Episc' Rev'
Deacon — Rev. Chizoba Nwankwo, Dcn..
"CURRENTLY WORKS IN ONCOLOGY as an Outcomes Research scientist."

She probably knows about CAR-T.
****************************
Chizoba Nwankwo
She works for Merck

https://www.google.com/search?q=Chizoba+Nwankwo+oncology&rlz=1C1CAFB_enUS681US681&oq=Chizoba+Nwankwo+oncology&aqs=chrome..69i57.2559290j0j8&sourceid=chrome&ie=UTF-8

She might listen to someone other than stupid me..

With all this recent press...
Sure wish I could drive by and check out their parking lot during 2nd and 3rd shift once a month. Over 100 employees now I read.
I don't know anybody up there who could do that for me.

Cytosorbent, Inc.
7 Deerpark Dr suite k, Monmouth Junction, NJ 08852
Located in: Princeton Corporate Plaza

3000' south of PetSmart on Hwy. 1
about midway between the PetSmart and The Double Tree Hilton place
Across the street from Cross Fit Nassau, on the right

MAP
https://www.google.com/maps/place/Durga+Mandir/@40.3768233,-74.5866941,15z/data=!4m12!1m6!3m5!1s0x0:0xcca2ff5b374aab0c!2sCytoSorbents+Corporation!8m2!3d40.3768233!4d-74.5866941!3m4!1s0x89c3e78b5f3e2fef:0x1b2345bf74764ef7!8m2!3d40.3830359!4d-74.5988309

Curious and frustrated, I looked for churches closest to Cyto' in Monmouth Junction.

Any Episcopalians on this board?

St. Barnabas Episcopal Church
http://www.stbarnabas-sbnj.org/
142 Sand Hills Road
Kendall Park, NJ 08852
(PHONE: 732-297-4607)

Right up Hwy 1 (couple of miles) north of Cytosorbent

MAP
https://www.google.com/maps/place/St.+Barnabas+Episcopal+Church/@40.4109757,-74.5513165,15z/data=!4m5!3m4!1s0x0:0xbc9fc7202c1eca3b!8m2!3d40.4109757!4d-74.5513165

Medically educated staff at the church too.
Deacon — Rev. Chizoba Nwankwo, Dcn
Chizoba grew up in Lagos (Nigeria),undergraduate degree in BIOLOGY from Rutgers University and holds a Doctorate in PUBLIC HEALTH from the Rutgers University School of Public Health.
worked as a researcher for over 10 years and CURRENTLY WORKS IN ONCOLOGY as an Outcomes Research scientist.

Postulant—Gerry Welch, R.N.C.: A REGISTERED NURSE, CERTIFIED, Gerry serves as nurse at a number of Diocesan events, and works at St. Peter’s Hospital’s Women’s Clinic. Gerry is a student in the Diocese of New Jersey’s School for Deacons and a Certified Disaster Chaplain. A member of St. Barnabas for more than 10 years, . She lives in Edison with her husband Steve and their two daughters.
http://www.stbarnabas-sbnj.org/our-staff/

I also saw that AA meets at this church 3/week.
I know a couple of AA guys. Maybe one could call them and arrange some 2nd/3rd shift parking lot surveillance 1/month. Some pix would be nice too.
But what do I know..That's probably not kosher.

Published: Sep 16, 2019, 4 months 1 week ago
First Study to Evaluate CytoSorb in Cytokine Release Syndrome (CRS) Following CAR T-cell Immunotherapy to Commence

"Hannover Medical School in Germany will begin the first clinical study called CYTORELEASE, evaluating the use of CytoSorb in treating CRS and inflammation of the brain called CAR-related Encephalopathy Syndrome (CRES), following CAR-T cell immunotherapy.

"..given that CRES is a common and sometimes life-threatening complication of CAR T-cell therapy that is not adequately addressed by IL-6 blockade. I am looking forward to the results of our first randomized, controlled pilot study."

