Diskussion zu CytoSorbents Corporation (Seite 324)

[Jano57]

new case report

New case report: First successful combination of ECMO with cytokine removal therapy in cardiogenic septic shock: a case report

Authors

Frank Bruenger, Lukasz Kizner, Jan Weile, Michael Morshuis, Jan F. Gummert

Corresponding author

Frank Bruenger
Heart and Diabetes Center
Clinic for Thoracic and Cardiovascular Surgery
Georgstraße 11
32545 Bad Oeynhausen, Germany
[e-mail]

Abstract

Purpose
A new hemoadsorption device intended as adjunctive treatment for patients with elevated cytokine levels in the setting of SIRS and sepsis has shown promising results. We report on the beneficial application of the device in a patient with cardiogenic septic shock receiving combined extracorporeal life support with rECMO, LVAD, and CVVH despite his highly septic condition.

Methods
A 39-year-old patient presented with fulminant ARDS and cardiogenic septic shock. A veno-arterial ECMO was implanted for circulatory support. During the course of illness, the patient developed acute renal failure in addition to his chronic renal insufficiency, making initiation of CVVH necessary. Due to a complete cardiac arrest in both ventricles, a left ventricular assist device (LVAD) in combination with right ECMO (rECMO) was implanted despite manifest septic conditions. In the post-operative course IL-6 levels and vasopressor dosages increased drastically. A CytoSorb hemoadsorption device was therefore installed in the CVVH circuit and 3 sessions were run during the following 4 days.

Results
During CytoSorb treatment, inflammatory markers IL-6, procalcitonin, and C-reactive protein decreased concomitant with significantly reduced vasopressor support. No adverse device-related side effects were documented during or after the treatment sessions.
Conclusions
This is the first clinical case report of a highly septic patient treated with the combined use of LVAD, rECMO, CVVH, and CytoSorb. The combination was practical, technically feasible, and beneficial for the patient. This combination represents a reasonable approach to improve survival in patients with multiple organ dysfunction necessitating several organ supportive techniques.

Article History
• Accepted on 1/7/2015
• Available online on 2/3/2015

Disclosures

Financial support: There was no financial support for this study.

[Jano57]

CytoSorbents Announces FDA Approval to Commence Initial U.S. Cardiac Surgery Study

CytoSorbents Announces FDA Approval to Commence Initial U.S. Cardiac Surgery Study


MONMOUTH JUNCTION, N.J., Feb. 2, 2015 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ CM: CTSO), a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to treat critically-ill and cardiac surgery patients in multiple countries worldwide, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to commence a planned U.S. cardiac surgery feasibility study. This single-arm study in 20 patients and three U.S. clinical sites represents the first part of a larger clinical trial strategy intended to support the U.S. approval of CytoSorb® for intra-operative use during cardiac surgery.



The study is designed to evaluate the safety of CytoSorb® when used intra-operatively in a heart-lung machine to reduce plasma free hemoglobin and cytokines in patients undergoing complex cardiac surgery. The length, complexity and invasiveness of these procedures cause hemolysis and inflammation, leading to high levels of plasma free hemoglobin, cytokines, activated complement, and other substances. These inflammatory mediators directly correlate with the incidence of serious post-operative complications such as kidney injury and failure. The goal of CytoSorb® is to actively remove these inflammatory and toxic substances as they are being generated during the surgery and reduce complications.

Concurrently, the Company is funding a non-interventional study amongst a broader array of U.S. cardiac surgery centers that will assess adverse event rates (e.g. incidence of acute kidney injury and respiratory failure) and levels of free hemoglobin and other inflammatory mediators in patients undergoing complex cardiac surgery. These patients will be selected using similar inclusion and exclusion criteria to the feasibility study. The data from these two studies will help to rapidly validate assumptions in this surgical patient population and help to appropriately power a U.S. pivotal cardiac surgery trial.

