Monday, December 31, 2012

High-School Video Gamers vs. OBGYN Residents at Robotic-Surgery Simulation


Study: High-School Video Gamers Match Physicians at Robotic-Surgery Simulation
SOURCE: SLATE, By Torie Bosch, posted Posted Wednesday, Nov. 21, 2012, at 10:09 AM ET
Full article below.
The applicability of video game skills to modern warfare—in the use of drones, in particular—is well known. But a new study suggests, not surprisingly, that gamers might also have an edge in robotic surgery.
Researchers from the University of Texas Medical Branch at Galveston tasked OB/GYN residents and 10th graders who regularly play video games to perform tasks on a robotic-surgery simulation—like suturing. On average, the high-school students, who played two hours of video games a day, performed just as well as the residents—a few individual teenagers even did better. (Some have reported that the study showed the teenagers did better than the residents, but the difference in their performances is statistically insignificant.)
UTMBG’s Sami Kilic, the lead author on the study, told me that the high-school students who played virtual doctor were devotees of first-person shooters (especially the Call of Duty franchise—“a wild game,” Kilic says), as well as games featuring sports, strategy, and auto racing. Those who devoted their time to shooting games and sports games did the best at the robotic-surgery simulation—perhaps, he speculates, because the unpredictability of the gameplay was similar to surgery. 
The question, Kilic says, is whether spending two hours a day at a game, as these high-schoolers did, might hinder other areas of their development, especially social skills. He hopes to explore that issue soon, with the help of behavioralists.
In the mean time, he told me, “I’m not encouraging [teenagers] to spend countless hours in front of the computer games, because our job is not to create the best surgeon ever or the best soldier ever … in this age group. They have to have the fundamental human being skills in their developing age.”
Of course, it’s not exactly surprising that “video games are making us better at video games.” Robot surgery will be increasingly common in the coming years—so it’s important for people to understand that gaming skills may have real-world applications, or at least virtual applications with real-world consequences.
As Kilic told me, it’s funny that a game like Call of Duty that includes so much death (an infographic released last year by Activision said that Black Ops players alone had killed the world’s population nine times over) could create skills to save a life. But what about using games to teach actual medicine? In the early ‘90s,the video game Life & Death made me briefly consider being a doctor. I became an expert at distinguishing gas from kidney stones and performing virtual appendectomies. But that game’s co-creator, Don Laabs, told me in an email that though they worked with a real surgeon (“and his graphic surgery videos”) to make the game feel true to life, it was never intended to be any sort of training ground or even necessarily to inspire kids to want to be physicians. “That having been said,” he continued,
I recently had a chance to try out a real surgical machine that allowed you to use tiny remote controlled instruments while being able to view the surgical area with magnified 3D vision. The video gamers among us proved quite adept at using the machine. We all agreed, though, that the 3D view was absolutely essential to get the job done. Things have certainly come a long way since Life & Death! With that type of tech available, I'm sure surgery games and simulators will become more and more applicable to real surgery training.
For now, though, Kilic warns that parents with MD ambitions for their children shouldn’t mandate two hours a day at the Xbox 360. Sorry, kids.

Wednesday, December 12, 2012

Clinical Publication News: ABIO AF paper published in Eur Journ of Heart Failure


Gencaro cardiovascular effect on patients with atrial fibrillation paper published in European Journal of Heart Failure.
SOURCE: ARCA biopharma, www.arcabiopharma.com
Full press release follows.


