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Cochlear Implant Robotics Start-Up Gains NIH Funds

Cochlear implant

Cochlear implant (Tabercil, Wikimedia Commons)

13 September 2017. A university spin-off enterprise developing robotics to make cochlear implants for hearing loss safer and more effective is receiving a Small Business Innovation Research, or SBIR, grant to advance its technology. The two-year $1.4 million award to iotaMotion Inc. in Iowa City, Iowa is made by National Institute of Deafness and Other Communication Disorders, part of National Institutes of Health.

IotaMotion is creating a robotics-based system to improve the surgical implanting of cochlear devices in people with hearing loss. Cochlear implants are electronic devices that restore some hearing by performing the functions of cochlear hair cells that convert sound waves into electrical nerve signals, sufficient to understand speech. These devices, however, cannot restore more qualitative hearing abilities, such as differentiating musical tones. Hearing loss affects millions of people worldwide, particularly older adults where the loss of hearing is a result of degenerating sensory cells.

The company’s product, called Iota-Soft, is a robotics device to aid surgeons to insert cochlear implant electrodes. iotaMotion says the system will reduce variability and provide more precision when implanting the electrodes. This greater precision and stability, says the company, will help protect the patient’s existing hearing anatomy, which is important particularly with hearing-preservation solutions that take advantage of residual hearing abilities.

Because iotaMotion already has evidence showing the system’s feasibility, the grant bypasses the usual first stage of SBIR awards indicating proof of concept and commercial viability. The project calls for verifying the company’s technology is open and compatible with existing cochlear implant devices, including current electrodes used with those devices. The work also requires the company to show the system meets FDA quality standards, such as biocompatibility and the ability for cochlear implants to remain functional for at least 6 months following surgery. Meeting these quality standards are expected to help achieve eventual approval by FDA.

In addition, the company plans to conduct tests of the system with larger animals, such as sheep. Those tests will establish the efficacy of the implants over 3 months. Successful completion of the tests are expected to lead to building production facilities that meet FDA quality standards.

IotaMotion was founded in 2015 by Chris Kaufmann, a physician, research fellow, and biomedical engineer in the otolaryngology — ear, nose, and throat — department at University of Iowa medical center in Iowa City. Kaufmann worked in the lab of Iowa otolaryngology professor Marlan Hansen, both a co-inventor of the robotics technology and co-founder of iotaMotion. Kaufmann is the company’s CEO, while Hansen serves as its chief medical officer. The company is also a recipient of a National Science Foundation grant and seed funding of $2 million.

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Microchips Designed for Tracking Bodily Functions

Atoms chip on penny

The Atoms chip placed on a U.S. penny (Shapiro and Emami Labs/Caltech)

13 September 2017. Engineering researchers designed a tiny chip device that identifies precise locations inside the body, a key feature for ingestible medical devices. A team from California Institute of Technology in Pasadena describes the microchips in yesterday’s issue of the journal Nature Biomedical Engineering.

The Caltech researchers, led by chemical engineering professor Mikhail Shapiro and electrical engineering professor Azita Emami, seek to advance miniaturized wireless medical technology for diagnostics and drug delivery. For many of these ingestible devices to operate effectively, however, they need to give their precise locations, a task made difficult by human tissue interfering with and distorting signals sent by the devices when inside the body.

Shapiro, Emami, and colleagues created tiny radio frequency transmitters that take features of magnetic resonance imaging, or MRI, scans to give their locations based on positions inside a magnetic field. As explained by Shapiro in a Caltech statement, atoms at different locations resonate or reflect at different frequencies with MRI, due to variations in the magnetic field, making it easier to identify their location. “We wanted to embody this elegant principle in a compact integrated circuit.”

And the circuit had to be compact. Emami notes that the chip needed to be both small and use little power. “We had to carefully balance the size of the device with how much power it consumes and how well its location can be pinpointed.”

