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Intelligent Liner Aims to Improve Prosthetic Limb Comfort

Leg amputee

(Veterans Health Administration)

15 April 2014. Engineers in the U.K. at University of Southampton and Chas A Blatchford & Son Ltd. in Basingstoke are designing a liner with sensors for lower-limb prosthetic devices that improve the fit and comfort of those devices for their wearers. The team is developing a prototype device that they aim to have available for patients in the U.K.’s National Health Service in about three years.

The prototype device will help identify and measure the forces pressing and pulling from the prosthetic socket on the wearer’s stump. “Socket fit is the single biggest factor determining whether prosthesis will be successful for a patient,” says Southampton engineering lecturer Liudi Jiang in a university statement. “If we had a simple way to accurately measure the load at the socket-stump interface and determine the best possible fit for that limb, it would completely transform the socket fit experience for amputees.”

Jiang, an electrical engineer, is designing the pressure sensors to be built into a liner worn over the lower-limb stump. Many prosthetic devices now have liners to cushion the device on the stump. No two stumps are the same size or shape, however, and in some cases the stumps can even change in shape over the course of a day. Pressures building up on an ill-fitting stump can cause sores and tissue damage.

Dan Bader, a biomedical engineer at Southampton on the development team, is designing sensors to assess the health of the tissue on the stump. The liner is expected to be worn over the stump, as is done today, but the sensors would make it possible for clinicians to to make immediate adjustments in the prosthetic device to improve comfort for the wearer.

In addition, the liner would monitor changes in socket fit over time, feeding a stream of data from the prosthetic device to a wireless receiver. The monitoring of the device’s fit would enable clinicians to make adjustments sooner than is done today, thus avoiding pressures to build up and cause skin sores. This function alone could make the liners a low-cost solution to a common problem for amputees, requiring frequent returns to rehabilitation centers and extra costs.

The university team is collaborating on the project with Chas A Blatchford & Sons, a manufacturer of prosthetic devices. Company staff are expected to help integrate the sensors into thin liners that work with sockets of any size. The researchers believe their technology can be extended to shoe insoles to prevent diabetic foot ulcers and with mattresses and wheel chairs to prevent bed sores with immobile patients.

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Microparticle Solution Devised to Identify Genuine Goods

Patrick Doyle

Patrick Doyle (Mass. Institute of Technology)

14 April 2014. Engineers at Massachusetts Institute of Technology and the affiliated Lincoln Laboratory developed a process for adding minute particles into materials that can be encoded and sensed by inexpensive readers to detect counterfeit goods from the originals. The team from the lab of chemical engineering professor Patrick Doyle published its findings yesterday online in the journal Nature Materials (paid subscription required).

The problem of counterfeiting ranges from knockoff fashion garments and electronic goods to currencies and phony medications with life-threatening implications. OECD estimates counterfeit goods account for 2 percent of all international trade, calculated at more than $250 billion in 2007. To combat counterfeiting, legitimate manufacturers and distributors use additional labels or electronic tags, yet these too can be counterfeited, or are unreliable and too expensive.

Doyle and colleagues in 2006 designed a system for making microscale particles — measured in increments of microns or one-millionth of a meter — that employs photolithography and microfluidics to imprint shapes into chemical components that make up more complex polymer materials like those found in many plastics. When exposed to ultraviolet light, the microfluidic stream of components reacts and forms into polymer particles.

The researchers today adapted that process to create new particles about 200 microns long imprinted with nanocrystals — measured in billionths of a meter — containing traces of rare earth elements ytterbium, gadolinium, erbium, and thulium. The imprinted nanocrystals form into colored stripes; the researchers report producing nine colors so far, but they say many more colors are possible.

The microscale particles can then be configured with combinations of these colored stripes to represent a unique identifier, in much the same way a bar code works. With combinations of six colors, up to 1 million unique identifiers are possible. Adding more microscale particles expands the potential number of identifiers exponentially.

