Posts Tagged ‘diabetes’

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PaQ Three Day Insulin Delivery Device Cleared in Europe

PaQ Three Day Insulin Delivery Device Cleared in Europe

The CeQur device, a small discreet, wearable insulin patch infuser, is for the continuous subcutaneous delivery of rapid acting insulin for the management of type 2 Diabetes mellitus.

The CeQur insulin delivery device is designed to meet the specific needs of people with type 2 diabetes who could benefit from intensive insulin therapy.

Its simple and discrete design may enable patients to more readily experience the benefits of intensive insulin therapy, all while remaining free from multiple daily injections.

The CeQur insulin infuser includes a disposable insulin reservoir that attaches to a reusable electronic messenger. The device easily attaches to the patient’s abdominal area with a safe and secure adhesive backing. Once in place, insulin is delivered subcutaneously through a fine, soft tube or cannula from the reservoir that is changed by the patient every few days.

The CeQur insulin delivery device is designed to use just one type of insulin for both basal and bolus dosing, and will be available in multiple basal rates.

CeQur of Horw, Switzerland received European approval for the PaQ Insulin Delivery Device. The PaQ provides three days of continuous insulin infusion for patients with type 2 diabetes, and also offers the option for users to initiate an extra bolus injection at any time.

The device consists of a disposable insulin container that connects to a reusable electronic component that can provide on-demand information on the status of the PaQ.

From the company announcement:

The CeQur insulin infuser includes a disposable insulin reservoir that attaches to a reusable electronic messenger. The device easily attaches to the patient’s abdominal area with a safe and secure adhesive backing. Once in place, insulin is delivered subcutaneously through a fine, soft tube or cannula from the reservoir that is changed by the patient every few days.

The CeQur insulin delivery device is designed to use just one type of insulin for both basal and bolus dosing, and will be available in multiple basal rates.

Source : http://cequrcorp.com/cequr-device/

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Medgenics’ EPODURE Biopump technology for EPO delivery receives U.S. patent

Medgenics’ EPODURE Biopump technology for EPO delivery receives U.S. patent

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of BiopumpTM a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced a patent granted by the U.S. Patent and Trademark Office (USPTO) protecting the use of Medgenics’ EPODURE Biopump technology for delivery of erythropoietin (EPO). Medgenics is developing EPODURE to address the need for safer, sustained treatment of anemia. The USPTO also allowed claims covering a similar method for delivery of clotting Factor VIII, underlying Medgenics’ HEMODURE™ Biopump technology for sustained prophylactic treatment of hemophilia.

Similar claims covering EPODURE and HEMODURE have also been recently allowed in Japan, China, Korea and Australia.

In total, Medgenics’ global portfolio now includes 36 patents issued, with 81 more pending.

Medgenics believes its approach to protein therapy has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics’ technologies target the global protein therapy market which is forecast to reach $132 billion in 2013.

“As we continue to progress in our clinical trials and move forward in our business development efforts, the protection of our intellectual property becomes critical. We believe that receiving method patents and allowance of key claims for our Biopump™ system for the production and delivery of EPO and Factor VIII proteins increases the value of our intellectual property assets and our company,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics.

Source : http://www.news-medical.net/news/20121122/Medgenicse28099-EPODURE-Biopump-technology-for-EPO-delivery-receives-US-patent.aspx

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New approach could help orthopaedic surgeons better deal with battlefield injuries

New approach could help orthopaedic surgeons better deal with battlefield injuries

Bones are resilient and heal well after most fractures. But in cases of traumatic injury, in which big pieces of bone are missing, healing is much more difficult, if not impossible. These so-called “large segmental defects” are a major clinical problem, and orthopaedic surgeons struggle to treat them, especially among the military in places like Afghanistan.

Now research led by investigators at Beth Israel Deaconess Medical Center (BIDMC) offers surgeons a new approach. Described on-line in today’s issue of the Journal of Bone and Joint Surgery, the results confirm that the bone healing process of large segmental defects is exquisitely sensitive to its mechanical environment and suggests that “reverse dynamization,” a straightforward and inexpensive process, could help speed healing of these traumatic injuries.

“Bones are greatly influenced by their mechanical environment, which is why casts, rods, plates and screws are typically used to heal fractures – with a great deal of success,” explains senior author Christopher Evans PhD, Director of the Center for Advanced Orthopaedic Studies at BIDMC. “But until now, no one has examined the relevance of the mechanical environment to the healing of large segmental bone defects.”