The actual devices, designed by doctoral candidate and first author Manuel Monge, are called transmitters operated as magnetic spins or Atoms, and include sensors, resonators, and wireless transmitters. The prototype chip used in lab and animal tests measures 1.4 millimeters square, about 1/250th the size of an American penny. Monge used standard CMOS — complementary metal-oxide-semiconductor — processes to fabricate the chip.

In proof-of-concept tests, the researchers implanted the Atoms device under the skin of an anesthetized lab mouse, moving the chip to four different locations. The mouse was then exposed to a magnetic field, with a signal receiver nearby to measure and track the chip’s location, and the captured signals plotted on a chart. The chart shows four peaks identifying the locations of the chip in the mouse, within 500 micrometers of the true location in all cases.

Further development of the chip is needed to extend its capabilities to three-dimensional location tracking — the tests reported on two-dimensional locations — as well as extending the range of the chips’ signals. The authors foresee the chips used in devices for tracking blood chemistry, such as pH or sugar concentrations, as well as temperature and pressure measurements in real time. The devices could also help release medications at precise locations in the body instead of systemic drugs that could trigger adverse side effects.

In addition, the chips are small enough for many devices to be used simultaneously. “You could have dozens of microscale devices traveling around the body taking measurements or intervening in disease,” adds Shapiro. “These devices can all be identical, but the Atoms devices would allow you to know where they all are and talk to all of them at once.”

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Synthetic DNA Start-Up Raises $13M in Early Funds

DNA puzzle

(Arek Socha, Pixabay)

12 September 2017. A company producing synthesized DNA for medical and other biotechnology applications is raising €11 million ($US 13 million) in its first venture funding round. DNA Script, based in Paris, is a three year-old enterprise with a technology the company says is simpler and more like natural processes than current DNA synthesis methods.

DNA Script produces synthetic nucleic acids, the building blocks in DNA and RNA, using more efficient enzymes than other methods, which the company says often employ harsh chemical solvents. The company claims its enzyme chemistry is simpler and faster, resulting in a higher quality output and at a more affordable cost. DNA from its process, says DNA Script, can produce longer strands with far fewer errors in a small fraction of the time compared to today’s techniques.

Among the near-term markets for the company are discovery of new biologic therapies, such as synthetic antibodies and for regenerative medicine, as well as medical diagnostics. The company is also targeting industrial biotechnology, such as biofuel and biomaterials development, and agricultural applications, including enhancement in plant crops to boost productivity and resist diseases or pests. Synthetic DNA, says CEO and co-founder Thomas Ybert in an interview earlier this year, could make possible printing customized DNA sequences, with expression of specific genes switched off as needed.

Also among the company’s target applications is data storage with DNA. The technology industry faces a chronic need for better long-term data storage methods, with current storage media soon expected to hit their physical limits. Synthetic DNA offers very high density, to molecular levels, and extreme durability with a 500-year half-life. In July 2016, Microsoft and University of Washington announced the ability to store some 200 megabytes of data on DNA strands, taking up barely a spot in a test tube.

The funding round is led by Illumina Ventures, a partner enterprise of genetic sequencing equipment maker Illumina. Joining in the financing are current investors Sofinnova Partners, Kurma Partners, and Idinvest Partners. DNA Script expects to use the proceeds of the round to refine and strengthen its enzymatic technology and nucleotide chemistry platform.

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Trial Shows Antibody Effective Against Asthma

lung illustration

(Kai Stachowiak, Pixabay)

12 September 2017. Results from a large-scale clinical trial show a synthetic antibody, when added to standard treatments, reduces asthma attacks and improves lung functioning. The drug, known as dupilumab, is being developed by drug makers Sanofi, based in Paris, and Regeneron Pharmaceuticals Inc., in Tarrytown, New York.

Asthma is chronic condition, where the airways become inflamed and narrow, causing people with asthma to experience wheezing, shortness of breath, tightness in the chest, and coughing for periods of time. Among asthma’s underlying causes are infections, pollutants in the air, and allergies to pollen, molds, or dust mites that trigger airway inflammation. Centers for Disease Control and Prevention estimates that in 2010 some 18.7 million adults had asthma, along with 7 million children.