"Tocilizumab® (an IL-6 receptor antagonist) and intravenous steroids are the current approved treatments for CRS but are not always successful in controlling CRS or CRES

https://www.biospace.com/article/releases/first-study-to-evaluate-cytosorb-in-cytokine-release-syndrome-crs-following-car-t-cell-immunotherapy-to-commence/
https://www.biospace.com/employer/547330/cytosorbents-inc-/
primary completion date Sept. 2021
https://clinicaltrials.gov/ct2/show/NCT04048434

The Italian connection.

The paper re CAR-T came from Italy.
aurthors -Bottari, Gabriella MD1; Merli, Pietro MD2; Guzzo, Isabella MD3; Stoppa, Francesca MD1; Ruggeri, Annalisa MD, PhD2; Di Nardo, Matteo MD1; Del Bufalo, Francesca MD2; Galaverna, Federica MD, PhD2; Corrado, Cecchetti MD1; Locatelli, Franco MD, PhD2Author Information-----all from Rome

CARL'S FRIENDS

"Alberto Mantovani, professor at the Humanitas University of Milan and scientific director of the Humanitas Research Hospital, who in the 1970s was one of the first people in the world to discover the mechanisms that cancer cells activate to block the natural defences of the body; CARL JUNE, director of the Center for Cellular Immunotherapies of the University of Pennsylvania and

https://www.ibsafoundation.org/forum/revolutionary-therapies-for-cancer/

"Dr Marco Ruella obtained his medical degree with honors from the University of Torino (Turin, Italy) in 2007, and completed his specialization in clinical hematology in 2012. He worked as an attending physician at the Hematology and Cell Therapy Division of the Mauriziano Hospital (Turin, Italy) and was an instructor at the Biotechnology School at the University of Torino.

From 2012, he was a post-doctoral fellow and then instructor at the University of Pennsylvania (PA, USA) in the Center for Cellular Immunotherapies under the mentorship of DR. CARL JUNE.."

https://www.bioanalysis-zone.com/2018/12/04/car-t-cell-immunotherapy-interview-marco-ruella_spotl_cell_gene/

"Dr. Rotolo received her MD from the University of Torino in her native Italy..
..Upon completing her PhD, Dr. Rotolo became a Postdoctoral Fellow at the University of Pennsylvania in order to work with CAR T-cell pioneer CARL JUNE, MD, and her Fellowship sponsor, Marco Ruella, MD (above link).

https://lymphoma.org/researcher-spotlight-rotolo/
***********************
Maybe The CRS Father, Chan, should make Gilead and Novartis an offer they can't refuse.

Other immunotherapies
Checkpoint inhibitors like Opdivo, Keytruda, Tecentriq, Bavencio, Imfinzi, Libtayo may
also have CRS problems

The incidence of CRS in patients receiving cancer immunotherapy varies widely depending on the type of immunotherapeutic agent.

https://www.google.com/search?sxsrf=ACYBGNSotBwIFy9HsxEj6IBkuD9wS3uE_w%3A1580955389172&ei=_XY7XqiRCvGH_Qbm9I6ADA&q=Checkpoint+inhibitors+CRS&oq=Checkpoint+inhibitors+CRS&gs_l=psy-ab.3...21405.37387..40197...1.2..1.325.4461.22j17j1j1......0....1..gws-wiz.....10..0i71j35i39j0j35i362i39j35i39i285j0i67j0i273j0i131j0i20i263j0i22i30.sRX5N4_SObY&ved=0ahUKEwjog4Lj7bvnAhXxQ98KHWa6A8AQ4dUDCAs&uact=5

In USA same two CAR-T as approved in EU, Kymriah (Novartis) and Yescarta (Gilead)

"Currently, the FDA-approved CAR T-cell therapy..there are two FDA-approved CAR-T therapies on the market — Gilead's Yescarta, a lymphoma treatment for adults, and Novartis's Kymriah, which also treats adult lymphoma as well as leukemia for children.Mar 12, 2019.....

***************
from M.D. Anderson Center
"The most common side effect of CAR T-cell therapy is called cytokine release syndrome, or CRS. It’s also known as a “cytokine storm.” About 70-90% of patients experience it.."

"There’s a very effective remedy for CRS now called tocilizumab, which reverses this side effect fairly quickly.
https://www.mdanderson.org/publications/cancerwise/car-t-cell-therapy--9-things-to-know.h00-159221778.html

**************************************
"The cost for Actemra (tocilizumab) intravenous solution (20 mg/mL) is around $477 for a supply of 4 milliliters

Isn't it about time for another Seeking Alpha hit piece?