According to the American Association of Orthopaedic Surgeons (AAOS), these injuries are one of the most demanding surgical challenges faced by orthopaedic trauma surgeons. Often as large as 20 centimeters in length, large segmental defects can be complicated by regional soft-tissue loss, reduced vascularity, regional scarring and infection. The AAOS notes that an increased number of missions being conducted on foot in Afghanistan has led to an increase in this type of combat blast injury.

Changing levels of stiffness during bone healing is known as “dynamization.” During standard dynamization, bone is first held rigidly in place by a mechanical intervention, or fixation device. Once healing has begun, the stiff rigidity is loosened to allow movement. “An ‘external fixator’ is placed on the outside of the skin and usually has a ‘cross-bar’ that determines the level of rigidity and can be adjusted to allow more or less motion,” explains Evans, who is also the Maurice Edmond Mueller Professor of Orthopaedic Surgery at Harvard Medical School. Evans and his colleagues thought that how firmly or loosely injured bone is held together by mechanical interventions -casts, rods, plates and screws – could impact these large segmental bone defects, just as it does for more minor fractures — but with one big difference. The scientists changed stiffness levels in the opposite order — hence, “reverse dynamization.”

“Our laboratory has a lot of experience with a rat model of segmental defect healing, and we noticed that during the healing process, the defect first fills with cartilage, and then the cartilage turns to bone,” says Evans. Technically known as “endochondral ossification” this process is well documented to occur in fracture healing. ‘We knew from other previous work that the early formation of cartilage is helped when mechanical fixation is loose. We also knew that a subsequent increase in fixator stiffness would provide the rigidity needed for the ingrowth of blood vessels and other aspects of healing.” Evans and his coauthors hypothesized that a period of loose “fixation” followed by a period of stiffened “fixation” would accelerate healing of large segmental defects. “If bones are allowed to move slightly, cartilage will form in the defect,” he adds. “If the area is then held rigidly in place, the new cartilage will then turn to bone.”

The team constructed external fixators capable of providing varying degrees of stiffness during the healing process. By implanting a growth factor called bone morphogenetic protein-2 on a collagen sponge, the scientists initiated healing of segmental defects in the femurs of 60 rats. Groups of the animals were then allowed to heal with either low-, medium-, or high-stiffness fixators. Healing also took place under conditions of reverse dynamization, in which the stiffness levels were changed from low to high after a period of two weeks. After eight weeks, the researchers assessed healing using various measures including radiographs, microscopic analyses, and mechanical tests.

The investigators found that when they looked only at unchanging stiffness, the low-stiffness fixator produced the best healing; however, by comparison, the reverse dynamization provided considerable improvement, leading to a marked acceleration in the healing process by all tests. Also, notes Evans, the bone mineral content and bone area of the defects healed by reverse dynamization were closer to normal, and the healed bone had greater mechanical strength.

“Our study confirms the exquisite sensitivity of bone healing to its mechanical environment,” he notes. The next step, says Evans, will be to see if this therapy works in large animals, while also gathering more information about the biological mechanisms that are at play. But, he adds, moving these findings into a clinical setting should be relatively straightforward. “The nice thing about this approach is that it’s simple and could be rapidly translated to human use if our proposed large-animal studies are successful. The regulatory hurdles should be minor.” Furthermore, he adds, reverse dynamization might also be applicable to other situations for which bone healing is problematic. “Sometimes in smokers or individuals with diabetes, fractures heal poorly,” he notes, adding that the same can be true when an infection is present.

Reverse dynamization is also an attractive option in terms of cost. “Often, strategies devised in the lab to solve clinical problems are far too complex and expensive to be translated into meaningful clinical use,” notes study coauthor Mark Vrahas, MD, Chief of the Harvard Orthopaedic Trauma Service. “But if the promise of this strategy holds out, it will be inexpensive enough to be used even in developing countries, where the burden of severe injuries are particularly high.”

source : http://www.news-medical.net/news/20121122/New-approach-could-help-orthopaedic-surgeons-better-deal-with-battlefield-injuries.aspx

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UNSW-developed nanoparticle could improve effectiveness of chemotherapy for neuroblastoma

UNSW-developed nanoparticle could improve effectiveness of chemotherapy for neuroblastoma

In a world-first, researchers from the Australian Centre for Nanomedicine at the University of New South Wales (UNSW) in Sydney have developed a nanoparticle that could improve the effectiveness of chemotherapy for neuroblastoma by a factor of five.

Neuroblastoma is an aggressive childhood cancer that often leaves survivors with lingering health problems due to the high doses of chemotherapy drugs required for treatment. Anything that can potentially reduce these doses is considered an important development.

