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I think they should aim to get the PPS to hover around $8.25 for its low support level as this is where the institutional investors came in. They worked last year to get the institutional investors on board so the company needs them happy to keep them on. Makes future cash raising easier if the big investors see the PPS goes up, rather than down shortly after the come in. People buying in the low $6 and $7 range are getting about $1-1.45 discount.
Thank you for your comments. I came to be aware of MSBT in 2009 from an article...from Tapebeat, I think, not 100% sure. The article was later retracted and then rewritten due to an error about when clinical data from the trial would be presented. My main background is in information technology. A randomized controlled trial that shows statistically mortality benefit would be huge as all sepsis trials have failed in the past. Xigris was pulled off the market worldwide in 2011 after their study showed that Xigris did no better than placebo in reducing mortality. The drug was approved in 2001 by the FDA after a small trial. The Spectral/Toray trial using Toraymyxin device is currently running. I think CytoSorb will get EAP designation and FDA approval this year, thus shifting the focus on post market study.
Summary of the Biocon Deal
Territories:
1. India
2. Sri Lanka
Applications Included:
Non-surgical, Critical Care Use, Intra-operative Surgical Procedures
(Critical Care including Sepsis, Cardiac Surgery, including Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation (ECMO), Graft vs. Host Disease, Allogeneic Bone Marrow Transplant, Organ Transplant, and Hemorrhagic Fever)
Product registration:
Biocon to register. If additional clinical trial of CytoSorb is required for marketing approval in Sri Lanka, then distribution agreement will be amended to remove Sri Lanka and substitue with another country/region not requiring human trials.
Minimum Purchase Requirements for each year:
not disclosed
Clinical studies:
Biocon to initate 4 (small) Investigator Initiated Trials (IIT). At least one substantial in nature with 20 patients. Qty limited to number of CytoSorb required to meet enrollment and not exceed 100 in total across all studies. Biocon shall publish at least 2 patient case studies in each of four (4) Applications pursuant to the IIT or routine use of CytoSorb in the Territory.
Investigator Initiated Trials (IIT) Focus Areas
(i) Sepsis.
(ii) Lung related diseases such as Acute Respiratory Distress Syndrome (ARDS) and Acute Lung Injury (ALI).
(iii) Intra-abdominal indications such as complicated intra-abdominal infections, Abdominal Compartment Syndrome.
(iv) Severe Acute Pancreatitis.
(v) Liver Disease; infective or non-infective associated ALF.
(vi) Post- operative SIRS.
(vii) Tropical disease; Dengue and Malaria.
(viii) Intra-operative use in Cardiopulmonary Bypass surgery
Effective date:
Four years from Oct 30, 2014 unless terminated
Export listing:
https://www.zauba.com/import-cytosorb-hs-code.html
(Cytosorb comes in units of 12 per case. So quantity of 300 is 25 cases.)
They are not experimenting with smaller beads. They are aware of possible antibiotic removal when CytoSorb is in use.
Here are the usage instructions for CytoSorb which mentions antibotics in point 1.6:
http://www.biocon.com/docs/prescribing_information/ccd/CytoSorb_DeviceInstructionsForUse.pdf
A case study here:
http://cytosorb-therapy.com/case-report/can-cytokine-adsorber-treatment-affect-antibiotic-concentrations-a-case-report/
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=102561486
So far the numbers are this: 50 hospitals in Germany and 200+ hospitals worldwide.
- From the Cytosorb therapy website, April 2015: "CytoSorb therapy has been used in more than 5,500 human treatments in more than 200 hospitals around the world.
- Innovations in medicine: The stabilizer article, Jan 2015: "In Germany the unit is used in 50 hospitals, since 2011 it has been approved in Europe."
Innovationen aus der Medizin: Der Stabilisator
http://www.spiegel.de/gesundheit/diagnose/sepsis-und-blutvergiftung-geraet-cytosorb-filtert-zytokine-aus-blut-a-1009252.html
"Accordingly, the importance of which is antibiotic to capture. "It has now set up a register in order to better study the effect of Cytosorb" says carrier. In Germany the unit is used in 50 hospitals, since 2011 it has been approved in Europe. Only in a few patients, the therapy has been shown clearly no effect. "
https://translate.google.com/translate?sl=auto&tl=en&js=y&prev=_t&hl=en&ie=UTF-8&u=http%3A%2F%2Fwww.spiegel.de%2Fgesundheit%2Fdiagnose%2Fsepsis-und-blutvergiftung-geraet-cytosorb-filtert-zytokine-aus-blut-a-1009252.html&edit-text=&act=url
You state that "Thus, I have a harder time believing that reduction of IL-6 will be accepted as a surrogate endpoint."
