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Using “Cerebral Organoids” to Trace the Elemental Composition of a Developing Brain

Curator: Marzan Khan, B.Sc

A research focused on the detection of micronutrient accumulation in the developing brain has been conducted recently by a team of scientific researchers in Brazil(1). Their study was comprised of a cutting-edge technology human cerebral organoids, which are a close equivalent of the embryonic brain, in in-vitro models to identify some of the minerals essential during brain development using synchroton radiation(1). Since the majority of studies done on this matter have relied on samples from animal models, the adult brain or post-mortem tissue, this technique has been dubbed the “closest and most complete study system to date for understanding human neural development and its pathological manifestations”(2).

Cerebral organoids are three-dimensional miniature structures derived from human pluripotent stem cells that further differentiate into structures closely resembling the developing brain(2). Concentrating on two different time points during the developmental progression, the researchers illustrated the micronutrient content during an interval of high cell division marked on day 30 as well as day 40 when the organoids were starting to become mature neurons that secrete neurotransmitters, arranging into layers and forming synapses(2).

Synchrotron radiation X-ray fluorescence (SR-XRF) spectroscopy was used to discern each type of element present(2). After an incident beam of X-ray was directed at the sample, each atom emitted a distinct photon signature(2). Phosphorus (P), Potassium (P), Sulphur (S), Calcium (Ca), Iron (Fe), and Zinc (Zn) were found to be present in the samples in significant concentrations(2). Manganese (Mn), Nickel (Ni) and Copper (Cu) were also detected, but in negligible amounts, and therefore tagged as “ultratrace” elements(2). The distribution of these minerals, their concentration as well as their occurrence in pairs were examined at each interval(2).

Phosphorus was discovered to be the most abundant element in the cerebral organoid samples(3). Between the two time points at 30 days (cell proliferation) and 45 days (neuronal maturation) there was a marked decrease in P content(2). Since phosphorus is a major component of nucleotides and phospholipids, this reduction was clarified as a shift from a stage of cell division that requires the production of DNA and phospholipids, to a migratory and differentiation phase(2). Potassium levels were maintained during both phases, substantiating its role in mitotic cell division as well as cell migration over long distances(2). Sulfur levels were reportedly high at 30 days and 45 days(2). It was hypothesized that this element was responsible for the patterning of the organoids(2). Calcium, known to control transcription factors involved in neuronal differentiation and survival were detected in the micromolar range, along with zinc and iron(2). Zinc commits the differentiation of pluripotent stem cells into neuronal cells and iron is necessary for neuronal tissue expansion(2).

The cells in an embryo start to differentiate very early on- the neural plate is formed on the 16th day of contraception, which further folds and bulges out to become the nervous system (containing the brain and spinal cord regions)(3). Nutrients obtained from the mother are the primary sources of diet and energy for a developing embryo to fully differentiate and specialize into different organs(2). Lack of proper nutrition in pregnant mothers has been linked to many neurodegenerative diseases occurring in their progeny(2). Spina bifida which is characterized by the incomplete development of the brain and spinal cord, is a classic example of maternal malnutrition(2,4). Paucity of minerals in the diet of pregnant women are known to hamper learning and memory in children(2). Even Schizophrenia, Parkinson’s and Huntington’s disease have been associated to malnourishment(2). By showing the different types of elements present in statistically significant concentrations in cerebral organoids, the results of this study underscore the necessity of a healthy nourishment available to mothers during pregnancy for optimal development of the fetal brain(2).

References:

1.Kenny Walter. 02/10/2017. Study focuses on Microcutrients in Human Minibrains. RandDMagazine.http://www.rdmag.com/article/2017/02/study-focuses-micronutrients-human-minibrains?et_cid=5825577&et_rid=461755519&type=cta&et_cid=5825577&et_rid=461755519&linkid=conten

2.Sartore RC, Cardoso SC, Lages YVM, Paraguassu JM, Stelling MP, Madeiro da Costa RF, Guimaraes MZ, Pérez CA, Rehen SK.(2017)Trace elements during primordial plexiform network formation in human cerebral organoids. PeerJ 5:e2927https://doi.org/10.7717/peerj.292

3.Fetal Development: Baby’s Nervous System and Brain; What to expect; 20/07/201. http://www.whattoexpect.com/pregnancy/fetal-brain-nervous-system/

4. Spina Bifida Fact Sheet; National Institute of Neurological Disorders and Stroke National Institutes of Health, Bethesda, MD 20892

https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Spina-Bifida-Fact-Sheet

Other related articles published in this Open Access Online Scientific Journal include the following:

 

Zinc-Finger Nucleases (ZFNs) and Transcription Activator–Like Effector Nucleases (TALENs)

Reporter: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2013/03/04/talens-and-zfns/

 

