3D printing enables the smalles complex micro-objectives

The femtosecond laser, with pulse durations smaller than 100 femtoseconds, is being focused in a microscope into liquid photoresist which rests on a glass substrate or an optical fiber. Two photons of the red laser beam with a wavelength of 785 nm are being absorbed simultaneously in the focus and expose the photoresist. This crosslinks the polymer and hardens it. The laser beam is directed with a scanner or by moving the substrate over the substrate. After exposure, the unexposed photoresist is washed away with a solvent. Only the hardened transparent polymer remains and forms the optical element.



Using this method, optical free form surfaces can be created with sub-micrometer accuracy. The precision of the 3D laser writing allows not only for construction of common spherical lenses, but also the more ideal surfaces such as paraboloids or aspheres of higher order are possible. Particularly optical lens systems with two or more lenses can be realized for the first time with this method. This opens the door to aberration correction and microoptical imaging systems with unprecedented quality.

Full story and contact information can be found from University of Stuttgart website.

Nerve Capping Device for Treatment and Prevention of Symptomatic Neuroma CE Marked

Polyganics, a privately held medical technology company, announced that it has received the CE mark for NEUROCAP®, its nerve capping device. Polyganics intends to launch NEUROCAP® in several European countries later this year.

NEUROCAP® is an absorbable implant for the treatment and reduction of symptomatic neuroma in peripheral nerves. The device was cleared for sales in the United States in January 2016, and Polyganics introduced NEUROCAP® during the Annual Meeting of the American Society of Surgery of the Hand in Phoenix last January.

In February, the European STOP NEUROMA study started to gather evidence for the long-term effectiveness of NEUROCAP® in the reduction of painful neuroma formation. The first patients have been successfully enrolled at the MC Groep hospital in Emmeloord, The Netherlands, by Coordinating Investigator Mariëtta Bertleff, MD. Through this study, Polyganics is collecting more data on the clinical performance of NEUROCAP®’s ability to isolate the nerve end, and the product’s effectiveness with respect to the reduction of pain from the symptomatic neuroma and prevention of pain reoccurrence.

Rudy Mareel, CEO of Polyganics said, “CE regulatory approval is a key milestone for our nerve capping device. We strongly believe NEUROCAP® represents an important addition to the surgeons’ tool-box in the treatment of peripheral nerve injuries enhancing surgical outcomes and patient recovery.

Furthermore, if NEUROCAP® shows effectiveness in terms of preventing pain symptoms to return over a one-year period, the device could be used in the prevention of painful neuroma formation following amputations. This is an additional, even more significant population which is steadily increasing due to the growing prevalence of diseases such as diabetes.”

More information can be found from Polyganics website.

Researchers Show How Stem Cells Exit Bloodstream

Researchers at North Carolina State University have discovered that therapeutic stem cells exit the bloodstream in a different manner than was previously thought. This process, dubbed angiopellosis by the researchers, has implications for improving our understanding of not only intravenous stem cell therapies, but also metastatic cancers.

When white blood cells need to get to the site of an infection, they can exit the bloodstream via a process called diapedesis. In diapedesis, the white blood cell changes its shape in order to squeeze between or through the epithelial cells that form the walls of the blood vessel. Diapedesis is a well-understood process, and researchers believed that other types of cells, like therapeutic stem cells or even metastatic cancer cells, exited blood vessels in a similar way – with the cells pushing or squeezing themselves out.

But a group of researchers led by Ke Cheng, associate professor of molecular biomedical sciences at NC State with a joint appointment in the NC State/UNC-Chapel Hill Department of Biomedical Engineering, found that these stem cells behaved differently.

Therapeutic stem cells share the same ability to exit the bloodstream and target particular tissues that white blood cells do. But the precise way that they did so was not well understood, so Cheng and his team utilized a zebrafish model to study the process. The genetically modified zebrafish embryos were transparent and had fluorescently marked green blood vessels. Researchers injected the embryos with white blood cells and cardiac stem cells from humans, rats and dogs. These cells had all been marked with a red fluorescent protein.

Through time-lapse three-dimensional light sheet microscopic imaging, Cheng and his team could trace the progress of these cells as they left the blood vessel. The white blood cells exited via diapedesis, as expected. When stem cells exited the blood vessel, however, the endothelial cells lining the vessel actively expelled them. Membranes surrounding the endothelial cells on either side of the stem cell stretched themselves around the stem cell, then met in the middle to push the stem cell out of the vessel.

“When you’re talking about diapedesis, the white blood cell is active because it changes its shape in order to exit. The endothelial cells in the blood vessel are passive,” Cheng says. “But when we looked at therapeutic stem cells, we found the opposite was true – the stem cells were passive, and the endothelial cells not only changed their shape in order to surround the stem cell, they actually pushed the stem cells out of the blood vessel. We’ve named this process angiopellosis, and it represents an alternative way for cells to leave blood vessels.”

The researchers found two other key differences between angiopellosis and diapedesis: one, that angiopellosis takes hours, rather than minutes, to occur; and two, that angiopellosis allows more than one cell to exit at a time.

“Angiopellosis is really a group ticket for cells to get out of blood vessels,” Cheng says. “We observed clusters of cells passing through in this way. Obviously, this leads us to questions about whether other types of cells, like metastatic cancer cells, may be using this more effective way to exit the bloodstream, and what we may need to do to stop them.”

The research is published in Stem Cells. Tyler Allen, a graduate student in the comparative biomedical sciences program, is the first author of the paper. The research was supported by the National Institutes of Health and the American Heart Association.

More information can be found from NCSU website.

AtriCure PRO2 left atrial appendage exclusion device CE marked

AtriCure announced that it has received CE Mark for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System, which offers increased functionality to occlude the LAA during minimally-invasive surgical (MIS) procedures. The device was previously launched in April 2016 with FDA 510(k) Clearance in the United States.



“We are excited to bring the AtriClip PRO2 device to the European market,” said Michael Carrel, President and CEO of AtriCure. “The US launch has been well received by our customers and we’re looking forward to the continued growth of the AtriClip franchise.”

The addition of the AtriClip PRO2 device has expanded the left atrial appendage product offerings and now provides an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. These features have improved the ease of use and time it takes to manage the left atrial appendage.

Product information can be found from AtriCure website.

Virus nanocapsules to treat infections

Scientists at the Universitat Autònoma de Barcelona (UAB) and the Catalan Institute for Nanoscience and Nanotechnology (ICN2) have developed a nanoencapsulation system with a liposome coating in order to increase the efficacy of bacteriophages in oral phage therapy. The research demonstrated that a liposome nanoencapsulation provides the bacteriophage with greater resistance to stomach acids and increases residence time in the intestinal tract of model broiler chickens in simulated poultry farming conditions. The technology developed could be applied to bacteriophages with different morphologies to be used in phage therapy, in both animals and humans.



The efficacy of encapsulated bacteriophages has been tested with animals treated with specific bacteriophages to fight against the zoonotic bacteria Salmonella. The results demonstrated a significant reduction in the concentration of Salmonella in the intestinal tract and prolonged effects when the treatment was administered using encapsulated bacteriophages, in comparison to the effects of nonencapsulated phages.

Oral phage therapy has demonstrated to be a feasible and effective tool in the control of infections caused by different bacterial pathogens. In previous studies, the UAB Molecular Microbiology Group had published the isolation and characterisation of three virulent bacteriophages (UAB_Phi20, UAB_Phi78, and UAB_Phi87) specific to Salmonella, and demonstrated their efficacy in the reduction of the concentration of this zoonotic bacteria in models of specific pathogen-free (SPF) White Leghorn chickens, and in several experimentally contaminated food matrices. Nevertheless, in this research two limitations were observed in the use of orally administered bacteriophages: the reduced stability of the phages in extremely acid environments, such as the stomach, and short residence time in the intestinal tract.