The UNSW researchers developed a non-toxic nanoparticle that can deliver and release nitric oxide (NO) to specific cancer cells in the body. The findings of their in vitro experiments have been published in the journal Chemical Communications.

“When we injected the chemo drug into the neuroblastoma cells that had been pre-treated with our new nitric oxide nanoparticle we needed only one-fifth the dose,” says co-author Dr Cyrille Boyer from the School of Chemical Engineering at UNSW.

“By increasing the effectiveness of these chemotherapy drugs by a factor of five, we could significantly decrease the detrimental side-effects to healthy cells and surrounding tissue.”

This synergistic effect between nitric oxide and chemotherapy drugs had previously been reported in other cancer cell lines, but the delivery compounds were potentially toxic and had very poor stability, or shelf life.

In contrast, the UNSW-developed nanoparticle is non-toxic and has a shelf life that has been extended from two days to more than two weeks: “Drug storage is critical and this is a substantial improvement over previous nitric oxide-carrier compounds,” says Boyer.

Nitric Oxide is an important cellular signalling molecule involved in many physical and mental processes, and deficiencies have been associated with heightened susceptibility to cancer, liver fibrosis, diabetes, cardiovascular illnesses and neurodegenerative diseases.

“If we can restore nitric oxide with these nanoparticles this could have implications for all the illnesses associated with NO deficiencies, including diabetes and neurodegenerative,” he says.

The key medical challenge, says Boyer, has been figuring out a way to deliver appropriate doses to specific sites within the body, without provoking an adverse reaction. The Australian Centre for Nanomedicine – which crosses science, engineering and medicine – is investigating multi-disciplinary solutions.

Boyer says that while biologists have experimented with nitric oxide, mixing it with cancer cells and observing the reactions, “no one has tried to develop a platform to specifically deliver nitric oxide – that is, where you want it, when you want it”.

The next step is to test the nanoparticle on other cell lines, such as lung and colon cancer cells, and to proceed to in vivo tests. The team also included researchers from the Children’s Cancer Institute Australia based at UNSW’s Lowy Cancer Research Centre.

Source : http://www.news-medical.net/news/20121121/UNSW-developed-nanoparticle-could-improve-effectiveness-of-chemotherapy-for-neuroblastoma.aspx!

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NIH-funded scientists develop new treatment to combat autoimmune disorders in mouse model

NIH-funded scientists develop new treatment to combat autoimmune disorders in mouse model

In a mouse model of multiple sclerosis (MS), researchers funded by the National Institutes of Health have developed innovative technology to selectively inhibit the part of the immune system responsible for attacking myelin-the insulating material that encases nerve fibers and facilitates electrical communication between brain cells.

Autoimmune disorders occur when T-cells-a type of white blood cell within the immune system-mistake the body’s own tissues for a foreign substance and attack them. Current treatment for autoimmune disorders involves the use of immunosuppressant drugs which tamp down the overall activity of the immune system. However, these medications leave patients susceptible to infections and increase their risk of cancer as the immune system’s normal ability to identify and destroy aberrant cells within the body is compromised.

Supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at NIH, Drs. Stephen Miller and Lonnie Shea at Northwestern University, Evanston, teamed up with researchers at the University of Sydney, and the Myelin Repair Foundation in Saratoga, Calif. to come up with a novel way of repressing only the part of the immune system that causes autoimmune disorders while leaving the rest of the system intact.

The new research takes advantage of a natural safeguard employed by the body to prevent autoreactive T-cells-which recognize and have the potential to attack the body’s healthy tissues-from becoming active. They report their results in the Nov. 18 online edition of Nature Biotechnology.

“We’re trying to do something that interfaces with the natural processes in the body,” said Shea. “The body has natural mechanisms for shutting down an immune response that is inappropriate, and we’re really just looking to tap into that.”

One of these natural mechanisms involves the ongoing clearance of apoptotic, or dying, cells from the body. When a cell dies, it releases chemicals that attract specific cells of the immune system called macrophages. These macrophages gobble up the dying cell and deliver it to the spleen where it presents self-antigens-tiny portions of proteins from the dying cell-to a pool of T-cells. In order to prevent autoreactive T-cells from being activated, macrophages initiate the repression of any T-cells capable of binding to the self-antigens.