Calcium Regulation Key Mechanism Discovered: New Potential for Neuro-degenerative Diseases Drug Development

Reporter: Aviva Lev-Ari, PhD., RN

https://pharmaceuticalintelligence.com/2013/01/17/calcium-regulation-key-mechanism-discovered-new-potential-for-neuro-degenerative-diseases-drug-development/

 

How Methionine Imbalance with Sulfur-Insufficiency Leads to Hyperhomocysteinemia

Curator: Larry H Bernstein, MD, FACP

https://pharmaceuticalintelligence.com/2013/04/04/sulfur-deficiency-leads_to_hyperhomocysteinemia/

 

Erythropoietin (EPO) and Intravenous Iron (Fe) as Therapeutics for Anemia in Severe and Resistant CHF: The Elevated N-terminal proBNP Biomarker

Co-Author of the FIRST Article: Larry H. Bernstein, MD, FCAP

Reviewer and Curator of the SECOND and of the THIRD Articles: Larry H. Bernstein, MD, FCAP

Article Architecture Curator: Aviva Lev-Ari, PhD., RN

https://pharmaceuticalintelligence.com/2013/12/10/epo-as-therapeutics-for-anemia-in-chf/

 

The relationship of S amino acids to marasmic and kwashiorkor PEM

Larry H. Bernstein, MD, FCAP, Curator

https://pharmaceuticalintelligence.com/2015/10/24/the-relationship-of-s-amino-acids-to-marasmic-and-kwashiorkor-pem/

 

Mutations in a Sodium-gated Potassium Channel Subunit Gene related to a subset of severe Nocturnal Frontal Lobe Epilepsy

Reporter: Aviva Lev-Ari, PhD., RN

https://pharmaceuticalintelligence.com/2012/10/22/mutations-in-a-sodium-gated-potassium-channel-subunit-gene-to-a-subset-of-severe-nocturnal-frontal-lobe-epilepsy/

 

Copper and its role on “progressive neurodegeneration” and death

Reported by: Dr. Venkat S. Karra, Ph.D.

https://pharmaceuticalintelligence.com/2012/08/14/copper-and-its-role-on-progressive-neurodegeneration-and-death/

 

Metabolomics, Metabonomics and Functional Nutrition: the next step in nutritional metabolism and biotherapeutics

Reviewer and Curator: Larry H. Bernstein, MD, FCAP 

https://pharmaceuticalintelligence.com/2014/08/22/metabolomics-metabonomics-and-functional-nutrition-the-next-step-in-nutritional-metabolism-and-biotherapeutics/

 

Nutrition and Aging

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/10/25/nutrition-and-aging/

 

The Three Parent Technique to Avoid Mitochondrial Disease in Embryo

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

https://pharmaceuticalintelligence.com/2016/10/07/the-three-parent-technique-to-avoid-mitochondrial-disease-in-embryo/

 

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Precision Medicine Market size worth $87.7BIL by 2023

 Article Publication Request by

Jui Kate | SEO Analyst

Global Market Insights

E-mail: jui.k@gminsights.com | Web: www.gminsights.com 

Published Date: July 25, 2016   Author: Global Market Insights, Inc.

Precision Medicine Market size is expected to reach USD 87.79 billion by 2023; as per a new research report by Global Market Insights, Inc.
Increasing demand for personalized medicine specifically in cancer treatments and advancements in new healthcare technologies will drive precision global medicine market size. Favorable government regulations and standards will help sustain revenue growth.
The individualized diagnosis approach has dramatically improved owing to large-scale biologic database development, efficient methods for patient characterization, and computational tools to analyze large data sets. Emphasizing the need for public health database, The White House dedicated USD 55 million for creation of its largest database ‘Precision Medicine Initiative’ (PMI).

 

 Request Sample Buy NowInquiry Before Buying

 

Recent research advances have helped expand benefits to various aspects of healthcare by enabling better understanding of disease mechanisms, assessment of disease risks and prediction of optimal therapy. A large number of investments in diagnostic research will further accelerate the shift from treatment to preventive medicine in healthcare.
Gene sequencing market size was over USD 8 billion in 2015. Post announcement of the PMI, FDA has recently issued draft guidelines on next generation sequencing-based tests to develop a new kind of healthcare that takes into account individual differences in people’s genes, environments and lifestyles.
Browse key industry insights spread across 94 pages with 85 market data tables & 62 figures & charts from the report, “Precision Medicine Market Size By Technology (Big Data Analytics, Gene Sequencing, Drug Discovery, Bioinformatics, Companion Diagnostics), By Application (Oncology, CNS, Immunology, Respiratory), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Scandinavia, Italy, Japan, China, India, Singapore, Mexico, Brazil, South Africa, UAE, Qatar, Saudi Arabia), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2023” in detail along with the table of contents:

https://www.gminsights.com/industry-analysis/precision-medicine-market
Key insights from the report include:

