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Did they only find this out because of your post? I emailed it to them twice demanding he be fired.
Chan just filed a new 8K a few hours ago regarding new CFO baggage:
https://ih.advfn.com/stock-market/NASDAQ/cytosorbents-CTSO/stock-news/91799730/form-8-k-current-report
" Company has placed Mr. D'Amico on paid administrative leave pending the results of this investigation. Pursuant to the existing consulting arrangement between the Company and Ms. Kathleen Bloch, Ms. Bloch will serve as the Company’s Interim Chief Financial Officer while Mr. D’Amico is on paid administrative leave."
He wasn't involved in recent cc I noticed. But your absolutely spot on fantomphan, he needs to be gone yesterday.
Needs to be fired today. Period end of story.
It seems our new CFO is already in hot water with his old company:
Can things get any worse here....?
https://markets.businessinsider.com/news/stocks/trulieve-cannabis-confronts-former-cfo-s-alleged-misuse-of-funds-corporate-credit-cards-1032542334
Trulieve Cannabis Confronts Former CFO's Alleged Misuse Of Funds & Corporate Credit Cards
Benzinga
Aug. 10, 2023, 05:19 PM
"Florida-based Trulieve Cannabis Corp (OTCQX:TCNNF) is grappling with a significant financial scandal involving its former CFO Alex D’Amico.
As investigations and potential legal measures unfold, the situation underscores the company's dedication to fiscal responsibility, all while CEO Kim Rivers prepares to seize the spotlight as a keynote speaker at the Benzinga Cannabis Capital Conference in Chicago on September 27-28.
What Happened: Accused of seeking reimbursements for personal expenses and misusing corporate credit cards, D’Amico allegedly amassed around $400,000 in improper expenses, reported MjBiz Daily.
In its latest quarterly earnings report, Trulieve Cannabis addressed the issue, stating, "The Audit Committee and the Company determined that Mr. D’Amico engaged in conduct that was inconsistent with the Company’s policies and procedures by both submitting expense reimbursements for personal expenses as well as utilizing corporate credit cards for personal expenses."
While the investigation has concluded, the monetary damages are yet to be repaid. Trulieve is now evaluating its next steps, which could involve seeking restitution from D’Amico and rectifying potential tax discrepancies stemming from the unapproved expenditures.
It's worth noting that the alleged financial improprieties have not had a substantial impact on Trulieve's financial statements, according to the company.
Trulieve's swift response to the situation is evident in the appointment of Tim Mullany as the new CFO, succeeding Ryan Blust, who held the interim position after D’Amico's departure. However, Mullany's tenure was short-lived due to unforeseen personal reasons, resulting in Blust's return to the interim CFO role as the company embarks on the search for a permanent replacement.
As for D'Amico, he took on a new role as chief financial officer at CytoSorbents, a New Jersey-based medical technology company. "
CytoSorbents Reports Second Quarter 2023 Financial and Operational Results
4:15 pm ET August 1, 2023 (Globe Newswire)
GlobeNewswireAugust 01, 2023
Q2 2023 Total Revenue was $9.4 million, an 11% increase from $8.5 million in Q2 2022.
Product sales rose 10% to $8.1 million vs $7.3 million in Q2 2022. Product gross margins grew 700 basis points to 74%
PRINCETON, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended June 30, 2023.
Second Quarter 2023 Financial Results
Total revenue for Q2 2023, including product sales and grant income, was $9.4 million, an increase of 11% compared to $8.5 million in Q2 2022
Q2 2023 product sales were $8.1 million versus $7.3 million in Q2 2022, an increase of 10%. The increase in the average exchange rate of the Euro to the U.S. dollar positively impacted Q2 2023 product sales by approximately $187,000
As expected, there were no COVID-19 related sales during the quarter, reflecting the low severity of current COVID-19 illness resulting from high rates of vaccination, anti-viral therapy, and natural immunity
Product gross margins were approximately 74% in Q2 2023, compared to 68% in Q1 2023 and 67% in Q2 2022
Total cash, including cash and cash equivalents, and restricted cash was $14.8 million as of June 30, 2023
Recent Operating Highlights:
The pivotal STAR-T trial completed enrollment ahead of internal projections among 30 participating trial centers in the U.S. and Canada. This follows the recommendation by the independent Data and Safety Monitoring Board (DSMB) in June 2023 to complete the trial without modifications, after it finished the second scheduled safety review at 80 patients enrolled
More than 212,000 CytoSorb devices have been cumulatively delivered across more than 75 countries worldwide as of the end of Q2 2023
Appointed Alexander D'Amico as Chief Financial Officer, who brings over 20 years of broad finance, SEC reporting, merger and acquisition, fundraising, and accounting experience to CytoSorbents, to start August 7, 2023. Interim CFO Kathy Bloch will continue to serve in a consulting capacity
Introduced Michael Bator as the new Chairman of the Board of Directors at the Annual Meeting in June, following the retirement of Al Kraus as former Chairman. A director of CytoSorbents since July 2015, Michael is founder and Partner of Quartz Advisory Group, a capital markets investment bank, and was formerly Managing Director of Healthcare Research at Jennison Associates, a multi-strategy buy-side family of investment funds with more than $175 billion of assets under management
Announced a theranostic collaboration with Humedics in the field of liver disease, focused on a joint promotion of CytoSorb, a superior extracorporeal liver support blood purification therapy, and Humedics' LiMAx(R) test, a rapid and precise E.U. approved diagnostic using its innovative breath analysis technology to quantitatively assess liver function
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "We are pleased to report another successful quarter of executing on our three key business objectives for 2023. Most importantly, we expect to complete the pivotal STAR-T randomized, controlled trial imminently, following the 30-day follow-up of the last patient, which we believe puts us on target for topline data before the end of the year.
https://finance.yahoo.com/news/cytosorbents-reports-second-quarter-2023-201500053.html
Very good sign imo...
They are gearing up ! Job just posted 1 day ago:
Regulatory Affairs Manager - PMA Submission
Fully Remote • Princeton, NJ
Description
CytoSorbents, a critical care leader specializing in blood purification and blood products technologies to treat critically ill, injured, and surgical patients, is seeking a Regulatory Affairs Manager who is experienced in authoring PMA submission(s).
The Regulatory Affairs Manager contributes to regulatory submission strategy, identifying submission risks and opportunities, while managing regulatory applications through approval. Provides regulatory expertise and guidance on procedural and documentation requirements. Is fully proficient in applying established standards. May facilitate strategic input. Participates in continuous improvement of process and tools/systems.
Come join us in saving lives!
Responsibilities:
Participating in writing, compiling, and publishing of PMA regulatory submissions.
Manages information pertinent to the regulatory process. Maintains Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with applicable regulatory requirements.
Provide regulatory input to cross-functional teams.
Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
Keeps management informed of regulatory requirements and emerging issues which may affect the registration approval of products.
Supports, and participates in the development of product labeling, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status.
Provides training and guidance to entry-level associates, interns, specialists, and project managers.