Dr. Miller was the first to demonstrate that by coupling a specific self-antigen such as myelin to apoptotic cells, one could tap into this natural mechanism to suppress T-cells that would normally attack the myelin. The lab spent decades demonstrating that they could generate antigen-specific immune suppression in various animal models of autoimmune diseases. Recently, they initiated a preliminary clinical trial with collaborators in Germany to test the safety of injecting the antigen-bound apoptotic cells into patients with MS. While the trial successfully demonstrated that the injections were safe, it also highlighted a key problem with using cells as a vehicle for antigen delivery:

“Cellular therapy is extremely expensive as it needs to be carried out in a large medical center that has the capability to isolate patient’s white blood cells under sterile conditions and to re-infuse those antigen-coupled cells back into the patients,” said Miller. “It’s a costly, difficult, and time-consuming procedure.”

Thus began a collaboration with Dr. Shea, a bioengineer at Northwestern University, to discuss the possibility of developing a surrogate for the apoptotic cells. After trying out various formulations, his lab successfully linked the desired antigens to microscopic, biodegradable particles which they predicted would be taken up by circulating macrophages similar to apoptotic cells.

Much to their amazement, when tested by the Miller lab, the antigen-bound particles were just as good, if not better, at inducing T-cell tolerance in animal models of autoimmune disorders.

Using their myelin-bound particles, the researchers were able to both prevent the initiation of MS in their mouse model as well as inhibit its progression when injected immediately following the first sign of clinical symptoms.

The research team is now hoping to begin phase I clinical trials using this new technology. The material that makes up the particles has already been approved by the U.S. Food and Drug Administration and is currently used in resorbable sutures as well as in clinical trials to deliver anti-cancer agents. Miller believes that the proven safety record of these particles along with their ability to be easily produced using good manufacturing practices will make it easier to translate their discovery into clinical use.

“I think we’ve come up with a very potent way to induce tolerance that can be easily translated into clinical practice. We’re doing everything we can now to take this forward,” said Miller.

In addition to its potential use for the treatment of MS, the researchers have shown in the lab that their therapy can induce tolerance for other autoimmune diseases such as type I diabetes and specific food allergies. They also speculate that transplant patients could benefit from the treatment which has the potential to retract the body’s natural immune response against a transplanted organ. Dr. Christine Kelley, NIBIB director of the Division of Science and Technology, points to the unique collaboration between scientists and engineers that made this advance a reality.

“This discovery is testimony to the importance of multidisciplinary research efforts in healthcare,” said Kelley. “The combined expertise of these immunology and bioengineering researchers has resulted in a valuable new perspective on treating autoimmune disorders.”

Source : http://www.news-medical.net/news/20121118/NIH-funded-scientists-develop-new-treatment-to-combat-autoimmune-disorders-in-mouse-model.aspx

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New nanoparticle halts relapsing remitting multiple sclerosis in mouse model

New nanoparticle halts relapsing remitting multiple sclerosis in mouse model

In a breakthrough for nanotechnology and multiple sclerosis, a biodegradable nanoparticle turns out to be the perfect vehicle to stealthily deliver an antigen that tricks the immune system into stopping its attack on myelin and halt a model of relapsing remitting multiple sclerosis (MS) in mice, according to new Northwestern Medicine research.

The new nanotechnology also can be applied to a variety of immune-mediated diseases including Type 1 diabetes, food allergies and airway allergies such as asthma.

In MS, the immune system attacks the myelin membrane that insulates nerves cells in the brain, spinal cord and optic nerve. When the insulation is destroyed, electrical signals can’t be effectively conducted, resulting in symptoms that range from mild limb numbness to paralysis or blindness. About 80 percent of MS patients are diagnosed with the relapsing remitting form of the disease.

The Northwestern nanotechnology does not suppress the entire immune system as do current therapies for MS, which make patients more susceptible to everyday infections and higher rates of cancer. Rather, when the nanoparticles are attached to myelin antigens and injected into the mice, the immune system is reset to normal. The immune system stops recognizing myelin as an alien invader and halts its attack on it.

“This is a highly significant breakthrough in translational immunotherapy,” said Stephen Miller, a corresponding author of the study and the Judy Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine. “The beauty of this new technology is it can be used in many immune-related diseases. We simply change the antigen that’s delivered.”

“The holy grail is to develop a therapy that is specific to the pathological immune response, in this case the body attacking myelin,” Miller added. “Our approach resets the immune system so it no longer attacks myelin but leaves the function of the normal immune system intact.”

The nanoparticle, made from an easily produced and already FDA-approved substance, was developed by Lonnie Shea, professor of chemical and biological engineering at Northwestern’s McCormick School of Engineering and Applied Science.