To overcome these limitations, researchers developed a nanoencapsulation system using liposome capsules and applied them to the three aforementioned virulent bacteriophages in order to compare the effects of liposome-encapsulated phages and nonencapsulated phages on the concentration of Salmonella in model broiler chickens experimentally contaminated with the bacteria. The experiment was conducted at the UAB Farms and Experimental Fields Services, with all the conditions of a real poultry farm.

Thanks to the study, nanometric capsules were developed, with an average diameter of 320 nm and a positive charge of 33mV. The nanocapsules containing the bacteriophages were observed using a cryo-electron microscope (Cryo-TEM) and confocal microscope. Researchers observed how the liposome coating allowed the encapsulated bacteriophages to be significantly more stable in the gastric fluids. The coating also significantly improved the time the bacteriophages stayed inside the intestinal tract of the chickens. After 72 hours encapsulated bacteriophages were detected in 38.1% of animals, while only 9.5% of animals showed signs of still containing the nonencapsulated bacteriophages.

In oral therapy experiments, once the treatment was suspended, the protection provided by nonencapsulated bacteriophages disappeared, while the encapsulated ones were effective for at least another week.

The methodology developed allows encapsulating bacteriophages of different sizes and morphologies, demonstrates the advantages of using encapsulated bacteriophages for oral phage therapy and, moreover, the nanometric size allows adding it to potable water and fodder.

The research was jointly conducted by the UAB Molecular Microbiology Group from the Department of Genetics and Microbiology, directed by Montserrat Llagostera, and the Supramolecular NanoChemistry & Materials group at the ICN2, directed by ICREA professor Daniel Maspoch. The work was published recently in the journal Applied and Environmental Microbiology and is part of the PhD thesis with international mention by Joan Colom Comas entitled “Studies of the Molecular features of Three Salmonella Phages for Use in Phage Therapy and of Encapsulation Methodologies to Improve Oral Phage Administration”.

The results of this work has given way to the processing of a joint UAB and INC2 European patent.

More details can be found from the Universitat Autònoma de Barcelona (UAB) website.

Researchers Devise Tool to Improve Imaging of Neuronal Activity in the Brain

In a partnership melding neuroscience and electrical engineering, researchers from UNC-Chapel Hill and NC State University have developed a new technology that will allow neuroscientists to capture images of the brain almost 10 times larger than previously possible – helping them better understand the behavior of neurons in the brain.



Nervous systems are complex. After all, everything that any animal thinks or does is controlled by its nervous system. To better understand how complex nervous systems work, researchers have used an expanding array of ever more sophisticated tools that allow them to actually see what’s going on. In some cases, neuroscience researchers have had to create entirely new tools to advance their work.

This is how an electrical engineering researcher ended up co-authoring a Nature Biotechnology paper with a group of neuroscientists.

A UNC-Chapel Hill research team made up of Jeff Stirman, Ikuko Smith and Spencer Smith wanted to be able to look at “ensemble” neuronal activity related to how mice process visual input. In other words, they wanted to look at activity in neurons across multiple areas at the same time.

To do that, the researchers used a two-photon microscope, which images fluorescence. In this case, it could be used to see which neurons “light up” when active.

The problem was that conventional two-photon microscopy systems could only look at approximately one square millimeter of brain tissue at a time. That made it hard to simultaneously capture neuron activity in different areas.

This is where Michael Kudenov comes in. An assistant professor of electrical and computer engineering at NC State, Kudenov’s area of expertise is remote imaging. His work focuses on developing new instruments and sensors to improve the performance of technologies used in everything from biomedical imaging to agricultural research.

After being contacted by the UNC researchers, Kudenov designed a series of new lenses for the microscope. Stirman further refined the designs and incorporated them into an overall two-photon imaging system that allowed the researchers to scan much larger areas of the brain. Instead of capturing images covering one square millimeter of the brain, they could capture images covering more than 9.5 square millimeters.

This advance allows them to simultaneously scan widely separated populations of neurons.

As the group notes in its Nature Biotechnology paper, this work addresses “a major barrier to progress in two-photon imaging of neuronal activity: the limited field of view.”

The paper, “Wide field-of-view, multi-region, two-photon imaging of neuronal activity in the mammalian brain,” was published June 27 in the journal Nature Biotechnology.

Details can be found from NCSU website by following this link.

LifeTech LAA Closure System gets CE approval

LifeTech received CE Mark approval for its LAmbre left atrial appendage (LAA) closure system , on 15 June 2016. This is the first CE marked LAA closure system from China.



LAA closure is considered as an alternative to anticoagulation in atrial fibrillation patients at risk of stroke. The recent multicenter study indicated that LAA closure is superior to anticoagulation on stroke prevention, bleeding complications and mortality. The LAmbreTM LAA closure system was designed to close LAA percutaneously through a small 8-10 Fr sheath. The main design of the device consists of a distal umbrella and a proximal cover disc connected by a short sleeve.

LAmbreTM LAA closure device is fully recapturable and repositionable. It is safe with its patented anchor design to ensure the stability of the device in LAA. It is also easy to learn and use for physicians. Dr. David Zhang, CTO of LifeTech said " The device can be easily implanted regardless of LAA anatomy. No device embolization was observed in our clinical trials."

Currently, only few LAA closure devices obtained CE Mark approval, including Watchman (Boston Scientific) and ACP (St. Jude Medical, acquired by Abbott). The CE mark of LAmbreTM is expected to provide more choice to physicians and patients all over the world and help increase the LAA closure acceptance in the field. LifeTech is also actively pursuing the approval of LAmbreTM LAA Closure System in China and US market.

"We are proud of the CE mark of the first LAA Closure system from China and confident that our LAmbreTM LAA closure system can compete in the global market, bringing a superior solution to both physicians and patients," said Mr. Yuehui Xie, Chairman and CEO of LifeTech.

A press release can be found from LifeTech website by following this link.

St. Jude Medical Launches New Deep Brain Stimulation System and Directional Lead

St. Jude Medical announced the European launch of the St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) System and directional DBS lead. The system, which received CE Mark approval late in 2015, will support the treatment of patients with the three most common movement disorders in the world: Parkinson’s disease, tremor and dystonia, a disorder which causes involuntary muscle contractions.



Movement disorders are neurologic conditions caused by a communication breakdown throughout the central nervous system that can result in a debilitating loss of muscle control, involuntary movement and reduced coordination. There are currently no proven cures for movement disorders, which means treatment options focus on alleviating symptoms to improve quality of life. St. Jude Medical designed the Infinity system to improve the experience of patients who rely on DBS therapy to manage their symptoms. The company also developed the St. Jude Medical directional lead to help physicians more accurately tailor DBS therapy to their patient’s specific needs while reducing side effects.

The first physician to implant the new Infinity system and the St. Jude Medical directional lead was Prof. Jan Vesper, a professor of functional neurosurgery and stereotaxy at the University Hospital in Düsseldorf, Germany, and president of the German Neuromodulation Society.

“The Infinity system is the first DBS system I’ve encountered that adjusts to the patient’s individual needs, rather than forcing the patient to adjust to the system,” said Prof. Vesper. “Offering my patients a DBS system with exceptional ease of use and smooth manageability is an exciting step in the treatment of debilitating movement disorders.”

A DBS system, like the St. Jude Medical Infinity DBS system, delivers mild electrical pulses to specific targets in the brain to stimulate the structures involved in motor control. With the launch of the Infinity system, St. Jude Medical aims to empower physicians to more accurately deliver stimulation with a DBS system. The new St. Jude Medical directional lead can deliver stimulation more precisely through eight independent electrodes that allow physicians to specifically direct current to targeted structures and areas of the brain. This advance will allow physicians to tailor the therapy to a patient’s specific needs while avoiding unnecessary stimulation to areas that may create side effects.