May communicate with Regulatory/Governmental agencies Miscellaneous responsibilities as assigned.
Writes and reviews SOPs as required to ensure compliance with applicable regulatory requirements.
Assists in regulatory audits and inspections.
Develop plans to meet pre-defined Regulatory goals.
Remote with occasional onsite visits.
Requirements
Bachelor’s degree in life sciences, engineering or related field. Advanced degree strong preferred.
5+ years of experience in Medical Device Regulatory Affairs, including preparation of PMA submission(s) to the FDA/EU.
Experience authoring at least one Premarket Approval (PMA) application and submission to the FDA.
Demonstrated the ability to complete internal update (letters to file) independently.
Regulatory Affairs Certification (US / EU) preferred.
https://recruiting.paylocity.com/recruiting/jobs/Details/1854410/Cytosorbents-Medical-Inc/Regulatory-Affairs-Manager---PMA-Submission?source=Indeed_Feed
NEWS -- CytoSorbents Appoints Alexander D’Amico as Chief Financial Officer
PRINCETON, N.J., July 19, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced the appointment of Alexander D’Amico as Chief Financial Officer, to begin employment on August 7, 2023.
Mr. D’Amico brings over 20 years of broad finance, SEC reporting, merger and acquisition, fundraising, and accounting experience to CytoSorbents. Most recently, Mr. D’Amico was the Chief Financial Officer of Trulieve Cannabis Corporation (CSE: TRUL; OTCQX: TCNNF), an industry leading, vertically integrated cannabis company and multi-state operator in the U.S., overseeing more than 7,600 employees, including more than 250 finance, accounting, shared service, human resource and investor relations professionals. Through strategic organic growth and eleven separate acquisitions with a transaction value totaling $2.5 billion, including the largest industry transaction in the U.S., Mr. D’Amico helped to engineer a rapid expansion of annual revenue from $250M to more than $1.2 billion, leveraging more than 4 million square feet of cultivation and processing space, and 180 retail stores across 12 states. Mr. D’Amico financed this growth through a series of equity and debt financings, totaling approximately $650 million, and drove the consolidation and integration of these acquisitions, navigating through complex state regulatory environments, and achieved cost savings and gross margins of 55% last year.
Prior to Trulieve, Mr. D’Amico co-led Telaria’s global expansion into 7 new countries, top line revenue growth of over 50% in two years, the acquisition and integration of Slimcut (a global video outstream technology solutions company), and ultimately positioned this leader in digital video advertising services and software for exit/sale via merger to Rubicon Project for a total equity value of $400M, as Vice President Finance/Controller. As Finance Director-Global Controllership at Cognizant, a $14.5 billion high-growth provider of information technology, consulting, and business process services, Mr. D’Amico led global accounting and finance consolidation as revenues grew nearly $4.6B in just 3 years and generated more than $50M in synergistic cost savings. As Senior Finance Manager at Quest Diagnostics, a Fortune 500 company and leading clinical laboratory, he co-championed the company’s Global Business Transformation from 50 domestic and 10 internationally decentralized business units to a Shared Service “Center of Excellence” (COE) reporting more than $7.4B in consolidated revenues. At Quest, he also led the introduction, standardization, and centralization of the Sarbanes Oxley methodology to global markets.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “We are thrilled to bring Alex on as Chief Financial Officer and as a key member of the CytoSorbents management team. Throughout his impressive career at major high growth publicly-traded companies, Alex has consistently demonstrated his key strengths in finance, international and domestic accounting, M&A, business strategy, execution, and SEC compliance and reporting. His record at Trulieve alone, which he helped to grow from a relatively small company to a massive commercial organization, highlights many of these key skills. Importantly, Alex has the perspective of scale of operations that will be invaluable as we drive expected rapid growth in the coming years based upon international sales of CytoSorb®, and if successful, sales of DrugSorb™-ATR in the U.S. and Canada. In addition, his extensive experience in M&A perfectly aligns with our longer-term growth strategy that includes both organic growth and acquisition.”
Alexander D’Amico stated, “I am excited to join CytoSorbents during this pivotal time in the Company’s history. In particular, I hope to leverage my diversified experience and expertise to help CytoSorbents expand its high margin international CytoSorb business, take advantage of new business prospects, and finance and build the U.S. and Canadian commercial organizations pending regulatory approvals. I believe CytoSorbents has an excellent future ahead and was immediately attracted to both its mission of saving lives and the deep sense of passion and purpose of the team. I consider this a compelling opportunity to use my skills and knowledge to help grow the Company, work with great colleagues, and serve people in need.”
Dr. Chan stated, “Separately, as we mentioned in a press release in October announcing her pending retirement, we are indebted to Kathy Bloch for her decade of service to the Company as CFO, helping to oversee and finance the rapid growth and commercialization of CytoSorb in 75 countries internationally to date, and for helping to manage this management transition.”
Mr. D’Amico began his career as an auditor for Deloitte, a global provider of audit and assurance, tax consulting, and risk and financial advisory services to corporations worldwide, where he served clients such as BASF and Brother International. He is a Certified Public Accountant in the State of New Jersey, and is a Chartered Global Management Accountant from the American Institute of Certified Public Accountants. Mr. D’Amico received his B.S. in accounting, graduating Summa Cum Laude from Rutgers University.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of Q1 2023, more than 203,000 CytoSorb devices had been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study, and has now completed patient enrollment at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
CytoSorbents’ purification technologies are 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. Its technologies have received non-dilutive grant, contract, and other funding of approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Please Click to Follow Us on Facebook and Twitter
CytoSorbents Corporation Contact:
Kathleen Bloch, Interim CFO
(732) 398-5429
mailto://kbloch@cytosorbents.com
This is why the company pivoted away from Sepsis. Too many variables for very sick patients, very difficult to pinpoint who benefits and when. The blood thinner application is much simpler.
Will have a look. Thanks
The publication referenced was actually published on May 31. While not great news, it appears to be a regurgitated hit piece. Here is the publication from May 31.
https://ccforum.biomedcentral.com/articles/10.1186/s13054-023-04492-9;
From the Yahoo Board:
One limitation of our meta-analysis is the heterogeneity of the studies. The observations of individual studies differed substantially, which we attribute to various reasons. First, there are a fair number of studies with only few study participants yet large effect sizes. Eight studies included less than 15 patients per group. These studies achieved great effects with Cyto Sorb intervention. By contrast, there are larger randomized controlled trials and observational studies with propensity score matching with notably smaller effect sizes. Secondly, the use of Cyto Sorb differed in many ways. The number of adsorbers, duration of therapy, time from diagnosis to first use of the adsorber, and blood flow rate were very inconsistent. Thirdly, medical conditions were compared that differ completely in their pathophysiology.....
By no means were all the studies suitable for inclusion in the meta-study.
Most of them were completely inadequate in terms of their scientific quality, had cohorts that were too small, used data from the same patients several times and compared completely different disease courses," explains Professor Schmidt.