In the Nature Materials paper, the researchers demonstrated these identifying particles in materials simulating pharmaceutical packaging, objects like glass made at high temperatures, and biocompatible materials. The tests embedded the particles into two different types of polymer materials, one that attracts water and one that repels water. The colors generated are identical in both types of polymer.  The team also reports tests of the particles show they can withstand extreme temperatures, exposure to the sun, and heavy wear.

Inexpensive technologies widely available today can read the encoded particles. When illuminated by near-infrared light, like that put out by a laser pointer say the researchers, the particles shine brightly. The illuminated particles can then be read by a smartphone camera with 20-times magnification. Doyle and colleagues are working on a smartphone app to read, process, and interpret the encoded particles.

The authors in March 2013 filed two provisional U.S. patents for this technology.

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On the Road Again

Airport rush (TSA.gov)

(TSA.gov)

9 April 2014. Science & Enterprise is taking a brief hiatus, while I travel for the remainder of this week, 10-12 April. The blog will return on Monday, 14 April.

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MRSA Toxicity Predicted Through Genomic Sequencing

MRSA bacteria emerge from dead white blood cells (Frank DeLeo, NIH)

MRSA bacteria emerge from dead white blood cells (Frank DeLeo, NIH)

9 April 2014. Researchers in the U.K., U.S., Sweden, and Turkey developed a technique based on genomic sequencing to predict the pathogenic severity of methicillin resistant Staphylococcus aureus or MRSA bacteria, an antibiotic-resistant microbe often found in health care facilities. The team led by University of Bath biologist Ruth Massey published its findings today online in the journal Genome Research.

The Centers for Disease Control and Prevention says the number of cases of MRSA infections are declining in U.S. hospitals and clinics, but remains a serious problem. A CDC study published last year in the American Medical Association’s journal Internal Medicine reports life-threatening MRSA infections declined by more than half (54%) between 2005 and 2011. The same study reported nearly 31,000 fewer MRSA infections from 2005 to 2011, with 9,000 fewer hospital deaths.

Nonetheless, the study reported more than 80,000 cases of life-threatening MRSA infections in 2011, with more than three-quarters of these cases (78%) diagnosed either while in the hospital or soon after release. A 2007 study estimated the direct economic burden on hospitals of MRSA infections between 1999 and 2005 at more than $6 billion, which does not include indirect costs related to patient pain, illness, and time spent in the hospital.

The MRSA microbe is a complex organism, which the authors note, may require a more sophisticated and nuanced response than many current approaches. Massey and colleagues sequenced the genomes of 90 pure MRSA cultures and identified 125 genetic mutations that made each culture either high or low in toxicity.

The team was then able to find a common genetic signature for the high-toxicity cultures. Knowing this signature, say the authors, makes it possible to predict the cultures most likely to be toxic and cause severe cases of MRSA infection.

These findings, says Massey, make it possible to develop a diagnostic technique based on sequencing a swab sample from the patient and personalized to the individual’s infection. “Clinicians will then be able to tailor the treatment to the specific infection,” notes Massey in a university statement. “This technique can tell them which combination of antibiotics will be most effective, or tell them which drugs to administer to dampen the toxicity of the infection.”

The university says the researchers are extending this technique to other virulent MRSA strains as well as other bacterial pathogens.

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UC-San Francisco Launches Brain Disease Trial Registry

Brain visualization image

(Univ of California, San Francisco)

9 April 2014. University of California in San Francisco opened an online registry that aims to reduce the time and cost of recruiting participants in clinical trials for disorders of the brain, such as Alzheimer’s and Parkinson’s disease and traumatic brain injuries. The Brain Health Registry is led by UC-San Francisco radiology professor Michael Weiner, who founded the registry, and psychiatry professor Scott Macklin, with collaboration from a number of companies.

The pharmaceutical industry is increasing its use of online tools to reduce the costs of clinical trials, which account for a large proportion of the development cost of medications. Services like MyClinicalTrialLocator.com and TrialReach.com act as search engines for trials, while PatientsLikeMe uses the community/social media model to encourage people with disease to discuss their experiences and volunteer for clinical studies.