BROOMFIELD, Colo.--(BUSINESS WIRE)—Dec. 12, 2012 -- ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, today announced that the paper "Effect of Bucindolol (Gencaro) on Heart Failure Outcomes and Heart Rate Response in Patients with Reduced Ejection Fraction Heart Failure and Atrial Fibrillation” was published in the European Journal of Heart Failure (www.escardio.org/journals/european-journal-heart-failure), a publication of the Heart Failure Association of the European Society of Cardiology.
The paper discusses post-hoc analyses of data from the Phase 3 clinical study of Gencaro in heart failure, known as the Beta-Blocker Evaluation of Survival Trial (BEST), which was sponsored by the National Heart, Lung and Blood Institute of the National Institutes of Health, and the Cooperative Studies Program of the Department of Veterans Affairs. These data demonstrate that patients with established atrial fibrillation (AF) in BEST who received Gencaro had improvements in heart failure clinical endpoints. Compared to placebo, the effects of Gencaro on improving heart failure clinical endpoints in the 303 patients in BEST with established AF were generally similar to the effects of Gencaro on these endpoints in the 2,176 patients in BEST with normal sinus rhythm.
The data also demonstrate that Gencaro made it more likely for patients with established AF to achieve ventricular rate control, and that Gencaro improved cardiovascular clinical endpoints for those AF patients who did achieve rate control. 67% of AF patients who received Gencaro achieved ventricular response rate control, defined as a resting heart rate of less than or equal to 80 beats per minute without symptomatic bradycardia (p < 0.005). In AF patients who achieved ventricular response rate control, Gencaro produced a 39% reduction (p = 0.025) in cardiovascular mortality/cardiovascular hospitalizations. In addition, Gencaro also improved cardiovascular clinical endpoints for those AF patients possessing the genotype which ARCA believes is most favorable for Gencaro response. In a substudy of 1,040 patients in BEST in which patient genotypes were analyzed, Gencaro was associated with a 72% decrease (p = 0.039) in cardiovascular mortality/cardiovascular hospitalizations in those 52 AF patients in the substudy with the beta-1 389 arginine homozygous genotype. ARCA believes that this genotype predicts a favorable response to Gencaro, and is estimated to be present in about 50% of the population in the U.S. These data are in contrast to the data reported for studies of other beta-blockers, including carvedilol, in which AF patients with the beta-1 389 arginine homozygous genotype who received those drugs exhibited evidence of resistance to heart rate reduction.
Christopher O'Connor, MD, Professor of Medicine and Cardiologist, Duke University Medical Center, and a co-author of the paper commented, "In placebo controlled trials of patients with heart failure and reduced left ventricular ejection fraction (HFREF) who also have permanent AF, currently approved beta blockers have not shown benefit by improving clinical endpoints. In this study, Gencaro exhibited evidence of efficacy against clinical endpoints in patients with HFREF and AF. In addition, this efficacy appears to be pharmacogenetically enhanced in patients with the beta-1 389 arginine homozygous genotype, and rate control was also effective in this genotype. This evidence of rate control by Gencaro in this genotype is important because it has been reported that other beta-blockers do not provide adequate rate control in AF patients with this genotype."
Michael Bristow, MD, PhD, President and CEO of ARCA biopharma and Professor of Medicine (Cardiology) at the University of Colorado Anschutz Medical Campus, and a senior author of the paper added, "These data from the BEST study suggest that Gencaro may be safe and effective in patients with permanent AF. ARCA would be able to further test this hypothesis in its proposed trial of Gencaro in AF prevention."
ARCA has been granted patents in the U.S., Europe, and other jurisdictions for methods of identifying and treating patients with the beta-1 389 arginine homozygous genotype. The Company plans to conduct a Phase 3 clinical trial to evaluate Gencaro as a potential treatment for the prevention of AF in patients with this genotype, subject to receiving the necessary funding.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company's lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with the Laboratory Corporation of America (LabCorp), under which LabCorp has developed a companion genetic test for Gencaro. For more information please visit www.arcabiopharma.com.
Safe Harbor Statement
This press release and the associated presentation may contain "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of genetic variations to predict individual patient response to Gencaro, Gencaro’s potential to treat atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2011 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Contacts
ARCA biopharma, Inc.
Christopher D. Ozeroff
Senior Vice President and General Counsel
720-940-2100

Thursday, December 6, 2012

Alzheimer's Clinical Study News: 1st US Patient Implanted w/ DBS system


First US patient implanted in Functional Neuromodulation study of deep brain stimulation for Alzheimer's Disease. University of Pennsylvania Joins the ADvance Study. 

SOURCE: Functional Neuromodulation, Ltd., www.fxneuromod.com
**Full press release follows.