Nevertheless, the meta-study does not exclude that CytoSorb might not have a positive effect under certain circumstances, emphasizes Professor Schmidt.
"In certain patients in the very early phase of sepsis, the adsorber could possibly help," he says. "But these are case-by-case decisions." In order to clearly prove the effectiveness, randomized, controlled studies on suitable patients in comparable disease states are missing.
Ouch. Germany study says there is no proven benefit. https://medicalxpress.com/news/2023-07-widely-blood-purifier-proven-benefit.html
A single centre experience with CytoSorb® as an adjunct therapy in critically ill patients with sepsis: a case series
IJMDAT 2023; 6: e398
DOI: 10.32113/ijmdat_20236_398
Topic: Infectious disease Category: Original Article
Gajera H., Gohil S., Chhatravala A. J.
Abstract
Objective: Sepsis is an immune response to infections that are caused by bacteria, viruses, fungi, or parasites. This potentially life-threatening condition is associated with high mortality and morbidity that causes a major global health burden and hence requires intense therapeutic support and close monitoring. As a result, substantial work has been done to enhance outcomes by focusing on alternate treatment strategies. One such approach is CytoSorb®, an extracorporeal blood purification therapy that is used for elevated cytokines levels in patients admitted to ICU suffering from sepsis and septic shock, cytokine release syndrome, COVID-19, ARDS, etc. We present authors’ experience of using CytoSorb® therapy as an adjuvant in six critically ill patients from India with sepsis or septic shock.
Patients and Methods: In this case series, we report the outcomes of six severely ill Indian adults with sepsis or septic shock who were treated by CytoSorb® as an adjuvant therapy.
Results: All patients across wide age groups demonstrated significantly reduced inflammatory mediators and vital parameters when CytoSorb® therapy was initiated within 24 hours of admission in ICU. It was also found to be effective and safe in patients with COVID-19 and associated post-COVID symptoms. The present case series showed rapid hemodynamic stability and enhanced survival in all patients except one, as a consequence of hemoadsorption utilizing CytoSorb®, especially in individuals for whom therapy was initiated early.
Conclusions: CytoSorb® treatment is efficient in cases where elevated levels of cytokines lead to hyperinflammation. It not only resolves excessive inflammation, but also improves organ dysfunction and provides further clinical benefits in severely ill patients.
https://www.ijmdat.com/article/398
Plus they have a credit line facility in place if needed. I'm looking for an expedited early FDA approval. That's just my own guess.
They won't run out of cash. They have cash to last awhile. Then the ever increasing sales come pouring in!
PR out that we've completed enrollment.
Extracorporeal hemoadsorption therapy as a potential therapeutic option for rapid removal of Apixaban in high risk-surgical patients: a case report
Case report Published: 07 July 2023
Vittorio Dalmastri, Andrea Angelini, …Gaetano La Manna Show authors
Journal of Medical Case Reports volume 17, Article number: 283 (2023) Cite this article
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Case report
Open Access
Published: 07 July 2023
Extracorporeal hemoadsorption therapy as a potential therapeutic option for rapid removal of Apixaban in high risk-surgical patients: a case report
Vittorio Dalmastri, Andrea Angelini, …Gaetano La Manna Show authors
Journal of Medical Case Reports volume 17, Article number: 283 (2023) Cite this article
Metricsdetails
Abstract
Background
Apixaban is a non-vitamin K antagonist oral anticoagulant (NOACs) recently emerged as an effective alternative to conventional vitamin K antagonists (VKAs) in the treatment of several thromboembolic disorders. However, in case of overdose or in patients requiring emergency surgery there is a high bleeding rate and severe adverse side effects due to the absence of an antidote. There is promising data from in vitro and clinical studies, that certain antithrombotic agents (that is Rivaroxaban and Ticagrelor) have been successfully removed by the extracorporeal hemoadsorption therapy CytoSorb. Here, we present the case of a patient successfully treated with CytoSorb as a kind of antidote to enable emergency surgery for bilateral nephrostomy.
Case presentation
A 82-year-old Caucasian man was admitted to the Emergency Room with acute kidney injury (AKI) in the context of severe bilateral hydroureteronephrosis. The patient’s medical history included chronic obstructive pulmonary disease, arterial hypertension, atrial fibrillation (anticoagulated with Apixaban) and a locally advanced prostate adenocarcinoma treated with trans-ureteral resection of the bladder and radiotherapy in the previous months. The indication for a bilateral nephrostomy could not be considered immediately given the major bleeding risk due to Apixaban, which was discontinued and replaced with calciparin. After 36 hours of continuous renal replacement therapy (CRRT), the Apixaban blood level was still elevated and it was decided to install CytoSorb into the running CRRT to accelerate the drug clearance. After 2 hours 30 minutes, there was good reduction of Apixaban from 139 to 72 ng/ml (reduction rate of 48.2%) registered, and this allowed for an easy placement of bilateral nephrostomies without complications. Four days after surgery renal function parameters further normalized, the patient did not require additional dialysis treatments and Apixaban therapy was prescribed again once the patient returned home.
Conclusions
In this case we report the findings of a patient with post-renal AKI requiring emergency nephrostomy placement while on chronic anticoagulation with Apixaban therapy. Combined treatment with CRRT and CytoSorb was associated with the rapid and effective removal of Apixaban allowing for prompt and urgent surgery while simultaneously ensuring the low risk of bleeding as well as an uneventful post-operative course.
Peer Review reports
https://link.springer.com/article/10.1186/s13256-023-03949-3
Cytosorbents (CTSO) Price Target Increased by 8.57% to 7.75
July 06, 2023 — 11:01 am EDT
Written by George Maybach for Fintel ->
The average one-year price target for Cytosorbents (NASDAQ:CTSO) has been revised to 7.75 / share. This is an increase of 8.57% from the prior estimate of 7.14 dated June 1, 2023.
The price target is an average of many targets provided by analysts. The latest targets range from a low of 5.56 to a high of 12.60 / share. The average price target represents an increase of 118.37% from the latest reported closing price of 3.55 / share.
https://www.nasdaq.com/articles/cytosorbents-ctso-price-target-increased-by-8.57-to-7.75
American Journal of Case Reports
IF 2022: 1.2
05 July 2023 : Case report Belgium
[In Press]ECMO and Extracorporeal Blood Purification with CytoSorb® Adsorber for Tricyclic Antidepressant Poisoning with Cardiogenic Shock and Severe Rhabdomyolysis
Management of emergency care, Educational Purpose (only if useful for a systematic review or synthesis)
Zakaria Zitoune ORCID logo1BCDEF, Luc Kugener ORCID logo2EF, Joop Jonckheer ORCID logo3EF, Katrien Lanckmans ORCID logo4BCD, Philippe Hantson ORCID logo5EF, Jacques Devriendt ORCID logo6EF, Patrick M. Honore ORCID logo1ABCDEF
DOI: 10.12659/AJCR.939884
Am J Case Rep In Press; DOI: 10.12659/AJCR.939884 The complete signature will be given at the time of publication
Available online: 2023-07-05, In Press, Corrected Proof
Publication in the "In-Press" formula aims at speeding up the public availability of the pending manuscript while waiting for the final publication. The assigned DOI number is active and citable. The availability of the article in the Medline, PubMed and PMC databases as well as Web of Science will be obtained after the final publication according to the journal schedule
Abstract
BACKGROUND
Tricyclic antidepressant (TCA) drugs are a common cause of fatal poisoning because of their cardiotoxic and arrhythmogenic effects. Classic supportive management includes sodium bicarbonate, gastrointestinal chelating agents, and vasopressors. Recently, intravenous lipid emulsion (supported by a low evidence level) has also been used.