Dr. Gregory Di Russo, Senior Vice President of Clinical Development at CytoSorbents stated, "Pending institutional review board (IRB) approval at our selected sites, we look to rapidly execute the feasibility study and advance the non-interventional study. We plan to work with these same institutions to begin a pivotal trial in the future with critical mass. Positive data from a U.S. pivotal trial and from cardiac surgery trials ongoing in Europe may help to establish CytoSorb® as a standard component of the heart-lung machine during cardiac surgery and fill a significant unmet medical need."

Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "We are excited to begin these trials, as they underscore our commitment to seeking U.S. approval of CytoSorb® for cardiac surgery. With strong interest from leading international cardiac surgery companies, and with success in our clinical trial programs, we believe that future approval in the U.S. will help pave the way for multiple commercialization options of CytoSorb® in the US and abroad. "

There are more than 500,000 cardiac surgeries performed in the United States, and more than 1.5 million surgeries worldwide each year for common applications such as coronary artery bypass graft (CABG) surgery, valve repair or replacement, congenital defect repair, heart/lung transplantation, implantation of left ventricular assist devices (LVAD) for heart failure, and others. This represents an estimated total addressable market of more than $1.5 billion for CytoSorb® in this indication alone, and adds to the overall $20 billion market potential of CytoSorb® for critical care applications worldwide.

http://finance.yahoo.com/news/cytosorbents-announces-fda-app…

[NoamX]

Antwort auf Beitrag Nr.: 48.945.794 von Jano57 am 01.02.15 10:29:09

Das ist nur eine Vermutung interpoliert aus dem letzten Transscript. Im Prinzip wäre es ja positiv zu werten wenn man mit einer hohen Kapazitätsauslastung arbeitet.

Vincent Capponi (CEO): As I mentioned in previous quarterly updates, we had initiated a number of infrastructure upgrades to accommodate further growth within our existing facility. These upgrades would allow us to increase production capacity within our current manufacturing facility with minimal cost. We have now completed those infrastructure upgrades and have begun the process of hiring manufacturing personnel to complete a second shift. The addition of a second shift provides additional capacity to bridge our transition from the current location into a new facility. Since our last meeting we have identified and contracted with an engineering firm for the new manufacturing, R&D and corporate center. We are completing the initial engineering phase of the project focusing on the manufacturing and office layout, while concurrently working with our recently signed real estate broker to identify a new site.

Our objective is to identify an existing facility that will not require extensive modification to keep costs down and expedite facility renovations to allow for occupancy in a timely manner. The new facility is a progression step to a final manufacturing facility and is expected to be able to meet our production needs for the next several years while increasing operational efficiency and helping us to work through any scaling issues.

Ich wollte nur darauf hinaus, dass der Fokus auf die Vertriebspartnerschaften vielleicht ein zu positives Bild vermittelt, wie schnell jetzt ein Umsatzwachstum zu erwarten ist, falls die Produktionskapazität nicht ebenso schnell mitwächst.

[Jano57]

Antwort auf Beitrag Nr.: 48.942.884 von NoamX am 31.01.15 14:32:16

Ich habe keine Ahnung wie hoch die Produktionskapazitäten im Moment bei CTSO sind!
Habe auch keinerlei Informationen darüber gefunden.
Fakt ist dass CTSO $3,500,000 aus der letzten KE in den Ausbau der Produktionskapazitäten investieren will. Geplant ist kein Neubau sondern ein Umbau passender Produktionsanlagen.

Was mich an deinem Post interessiert, ist deine Äußerung über bestehende Engpässe

Was veranlasst dich zu glauben(wissen) dass bei CTSO im Moment ein Engpass besteht?

[NoamX]

Antwort auf Beitrag Nr.: 48.942.503 von Jano57 am 31.01.15 13:17:41

Hat jemand einen Überblick wie hoch die Produktionskapazitäten bei CTSO sind? Im letzten Call sprach das Management davon, mit der bisherigen Produktion in den Zweischichtbetrieb gehen zu wollen, und auch davon, weitere Räumlichkeiten für eine weitere Produktionslinie zu suchen. Deshalb würde ich bis auf weiteres vermuten, dass eher die Produktionskapazität der Engpass ist anstatt die Vertriebskapazitäten.