“This is a major breakthrough in nanotechnology, showing you can use it to regulate the immune system,” said Shea, also a corresponding author. The paper will be published Nov. 18 in the journal Nature Biotechnology.

Miller and Shea are also members of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. In addition, Shea is a member of the Institute for BioNanotechnology in Medicine and the Chemistry of Life Processes Institute.

CLINICAL TRIAL FOR MS TESTS SAME APPROACH — WITH KEY DIFFERENCE

The study’s method is the same approach now being tested in multiple sclerosis patients in a phase I/II clinical trial — with one key difference. The trial uses a patient’s own white blood cells — a costly and labor intensive procedure — to deliver the antigen. The purpose of the new study was to see if nanoparticles could be as effective as the white blood cells as delivery vehicles. They were.

THE BIG NANOPARTICLE ADVANTAGE FOR IMMUNOTHERAPY

Nanoparticles have many advantages; they can be readily produced in a laboratory and standardized for manufacturing. They would make the potential therapy cheaper and more accessible to a general population. In addition, these nanoparticles are made of a polymer called Poly(lactide-co-glycolide) (PLG), which consists of lactic acid and glycolic acid, both natural metabolites in the human body. PLG is most commonly used for biodegradable sutures.

The fact that PLG is already FDA approved for other applications should facilitate translating the research to patients, Shea noted. Miller and Shea tested nanoparticles of various sizes and discovered that 500 nanometers was most effective at modulating the immune response.

“We administered these particles to animals who have a disease very similar to relapsing remitting multiple sclerosis and stopped it in its tracks,” Miller said. “We prevented any future relapses for up to 100 days, which is the equivalent of several years in the life of an MS patient.”

Shea and Miller also are currently testing the nanoparticles to treat Type one diabetes and airway diseases such as asthma.

In the study, researchers attached myelin antigens to the nanoparticles and injected them intravenously into the mice. The particles entered the spleen, which filters the blood and helps the body dispose of aging and dying blood cells. There, the particles were engulfed by macrophages, a type of immune cell, which then displayed the antigens on their cell surface. The immune system viewed the nanoparticles as ordinary dying blood cells and nothing to be concerned about. This created immune tolerance to the antigen by directly inhibiting the activity of myelin responsive T cells and by increasing the numbers of regulatory T cells which further calmed the autoimmune response.

“The key here is that this antigen/particle-based approach to induction of tolerance is selective and targeted. Unlike generalized immunosuppression, which is the current therapy used for autoimmune diseases, this new process does not shut down the whole immune system,” said Christine Kelley, National Institute of Biomedical Imaging and Bioengineering director of the division of Discovery Science and Technology at the National Institutes of Health, which supported the research. “This collaborative effort between expertise in immunology and bioengineering is a terrific example of the tremendous advances that can be made with scientifically convergent approaches to biomedical problems.”

“We are proud to share our expertise in therapeutics development with Dr. Stephen Miller’s stellar team of academic scientists,” said Scott Johnson, CEO, president and founder of the Myelin Repair Foundation. “The idea to couple antigens to nanoparticles was conceived in discussions between Dr. Miller’s laboratory, the Myelin Repair Foundation’s drug discovery advisory board and Dr. Michael Pleiss, a member of the Myelin Repair Foundation’s internal research team, and we combined our efforts to focus on patient-oriented, clinically relevant research with broad implications for all autoimmune diseases. Our unique research model is designed to foster and extract the innovation from the academic science that we fund and transition these technologies to commercialization. The overarching goal is to ensure this important therapeutic pathway has its best chance to reach patients, with MS and all autoimmune diseases.”

Source : http://www.news-medical.net/news/20121119/New-nanoparticle-halts-relapsing-remitting-multiple-sclerosis-in-mouse-model.aspx

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Exclusive Interview with Cibiem, a New Player in Carotid Body Modulation

Exclusive Interview with Cibiem, a New Player in Carotid Body Modulation

Exclusive Interview with Cibiem, a New Player in Carotid Body Modulation

Cibiem is a medical device company leveraging its proprietary, minimally invasive, catheter-based approach focused on Carotid Body Modulation™ (CBM) for the treatment of sympathetic nervous system-mediated diseases such as hypertension, heart failure, diabetes and renal failure. The company was co-founded by Mark Gelfand and Howard R. Levin, M.D., the proven team of innovators and entrepreneurs behind Coridea. The company is backed by top-tier venture investors Third Rock Ventures and SV Life Sciences.