CASE REPORT
We report the case of a 55-year-old woman admitted to our Intensive Care Unit (ICU) with acute imipramine self-poisoning. She arrived at the emergency department 7 hours after imipramine ingestion; she had severe rhabdomyolysis upon admission, with creatine phosphokinase levels at about 52 500 IU/L (normal, <200 IU/L).
She quickly developed cardiogenic shock and malign arrhythmia requiring veno-arterial extra corporeal membrane oxygenation (VA-ECMO). Continuous renal replacement therapy (CRRT) with CytoSorb® (CytoSorbents, Monmouth Junction, New York, United Sates of America) was started 19 hours after admission. We performed serial blood measurements of imipramine and its active metabolite desipramine as well as viewing the levels on the CRRT-circuit monitor. Cardiac function improved and ECMO was explanted after 4 days. She also had severe acute respiratory distress syndrome, which resolved spontaneously. The neurologic outcome was favorable despite early myoclonus. The patient regained consciousness on the fifth day. Her clinical evolution was marked by acute ischemia of the lower left limb due to the arterial ECMO cannula.
CONCLUSIONS
These measurements document the efficacy of the CytoSorb® adsorber in removing a lipophilic drug from a patient’s bloodstream. To our knowledge, this is the first published case of CytoSorb® extracorporeal blood purification therapy for acute TCA poisoning.
https://amjcaserep.com/abstract/index/idArt/939884
Case of the Month
Literature Database
Successful use of extracorporeal life support and hemadsorption in the context of venlafaxine intoxication requiring cardiopulmonary resuscitation: a case report
Matthias Hoffmann1, Samira Akbas1, Rahel Kindler2, Dominique Bettex1 | 1 Institute of Anesthesiology, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland | 2 Institute of Intensive Care Medicine, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland | J Artif Organs 2023; epub
07/05/2023
New!Case of the Week / Month
Download documentDownload document
Summary
CoM 07/2023 – This case reports on a 17-year-old female patient who was admitted to a regional hospital for mixed intoxication with a presumed intake of 24 g of venlafaxine (both immediate and extended-release preparations) and unknown amounts of oxycodone, zolmitriptan and itinerol B6.
Case presentation
The patient had been treated with venlafaxine by her outpatient psychiatrist for severe depression with suicidal ideation for two weeks prior to the event. An inpatient psychiatric stay had already been planned
Approximately five hours after taking the medication, the patient was found somnolent and brought to the hospital by ambulance
Due to the severity of the intoxication with the risk of developing hemodynamic instability, the patient was immediately transferred to the intensive care unit
Shortly after that, the patient went into status epilepticus
Because of this the patient was then analgosedated and intubated
After tracheal intubation, progressive hemodynamic deterioration occurred with sinus tachycardia up to 140 bpm, hypotension with systolic blood pressure of 70 mmHg and vasoconstriction (prolonged capillary refill time > 3 s)
ECG on the day of admission showed sinus tachycardia and a prolongation of cQT-time
Furthermore, echocardiography revealed severely impaired left ventricular function (Ejection Fraction – EF 10–15%) with hypokinetic left ventricle, apical and midventricular akinesia with normal right ventricular function. Pericardial effusion was excluded
Arterial blood gas analysis showed metabolic acidosis (pH 7.28) and a serum lactate of 7.8 mmol/l
Despite extended catecholamine therapy with high-dose norepinephrine, dobutamine and epinephrine, the patient could not be stabilized and cardiopulmonary resuscitation due to cardiac arrest had to be initiated
After 2.5 h (150 min) of mechanical resuscitation, extracorporeal life support (ECLS) system was established on-site with subsequent air-ambulance transfer to a tertiary hospital
Shortly after arrival at the tertiary hospital, a large volume of tablets (filling one-third of the stomach) was removed during primary decontamination via gastroscopy. The gastric mucosa was slightly hemorrhagic
A total of 55 g of activated charcoal was applied for additional adsorption. Because of her distended abdomen with subileus, repeated administration was withheld
Laboratory chemistry revealed disseminated intravascular coagulation (DIC) and acute liver failure with transaminase elevation, drop in coagulation factor V (Factor V: < 10%), INR elevation (max. INR 5.9) and lactic acidosis (lactate max. 9.8 mmol/l, pH min. 7.27), leading to the administration of N-acetylcysteine following Prescott schema for four days despite negative paracetamol serum levels
Sonographically, the liver was well perfused without obstructive intra- or extrahepatic cholestasis
Balanced hemodynamic management using volume and low-dose epinephrine (0.1 µg/kg/min) to promote inotropy, as well as high ECLS blood flow (maximum 5 l/min), were used to maintain sufficient
mean arterial pressure
Toxicological screening in urine and blood detected the metabolites of oxycodone, tramadol, nicotine and lidocaine, venlafaxine, metoprolol, metoclopramide, naloxone, and caffeine. In addition, iatrogenic amoxicillin, midazolam and levetiracetam metabolites were found
The initial compound venlafaxine plasma concentration was markedly elevated (maximum 52.53 µmol/l, therapeutic range of 0.7–1.44 µmol/l)
Therefore, a CytoSorb adsorber was initiated 6 h after admission to support drug removal
Treatment
Hemoadsorption treatment with CytoSorb was run for a total of 72 h with three adsorber changes during that time
The adsorber was integrated into a bypass within the running ECLS circuit
Blood flow rate: 300 ml/min
Measurements
Venlafaxine systemic plasma concentration
Left ventricular ejection fraction (LV-EF)
Results
Venlafaxine plasma concentrations were reduced significantly from a maximum of 52.53 µmol/l to 9.60 µmol/l within the first 12 hours. On day 2, it was 7.17 µmol/l and decreased further to 3.74 µmol/l
LV-EF increased steadily reaching ~22% at discontinuation of CytoSorb and ~36% on day 7
Patient Follow-Up
A 900 ml serous left pleural effusion was drained following the correction of coagulation on day four
The patient was anuric with acute kidney injury (AKIN stage 3, max. creatinine 331 µmol/l) and required continuous hemodiafiltration from day five
Already on admission, microbiological sampling was performed after documented aspiration and the established antimicrobial therapy with amoxicillin/clavulanic acid was continued
Despite negative bacterial detection, antimicrobial therapy was escalated to piperacillin/tazobactam on day eight due to respiratory deterioration and increasing inflammatory parameters (C-reactive protein peak level 154 mg/l)
The patient’s health condition progressively improved over the next few days
In addition to an increased blood pressure amplitude over 20 mmHg, serial transthoracic echocardiograms documented improved cardiac function and sufficient ejection fraction
Electrocardiographically, cQT peaked at 507 ms with no arrhythmias
Three days post-admission, levosimendan (0.1mcg/kg/min) intravenously (25 mg) facilitated weaning and removal of the ECLS system
Hepatic function recovered and after 7 days of high-volume hemodiafiltration, acid–base and fluid hemostasis were restored
The patient was transferred back to the peripheral hospital on day 11 post symptom onset and completely recovered neurologically and cardiopulmonarily
The discharge to inpatient psychiatric treatment was organized 31 days after the initial intoxication due to persistent suicidality
Conclusions
The combination of hemadsorption with CytoSorb with ECLS, along with traditional decontamination strategies, resulted in the intact neurological survival of the highest venlafaxine intoxication reported in the literature to date
The authors state this case supports the evidence that hemadsorption with CytoSorb might help to reduce blood serum levels of venlafaxine, and that swift clearance of toxic blood levels may support cardiovascular recovery after life-threatening intoxications.