FDA had already approved an IDE for a 30-patient study amongst trauma patients with rhabdomyolysis where the primary endpoint is myoglobin removal. If it is for sepsis, reduction iL-6 would be no different.
https://clinicaltrials.gov/ct2/show/NCT02111018?term=NCT02111018&rank=1
The US Air Force funded this pilot study. In the company's PR announcing this, they have this: "As part of the IDE application process, the FDA has reviewed the CytoSorb® treatment safety data from the European Sepsis Trial. We believe this early review of the European Sepsis Trial safety data will help streamline our future discussions with the FDA about a planned U.S. pivotal trial in sepsis."
http://globenewswire.com/news-release/2013/06/17/554439/10036517/en/CytoSorbents-Announces-FDA-Approved-US-Air-Force-Funded-Human-Trauma-Pilot-Study-for-Rhabdomyolysis.html
Originally it started out with an SBIR grant from the US Army to evaluate the technology for cytokine and myoglobin removal in the treatment of burn injury and trauma with the added bonus of developing "a portable, robust, and logistically-friendly blood purification system that combines a state-of-the-art battery-powered blood pump". Contract W81XWH-12-C-0038.
https://www.sbir.gov/sbirsearch/detail/414744
So taking into considering this information and in my first post in response to this, I see no reason why the FDA would not allow CytoSorb EAP designation and have IL-6 reduction as endpoint. Safety has been proven. CytoSorb is already marketed in many countries.
Herpes viruses can cause blood poisoning
Translated into English:
"Blood purification removes inflammatory neurotransmitters
There is new scientific evidence that can be influenced by the removal of pro-inflammatory messenger substances from the blood, the overreaction of the immune system and the clinical condition of septic patients with organ failure low. Since the year 2011 is to a particular device: a so-called Zytokinabsorber (Cytosorb). Similar to a dialysis thus may be removed as part of a blood purification from the blood substances (especially cytokines) that initiate or maintain inflammation.
However, all questions about this therapy are not fully understood. Perhaps the hemodialysis affects not only the cytokine concentration in the blood, but also the concentration of other vital messengers and essential medicines and nutrients. Can be used until the Zytokinabsorber default, yet studies have to be carried out."
https://www.ndr.de/ratgeber/gesundheit/Herpesinfektion-loest-Sepsis-aus,herpesviren100.html
At the Needham conference, Dr Chan talked about softer clinical endpoints such as less days on ventilator. So, it's just not iL-6 reduction. Don't overfocus, look at the big picture and intended purpose of the EAP which is to get a safe and effective potentially life saving product sooner on the market. The focus shifts to post-market data.
----------------------------
The CytoSorbents Needham presenation, slide 40:
"Advantages of EAP Designation
The first step is to submit an application to the FDA to request EAP Designation.
If successful, this has a number of advantages:
• CytoSorb® would be given priority status and be assigned an FDA case manager which would facilitate future discussions with the FDA
• Valid for both PMA and De Novo 510(k) paths
• Shifts Premarket data collection to the post-market setting with the appropriate safeguards for safety
• May allow for the potential acceptance of softer clinical endpoints to justify approval, in anticipation of more conclusive post-market data on endpoints such as mortality
• 30-day review of the application
This program is designed to facilitate early and faster US regulatory approval of
potentially life-saving medical devices. We believe this squarely applies to the core of
our critical care strategy at CytoSorbents. As we move forward with our cardiac
surgery trial, we plan to pursue this EAP opportunity in critical care applications and
foster open discussions and collaboration with the FDA."
I'm not sure about June/July but we would most likely see FDA approval in the sepsis condition sometime this year. The EAP program went into affect April 15...but the company would need time to draft their plans and prepare a submission for the EAP program. CytoSorb is suitable for EAP designation. The FDA responds to the application within 30 days. If they have further questions, it may take longer. Before approval, the FDA would like to see reasonable assurance of safety and effectiveness for premarket. CytoSorb has already shown that it is safe and has saved lives. Having CE Mark approval and already being marketed in Europe, Asia and planned expansion into other countries will certainly be factored in. I'm interested to see how they will obtain the clinical data as part of the post market data collection. Whether entries into the CytoSorb registry will be sufficient or they would still have to obtain data which they can probably get from the planned EU sepsis study later this year.
"FDA Response to requests for EAP designation
The FDA intends to notify the sponsor of its determination in writing within 30 days of receipt of a request for EAP designation.
If there is insufficient information for the FDA to make a decision about EAP designation, the FDA may request the sponsor submit additional information.
In response to such request, any additional information provided by the sponsor should be submitted as a supplement to the Pre-Sub.
If the FDA requests additional information from the sponsor, the FDA will notify the sponsor in writing whether or not EAP designation is granted within 30 days of the date of the request for additional information.
If the FDA has not received enough information in time to make a decision by 30 days after a request for additional information is sent, the FDA intends to deny the EAP designation."
