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RESEARCH TRIANGLE PARK, NC / ACCESSWIRE / April 18, 2017 / Clinical Sensors, Inc. announced today that it was awarded two Small Business Research Grants from the National Institutes of Health (NIH). Together, these grants provide over $1.5 million to support the company's continued development and demonstration of its point-of-care device that directly measures a patient's blood nitric oxide level within a few seconds. Nitric oxide is involved in the progression of sepsis, a life-threatening illness where early and rapid recognition is critical to accelerate the administration of life-saving care. "These two awards will help us demonstrate the clinical impact of our technology, which is designed to directly measure nitric oxide and related metabolites from biological fluids," said Philippe Chemla, Ph.D., CEO at Clinical Sensors. "Our device requires a single blood sample at bedside to quickly deliver this information." The $1.29 million Phase 2 STTR award extends this work, which includes a clinical study at the Jaycee Burn Center at UNC. Patients with severe burns often develop sepsis, leading to prolonged hospital stays, increased costs, and a higher risk of death. "This NIH-supported study will use our device to follow 120 patients during their ICU stays and demonstrate the dynamic nature of nitric oxide in these patients," said Jon McDunn, Ph.D., Head of Research and Development at Clinical Sensors. "We are honored to have Dr. Bruce Cairns, Professor of Surgery and Director of the Jaycee Burn Unit, as co-Principal Investigator on the grant to lead the clinical study." Clinical Sensors also won a $215,000 Phase 1 SBIR award to add the measurement of low molecular weight S-nitrosothiols to its sensor platform. S-nitrosothiols are endogenous compounds that store nitric oxide in the body and are a critical component of redox biology and physiologic homeostasis. Currently, there is not a reliable method to measure these compounds to better assess the role they play in sepsis and other diseases. Sepsis, the body's overwhelming systemic response to infection, is an all-too-common occurrence in the modern hospital, with over 1.6 million patients diagnosed annually in the United States. One of the most critical factors driving patient outcomes is rapid recognition. For every hour that sepsis diagnosis is delayed, a patient's risk of death increases by over 7 percent. Delayed treatment is believed to play a significant role in many of the over 250,000 deaths that occur each year from sepsis. Clinical Sensors (www.clinicalsensors.com) is a development-stage company based in Research Triangle Park, N.C. committed to pioneering diagnostic devices that harness the physiologic properties of nitric oxide to improve patient management. Clinical Sensors has been awarded $3.8 million in NIH SBIR/STTR grants since 2014. Research reported in this press release was supported by the National Institute of Allergy and Infectious Disease and the National Institute of General Medical Sciences of the National Institutes of Health under award numbers R42AI112064 and R43GM122152. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.