New on PubMed
Extracorporeal liver support techniques: a comparison
Ivano Riva et al. J Artif Organs. 2023.
Hide details
J Artif Organs
. 2023 Jun 19.
doi: 10.1007/s10047-023-01409-9. Online ahead of print.
Authors
Ivano Riva 1 , Antonella Marino 2 , Tino Martino Valetti 3 , Gianmariano Marchesi 3 , Fabrizio Fabretti 3
Affiliations
1 General Intensive Care Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Piazza OMS, 1, 24127, Bergamo, Italy. iriva@asst-pg23.it.
2 General Intensive Care Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Piazza OMS, 1, 24127, Bergamo, Italy. antonellamar@gmail.com.
3 General Intensive Care Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Piazza OMS, 1, 24127, Bergamo, Italy.
PMID: 37335451
DOI: 10.1007/s10047-023-01409-9
Cite
Abstract
ExtraCorporeal Liver Support (ECLS) systems were developed with the aim of supporting the liver in its detoxification function by clearing the blood from hepatic toxic molecules. We conducted a retrospective comparative analysis on patients presenting with liver failure who were treated with different extracorporeal techniques in our intensive care unit to evaluate and compare their detoxification abilities. To verify the effectiveness of the techniques, mass balance (MB) and adsorption per hour were calculated for total bilirubin (TB), direct bilirubin (DB), and bile acids (BA) from the concentrations measured. MB represents the total amount (mg or mcMol) of a molecule removed from a solution and is the only representative parameter to verify the purification effectiveness of one system as it is not affected by the continuous production of the molecules, released in the circulation from the tissues, as it is the case for the reduction rate (RR). The total adsorption per hour is calculated by the ratio between MB and the time duration and shows the adsorption ability in an hour. Our comparative study shows the superior adsorption capability of CytoSorb system regarding TB, DB, and BA, evaluated through the MB and adsorption per hour, in comparison with CPFA, MARS, Prometheus, and PAP. In conclusion, as extracorporeal purification in liver failure could be considered useful for therapeutic purposes, Cytosorb, being more performing than other systems considered, could represent the device of first choice.
Keywords: Extracorporeal support; Liver failure; Liver support.
CytoSorbents Announces Independent Data Safety and Monitoring Board Recommends Completion of the Pivotal STAR-T Trial Without Modifications Following Second Scheduled Safety Review
PRINCETON, N.J., June 15, 2023 — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received the recommendation from the independent Data and Safety Monitoring Board (DSMB), following the second scheduled safety review, to complete the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial as planned without any modifications.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, “We would like to thank the independent DSMB for the prompt review of the full unblinded dataset from the first 80 patients enrolled in the STAR-T trial. We are very pleased with the recommendation to continue the study as planned without modifications that now allows us to push towards the finish line in an expedited fashion. Based on the continued excitement and strong contributions from our U.S. and Canadian investigative sites, we continue to project that the trial, which remains blinded, will complete enrollment this summer.”
The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study being conducted in both the U.S. and Canada that is designed to evaluate the ability of DrugSorb-ATR® to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery. Brilinta is one of the leading “blood thinners” used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. But if the patient is one of the up to 10% that need to undergo coronary artery bypass graft (CABG) or other open heart surgery, the risk of major fatal or life-threatening CABG-related bleeding can be as high as 50-65%, particularly if the surgery is performed within several days of the last Brilinta dose. Waiting in the hospital to wash out the drug is the only acceptable alternative, but this comes at high cost and potential clinical risk. The goal of DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study is being conducted by many of the leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
Avenir Corp Buys 132,235 Shares of Cytosorbents Co. (NASDAQ:CTSO)
"Avenir Corp increased its stake in Cytosorbents Co. (NASDAQ:CTSO - Get Rating) by 5.7% during the fourth quarter, according to its most recent filing with the Securities and Exchange Commission. The firm owned 2,447,089 shares of the medical research company's stock after purchasing an additional 132,235 shares during the quarter. Cytosorbents makes up approximately 0.4% of Avenir Corp's portfolio, making the stock its 24th biggest holding. Avenir Corp owned 5.61% of Cytosorbents worth $3,793,000 at the end of the most recent reporting period.
A number of other hedge funds also recently modified their holdings of the stock. Millennium Management LLC bought a new stake in Cytosorbents during the 2nd quarter valued at $1,149,000. Skylands Capital LLC raised its holdings in Cytosorbents by 8.3% during the 4th quarter. Skylands Capital LLC now owns 2,542,091 shares of the medical research company's stock valued at $3,940,000 after acquiring an additional 195,057 shares during the period. Goldman Sachs Group Inc. raised its holdings in Cytosorbents by 129.6% during the 1st quarter. Goldman Sachs Group Inc. now owns 298,877 shares of the medical research company's stock valued at $954,000 after acquiring an additional 168,712 shares during the period. Neuberger Berman Group LLC raised its holdings in Cytosorbents by 11.4% during the 3rd quarter. Neuberger Berman Group LLC now owns 1,479,570 shares of the medical research company's stock valued at $2,003,000 after acquiring an additional 151,300 shares during the period. Finally, Citadel Advisors LLC grew its position in shares of Cytosorbents by 461.4% during the 2nd quarter. Citadel Advisors LLC now owns 126,898 shares of the medical research company's stock valued at $278,000 after purchasing an additional 104,296 shares in the last quarter. Institutional investors own 34.04% of the company's stock."
https://www.marketbeat.com/instant-alerts/nasdaq-ctso-sec-filing-2023-06-12/
Nobody asked me but that was a good meeting today. Organized, positive, prepared, pertinent. They did well.