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm441467.htm
The role of PCT in timing adjunctive therapy such as IgM and Cytosorb in sepsis - Z. Molnar
20th “International Intensive Care Symposium” will be held in Istanbul between May 8th and 9th, 2015.
http://www.anzics.com.au/Lists/Events/Attachments/18/IC%20Istanbul%202015.pdf
-------------------
Note about PCT:
PCT = procalcitonin (Thermo Fisher Scientific's)
http://globenewswire.com/news-release/2013/07/08/558670/10039285/en/CytoSorbents-Appoints-Dr-Rainer-Kosanke-as-European-Director-of-Scientific-Affairs.html?print=1
"Dr. Kosanke was formerly the Head of Medical Marketing for Germany, Austria, and Switzerland and Deputy Sales Director at B.R.A.H.M.S AG where he helped to lead the market introduction and development of the now leading sepsis biomarker in the world, procalcitonin (also known as PCT), from 2003-2009. PCT has become the gold standard in Europe to both diagnose bacterial sepsis, and to help guide the length of antibiotic treatment. In 2009, Thermo Fisher Scientific acquired B.R.A.H.M.S. AG for $470 million, or 4.5 times 2008 revenue of $105 million, based primarily on the potential worldwide market for PCT, but also for biomarkers for cardiovascular disease and neurologic disorders. At Thermo Fisher Scientific, Dr. Kosanke was in charge of coordinating a number of large randomized controlled clinical trials using PCT and other sepsis biomarkers under development, with combined target enrollment of more than 2,800 patients. Dr. Kosanke received his PhD from the Ernst-Moritz-Arndt University of Greifswald, where he became an Associate Professor. He has extensive expertise in inflammation, blood coagulation, the systemic inflammatory response syndrome (SIRS, which includes sepsis), and biomarkers of sepsis."
I suspect the dosing data will be present at the German Sepsis Society's conference to be held September 9-11, 2015 in Weimar, Germany. The German Sepsis Society and the International Cytosorb registry is put on/supported by the doctors at the Jena University Hospital and are part of SepNet. In addition, this conference was where they released the results of their German sepsis study. A follow up for this study regarding the new dosage results makes sense here.
Dr. John Kellum Attends Royal Award Ceremony in Thailand
Tue, 03/03/2015
On January 28, 2015 Dr. John A. Kellum, along with two of his prior fellows, Dr. Nattachai Srisawat and Dr. Passisd Laoveeravat, attended the Prince Mahidol Award Presentation Ceremony at Chalkri Throne Hall in Bangkok,Thailand. This ceremony was presided over by Her Royal Highness Princess Maha Chakri Sirindhorn as the Representative of His Majesty the King.
During his visit, Kellum was invited to present his work on Blood Purification in Sepsis at the Prince Mahidol Award Youth Program Conference. World-renowned experts in the fields of medicine and public health were invited to speak at this Youth Conference to inspire young physicians to contribute to the advancement of medicine, public health and human services. Dr. Srisawat gave a presentation on Early Diagnosis and Early Renal Replacement Therapy, and Dr. Passisd Laoveeravat, who was a recipient of the Prince Mahidol Award in 2012, presented his work on Novel Biomarkers to Detect Severe Sepsis in Hospitalized Patients with Community Acquired Pneumonia.
https://www.ccm.pitt.edu/news/dr-john-kellum-attends-royal-award-ceremony-thailand
35th International Symposium on Intensive Care and Emergency Medicine
March 17-20, 2015, Brussels
Copper Hall
Extracorporeal therapies in sepsis [Standard presentation]
Thierry Calandra ( Lausanne , Switzerland) - Marlies Ostermann ( London , United Kingdom) -
8:00 The various options
John Kellum ( Pittsburgh , United States) -
8:15 Adsorption or filtration?
Axel Nierhaus ( Hamburg , Germany) -
8:30 New adsorption of filtration?
Detlef Kindgen-Milles ( Düsseldorf , Germany) -
http://www.intensive.org/1/m2I1_1.asp?L1=2&L2=1&L3=1&ety=1
22. Januar 2015, 18.30 Uhr
Dorint Charlottenhof Halle (Saale),
Dorotheenstraße 12, 06108 Halle
Neue Technologien
- Extrakorporale Cytokinadsorption
Prof. Dr. med. Michael Quintel, Göttingen
- Elektrische Impedanztomographie
Prof. Dr. med. Inéz Frerichs, Kiel
Anschließend sind die Teilnehmer zu einem Imbiss eingeladen. Die Veranstaltung ist mit 3 Punkten für das Fortbildungszertifikat durch die Ärztekammer Sachsen-Anhalt zertifiziert.
Wir weisen Sie gemäß dem FSA-Kodex (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V.) auf die finanzielle Unterstützung dieser Veranstaltung durch nachfolgende Unternehmen hin. (Möglichkeit zur Produktpräsentation und Aufstellen eines Informations-/Werbestandes)
http://www.medizin.uni-halle.de/fileadmin/Bereichsordner/Kliniken/AnaesthesiologieIntensivmedizin/0_Veranstaltungen/HAL_Kolloq/Kolloquium_aktuell.pdf
OneMedForum Live TV
Videos not live yet, here are links I am aware of for the company presentations:
http://www.onemedmarket.com/
http://www.ustream.tv/channel/onemedforum-2015-san-francisco
The doctors in Germany have cardiac surgery studies going on or planned including a 300-patient one with the University Hospital of Cologne that is currently enrolling patients. France is another market to develop to gain KOL support. The PR brings up that Cytosorb can be put into a heart-lung machine. The Sorin Group has the world's best selling heart-lung machine. It's a great partnership especially if the partnership can get CytoSorb used as a standard in cardiac surgery. I hope it is Sorin Group when the official PR confirming the partner' name comes out.