  • Drug discovery technology contributed over USD 9 billion to the global precision medicine market size in 2015, and is estimated to expand at 8.3% CAGR from 2016 to 2023. NGS and other such technologies will open new opportunities for industry participants. Regulation of NGS based test development will help create regulatory processes for genetic test development and application.
  • The global companion diagnostics market is predicted to reach USD 17 billion by 2023. It plays a significant role in development of targeted drugs, thus speeding up the move towards more precise and individualized pharmacotherapy.
  • Oncology application was over 30% of the precision medicine market share in 2015. There have been significant developments taken place across the globe in the area of breast cancer and other related cancers. Predictive biomarkers in lung cancer therapy targets receptors such as c-ros oncogene 1 receptor tyrosine kinase (ROS1), Epidermal Growth Factor Receptor (EGFR), Immune Checkpoints, and Anaplastic Lymphoma Kinase (ALK).
  • U.S. precision medicine market share accounted for over 65% of the North American revenue in 2015, and is anticipated to continue witnessing growth due to increased government initiatives. For instance, The President’s budget in 2016 has allocated USD 130 million to the NIH for development of a national research cohort of a million voluntary U.S. participants, and the data is linked to EHR for easy access to academic scientists and physicians.
  • China contributed 25% to the Asia Pacific precision medicine market size in 2015, mainly due to considerable government initiatives supporting growth in the region. Pfizer, Novartis, Covance, Medtronics, Qiagen, Quest Diagnostics, Roche Holding, Teva Pharmaceuticals, and Biocrates Life Sciences are some notable industry participants.

Global Market Insights has segmented the precision medicine industry on the basis of technology, application, and region:

  • Precision Medicine Market Technology Analysis (Revenue, USD Million; 2013 – 2023)
    • Big data analytics
    • Gene Sequencing
    • Drug discovery
    • Bio Informatics
    • Companion Diagnostics
  • Precision Medicine Market Application Analysis (Revenue, USD Million; 2013 – 2023)
    • Oncology
    • CNS
    • Immunology
    • Respiratory
  • Precision Medicine Market Regional Analysis (Revenue, USD Million; 2013 – 2023)
    • North America
      • U.S.
      • Canada
    • Europe
      • UK
      • Germany
      • France
      • Italy
      • Scandinavia
    • Asia Pacific
      • China
      • Japan
      • India
      • Singapore
    • Latin America
      • Mexico
      • Brazil
    • MEA
      • South Africa
      • Saudi Arabia
      • Qatar
      • UAE

SOURCE

From: Jui Kate <jui.k@gminsights.com>

Date: Friday, February 17, 2017 at 6:35 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Article Publication Request


Pharmacovigilance Market size to exceed $8BIL by 2024

Article Publication Request by

Jui Kate | SEO Analyst

Global Market Insights

E-mail: jui.k@gminsights.com | Web: www.gminsights.com 

Published Date: December 13, 2016   Author: Global Market Insights, Inc.

Pharmacovigilance Market size is expected to exceed USD 8 billion by 2024; according to a new research report by Global Market Insights, Inc.
Growing number of adverse drug reactions (ADRs) coupled with increasing prevalence of chronic diseases will drive global pharmacovigilance market size. Furthermore, growing geriatric population base is associated with increased drug consumption for treatment of chronic diseases such as diabetes, oncology cardiovascular and respiratory disorders.
Rising demand for drugs has driven the need for new drug development through clinical trials. Pharmaceutical companies are collaborating with CROs to streamline R&D, medical writing, manufacturing operations, clinical data management and other pharmacovigilance activities to achieve greater efficiency at reduced cost. Outsourcing should enable better regulatory compliance, higher productivity and improved strategic outcomes spurring pharmacovigilance market growth.
Increasing number of National pharmacovigilance centers across the globe along with rising patient awareness regarding adverse drug events will stimulate global pharmacovigilance market growth. However, lack of skilled professionals and risk associated with data security and web-based drug sales will hamper business expansion.

 