Looks like blocks husband added to his retirement account
Intraoperative ticagrelor removal via hemoadsorption during on-pump coronary artery bypass grafting
Hassan K, Geidel S, Zamvar V, Tanaka K, Knezevic-Woods Z, Wendt D, Deliargyris EN, Storey RF, Schmoeckel M. JTCVS 2023; epub
05/2023
This three centre study prospectively included 11 patients on ticagrelor undergoing urgent coronary artery bypass graft (CABG) surgery. CytoSorb hemoadsorption was incorporated in the cardiopulmonary bypass (CPB) circuit and remained there for the duration of the pump run. Blood samples were collected pre and post CPB so that mean ticagrelor levels could be measured. The time interval between surgery and last ticagrelor dose was £48 hrs and the mean intraoperative hemoadsorption duration was 97 minutes with a mean flow rate through the device of 422 mL/min. Mean ticagrelor levels pre-CPB were 103±63.8 ng/mL compared to mean post CPB levels of 34.0±17.5 ng/mL (significant reduction of 67.1%, p< 0.001). There were no re-operations performed for bleeding and no BARC-4 bleeding events occurred. Median chest tube drainage over 24 hours was 520mL (375mL-930mL). Intraoperative integration of CytoSorb into the CPB circuit was simple and safe without any device related adverse events reported. This is the first in vivo report showing that the intraoperative use of CytoSorb can efficiently remove ticagrelor and significantly reduce circulating drug levels. As the authors state, whether this active removal can reduce serious postoperative bleeding in patients undergoing urgent cardiac surgery is currently being evaluated in the double blinded randomized Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial.
No opinion at this time
Andy, any thoughts on where we are regarding getting to 120 enrollees? Your post says to me we are in good shape when the data is analyzed. Opinions?
Cost-Effectiveness and Budget Impact of a Novel Antithrombotic Drug Removal System to Reduce Bleeding Risk in Patients on Preoperative Ticagrelor Undergoing Cardiac Surgery
Benjamin G Cohen et al. Am J Cardiovasc Drugs. 2023.
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Am J Cardiovasc Drugs
. 2023 May 19.
doi: 10.1007/s40256-023-00587-4. Online ahead of print.
Authors
Benjamin G Cohen 1 , Francine Chingcuanco 2 , Jingwei Zhang 3 , Natalie M Reid 2 , Victoria Lee 3 , Jonathan Hong 4 , Efthymios N Deliargyris 3 , William V Padula 5 6 7
Affiliations
1 Stage Analytics, Duluth, GA, USA. benjamin.cohen@stageanalytics.com.
2 Stage Analytics, Duluth, GA, USA.
3 CytoSorbents Corporation, Princeton, NJ, USA.
4 St. Boniface Hospital, University of Manitoba, Winnipeg, MB, Canada.
5 Stage Analytics, Duluth, GA, USA. padula@usc.edu.
6 Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles, CA, USA. padula@usc.edu.
7 The Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, USC Schaeffer Center, 635 Downey Way (VPD), Los Angeles, CA, 90089, USA. padula@usc.edu.
PMID: 37204675
DOI: 10.1007/s40256-023-00587-4
Cite
Abstract
Background: Antithrombotic drugs, including the P2Y12 inhibitor ticagrelor, increase the risk of perioperative bleeding in patients requiring urgent cardiac surgery. Perioperative bleeding can lead to increased mortality and prolong intensive care unit and hospital stays. A novel sorbent-filled hemoperfusion cartridge that intraoperatively removes ticagrelor via hemoadsorption can reduce the risk of perioperative bleeding. We estimated the cost-effectiveness and budget impact of using this device versus standard practices to reduce the risk of perioperative bleeding during and after coronary artery bypass grafting from the US healthcare sector perspective.
Methods: We used a Markov model to analyze the cost-effectiveness and budget impact of the hemoadsorption device in three cohorts: (1) surgery within 1 day from last ticagrelor dose; (2) surgery between 1 and 2 days from last ticagrelor dose; and (3) a combined cohort. The model analyzed costs and quality-adjusted life years (QALYs). Results were interpreted as both incremental cost-effectiveness ratios and net monetary benefits (NMBs) at a cost-effectiveness threshold of $100,000/QALY. We analyzed parameter uncertainty using deterministic and probabilistic sensitivity analyses.
Results: The hemoadsorption device was dominant for each cohort. Patients with less than 1 day of washout in the device arm gained 0.017 QALYs at a savings of $1748 (USD), for an NMB of $3434. In patients with 1-2 days of washout, the device arm yielded 0.014 QALYs and a cost savings of $151, for an NMB of $1575. In the combined cohort, device gained 0.016 QALYs and a savings of $950 for an NMB of $2505. Per-member-per-month cost savings associated with device was estimated to be $0.02 for a one-million-member health plan.
Conclusion: This model found the hemoadsorption device to provide better clinical and economic outcomes compared with the standard of care in patients who required surgery within 2 days of ticagrelor discontinuation. Given the increasing use of ticagrelor in patients with acute coronary syndrome, incorporating this novel device may represent an important part of any bundle to save costs and reduce harm.
Talking to a buddy yesterday and he told me his friend's girlfriend needs major heart valve operation and that specifically the 3rd Covid vaccination has been causing all kinds of heart problem mayhem.
I only got the first two Covid vaccines thankfully !
He also told me that the Covid virus itself can also lead to these issues.
So gang, sit tight the real Covid related revenues could be just starting...
Now that is a very good sign. Hopefully more will do the same!
Bloch bought 10,000 shares at market price $31K.
15 years like a lot patience. Why do you think hecwukk get better at his job? He totally misread the outlook, did not raise money when could have and the clock and cash are ticking away.
JGR, you state "Chan blamed that on the factory's lack of ability to produce caused the lack of sales". I just don't recall that occurring. Can you post a link? It really doesn't seem like something he would state.
This is beyond remarkable. That she survived all of those medical emergencies, any of which could have taken her out, is simply amazing. How can our stock be sub $3? How?
Case of the Month
Literature Database
Use of CytoSorb for bilirubin removal in ischemic hepatitis and multiple organ failure due to uterine rupture with massive postpartum hemorrhage
Henry Kai Wing Chan, Kenny King Chung Chan | Department of Anesthesia and Intensive Care, Tuen Mun Hospital, Hong Kong, China
05/03/2023
New!Other indicationsBilirubinCase of the Week / MonthCase reportCritical CareCRRT pre filterLiver failure
Download documentDownload document
Summary
CoM 05/2023 – This case reports on a 43-year-old pregnant woman, who was hospitalized for an anticipated complicated delivery.