The Infinity system also offers new, distinct patient advantages. For patient comfort, the system is available in two different sizes, offers a maintenance-free and long-lasting recharge-free system, and uses Bluetooth® wireless technology and Apple™ digital devices for its patient controller and physician programmers. In addition, the St. Jude Medical Infinity system is also upgradeable, which provides patients the potential to access new therapy advances as they’re approved without the need for repeat surgery.

“The Infinity DBS system and directional lead design was designed to meet the needs of physicians who confirmed that they needed a system that prioritized improved stimulation targeting, device longevity and improved patient ease of use,” said Dr. Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “The Infinity DBS system is our answer for these previously unmet needs, demonstrating St. Jude Medical’s commitment to patient-centric solutions that help alleviate the debilitating effects of movement disorders.”

A press release can be found from St. Jude website.

Biotronik Smallest MR Conditional Pacing Lead Available in the United States

Biotronik announced the commercial launch of Solia S ProMRI®, with a 5.6 French lead body, the smallest MR conditional pacing lead available in the United States. Solia S ProMRI is available in 45, 53 and 60 centimeter lengths.

   

Solia received Food and Drug Administration (FDA) approval on June 9, 2016 based on data collected during the Pre-Market Study (IDE) phase of the SIELLO clinical study. All Pre-Market Study primary safety and efficacy endpoints were met with statistical significance:
Primary endpoint one: 100 percent 12-month event-free rate for patients with an atrial Solia lead
Primary endpoint two: 99.6 percent 12-month adverse event-free rate for patients with a ventricular Solia lead
Primary endpoint three: 100 percent rate of successful sensing and pacing at 12 months for patients with one or two
Solia leads

The SIELLO clinical study enrolled 1,758 patients at 60 US sites with 3,220 implanted Solia leads.

“BIOTRONIK has a long-standing history of providing reliable leads without recall. Nearly 600,000 BIOTRONIK leads of this product family have been implanted worldwide. We’ve built a reputation that physicians can trust,” said Marlou Janssen, President, BIOTRONIK, Inc. “We invest significantly in innovation, but never at the expense of safety or reliability. BIOTRONIK enrolls more patients in lead studies than any other global CRM device company. We make this investment because physicians and patients deserve that level of confidence.”

With a polyurethane coating over silicone designed to reduce friction, Solia enables easier introduction through small vessels and complex anatomy. Solia’s soft distal segment is designed to help reduce stress and minimize myocardial trauma.

“Because there is a wide range of patient anatomy types, it is necessary to have various lead lengths to ensure the best outcomes. There have been, however, limitations in the variety of leads available, so this new technology will offer a more versatile lead and improve procedures,” said Ulrika Birgersdotter-Green, MD, director of pacemaker and ICD services at UC San Diego Health and professor of medicine at University of California, San Diego School of Medicine.

A press release can be found from Biotronik website.

Bioactive Film Improves How Implants Bond With Bone in Animal Study

Researchers have developed a technique for coating polymer implants with a bioactive film that significantly increases bonding between the implant and surrounding bone in an animal model. The advance could significantly improve the success rate of such implants, which are often used in spinal surgeries. The work was done by researchers at North Carolina State University, the University of Cambridge and the University of Texas at San Antonio.



The polymer in question is called polyether ether ketone, or PEEK, which has mechanical properties similar to bone, making it attractive for use in spinal implants. However, PEEK doesn’t bond well with bone. To that end, researchers had previously developed a technique for coating PEEK with a substance called hydroxyapatite (HA), which is a calcium phosphate that bonds well with bone. Proof-of-concept studies were promising, but researchers were then only able to apply the HA coating to flat surfaces and had not tested HA-coated implants in an animal model.

“We can now use our technique to coat the entire surface of an implant, and testing HA-coated implants in an animal model has given us very promising results,” says Afsaneh Rabiei, a professor of mechanical and aerospace engineering at NC State and corresponding author of a paper on the work.

The first step of the HA-coating technique – which was developed in Rabiei’s lab – coats a PEEK implant with a thin film of yttria-stabilized zirconia (YSZ). The second step applies a coating of HA. The researchers then heat the HA layer using microwaves. The YSZ layer acts as a heat shield, preventing the PEEK from melting. Meanwhile, the heat gives the HA a crystalline structure that makes it more stable in the body, meaning that the calcium phosphate will dissolve more slowly – promoting bonding with surrounding bone.

In their new study, researchers tested three types of PEEK implants in a rabbit model: PEEK implants with no coating; PEEK implants with an HA coating treated only with microwaves; and PEEK implants with an HA coating treated with both microwaves and brief exposure to an autoclave in order to enhance the HA’s crystalline structure.

The researchers used microscopic evaluations of tissue cells and three-dimensional X-ray imaging to assess the performance of all three types of implants. Eighteen weeks after surgery, the researchers found that both types of HA-coated implants had more than double the bone formation of PEEK alone, with comparable bone density. The HA-treated implants also had higher bone-to-implant contact ratios than PEEK alone.

“These results indicated an improved implant fixation in the body, decreasing the chances of loosening of the implant after surgery and the need for revision surgery to remove and replace the implant,” Rabiei says. “This improvement is due to increased regenerated bone volume around coated implants compared to uncoated PEEK.”

The researchers also did biomechanical testing on the implants, assessing their “toughness,” or how well the implant bonded to the surrounding bone.

Full story can be found from NCSU website.

Philips expands its Digital Pathology Solutions portfolio with the acquisition of PathXL

Royal Philips announced that it has acquired PathXL, a Northern Ireland-based leader in digital pathology image analysis, workflow software and educational tools. PathXL’s image analysis and tissue pathology software will complement Philips’ Digital Pathology Solutions offering, and help expand the business’ leadership in this fast-growing field. Financial details of the transaction were not disclosed.

Pathology involves the examination of patient tissue samples and plays a crucial role in the diagnosis and treatment of a wide variety of diseases, including cancer. Philips is a pioneer and leader in the digitization of pathology, a fast-growing area in healthcare as pathology labs are under pressure to improve throughput and efficiency, enhance quality and to deliver new diagnostic tests for precision medicine.

“With this acquisition, we are accelerating our drive to support global medical institutions in their transition to digitized pathology workflows,” said Russ Granzow, General Manager of Philips Digital Pathology Solutions. “Together with PathXL we see a unique opportunity to amplify our combined technology leadership positions. We will be able to offer an intelligent and integrated solution that fulfills many needs in computational pathology, education, workflow solutions and image analytics. These important and growing disciplines within pathology will enable a high-quality quantitative analysis of digital whole slide images.”

Digital pathology will enable pathologists to review and share large sets of clinical data using image analytics with the aim to help improve the quality of diagnosis and has the potential to enable new therapies and ultimately improve patient outcomes. Philips’ lntelliSite Pathology Solution* is an automated digital pathology image creation, management and viewing system comprised of an ultra-fast pathology slide scanner, an image management system and dedicated software tools.

PathXL, founded in 2004 and headquartered in Belfast, Northern Ireland, offers a range of digital pathology software applications to research and education segments of pathology and bio-pharma markets. The company has approximately 30 employees, offices in the UK and USA and distributors across three continents.

A press release can be found from Philips website.

The First Clinically Proven Bioresorbable Magnesium Scaffold Receives CE Mark

BIOTRONIK announced that the Magmaris bioresorbable scaffold has received CE mark approval. The first clinically proven magnesium scaffold, Magmaris grants physicians a new option for treating coronary artery disease without leaving a permanent implant behind. Positive data regarding the device’s safety and clinical performance from the BIOSOLVE-II trial was previously published in The Lancet; one-year data confirming long-term safety was recently published in The European Heart Journal.



“Now that clinical results have firmly established the safety and clinical performance of Magmaris, the magnesium-based scaffold could emerge as a strong alternative to currently available polymer-based scaffolds,” commented BIOSOLVE-II principal investigator Dr. Michael Haude of the Lukaskrankenhaus, Neuss, Germany. “Because it is made of magnesium, the scaffold has some unique advantages over polymer-based options in terms of deliverability and radial resistance following the implantation procedure.”