"About Sorin Group
Sorin Group is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, Sorin Group focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement prostheses) and Cardiac Rhythm Management (pacemakers, defibrillators and noninvasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 100 countries."
Sorin Group as partner?
From PR:
"In the initial phase of this partnership, CytoSorbents will work closely with an outstanding organization that has influenced the modern design of nearly all of the equipment used during cardiac surgery.
"announced that following significant due diligence, it has entered into an initial partnership agreement with a leading global medical device company in cardiac surgery and other cardiovascular diseases"
SORIN's Overview:
***"Over the past six decades, Sorin has influenced nearly all of these procedures from the equipment that performs the function of the heart and lungs, to blood management systems, to a full range of accessories that enhances the exceptional results achieved by surgical teams."
****Today, Sorin's Cardiopulmonary Products and Services can be found in the vast majority of the world’s leading hospitals in more than 80 countries. In fact, more than 2 out of 3 cardiac surgeons use Sorin's Cardiopulmonary Products! This is not surprising considering that over the past six decades, Sorin has been responsible for many of the innovations that have made cardiopulmonary bypass surgery among the safest and most effective heart procedures performed today.
http://www.sorin.com/medical-professionals/cardiopulmonary/focus/overview
Mumbai CRITICON 2014
Renal Replacement Therapy Workshop
Friday, 14th November 2014
http://www.isccmmumbai.com/pdf/Renal_Repalcement_Therapy_Workshop_Programme.pdf
Hemoperfusion Adsorba cartridge from Gambro, Toraymyxin cartridge from LG and Cytosorb from Biocon.
(these could be dummy cartridges)
Vijaya Patil Ramesh Venkatraman
"The dialysis centre is now ready to provide RRT for critically ill patients in ICU/ICCU with multi-organ failure, where peritoneal or routine hemodialysis not possible for various reasons. It has the latest version of Gambro’s Prismaflux Plus capable of performing various advanced extra corporeal continuous renal replacement therapy techniques including CVVH (Continuous Veno-Venous hemofiltration), CVVHD (Continuous Veno-Venous hemodialysis) and CVVHDF (Continuous Veno-Venous hemodiafiltration). In addition to this, the unit provides extra corporeal therapy for septic patients including Cytosorb or Toraymyxinhemadsorption in septic patients. Not only kidney, but even liver function can be bridged temporarily with the extra corporeal systems till liver transplantation or till recovery with liver dialysis systems like SPAD, MARS and CVVHDF"
http://www.simshospitals.com/sims-dialysis.php
"Ebola and Dialysis: Lessons learned". Emory University Hospital in Atlanta has now been involved in the care of four Ebola patients. Two nephrologists there -- Michael Connor, MD, and Harold Franch, MD -- answered questions about dialysis for Ebola in an email exchange with MedPage Today.
"Does regular dialysis work, or do you need a special filtration device, such as the one being used for the patient in Germany?
Conventional filter technologies are sufficient for dialysis of EVD [Ebola virus disease] patients. The patient in Germany underwent an experimental treatment for blood purification in septic shock designed more to enhance removal of nonrenal toxins/cytokines associated with severe infection. They also were interested if the virus itself would be removed. Like all experimental therapies, it is not clear if there will be clinical benefit from their approach, and we look forward to seeing presentations of their data."
http://www.medpagetoday.com/Nephrology/GeneralNephrology/48154
New options for patients with severe SIRS and SEPSIS – Hemoperfusion with CytoSorb
Claus Krenn, Vienna, Austria presenting on Oct 23, 2014
http://www.ati2014.medical-congresses.ro/Content/downloads/program_CGPATI_2014_ro.pdf
National Guidelines and Protocols Course in Anaesthesia, Intensive Care and Emergency Medicine will be held from October 23 to 25
NJTC Beacon of Light award
Cytosorbents
Page 17
http://www.njtc.org/media/TN-oct-2014.pdf
CytoSorb product info on Biocon's website:
http://www.biocon.com/biocon_products_bio_BF_comprehensive.asp
Two job postings in manufacturing:
http://jobsearch.monster.com/search/?co=xw239026120wx&re=3101
* Process Engineer
* Manufacturing/Production Associate
Company: Cytosorbents, Inc.
-----------------------------
Process Engineer
About the Job
CytoSorbents Inc.
Process Engineer
Come grow with us! CytoSorbents, Inc. is a growing Medical Device companyand we are ready to expand our team. We are seeking a versatile Process Engineer who is capable of instigating and leading efficiency improvement initiatives in our manufacturing process, as well as recommending and installing process improvements from a practical, technology, quality and innovation standpoint. The successful candidate’sresponsibilities:
Establishes a solid focus on long-term continuous improvement activities through interaction with the entire Engineering and Operations Staff.
Initiates, leads, and manages cost saving initiatives as it relates to business objectives, current Projects, and future investments in technology and Production / Manufacturing processes.
Drives Engineering project initiatives to decrease batch times, reduce labor hours, and reduce reject rates in collaboration with Operations staff.
Proficient in leading and managing multiple engineering projects from start to finish with sound project management methodologies.
Provides individual project schedules and specifications as well as a weekly department report to Engineering Management.