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The phase IV clinical trial market size was valued more than USD 2 billion in 2015 and is expected to grow at over 10% by 2024. Phase IV studies ensure that restrictions could be imposed on a drug being sold depending on its safety performance.
Contract outsourcing market size was valued over USD 1 billion in 2015, poised to grow at 12.2% from 2016 to 2024 and surpass USD 4 billion by 2024. Contract outsourcing reduces overall economic losses linked with drug approval delays and trial failures. It is widely opted by companies to avoid huge investments and delegate such activities to specialized firms in this area.
U.S. pharmacovigilance market size was valued at more than USD 1 billion in 2015, with expectations to grow at 10.7% over the forecast period, owing to favorable governmental regulations, huge clinical trial volume and presence of large scale research companies. Additionally, growing patient concerns related to the drug safety and rising adverse drug events related mortality rates will positively impact pharmacovigilance market share.
Spain pharmacovigilance market size was valued over USD 230 million in 2015 and should witness 10.2% CAGR from 2016 to 2024, to surpass USD 550 million by 2024. Rising demand for new drug development, growing geriatric population and increasing outsourcing by pharmaceutical companies should fuel regional industry growth. India pharmacovigilance market growth was more than 14% from 2016 to 2024, and expected to reach USD 668 million by 2024. The strong and robust growth is attributed to increasing number of clinical trials conducted across Asian countries, owing to low cost trial advantage over developed countries.
Key industry players such as Quintiles offer literature monitoring, safety aggregate reporting, benefit risk management, analytics and signal detection services. Synowledge offer signal detection services, which help clinical experts determine medical significance with the use of hi-tech visualization techniques.
Many industry participants are focusing on outsourcing pharmacovigilance services as a feasible cost reduction avenue. Outsourcing helps achieve better pharmacovigilance through regulatory compliance, better quality, enhanced productivity and improved strategic outcomes.
Browse key industry insights spread across 111 pages with 66 market data tables & 6 figures& charts from the report, “Pharmacovigilance Market Size By Clinical Trial Phase (Preclinical, Phase I, Phase II, Phase III, Phase IV), By Service Provider (In-house, Contract outsourcing) Industry Analysis Report, Regional Outlook (U.S., Canada, UK, Germany, Spain, Italy, France, China, Japan, India, Australia, Argentina, Brazil, Mexico, South Africa, Saudi Arabia, UAE, Qatar), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2024” in detail along with the table of contents:

https://www.gminsights.com/industry-analysis/pharmacovigilance-market
Key insights from the report include:

  • Europe pharmacovigilance market size was over USD 790 million in 2015 growing at anticipated close to 10% CAGR. Germany, UK, Spain together contributed for over 70% of regional pharmacovigilance market share in 2015.
  • Brazil pharmacovigilance market share was more than 60% of regional revenue for 2015, with target slated to exceed USD 300 million by 2024. South Africa pharmacovigilance market size was more than USD 37 million and anticipated for over 5% growth.
  • Phase III clinical trial market size was more than USD 450 million in 2015, with expectations to grow over 10% CAGR, due to increasing requirement for drug safety monitoring and evaluation.
  • Contract outsourcing held more than 50% of pharmacovigilance market share with target market size of over USD 1.7 billion in 2015. Increasing outsourcing trend adopted by pharmaceutical companies will serve as a high impact driver for the business growth.
  • Global pharmacovigilance market will be driven by collaboration between pharmaceutical companies and contract research organizations (CROs). The key industry participants include Accenture, Quintiles, Cognizant Technology Solutions, Boehringer Ingelheim, Covance, PAREXEL International Corporation, Bristol-Myers Squibb, Janssen Research & Development, Synowlwedge, United BioSource Corporation and ICON.

Pharmacovigilance market research report includes in-depth industry coverage with estimates & forecast in terms of revenue in USD million from 2012 to 2024, for the following segments:

Pharmacovigilance Market By Clinical Trial

  • Preclinical
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Pharmacovigilance Market By End User

  • In-house
  • Contract outsourcing

 

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
  • Latin America
    • Argentina
    • Brazil
    • Mexico
  • Middle East and Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Qatar

SOURCE

From: Jui Kate <jui.k@gminsights.com>

Date: Friday, February 17, 2017 at 6:35 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Article Publication Request


CRISPR Patent Battle Determined on 2/15/2017 – USPTO issues a verdict in legal tussle over rights to genome-editing technology

Curator: Aviva Lev-Ari, PhD, RN

Broad Institute prevails in heated dispute over CRISPR patents

Sharon Begley sharon.begley@statnews.com
@sxbegle

In a one-sentence judgment by the Patent Trial and Appeal Board, the three judges decided that there is “no interference in fact.” In other words, key CRISPR patents awarded to the Broad beginning in 2014 are sufficiently different from patents applied for by UC that they can stand. The judges’ full 51-page decision explaining their reasoning stated that the Broad had persuaded them “that the parties claim patentably distinct subject matter.”

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

MIT

The Broad said in a statement that the decision “confirms that the patents and applications of Broad Institute and UC Berkeley are about different subjects and do not interfere with each other.”

UC, Berkeley

In a statement, the University of California said it was pleased that its patent application, which it described as covering “the invention and use of CRISPR gene editing in all cells,” can move forward. “We continue to maintain that the evidence overwhelmingly supports our position that the Doudna/Charpentier team was the first group to invent this technology for use in all settings and all cell types,” it said, “and that the Broad Institute’s patents directed toward use of the CRISPR-Cas9 system in particular cell types are not patentably distinct from the Doudna/Charpentier invention.”