Would someone send Juan Valdez to:

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

This too bears repeating..

CytoSorb Used Successfully to Help Treat Grade 4 Cytokine Release Syndrome (CRS) Following CAR T-cell Immunotherapy in First Published Case Report

-" Tocilizumab® (an IL-6 receptor antagonist) and intravenous steroids are the current approved treatments for CRS but are not always successful

-"..the rapid progression of respiratory failure that did not respond to an initial dose of tocilizumab and low dose steroids(Standard of Care) .

-"More importantly, it led to a dramatic reversal of acute respiratory distress syndrome, one of the most deadly forms of lung injury that is a root cause of death in the WUHAN CORONAVIRUS outbreak..

-This kid whould have died (8 filters) - "The patient underwent five blood purification treatments with CytoSorb, changed every 12 hours for the first day, and then every 24 hours for the next 3 days..

-.." discharged from the ICU a week later."

"Kymriah® - Novartis; Yescarta® – Gilead"

"The blood purification strategy in this setting has important therapeutic implications:

(1) "first, it does NOT INTERFERE with the first-line pharmacologic therapy based on tocilizumab administration (molecular weight > 100?kDa)"....WOW

(2)"second, Cytosorb could represent an interesting therapeutic resource in grade 3/4 CRS in order to dampen the hyperinflammatory reaction WITHOUT AFFECTING CAR-Ts EFFICACY (3,4)......WOW

https://finance.yahoo.com/news/cytosorb-used-successfully-help-treat-125100174.html
https://journals.lww.com/ccejournal/FullText/2020/01000/Multimodal_Therapeutic_Approach_of_Cytokine.10.aspx

Sales of Kymriah and Yescarta in EU

https://www.google.com/search?sxsrf=ACYBGNSS14RCqhx4-fn6Dp5wrosVsDAw3w%3A1580929429205&ei=lRE7XpGBDIKo_QaRvqOgAg&q=2019+sales+of+Kymriah+in+EU&oq=2019+sales+of+Kymriah+in+EU&gs_l=psy-ab.3...4235.35618..38296...0.2..0.247.2758.13j12j1......0....1j2..gws-wiz.......0i71j33i10.mGNkkNQeOpw&ved=0ahUKEwjRn6uIjbvnAhUCVN8KHRHfCCQQ4dUDCAs&uact=5

https://www.google.com/search?sxsrf=ACYBGNQcL3M-JKGyoXbfCYvfbSdYK6pckw%3A1580929582470&ei=LhI7XoOmHPGFggfw-4r4CA&q=2019+sales+of+Yescarta+in+EU&oq=2019+sales+of+Yescarta+in+EU&gs_l=psy-ab.12...569407.574223..577777...0.2..0.151.1367.11j4......0....1..gws-wiz.......0i71.bVadTTP-HLQ&ved=0ahUKEwiD9bXRjbvnAhXxguAKHfC9Ao8Q4dUDCAs

29/06/2018
First two CAR-T cell medicines recommended for approval in the European Union Share

"The main safety concerns related to the administration of CAR-T cells are cytokine release syndrome (CRS), which is..Both can be life-threatening and in some cases even fatal. Monitoring and mitigation strategies..CRS can be treated successfully with RoActemra (tocilizumab).

"The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). KYMRIAH (tisagenlecleucel) and YESCARTA (axicabtagene ciloleucel) are advanced therapies for blood cancer.

https://www.ema.europa.eu/en/news/first-two-car-t-cell-medicines-recommended-approval-european-union

Triv' - "Many European countries (and all European Union countries) offer their citizens a European Health Insurance Card which, on a reciprocal basis, provides insurance for emergency medical treatment insurance when visiting other participating European countries.[3]

'was trying to find anything on European SOC, and that's all I found.
Apparently each country runs its own show.

"Johnny Rhabdo" - About 26,000 cases of rhabdomyolysis are reported in the United States each year.May 20, 2019

Viruses, such as influenza and HIV, are the most common infectious cause of rhabdomyolysis. In fact, the viral infection is the most common cause of rhabdomyolysis in children, with influenza being the most common specific virus.