Dr. Neumeister has previously served as President of the Plastic Surgery Foundation, Plastic Surgery Research Council and a Leader in Translational Regenerative Medicine SOUTH PLAINFIELD, NJ--(Marketwired - Dec 9, 2016) - Majesco Entertainment, Inc. ( : COOL) ("Majesco") following announcement that it had signed a definitive merger agreement with PolarityTE, Inc. ("Polarity") www.polarityte.com  announced it has appointed Michael W. Neumeister, MD, FRCSC, FACS as Chief Medical Officer (http://www.siumed.edu/surgery/plastics/cvs/neumeister_cv.html). Dr. Neumeister was formerly President of the Plastic Surgery Foundation and Plastic Surgery Research Council and is a Leader in Regenerative Medicine (http://www.siumed.edu/surgery/plastics/cvs/MWN%20CV.pdf). Following satisfaction of the conditions to closing, including approval of stockholders, Polarity will be acquired by Majesco, and will operate as a wholly-owned subsidiary of Majesco, which will change its name to Polarity in connection with the contemplated transaction.  "Polarity seeks to alter the paradigms of regenerative medicine and patient-specific tissue engineering for the future. It is with these ambitious goals in mind that I am pleased to announce world renowned plastic and reconstructive surgeon Dr. Michael Neumeister has agreed to join as Chief Medical Officer of PolarityTE™. Beyond his tremendous expertise in some of the most complex reconstructive procedures performed, he has remained a leader and mentor in the field and an innovator in pragmatic translational regenerative medicine," said Chief Executive Officer and Chairman Dr. Denver Lough. "I am extremely excited to join the Polarity Team and help transform the landscape of translational tissue engineering and reconstructive surgery. I believe I can add tremendous value with a large network of clinical thought leaders and practical viewpoint on the application of the technology. Dr. Lough and I have a close working relationship and I consider him to be one of the most gifted and brilliant innovators in regenerative medicine, and it is an honor to be brought on to his team in this role. I have no doubt, he will change field as we know it," said Dr Neumeister. About PolarityTE PolarityTE, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough MD, PhD. This radical and proprietary technology employs a patients' own cells for the healing of full-thickness functionally-polarized tissues. If clinically successful, the PolarityTE platform will be able to provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. It is because PolarityTE uses a natural and biologically sound platform technology, which is readily adaptable to a wide spectrum of organ and tissue systems, that the company and its world-renowned clinical advisory board, are poised to drastically change the field and future of translational regenerative medicine. More info can be found online at www.polarityte.com. Welcome to the Shift™. About Michael W. Neumeister, MD, FRCSC, FACS Professor & Chairman - Department of Surgery The Elvin G. Zook Endowed Chair in Plastic Surgery Microsurgery/Research Lab Director Director: Memorial Medical Center Regional Burn Unit Director: Memorial Medical Center Wound Center Southern Illinois University School of Medicine, Springfield, IL Dr. Neumeister is Professor & Chairman of the Department of Surgery and The Elvin G. Zook Endowed Chair in Plastic Surgery at Southern Illinois University School of Medicine in Springfield, IL. He received his medical degree from the University of Toronto and previously completed a degree in physiology and pharmacology at the University of Western Ontario. Dr. Neumeister began his residency at Dalhousie University in Halifax, Nova Scotia in general surgery and went on to complete his plastic surgery residency at the University of Manitoba. He continued his training as a microsurgery fellow at Harvard University's Brigham & Women's Hospital in Boston and completed a one year hand and microsurgery fellowship at Southern Illinois University School of Medicine. Dr. Neumeister is board certified in plastic surgery by the Royal College of Surgeons of Canada and the American Board of Plastic Surgery. He has also received his Certificate in (SOTH) Surgery of The Hand. Dr. Neumeister has received awards for presentations given regionally, nationally and internationally, has over 150 book chapters and articles, and has multiple research interests in tissue engineering and regenerative medicine. Dr. Neumeister is the Editor in Chief of the official AAHS journal HAND. He is the past President of the American Society of Reconstructive Microsurgery, American Association for Hand Surgery, The Plastic Surgery Foundation (The Research Body of The American Society of Plastic Surgeons), Plastic Surgery Research Council, and the Midwest Association of Plastic Surgeons. His memberships include the American Society of Plastic Surgeons, Plastic Surgery Foundation, Plastic Surgery Research Council, American Association for Hand Surgery, American Society of Reconstructive Microsurgery, American Society for Surgery of the Hand, American Burn Association, American Council of Academic Plastic Surgeons and the American Association of Plastic Surgeons where he also serves as an elected official on several of their committees. Dr. Neumeister has received awards for presentations given regionally, nationally and internationally and has over 150 published manuscripts and book chapters. Dr. Neumeister's research interests include: allotransplantation, tissue engineering, the role of stem cells in reconstruction, ischemia reperfusion, peripheral nerve, and burn modulation. Forward-Looking Statements Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.