The registry asks volunteers to provide a brief personal medical history and take a few online neuro-psychological tests to provide an outline of visitors’ mental functions. From this first pool, some participants will be asked to provide saliva or blood samples, and take part in clinical trials. All data, says the university, will be protected according to federal privacy laws and the highest medical ethics standards.

Brain Health Registry is seeking volunteers initially from the San Francisco Bay area, and hopes to enroll some 100,000 participants by 2017; about 2,000 already enrolled during the site’s testing phase. The registry’s collections are expected to offer researchers data on brain capabilities through the aging process and help develop diagnostic tools, as well as provide a pool of potential clinical trial volunteers.

The registry is partnering with Lumiosity, a San Francisco company that offers online brain training games. Lumiosity is providing a series of assessments included in the registry’s brain performance tests, as well as recruiting volunteers. Other collaborating companies are Johnson & Johnson Innovation Center and Cogstate, an Australian company developing cognitive testing tools.

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University, Board Maker Partner on Point-of-Care Diagnostics

Microfluidic chip

Microfluidic chip (Sandia National Lab)

8 April 2014. Computer scientists in the U.K. at Southampton University and circuit board manufacturer Newbury Electronics Ltd. are designing a device to detect protein indicators for diagnosing diseases at a doctor’s office or clinic rather than sending out samples to a lab for analysis. The three-year project led by Southampton’s Themis Prodromakis, is funded by a £870,000 ($US 1.45 million) grant, from the Engineering and Physical Sciences Research Council, a science funding agency in the U.K.

The new device aims to perform the diagnostic and analytical functions of an enzyme-linked immunosorbent assay, or ELISA, now used to monitor cell-signaling proteins. But the device needs to be simple and inexpensive enough to perform its analysis at the point of care, return results within at least the same day, and at a much lower cost than today’s techniques that require a remote lab for analysis.

Prodromakis and colleagues plan to develop electronic components acting as chemical sensors, combined with microfluidic chips having tiny channels that capture fluid samples for analysis. The developers anticipate adapting current techniques for producing printed circuit boards to build the device, even if the boards have customized components and microfluidic channels and chambers.

Prodromakis’s lab, part of the university’s Nano Group, is working with Newbury Electronics to better understand processes used for making printed circuit boards. The Nano Group’s research includes work on hybrid biodevices for environmental sensing as well as medical diagnostics.

The project includes clinical trials of the new device at infection and immunity facilities of Imperial College Healthcare NHS, a health system of five hospitals in London. If the work proceeds according to plan, says the university, first prototypes should be available for testing by next year.

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U.S. Patent Granted for Simple Dry-Powder Drug Inhaler

XCaps dry-powder inhaler

XCaps dry-powder inhaler (Hovione International)

7 April 2014. Medical device manufacturer Hovione International in Lisbon, Portugal, received a patent for its inhaler for administering respiratory drugs in dry powder form. U.S. Patent and Trademark Office awarded patent 8,677,992 on 25 March to three inventors and assigned to Hovione International. Among the inventors is Peter Villax, the company’s vice-president for innovation.

Dry-powder inhalers are used by people with asthma, COPD, and other respiratory disorders that make it possible for them to take the drug compound directly into the lungs. The force needed to inhale the drugs is generated by the user who breathes in through the inhaler, which releases the fine powder into the lungs. Some dry-powder inhalers have the drugs preloaded, while others, like the design patented by Hovione, require the user to add the drugs.

The Hovione device, which it markets under the brand-name XCaps, can be configured for inhalation through the nose or mouth. The inhaler has two components: a sliding tray that holds a capsule with a pre-measured dose of the dry-powder medication, and an outer body with an attached inhalation tube.

