Barrow Neurological Institute
Barrow Neurological Institute
News Article | May 15, 2017
CHANDLER, Ariz.--(BUSINESS WIRE)--On May 12, 2017, Governor Doug Ducey signed Arizona’s $9.8 billion 2018-2019 Budget which provides bonding authority for $1 billion for investments in University Research Infrastructure. This investment continues a collaboration between the State of Arizona, Industry Leaders, Philanthropists, and Arizona’s Universities that is driving Arizona towards its goal of becoming a top-tier bioscience state. The Biotechnology Innovation Organization in partnership with TEConomy Partners publishes the biennial report on the economic impact of the bioscience industry that provides a national overview and ranks the 50 states and Puerto Rico across five quintiles or tiers. The 2016 Report, The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life 2016, was released in June of 2016 at the BIO International Convention in San Francisco. The report includes a wide range of metrics and economic indicators on a national and state basis. As reported in 2016, the top 10 states based on the number of bioscience firms (Tier I) were California, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania, Ohio, and Texas. Could Arizona achieve the growth necessary to reach the top-tiers? Arizona’s leaders began the journey to achieve this goal twenty years ago. In 1997, the Arizona Bioindustry Cluster was founded by Bob Case and Michael E. Berens, Ph.D. laying the foundation for what would become the Arizona Bioindustry Association or AZBio in 2003. Work by the Arizona Legislature and a coalition of community leaders supported voter passage of Proposition 301 in the year 2000. Prop. 301 established a six-tenths of one cent sales tax to support education that included funding for an estimated $1 billion (generated and disbursed over 20 years) for research at Arizona universities. The resulting Technology Research Initiative Fund (TRIF) is administered by the Arizona Board of Regents and has distributed $892 million for the period spanning from 2001-2016 and is well on its way to reach the billion dollar goal by June 30, 2021. The following year, the Flinn Foundation committed to 10 years of major funding for Arizona biosciences and brought together over 100 leaders to begin to craft what would become the Arizona Bioscience Roadmap. Under the stewardship of the Flinn Foundation, the strategic plan for the biosciences in Arizona would include key initiatives along with a commitment to measurement and reporting of the results. The first decade of the new century marked the completion of The Human Genome Project and a new era for life science research and development globally. From 2000 to 2010, Arizona’s Bioscience community activity included the International Genomics Consortium establishing its home in Phoenix and the subsequent creation of the Translational Genomics Research Institute (TGen) which was funded by a $90 million fundraising effort and spun out of IGC. In addition to the funding from Prop. 301, the Arizona legislature approved $440 million for construction of new university research facilities supporting the growth of the Biodesign Institute at Arizona State University, the BIO5 Institute at the University of Arizona, new research facilities at Northern Arizona University and more. An additional $100 million was approved by the voters for bioscience and health care training and facilities at Maricopa Community Colleges. The Virginia G. Piper Charitable Trust committed $50 million to personalized medicine in Arizona and local philanthropists have supported the community with additional resources for research and patient care across the state. Over the last two decades, Arizona’s bioscience industry has focused and grown. Arizona has risen in the rankings to take its place in the second tier of the Bioscience rankings based on number of firms. The Biodesign Institute at Arizona State University has grown from one building to two with a third building under construction. Arizona is now home to the Critical Path Institute, the National Biomarker Development Alliance, the Arizona Alzheimer’s Alliance, the Banner Alzheimer’s Institute, Cancer Treatment Centers of America, and Banner MD Anderson. Barrow Neurological Institute, founded in 1962 as a regional specialty center, has grown into one of the premiere destinations in the world for neurology and neurosurgery. Phoenix Children’s Hospital is now one of the largest children’s hospitals in the country and is ranked in 10 out of 10 specialties. Mayo Clinic has expanded its research and patient care capacity, added proton beam capabilities and will welcome the first class to its Arizona-based Mayo Medical School in 2017. The University of Arizona extended its reach from Tucson to Phoenix which now includes the The University of Arizona College of Medicine-Phoenix and the The University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center on the Phoenix Biomedical Campus. The number of life science companies in Arizona is now over 1,400 and multi-billion dollar exits include the sale of Ventana Medical Systems, Inc. to Roche for $3.4 Billion and Abraxis Biosciences for $2.9 billion to Celgene. Today, companies that were born in Arizona are now publicly traded including Insys, HTG Molecular, and SensTech while others have been acquired by AMAG Pharmaceuticals, Caris Diagnostics, Thermo Fischer, IMS Health, Merz, Stryker and more. These companies have continued