UC said it is considering its legal options, including the possibility of an appeal, but it contended that anyone who wants to develop CRISPR-based treatments for human diseases would have to license not only the Broad’s patents but also those that UC expects to be awarded. “Ours,” Doudna told reporters, “is for the use [of CRISPR] in all cells,” including human ones.

PTAB appeals are heard by the US Court of Appeals for the Federal Circuit, which sits in Washington. In recent years, more than half of PTAB’s decisions have been upheld.

“The Federal Circuit heard three appeals of interferences in 2016,” said Sherkow. “All three were at least affirmed in part. It’s completely unclear whether that’s meaningful — it’s an N of 3–but there you go.” Overall, on 155 appeals since PTAB was created in 2012, the Federal Circuit affirmed 120 on every issue, dismissed or reversed 21 on every issue, and issued partial decisions (that is, upholding parts of a PTAB decision and reversing others) in the other 14.

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

Said UC attorney Lynn Pasahow:

For “all tennis balls,” read “all cells.” For “green tennis balls,” read “eukaryotic cells.”

https://www.statnews.com/2017/02/16/crispr-patent-decision-six-takeaways/

 

What will that mean for licensees of CRISPR patents?

Stanford University Voice

UC believes that any company that wants to use CRISPR to develop human therapies — we’re looking at you, Editas Medicine — will need to license not only the Broad’s patents on eukaryotic cells but also those UC expects to receive on all kinds of cells. “It looks to me as if someone wanting to use the Broad patent would also have to license the UC patent,” agreed law professor Hank Greely of Stanford University. “The UC patent (if granted) would be on any use; the Broad would be on use in eukaryotes. I think someone who wanted to do this in eukaryotes would need to have licenses to both.”

CRISPR-Cas9 is unlikely to be the last genome-editing technology ever discovered. In 2015, Zhang and his colleagues discovered a version called Cpf1, which they’ve now patented and licensed to Editas. “I continue to think the possibility of inventing around the [CRISPR] patents seems very likely,” said Stanford’s Greely. Bacteria “have certainly come up with other ways to reach the same end [of genome editing], ways that aren’t covered by UC’s or the Broad’s claims. That could make either of these patents ultimately of little importance … especially if the licensing conditions give people a strong incentive to come up with invent-arounds.” Science will march on.

https://www.statnews.com/2017/02/16/crispr-patent-decision-six-takeaways/

What does the CRISPR ruling mean for biotech?

By DAMIAN GARDE @damiangarde

FEBRUARY 15, 2017

Editas Medicine, which has aligned with the winning Broad, saw its share price rise more than 25 percent on Wednesday. Intellia Therapeutics, affiliated with UC, fell about 11 percent, while compatriot CRISPR Therapeutics dipped 24 percent.

https://www.statnews.com/2017/02/15/what-does-the-crispr-ruling-mean-for-biotech/

 

Broad Institute wins bitter battle over CRISPR patents

The US Patent and Trademark Office issues a verdict in legal tussle over rights to genome-editing technology.

15 February 2017 Updated:In December 2016, lawyers representing the University of California and the Broad Institute participated in oral arguments before a trio of patent-court judges. University of California attorney Lynn Pasahow said that the team had not yet decided whether it would appeal the verdict on 2/15/2017.

Lawyers representing the University of California filed for an ‘interference’ proceeding, in an effort to have the Broad’s patents thrown out. But on 15 February, patent judges determined that there was no interference, meaning that the Broad’s invention is distinct from that of the University of California, and the Broad patents will stand. The University of California’s patent application will now be referred back to an examiner, but legal challenges could continue.

molecular biologist Jennifer Doudna of the University of California in Berkeley, likened the situation to licensing permission to someone who wants to use green tennis balls. “They will have a patent on the green tennis balls,” she said, referring to the Broad patents. “We will have a patent on all tennis balls.” ”Doudna argued at the press conference that the patent battle had not hampered research, given the speed with which researchers had taken up the technique and companies had rushed to commercialize it.”

The University of California’s invention would cover the design of the RNA molecule that guides the key step in CRISPR–Cas9 gene editing, directing the Cas9 enzyme to a specific site in the genome. But getting that system to work in eukaryotes was an additional inventive step, Coombes says, a patent lawyer at intellectual-property specialists HGF in York, UK.