Blades to cut open the powder capsule are fitted on the walls of the outer body. The user loads a capsule into the sliding tray, and pushes the tray into the inhaler body, where the blades open the capsule. The individual then breathes the medication through the inhalation passage. The tray slides out to dispose of the empty capsule.

Hovione says the XCaps device works with both lactose-based and engineered-particle powders. The company also provides formulation services to prepare medications for dry-powder inhalers. Patents for the device have already been awarded in Europe, Canada, South Africa, and three Asian countries.

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Clinical Trial to Test Advanced Lung Cancer Immunotherapy

Lung cancer X-ray

(National Cancer Institute)

7 April 2014. EMD Serono, a subsidiary of the pharmaceutical company Merck in Rockland, Massachusetts, is beginning a clinical trial to test a vaccine-type therapy for advanced cases of non-small cell lung cancer. The late-stage trial is assessing the ability of tecemotide, an experimental drug designed to trigger an immune response against cancer cells, to extend survival time of patients who already received concurrent chemo- and radiation therapy, but whose lung cancer cannot be removed by surgery.

Non-small cell lung cancer accounts for 85 to 90 percent of all lung cancer cases; the name refers to the size of the cancer cell when viewed under a microscope. This category of lung cancer has various sub-types, which are similar in treatment and prognosis.

Tecemotide is formulated as a vaccine to stimulate T-cells in the body’s immune system for controlling the growth and spread of cancer cells. It is made up of proteins that seek out the antigen MUC1, which appears on the surface of several types of cancer cells, including those of non-small cell lung cancer. Tecemotide was first developed by the biotechnology company Oncothyreon Inc. in Seattle, and licensed to Merck and EMD Serono for clinical trials and commercialization.

An earlier trial of tecemotide with patients having inoperable non-small cell lung cancer showed the therapy was about as successful in extending overall survival time as patients receiving a placebo. Patients in this first trial already received both chemo- and radiation therapy treatments, but the results showed longer survival times for those receiving tecemotide after concurrent chemo- and radiation therapy — median of 30.8 months — compared to the placebo (20.6 months). Patients receiving tecemotide after sequential chemo- and radiation therapies survived about as long as the patients receiving a placebo.

The new trial has a similar design as the earlier study, but in this case participants first receive only concurrent chemo- and radiation therapies, with the group of 1,000 non-small cell lung cancer patients divided about equally between those then receiving tecemotide or a placebo. Patients are being recruited in both the U.S. and Europe. A clinical study similar to the original trial is recruiting some 500 patients in China, Hong Kong, Taiwan, Singapore, and South Korea.

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Cancer Radiotherapy Company Lands $11.6M First Round Funds

PET scanner (DoE)

PET scanner (U.S. Department of Energy)

4 April 2014. RefleXion Medical, a company in Burlingame, California designing a more accurate form of radiation therapy to treat solid tumors, gained $11.6 million in its first round of venture financing. The financing was lead by venture capital company Sofinnova Partners, with participation by Pfizer Venture Investments and Venrock.

RefleXion Medical is developing a new form of radiation therapy for solid-tumor cancers, such as breast, prostate, and lung cancers. The company’s technology harnesses positron emission tomography (PET) scanning, where small amounts of radioactive tracers collect in organs and tissues, and emit signals that become visible when interacting with PET scans. Scans in a PET session are retrieved, assembled, and visualized by computer, providing a three-dimensional image of the target.

While PET scanning is used for cancer diagnosis, it has not been used up to now for treating cancer. Among the problems limiting PET scans for treatment with radiation therapy is the extended time — several minutes — needed to assemble a high-quality image and difficulty compensating for movement of organs and tumors, such as caused by breathing when trying to treat lung cancer.

RefleXion Medical’s solution tightly integrates PET scans with radiation therapy to sharply reduce the lag time between signal detection and radiation dosage. The system employs an algorithm that links light particles detected in PET scans to targeting of radiation therapy. This linkage, says the company, allows the signals detected in PET scans to guide the application of radiation therapy in real time directly to the tumor, delivering more radiation and avoiding healthy tissue nearby.