to grow in Arizona joining global leaders including BARD, Medtronic, and W.L. Gore. The combined benefits of Arizona’s world-class healthcare institutions and diverse population demographics are driving the number of active clinical trials in the state which have more than doubled over the period from 2012 – 2017 based on data at ClinicalTrials.gov. Long-time residents and new industry partners are benefiting from Arizona’s business-friendly public policy and regulatory environment, affordable operating cost structures, stable and reliable energy suppliers, well-managed water resources, talent, and an affordable cost of living in communities that provide their employees the opportunity for an excellent quality of life. Free from the business disruptions that can be caused by earthquakes, hurricanes, tornadoes, and floods, Arizona has become a go-to site for both high-tech manufacturing and corporate data centers. The Arizona Innovation Challenge, which made its first awards in 2011 and is powered by the Arizona Commerce Authority, awards the most money in the country for a technology commercialization challenge – $3 million ($1.5 million twice yearly) to the world’s most promising technology ventures. Awards range from $100,000 to $250,000 per company. Over this 20-year span, Arizona has gained a reputation as the state with the “collaborative gene” and attracts thought leaders looking to discover, develop, and deliver life-changing and life-saving innovations to patients. Globally recognized thought leaders have left the hallowed halls of Harvard, the National Institutes of Health and other world-class institutions to innovate and collaborate in Arizona. One real-world example of this collaboration is Arizona State University’s International School of Biomedical Diagnostics. A global center for research, teaching and service in the emerging field of biomedical diagnostics, the school pulls expertise from faculty across ASU, in collaboration with Dublin City University (DCU), Ventana Medical Systems, and other industry partners. ASU faculty come from: the Biodesign Institute, College of Health Solutions, Ira A. Fulton Schools of Engineering, School of Life Sciences in the College of Liberal Arts and Sciences, the W. P. Carey School of Business, and the Consortium for Science, Policy & Outcomes. The initiative also leverages the expertise of the National Biomarker Development Alliance that is led by ASU. Under the leadership of President Michael Crow, Arizona State University has been named the Most Innovative University in the United states for two years running and out-ranking Stanford and MIT. Throughout the Arizona Bioscience Roadmap’s first decade, Battelle tracked performance data that was released annually by the Flinn Foundation. The performance metrics released in 2014 serve as the benchmark for the second decade of the Roadmap, with new data reported on a biennial basis. The most current data is available in “2015 Progress of the Biosciences in Arizona,” a report produced by TEConomy Partners (a spinoff of Battelle) that was released in March 2016. The Flinn Foundation will continue to track the progress of the bioscience sector each year by highlighting the state’s major developments. In April of 2017, the Flinn Foundation released its most recent update, the 2016 Progress of the Biosciences in Arizona. Could Arizona achieve the growth necessary to reach the top-tiers? Absolutely. Now, twenty years into the process, Arizona’s Bioindustry has a new funding catalyst. With the Governor’s vision and the Legislature’s support, an additional $1 billion dollars will be invested in university research infrastructure beginning in July of 2018. Arizona’s leaders are already discussing what the next iteration of Prop. 301 will look like as it approaches its renewal on or before 2020. The Arizona Legislature has passed HB2191 which authorizes an additional $10 million in Angel Investor Tax Credits spread over the next four years and SB1416 which continues Arizona’s Quality Jobs Tax Credit, Arizona's Research and Development Tax Credits and other business incentives. Both bills have been sent to the Governor for his signature. Arizona’s leaders are continuing the journey to take the state into the top tiers of the bioscience rankings. The Flinn Foundation has extended its commitment to steward the Arizona Bioscience Roadmap through the year 2025 with the support of the 100-person Arizona Bioscience Roadmap Steering Committee and the Arizona Bioindustry Association (AZBio) Board of Directors is committed to the vision of making Arizona a top-tier bioscience state and works collaboratively to make that vision a reality. A key component in Arizona’s life science ecosystem, the Arizona Bioindustry Association (AZBio) is the only statewide organization exclusively focused on Arizona’s bioscience industry. AZBio membership includes patient advocacy organizations, life science innovators, educators, healthcare partners, municipalities and leading business organizations. AZBio is the statewide affiliate of the Biotechnology Innovation Organization (BIO) and works in partnership with AdvaMed, MDMA, and PhRMA to advance innovation and to ensure that the value delivered from life-changing and life-saving innovation benefits people in Arizona and around the world. For more information visit www.AZBio.org and www.AZBio.TV To learn more about Arizona’s Bioindustry:
News Article | May 15, 2017