Provides technical specifications for Engineering project designs, and equipment upgrades.
Applies Good Manufacturing Principles in all areas of responsibility.
Develops and implements equipment and/or control system validation documents for modifications and new installations.
Conducts instrument calibration checks, equipment operation verifications, and maintains database.
Interface with molding suppliers to manage tool builds and qualifications
Qualifications:
Bachelor of science degree from an accredited college in Chemical Engineering.
5+ years of practical work experience preferably in API or medical device industry.
Basic PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word.
Knowledge of PLC controllers desirable.
We offer a friendly, team-oriented environment with competitive benefits. Qualified candidates, please send your resume and qualifications by email only (no phone calls please) to llevine@cytosorbents.com We will contact qualified candidates directly for additional information.
About CytoSorbents Corporation, 7 Deer Park Road, Monmouth Junction, NJ
CytoSorbents Corporation (OTCBB: CTSO; Monmouth Junction, NJ) is a publicly-traded, critical care immunotherapy company using blood purification to treat life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Each polymer bead contains millions of pores and channels that can be modified to remove substances as small as drugs, to substances as large as antibodies from blood. These beads are synthesized at its ISO 13485 certified manufacturing facility in New Jersey. The technology is protected by 32 issued U.S. patents and multiple patent applications pending.
-----------------------
Manufacturing/Production Associate
About the Job
CytoSorbents Inc.
Manufacturing/Production Associate
Come grow with us! CytoSorbents, Inc. is seeking Production Associates to join our expanding team. Candidate will perform GMP activities associated with producing, cleaning, and packaging. Duties include preparing raw materials, cleaning and setting up equipment, monitoring process progress, closely following written Standard Operating Procedures, recording data on paper batch records, moving 40 lb carboys and 55 gallon drums, filling devices, inspecting and packaging products prior to shipment. Requirements: Good written and verbal language skills, basic math, ability to follow SOPS, ability to lift up to 75 pounds, flexibility, and attention to detail. Typical work schedule: 4 days/wk, 9-11 hours/day with one 15-16 hour day weekly. Will also work some second shift (2-11PM).
Qualifications:
High school graduate or AS degree in chemistry, biology or engineering or related field with 2-5 years experience in production or pilot plant operating under GMP. Alternatively, BS in chemistry biology or engineering or related field with 1-3 years experience in production or pilot plant operating under GMP.
We offer a friendly, team-oriented environment with competitive benefits. Qualified candidates, please send your resume and qualifications by email only (no phone calls please) to llevine@cytosorbents.com We will contact qualified candidates directly for additional information.
About CytoSorbents Corporation, 7 Deer Park Road, Monmouth Junction, NJ
CytoSorbents Corporation (OTCBB: CTSO; Monmouth Junction, NJ) is a publicly-traded, critical care immunotherapy company using blood purification to treat life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Each polymer bead contains millions of pores and channels that can be modified to remove substances as small as drugs, to substances as large as antibodies from blood. These beads are synthesized at its ISO 13485 certified manufacturing facility in New Jersey. The technology is protected by 32 issued U.S. patents and multiple patent applications pending.
European Association for Cardio-Thoracic Surgery
28th EACTS Annual Meeting
Milan, Italy
11 - 15 October 2014
CytoSorbents is an exhibitor.
http://www.biocer-gmbh.de/fileadmin/user_upload/Messen/eacts-exhibition-invite-milan-a4.pdf
I have not seen any additional grant funding since the 2010 one. I think the product has matured enough that it is ready to be announced as an official product in the pipeline for partners to do further advancements.
Evaluation of EntericSorb, a Non-absorbable Anti-Inflammatory Oral Therapy, in a Mouse Model of Gastrointestinal Acute Radiation Syndrome - Humayra Ali (CytoSorbents Corporation, NJ) and
Catherine Booth (Epistem, Ltd.)
Oct 9 : 1:20 - 1:40p
CMCR Workshop II: Mitigation and Treatment of Radiation Injury
October 8 - 10, 2014 Embassy Suites Inner Harbor, Baltimore MD
http://www.ameetingbydesign.com/ambddrop/CMCRSAG.pdf
Sepseast meeting in Budapest 18-20 September, 2014
CytoSorbent as one of the sponsors; Thermo Fisher is gold sponsor.
http://www.sepseast.eu/sponsors.php#
Program with some topics about sepsis and blood purification.
http://www.sepseast.eu/program.php
Global threat to humanity
Doctors around the world celebrate on September 13, the World Day sepsis - and have for the first time hope of healing: A new medical technology can stop the deadly disease.
As Mariana Bridi was 20, admitted shortly after Christmas in a Brazilian hospital, she looked amazing and she was still relatively good. She had elevated temperature, and the doctors diagnosed the top model an infection of the urethra, nothing earth-shattering. Then, within days, her condition worsened dramatically, the doctors lost control. The kidneys failed, hands and feet began to die. In emergency surgery her limbs, the kidneys and a portion of the stomach were amputated away - too late. End of January, the supermodel died from sepsis to German: blood poisoning.