Rhabdomyolysis is most commonly caused by an infection in children, accounting for approximately one-third of cases. In adults rhabdomyolysis is most commonly multifactorial, often involving trauma and drugs.

Mortality for intensive care until (ICU) patients with rhabdomyolysis without acute renal failure is 22%. This mortality jumps to 59% when these patients develop acute renal failure.[6][7]

The myoglobin is nephrotoxic, and its accumulation is thought to be the primary cause of renal injury in rhabdomyolysis.

Liver stuff - WHO data published in 2017 Liver Disease Deaths in Germany reached 14,820 or 2.03% of total deaths. The age adjusted Death Rate is 10.09 per 100,000 of population ranks Germany #128 in the world.

Alcoholic liver disease is one of the leading causes of death in the United States, Wong noted, adding that nearly 250,000 deaths were attributed to the disease in 2010.
In fact, he said, “a 2016 study showed that it’s become the number one reason for liver transplants in the U.S.”

The burden of liver disease in Europe: A review of available epidemiological data
https://www.sciencedirect.com/science/article/pii/S0168827812009245

Select a country and disease (that ctso could help?)
https://www.worldlifeexpectancy.com/france-liver-disease
https://www.worldlifeexpectancy.com/world-health-rankings

The U.K. -
"In England alone there were approximately 146,000 ACS hospital admissions in 2008-2009.
In the UK, approximately 16% of all ACS patients die before admission to a hospital while survivors often have persistent angina symptoms, heart failure and a high risk of further ACS
episodes.

"Ticagrelor is a new class of oral platelet inhibitor which, in comparison to clopidogrel, has
demonstrated a significant reduction in the composite of CV death, non-fatal MI, or non-fatal
stroke across a broad spectrum of ACS patients, without an increase in overall major
bleeding.

"Ticagrelor has the potential to significantly improve outcomes in ACS patients
regardless of management strategy – invasive, conservative, medical, surgical, or
percutaneous coronary intervention (PCI). Full adoption of ticagrelor for 12 months use
within licensed indications by the NHS could save approximately 160 lives (assuming 12,000
patients taking the drug).

"Acute coronary syndromes (ACS) are a major cause of morbidity and mortality in the UK. Early diagnosis and prompt, effective therapy are essential to reverse ischaemia, restore
normal coronary blood flow, and limit myocardial damage. (see Section 2.1)

https://www.nice.org.uk/guidance/TA236/documents/acute-coronary-syndromes-ticagrelor-astrazeneca4

Other scenarios for cytosorb
Besides heart patients - acute coronary syndrome (ACS), non-valvular atrial fibrillation, metallic heart valves, percutaneous coronary intervention(PCI)

The forgotten "other" non-heart people who take ticagrelor might, in the future, need some type of emergency, immediate surgery also - prior stroke, DVT(deep vein thrombosis/clot), PE(pulmonary embolism).
**********************
January 27, 2020

Ticagrelor Hits Mark in Large Stroke Study: THALES Topline Results
https://www.tctmd.com/news/ticagrelor-hits-mark-large-stroke-study-thales-topline-results

*********************************************************
"Ticagrelor is a cyclopentyltriazolopyrimidine and an oral reversible P2Y12 ... It is indicated for the treatment of DVT and PE following 5–10 days of initial therapy ...


"Drugs for DVT fall into one of two main categories: anticoagulants and antiplatelets. ... Antiplatelet medications include aspirin, clopidogrel (Plavix), prasugrel (Effient), and TICAGRELOR (Brilinta). Physicians may prescribe blood thinners if you have a blood clot or to help prevent blood clots if you're at risk.Jun 18, 2014

"When researchers stratified results by type, risk reduction with TICAGRELOR was consistent for DVT/PE/right-sided cardiac thrombosis (HR: 0.79, 95% CI: 0.55–1.13), superficial thrombophlebitis (HR: 0.81, 95% CI: 0.34–1.96), and other thrombotic complications including left-sided intra-cardiac thrombus (HR: 0.58, 95% CI: 0.27–1.21).
https://www.mdlinx.com/oncology/conference-abstract.cfm/58826/?nonus=0&searchstring=&coverage_day=&page=1
************************************