"We are off to a fast start in 2017," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We have already had a series of positive developments this year that will make important contributions toward our goal of delivering long-term sustainable growth." Cumberland announced an agreement with the Clinigen Group plc to acquire exclusive U.S. rights to the FDA approved oncology support drug, Totect®. This is the second product Clinigen has licensed to Cumberland under a strategic alliance entered into between the companies. Totect is an FDA-approved emergency oncology intervention which is indicated to reverse the toxic effects of extravasation associated with anthracycline chemotherapy. Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body causing severe damage and serious complications. Totect can reverse such damage without the need for additional surgeries and procedures, enabling patients to continue their essential anti-cancer treatment. Under the terms of the agreement, Cumberland will be responsible for all marketing, promotion, and distribution of the product in the United States. Clinigen will retain responsibility for manufacturing and regulatory management of the product. The U.S. launch of Totect is currently expected in late 2017. Early in the first quarter, Cumberland announced the publication of a multicenter clinical study demonstrating that Caldolor® delivered significant fever reduction in hospitalized children. The study evaluated the efficacy and safety of intravenous ibuprofen in pediatric patients, six months and older, with fever. Results from the study demonstrated that a single 10 mg/kg dose of intravenous ibuprofen provided a significant reduction of temperature in the pediatric patients and provides an effective option for reducing fever in children. This pivotal data published in the British BMC Pediatrics Journal supported the FDA approval of Caldolor for use in this pediatric patient population. In March 2017, the Company announced the publication of a trial providing evidence that using Caldolor in multimodal pain control strategies improves postoperative pain control and reduces opioid use in patients undergoing surgery. The trial compared outcomes in two groups of patients treated with multimodal pain management protocols following transsphenoidal surgery for pituitary lesions: Group 1 patients treated intraoperatively with IV Ibuprofen (Caldolor 800 mg.), scheduled oral acetaminophen and rescue opioids, versus Group 2 patients treated with IV saline placebo, scheduled oral acetaminophen, and rescue opioids. The patients receiving Caldolor demonstrated a significant reduction of 43% in their mean pain scores compared with those receiving placebo. Opioid use was also significantly impacted with a 58% reduction in the Caldolor Group patients compared to Placebo Group patients. The trial was conducted at the Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center in Phoenix, Arizona. The study results were published in the Journal of Neurosurgery, March 2017. In January 2017, a Federal Appeals Court affirmed the District Court ruling in the Company's favor in its lawsuit for infringement of its Acetadote Patent. The Appeals Court opinion affirmed the District Court's ruling, expressly rejecting validity challenges, and upholding Cumberland's Patent. Since 2012, the USPTO has a series of patents associated with Acetadote, Cumberland's injectable formulation of N-Acetylcysteine ("NAC") for the treatment of acetaminophen overdose. In January 2017, Cumberland announced the addition of Kenneth J. Krogulski, CFA to the Company's Board of Directors. Mr. Krogulski is the President and Chief Executive Officer of Berkshire Asset Management LLC. He is also the Chief Investment Officer of Berkshire, an SEC-registered investment advisory firm. Mr. Krogulski has over 38 years of experience in security analysis and portfolio management. Under his leadership, Berkshire's assets under supervision have grown from $600 million in 2006 to over $1.7 billion in 2017. Net Revenue: For the three months ended March 31, 2017, net revenues were $9.6 million, compared to $7.7 million for the prior year period. Net revenue by product for the three months ended March 31, 2017, included $3.7 million for Ethyol®, $2.4 million for Kristalose®, $1.3 million for Acetadote® (including $0.9 million for the Company's Authorized Generic) $0.8 million for Caldolor®, $0.7 million for Vaprisol® and $0.6 million for Omeclamox®-Pak. Operating Expenses: Total operating expenses for the three months ended March 31, 2017 were $10.3 million, compared to $8.2 million during the prior year period. The primary reasons for this increase were the additional cost of goods sold and royalty expenses associated with the growth in sales. Earnings: Net income (loss) for the first quarter of 2017 was $(1.3) million or $(0.08) per diluted share, compared to $(0.3) million or $(.02) a share for the prior year period. This difference was impacted by a non-cash charge to taxes associated with an increase in the valuation allowance for prior Research and Development tax credits. Adjusted Earnings for the first quarter were $0.3 million or $0.02 per diluted share, similar to the prior year period. The definition and reconciliation of Adjusted Earnings to net income (loss) is provided in this release. Balance Sheet: At March 31, 2017, Cumberland had $50.5 million in cash and marketable securities, including approximately $35.0 million in cash and equivalents. Total Assets