Bench tests show that Magmaris is superior to a leading polymer-based scaffold in terms of deliverability, as it requires 40 percent less force to enter and cross a lesion.1 Physicians will find it easier to steer through vascular anatomy, as 34 percent more force is transmitted to the delivery system end.1 Additionally, Magmaris’s magnesium backbone minimizes recoil following the procedure, meaning that the scaffold is able to withstand external force within the vessel. This ensures the vessel remains open following implantation to prevent potential complications.

In addition to these properties, Magmaris offers a faster resorption compared to polymer-based scaffolds. “The body’s ability to quickly resorb magnesium leads to a faster and therefore more desirable resorption time,” stated
Dr. Stephan Kische, Vivantes Cardiology Clinic, Berlin, Germany. “As the results of BIOSOLVE-II demonstrate, vessels can restore vasomotion as soon as six months after the procedure.”2

“CE mark approval for Magmaris opens a new horizon in the vascular therapeutic field,” said Dr. Daniel Buehler, President, Vascular Intervention at BIOTRONIK. “We are eager to bring our magnesium scaffold to market, as we strongly believe that only a resorbable metal alloy can provide patients the distinctive advantages capable of addressing their future needs.”

More information can be found from Biotronik website.

Engineers develop a new biosensor chip for detecting DNA mutations

Bioengineers at the University of California, San Diego have developed an electrical graphene chip capable of detecting mutations in DNA. Researchers say the technology could one day be used in various medical applications such as blood-based tests for early cancer screening, monitoring disease biomarkers and real-time detection of viral and microbial sequences. The advance was published June 13 in the online early edition of Proceedings of the National Academy of Sciences.



“We are at the forefront of developing a fast and inexpensive digital method to detect gene mutations at high resolution—on the scale of a single nucleotide change in a nucleic acid sequence,” said Ratnesh Lal, professor of bioengineering, mechanical engineering and materials science in the Jacobs School of Engineering at UC San Diego.

The technology, which is at a proof-of-concept stage, is a first step toward a biosensor chip that can be implanted in the body to detect a specific DNA mutation—in real time—and transmit the information wirelessly to a mobile device such as a smartphone or laptop.

The team led by Lal, who serves as co-director for the Center of Excellence for Nano-Medicine and Engineering, a subcenter of the Institute of Engineering in Medicine (IEM) at UC San Diego, and Gennadi Glinsky, a research scientist at IEM, developed a new technique to detect the most common genetic mutation called a single nucleotide polymorphism (SNP), which is a variation of a single nucleotide base (A, C, G or T) in the DNA sequence. While most SNPs have no discernable effect on health, some are associated with pathological conditions such as cancer, diabetes, heart disease, neurodegenerative disorders, autoimmune and inflammatory diseases.



Current SNP detection methods are relatively slow, expensive and require the use of cumbersome equipment. “We’re developing a fast, easy, inexpensive and portable way to detect SNPs using a small chip that can work with your cell phone,” said Preston Landon, a research scientist in Lal’s research group and co-first author on the PNAS paper.

The chip consists of a DNA probe embedded onto a graphene field effect transistor. The DNA probe is an engineered piece of double stranded DNA that contains a sequence coding for a specific type of SNP. The chip is specifically engineered and fabricated to capture DNA (or RNA) molecules with the single nucleotide mutation—whenever these pieces of DNA (or RNA) bind to the probe, an electrical signal is produced.

The chip essentially works by performing DNA strand displacement, the process in which a DNA double helix exchanges one strand for another complementary strand. The new complementary strand—which, in this case, contains the single nucleotide mutation—binds more strongly to one of the strands in the double helix and displaces the other strand. In this study, the DNA probe is a double helix containing two complementary DNA strands that are engineered to bind weakly to each other: a “normal” strand, which is attached to the graphene transistor, and a “weak” strand, in which four the G’s in the sequence were replaced with inosines to weaken its bond to the normal strand. DNA strands that have the perfectly matching complementary sequence to the normal strand—in other words, strands that contain the SNP—will bind to the normal strand and knock off the weak strand. Researchers engineered the chip to generate an electrical signal when an SNP-containing strand binds to the probe, allowing for quick and easy SNP detection in a DNA sample.

Detailed report can be found from UCSD website by following this link.

Masimo Announces FDA Clearance for O3 Regional Oximetry

Masimo announced that it had received FDA 510(k) clearance for O3™ regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed.


O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. In a study on 27 subjects published in Anesthesia and Analgesia in 2014, Dr. Daniel Redford of the University of Arizona compared cerebral oxygen saturation measurements obtained from O3 with saturations obtained from blood samples (SavO2) through induced hypoxia.1 O3 regional oximetry provided absolute root-mean-squared error of 4% and relative root-mean-squared error of 2.1%.1 This study did not require that end tidal carbon dioxide (EtCO2) levels be fixed in the study protocol, allowing the rSO2 measurement to be responsive to changes in tissue oxygen saturation due to changes in CO2 in the blood. Follow up studies with O3 extended the subject pool to 74 subjects and demonstrated that O3 maintained its absolute and relative accuracy.2

"O3 regional oximetry delivers again on Masimo's technical prowess and gives clinicians access to valuable, accurate data about cerebral oxygen saturation," stated Joe Kiani, Founder and CEO of Masimo. "With the addition of O3 regional oximetry to the Root platform, clinicians can simultaneously access rSO2 and other measurements including SedLine brain function monitoring, Masimo SET SpO2, PVI, and SpHb monitoring – all in one monitoring platform."

O3 regional oximetry is currently intended for use with adults weighing 40 kg (88 lbs) or greater.

More information can be found from Masimo website by following this link.

Male Fertility Testing System Gets FDA Approval

Sandstone Diagnostics announced that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the company’s Trak Male Fertility Testing System.

“This FDA clearance represents a monumental milestone for Sandstone Diagnostics as we prepare to launch Trak as a radically new approach to personal fertility management,” said Greg Sommer, Sandstone CEO. “Male infertility is a dramatically under-appreciated condition affecting millions of couples every year. Trak is a complete system that not only gives couples the ability to conveniently measure semen quality at home, but also provides digital health tools and population-based data to help men take charge of their reproductive health in a whole new way.”

Data suggest that men contribute to up to half of all infertility cases, but couples currently have very few options for tackling the male half of the conception equation 1. Today’s standard practice of medical evaluation by clinical semen analysis done in an office setting is generally viewed as an awkward and embarrassing experience for men, which further contributes to low rates of male evaluation and treatment.

Trak, which will be available for purchase beginning October 2016, is an in-home test that allows couples to measure and track sperm count conveniently and privately as they try to conceive. The innovative design uses centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges. The system includes the Trak Engine and several disposable test kits for repeat testing.

Trak is the first device cleared by the FDA that provides semi-quantitative results, classifying sperm counts as “Low”, “Moderate” or “Optimal” based on World Health Organization guidelines and clinical studies that correlate higher sperm counts with faster time to pregnancy. A fully-integrated digital health system, the Trak System pairs with the Trak mobile app (available free on Google Play, the Apple App Store and Amazon), to allow men to enter, track and compare their results to population statistics via the cloud-based community of users and clinical databases, and receive personalized feedback on lifestyle and wellness steps that may boost their sperm count.

“This is a game changer for men’s health,” said Michael Eisenberg MD, director of Male Reproductive Medicine & Surgery at Stanford University Medical Center. “Sperm count provides a window into a man’s overall health and it’s very exciting to see a technology that lowers the barrier for men to get tested, see changes and address fertility concerns. I believe with the convenience and availability of in-home testing, we are poised to improve our understanding of male fertility and empower men to better manage their health.”

More information can be found from Sandstone website.