American College of Cardiology
Ticagrelor Is the Best Antiplatelet Agent for Pretreatment in Patients With ACS

https://www.acc.org/latest-in-cardiology/articles/2016/06/13/10/01/ticagrelor-is-the-best-antiplatelet-agent-for-pretreatment-in-patients-with-acs

THE SYSTEMIC INFLAMMATORY RESPONSE SYNDROME RELATED TO THE RELEASE OF CYTOKINES FOLLOWING SEVERE ENVENOMATION

"Envenomation by insects, snakes, scorpions, and spiders involves the activation of the inflammatory system with the release and activation of pro-inflammatory cytokines, chemotactic mediators, cellular infiltration, and other vasoactive mediators. Activation of the inflammatory system and its cascade of events play a major role in the pathogenesis of envenomation, its clinical picture, and outcome.
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0104-79301999000100002
************
The World's Largest Killer Bee Can be Found in This Texas ...Arizona..Florida
Africanized bee swarm kills Texas man - CNN

African honeybees are considered an invasive species in the Americas. As of 2002, the Africanized honeybees had spread from Brazil south to northern Argentina and north to Central America, Trinidad (West Indies), Mexico, Texas, Arizona, Nevada, New Mexico, Florida, and southern California.
*******************
Elevated serum cytokines during human anaphylaxis:
Identification of potential mediators of acute allergic reactions
https://www.jacionline.org/article/S0091-6749(09)01166-X/pdf

Snake bites! Wow.

In the United States, 7,000 to 8,000 people are bitten by venomous snakes each year. 55 percent of people bitten by snakes are male, ages 17 to 27. 85 percent of bites are to the fingers and hands. 13 percent of snakebites occur on the feet and legs, rarely above the ankle.May 9, 2018

Vipera berus, also known as Marlies, Prags, Bardas or the common European adder or common European viper, is a venomous snake that is extremely widespread and can be found throughout most of Western Europe and as far as East Asia.

Well, to my mind this leads to "What about Anaphylactic Shock?"

..in the case of anaphylaxis, the immune system overreacts in a way that causes a full-body allergic reaction. Common causes of anaphylaxis include medication, peanuts, tree nuts, insect stings, fish, shellfish, and milk. Other causes may include exercise and late

Anaphylaxis causes your immune system to release a flood of chemicals that can cause you to go into shock — your blood pressure drops suddenly and your airways narrow, blocking breathing. Signs and symptoms include a rapid, weak pulse; a skin rash; and nausea and vomiting.Sep 14, 2019

Common anaphylaxis triggers include:

foods – including nuts, milk, fish, shellfish, eggs and some fruits
medicines – including some antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin
insect stings – particularly wasp and bee stings
general anaesthetic
contrast agents – dyes used in some medical tests to help certain areas of your body show up better on scans
latex – a type of rubber found in some rubber gloves and condoms
In some cases, there's no obvious trigger. This is known as idiopathic anaphylaxis.
********************
Risk of Anaphylaxis Now 1 in 50 People
https://www.allergicliving.com/2013/11/19/risk-of-anaphylaxis-now-1-in-50-people/


EU will approve this indication first?

Trivia: Hope these columns align right.

There were 78 German heart surgery departments during the year 2018

For this period, a total of 174,902 procedures were submitted to the registry

https://en.bookimed.com/clinics/country=germany/direction=heart-surgery/
******************
Nice charts
Clopidogrel Prasugrel Ticagrelor Cangrelor

Bioavailability 50% 80% 36% 100%

Half-life 1-2 hours 2-15 hours 7-9 hours 3-6 minutes

Binding reversib. Irrevers Irrevers Revers Revers

Onset of action 2-6 hours 30 minutes 30 minutes 2 minutes

Frequency Once daily Once daily Twice daily Intravenous

Duration effect 3-10 days 7-10 days 3-5 days 1-2 hours

Antidote No No No No

Discontinuation,b4
non-acute surgery =/> 5 days =/> 7 days =/> 3 days 1 hour

https://www.landspitali.is/library/Sameiginlegar-skrar/Gagnasafn/BRUNNURINN/Reglur-og-leidbeiningar/Laekningar-og-hjukrun/2017_eacts_guidelines_on_perioperative_medication_in_adult_cardiac_surgery.pdf
***************************************
Clopidogrel oral tablet 75 mg is around $14 for a supply of 30 tablets