That was in 2009, and since then more than 130 million people worldwide are suffering from sepsis, nearly 45 million have died from the debilitating disease, including many celebrities. The sepsis-victims include Prince Rainer of Monaco, Superman actor Christopher Reeves, publisher Rudolf Augstein, Chancellor Schmidt's wife Loki and the TV presenter Ilona Christen.
Sepsis is the leading cause of death of children and neonates, the overall infection rate increases per year by about ten percent. The National Academies of Sciences of the G-states are already warning of a "global threat to humanity". On September 13 physicians from around the world celebrate the World sepsis therefore Day to make to cases such as that of Bridi and the largely unknown and underestimated disease attentive.
Complex overreaction of the immune system
Calls for Germany calls Professor Konrad Reinhart, chief of the Department of Anesthesiology and Intensive Care Medicine at the University Hospital Jena and Chairman of the German Sepsis Foundation, by the federal government a "National Action Plan against sepsis". In the Federal Republic of cancer every year approximately 180,000 people suffer from sepsis, more than 60,000 die - more than by heart attack together or lung, breast and colon cancer. Reinhart believes that a combination of better hygiene measures, vaccination against sepsis pathogens, reconnaissance and other measures can reduce the morbidity and mortality significantly.
Sepsis is a complex overreaction of the immune system to bacteria or fungi, which is so strong that vital body functions are limited, and one or more organs fail. It occurs as a consequence of infection or after major surgery. The defense system of the body produces in the case of an infection called cytokines that coordinate as messengers the entire defense. If the amount of cytokines a certain values, proposes to the defensive struggle: Institutions are no longer protected but harmed.
In the past there have been several attempts to get at the disease by pharmaceutical or medical therapies. But success came from modest or completely. Only now there's a promising new approach that could save the lives of many sufferers.
The small U.S. company Cytosorbents from New Jersey has developed a cytokine adsorbent that removes the dangerous messengers and other inflammatory mediators from the blood: the blood of an infected person is passed through a 20 cm long cylinder, stuck in the tens of thousands of small plastic balls. They are made of highly biocompatible polymers, each of them is perforated with countless tiny holes remain in which hanging the unwanted molecules. So living dangerously high cytokine levels are reduced to a level at which the body's runaway immune response can control himself again. "We," says Christian Steiner, head of Cytosorbents Europe, "give the doctors an instrument in the hand to regain control of these patients and thus save lives."
In eleven states of the cytokine filter is already used. In Germany spend more than 40 clinics the cartridge successfully, therapy belongs in the Munich University Hospital Grosshadern and Augustinum for certain patients already as routine as at the University Hospital of Essen, Greifswald and Halle. In more than 20 studies, the effectiveness of the adsorber is being studied closely - and there are the first results very promising. The decisive factors in the use during long operations seem to be two facts to be: inflammatory mediators such as interleukin 6 are effectively reduced, and the effect persists postoperatively, which suggests that the adsorbent exerts an influence on the production of interleukins.
Private online medium for new technology
Whether a 60-year-old who suffered a streptococcal infection after a forearm fracture and was saved thanks to the adsorber, or a 37-year-old man who suffered a staph infection after liver cirrhosis and convalesced - the results of the new form of therapy are consistently positive .
As fast growing insights into the cytokine-adsorber that Professor Frank Brunkhorst, director of the Center for Clinical Studies at the University Hospital Jena and Secretary General of the German Sepsis Society, in cooperation with the manufacturer created its own online media for the new technology: In Cytosorb register , users can capture common data centers to use which document safety and efficacy.
Side effects that exist in almost all forms of therapy have so far occurred nowhere. Although it can not be excluded that the small polymer beads also substances from the blood to get that there are desirable - for example, antibiotics that are administered to a bacterial infection. Which could meet, however, by the doctors increase the dose of the drug. The relevant data for this purpose are currently collected in several studies.
"Enormous potential in combating sepsis" therefore sees the senior physician in the Department of Intensive Care Medicine at the University Hospital Hamburg Eppendorf, Axel Nierhaus. Professor Karl carrier, director of the cardiac intensive care unit of Universtätsklinikums Ulm, who proved to be one of the first heart specialists, the reduction of inflammatory mediators through the adsorber, notes, Cytosorb was a "promising new treatment option" and have "greatest benefit".
What is exactly is still difficult to discern. As the Eppendorf intensivists Nierhaus recently got a suicidal patients on his ward, who had swallowed an overdose of the painkiller acetaminophen, it was no longer pump the stomach. The active ingredients of the drug had already paralyzed the liver. Nierhaus put the cytokine filter - and rescued the man and life liver.
http://www.welt.de/wissenschaft/gesundheitstipp-des-tages/article132242798/Globale-Bedrohung-der-Menschheit.html
http://translate.google.com/translate?hl=en&sl=de&tl=en&u=http://www.welt.de/wissenschaft/gesundheitstipp-des-tages/article132242798/Globale-Bedrohung-der-Menschheit.html
Third job posting in India for CytoSorb task force:
Key Account Manager - Sales - Chennai, Hyderabad
Job Description:Part of the Cytosorb task force team Market Understanding & Development Gather in-depth knowledge about the customers prescribing habits, preferences and the reasons for the same. Meeting them frequently and build rapport with the potential Drs and Dr Group involved during the procedure. Facilitate in updating scientific knowledge and latest happenings to key customers Achieving the monthly targets assigned. Maintaining records of sales & customer. Maintaining records of customer investments made and ROI.