Compound eye for high-density 3D imaging

Prof. Lee Wing-bun and his research team at the Department of Industrial and Systems Engineering of The Hong Kong Polytechnic University have developed a system named "Compound eye for high-density 3D imaging". This innovation was inspired by the physiological structure of flies' compound eyes. Applying ultra-precision rolled plate machining technology, this low-cost system realises higher quality of images.



Adopting microlens arrays composed of 12,000 microlens, the technology can acquire realistic 3D images of objects at both near and far fields and achieve “shoot first, focus later” effect. By processing the captured images, this technology provides a solution for image distortion caused by conditions such as insufficient light and inadequate resolution.

This technology can be broadly applied in imaging applications, including high precision surface profile, displacement and velocity measurements. In future, such type of lens can be used for optical cameras for medical devices, Lytro cinema cameras, 3D scanners, as well as the production of 3D images and movies etc.

The invention won a Gold Medal and the Prize of Association “Russian House for International Scientific and Technological Cooperation” at the 44th International Exhibition of Inventions of Geneva.

More information can be found from The Hong Kong Polytechnic University website.

Transapical access and closure device receives CE approval

Micro Interventional Devices announced that it received CE Mark approval for the Company’s first product: Permaseal™ transapical access and closure device. The Permaseal device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium. Permaseal is the world’s first device using compliant soft-tissue PolyCorTM anchor technology.

Permaseal was validated in the STASIS Clinical Study (Secure Transapical Access and Closure Study) conducted at five European Sites. Results indicated that Permaseal shortened operating time and hospital stay, reduced adverse events including the need for transfusion and reduced 12-month mortality and stroke rates to 0%. The technology provides a direct, safe and simple, access and closure site for emerging complex structural heart disease procedures including TAVR, TMVR, PFO, and other minimally invasive cardiac procedures.

“The CE Mark approval of Permaseal is a tremendous achievement for MID,” said Michael Whitman, MID’s Founder, President & CEO. “Permaseal is the first in a series of products designed to replace the need for suturing in structural heart procedures. We are excited that this technology is now available to our European surgeons and their patients.”

“In the near future, PolyCor and MyoLastTM technologies will be utilized in a broad range of proprietary, catheter-based products, addressing unmet needs in tricuspid repair, mitral repair and mitral valve fixation,” added Whitman. “MID’s technology platform enables open-surgical procedures to be performed percutaneously.”

Permaseal is currently the only transapical access and closure device available for commercial use in the EU. FDA clearance to market Permaseal is pending.

Product information can be found from MID website by following this link.

The smallest robust eye tracker

For someone who is unable to use their hands or fingers, eye tracking is one of the quickest, easiest and most ergonomically sound ways to operate a computer. The PCEye Mini lets people surf the web, connect with friends online, play games, Skype, turn on the lights or TV, and even make spreadsheets and documents, using only the eyes. Ultimately, the PCEye Mini gives people greater personal freedom and independence.

  

With PCEye Mini, clicks and navigation becomes more intuitive, creating a relaxed and natural computing environment. Because of its simple magnetic mounting bracket and convenient USB connection, the PCEye Mini easily attaches and detaches from a computer. It is also easily transported and able to be used with different computers, like at work or in school. All processing for the eye tracker is done on the device itself and doesn’t slow down the computer. This means that one does not need the latest, most expensive desktop or laptop in order to use the PCEye Mini.

Product details can be found from Tobii Dynavox website.

New Chemical ‘Sponges’ to Soak Up Toxic Cancer-fighting Drugs After Targeting Tumors

Doctors have a powerful arsenal of cancer-fighting chemotherapy drugs to choose from, though a key challenge is to better target these drugs to kill tumors while limiting their potentially harmful side effects.

Now, researchers at the Department of Energy’s Lawrence Berkeley National Laboratory (Berkeley Lab) are helping to develop and test materials for a new device that can be inserted via a tiny tube into a vein and soak up most of these drugs like a sponge. That’s after a separate tube delivers a more concentrated dose to tumors—and before the drugs can widely circulate in the bloodstream.

Researchers say the drug-capture system could also potentially be applied to antibiotic treatments in combating dangerous bacterial infections while limiting their side effects.



X. Chelsea Chen, a postdoctoral researcher working in the Soft Matter Electron Microscopy program in Berkeley Lab’s Materials Sciences Division, had been investigating polymer membranes—which help current to flow in a fuel cell that converts hydrogen and oxygen into electricity—when she learned about the concept for this new type of medical device.

She saw that the proposed drug-capture device could benefit from the same property in the fuel cell material, which allows it to attract and capture certain molecules by their electric charge while allowing other types of molecules to flow through.

“We used to use this material for transporting protons in a fuel cell,” Chen said. “I was really excited when I found out this could be used for chemotherapy—this was branching out in a totally different direction.”

The polymer material includes polyethylene, which is strong and flexible and is used for garbage bags, and another polymer containing sulfonic acid, which has a negative electric charge.

Certain types of chemotherapy drugs, such as doxorubicin, which is used to treat liver cancer, have a positive charge, so the polymer material attracts and binds the drug molecules. “In our lab experiments, the current design can absorb 90 percent of the drug in 25-30 minutes,” Chen said.

That is important, since an increasingly popular liver-cancer treatment, known as TACE, can allow up to half of the chemotherapy dose to reach the rest of the body even though it is intended to reduce its circulation.



“Doxorubicin has been around for decades. It is very well understood, and it is also very toxic,” said Steven Hetts, an associate professor of radiology at UC San Francisco and an interventional neuroradiologist at the UCSF Medical Center who conceived of the new treatment system, called ChemoFilter. “If you get exposed to too much, when it goes through the heart you can go into heart failure.” So doctors are very careful with the dose.

Hetts specializes in treating eye tumors by navigating a tube, called a catheter, from the femoral artery in the thigh to the opthalmic artery that supplies blood to the affected eye, and pumping chemotherapy medication through the catheter to the tumor.

“You can get very high concentrations of that chemotherapy in the eye and relatively low concentrations in the rest of the body, but some will wash through the eye and into the veins in the head,” Hetts said, “so you can have side effects from that.”

Hetts began to question, “Is there a way to drain, to remove that excess drug before it has side effects? If you can remove a lot of the drug, you could escalate the dose of the drug you can give, for better tumor control and potentially a cure—and you could basically eliminate any side effects.

“It occurred to me that maybe we could navigate a separate catheter into the vein that drains the blood, and have a material that binds up any excess chemotherapy,” he said.

While the eye cancers he treats are rare—there are several hundred children per year in the U.S. who are affected by this kind of tumor—he saw a parallel need to improve the treatment options for liver cancer, which is far more pervasive: It is the third-leading cause of cancer deaths globally, with an estimated half a million new cases each year.

More information can be found from Berkeley Lab website.

EU Council and Parliamentary Committees endoreses new MDD & IVD directives

Medical devices (MDs) cover a wide array of products, from sticking plasters, to dental filling material, to heart valves and X-ray machines. In vitro diagnostic medical devices (IVDs) range from pregnancy self-tests, to blood-glucose meters, to state-of-the-art analytical laboratory equipment. There are over 500 000 devices on the market in the EU. The industry employs 575 000 people in about 25 000 companies, of which 95% are small and medium-sized enterprises (SMEs).

The EU legal framework relating to MDs and IVDs was harmonised in the 1990s. Given the fact that these devices have become increasingly sophisticated and innovative, the European Commission has considered it necessary to adapt existing rules to technological and scientific progress, improve the safety and traceability of devices, and ensure greater transparency, including for patients/users and the general public. The need for a revision was further reinforced by the breast implants scandal of 2010, in which a French manufacturer (Poly Implant Prothèse, PIP) had apparently used industrial silicone for the manufacture of breast implants for a number of years, potentially harming thousands of women worldwide.

Against this background, the Commission decided to undertake a revision of the current legislative framework. On 26 September 2012, it presented a package consisting of two proposals for regulations: on medical devices ('MD proposal') and on in vitro diagnostic medical devices ('IVD proposal'), accompanied by a communication. Both proposals have common horizontal aspects, but their specific features require separate legal acts.