at March 31, 2017 were $91.9 million. Total Liabilities were $19.6 million, including $4.1 million outstanding on the Company's revolving line of credit, resulting in Total Shareholder's Equity of $72.4 million. Cumberland also has approximately $44 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options. As part of the adoption of the recent Stock Compensation standard, these tax net operating loss carryforwards resulted in the addition of a new tax asset to the balance sheet along with a significant allowance. The net change in deferred tax assets was an increase of $0.41 million for the first quarter. A conference call and live Internet webcast will be held on Monday, May 15, 2017 at 4:30 p.m. Eastern Time to discuss the Company's first quarter 2017 financial results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 11376419. The live webcast and rebroadcast can be accessed via Cumberland's website at http://investor.shareholder.com/cpix/events.cfm. Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's six marketed products include Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, for the treatment of pain and fever, Kristalose® (lactulose) for Oral Solution, a prescription laxative, Vaprisol® (conivaptan) Injection, for the treatment of hyponatremia and Omeclamox-Pak® for the treatment of H. pylori infection and duodenal ulcer disease, and Ethyol® (amifostine) for Injection, for the treatment of oncology patients. Cumberland is developing Hepatoren® (ifetroban) Injection for the treatment of Hepatorenal Syndrome, Boxaban® (ifetroban) Oral Capsule for the treatment of Aspirin-Exacerbated Respiratory Disease, VasculanTM (ifetroban) Oral Capsule for the treatment of systemic sclerosis, and Portaban™, for the treatment of portal hypertension Cumberland is dedicated to providing innovative products that improve quality of care for patients. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company's website www.cumberlandpharma.com. Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death. For full prescribing information, visit www.acetadote.com. Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, including boxed warning, visit www.caldolor.com. Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia and hypernatremia. Nausea and vomiting have been reported. Use with caution in diabetics. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing information, visit www.kristalose.com. Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. The safety and effectiveness of Omeclamox-Pak in the pediatric population has not yet been established. Omeclamox-Pak was approved by the U.S. Food and Drug Administration in 2011. For full prescribing information, visit www.omeclamox.com. Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol was approved by the U.S. Food and Drug Administration in 2005 for euvolemic hyponatremia and in 2007 for hypervolemic hyponatremia. For full prescribing information, visit www.vaprisol.com. Ethyol is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. It is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Cumberland Emerging Technologies, Inc. ( ) is a joint initiative between Cumberland Pharmaceuticals Inc., Vanderbilt University, LaunchTN, and Gloria Pharmaceuticals. The mission of CET is to advance biomedical technologies and products conceived at Vanderbilt University and other regional research centers towards the marketplace. CET helps manage the development and commercialization process for select projects, and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products. CET's Life Sciences Center, provides laboratory space, equipment and infrastructure for CET's activities and other early-stage life sciences ventures. This announcement contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure and other factors discussed in the Company's most recent Form 10-K and subsequent 10-Q's as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-reports-revenue-growth-of-25-in-first-quarter-2017-300457641.html
News Article | August 16, 2017
PHOENIX, Ariz. Aug. 16, 2017 -- Research led by the head of the Barrow Neurological Institute and published in the July 20, 2017 issue of The New England Journal of Medicine reveals that subarachnoid hemorrhages, which are caused by ruptured brain aneurysms, account for 5-10 percent of all strokes and are best managed by experienced and dedicated experts at high-volume centers with neurosurgeons, endovascular surgeons and stroke neurologists. The article was co-authored by Barrow President and CEO Michael T. Lawton, M.D. and G. Edward Vates, M.D., Ph.D, of the University of Rochester Medical Center's Department of Neurosurgery. "Subarachnoid hemorrhage victims tend to be younger than typical stroke victims, and they risk a greater loss of productive life," Dr. Lawton said. "It is critical that they receive the best treatment for aneurysms - like the multidisciplinary team approach and state-of-the-art therapy like that offered at Barrow." Neurosurgeons at Barrow have experience treating more than 12,000 aneurysms over the past 20 years. Dr. Lawton, has treated more than 4,000 aneurysms and recently succeeded Robert Spetzler, M.D., as the head of Barrow. There are an estimated 14.5 hospitalizations for aneurysmal subarachnoid hemorrhage per 100,000 U.S. adults annually, according to the 2003 Nationwide Inpatient Sample. Aneurysmal subarachnoid hemorrhage is more common among women than among men, and the incidence increases with