The trial is testing dupilumab, a synthetic antibody that specifically targets the signaling protein interleukin 4, a modulator of signals driving type 2 helper T cells, a type of white blood cells triggering inflammatory immune system responses. Dupilumab was originally developed by Regeneron, then licensed to Sanofi for further development and commercialization. The drug is given as an injection under the skin.

The late-stage clinical trial recruited 1,902 individuals having asthma for more than 1 year, with separate samples of adults and adolescents, starting at age 12, at 413 sites worldwide. Participants were randomly assigned to receive injections of dupilumab every 2 weeks in doses of 200 or 300 milligrams, or equivalent doses of a placebo, taken with their current drugs for controlling asthma — inhaled corticosteroids and 2 other medications — for 1 year. The study team looked primarily for changes in the rate of severe exacerbations, or asthma attacks, over the year, as well as forced expiratory volume, the amount of air expelled in one second, after 12 weeks. Forced expiratory volume is an indicator of lung functioning.

The results show participants receiving the 300 milligram dupilumab dose reported 46 percent fewer severe asthma attacks than their counterparts receiving the placebo after 1 year, and greater improvement in forced expiratory volume, to 130 milliliters, after 12 weeks. In both measures, participants having higher eosinophil counts in their blood experienced lower severe exacerbation rates and higher forced expiratory volumes. Eosinophils are white blood cells in the immune system that help fight infections and inflammation.

Sanofi and Regeneron say results for participants receiving 200 milligrams of dupilumab were similar to the 300 milligram dose. More individuals receiving dupilumab (17%) experienced injection site reactions than placebo recipients (8%). Adverse events of all kinds and drop-outs from the study, whether or not related to the clinical trial, were comparable between dupilumab and placebo recipients.

The companies plan to submit dupilumab to the Food and Drug Administration for review as an asthma treatment by the end of the year. In March 2017, FDA approved dupilumab as a therapy for moderate-to-severe atopic dermatitis, skin inflammation also known as eczema, in adults, and is marketed under the brand name Dupixent.

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Hat tip: FirstWord Pharma

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Risks of E-Cigarette Use, Ingredients Highlighted

E-cogarette and refill

(Horst Winkler, Pixabay)

11 September 2017. Several sessions at a scientific meeting on respiratory diseases report on effects of electronic cigarettes on people’s health, including those who also smoke conventional cigarettes. The papers are scheduled to be delivered this week at the European Respiratory Society congress in Milan, Italy.

Electronic cigarettes are battery-powered nicotine delivery devices, that heat a liquid containing nicotine, moisturizing agents — propylene glycol or glycerol — and flavoring agents, as well as preservatives and artificial colorings. Makers of e-cigarettes often market the devices as safer alternatives to tobacco-burning cigarettes and sometimes as a technique to help tobacco smokers quit conventional cigarettes.

A team led by public health researcher Constantine Vardavas at American College of Greece in Athens analyzed the ingredients in e-cigarette liquid refills. The researchers looked at 122 of the most commonly sold refills in 9 European countries, using liquid and gas chromatography, forms of mass spectrometry.

The results show large percentages of the samples contain chemicals known to cause respiratory problems. Some 43 percent of the samples had menthol and 17 percent had ethyl vanillin, both classified as respiratory irritants, according to the UN’s Globally Harmonized System of Classification and Labelling of Chemicals. Plus, 26 percent of the samples contained methyl cyclopentanolone, considered a threat to cause asthma or allergy symptoms if inhaled. Other chemicals associated with these irritations or symptoms were found in 10 percent or less of the samples.

Researchers led by Magnus Lundbäck of Danderyd University Hospital, affiliated with Karolinska Institute in Stockholm, Sweden, studied effects of e-cigarette smoking on blood vessels and pressure with a group of 15 young, healthy volunteers. Participants in the study did not use e-cigarettes before and smoked less than 10 tobacco cigarettes a month.