The legislation is complex, wide-ranging and highly technical, and has been debated for nearly four years. The European Parliament adopted its position in first reading on 2 April 2014, the Council agreed on its general approach on 5 October 2015. Interinstitutional trilogue negotiations between Council, Parliament and Commission started on 13 October 2015 and were concluded at the tenth meeting on 25 May 2016.

The current EU regulatory framework consists of three different pieces of legislation: for medical devices, it is Council Directive 90/385/EEC on active implantable medical devices ('AIMD Directive') and Council Directive 93/42/EEC on medical devices ('MD Directive'); for in vitro diagnostic medical devices, it is Directive 98/79/EC of the European Parliament and of the Council ('IVD Directive').

Unlike medicinal products, MDs and IVDs are not subject to a pre-market authorisation, but to a conformity assessment. Conformity is assessed by 'notified bodies' – public third-party organisations or private companies designated by the Member States. These bodies issue a certificate of conformity ('CE' mark) for all but low-risk devices,1 the certification of which is handled by their manufacturers.

According to the Commission, the existing framework for regulating medical devices has proven its merits and is not fundamentally unsound. The revision aims to address anumber of weaknesses, such as differences in Member States' interpretation and application of rules, as well as regulatory flaws and gaps in regard to certain devices.

This is to be pursued within the overall objective of guaranteeing a high level of protection of human health and safety, ensuring smooth functioning of the internal market, and providing a regulatory framework that supports innovation and the competitiveness of the European medical device industry.

The main focus of the proposals is on the pre-market scrutiny and post-market surveillance of devices, and on their traceability along the supply chain.

The announcement can be found here by following this link.

FDA approves surgically placed obesity device

The U.S. Food and Drug Administration today approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.

The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight. It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.

“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “Patients need to be regularly monitored by their health care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”

To place the device, surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. The device removes approximately 30 percent of the calories consumed.

The FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy, and 60 control patients who received only the lifestyle therapy. After one year, patients using AspireAssist lost an average of 12.1 percent of their total body weight compared to 3.6 percent for the control patients.

Clinical trial results also suggested that both patient groups had small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life. These improvements may be attributable to the lifestyle therapy, which includes nutrition and exercise counseling.

Patients require frequent monitoring by a health care provider to shorten the tube as they lose weight and abdominal girth, so that the disk remains flush against their skin. Frequent medical visits are also necessary to monitor device use and weight loss and to provide counseling on lifestyle therapies. The device also has a safety feature that keeps track of the number of times the drain tube is connected to the port and automatically stops working after 115 cycles (approximately five to six weeks of therapy); patients must return for a medical visit to get a replacement part for the device in order to continue the therapy. This safety feature helps ensure patients use the device properly during therapy.

Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation and diarrhea.

The endoscopic surgical placement of the gastric tube is associated with risks, including sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the lining of the abdomen, sores on the inside of the stomach, pneumonia, unintended puncture of the stomach or intestinal wall and death.

Risks related to the abdominal opening for the port valve include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site where the tube is placed, leakage, bleeding and/or infection around the site where the tube is placed and device migration into the stomach wall. All have the potential to necessitate removal of the device. After device removal, there may be a risk of persistent fistula, an abnormal passageway between the stomach and the abdominal wall.

AspireAssist is contraindicated in those with certain conditions, including uncontrolled hypertension, diagnosed bulimia, diagnosed binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease or stomach ulcers. AspireAssist is also contraindicated in patients with a history of serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain or those at a high risk of medical complications from an endoscopic procedure. 

FDA approval announcement can be found from FDA website.

Product information can be found from Aspire Bariatrics website.

UK Regulatory Authority Approves Clinical Trial result for Pixium Vision’s Bionic Vision System

Pixium Vision announced that it has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK to initiate a clinical trial for patients who have lost sight due to retinitis pigmentosa (RP) with the IRIS® II bionic vision system. This system being evaluated includes a mini bio-inspired camera and a 150 electrode epi-retinal implant with an explantable design.



Participation of Moorfields Eye Hospital NHS Foundation Trust broadens the clinical study centres of excellence in addition to sites across France, Germany and Austria. Moorfields Eye Hospital is the oldest and largest centre for ophthalmic treatment, teaching and research in Europe. Additional clinical centres across Europe enables broader patient outreach, increased opportunity to participate in the clinical trial, and paves the way for future commercialisation of the bionic vision system.

In parallel, Pixium Vision initiated last December CE mark approval process on the basis of IRIS clinical experience. Subject to CE mark approval timing, commercialisation is expected to start in H2 2016.

More details can be found from Pixium Vision website.

CFDA signs MOU on strategic cooperation with the Bill & Melinda Gates Foundation

China Food and Drug Administration (CFDA) Minister Bi Jingquan and Bill & Melinda Gates Foundation Co-Chair Bill Gates recently officially signed the Memorandum of Understanding on Strategic Cooperation between the China Food and Drug Administration of the People's Republic of China and the Bill & Melinda Gates Foundation.

According to the Memorandum of Understanding, both sides will cooperate to improve China’s drug supervision capability and drug technical standards, and establish the mechanism of introducing international high-end talent of drug supervision and fostering internationalized supervision talents. Under the Memorandum of Understanding, efforts will be made to implement the international expert introduction projects for drug evaluation and inspection, and set up drug supervision think tank to support China's reform of drug evaluation and approval system.

Rechargeable implantable Sacral Neuromodulation System CE marked

Axonics Modulation Technologies announced that it has received CE approval for its SNM System to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.

The CE Mark confirms that the Axonics product meets all of the essential requirements of the European Medical Device Directive for Active Implantable Medical Devices and enables Axonics to market its SNM System throughout the European Union.

Axonics has also received ethics committee approval from select centers in Western Europe and will start a 65-patient post-market clinical follow up (PMCF) study.

The Company also announced that Neurourology and Urodynamics published the results of a peer-reviewed study titled, “Cost Profiles and Budget Impact of Rechargeable Versus Non-Rechargeable Sacral Neuromodulation Devices in the Treatment of Overactive Bladder Syndrome.” The study assesses the potential cost impact to U.S. healthcare payers of a rechargeable SNM system. Findings determined that compared to non-rechargeable SNM systems for the treatment of OAB, a rechargeable SNM system with a long-lived battery could save the U.S. healthcare system more than $12 billion over the next 15 years. Physicians and researchers collaborating on the study included Karen L. Noblett, MD, University of California, Riverside; Roger R. Dmochowski, MD, Vanderbilt University; Sandip P. Vasavada, MD, Cleveland Clinic, and Abigail M. Garner, MS; Shan Liu, PhD; Jan B. Pietzsch, PhD of Wing Tech, Inc., Menlo Park, CA.

“The Axonics device promises increased patient comfort given its small size. Moreover, the fact that it is rechargeable and can function three times longer in patients will eliminate the need for repeat surgeries that are currently required every four or five years to replace implanted devices with drained batteries,” said Prof. Karen L. Noblett, M.D., Chair of the Department of Obstetrics and Gynecology, University of California Riverside School of Medicine. “Our economic study findings clearly show the Axonics System has the ability to also lower healthcare costs. This potentially allows more patients to benefit from a therapy that has been proven over many years to improve the quality of life of patients suffering from urinary and fecal dysfunction.”

OAB affects an estimated 85 million adults in the US and Europe. Another 40 million are reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed in Europe and the US for the past two decades. Over 200,000 patients have benefited from the therapy to date. SNM is the only OAB treatment with proven clinical superiority to standard medical therapy and OAB patients who receive SNM report significantly higher quality of life than patients undergoing drug treatment.

“Axonics has successfully developed a unique product to deliver SNM therapy that we believe will greatly improve the patient and clinician experience,” said Raymond W. Cohen, Axonics’ Chief Executive Officer. “We look forward to treating patients in our upcoming PMCF study.”