Cibiem is a medical device company focusing on a minimally invasive, catheter-based approach for Carotid Body Modulation (CBM). Currently in its early stages, the company is assessing CBM’s role in potentially treating hypertension, diabetes, heart failure, and/or renal failure. The company was co-founded by Mark Gelfand and Howard R. Levin, M.D., who were behind Ardian, a firm developing renal denervation technology to treat hypertension, which was acquired by Medtronic in 2010. Dr. Levin and Mr. Gelfand recently participated in an interview with Medgadget, answering questions about Cibiem and the potential role of Carotid Body Modulation for well known chronic diseases.

Ronney Shantouf, Medgadget: What is carotid body modulation (CBM) and can you tell us a little about Cibiem’s product?

Mark Gelfand and Howard Levin Exclusive Interview with Cibiem, a New Player in Carotid Body ModulationMark Gelfand and Howard Levin, Cibiem: Cibiem’s proprietary, minimally invasive, catheter-based approach is focused on Carotid Body Modulation (CBM) for the treatment of sympathetic nervous system-mediated diseases such as hypertension, heart failure, diabetes and renal failure. Our approach is innovative, proprietary and, importantly, minimally invasive. It focuses on modulation of the carotid body – a key chemosensor located at the fork of the carotid artery that helps regulate respiratory activity. This Carotid Body Modulation (CBM) is a breakthrough innovation based on extensive studies and a deep understanding of the interdependence of the body’s various systems. Cibiem believes this approach could mean exciting new treatment possibilities for a broad range of diseases.

Medgadget: Of the different medical conditions such as congestive heart failure, hypertension, renal failure, or diabetes – where do you feel carotid body modulation will have the greatest impact and why?

One of the key differentiators of our proprietary CBM technology and approach is that it has the potential to drive significant impact across a broad range of sympathetic nervous system-mediated diseases such as hypertension, heart failure, diabetes and renal failure.

Medgadget: What can you tell us about the current first-in-man clinical trials going on with the CBM device?

Cibiem already is testing its unique CBM physiological approach in first-in-man clinical trials.The first-in-man trials are being conducted in Wroclaw, Poland. The PI is Piotr Ponikowski, M.D., Ph.D., who is formerly the president of the Heart Failure Association of the European Society of Cardiology. The treatment is being evaluated for heart failure.

Medgadget: How did the idea of CBM come about? What inspired the product development?

The idea of modulating the carotid body to have an effect on sympathetic nervous system-mediated diseases is not a new one – it had been surgically done in the 1940s and lasted through the 1990s in some places. However, the idea of inventing a minimally-invasive, catheter-based medical device to modulate the carotid body is truly novel and could fundamentally change the way we treat diseases like heart failure, hypertension, diabetes and renal failure – all conditions that are not optimally addressed or managed by the current drug therapies or standard of care.

Medgadget: How long have you been working on Cibiem’s CBM product?

Cibiem raised its Series A financing in May 2012 and we started our first-in-man trials in August.

Medgadget: What makes Coridea unique over other incubator and consulting firms?

Coridea is designed to minimize risk and create value quickly and efficiently. Our team is comprised of leaders and innovators in the medical device arena with a proven track record in converting innovative technology into high impact solutions for patients and high value returns for investors (for example, the Ardian model). We view medical device design through the lens of translational healthcare, delivering innovative, unexpected solutions to cardio, pulmonary and renal patients who have failed existing drug treatments.

Medgadget: Out of all of Coridea’s projects, which, to you, stands out the most and why?

The way Coridea really stands apart is our ability to rapidly translate novel inventions and intellectual property into clinical trials and clinical practice. All of the incubator’s companies have advanced breakthrough technology and devices, but it is important to note the success of Ardian, a company that we founded and was then acquired by Medtronic in one of the largest deals ever for a private, VC-backed company ($800 million plus $500 million in potential milestones). Our strategy is to continue to drive that level of innovation and value for Coridea companies.

Source : http://cibiem.com/

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Magical Medical Cellphones: Measuring Fat & Radiation

Magical Medical Cellphones: Measuring Fat & Radiation

Magical Medical Cellphones: Measuring Fat & Radiation

We’ve seen phones with lots of crazy features, but in my opinion BenQ’s fat-measuring phone beats them all. The alleged phone keeps track of your pudge by shooting out a micro-current that travels through your body.