Case presentation
The patient had hypothyroidism and was additionally on antihypertensive medication (methyldopa). She had also suffered from persistent liver impairment with hyperbilirubinemia from admission to hospital
Due to her medical condition, she was transferred to the Department of Anesthesia and Intensive Care for further management and induction of labor was performed at the 39-weeks gestation
Postpartum, the patient suddenly developed pulseless electrical activity (PEA) which resulted in a cardiac arrest for 20 minutes. An uterine rupture was noted and treated by emergency hysterectomy with embolization of the right internal iliac artery and ligation of left internal iliac artery. During the operation, the patient developed abdominal compartment syndrome with hypoxemia and so she was eventually connected to veno-venous extracorporeal membrane oxygenation (VV-ECMO) therapy
In addition to fluid substitution given her hypovolemic shock state high dose inotropic support was initiated
In the postoperative period, she required mass blood transfusions to manage her postpartum hemorrhage
Although the patient could eventually be weaned from ECMO, she developed signs of ischemic hepatitis accompanied by massive liver failure with serum bilirubin levels increasing to over 64 mg/dL on day 10 after ICU admission
Simultaneously, she developed acute renal failure, resulting in the initiation of continuous renal replacement therapy (CRRT)
Moreover, she was noted to be in atrial fibrillation with short pause intervals, followed by severe bradycardia (heart rate 40-50 bpm) and asystole for 2 minutes. Therefore, transvenous pacing (TVP) was inserted by the cardiologist for severe bradycardia
With the rationale to reduce her elevated bilirubin levels, a CytoSorb adsorber was integrated into the CRRT circuit
Treatment
A total of three treatment sessions of CytoSorb were run consecutively for a total of 52 hours
The CytoSorb absorber was installed pre-hemofilter into the CRRT circuit (AV1000S, multiFiltrate, Fresenius)
Blood flow rate: 80-100 ml/min
Measurements
Bilirubin serum levels
Results
CytoSorb treatment led to a reduction in serum bilirubin levels from 64 to 33 mg/dL within 12 hours of initialization. A slight rebound of bilirubin was observed and a second CytoSorb treatment was started. The patient’s serum bilirubin remained stable during CytoSorb treatment and continued to decrease over time
Patient Follow-Up
The patient was eventually weaned from TVP two days after discontinuation of CytoSorb treatment as her heart rate returned to normal sinus rhythm
Over time, her clinical condition further stabilized and liver as well as renal function progressively improved, both returning to normal values
She was discharged home four months later after a prolonged course of rehabilitation with her healthy baby
Conclusion
To the best of the authors knowledge, this is the first case that describes the use of CytoSorb for bilirubin removal in multiple organ failure, including cardiac arrest, ischemic hepatitis and renal failure following severe postpartum hemorrhage postpartum with uterine rupture
In this complex and multifactorial scenario, implementation of CytoSorb treatment successfully reduced the patient’s serum bilirubin level and was associated with improved liver and cardiac function, and eventually enabled weaning-off from transvenous pacing within a short time period
These data further support the use of hemoadsorption for bilirubin removal while treatment with CytoSorb was safe and feasible without technical problems.
Kathy had to leave the call to get to the bank. Sorry everyone.
Q1 2023 was $9.4 million...
CytoSorbents Reports First Quarter 2023 Results
May 2, 2023 - 4:15 pm
Pivotal U.S. and Canada STAR-T Trial enrollment enters the last third of the study. Strong customer demand from Q4 2022 continued into Q1 2023, with current expectation of overall sales growth in 2023
PRINCETON, N.J., May 02, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended March 31, 2023.
First Quarter 2023 Financial Results
Total revenue, including product sales and grant income, for Q1 2023 was $9.4 million, an increase of 9% compared to $8.7 million in Q1 2022
Q1 2023 product sales were $7.9 million versus $7.9 million in Q1 2022.
There were no COVID-related sales this quarter, compared to approximately $300K of COVID-related sales in Q1 2022
Currency effects negatively impacted Q1 2023 sales by approximately $349K. Constant currency core product sales in Q1 2023 were $8.3 million, an increase of $635K or 8.3%, over core products sales of $7.6 million in Q1 2022
Q1 2023 represents the second consecutive period of sequential quarterly product sales growth, and the first time that Q1 core product sales sequentially exceeded seasonally strong core Q4 sales in the past five years, which we believe represents a positive indicator of improving business
Q1 2023 product gross margin was approximately 68%, compared to 80% in Q1 2022 due to start-up activities of our new manufacturing facility
We believe the Company remains well-capitalized with cash and cash equivalents of $20.7 million (which includes $1.7 million in restricted cash) as of March 31, 2023
Recent Operating Highlights
We have now surpassed 200,000 cumulative human treatments globally after achieving 100,000 cumulative CytoSorb treatments in August 2020 less than 3 years ago. As of the end of Q1 2023, there have been more than 203,000 CytoSorb cumulative treatments delivered across more than 75 countries worldwide
The pivotal STAR-T randomized controlled trial achieved its second milestone of 80 patients enrolled on schedule in mid-April 2023, following the first milestone of 40 patients enrolled in November 2022, triggering a second pre-specified Data and Safety Monitoring Board (DSMB) review, which is expected to complete in the next few months. The trial continues to enroll well and is now in its last stage of enrollment, which is expected to complete this summer
Our Board Chairman, Al Kraus, announced his intent to retire at the end of his term in June 2023, following 20 years of leadership with the Company at age 78. He will continue to consult for the Company as needed. Pending the results of the 2023 Annual Meeting, current Board Director Michael Bator will succeed Al Kraus as Chairman of the Board
Highlighted a landmark publication in the high impact, peer-reviewed journal, Critical Care, underscoring the power of CytoSorb to reduce cytokine storm during systemic hyperinflammation caused by a very important toxin in half of sepsis cases, in a well-controlled, balanced, and definitive human study
Hosted a successful and highly attended scientific symposium and exhibition at the 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM 2023) in Brussels, Belgium in March 2023, where data from the latest studies were presented and live-streamed, detailing the effect of CytoSorb in treating cytokine storm and deadly inflammation in diseases such as sepsis, shock, and acute respiratory distress syndrome (ARDS), including the study above which was the centerpiece of the session
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We believe we have started 2023 with favorable momentum and are pleased with the continued execution of three key goals described in the shareholder letter earlier this year.
1. Opening the U.S. and Canadian markets with DrugSorb®-ATR
The STAR-T (Safe and Timely Antithrombotic Removal - Ticagrelor) pivotal, randomized controlled trial is designed to support U.S. FDA and Health Canada marketing approval of DrugSorb-ATR with the goal of demonstrating that DrugSorb-ATR reduces the risk of perioperative bleeding in patients undergoing cardiothoracic surgery on Brilinta® (ticagrelor, AstraZeneca). The STAR-T trial is enrolling well with recruitment by nearly all trial sites, both here in the U.S. and in Canada, and has recently outpaced our own internal projections. Should these trends continue, we expect to enroll the final third of the study this summer and have topline data by year-end that if positive, we believe would support the application for FDA and Health Canada marketing approval of DrugSorb-ATR.