More details can be found from Axonics website.

World’s first child-exoskeleton for spinal muscular atrophy

The Spanish National Research Council (CSIC) introduced the world’s first infant exoskeleton which is designed to help children with spinal muscular atrophy, a degenerative illness which affects one in ten thousand babies in Spain. Weighing 12 kilos, the apparatus is made of aluminium and titanium, and is designed to help patients walk- in some cases for the first time. Furthermore, it will also be used in physiotherapy in hospitals to prevent the secondary effects associated with the loss of mobility in this illness. The technology, which has been patented and licensed jointly by CSIC (the Spanish National Research Council) and its technology-based business unit, Marsi Bionics, is currently in the preclinical phase.



The brace consists of long support rods, or orthoses, which are adjusted to fit around the child’s legs and torso. In the joints, a series of motors mimic human muscles and give the child the necessary strength to stand upright and walk. Finally, a series of sensors, a movement controller, and a battery with 5 hours of life complete the system.

“The number one drawback in developing this type of paediatric exoskeleton is that the symptoms of neuromuscular illnesses- such as spinal muscular atrophy- change over time, as much in the articulations as in the body.That’s why it’s fundamental to have an exoskeleton capable of independently adapting to these changes. Our model includes intelligent joints which alter the brace’s rigidity automatically and adapt to the symptoms of each individual child at whenever required”, explains Elena Garcia, from the Automatics and Robotics Centre, a CSIC/Politechnic Univerity of Madrid.

The exoskeleton is aimed at children between the ages of 3 and 14. With five motors in each leg (each requiring its own space to function), the minimum possible length of each leg is restricted. Furthermore, the unpredictability of the involuntary body movements of under-3s have forced researchers to set a lower age limit for the device. In other pathologies, which don’t restrict any joint movement and so require fewer motors, it would be possible to build a smaller frame”, adds García.

Spinal muscular atrophy is one of the most serious degenerative neuromuscular diseases in children and, although it is rare, it results in high rates of mortality in the babies and children it affects. It is of genetic origin and causes progressive general muscular weakness. This loss of strength leaves the child prostrate which is when the most drastic effects of inability to walk set in- such as escoliosis and osteoporosis- which also cause lung disfunction, jeapordising the child’s survival.

Type 1, the most severe of the three types, is diagnosed in the first few months of life. Babies seldom make it through their first 18 months. Type 2, which the exoskeleton is aimed at combating, can be diagnosed between the first 7-18 months of life. Children who show symptoms are never able to walk, thus leading to a serious decline in their health. Children’s life expectancy is seriously affected by this lack of mobility and any respiratory infection becomes critical to over-twos. There are however cases of some sufferers who reach adulthood. Diagnosis of Type 3 is made once a child reaches 18 months, although the symptoms don’t become evident until adolescense, when sufferers lose the ability to walk. In this final case, life expectancy is normal, though with a reduced quality of life”, comments Garcia.

By using the device, Elena García and her team hope to help patients walk and in so doing prevent the setting in of escoliosis, as well as the chain of resulting conditions caused by the anability to stand upright and walk.

More information can be found from the Spanish National Research Council (CSIC) website.

Pioneering artificial pancreas to undergo final tests

A device developed by University of Virginia School of Medicine researchers to automatically monitor and regulate blood-sugar levels in people with type 1 diabetes will undergo final testing in two clinical trials beginning in early 2016.

Favorable results from these long-term clinical trials examining how the artificial pancreas works in real-life settings could lead the U.S. Food and Drug Administration and other international regulatory groups to approve the device for use by people with type 1 diabetes, whose bodies do not produce enough insulin. Approximately 1.25 million Americans have type 1 diabetes, according to the U.S. Centers for Disease Control and Prevention.



The trials will be conducted at nine locations in the U.S. and Europe, supported by a grant of more than $12.6 million from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The first study – the International Diabetes Closed-Loop trial – will test technology developed at UVA by a research team led by Boris Kovatchev, PhD, director of the UVA Center for Diabetes Technology. That technology has been further refined for clinical use by TypeZero Technologies, a startup company in Charlottesville that has licensed the UVA system.

The second trial will also examine a new control algorithm developed by the team of Dr. Francis Doyle III at the Harvard John A. Paulson School of Engineering and Applied Sciences to test whether it further improves control of blood-sugar levels.

“To be ultimately successful as an optimal treatment for diabetes, the artificial pancreas needs to prove its safety and efficacy in long-term pivotal trials in the patient's natural environment,” Kovatchev said. “Our foremost goal is to establish a new diabetes treatment paradigm: the artificial pancreas is not a single-function device; it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem."

The goal of the artificial pancreas is to eliminate the need for people with type 1 diabetes to stick their fingers multiple times daily to check their blood-sugar levels and to inject insulin manually.

Instead, the artificial pancreas is designed to oversee and adjust insulin delivery as needed. At the center of the artificial pancreas platform – known as InControl – is a reconfigured smartphone running advanced algorithms that is linked wirelessly to a blood-sugar monitor and an insulin pump, as well as a remote-monitoring site. People with the artificial pancreas can also access assistance via telemedicine.

Two trials are planned as part of the NIH-funded study. In the first study, 240 patients with type 1 diabetes will test the safety and effectiveness of the artificial pancreas for six months while going about their regular daily routines. The artificial pancreas will be compared with a standard insulin pump on two key measures: how well blood-sugar levels are controlled and whether the risk of hypoglycemia, or low blood sugar, is reduced.

A second trial will follow 180 patients who completed the first study for an additional six months to test the Harvard University-developed algorithm and determine whether it further enhances blood sugar control.

Along with UVA, the artificial pancreas will be tested at eight additional sites: Harvard University, Mount Sinai School of Medicine, Mayo Clinic, University of Colorado, Stanford University, University of Montpellier in France, University of Padova in Italy and Academic Medical Center at the University of Amsterdam in The Netherlands.

More details can be found from UVA website by following this link.

Zimmer Biomet To Acquire LDR To Enhance Innovation And Growth Of Spine Business

Zimmer Biomet and LDR Holding Corporation announced that both Boards of Directors have approved a definitive agreement under which Zimmer Biomet will commence a tender offer to acquire all of the outstanding shares of LDR for $37.00 per share in cash, which implies a transaction value of approximately $1.0 billion. The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2016.

Founded in France in 2000, LDR designs and commercializes innovative technologies making surgical procedures easier to perform and providing improved clinical outcomes in the treatment of spine disorders. The addition of LDR will bolster Zimmer Biomet's presence in the global Spine market and provide the Company with an immediate and a leading position in the fast growing cervical disc replacement (CDR) and MIS segments. The combination is expected to meaningfully accelerate the growth of Zimmer Biomet's Spine business through the incremental revenues associated with entry into the cervical disc replacement market and cross-portfolio selling opportunities to both Zimmer Biomet and LDR customer bases.

Zimmer Biomet also expects the transaction to accelerate the future growth of its overall business. With respect to 2016, the Company reiterates its previously provided revenue guidance, an increase of 2.0% to 3.0% as compared to adjusted pro forma full year 2015 on a constant currency basis. The Company will update its revenue guidance to reflect this transaction at or about the time of closing. Zimmer Biomet is also reiterating its 2016 adjusted diluted EPS guidance of $7.85 - $8.00. The transaction is expected to be neutral to adjusted diluted EPS in 2017 and accretive thereafter.

"This highly strategic and complementary transaction will enhance Zimmer Biomet's innovation leadership in musculoskeletal healthcare by adding a premier spine platform to our portfolio of solutions," said David Dvorak, President and CEO of Zimmer Biomet. "This combination is consistent with our goal of driving meaningful growth across all musculoskeletal markets with innovative products, technologies and services that enhance patient outcomes. The talented LDR team uniquely shares our deeply held commitment to innovating in a manner that restores mobility and alleviates pain for patients around the world, and we look forward to welcoming them to Zimmer Biomet. We are confident that the combination of Zimmer Biomet's Spine division and LDR will create a Spine company with the scale, talent and technology portfolio to become a leader in the $10 billion global Spine market."