When you touch two separate electrodes on the phone, a special chip will measure the electrical signal and before you know it, you’ll be dropping those Twinkies in no time flat. I think the idea is pretty far-fetched—the last thing anyone wants is a phone telling them when they’ve had one too many Doritos. – Louis Ramirez

Cellphones are the under-appreciated work horses of the medical industry, doing everything from transmitting ECG data to your doctor, to managing your diabetes and keeping tabs on your alcoholic liver. Well, now we have more cell phone uses that you didn’t know you couldn’t live without until now:

Engadget is reporting that the Department of Homeland Security is considering equipping government employees with cellphones capable of detecting radiological, biological, and chemical weapons.

Homeland Security Department officials are looking into outfitting cell phones with tiny, sensitive detectors that would alert the government and emergency responders to the presence of radiological isotopes, toxic chemicals and deadly biological agents such as anthrax. nuke cellphone Magical Medical Cellphones: Measuring Fat & Radiation

“”If it’s successful, it’ll change the way chemical, biological and radiation detection is done,” says Rolf Deitrich, deputy director of the Homeland Security Advanced Research Projects Agency, which invests in high-tech solutions to secure the nation against terrorist attacks. ”It’s a really, really neat thing.”

Deitrich says it’s way too early to know whether the idea would work, and department officials are just beginning talks with phone companies, privacy advocates and researchers. If it does work, he says, it could be a “”game-changer” in how the nation recognizes and responds to a deadly attack.

body feat measuring phone Magical Medical Cellphones: Measuring Fat & Radiation

Meanwhile, Gizmodo has it on good authority that the cellphone giant BenQ is planning on a cell phone that can monitor your body fat percentage. Apparently, the technology is very similar to body impedance devices on gym equipment which require you to touch two electrodes. Unfortunately, BenQ says a cellphone that also nags you about your increased weight is several years away…

Source : http://gizmodo.com/257720/benqs-fat+measuring-phone-keeps-your-spare-tire-in-check?tag=gadgetsfattiephone

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New understanding of how noise can break critical tip link protein structure in inner ear cells

New understanding of how noise can break critical tip link protein structure in inner ear cells

Researchers describe for the first time the structure of a bond formed by 2 proteins critical for hearing and balance

Researchers have mapped the precise 3-D atomic structure of a thin protein filament critical for cells in the inner ear and calculated the force necessary to pull it apart.

In a study to be published November 7 in the journal Nature, a group led by David Corey, HMS professor of neurobiology, and Rachelle Gaudet, professor of molecular and cellular biology in the Faculty of Arts and Sciences at Harvard University, revealed the characteristics of the most vulnerable area of a structure called the tip link. Their findings open avenues for research in fields related to noise-induced hearing loss and certain genetic diseases.

“Tip links are absolutely vital to hair cells, and hair cells are absolutely vital for hearing and balance,” said Corey. “We now have this new understanding of how noise can break a tip link and potentially cause a hearing problem.”

The sensations of hearing and balance rely on hair cells, a family of cells located in the inner ear. Crucial to their function are tip links, strings of protein that physically connect the cilia or “hairs” found on these cells. When the cilia move in response to sensory stimuli – head movement or the vibration of sound, for example-tension is applied to the tip links, which begins a process that ultimately sends nerve impulses to the brain.

Tip links are composed of two different types of proteins called cadherins, which connect in the middle to make one long string. Mutations in these proteins often result in congenital deafness and balance disorders. Scientists have only recently made strides toward understanding the nature of these cadherins, especially at their connection to each other-hypothesized to be the first area to break under stress.

To test this, Marcos Sotomayor, first author on the paper and a postdoctoral researcher in the lab of David Corey, investigated the structure of that bond.

He first synthesized and purified a large amount of the very ends of the proteins, where they connect. After crystallizing the purified proteins bound to each other, the team took advantage of powerful X-rays generated by a 3000-foot long electron accelerator at Argonne National Laboratory.

When X-ray light passes through a highly ordered crystal, it creates a regular diffraction pattern that can be used to reveal the structure of the proteins forming the crystal.

Sotomayor analyzed the diffraction pattern generated at Argonne and coupled it with biochemical data. From this, he created a complete 3-D map of the structure of bonded region, down to the position of each individual atom.

The map revealed that the two different cadherins bonded like two hands gripping each other’s wrists. This molecular handshake was not mediated by calcium ions, as had been hypothesized, but it showed an intimate and extended interface not seen before in cadherin-cadherin bonding.

With this precise 3-D structure, the team used supercomputers to simulate the dynamics of these proteins under a variety of conditions, including applying forces to pull the bond apart. They found that it takes only half as much force to break the connection as it does to unfold the cadherins themselves-confirming that the bond is indeed the weakest region of the tip link. They suggest the tip link is strong enough to withstand normal sound, but the connection is likely the first to break under loud noises.