Prasugrel (Effient) Expensive..Effient oral tablet 5 mg is around $393 for a supply of 24

Ticagrelor(Brilinta) Expensive..On average, Brilinta costs $489.99 per 60, 90MG Tablet per month

Cangrelor (Kengreal) One expensive shot - The standard dosage to treat one patient undergoing percutaneous coronary intervention (PCI) with cangrelor (Kengreal) will have a wholesale acquisition cost of $749, Raymond Russo, senior vice president of The Medicines Company. - for blot clot?

China reports H5N1 bird flu outbreak in Hunan province
BEIJING, Feb 1 (Reuters)

(Hunan Province abuts most of the southern border of Hubei Province; Wuhan, coronavirus)

https://www.reuters.com/article/health-birdflu-china/china-reports-h5n1-bird-flu-outbreak-in-hunan-province-idUSL4N2A10GC

They can't eat pork, bats, snake and now poultry.

I aplogize. I couldn't resist
Have no fear! Toraymyxin is here!
Oooops. Sorry Esk'.
The coronavirus is not gram-negative. And my orange cat's girlfriend told me it's not bacteria either.
Those pesky details.

Spectral Medical’s Toraymyxin fails pivotal trial

"The system aims to use a 2-column hemoperfusion to remove septic toxins from the bloodstream
"CEO Dr. Paul Walker told Reuters that the mortality reduction number took a hit from a smaller-than-expected endotoxin decrease.(Hey, try 50 columns!Dattlework!)
"..endotoxin is bad and taking it out is good” - I get it!
“more columns take out more endotoxin, then I think we can get approved.”
"...for more than 20 years..but trials have failed prove its efficacy.
https://www.massdevice.com/spectral-medicals-toraymyxin-fails-pivotal-trial/

WHO global health emergency declared
Global Responders

"The Global Health Security Agenda (GHSA) is a partnership between U.S. government sister agencies, other nations, international organizations, and public and private stakeholders.

"Stockpile EXPERTS work with health and emergency..other countries..supply chain..critical medicines and supplies (medical countermeasures)..during a public health emergency..INFLUENZA PANDEMIC or Ebola outbreak.
"This effort helps protect the United States by slowing down or stopping health threats early and close to the source.
https://www.phe.gov/about/sns/Pages/global.aspx
*************************
Look at all the bureaucracy - we'll all be dead before before they finish their yoga classes.
"..nimble, flexible..". Really. Lots of dead links in some of this stuff.
https://www.phe.gov/Preparedness/mcm/phemce/Pages/default.aspx
*************************
Here ya go

Influenza and Outbreaks

It's all about vaccinations - There is no vaccine for this Chinese coronavirus

https://www.phe.gov/emergency/pandemic/Pages/default.aspx
*****************************
Pandemic Influenza

MY FAVORITE
"CDC influenza programs protect Cdc-pdf[1.1 MB, 2 pages, 508] the United States from seasonal influenza and an influenza pandemic, which occurs when a new flu virus emerges that can infect people and spread globally.

https://www.cdc.gov/flu/pandemic-resources/index.htm

fishing trip....I guess that Fresenius unsold inventory is gone now.

"Effective Oct. 1, 2018, the Strategic National Stockpile is managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services.Oct 9, 2018"(Trump)

Strategic National Stockpile
https://www.phe.gov/about/sns/Pages/default.aspx
************************
Stockpile Products
"Products in the stockpile may require an Emergency Use Authorization, which is granted by the U.S. Food and Drug Administration (FDA).