Raz-Pasteur A.,Infectious Diseases Unit | Hussein K.,Infectious Diseases Unit | Finkelstein R.,Infectious Diseases Unit | Ullmann Y.,Burn Unit | Egozi D.,Burn Unit
Burns | Year: 2013

Bloodstream infections (BSI) and sepsis are among the most common complications occurring in severe burn patients. This study was designed to evaluate changes in BSI pathogens over almost a decade in severe burn patients at Rambam Healthcare Campus, and BSI occurrence during early and late hospitalization periods. Retrospective computerized data was retrieved from all severe burn patients hospitalized in our institution during the years 2001-2009. BSI in the first week was defined as early BSI, and in the second week and beyond, late BSI. Of 159 severe burns patients, 74 had at least one BSI episode. Most first BSI episodes were diagnosed during the first week of hospitalization. In late BSI, an increased prevalence of resistant bacteria (methicillin-resistant Staphylococcus aureus [MRSA], carbapenem-resistant Klebsiella pneumoniae [CRKP], imipenem-resistant Pseudomonas aeruginosa [PSE-IMP]) and Candida spp. were observed. However, over the 9-year study period, only CRKP increased significantly. In summary, except for the sudden appearance and increase in CRKP (8% increase; p = 0.045), we did not observe a significant change in the BSI pathogen profile over the 9-year period. Nevertheless, over the hospitalization period, there is a clear change in the BSI bacteria profile, especially after 4 weeks of hospitalization. © 2012 Elsevier Ltd and ISBI.


News Article | November 29, 2016
Site: www.prweb.com

ClassAction.com attorney Mike Morgan has filed a product liability and negligence lawsuit against e-cigarette manufacturers and retailers over an alleged vape explosion that he says injured his clients, Florida couple James Dardini and Angela Dardini. Mr. and Mrs. Dardini’s complaint was filed in the Seventh Judicial Circuit in and for Volusia County, Florida, on September 16, 2016. Defendants include Kangertech, which allegedly made the vape devices; Sunshine Vapor, the retailer that allegedly sold Mr. Dardini the vape products; and Perfect Vape, which allegedly imported the devices and sold them to Sunshine Vapor. The lawsuit seeks damages, costs, interest, and attorney fees, plus any further relief that the Court deems just and proper. The complaint alleges strict liability, negligence, design and manufacturing failures and failure to adequately warn plaintiffs of the products’ risks, among other charges. The complaint states that Mr. Dardini purchased a Kanger vaporizer and battery from the Sunshine store on September 21, 2015. On December 28, 2015, while at work in Ocoee, Florida, Mr. Dardini alleges that around 11am—a few hours after allegedly using the device on his way to work—the vaporizer device exploded in his front right pocket, “engulfing Mr. Dardini’s leg in flames.” The complaint alleges that Mr. Dardini had to be transported to Health First Hospital in Clermont, Florida, before then being transferred to the Burn Unit at Orlando Regional Medical Center (ORMC) to be treated for second and third degree burns. While at ORMC, the complaint claims that Mr. Dardini had to undergo “a significant skin graft surgery to his right leg.” As a result of this alleged incident, the complaint states, “Mr. Dardini sustained severe, permanent and life-altering injuries to his groin, legs and lower back.” The complaint continues by claiming these allegations: As a direct and proximate cause of the foregoing conduct of Defendant Perfect Vape [and Sunshine, and Kangertech], Mr. Dardini sustained serious and permanent bodily injuries resulting in pain and suffering, permanent impairment, disability, mental anguish, inconvenience, loss of the enjoyment of life, expense of medical care and treatment, expense of hospitalization, lost wages in the past and the loss of ability to earn wages in the future. Mr. Dardini’s wife Angela is a plaintiff because the lawsuit claims that Mr. Dardini’s alleged injuries have affected their marriage and caused Mrs. Dardini “loss of affection” and “mental anguish.” The complaint alleges: …as a direct and proximate result of the foregoing, Mrs. Dardini suffered the following damages: (1) loss of consortium and damage to her husband/wife relationship; (2) loss of affection, solace, comfort, companionship, society, assistance, sexual relations, emotional support and love; and (3) mental anguish. The complaint includes photos of the alleged injuries and vape devices in question. ClassAction.com is part of the Complex Litigation branch of nationwide plaintiff’s law firm Morgan & Morgan. Mike Morgan is the managing partner of Morgan & Morgan’s Product Safety Group, which represents individuals who have been injured due to poorly designed and defective products. CIRCUIT COURT OF THE SEVENTH JUDICIAL CIRCUIT IN AND FOR VOLUSIA COUNTY, FLORIDA JAMES DARDINI and ANGELA DARDINI, Plaintiffs vs. SUNSHINE VAPOR, LLC, Florida Limited Liability Company; KANGERTECH U.S., LLC, a Georgia Limited Liability Company; KANGERTECH US DISTRIBUTIONS LLC, a Georgia Limited Liability Company; KANGERTECH HOLDINGS LLC, a Georgia Limited Liability Company; and PERFECT VAPE, LLC, an Oklahoma Limited Liability Company; Defendants CASE NUMBER: 201610220CIDL E-Filed: 09/16/2016