Post Details
Job Title Key Account Manager - Sales - Chennai, Hyderabad - 1 Opening(s) at null
Classification Sales and Marketing Jobs
Job Type Full-time
Location Chennai
This is not my area of knowledge. Here is a recent filing where there is a conversion:
http://ih.advfn.com/p.php?pid=nmona&article=63407951
Not sure if people are aware, Jim Gunton is a general partner at the NJTC Venture Fund. Dr Chan was a former venture capitalist from the NJTC. So they have long history together.
This is from an email that Dr Chan responded to someone way back when:
"With the Series A shares, there is a redemption provision that would enable us to purchase back the shares at $1.25 per share. For the Series B shares, there is no such redemption option for the company. Our goal with the remaining preferred shares is to eventually force their conversion into common stock when we are ready to uplist to a national exchange."
I think it is a good indication of when there is a R/S on a company that is moving up. With institutional support, the price will go from there.
Dr Chan's response to a shareholder recently:
"As you are aware, we have been talking about this up-listing for some time, as a means to tip the supply-demand curve in our favor. Our goal was to do this when our story demonstrated sustainable growth with milestones in place that would not only support an up-listing, but ensure that we stay there. Our goal is to still up-list by the end of this year. That said, our last financing with institutional investors was heavily oversubscribed, and our raise was at the high end of what was allowable by our registration. We know that there is considerable institutional interest in our company, and our objective is to increase this level of interest going into an up-listing."
There is also the possibility of upfront cash with a partnership. Here is an example of one (see below):
AstraZeneca and Protherics Announce Late Stage Licensing Agreement On CytoFab™
Thursday, 8 December 2005
AstraZeneca today announced a global development and commercialisation agreement for Protherics anti-sepsis product CytoFab™. CytoFab™ is currently being prepared for a single phase III registration study in severe sepsis in line with guidance received at an end of phase II meeting with the US Food and Drug Administration (FDA).
AstraZeneca will be responsible for developing CytoFab™, an anti-TNF-alpha polyclonal antibody fragment (Fab) product, as a treatment for TNF-alpha mediated diseases in man, with an initial target indication of severe sepsis. Sepsis is a life-threatening condition resulting from uncontrolled severe infections which affects an estimated three million people a year worldwide. Under the terms of the agreement, AstraZeneca will undertake all clinical development work for CytoFab™ and Protherics will be primarily responsible for bulk drug manufacturing, including the supply of clinical trial material. The agreement will become effective upon the expiration of the Hart-Scott-Rodino waiting period in the US, which is anticipated early in 2006.
The agreement has a potential total deal value, excluding royalties, of approximately £195 million to Protherics, including an initial payment of £16.3 million. In addition, AstraZeneca will make a £7.5 million equity investment in Protherics to be paid in cash, at 68.24 pence per share, being a 30 percent premium to the average middle market closing price of Protherics shares over the three months prior to the date of the agreement. AstraZeneca will own approximately 4.3 percent of Protherics’ enlarged share capital.
Protherics will receive additional payments worth up to £171 million payable upon the achievement of milestones. A significant proportion of these payments are contingent on pre-approval milestones being achieved. There are no milestone payments related to sales performance. Protherics will also receive royalties on global product sales of 20 percent of net sales which reflect the late stage development status and market potential of CytoFab™. Protherics will also receive additional payments in return for the commercial supply of the product and will invest to expand its manufacturing capacity accordingly.
AstraZeneca plans to start the pivotal phase III study for CytoFab™ in the US and EU in 2007 following completion of improvements to the current manufacturing process. Protherics has previously demonstrated in a phase IIb study that CytoFab™ caused a marked reduction in TNF-alpha in the blood and lung tissues of patients with severe sepsis, and that patients required on average five days’ less mechanical ventilation than when treated with placebo. In addition, CytoFab™ showed an encouraging trend suggesting a survival benefit compared to placebo and a favourable side-effect profile.
Approximately one third of patients with severe sepsis die from major organ failure. Patients typically require mechanical ventilation and intensive care. There is only one product currently available for the treatment of severe sepsis and there remains a considerable unmet need for treatment of this life-threatening condition.
Dr John Patterson, Executive Director of Development, AstraZeneca, said: “ CytoFab™ is an exciting opportunity for AstraZeneca to extend its infection franchise. By working together with Protherics, we now have the opportunity to build on the excellent phase IIb data already generated. Our goal is to make CytoFab™ the standard of care for patients with sepsis, improving their chances of recovery and reducing their length of stay in intensive care. We hope it will provide clinicians with a new means of addressing this devastating condition and ultimately, help save lives.”
Dr Andrew Heath, Chief Executive of Protherics, said: “We are delighted to announce a major licensing deal with AstraZeneca for CytoFab™. AstraZeneca has proven to be a focused and agile partner and as one of the leading pharmaceutical companies in the world, it has the clinical, regulatory and marketing strength to maximize the potential of CytoFab™. ”
Sabai,
From the Aug 12 transcript regarding up-listing:
"Management remains committed to up-listing to a major national exchange before the end of 2014 because of the many advantages it brings."