They also showed how certain mutations that produce deafness could weaken the bond, perhaps allowing it to come apart even with quiet sound.

The group plans to characterize tip-link structure further, moving on to other parts such as where the cadherins link to tension-activated ion channels at the tips of the hair cells’ cilia.

source : http://www.news-medical.net/news/20121108/New-understanding-of-how-noise-can-break-critical-tip-link-protein-structure-in-inner-ear-cells.aspx

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Bayer Releases New A1C Model for Diabetics

Bayer Releases New A1C Model for Diabetics

Bayer Releases New A1C Model for Diabetics

Bayer HealthCare is reporting that its diabetes portfolio “now includes a innovative device for self-testing of HbA1c– the gold standard indicator of ongoing blood sugar control…”

A1CNow+®, device, designed for at-home monitoring of HbA1c–a glycosylated hemoglobin–was acquired by Bayer when it bought Metrika Inc., a company based in Sunnyvale, CA.

From the press release:

According to the American Diabetes Association (ADA), tight glycemic control sustained over time, as measured through HbA1c scores, slows the development of diabetic complications including heart, eye, kidney and nerve diseases and even a small reduction in HbA1c is important. The HbA1c value is an index of mean blood glucose levels over the past two to three months with significant changes in the HbA1c levels due to blood sugar variability over the last 30-40 days being detectable.

4534343hg3 A1CNow+® for Home HbA1c Monitoring

The newly-released, improved A1CNow+ is a portable, easy-to-use and reliable system that provides immediate access to lab-quality NGSP* certified HbA1c results in just five minutes. This helps to improve the overall efficiency of diabetes care by reporting HbA1c values directly to the patient or during the patients’ office visit eliminating absent or delayed lab results. Utilizing the integration of micro-optical technology and solid state chemistry into a proprietary monitor with disposable cartridges, AICNow+ provides rapid HbA1c results with precision and accuracy equivalent to certified laboratories.

The test can be performed with a simple three-step procedure using finger-stick or venous blood. Fast, easy measurement of HbA1c enables people with diabetes and their healthcare providers to make immediate diabetes management decisions and to help optimize and calibrate therapy with the goal of improved outcomes…

HbA1c is formed when glucose in the blood binds irreversibly to hemoglobin to form a stable glycated hemoglobin HbA1c complex. Since the normal life span of red blood cells averages about 120 days, the HbA1c level will change as new red cells are made. HbA1c values are directly proportional to the average concentration of glucose in the blood over the past two to three months. HbA1c values are not subject to the daily fluctuations that are seen with blood sugar monitoring…

The ADA recommends that the test be performed every three months for patients who have HbA1c values at or above 7% and every six months for patients with HbA1c values below 7% as well as during treatment changes or after periods of elevated blood glucose levels. The ADA also added a recommendation for point-of-care HbA1c monitoring to their 2006 professional practice guidelines emphasizing the importance of routine real-time HbA1c monitoring of persons with diabetes.

The Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) studies showed that lower HbA1c values are associated with prevention of, or significant decreases in, the development of serious eye, kidney and nerve disease.

The ADA clinical practice guidelines indicate diabetes is under control when the HbA1c result is 7% percent or less.

Bayer Diabetes Care have finally released the updated version of the A1CNow SelfCheck home testing kit. Claiming to now produce more accurate A1C results that mimic lab testing, the unit comes packaged with two single-use cartridges.

From the press release:

A1CNow SELFCHECK, which is now available without a prescription and through leading online pharmacies, provides at-home results within five minutes, has an easy-to-use design and delivers lab accuracy. Measuring A1C levels is important for consistent diabetes management, as even a one-percent reduction in A1C reduces the risk of serious complications by 40 percent(1).

At the healthcare provider’s office patients can be tested with Bayer’s A1CNow+ monitor, which provides results within five minutes, enabling physicians to evaluate their patients’ overall diabetes control and discuss lifestyle and treatment modifications during the appointment, rather than waiting for lab results a few days later. A1CNow SELFCHECK complements the healthcare provider-administered A1C test but is not intended to replace it or routine blood glucose testing. Bayer’s A1CNow SELFCHECK, when used in conjunction with Bayer’s CONTOUR(R) or BREEZE(R)2 blood glucose meters, may help patients achieve tighter control in managing their diabetes, and therefore may reduce longer term complications.

Source : http://www.bayercontour.com/default.aspx

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