The volunteers were asked to smoke e-cigarettes for 30 minutes, with the devices randomly assigned to deliver nicotine or only the flavored vapor. Participants then had their blood pressure and heart rate measured, as well as pulse wave velocity — an indicator of artery stiffness — immediately after the smoking session. The measures were repeated 2 and 4 hours later.

The results show participants using e-cigarettes with nicotine experienced a three-fold increase in artery stiffness, measured by pulse wave velocity, in the 30 minutes after using the devices, along with higher blood pressure and heart rate. Among volunteers using e-cigarettes without nicotine, however, artery stiffness and heart rate remained about the same as before.

Linnéa Hedman, a public health researcher at Umeå University in Sweden, and colleagues studied results of two health surveys conducted in Sweden, with more than 30,200 respondents. The team analyzed results of non-smokers, compared to 12 percent of the samples who smoked conventional cigarettes, 2 percent who used e-cigarettes, and 1.2 percent who both smoked tobacco cigarettes and used e-cigarettes.

These users of both forms of cigarettes represent about 10 percent of tobacco smokers. However, only about 1 percent each of former or non-smokers used e-cigarettes. “One argument for e-cigarettes,” says Hedman in an ERS statement, “is that they could help smokers to quit, but our study does not support this argument. If that was the case, e-cigarette use would have been most common among former smokers.”

In addition, more than half (56%) of dual-users reported respiratory problems, such as wheezing or chronic coughing, compared to about 46 percent who smoked cigarettes, one-third (34%) of e-cigarette users, and a quarter (26%) of non-users of either cigarette forms.

“It is very important that the results of this and other studies reach the general public and the health care professionals working in preventive health care, for example in smoking cessation,” notes Lundbäck in a separate ERS statement. “E-cigarette users should be aware of the potential dangers of this product, so that they can decide whether to continue or quit based on scientific facts.”

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Infographic – Numbers of Atlantic Hurricanes

Infographic: Stormy Season I: Number of Hurricanes Since 1967 | Statista You will find more statistics at Statista

9 September 2017. Here in the U.S., we’re trying to recover from Hurricane Harvey in Texas and Louisiana, while preparing as best we can for Irma in Florida. Our thoughts and best wishes go out to the residents of those regions. Our friends at Statista prepared a chart yesterday that gives the number of hurricanes in the Atlantic from 1967 through 2015, divided between smaller storms in categories 1-2 and larger storms in categories 3-5.

We look forward to going back to reporting on venture funding and biotechnology.

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University, Drug Maker Partner on Suicide Genetics

Map: Risk of suicide by state

Risk of suicide by state. Click on map for full-size image. Source: CDC (University of Utah Health)

8 September 2017. Pharmaceutical company Janssen Research and Development and University of Utah Health in Salt Lake City are studying genetic factors linked to higher suicide risks. Financial and intellectual property aspects of the collaboration were not disclosed.

The initiative aims to build on earlier work by Utah research professor Hilary Coon, a specialist in psychiatry and biomedical informatics, who heads the Utah Suicide Genetics Project and is co-leader of the partnership. That study is looking into genetic variations associated with suicide in more than 3,500 DNA samples from suicide victims in Utah. The samples are linked to data in the Utah Population Database that collects medical, demographic, and genealogical information. In that project, researchers are seeking genetic variations associated with suicide, while controlling for other psychiatric and physical disorders.

According to Centers for Disease Control and Prevention, suicide took the lives of nearly 43,000 people in the U.S. in 2014, or 13.4 deaths per 100,000 population, making it the 10th leading cause of death. Firearms account for about half of all suicides. According to 2015 data, Utah is one of the top 5 states in suicide rate, at about 23.5 per 100,000.

