The Hunt for Virus Treatments Continues Post Covid-19 (NASDAQ: $AEMD) (NASDAQ: $MRNA) (NYSE: $PFE) (NASDAQ: $IBRX) (NASDAQ: $ALGS) @moderna_tx @pfizer @ImmunityBio @AligosThera

 

The Hunt for Virus Treatments Continues Post Covid-19 (NASDAQ: $AEMD) (NASDAQ: $MRNA) (NYSE: $PFE) (NASDAQ: $IBRX) (NASDAQ: $ALGS) @moderna_tx @pfizer @ImmunityBio @AligosThera

 

June 7, 2024 - Investorideas.com, a go-to investing platform, releases the second of a two-part series looking at news and developments for the treatment of viruses, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.

 

The threat of viruses is back in the news with multiple news sources, including the Guardian reporting, ”The World Health Organization (WHO) has said a man’s death in Mexico was caused by a strain of bird flu called H5N2 that has never before been found in a human.”

 

This news is paid advertisement/ news disseminated on behalf of/issued on behalf of Aethlon Medical Inc.

 

Read this article featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/06071Virus-Treatments-Post-Covid-19.asp

 

The WHO said Wednesday it wasn’t clear how the person became infected. “Although the source of exposure to the virus in this case is currently unknown, A (H5N2) viruses have been reported in poultry in Mexico,” it said in a statement.

 

Continued: “Scientists are on alert for changes in the virus that could signal that bird flu is adapting to spread more easily among humans.

 

Continued:  “But the UN agency said Wednesday said the current risk of the bird flu virus to the general population in Mexico is low.”

 

With global populations and economies still feeling the impact of Covid-19, any virus threat is going to make headlines.

 

As viruses make headlines, companies are seeking solutions and not all are focused on vaccine development.

 

Aethlon Medical, Inc. (Nasdaq: AEMD) just recently announced an update on its technology for cancer treatment on its planned phase 1 safety, feasibility and dose-finding clinical trials of its Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

 

The Aethlon Hemopurifier® technology is designed for the rapid depletion of cancer-promoting exosomes and circulating viruses. The United States Food and Drug Administration (FDA) has designated the Hemopurifier® as a “Breakthrough Device” for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and life-threatening viruses that are not addressed with approved therapies.

 

As reported previously, separate from its current focus on cancer treatment, Aethlon has investigated the potential for the use of the Hemopurifier® in viral diseases.

 

According to their SEC filing, “We also believe the Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals infected with human immunodeficiency virus, or HIV, hepatitis-C and Ebola.”

 

“Additionally, in vitro, the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government research institutes.”

 

Recently, Zacks reported that “Vaccine Stocks Rise on Growing Threat of Bird Flu Infections”

 

“Shares of several vaccine makers soared after reports suggest that the Biden administration is in discussions with Moderna (NASDAQ: MRNA) and Pfizer (NYSE:PFE) to set up a possible vaccine program aimed at preventing the spread of the H5N1 virus, also known as bird flu, in humans.”

 

Continued: “These reports came to light after the discovery of two cases of H5N1 virus in dairy farm workers in Texas and Michigan this year. Both these workers experienced symptoms in the eye after coming into contact with dairy cows infected with the H5N1 virus.”

 

But the treatment of viral diseases has other options including immunotherapy.

 

ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced earlier this year the publication of preclinical data in the online issue of Science, First Release indicating that combination therapy with N-803, an IL-15 superagonist, and broadly neutralizing antibodies may potentially enable the immune system to manage human immunodeficiency virus (HIV) without the need for antiretroviral treatment.

 

From the news: In the preclinical non-human primate study, researchers led by Dr. James Whitney, Ph.D. and funded by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases (NIAID) demonstrated that using N-803, in combination with broadly neutralizing antibodies (bNAbs), led to sustained viral control after discontinuation of antiretroviral therapy (ART) in ART-suppressed rhesus macaques infected with simian-human immunodeficiency virus AD8 (SHIV-AD8). Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir. Upon ART discontinuation, all animals experienced viral rebound, followed by long-term virus control for up to 10 months in approximately 70% of those treated with N-803 and bNAbs.

 

"The viral reservoir in people with HIV is established within the first few days of infection and cannot be eliminated by the body’s immune system or currently available treatments, representing a significant obstacle in curing an established HIV infection," said James B. Whitney, M.D., Study Author and Researcher at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Harvard Medical School. "When combined with broadly neutralizing antibodies, N-803 has the potential to provide viral control without significant reduction in the viral reservoir, which further suggests that the complete eradication of this reservoir may not be required to induce sustained remission after discontinuing antiretroviral therapy."

 

Taking another approach to viral diseases, Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses.

 

The Company just announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy.

 

From the news: Reported for the first time were antiviral and safety data in HBeAg-negative CHB subjects who received a daily single dose of 300 mg ALG-000184 monotherapy for ≤60 weeks. In all 11 subjects (100%), complete suppression of HBV DNA (<LLOQ 10 IU/mL) and RNA (<LLOQ 10 copies/mL) were noted, with reduction in HBcrAg levels indicating inhibition of HBV replication, as well as inhibition of cccDNA establishment/replenishment. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough.

 

With bird flu cases on the rise, retail investors are once again on the hunt for stocks with potential solutions.

 

As Bloomberg reported recently,”Mounting cases of bird flu in humans is luring the day trading crowd to snap up stock in vaccine developers. It’s a familiar setup for industry veterans who have witnessed past trading frenzies at the first signs of an outbreak.”

 

This won’t be the last viral outbreak. There are more viruses than stars in the universe. And there are multiple solutions to treating viruses in addition to vaccines.