age to a peak among persons in their 50s. In The New England Journal of Medicine article, the doctors described the case of a 17-year-old boy who experienced a sudden, severe headache and loss of consciousness at soccer practice. The patient described in the vignette had clinical and radiographic findings that are consistent with subarachnoid hemorrhage. Catheter angiography was indicated to identify the source of his bleeding. An aneurysm is the most common cause and, if identified, is associated with a very high risk of re-rupture during the next 30 days; thus, the researchers recommend immediate treatment. "Given this patient's age, his otherwise healthy status, and the location of the aneurysm in the anterior circulation, we would recommend open-surgical treatment by a specialized, experienced surgeon," Dr. Lawton wrote. Open-surgical treatment (surgical clipping) is preferred on the basis of certain features of the aneurysm (e.g., morphologic characteristics of the aneurysm and an associated large hematoma) or in younger patients, given the greater durability of the open-surgical treatment in the randomized trials. "If a surgeon with expertise in open-surgical technique is not available at the center, endovascular treatment could be provided instead to eliminate the immediate risk of re-rupture." Subarachnoid hemorrhage without a preceding trauma is caused by the rupture of an intracranial aneurysm in 80 percent of cases; other causes include vascular malformations and vasculitis. Subarachnoid hemorrhage accounts for 5 to 10 percent of all strokes in the United States, and affected patients tend to be younger than those affected by other subtypes of stroke, which results in a greater loss of productive life. Among the patients with aneurysmal subarachnoid hemorrhage who survive, half suffer long-term neuropsychological effects and decreased quality of life. The article describes "sentinel" headaches, which occur several weeks before aneurysmal subarachnoid hemorrhages in 10 to 40 percent of patients. Because such headaches are rare, accounting for only 1 percent of all headaches evaluated in the emergency department, a sentinel headache may be dismissed as a migraine headache or other headache without further evaluation; the likelihood of death or disability is four times as high among patients in whom a sentinel headache is misdiagnosed as it is among patients in whom a sentinel headache is correctly diagnosed. "A high index of suspicion for aneurysmal subarachnoid hemorrhage from the patient's history is warranted and potentially lifesaving," Dr. Lawton said. "Expert care, analogous to that at a dedicated neuroscience institute like Barrow, is critical in these cases." Read the entire article and see associated graphics and surgical video: http://www. Barrow Neurological Institute is an internationally renowned medical institute, exclusively dedicated to neurological conditions. Patients from throughout the world with brain and spine diseases, disorders and injuries travel to Barrow for expert care. Barrow performs more neurosurgeries annually than any facility in the United States and trains more neurosurgeons than any facility in the world. U.S. News & World Report routinely recognizes Barrow as a leader for neurological and neurosurgical care. The institute is located in Phoenix, Ariz. at Dignity Health St. Joseph's Hospital and Medical Center.
Research Triangle Institute, Virginia Commonwealth University and Barrow Neurological Institute | Date: 2012-11-19
The invention provides hydroxybupropion analogues capable of inhibiting the reuptake of one or more monoamines and/or acting as antagonists at nicotinic acetylcholine receptors. The compounds may selectively bind to one or more monoamine transporters, including those for dopamine, norepinephrine, and serotonin and/or may selectively bind to one or more nicotinic acetylcholine receptor subtypes. Such compounds may be used to treat conditions that are responsive to modification of monoamine levels and/or antagonism of nicotinic acetylcholine receptors, including drug dependency, depression, and obesity.
Otero-Millan J.,Barrow Neurological Institute
Journal of vision | Year: 2014
Microsaccades, small involuntary eye movements that occur once or twice per second during attempted visual fixation, are relevant to perception, cognition, and oculomotor control and present distinctive characteristics in visual and oculomotor pathologies. Thus, the development of robust and accurate microsaccade-detection techniques is important for basic and clinical neuroscience research. Due to the diminutive size of microsaccades, however, automatic and reliable detection can be difficult. Current challenges in microsaccade detection include reliance on set, arbitrary thresholds and lack of objective validation. Here we describe a novel microsaccade-detecting method, based on unsupervised clustering techniques, that does not require an arbitrary threshold and provides a detection reliability index. We validated the new clustering method using real and simulated eye-movement data. The clustering method reduced detection errors by 62% for binocular data and 78% for monocular data, when compared to standard contemporary microsaccade-detection techniques. Further, the clustering method's reliability index was correlated with the microsaccade-detection error rate, suggesting that the reliability index may be used to determine the comparative precision of eye-tracking devices.