Aus meiner Erfahrung ist im Healthcarebereich eine neue Produktionslinie nicht so einfach wie zum Beispiel im Maschinenbau einzuführen. Im Prinzip muss je neue Anlage und jeder neue Prozessschritt verifiziert und validiert werden. Außerdem wird es für CTSO auch vermutlich ein Übergang von einer Entwicklung oder Vorserienproduktion zu einer Serienproduktion bedeuten, d.h. dass Design der Linie könnte sich unterscheiden.

[Jano57]

Antwort auf Beitrag Nr.: 48.810.599 von Jano57 am 18.01.15 12:02:35

CytoSorbents And Aferetica Introduce CytoSorb® to Italy

Der Form halber die offizielle Nachricht über den neuen Distributor in Italien!

http://finance.yahoo.com/news/cytosorbents-aferetica-introdu…

[Jano57]

CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology

http://finance.yahoo.com/news/cytosorbents-receives-385-000-…

[Jano57]

Antwort auf Beitrag Nr.: 48.810.623 von Jano57 am 18.01.15 12:06:50

Stefano Rimondi war CEO of Sorin Group Italy SpA

so langsam wird die Beweislast immer drückender, dass Sorin der ungenannte Partner im Cardio-Bereich ist

[Jano57]

Antwort auf Beitrag Nr.: 48.810.599 von Jano57 am 18.01.15 12:02:35

Apheretic is a startup founded by some operators and managers with decades of experience in the field of dialysis, the Intensive care, cardiology, medical devices in general.

Apheretic was created to act as a catalyst for the creation of a n etwork of clinicians, academics, researchers, industry, institutions, able to create, validate, use in clinical therapies apheretic, initiating their use in new and unexplored areas of dentistry.

Therapies made not only of products but also of knowledge, "know-how", treatment protocols, clinical research, comparison of a specific culture.

Apheretic born in the incubator of Mirandolese Biomedical District. In this area there are knowledge, technology, business, manufacturing capabilities that enable apheretic to develop and produce therapies and products quickly and efficiently.

Among the proposals of apheretic of particular importance the development of systems for the perfusion and the purification of the organs dedicated to transplantation.
The shortage of organs for transplantation, compared with a growing demand.
The consequence is the lengthening of waiting lists. It should ensure the use of every organ even those marginal. Organ perfusion techniques have been proposed recently to improve the "usability". Apheretic aims to radically increase the suitability of organs for transplantation, combining perfusion Aferetici purification systems, with a system owner of which has already been filed and accepted the patent and for which are scheduled in the fall of the first clinical experience of some organs.
Apheretic has been recognized as innovative startups at national and regional level, making it one of the winners of the regional contribution to support innovative startups. Apheretic presented at national and European projects in collaboration with major institutions such as the University of Bologna, Modena and Reggio Emilia, Turin, Bari; the Bicocca Milanoe the Institute Mario Negri Pharmacological.

Mauro Acts is the CEO, with thirty years experience in the field of dialysis and apheresis therapy. He worked in the Gambro Group coming to fill the role of Director of Brand Marketing Hospal first in Italy and then in the world. For over 10 years he has worked in Bellco covering simultaneously the role of Director of Sales & Marketing and Scientific Director. He has produced over 100 publications in the field of purification of the blood.

Stefano Rimondi, founder and business angel, in the course of his career has played leading roles in major companies Biomedical, including: CEO of Bellco Srl ,, CEO of Sorin Group Italy SpA, Director Business Unit therapies for kidney Italy , Spain, Greece, Portugal Group Baxter. Stefano Rimondi is currently president of Assobiomedica, the association Confindustria which brings together all the companies operating in the biomedical, diagnostic and electro in general.

[Jano57]

anscheinend haben wir einen neuen Vertriebspartner für Italien!!

http://www.aferetica.com