The company tested its technology in a simulation with lung and prostate tumors using a four-dimensional human model, conducted with engineering researchers at Georgia Tech, and published in 2012 in the journal Medical Physics. The simulation showed RefleXion Medical’s emission guided radiation therapy delivered between 19 and 41 percent more radiation to the tumors in doses aiming for 95 percent of the tumors’ gross volumes. When aiming the radiation to cover 50 percent of the tumors’ gross volumes, the technique delivered 52 to 55 percent more radiation.

RefleXion Medical’s technology was invented by company president Sam Mazin while a postdoctoral researcher in radiology at Stanford University. Also while a postdoc in 2009, Mazin was selected by the Ewing Marion Kauffman Foundation for a fellowship to commercialize the technology, and he went on the found the company soon thereafter.

Proceeds of the financing are expected to expand RefleXion Medical’s research organization and accelerate development of the technology. The company received a Small Business Innovation Research grant from National Cancer Institute in September 2011 to initially develop the technology.

Sofinnova Partners that led the financing is a Paris-based venture capital company specializing in life sciences enterprises. Pfizer Venture Investments is the venture capital arm of Pfizer Inc. Venrock was first established as the venture capital organization representing the Rockefeller family, but today focuses on technology and health care companies.

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Hat tip: Fortune/Term Sheet

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Daiichi Sankyo, UCSF Partner on Neurodegenerative Disorders

3-D brain wiring illustration

3-D brain wiring illustration (NIH)

4 April 2014. The pharmaceutical company Daiichi Sankyo in Tokyo and University of California in San Francisco (UCSF) are collaborating on discovering new drugs to treat neurodegenerative conditions such as Alzheimer’s, Parkinson’s, and Creutzfeldt-Jakob disease. While funding amounts were not disclosed, the deal gives Daiichi Sankyo the option to license compounds discovered through the partnership, in exchange for milestone payments and royalties to UC-San Francisco.

Neurodegenerative diseases cover a number of conditions where neurons or nerve cells in the brain or spinal cord are damaged or die. These disorders are today incurable, and treatments generally try to control symptoms affecting muscle movement and mental functioning. The EU’s Joint Programme on Neurodegenerative Disease says the breakdown of mental functions known as dementias cause the biggest burden of these disorders, with Alzheimer’s disease accounting for most (60 to 70%) of dementia cases.

The agreement calls for Daiichi Sankyo to provide its library of drug compounds to UC-San Francisco’s Institute for Neurodegenerative Diseases. Researchers from the company’s Venture Science Laboratories and the institute will perform high-throughput screening of the compounds to find promising biological connections among the compounds, genes, and molecular pathways that point to new targets for those compounds.

Much of recent research at the Institute for Neurodegenerative Diseases focuses on the role of prions in these disorders. Prions are pathogenic agents that propagate, are transmittable,  and cause abnormal folding of cellular proteins concentrated in the brain. Stanley Prusiner, director of the institute, conducted some of the early research connecting prions to “mad cow” and Creutzfeldt-Jakob disease. In an article published in the journal Science in June 2012, Prusiner outlined the potential role of prions in neurodegenerative disorders other than Creutzfeldt-Jakob disease.

“Alzheimer’s alone kills as many people every year as cancer does, but it only receives one-tenth of the funding that we dedicate to cancer research,” notes Prusiner in a university statement. “This collaboration won’t fill that funding gap, but it will offer the tremendous value of Daiichi Sankyo’s scientific expertise to make progress on these diseases.”

Neurodegenerative diseases represent a new direction for Daiichi Sankyo. The company’s current pipeline has drugs for chronic pain and spinal cord injury in clinical trials, but no programs underway for Alzheimer’s, Parkinson’s, or related diseases. Its Venture Science Laboratories taking part in the collaboration with UC-San Francisco operates as an internal entrepreneurial enterprise for the discovery of new therapeutic targets.

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