From the same transcript these will happen before the uplisting (see below). One of them is a new partnership. I expect that the company will announce an expanded partnership with Biocon before the year is out too.
"It is also important for shareholders to remember that we have repeatedly stated that we will execute the up-listing when the Company is ready and when we are experiencing major operational momentum—such as continued growth in sales, a new strategic partnership, advances in our U.S. Pivotal trial, to name a few—and that is the principal that continues to guide us overall in the up-listing process."
Regional Manager - direct sales Germany
CytoSorbents Europe GmbH
Employment Type: Full time
Job Location: Berlin
WE ARE LOOKING FOR STRENGTHENING OUR SALES
YOUR SUCCESS CAN SAVE LIVES!
The successful launch of our new therapy
pie in the ICU is many people
help. Die every year in Germany more than
60,000 people to the consequences of severe
Sepsis (blood poisoning), severe burns,
Polytrauma or after major surgery.
All these patients have one thing in common: a
overreaction of the immune system,
which serious complications and Organschä-
after the runs.
Our CytoSorb adsorber technology is the
Physicians a tool in the hand, this situation
tion to bring back under control. Extensive
Blood levels of inflammatory mediators can
with our innovative blood purification technology
and in the clinics of existing dialysis technique
. reduced Easy to use - Celebrity
ker effect!
The CytoSorbents Europe GmbH, based in Berlin,
is a subsidiary of CytoSorbents
Corp., New Jersey, USA. We are a strong
growing company in the field of intensive care and
intend to maintain our quality to the
tasks of the highest quality to
manage and our customers adequately satisfactory
observed.
For the nationwide expansion of our direct sales, we also look for regional manager for Germany
country: Baden-Württemberg, Hesse / Rhineland-Palatinate / Saarland, Hamburg, Schleswig-Holstein, Bremen,
Northern Lower Saxony
We are looking for experienced and highly motivated sellers, in a demonstrable successful sales career
have of medical intensive care / cleaning blood or method in cardiac surgery and the
have excellent contacts with leading clinicians and decision-makers in hospitals.
WHAT YOU EXPECT:
•
You can build something! You can
change! You can achieve something
chen!
•
A product with an exciting scientific
chen background and potential, Critical Care
to revolutionize medicine
•
Hard work, unusual Erfolgserlebnis-
se, motivated customers
•
Currently, three-digit percentage growth
•
A dedicated single-minded team with fun
and passion in this work and a
flat hierarchy
•
Very good working conditions with a
highly attractive benefits package
•
Appreciation by our clients and accident
companies
WHAT TO BRING:
•
Professionalism!
•
Passion, pioneering spirit and will to ER
success
•
At least 3 years experience in the
Field of intensive care or cardiac surgery
•
Resilient customer network
•
Confident manner. Communication on
Chief physician and assistant medical level
•
Negotiation skills, assertiveness
and sustainability
•
Flexibility, autonomy and endurance
nently high motivation
•
Computer Skills
•
Good English skills advantageous
INTERESTED?
We look forward to receiving your application documents, the earliest with your salary expectations and your
possible starting date. Written application like online or by mail. If you have further questions about the
Have job profile or about the requirements, please contact us.
CytoSorbents Europe GmbH
Dr. Christian Steiner
Bölschestraße 116
12587 Berlin
https://translate.googleusercontent.com/translate_c?depth=1&hl=en&prev=/search%3Fq%3Dcytosorbents%2Beurope%2Bgmbh%26rlz%3D1I7GGNI_en-GBCA529%26biw%3D1920%26bih%3D833%26tbs%3Dqdr:w&rurl=translate.google.com&sl=de&u=https://www.xing.com/jobs/berlin-regionalleiter-direktvertrieb-deutschland-2622108&usg=ALkJrhgHrnlyz6hBO0irnoO_SO6eyR_Adw
https://translate.googleusercontent.com/translate_c?depth=1&hl=en&prev=/search%3Fq%3Dcytosorbents%2Beurope%2Bgmbh%26rlz%3D1I7GGNI_en-GBCA529%26biw%3D1920%26bih%3D833%26tbs%3Dqdr:w&rurl=translate.google.com&sl=de&u=https://www.xing.com/user-ass/jobs/posting_pdf/52259/original/posting.pdf%3F1407936692&usg=ALkJrhip1dtV0P17FplR3WBe2j2zTaRfgw
Extracorporeal Liver Support Targeting Inflammation & Renal Failure
August 30, 2014
02:50 – 03:15 pm Steiner C (Berlin)
Haemoadsorption of Cytokines with the CytoSorb Device
http://www.albumin-dialysis.org/program.html
Q2 2014 Results - Earnings Call Transcript
http://seekingalpha.com/article/2416925-cytosorbents-ctso-ceo-phillip-chan-on-q2-2014-results-earnings-call-transcript?uprof=82&dr=1
De Novo Classification Process (Evaluation of Automatic Class III Designation)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm