries, reducing the flow of blood and the oxygen it carries to tissues, particularly in the legs. Smoking and age are key risk factors for peripheral artery disease causing pain and numbness in affected areas, and gangrene from infection in advanced cases, leading to amputation.

Profusa’s technology, called the Lumee oxygen sensing system, continuously monitors oxygen levels in tissue in the limbs of people with peripheral artery disease. The system employs sensors, injected into patients, measuring no more than 5 millimeters in length, about 0.2 inches, and 500 microns, or 0.02 inches, in diameter, and made from a porous gel that simulates the microenvironment of cells. The gel contains fluorescent molecules that react to the presence of target biomarkers.

An optical reader measures the level of fluorescent signal from the sensor indicating the level of target molecule, in this case oxygen in tissue. Although worn on the skin, the device is bulky and protruding. The new initiative expects to take advantage of the the Assist Center’s work with wearable, low power nanotechnology and wearable nanoscale sensors to devise a thin, more flexible monitor worn on affected feet or limbs like a bandage. Among the Assist Center’s current projects is sampling of a person’s sweat for non-invasive monitoring of glucose or lactose levels.

A flexible patch monitor is expected to do more than be easier to wear. The project team plans to design the patch monitor for continuous monitoring, generating data transmitted wirelessly for physicians and caregivers, as well as the patients themselves. In addition, the team expects the device platform to be applicable to a wider array of sensors and monitors, and broader range of disorders.

The NIH award is part of the agency’s Small Business Innovation Research, or SBIR program that sets aside grant money for small companies developing new treatments or medical devices. This award is a phase-2 or advanced development grant to Profusa that plans to conclude with a clinical trial testing the device in humans for safety, wearability, functionality.

As reported in Science & Enterprise, the company received an early-stage SBIR grant in April 2016 to demonstrate the feasibility of its technology. In October 2016, Profusa received Conformité Européene or CE regulatory approval for the Lumee device in Europe.

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Companies Recognized for Patient Safety Innovations

Surgery

(Sasin Tipchai, Pixabay)

6 February 2017. Three companies received awards for their products aimed at reducing the number of preventable deaths occurring in American hospitals. The awards totaling $85,000 were made 5 February at the World Patient Safety, Science & Technology Summit in Dana Point, California.

The event and awards are sponsored by the Patient Safety Movement Foundation in Irvine, California, an advocate for large reductions in the number of preventable deaths in American hospitals that the group says exceeds 200,000 per year. A study by Johns Hopkins University released in May 2016 estimates even larger numbers of preventable hospital deaths, more than 250,000, making it the third largest cause of death in the U.S., behind heart disease and cancer, and ahead of respiratory disorders.

The first-place award of $50,00n went to ReavillMED LLC in Plainfield, Illinois, maker of a simpler central line infusion system that the company says sharply reduces the chance for infections. Central lines, also known as central venous catheters, are tubes placed in a large chest, groin, or neck vein to provide drugs and fluids or draw blood. These catheters are meant to remain in place for weeks or months, compared to intravenous or IV tubes, placed in the arm for much shorter periods. Centers for Disease Control and Prevention says central line infections cause thousands of deaths each year, and recommends a series of preventive steps, including sterile barrier precautions.

The ReavillMED technology makes it possible to carry out central line functions through an IV tube in the arm, eliminating the need for catheters in the larger veins. The company says its process can convert an IV into central line delivery with a push of fluid that takes about 30 seconds, meeting CDC’s guidelines for sterile barrier precautions. ReavillMED says the IV tubes can stay in place for up to a year, but almost completely eliminate risks of infection as well.

A system to quickly and accurately calculate drug doses for children took the second place award of $25,000. SafeDose Scan made by eBroselow LLC in Blacksburg, Virginia computes the dose, concentration, volume, and dilution of drugs for children of varying ages, weights, and their illnesses. The company offers the system as an online web application and in a mobile app that connect to the eBroselow database. Clinicians can scan a drug’s standard National Drug Code, a unique identifier for each medication, and enter simple color-coded data elements to compute or verify dosages.

The third prize of $10,000 went to software made by Wiser Systems LLC in Charlotte, Vermont. The software, known as Systematic Electronic Risk Assessment for Suicide, or Seras, is designed to reveal risks of suicide by  hospitalized patients that according to the company occur every other day. Patients complete a brief Seras questionnaire on a tablet, which the company says takes less than a minute, with the data then analyzed by algorithms to uncover suicidal tendencies.

Wiser Systems says the algorithms are based on evaluations derived from networks of experts that replicate the judgements made by clinical psychologists. Yet Seras can be administered by regular hospital staff to assess suicide risk in the first 72 hours after admittance.

Patient Safety Movement says the three winners were selected from more than 100 entries.

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