"The authorization allows for the emergency use of an UNAPPROVED medical product (e.g., drugs, vaccines, and DEVICES) or unapproved use of an approved medical product to diagnose, treat, or prevent serious or life-threatening diseases or conditions for which no adequate, FDA-approved alternative is available.
https://www.phe.gov/about/sns/Pages/products.aspx
***********************
Advancing Innovation Act
"PAHPAIA also amends the Federal Food, Drug & Cosmetic Act to enhance the authority of the U.S. Food and Drug Administration (FDA) to support rapid responses to public health emergencies.
" advance funding for buying medical countermeasures under the Project BioShield Act and to funding to support advanced research and development of potential medical countermeasures.

https://www.phe.gov/Preparedness/legal/pahpa/Pages/pahpaia.aspx

Techxen, could you tie in you post (NMPA, CMDE, MDCO...) to anything I'm about to post?

Ranch, I think (not sure) AEMD's filter will do it.
something to do with nanameters
Their chart is like CTSO's, for the same reason.

Techxen, thanks for info.

I called CTSO yesterday. I asked "How's business?" He said GREAT.

Monmouth Junction is 1.4 sq. miles and less than 1000 people.
??? Maybe I found the wrong town.
Could not find a webcam for parking lot at facility

I know, I know. "Get a life!"

Zack's(and others') next take on ctso should be worth the read.
Q1,Q2,Q3 and Q4 numbers on ticagrelor, etc.

When FDA approves for ticagrelor, might those surgeries provide acceptable data for REFRESH 2?

6 months from now, July, right about the time of Q2 ER
10:50 mark

Ranchand, click on influenza, on the right

https://literature.cytosorb-therapy.com/

I'm a heart surgeon in the EU.

My country does not yet reimburse for the filter.

Not even a code.

My next emergency patient uses ticagrelor.

If I don't use the filter and the patient dies (from surgery/waiting 5-7 days),
will my employer(hospital) face litigation/torches and pitchforks?

Would it "best practices" to use the filter and just charge the patient?

Or use the filter, eat the cost because it's far less than litigation?

You know, use the filter to save a life?

What do you think?

It's only $1,000, while the surgery package itself (reimbursed) is very expensive.
If it's granted SOC, will the filter be included in the reimbursed surgery package?

Can the EU authorities declare it SOC throughout the EU, or is that a country-by-country process?

Does anybody on this board familiar with/from the EU, or have medical friends there who knows?

My gut says that I'm missing something here.

REFRESH II vs. blood thinner removal.

Where would they source their galanthus(snowdrops) for lectin,
if demand soared which I expect in the future?

It was meant as sarcasm, even ridicule.
I had just read the naysayers comments,
which by my lights are ludicrous.
I can't see the FDA not following in EU's footsteps sooner than later.
Sorry for the confusion.

Yes, this'll blow over. CTSO wont make it.

"The use of CytoSorb during emergency cardiac surgery..had projected cost savings of approximately $5,000 per patient, including the cost of the device.

"..remove ticagrelor from the body in 1-2 hours, as compared to 3-7 days with natural clearance

"..roughly 10-15% of these patients, or approximately 110,000-165,000 patients in the U.S., and approximately 70,000-100,000 patients in Europe each year will require emergent or urgent cardiac surgery and will be at high risk of bleeding.."

Calc. addressable market (most you longs no doubt have done this)

EU

(70k+100k)/2= 85k EU patients/year, aver.
85,000 X $1,000 filter = $85m sales hmmmmmmmmmmmmmmmmmmmmm?
85,000 X $5,000 savings= $425m total savings to providers

USA

(110k+165k)/2=138k US patients/year, aver.
138,000 X $1000 filter = $138,000,000 hmmmmmmmmmmmmmmmmmmmm?
138,000 X $5000 savings= $690,000,000 total savings to providers

The other savings -
"..the risk of major fatal/life-threatening bleeding has been reported to be as high as 65%

I still have not found CTSO's manufacturing capacity.
It surprised me also how soon this approval happened.

Stiff competition
https://www.seastarmedical.com/product/

Anyone live near the new Monmouth manufacturing site and can check out
whether there're cars there during 2nd/3rd shift?

Didn't Chan have an older factory that they were going to convert to HemoDefend?

Perhaps they should hold off on that conversion since Hemodefend hit a bump.

" We anticipate that 100% of CytoSorb production will originate in the new facility by the end of the third quarter of 2018. Meanwhile, we plan to utilize the current manufacturing facility, leveraging existing assets and infrastructure, to produce HemoDefend clinical devices for the planned HemoDefend U.S. pivotal trial to start in late 2018-early 2019.”