Hagert E.,Karolinska Institutet | Hagert E.,Hand and Foot Surgery Center | Lluch A.,Institute Kaplan | Lluch A.,Vall dHebron Hospital | And 2 more authors.
Journal of Hand Surgery: European Volume | Year: 2016

Carpal stability has traditionally been defined as dependent on the articular congruity of joint surfaces, the static stability maintained by intact ligaments, and the dynamic stability caused by muscle contractions resulting in a compression of joint surfaces. In the past decade, a fourth factor in carpal stability has been proposed, involving the neuromuscular and proprioceptive control of joints. The proprioception of the wrist originates from afferent signals elicited by sensory end organs (mechanoreceptors) in ligaments and joint capsules that elicit spinal reflexes for immediate joint stability, as well as higher order neuromuscular influx to the cerebellum and sensorimotor cortices for planning and executing joint control. The aim of this review is to provide an understanding of the role of proprioception and neuromuscular control in carpal instabilities by delineating the sensory innervation and the neuromuscular control of the carpus, as well as descriptions of clinical applications of proprioception in carpal instabilities. © The Author(s) 2015.


Pina G.,Nuclear Medicine Center | Brun J.,Nuclear Medicine Center | Tissot S.,Burn Unit | Claustrat B.,Nuclear Medicine Center | Claustrat B.,French Institute of Health and Medical Research
Chronobiology International | Year: 2010

Melatonin, which shows a robust nycthemeral rhythm, plays the role of an endogenous synchronizer, able to stabilize and reinforce circadian rhythms and maintain their mutual phase relationships. Additionally, melatonin is a potent antioxidant and displays immunological properties. Because free radical generation, immune dysfunction, and sleep and metabolic disorders are involved in the short- and long-term pathophysiology of the burn syndrome, we undertook the study of daily urine melatonin, 6-sulfatoxymelatonin (aMT6s, the main hepatic melatonin metabolite), and cortisol variations plus temperature profiles in burn patients using a non-invasive protocol. Eight patients (6 males, 2 females) were studied on three occasions after admission to the intensive care unit (early session: days 1 to 3; intermediate session: day 10; late session: days 20 to 30). Melatonin, aMT6s, and free cortisol levels were determined in urine samples collected at 4 h intervals over a continuous 24 h span. Core temperature was recorded daily. Controls consisted of healthy subjects in the same age range. Cosinor analysis of the data provided an evaluation of mesor, amplitude, and acrophase of circadian rhythms. Also, we calculated day (D), night (N), and 24 h hormone excretions, ND ratio for melatonin and aMT6s, and DN ratio for cortisol. These data were analyzed using Kruskal-Wallis test followed by multiple comparisons. Cosinor analysis did not detect a circadian rhythm in melatonin, aMT6s, or cortisol in any of the three sessions. D melatonin excretion displayed a major increase, resulting in a decreased ND melatonin ratio, and the melatonin mesor (24 h mean) was increased in the early session, compared with controls. For aMT6s, only the early ND ratio was decreased, and the mesor of the intermediate session increased. These results were not the consequence of hepatic andor kidney alteration, as the patients' hepatic and renal parameters were in the normal range. The D and N melatoninaMT6s ratios of controls and patients were similar, and the aMT6s profiles were superimposed on the melatonin ones, mainly during the day. The D, N, and 24 h cortisol values were increased in all sessions, except for the D level of the early session. The consistently increased mesors in the three sessions provided confirmation. The core temperature profiles were abnormal in all three sessions, mainly during the night, although there was a tendency toward normalization with time. The individual mesors were consistently increased compared with controls. Globally, the abnormalities we report could participate in the pathophysiology of short- and long-term alterations observed in burn syndrome, especially disturbances of sleep, metabolism, and immune function. © Informa UK Ltd.