SOURCE

Nature doi:10.1038/nature.2017.21502

http://www.nature.com/news/broad-institute-wins-bitter-battle-over-crispr-patents-1.21502?WT.ec_id=NEWSDAILY-20170216%20

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

Related articles from nature.com

Other related articles published in this Open Acceaa Online Scientific Journal include the following:

UPDATED – Status “Interference — Initial memorandum” – CRISPR/Cas9 – The Biotech Patent Fight of the Century: UC, Berkeley and Broad Institute @MIT

Reporter: Aviva Lev-Ari, PhD, RN

 


Cheetah Medical Introduces New Algorithm for Fluid Management

Reporter: Lawrence J Mulligan, PhD

 

Cheetah Medical Advances the Science of Fluid Management

Cheetah Medical is the pioneer and leading global provider of 100% noninvasive hemodynamic monitoring technologies that are designed for use in critical care, OR and emergency department settings. The CHEETAH NICOM™ and STARLING™ SV technologies use a proprietary algorithm to calculate parameters related to the volume of blood and the functioning of patients’ circulatory systems. Medical professionals use this information to assess patients’ unique volume requirements, guide volume management decisions and maintain adequate organ perfusion. Cheetah Medical technologies are designed to enable more confident, informed therapy decisions that support clinical goals of improving patient outcomes and driving economic efficiencies.

NEWTON, Mass. –(BUSINESS WIRE)– Cheetah Medical announced today that its eighth abstract on fluid management will be presented at Society of Critical Care Medicine meeting in January. Building on previous work, this abstract demonstrates a strong association between large volume fluid administration in septic shock and increased risk of death in more than 23,000 patients.

Each year, millions of patients require hemodynamic monitoring to ensure optimal volume and perfusion management. While intravenous fluid is typical first-line therapy for many critical care situations, volume management has been a challenge for the healthcare community. It is often difficult for a clinician to know the right amount of fluid to administer to patients, and there are serious complications associated with both under and over resuscitation.

“Ever since we’ve been using intravenous fluid, clinicians have been asking, ‘What is the right amount?’” said Doug Hansell, MD and Cheetah’s Chief Physician Executive. “Today, with non-invasive Cheetah technology, we have new tools to answer this question, and we are learning that getting this question right is more important than ever.”

Cheetah Medical has been working with leading researchers using a large U.S. dataset to better understand the risks and benefits of fluid administration. During the past two years, researchers have now released eight clinical abstracts on the importance of fluid management.

  • FLUID ADMINISTRATION IN SEPSIS AND SEPTIC SHOCK – PATTERNS AND OUTCOMES: Sepsis and septic shock is a huge national priority, as it is the most expensive condition to treat, at $24 billion per year (AHRQ). This study identified a strong association between large fluid administration (more than five liters) and excess mortality in septic shock patients. As expected, sicker patients received more fluid. However, even after accounting for the severity of illness, these patients had an increased risk of dying. (Society of Critical Care Medicine Annual Conference, January 2017)
  • FLUID ADMINISTRATION IN OPEN AND LAPAROSCOPIC ABDOMINAL SURGERY: The study looked at the relationship between intraoperative fluid therapy and complications following abdominal surgery.Based on data from 18,633 patients, an increase in complications was found with day-of-surgery fluid use above five liters for open abdominal procedures. The study recommended individualized fluid therapy to reduce potentially negative effects from over/under resuscitation with intravenous fluids. (American Society of Anesthesiologists [ASA] 2016 Annual Meeting)
  • FLUID PRESCRIPTIONS IN HOSPITALIZED PATIENTS WITH RENAL FAILURE: The implication of volume resuscitation and potential complications among patients with acute kidney injuries (AKIs) has been widely debated. This study examined the relationship between fluid administration and outcomesamong 62,695 AKI patients. It found the potential for both under and over resuscitation in those who received treatments with vasopressors. A better understanding of individual fluid needs was seen for patients requiring pressor and mechanical ventilation support. (European Society of Intensive Care Medicine [ESICM] Annual Congress, 2016)
  • EFFECTS OF FLUIDS ADMINISTRATION IN PATIENTS WITH SEPTIC SHOCK WITH OR WITHOUT HEART FAILURE (HF): The study examined the relationship between indications of fluid overload in sepsis patients (with or without diastolic HF) and outcomes. For 29,098 patients, mortality was the highest among those who received the highest volumes of fluid. It also noted that patients with diagnosed diastolic HF received less fluids and exhibited a significantly lower mortality than predicted. These lower mortality rates could be a result of a more conservative fluid treatment strategy applied in patients known to be at risk for fluid overload. (American Thoracic Society [ATS] 2016 International Conference)
  • WIDE PRACTICE VARIABILITY IN FLUID RESUSCITATION OF CRITICALLY ILL PATIENTS WITH ARDS: The study looked at how variable fluid resuscitation testing and treatments impacted the outcomes of patients with acute respiratory distress syndrome (ARDS). An analysis of 1,052 patients highlighted a highly variable fluid resuscitation. The findings suggest a widespread variability in provider decision-making regarding fluid resuscitation, which may be detrimental to quality and costs, lowering the overall value of care. (American Thoracic Society [ATS] 2016 International Conference)
  • POTENTIAL HARM ASSOCIATED WITH SEVERITY-ADJUSTED TREATMENT VARIABILITY IN FLUID RESUSCITATION OF CRITICALLY ILL SEPTIC PATIENTS: The study set out to determine treatment variability for patients with severe sepsis and how it may impact mortality. Retrospectively analyzing 77,032 patients, a high degree of treatment variability was found for fluid resuscitation, with a range of 250 ml to more than 7L of fluid administered. For patients who received less fluid, there was no increased risk of mortality. In those who received the most fluid, there was a strong association with worse hospital mortality. (American Thoracic Society [ATS] 2016 International Conference)
  • ASSOCIATION OF FLUIDS AND OUTCOMES IN EMERGENCY DEPARTMENT PATIENTS HOSPITALIZED WITH COMMUNITY-ACQUIRED PNEUMONIA (CAP): Analyzing 192,806 CAP patients, the study looked at the correlation between fluid-volume overload, hospital mortality and ventilator-free days (VFDs). A significant association was found between the amount of fluid administered on day one, increased mortality and decreased VFDs. The study may have also identified a subset of CAP patients who could benefit from a more restrictive fluid strategy. (36thInternational Symposium on Intensive Care and Emergency Medicine)
  • FLUID ADMINISTRATION IN COMMUNITY-ACQUIRED SEPSISEXAMINATION OF A LARGE ADMINISTRATIVE DATABASE: The study looked at variation in fluid administration practices and compliance with “Surviving Sepsis” guidelines, which recommend a minimum initial fluid administration of 30cc/kg in sepsis-induced tissue hypoperfusion patients. It found that a substantial proportion of patients (47.4 %) with community-acquired sepsis received less than the recommended guidelines within the first 24 hours. (Society of Critical Care Medicine Annual Conference, 2016)