Christophe Lavigne, Co-Founder, Chairman, President and CEO of LDR, said, "We are delighted with this combination, which will further our commitment to improving spine care by providing greater access to our innovative product offerings for patients around the world, while offering our stockholders immediate cash value. We have great respect for the Zimmer Biomet team, who shares our passion for innovation as well as our commitment to patients and providers. We look forward to working closely with Zimmer Biomet to achieve a seamless transition and create lasting value for all of our stakeholders."

Strategic Benefits of the Transaction
Enhances Zimmer Biomet's innovative product portfolio: The combination with LDR is a natural expansion of Zimmer Biomet's Spine business. LDR's talent, culture and track record of innovation is evidenced by its primary product offerings based on its Mobi-C® cervical disc replacement device and MIVo™ portfolio to support lumbar and cervical fusion procedures, both of which are complementary to Zimmer Biomet's current portfolio. Combined, Zimmer Biomet and LDR create a differentiated and comprehensive Spine portfolio, improving Zimmer Biomet's position for sustainable growth.
Positions Zimmer Biomet as a market leader in CDR: CDR represents the fastest growing segment within the $10 billion Spine industry. LDR's Mobi-C CDR device has been well received in the market as the first and only device FDA approved to treat both one- and two-level adjacent damaged cervical discs. Long-term clinical studies for Mobi-C have demonstrated the efficacy of this unique technology, with Mobi-C showing superiority to fusion for two-level procedures. These excellent clinical outcomes coupled with market-leading ease of use are expected to drive further market penetration as a part of Zimmer Biomet's Spine portfolio. Finally, the combination positions Zimmer Biomet to leverage its scale and resources to accelerate the development of the CDR market globally.
Significant opportunity to leverage expanded commercial channel: The Company expects to capture cross-portfolio selling opportunities to both Zimmer Biomet and LDR customer bases. Zimmer Biomet anticipates enhancing LDR's product growth and reach by capitalizing on an expanded combined distribution channel in the U.S. and key international Spine markets. The combination also will create a comprehensive Spine portfolio with innovative surgical solutions that place Zimmer Biomet in an advantaged position to compete for large hospital vendor contracts.

Financing

Zimmer Biomet plans to finance the transaction using cash balances on hand and existing availability under its revolving credit facility and expects to maintain an investment grade profile. Following consummation of the transaction, Zimmer Biomet plans to issue $750 million of senior unsecured notes, the proceeds of which will be used to repay the credit facility. Zimmer Biomet intends to maintain its previously discussed deleveraging strategy.

Organization and Leadership

Upon consummation of the transaction, LDR will be combined with Zimmer Biomet's Spine & CMF category and will be led by Adam Johnson, Zimmer Biomet Group President, Spine, CMF and Thoracic, and Dental. Christophe Lavigne, Co-Founder, Chairman, President and CEO of LDR and Patrick Richard, Co-Founder of LDR and Executive Vice President and General Manager of LDR Médical, are committed to driving the benefits of this transaction and will remain with the Company in key leadership positions within the global Spine business. To leverage talent and product expertise from both companies, Zimmer Biomet plans to complement the Spine business headquarters in Broomfield, Colorado by maintaining a significant presence in LDR's strong technology hubs of Austin, Texas and Troyes, France.

Transaction Structure, Approvals and Time to Closing

The transaction is structured as an all-cash tender offer for all outstanding shares of LDR common stock at a price of $37.00 per share, followed by a merger in which each share of LDR common stock that is not tendered pursuant to the tender offer would be converted into the right to receive in cash $37.00 per share.

The transaction is subject to the expiration or termination of the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the tender of a majority of the outstanding LDR shares in the tender offer and other customary closing conditions. The transaction is expected to close in the third quarter of 2016.

The announcement can be found from Zimmer website.

High-definition imaging to improve early diagnosis of cancer

Researchers from Universidad Politécnica de Madrid (UPM) are involved in a European network to develop an endoscopic scanner for early detection of certain types of cancers that have a high mortality rate today.

Endo TOFPET-US project aims to develop a generation of medical scanners specifically designed for the examination of certain organs. Endo TOFPET-US is an international consortium which is technically led by CERN and uses the latest advances on detectors of high energy physics to enhance the quality of nuclear medical images, particularly the images known as Positron Emission Tomography (PET).

Researchers from Biomedical Image Technologies (BIT) at Universidad Politécnica de Madrid (UPM) are involved in the project through the PicoSec educational project and have collaborated in the design and implementation of both the electronics and data acquisition system of the developed sensor. This work was carried out along with the lab of Experimental High Energy Physics and Associated Instrumentation in Portugal (LIP) that gave as a result the spin-off company PETsys Electronics SA. This electronics will help obtain high-definition images that will allow us to early detect cancers. An example is the case of pancreatic cancer that has a mortality rate up to 90% nowadays.



The latest innovations in detectors for high energy physics carried out in CERN are exceeding the speed limit when detecting elementary particles. PET medical imaging is one application of this technology and consists in a technique that detects pairs of gamma rays emitted indirectly by a positron-emitting and which is used in medical scanners for cancer diagnosis.

As part of the Seventh Framework Programme, the European Union funded the international collaboration known as EndoTOFPET-US in which various multidisciplinary groups joined forces to develop the first endoscopic PET scanner for specific organs. Besides, in order to boost the future of research in Europe, this consortium trained a group of young researchers who participated in the development of the scanner within the PicoSEC programme.

BIT researchers from School of Telecommunications Engineering at UPM took part of this project and have actively participated in the design and implementation of the electronics and the data acquisition system of the detector with the collaboration of PETsys Electronics SA.

In spite of the latest advances in cancer detection and diagnosis, some types of cancers are detected in advanced stages due to their morphology and location. Improving an early detection of the different types of cancers is essential to increase the survival rates of this disease.


The project includes two trends in medical imaging: detectors for examination of certain organs and a multimodal imaging technique, all this in order to provide data about the cancer that is not available so far.

In the case of conventional PET scanners, the patient's body is introduced in a ring of detectors to obtain a cross-section image. Given the new possibilities of miniaturization, researchers are studying a new asymmetric architecture in which a miniaturized detector is introduced inside the patient's body and placed close to the organ of interest. As a result, this proximity provides higher sensitivity since the patient would receive lower radioactive dose to visualize the lesion without losing the image quality.

In addition to this sensitivity, the new endoscopic detector includes other innovative features. According to UPM researchers: “thanks to its high-speed electronics, this scanner measures the time of flight of photons and this allows researchers a precise identification of the origin point in where particles are concentrated in the tumor mass, filtering the background noise and giving as a result clear images”. Researchers also add: “the system has a high degree of pixels, providing higher spatial resolution of the image and detecting millimeter lesions”.

The project also includes another trend in biomedical imaging, the multimodal imaging, a way to obtain information by combining diverse techniques and merging the resulting images. Specifically, the scanner combines ultrasounds (US), which give morphological information of the area of interest, with PET, that provides metabolic information to identify cancerous cells.

This innovative scanner requires a high-performance data acquisition system. Thus, UPM researchers in collaboration with PETSys Electronics SA have designed an intelligent, distributed and asymmetric system, which manages a great volume of data due to the large number of channels with different data rates for each type of detector (Endoscopic and abdominal detectors).

Part of the success of this system is based on the decentralization, since this system moves part of its complexity to the electronics embedded in the detectors. Therefore, the system can implement a multi-level triggering scheme with various stages of filtering data depending on the information available on each stage.

According to UPM researchers: “this new generation of endoscopic scanners will contribute the development of devices that will allow us to visualize cancers in the early stages, and consequently to enhance their prognosis”.

More information can be found from Universidad Politécnica de Madrid website.