As discussed recently, the rapid pace of enrollment of STAR-T led us to elect to forego a formal interim analysis on the first 80 patients. To fully understand this decision, it is important to clarify that the original intent of this interim analysis was to provide the opportunity to stop the trial early, an important option if enrollment was expected to be slow or delayed. However, the current enrollment pace is brisk and our projections suggest that the trial will likely be completed by the time a formal interim analysis - that requires fully monitored, cleaned, locked, and adjudicated data - would have been completed. Accordingly, a trial that is fully enrolled cannot be stopped early and as such we are now focusing our efforts on the final analysis. We believe it is also important to emphasize that there are no other considerations or information underlying this decision and that the STAR-T study data remain fully-blinded. The next milestone for the STAR-T trial is the second independent Data and Safety Monitoring Board (DSMB) safety evaluation after the first 80 patients which we expect to be completed in the next 2-3 months. As previously disclosed, the DSMB recommendation after the safety evaluation of the first 40 patients was to continue the study as planned without any modifications.
In parallel to the clinical study, Dr. Irina Kulinets, Senior Vice President of Global Regulatory, is leading the execution of the regulatory strategy for DrugSorb-ATR that at this stage includes strengthening her team, planning for future regulatory submissions, and driving interdepartmental alignment and responsibilities to meet our regulatory objectives and timelines.
Finally, we spoke previously of a pending proposal from Centers for Medicare & Medicaid Services (CMS) for Transitional Coverage of Emerging Technology (TCET) that could establish four years of U.S. Medicare coverage to breakthrough medical devices approved by the FDA. This proposal was expected in April 2023, and is still expected imminently. We believe that DrugSorb®-ATR, as an FDA Breakthrough Designated Device that targets many patients in the Medicare population undergoing open heart surgery and at high risk of unwanted bleeding due to blood thinners, could be well-suited for such a program.
2. Return to Sales Growth
We believe the achievement of sequential growth in Q1 2023 product sales from the prior quarter, and 8% quarterly core product sales growth year-over-year on a constant currency basis, represent an encouraging sign towards our goal of returning to sales growth this year. More important than this, however, is the general perception of our employees across each of our business segments of strong customer engagement, excellent feedback on our most recent clinical and scientific data across multiple indications in our therapeutic area verticals, and a trend of improvement in our hospital markets in core countries - though healthcare professional staffing remains a key issue. For example, in Germany, the DIVI Critical Care Society is reporting an increase in regularly operating adult intensive care units, and a concomitant sharp reduction in restricted ICUs – an important, non-quantitative assessment of the supply situation, which is governed by availability of staff, rooms, materials, and other factors. This has correlated with a major drop in COVID-related ICU admissions. If sustained, we believe it is likely that the mandate to have emergency reserve ICU beds for COVID-19 will also likely be lifted, freeing additional ICU capacity throughout the country. We expect this to translate into the ability to accept more non-COVID critically ill patients to the ICU and to do more surgical procedures, such as cardiac surgery, that require ICU postoperative care, which are all drivers of our business. Among our many growth initiatives, we are also seeing good progress in our strategy of expanding into German hospitals within private networks based on our preferred supplier agreements, increasing our accounts in these German networks by 50% last year over 2021.
https://www.stocktitan.net/news/CTSO/cyto-sorbents-reports-first-quarter-2023-qb8krwzat2t2.html
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Sorry that's one million two hundred thousand dollars a year!
Less than one tenth of that capacity of this factory was sold in 2022. Yet Chan blamed that on the factory's lack of ability to produce caused the lack of sales. This guy is making over one million two hundred dollars in salary and perks. Totally undeserved!! Been here over fifteen years hoping things would change. With this product we should be well above this price point. Total BAD leadership!
no "we" Harbor6460. I like that he has moved us from OTC to the Nasdaq, built a new production facility that can produce $400 million in product, got us to within a short period of time that we will have an expedited FDA approval, then restart the second one.
Chan we know is Worst CEO of all time. Imagine this product and we are still here 15 years later. Sad. And how about the amount of people that have died cause this product is not available.
I would like to ask Chan what 190 employees are doing!
Market seems to be worried that Chan will run out of cash before revenues pick up significantly. CFO Block had retired to a nifty consulting relationship and thus no liability.? Why no CFO to replace her? Have you noticed that press release -are often not posted on their website until hours or a day later? Poor IR effort .Chairman has resigned so he has no liability. No replacement. Chan getting rid of his detractors?Still paying lease on old facilities? What has happened to number of salesmen in Germany? Rough quarter?
CytoSorbents’ Pivotal STAR-T Trial Reaches Second Key Milestone With 80 Patients Enrolled
CytoSorbents
Thu, April 20, 2023 at 7:00 AM EDT
PRINCETON, N.J., April 20, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces that its pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial has enrolled 80 patients, achieving the second of three key enrollment milestones, and triggering a pre-specified Data and Safety Monitoring Board (DSMB) safety review.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are pleased with the solid enrollment pace of the STAR-T trial, now two-thirds enrolled, and believe it reflects a) the positive enthusiasm and commitment of participating U.S. and Canadian study centers, b) the large unmet medical need and numbers of patients on ticagrelor undergoing cardiothoracic surgery, and c) the laser focus of our clinical team. We expect completion of the second DSMB safety review over the next several months.”
Dr. Deliargyris continued, “Because of the brisk enrollment of the trial, we continue to project that STAR-T will be fully enrolled this summer. Because of this, as we discussed in our last earnings call in March, we have elected to forego an interim analysis at this stage which would have otherwise taken several months to conclude, and instead race to complete trial enrollment on schedule and initiate the final study analysis, while preserving the full statistical power of the study. This would put us in the position of having top-line data later this year, with the goal of filing for U.S. FDA and Health Canada regulatory approval thereafter.”
The STAR-T trial intends to enroll approximately 120 patients at 30 centers in the U.S. and Canada to evaluate whether intraoperative use of DrugSorb®-ATR can reduce the high perioperative risk of bleeding in patients undergoing cardiothoracic surgery who have recently received the blood thinning agent, ticagrelor. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application, for which CytoSorbents received FDA Breakthrough Device Designation in April 2020, recognizing it as a major unmet medical need for which there are no FDA-approved or cleared therapies.
https://finance.yahoo.com/news/cytosorbents-pivotal-star-t-trial-110000273.html
I'm not an expert on this. That said, I am a heart patient on blood thinners. Here's my guess. There is no delay from the point of agreeing to be enrolled and the surgery. The whole point of the CTSO filter is to facilitate a quicker surgery when time is of the essence. These 80 couldn't wait. So, again my guess, all 80 already had surgery. The good news for us? The company has to know how this has been going AND I was buoyed by the positive comments in the cc. If the results haven't been good, they (Makis, Chan) certainly didn't let on. Again, not a doctor so all this is just an educated guess on my part. In 1993 I needed an emergency surgery and was given something to counteract my Coumadin. When the conversation goes like this "Take this and we can operate now. Or we can wait up to 5 days and you can die on any one of them". The choice is easy.
Thanks for sharing fantom. So how does this trial work? We wait for one of those of the 80 tacking a blood thinner to have a heart attack or heart complications, go back into the hospital and then (depending if not one of the placebo controlled) that patient gets treated with the cytosorbents filter during the the procedure/operation?
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