Toronto, Ontario – December 6, 2012 – The first U.S. patient to enroll in Functional Neuromodulation's ADvance Study was successfully implanted with a deep brain stimulation (DBS) system. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain's memory circuit, for patients with mild Alzheimer's.
The ADvance Study is making rapid progress, with six implants conducted to date. The first U.S. implant was done at Johns Hopkins and five patients have been implanted at Toronto Western Hospital. The University of Pennsylvania has joined the study, bringing the total to five leading North American research centers participating in ADvance.
"In just two years, we have partnered with expert clinical researchers and assembled a lean team of seasoned professionals that have propelled the company through funding, regulatory requirements, study initiation and significant patient enrollment," said Todd Langevin, President and COO of Functional Neuromodulation.
"Given the urgent need for progress and the ongoing challenges in drug research for Alzheimer's, we are excited to assess a completely new circuitry-based approach that could offer hope," commented David Wolk, MD, Assistant Professor of Neurology and Assistant Director of the Penn Memory Center. "Pre-clinical testing has suggested that DBS may result in physiological changes that could alter disease progression. ADvance will help us to determine whether stimulation of the fornix can drive activity in the memory circuit to improve memory and lead to better clinical outcomes."
About ADvance
ADvance is a randomized double-blind controlled trial initially involving 20 people aged 55-80 with mild Alzheimer's disease. Patients are currently being recruited to participate in the study at the Banner Alzheimer's Institute in Phoenix, AZ, Johns Hopkins Bayview Medical Center, Toronto Western Hospital, University of Florida Center for Movement Disorders and Neurorestoration and the University of Pennsylvania. The trial will compare the effects of DBS turned on to those observed with the system turned off. The patients will undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the off group will be eligible to have the system activated. Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory will also be assessed at multiple time points.

ADvance is co-chaired by Andres Lozano, MD, PhD, R.R. Tasker Chair in Stereotactic and Functional Neurosurgery at the University Health Network and University of Toronto and Scientific Founder of the company; and Constantine Lyketsos, MD, MHS, Elizabeth Plank Althouse Professor, Johns Hopkins University, and Director, Johns Hopkins Memory and Alzheimer's Treatment Center.
About Deep Brain Stimulation
Deep brain stimulation (DBS) uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain.  Medtronic, in collaboration with leading physicians around the world, pioneered DBS therapy, which was first approved in Europe in 1995 and in the United States in 1997.  The therapy is currently licensed in Canada and approved in other regions, including the European Union and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease and chronic intractable primary dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE)1.  In Europe and Canada, DBS therapy is approved for the treatment of refractory epilepsy.  The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union and in the United States under an HDE2.  More than 85,000 people worldwide have received DBS therapy.
About Functional Neuromodulation Ltd.
Founded in Toronto, Ontario in 2010, Functional Neuromodulation is dedicated to advancing the application of deep brain stimulation (DBS) therapies to help improve the lives of people with Alzheimer's and other memory and cognitive disorders. The Company has received funding from Genesys Capital, Foundation Medical Partners and Medtronic.
Contact: 
Susan Klees
Director of Communications
Functional Neuromodulation, Ltd.
susan@fxneuromod.com
  1. Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of dystonia has not been demonstrated.
  2. Humanitarian Device in the U.S.:  The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

Tuesday, December 4, 2012

Clinical Trial News: Vascular Closure Systems' Successful Completion of FIH Clinical Trial


Vascular Closure Systems, Inc. Announces the Successful Completion of the First in Human (FIH) Clinical Trial of the 6 Fr. / 7 Fr. FastSeal® Bioabsorbable Vascular Access Closure System. 100% Success Rate With Exceptional Time to Hemostasis (TTH) and Time to Ambulation (TTA). The FIH Clinical Trial Results Demonstrate Superior Safety, Ease of Use, Performance, Patient Comfort and Cost Effectiveness.

***The Company is planning to begin International commercialization (outside the US, pending regulatory approval) of the 6 Fr. / 7 Fr. system during the second quarter of 2013.

SOURCE: Vascular Closure Systems, Inc., www.vclosure.com

Full press release follows.