“We are very proud to have supported this work – we are advancing the science of fluid management and helping to improve our understanding of how better fluid management may improve patient outcomes,” said Chris Hutchison, CEO of Cheetah Medical.

 

SOURCE

https://www.cheetah-medical.com/cheetah-medical-advances-science-fluid-management/

 

Other related articles published in this Open Access On-line Scientific Journal includes the following:


Income Geographic Distribution in California: Average income per filer by the Top-20 California Counties

Reporter: Aviva Lev-Ari, PhD, RN

The top-20 California counties with the most millionaires per square mile

 

#20: Yolo County: Average income per filer – $2.21M & Total Million $ Filers: 149

#20: Monterey County: Average income per filer – $2.43M & Total Million $ Filers: 429

#18:  Stanislaus County: Average income per filer – $2.35M & Total Million $ Filers: 287

#18:  San Joaquin County: Average income per filer – $2.21M & Total Million $ Filers: 300

#16:  Santa Barbara County: Average income per filer – $2.78M & Total Million $ Filers: 801

#16:  Pacer County: Average income per filer – $2.68M & Total Million $ Filers: 446

#14:  Sonoma County: Average income per filer – $2.64M & Total Million $ Filers: 577

#14:  Napa County: Average income per filer – $2.98M & Total Million $ Filers: 299

#12: Venture County: Average income per filer – $2.61M & Total Million $ Filers: 1,123

#12:  Sacramento County: Average income per filer – $2.34M & Total Million $ Filers: 559

#10:  Santa Cruz County: Average income per filer – $2.74M & Total Million $ Filers: 341

#9:  San Diego County: Average income per filer – $2.7M & Total Million $ Filers: 4,225

#8:  Contra Costa County: Average income per filer – $2.43M & Total Million $ Filers: 2,528

#7:  Alameda County: Average income per filer – $2.52M & Total Million $ Filers: 2,735

#6:  Los Angeles County: Average income per filer – $3.37M & Total Million $ Filers: 16, 507

#5:  Marin County: Average income per filer – $3.03M & Total Million $ Filers: 2,123

#4:  Santa Clara County: Average income per filer – $3.7M & Total Million $ Filers: 7,922

#3:  Orange County: Average income per filer – $3M & Total Million $ Filers: 5,971

#2:  San Mateo County: Average income per filer – $4.1M & Total Million $ Filers: 4,879

#1:  San Francisco County: Average income per filer – $3.5M & Total Million $ Filers: 4,954-Million $ filers per SQ Mile – 105.7

 

SOURCE

http://www.bizjournals.com/sanjose/news/2017/02/14/bay-area-san-francisco-millionaires-wealthy.html?ana=e_ae_set1&s=article_du&ed=2017-02-14&u=X%2FweEFUOw1ERKtmMRu2T1g0e37142c&t=1487200568&j=77389661#g1


3D Printing for Surgical Planning: The Clinical and Economic Promise using Quantitative Clinical Evidence

Reporter: Aviva Lev-Ari, PhD, RN

The Clinical and Economic Promise of 3D Printing for Surgical Planning

M A K I N G  T H E  C A S E  T H R O U G H  Q U A N T I TAT I V E CLINICAL EVIDENCE

Stratasys engaged Quorum Consulting, experts in health economics and outcomes research, to conduct a comprehensive analysis of the clinical and economic evidence on 3D printing for surgical planning. This white paper, authored by Quorum Consulting, summarizes the result of that analysis.