Anyone remember the production capacity of each?

I hope this one doesn't mutate such that it can be spread by bird migrations

Avian Coronavirus in Wild Aquatic Birds (Journal of Virology)

"there is diversity of coronaviruses circulating in wild birds (13, 17). These findings have prompted us to launch wild bird surveillance for avian coronaviruses in Hong Kong and Cambodia.

https://jvi.asm.org/content/85/23/12815

Today,Jan 28, 2020

from the medical authority, The Lancet(!) entitled, " Clinical features of

patients infected with 2019 novel coronavirus in Wuhan , China

CytoSorb, the Wuhan Coronavirus, and Cytokine Storm

China -"Those that were admitted to the ICU, particularly those with severe disease, exhibited significantly higher levels of inflammatory cytokines compared to those that did not... same..in both SARS and MERS patients.

"5 confirmed cases and more than 100 suspected cases in the U.S.

https://www.prnewswire.com/news-releases/cytosorb-the-wuhan-coronavirus-and-cytokine-storm-300994196.html

Andy, get ready for your next "Case of the Week" (it'll go..uh..viral)

28.01.2020

Germany records first confirmed case of coronavirus

Originated in China's Wuhan city early January, novel coronavirus spreading across world
https://www.aa.com.tr/en/europe/germany-records-first-confirmed-case-of-coronavirus/1716065

Fresenius is in China

https://www.google.com/search?sxsrf=ACYBGNTJjymzTrCs2_Gnc44Da3nWheXzQw%3A1580232433273&source=hp&ei=8W4wXr7aDaWa_QbSvbWwDw&q=Fresenius+China&oq=Fresenius+China&gs_l=psy-ab.3..0j0i22i30l9.378087.387229..390365...0.0..0.324.1534.12j1j1j1......0....1..gws-wiz.......0i131.MniGUnr-U5E&ved=0ahUKEwj-luHG6KbnAhUlTd8KHdJeDfYQ4dUDCAg&uact=5

techxen Saturday, 03/02/19 09:42:44 AM
Post # 15342 of 18660
China is going all in on adsorbents

There have been several adsorbent technologies the Chinese have been developing over the past several years, but this is the first clinical trial that I have run across in China related to hemoadsorption and sepsis. This is a 144 patient trial which just started recruiting last month:

Efficacy and Safety Study of CA330 Hemoadsorption Device on IL-6 Removal in Septic Patients
https://clinicaltrials.gov/ct2/show/NCT03847961?term=cytosorb&rank=24

I thought it entertaining to see a statement in their study description bashing Cytosorb and Toraymyxin stating "...the clinical evidence to date supporting hemoadsorption for removal of endotoxins and/or proinflammatory mediators in sepsis remains incompetent and controversial."

This trial is using CA330 from Jafron Biomedical Co, a Chinese firm, and is supposed to be their improved version that targets more mid-molecular weight toxins and cytokines. Their earlier version HA330 only targeted low molecular weight toxins and was an activated charcoal and hyper-crosslinked adsorption resin and could not target cytokines.

The Chinese published a study back in 2017 comparing these adsorbents against NKU-9 which outperformed all of them including Cytosorb with faster and better adsorption rates. However, NKU-9 is no where near commercialization as is CA330. Take this published article for what its worth as it was funded by grants from National Natural Science Foundation of China.

High performance of a unique mesoporous polystyrene-based adsorbent for blood purification
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5274706/

CytoSorbents worldwide
CytoSorbents products are currently distributed in 58 countries around the world
Hong Kong
Chong Lap Co Ltd
Suite 801, Tower 6 China Hong Kong City 33 Canton Road
Tsim Sha Tsui Kowloon
Hong Kong
******
Vietnam
Hoang Long Pharma Corporation
143 Street No 17, Block B, An Phu-An Khanh, An Phu Ward,
District 2, Ho Chi Minh City
******
TekMed
12 Bellevue Crescent
3072 Preston VIC
https://cytosorb-therapy.com/en/about-us/cytosorbents-worldwide/