PALO ALTO, Calif.--()--(Dec. 4, 2012)--Vascular Closure Systems, Inc.:
The Company is pleased to announce the successful conclusion of Phase I and Phase II of the First in Human (FIH) clinical trial for our 6 Fr. / 7 Fr. FastSeal® Bioabsorbable Vascular Access Closure System, achieving a 100% success rate throughout both phases of the clinical trial, with exceptional Time to Hemostasis (TTH) and Time to Ambulation (TTA). The clinical trial included patients with challenging anatomy and vessel condition. Additionally, the patient comfort with the system was excellent, with no groin pain during the deployment of the sealing element, immediately after, and throughout the vessel healing process. The post deployment follow-up evaluation (including echo doppler) confirmed normal vessel healing, without inflammation, and complete absorption of the FastSeal® sealing element.
The FIH clinical trial results are as follows:
Phase I (10 patients, all diagnostic cases)
TTH
TTA
(min:sec)(hrs:min)
Time
1:136:40 Hrs.
Std. Dev.
0:402:44
Phase II (20 patients total, 15 PCI cases)
TTH
TTA
(min:sec)(hrs:min)
Time
0:432:14 Hrs.
Std. Dev.
0:341:07
The FIH clinical trial cases were performed by Prof. Alessandro Bortone, and Prof. Emanuela de Cillis of the Policlinico di Bari, University of Bari School of Medicine, Italy.
Videos of FIH cases are available to view at the following link: http://vclosure.com/fastsealvideos.php
The detailed Phase I and Phase II FIH clinical trial results will be presented at multiple upcoming medical conferences.
The Company is planning to begin International commercialization (outside the US, pending regulatory approval) of the 6 Fr. / 7 Fr. system during the second quarter of 2013.

Additional Versions of Our FastSeal® System
An 18 Fr. version of our FastSeal® Bioabsorbable Vascular Access Closure system has been designed, developed and successfully tested, for the nonsurgical deployment of large diameter / large bore transcatheter therapeutic devices, such as Transcatheter Aortic Valve Implants / Replacements (TAVI / TAVR) and Endovascular Aneurysm Repair (EVAR) devices. These additional versions of our technology will in the future enable us to offer solutions for these rapidly growing market segments. The Company has also designed and is developing a non-absorbable closure system for left ventricle transapical access procedures. A video showing our large bore vessel closure system sealing an 18 Fr. puncture, is available to view at the following link: http://vclosure.com/fastseal_bioabsorb18wmv.php
All versions of our FastSeal® Vascular Access Closure systems have been designed in close collaboration with our world-class medical advisors.

About the FastSeal® Product
Our FastSeal® Bioabsorbable Vascular Access Closure System is intended for use following a diagnostic or therapeutic, interventional cardiology or interventional radiology procedure. The system is packaged and used as a single piece unit, with no assembly required prior to use, and no separate deployment device is needed to be inserted into the puncture site. Simply insert the FastSeal® system into the hub of the procedural introducer sheath, and advance the attached plunger. The system design enables hemostasis within less than a minute after the non-collagen sealing element has been deployed. Our system doesn't require the use of a specific type or brand of vascular introducer sheath, and is compatible with any commercialized vascular introducer sheath with a useable length of between 10 to 12 cm (such as Cordis, St. Jude Medical, Terumo, etc.). Once the sealing element has been deployed, no external compression is required. The inner vessel section of the sealing element is absorbed within 10 to 14 days. The remainder of the sealing element is completely absorbed within 21 days. The FastSeal® system has the ability to be removed after being deployed (if desired), without causing trauma to the vessel or requiring a surgical intervention.

About Vascular Closure Systems, Inc.
Vascular Closure Systems, Inc. is a privately held medical device company, based in part on the early and established intellectual property of CardioVascular Technologies, Inc. (http://cvtechinc.com), and is focused on the development and commercialization of the next generation vascular access closure technology for the Interventional Cardiology and Interventional Radiology markets. The Company is comprised of several seasoned medical device professionals and world class physicians, with a proven record of innovation, clinical acumen, access to the industry and successful commercialization of multiple medical device technologies.
The Company is currently exploring multiple strategic options to enhance shareholder value, including, but not limited to, private funding, a possible strategic alliance, a merger or sale of the Company. The current funding round will close in the near future.
The Company is represented by Casey McGlynn of Wilson Sonsini Goodrich & Rosati.
Jim Heslin (Wilson Sonsini Goodrich & Rosati) has taken the lead on the maintenance and prosecution of the Company’s Intellectual Property (IP).
Please note that the Company's devices have not yet been approved by the US FDA and are not currently for sale or use in the US.
Additional information is available at the Company’s website: www.vclosure.com