Wade Aubry1,2, Raj Stewart1 , Chance Scott1 , Jeffrey Chu1

The modern emphasis on evidence-based medicine centers on three core tenets: • Best available research findings • Clinical expertise • Patient value Incorporating cutting-edge technology alongside these principles – often delicately balancing material innovation against scientific rigor, state-of-the-art professional training and experience, and attempts to provide the best care while respecting patient perspectives – is a challenge. 3D printing, however, aligns with the first two tenets, and when appropriately employed, may inform and indirectly influence the third.1

1 Quorum Consulting, Inc., San Francisco, CA, USA

2 University of California, San Francisco; San Francisco, CA, USA

 

3D printing was used in surgical planning applications in a wide range of specialties including cardiothoracic, orthopedic, neurological, reconstructive and transplant surgeries, as well as gastroenterology and surgical oncology. When examining these use cases, five general benefits emerge in association with 3D printing for surgical planning:

  • Patient communication
  • Anatomic familiarity
  • Procedure practice
  • Procedure selection
  • Patient selection / rule-out

 

INDICATION-SPECIFIC UTILIZATION AND EVIDENCEBASED EFFECTIVENESS DATA / RESULTS

  • Cardiothoracic surgery
  • Neurosurgery
  • Reconstructive surgeries

 

CONCLUSION

In a healthcare environment continuing to shift towards value- and outcome-contingent systems that penalize providers for inefficiencies and suboptimal outcomes in rendered care, 3D printed models for surgical planning – with their ability to facilitate procedural efficiency, improve treatment outcomes, and reduce downstream re-intervention costs – offer high potential value. Patients, clinicians and hospitals all have a vested interest in quality, affordable patient care and service, and surgical planning with 3D models appeals to each of these stakeholders.

Accordingly, results and trends from published literature and healthcare data support the effectiveness of 3D printing for surgical planning. As shown for several surgical procedures, clinicians with access to 3D printed models are able to provide better, more efficient care likely to improve patient outcomes and reduce the need for additional surgical interventions. Procedures that would most justify the financial and resource cost in creating 3D printed patient models are those with long operating times, high Relative Value Units (RVUs), greater risk and uncertainty, and risk of complications. Concurrently, this quality care is also potentially less costly and more profitable to providers. Amidst the growing commercial market for 3D printers and related technologies, there are some key differentiators when evaluating utility for surgical planning. As reflected in clinician surveys, the most effective 3D models should capably depict complex, fine anatomy with high fidelity to actual patient physiologies. This degree of fidelity crosses several characteristics:

  • Accurate depiction of a variety of colors
  • Simulation of multiple textures
  • Manipulability,

including the ability to be dissected or probed with surgical instruments.22 Given these real-world requirements, next generation multi-material and multi-color 3D printers likely represent the best option for facilities and clinicians. Viewed objectively, additional data addressing the quantitative impact of 3D printed models is needed. Preferably, this data will be generated from well-designed, patient outcome-oriented studies. However, in the interim, the tide of evidence favors 3D printed models for surgical planning, particularly for leading-edge clinicians and healthcare administrators who are able to recognize its value.

A Brief RVU Primer:

Relative Value Units (RVUs) are used by Medicare to determine reimbursement rates for a given service:

• For each service, Medicare determines the cost value of three primary components – physician’s work, practice expenses and malpractice insurance.

• These three components are then adjusted based on differences in living and business costs nationwide, using a factor called the Geographic Practice Cost Index (GPCI).

• The adjusted values are multiplied by an annual conversion factor, established by the U.S. Congress, and totaled to calculate final reimbursement rates.

SOURCE

http://s3.amazonaws.com/engineering.whitepapers/Stratasys/SurgicalPlanningPromise_Quorum_WP.pdf

From: Medical Design & Outsourcing <newsletters@e.medicaldesignandoutsourcing.com>

Reply-To: <newsletters@e.medicaldesignandoutsourcing.com>

Date: Wednesday, February 15, 2017 at 2:00 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: The Clinical and Economic Promise of Surgical Planning Using 3D Printing

Other related articles published in this Open Access Online Scientific Journal including the following:

Curator: Aviva Lev-Ari, PhD, RN

 

Technologies for Patient-centered Medicine: From R&D in Biologics to New Medical Devices