Rowley-Conwy G.,Burn Unit
Nursing standard (Royal College of Nursing (Great Britain) : 1987) | Year: 2012

Many patients with minor burns can be cared for in the emergency department or community setting, but clinicians must be confident in assessing and managing a burn injury to ensure the best possible outcome. This article defines a minor burn, reviews burn assessment and considers aspects of nursing management that optimise minor burn care.


Rowley-Conwy G.,Burn Unit
Nursing standard (Royal College of Nursing (Great Britain) : 1987) | Year: 2013

Patients with major burns require specialist care in burn centres, taking into account the complex systemic response to a burn injury, avoidance of complications, specialist wound care and supportive multidisciplinary management. Occasionally, these patients may be managed in other settings, such as emergency departments or general intensive care units and ward areas, for example after an explosion or major disaster. Therefore, general nurses require an understanding of patients' complex needs, and should be aware of the latest developments in burn care and up-to-date evidence to ensure best practice.


Introduction: The lack of autograft donor sites with major burns provides the impetus to develop innovative solutions due to the difficulty of wound closure. Autograft donor sites are particularly limited in patients with burns involving over 50% total body surface area (TBSA). The introduction of cultured epithelial cell autografts offers a potential solution to assist in wound closure. The objective of this study was the assessment of clinical results after sprayed application of the cultured epithelial autograft (CEA, Keraheal™, Seoul, Korea, MCTT) suspension onto the wounds of extensively burned patients. Materials and methods: This retrospective clinical audit of major burn patients (n = 16) describes the use of CEA which was combined with 6:1 meshed expansion grafts in those with the burn over 40% TBSA in our hospital between the period of August 2007 and January 2010. The burn patients included 12 males and 4 females with a mean age 41.5 and a burn area of 51.3 ± 3.1% TBSA (30-70%; median: 50.5%) and a mean third burn area of 32.5 ± 3.0% TBSA (median 34.0%). Results: The take rates were 37.6%, 68.0% and 90.0% on average at 2, 4 and 8 weeks after treatment with the suspension, respectively, and the transplantation of the cultured cells was applied to full-thickness burns, with the coverage of a skin area of 497.5 cm 2 per 1 ml of the cultured cells. For clinical follow-up, 12 patients were observed for 21.5 months on average, with a maximum follow-up period of 39 months. Six patients were excluded from the surveillance because two died during hospitalisation and the other four were impossible to trace. Conclusion: The use of a sprayed cultured epithelial cell autograft (Keraheal™) in treating a full-thickness skin wound in severely burned patients results in favourable quality of scars and also good potential to save lives by providing epidermal cover. © 2012 Elsevier Ltd and ISBI.


Rowley-Conwy G.,Burn Unit
Nursing standard (Royal College of Nursing (Great Britain) : 1987) | Year: 2013

A burn can be categorised as a major trauma injury, and assessment and management should follow the advanced trauma life support (ATLS) principles. This article aims to identify specific considerations during ATLS assessment of a patient with a major burn in the emergency department. Guidance on stabilisation and referral of the patient to the regional burns centre is provided.

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