The joint project will investigate genetic clues in large extended families with unusually high rates of suicide, by finding associations between genetic variations and characteristic behavioral traits. The university and state’s medical examiner’s office say they can mine the database while protecting the privacy of suicide victims and their families by removing names, dates of birth, or other individual identifiers.

The researchers note that suicide and mental illness are often studied together, but many people with mental illness do not die of suicide. Therefore identifying genetic factors could provide ways of predicting which individuals are most at risk and take actions earlier to prevent a tragic outcome.

Coon notes in a university statement that this strategy could lead to new drugs or make existing medications more readily available for people deemed at higher risk of suicide. “We believe this work may help us identify high-risk groups for better, more targeted therapies and interventions to reduce the incidence of suicide.”

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Disclosure: The author owns shares in Johnson & Johnson, parent company of Janssen R&D.

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NIH Funds Heart Tissue Regeneration Tests in Pigs

Kevin Strange and Voot Yin

Kevin Strange, left, and Voot Yin are inventors of MSI-1436 (MDI Biological Laboratory)

8 September 2017. An experimental drug to help grow new heart tissue after a heart attack is advancing to tests in pigs, with help from National Institutes of Health. Novo Biosciences Inc., developer of the drug, was awarded a two-year, $1.5 million Small Business Innovation Research grant from National Heart, Lung, and Blood Institute, part of NIH.

Novo Biosciences is a spin-off company from MDI Biological Laboratory in Bar Harbor, Maine, founded in 2013 by lab scientists Kevin Strange and Viravuth (Voot) Yin, now the company’s CEO and chief scientist respectively. The company’s drug, code-named MSI-1436, is derived from a naturally occurring compound that inhibits a protein known as tyrosine phosphatase 1B. This protein inactivates an enzyme that regulates innate tissue repair and regeneration.

The drug, in this case, is designed to stimulate heart muscle cells called cardiomyocytes that repair heart tissue damage from heart attacks. That damage is often replaced by scar tissue, which prevents the heart from beating in its normal rhythm. In tests with lab mice induced with damage similar to a heart attack, recipients of MSI-1436 reduced the amount of scar tissue, improved heart function, reduced the thinning of heart walls, increased production of cardiomyocytes, and increased survival times. The company says MSI-1436 was also well-tolerated in early-stage clinical trials of its safety in patients with type 2 diabetes and obesity.

As reported in Science & Enterprise, MDI Biological Laboratory received a patent on the technology to treat heart disease in August 2016. The patent is shared with Michael Zasloff of the MedStar-Georgetown Transplant Institute at Georgetown University Hospital in Washington, D.C.

The drug still needs to be tested in animals with hearts more like humans, thus the tests with pigs, whose hearts are similar in size and function. Novo Biosciences proposes measuring effects of the drug on restoring heart functions with echocardiograms that provide images of the heart with ultrasound. The tests with pigs will be structured much like clinical trials, where the animals will be randomly assigned to receive either MSI-1436 or a placebo, and the lab researchers not aware if they are administering the test drug or the placebo. A cardiovascular team at Louisiana State University in New Orleans will conduct the tests.

“If the pig study is successful, Novo Biosciences will seek investors to move the potential drug through the multi-stage clinical trial process,” says Yin in an MDI statement. “If MSI-1436 shows results in humans that are anything like what we have demonstrated in mice, it will be a game-changer for patients who have suffered a heart attack.”

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Wearable-Implant Diagnostics Device in Development

Circuit graphic

(Gerd Altmann, Pixabay)

7 September 2017. A university engineering lab is developing a device combining a sensor chip implanted under the skin and wrist band to diagnose serious diseases and transmit the data. The three-year project, led by University at Buffalo electrical engineering professor Josep Jornet, is funded by a $1 million grant from National Science Foundation.

Jornet and colleagues seek to extend the ability of common wearable devices like wrist bands to capture and transmit more vital medical data, particularly when coupled with sensors that can screen for diseases. So far, wearable devices are useful for capturing basic indicators of fitness or overall health, with their value expanded by transmission to the cloud and combining those results with others. Adapting this technology for more detailed medical data is limited by the state of current monitoring devices that tend to be too large or heavy for practical use.