Contacts

Vascular Closure Systems, Inc.
Russ Houser, CEO, +1 925-371-1029
Investor Relations:
ir@vclosure.com
General Information:
info@vclosure.com

Oncology Funding News: CEL-SCI to Raise $10.5M in Registered Direct Offering


CEL-SCI Corporation to Raise $10.5 Million in Registered Direct Offering. CEL-SCI Corporation plans to use the net proceeds for general and administrative expenses and for CEL-SCI’s Phase III clinical trial involving its investigational product Multikine (Leukocyte Interleukin, Injection)*

Full Press Release follows.

SOURCE: CEL-SCI Corporation, www.cel-sci.com

VIENNA, Va.--()--Dec 4, 2012, CEL-SCI Corporation (NYSE MKT: CVM), a late-stage oncology company, has entered into a definitive agreement to sell 35 million shares of its common stock at a price per share of $0.30 in a registered direct offering to institutional investors, representing gross proceeds of approximately $10.5 million.
The investors will also receive warrants to purchase up to 26.25 million shares of CEL-SCI Corporation’s common stock. The warrants have an exercise price of $0.40 per share, are not exercisable for six months from the close of the transaction and have a term of exercise of 4 years from the date of issuance. The closing of the offering is expected to take place on or before Friday, December 7, 2012, subject to the satisfaction of customary closing conditions. CEL-SCI Corporation plans to use the net proceeds for CEL-SCI's general and administrative expenses and for CEL-SCI’s Phase III clinical trial involving its investigational product Multikine (Leukocyte Interleukin, Injection)*.
The shares and warrants are being offered by CEL-SCI Corporation pursuant to an effective shelf registration statement declared effective by the Securities and Exchange Commission on October 5, 2012.
Chardan Capital Markets, LLC acted as the exclusive placement agent for the transaction.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities may only be offered by means of a prospectus. Copies of the final prospectus supplement and accompanying base prospectus can be obtained from the SEC's website at http://www.sec.gov.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2011. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contacts

CEL-SCI Corporation
COMPANY CONTACT:
Gavin de Windt, 703-506-9460

Thursday, November 29, 2012

Diabetes News: Implantable Blood Glucose Monitor Sensor, Texas A&M Research

Prospects For Better Diabetes Self-monitoring Based On Texas A&M Research: Implantable sensor that monitors blood sugar levels