Craig A.D.,Barrow Neurological Institute
Brain structure & function | Year: 2010
This article addresses the neuroanatomical evidence for a progression of integrative representations of affective feelings from the body that lead to an ultimate representation of all feelings in the bilateral anterior insulae, or "the sentient self." Evidence for somatotopy in the primary interoceptive sensory cortex is presented, and the organization of the mid-insula and the anterior insula is discussed. Issues that need to be addressed are highlighted. A possible basis for subjectivity in a cinemascopic model of awareness is presented.
Craig A.D.(B.),Barrow Neurological Institute
Brain Structure and Function | Year: 2010
This article addresses the neuroanatomical evidence for a progression of integrative representations of affective feelings from the body that lead to an ultimate representation of all feelings in the bilateral anterior insulae, or "the sentient self." Evidence for somatotopy in the primary interoceptive sensory cortex is presented, and the organization of the mid-insula and the anterior insula is discussed. Issues that need to be addressed are highlighted. A possible basis for subjectivity in a cinemascopic model of awareness is presented. © 2010 Springer-Verlag.
Craig A.D.B.,Barrow Neurological Institute
Annals of the New York Academy of Sciences | Year: 2011
An ascending sensory pathway that underlies feelings from the body, such as cooling or toothache, terminates in the posterior insula. Considerable evidence suggests that this activity is rerepresented and integrated first in the mid-insula and then in the anterior insula. Activation in the anterior insula correlates directly with subjective feelings from the body and, strikingly, with all emotional feelings. These findings appear to signify a posterior-to-anterior sequence of increasingly homeostatically efficient representations that integrate all salient neural activity, culminating in network nodes in the right and left anterior insulae that may be organized asymmetrically in an opponent fashion. The anterior insula has appropriate characteristics to support the proposal that it engenders a cinemascopic model of human awareness and subjectivity. This review presents the author's views regarding the principles of organization of this system and discusses a possible sequence for its evolution, as well as particular issues of historical interest. © 2011 New York Academy of Sciences.
Sanai N.,Barrow Neurological Institute
Current Opinion in Neurology | Year: 2012
PURPOSE OF REVIEW: In recent years, the safety and efficacy of neurosurgical intervention has rapidly improved for brain tumor patients. Technological advances, combined with refined intraoperative techniques, now enable well tolerated surgical access to any region of the human brain. For patients with gliomas, these improvements have redefined the clinical possibilities, and here we review several emerging operative strategies that are essential for next-generation neurosurgical oncologists and major brain tumor centers. RECENT FINDINGS: The value of glioma extent of resection remains controversial, but review of the modern literature reveals important opportunities for early neurosurgical intervention. Although microsurgical resection must be balanced by the risk of neurological compromise, improvements in intraoperative stimulation techniques now enable resection of highly eloquent tumors with minimal morbidity. Additionally, the emergence of fluorescence-guided surgery as a new operative paradigm provides a unique opportunity to resect tumors to the margins of microscopic infiltration. SUMMARY: Neurosurgical intervention remains the first step in effective glioma management. With intraoperative mapping techniques, aggressive microsurgical resection can be safely pursued even when tumors occupy essential functional pathways. With the development of tumor-specific fluorophores, such as 5-aminolevulinic acid, real-time microscopic visualization of tumor infiltration can be surgically targeted prior to adjuvant therapy. © 2012 Wolters Kluwer Health / Lippincott Williams & Wilkins.
Prigatano G.P.,Barrow Neurological Institute
Cortex | Year: 2014
Disturbances of self-awareness are observed in a wide variety of patients. While group studies can provide useful information concerning potential mechanisms underlying these complex disturbances, experienced clinicians, such as Babinski, recognized the potential value of repeated observations on individual patients to insure the reliability of findings and to aid in diagnosis. This paper describes patterns of impaired self-awareness (ISA) that are observed in clinical practice that suggest a model for clinical classification. Repeated observations are reported on four patients ranging from anosognosia for hemiplegia (AHP), ISAassociated with bilateral cerebral dysfunction with frontal lobe involvement, and apparent denial of disability (DD). A patient who presents with denial of ability (DA) is also studied for comparison purposes. When coupled with brain imaging findings, the nature of the patients' subjective responses to feedback regarding their functional capacities, speed of finger tapping in the left, nondominant hand, and their capacity to express and perceive affect suggests different clinical correlates in these four conditions. © 2014 Elsevier Ltd.