The Buffalo team is instead proposing implanted sensors under the skin that analyze an individual’s blood for indicators of serious disease. The sensors can then send wireless signals to a wrist band that like today’s fitness bands can relay the data to a smartphone, for further analysis or transmission to the cloud. The researchers underscore that a system of this kind would be used only in cases where there’s a high risk of the disease, from previous cases or family history, for example.

“We are developing an integrated system,” says Jornet in a university statement, “that will provide a faster and more accurate way to diagnose and monitor diseases than conventional technologies by leveraging the state-of-the-art in nano-bio-photonics and wireless communications.”

The key new element in this system is the implanted sensor. The researchers propose advancing optical detectors with metallic nanoparticles fit into a tiny gold biochip, about 10 microns square, that read variations in light waves to determine the absence or presence of specific proteins in the blood. The team is also studying ways to optimize the performance of the chip inside human tissue, and more general human factors in the system design, such as the longevity of the chip over time.

Another key element is the system’s software, including a set of algorithms written to calibrate, collect, and process the optical signals, residing in the wrist band. The project includes routines to convert the signals to meaningful data and share the information with health care providers.

For this project, the targets are indicators of lung cancer, with Roswell Park Cancer Institute, a cancer research center in Buffalo, as one of the partner organizations. The other partners are Intel Corporation and Garwood Medical Devices, also in Buffalo, a developer of medical implants for wound healing. Jornet is one of a team of researchers that works with Garwood.

The researchers will also develop an entire test environment for the system. The Buffalo team expects to test the chips in the lab with blood samples from people with lung cancer, as well as test in tissue samples and with cadavers.

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MIT, IBM Open Artificial Intelligence Lab

Artificial intelligence graphic

(Gerd Altmann, Pixabay)

7 September 2017. Massachusetts Institute of Technology and IBM are establishing a joint lab to advance the state of knowledge and business impact of artificial intelligence. The lab, in Cambridge, Massachusetts near the MIT campus, is backed by $240 million in funding from IBM over 10 years.

The MIT-IBM Watson AI Lab expects to conduct basic and applied research in artificial intelligence in four categories it calls pillars:

Advanced algorithms to expand machine learning and reasoning. The new algorithms plan to go beyond specialized tasks addressed today to more complex tasks requiring higher orders of learning, and using smaller stores of data than the large-scale databases now tapped.

Physics behind artificial intelligence. Researchers will investigate new materials and devices to support future computational architectures, including quantum computing for artificial intelligence. In these studies, research teams are expected to both use artificial intelligence to advance quantum computing, as well as apply quantum computing concepts to build algorithms for machine learning.

Artificial intelligence in industries. This part of the lab will develop new applications for artificial intelligence in fields such as health care and cyber security. These two fields overlap in the need to better protect medical data, but artificial intelligence can also help analyze medical images as well as personalize medical plans and treatments for patients.

Economic implications of artificial intelligence. Researchers expect to examine ways of expanding social and economic benefits of artificial intelligence to more people, companies, communities, and nations.

In a related effort, researchers in the joint lab, both faculty and students, will be encouraged to start new enterprises to commercialize their findings. The lab’s 100 scientists are also expected to publish their work and contribute to open-source collections.

In an online interview, Anantha Chandrakasan, dean of MIT’s School of Engineering who negotiated the deal with IBM says, “The project will support many different pursuits, from scholarship, to the licensing of technology, to the release of open-source material, to the creation of start-ups. We hope to use this new lab as a template for many other interactions with industry.”

The joint lab plans to issue a call for proposals to scientists at IBM and MIT for ideas related to the four research pillars. Chandrakasan co-chairs the lab with Dario Gil, a research vice-president at IBM responsible for artificial intelligence.

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Disclosure: The author owns shares in IBM

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