***Full Press release follows.
SOURCE: Texas A&M University

COLLEGE STATION, TexasNov. 29, 2012 /PRNewswire-USNewswire/ -- An implantable sensor that allows diabetics to monitor their blood-sugar levels more effectively is a step closer to reality, thanks to a researcher at Texas A&M University who is developing technology aimed at enabling these sensors to remain functional in the body for an extended period of time.
(Logo: http://photos.prnewswire.com/prnh/20120502/DC99584LOGO)
Melissa Grunlan, associate professor in the university's Department of Biomedical Engineering, is developing a "self-cleaning" membrane that envelops an implanted glucose sensor, shielding it from the body's immune response that would otherwise render it nonfunctional.
Grunlan's work is detailed in the scientific journal Soft Matter, and she has received a $1.5 million-grant from the National Institutes of Health to continue her research aimed at overcoming a significant obstacle in the development of an implantable glucose sensor known as "biofouling."
Biofouling, she explains, occurs when an implanted sensor is rendered nonfunctional because of the human body's immune response that is triggered by a foreign object like a sensor.
During this response, proteins and cells adhere and accumulate onto the surface of the sensor in an attempt to seal it off from the rest of the body. These adhered proteins and cells act as a physical barrier to inhibit glucose diffusion to the sensor so that the sensor is no longer capable of accurately measuring glucose levels, Grunlan explains.
Typically, biofouling can make the sensor useless in days to a week, necessitating removal and implantation of new sensor at a rate that is not feasible, Grunlan adds. But Grunlan's work could overcome this challenge and pave the way for a long-term, implanted glucose sensor that would provide marked improvement over the traditional finger-prick method used for decades.
"Typically, physicians recommend that diabetic patients do a finger-prick test at least three times a day to measure their blood sugar levels, and many patients, particularly younger patients, don't comply with this," Grunlan says. "Even with multiple tests per day, this provides discontinuous and insufficient data. Given that blood-sugar levels can change significantly even within an hour, keeping track of blood sugars is currently a guessing game.
"This is not how blood sugars should be monitored. Individuals need to be continuously aware of blood sugars that are too high or too low so that they can take immediate steps to correct it. Otherwise, short-term and eventually long-term complications – with some being very serious and even fatal - can arise from poorly managed blood sugar levels."
With that in mind, scientists hope to develop an implanted glucose-sensing device that would provide continuous measurement of blood sugar and even alert an individual to dangerously high or low levels. In order to do that, the biofouling issue must be resolved– and that's where Grunlan's technology comes in.
While previous attempts at producing protective sensor membranes have focused on making the membrane surface less adhesive to cells, Grunlan has opted to create a "self-cleaning" membrane that periodically "shakes off" the cells by repeated contraction and re-expansion.
"Rather than attempt to produce a membrane that never allows these cells to attach to itself, we are accepting that fact that these cells and proteins are going to attach and begin to biofoul our sensor, and knowing this, we're creating a membrane that can regularly clean itself when this happens and before glucose diffusion is compromised," Grunlan says.
Made from a material called a hydrogel (the same general type of material from which contact lenses are made), Grunlan's self-cleaning membrane is thermoresponsive, meaning it contracts and expands in response to changes in temperature.
When the sensor is implanted, the membrane is swollen and expanded, allowing glucose to diffuse to the sensor, Grunlan explains. By increasing the temperature slightly above body temperature, the membrane rapidly contracts as it deswells with loss of water. When this occurs, proteins and cells are unable to withstand the dimensional change of the membrane, so they get dislodged from the surface, she adds. When the heat is removed, the membrane returns to its expanded state.
This heating/cooling process can be repeated until the membrane is cleaned, Grunlan notes. Once back to its expanded state, the clean membrane can maintain sufficient glucose diffusion, allowing the sensor to function properly, she says.
"The big-picture idea is to take our membrane and wrap it around a sensor," Grunlan says. "The sensor would then be implanted in the subcutaneous tissue just below the wrist, possibly delivered with a needle. A person would wear a device that looks similar to a watch but in reality would be a glucose meter that reads the information from the implanted sensor and tells the person what his or her blood sugar levels are. The meter device also would periodically give off a slight degree of heat that would trigger the sensor's membrane to self-clean."
While early indications of the membrane's effectiveness have been promising, further work on the membrane is under way, Grunlan notes. Because the sensor cannot function properly when the membrane is in a collapsed state, the entire cleaning process needs to occur quickly so that glucose measurements can resume, she says. Her goal, she says, is to create a membrane that initiates and completes successful self-cleaning in less than five minutes. In addition, Grunlan is working to create a more mechanically robust membrane that can withstand greater amounts of force that occur during implantation and removal of the device as well as forces from daily activities.
"An estimated 300 million people suffer from diabetes; it can lead to serious secondary health issues, and it ranks among the top five causes of death in the United States," Grunlan notes. "Our membrane technology would allow implantable sensors to function inside the human body and provide continuous measurement so that diabetics can better adjust and maintain proper blood-sugar levels and reduce complications related to diabetes."
About Research at Texas A&M University: As one of the world's leading research institutions, Texas A&M is in the vanguard in making significant contributions to the storehouse of knowledge, including that of science and technology. Research conducted at Texas A&M represents an annual investment of more than $700 million. That research creates new knowledge that provides basic, fundamental and applied contributions resulting in many cases in economic benefits to the state, nation and world.
More news about Texas A&M University, go to http://tamutimes.tamu.edu/
Follow us on Twitter at http://twitter.com/tamu/
SOURCE Texas A&M University
 (Note to editors: A video illustrating this story is available at http://www.youtube.com/watch?v=Z1l23H_Rdfg&list=PLG0CWry7JAMDnYG0gL5lLJLoF-Wrd08nZ&index=1&feature=plcp)
CONTACT: Melissa Grunlan, Associate Professor, +1-979-845-2406, mgrunlan@tamu.edu or Ryan A. Garcia, +1-979-847-5833, ryan.garcia99@tamu.edu.