 

Read part one of the series at Investorideas.com

https://www.investorideas.com/news/2024/biotech/06031Blood-Purification-Medical-Devices.asp

 

Research biotech and medical device/ tech stocks at Investorideas.com

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Disclaimer/Disclosure: This news article featuring AEMD is a paid for news release on Investorideas.com.  AEMD is a paid featured medical tech stock on our site. Our site does not make recommendations for purchases or sale of stocks, services or products.  This is not investment opinion: Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services and prices on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp

 

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Medical Technology Stocks in Play - SOBR Safe, Inc. (NASDAQ: SOBR) Gets Investors High on Stock Run

Medical Technology Stocks in Play - SOBR Safe, Inc. (NASDAQ: SOBR) Gets Investors High on Stock Run: Medical Technology Stocks in Play - SOBR Safe, Inc. (NASDAQ: SOBR) Gets Investors High on Stock Run

 

Medical Device Stocks Setting New Standards (NASDAQ: $AEMD) (NASDAQ: $CTSO) (NASDAQ: $CERS) (NYSE: $BAX) (TSX: $EDT.TO) @CytoSorbents @SpectralMedical @baxter_intl

 

June 4, 2024 - Investorideas.com, a go-to investing platform, releases the first of a two-part series looking at medical device advancements for blood purification, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.

 

According to Straits Research ”The global blood purification equipment market size was valued at USD 17,755.6 million in 2021. It is expected to reach USD 29242.21 million by 2030.”

 

Aethlon Medical, Inc. (Nasdaq: AEMD), with a long history of development for its patented Hemopurifier® blood purification device, just released an update on its planned phase 1 safety, feasibility and dose-finding clinical trials of its Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

 

This news is paid advertisement/ news disseminated on behalf of/issued on behalf of Aethlon Medical

 

Read this article, featuring AEMD in full at  https://www.investorideas.com/news/2024/biotech/06041Medical-Device-Stocks.asp

 

"We continue to make progress preparing for our planned, safety, feasibility and “dose finding” oncology trials in Australia and India, and want to provide our shareholders and other constituents with an update”, stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “In early May, we announced new data showing the in vitro removal of exosomes from cancer patient plasma using a miniature version of our Hemopurifier®. This data has been quickly integrated into the required documentation for Ethics Committees at our potential clinical sites. On May 17, 2024, we provided these documents to the Contract Research Organizations for these planned clinical trials. Subsequently, on May 24, 2024, one potential site submitted the documents to its Ethics Board.  An additional site in Australia and another in India are currently assembling the packages for submission to their Ethics Committees.”

 

“Once we receive the expected Ethics Committee approvals, we will finalize the Clinical Trial Agreements. After this, hospitals can begin recruiting patients for the trials.”

 

As a reminder, the target patient population for these safety, feasibility, and dose finding trials is oncology patients with solid tumors who are failing their anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

 

The Aethlon Hemopurifier® is a first-in-class technology designed for the rapid depletion of cancer-promoting exosomes and circulating viruses. The United States Food and Drug Administration (FDA) has designated the Hemopurifier® as a “Breakthrough Device” for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and life-threatening viruses that are not addressed with approved therapies.

 

Zach’s Research recently commented on Aethlon following positive data from an in vitro binding study it had implemented of the potential for the Hemopurifier® to remove extracellular vesicles (EVs) directly from plasma of cancer patients.

 

“The data from this in vitro study is a critical element enabling the company to move the Hemopurifier forward in clinical oncology studies towards potential regulatory approval and commercialization. The company next intends to add this data to its Clinical Investigator Brochure, which will then be submitted to the Ethics Committees at clinical sites that are interested in participating in the planned phase 1 oncology trials in Australia and India. We expect AEMD to submit the Clinical Investigator Brochure this month.”

 

“AEMD will then seek to obtain approval by the respective Ethics Boards of interested sites in India. The company has a strong clinical working relationship with Medanta Medicity Hospital in Delhi, India, which is currently participating in a study of the Hemopurifier in COVID patients and it would not surprise us if Medanta Medicity Hospital had interest in participating in the oncology study.”

 

“Depending on how long it takes for the sites to review and potentially approve moving forward to participate in Aethlon’s phase 1 trial, we believe clinical efforts could begin in 2H24. If Aethlon can demonstrate the ability of the Hemopurifier to improve outcomes of cancer patients suffering from a variety of different cancer types, we would anticipate strong commercial prospects for the Hemopurifier.”

 

In early May, CytoSorbents Corporation (NASDAQ: CTSO), a pioneer in critical care and cardiac surgery blood purification technologies, announced unaudited financial and operating results for the quarter ended March 31, 2024. The Company reported a robust 14% increase in product sales year over year and a sequential quarterly increase of 22%.

 

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We are pleased to announce a strong start to 2024, driven by significant sales growth and operational efficiencies. First quarter 2024 product sales were $9.0 million, marking the highest quarter for core CytoSorb sales in nearly 3 years. We expanded our product gross margins to 76%, exclusive of a non-recurring inventory adjustment, up an absolute 8% from Q1 2023, which we believe highlights the scalability and efficiency of our state-of-the-art manufacturing facility and processes.”

 

Furthermore, Principal Investigator Dr. Michael Mack presented the results of the U.S. and Canada pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized controlled trial at the Annual Meeting of the American Association for Thoracic Surgery (AATS) and at the KOL and Investor/Analyst Day we hosted earlier this week (replay available) that we believe support a favorable benefit-to-risk profile of the DrugSorb-ATR system* in the perioperative bleeding risk of patients undergoing isolated coronary artery bypass graft (CABG) surgery within 2 days of receiving Brilinta® (ticagrelor, AstraZeneca). We received positive and encouraging feedback on the importance of these data and the continued unmet medical need from cardiothoracic surgeons. Looking ahead, we expect to submit marketing applications for DrugSorb-ATR, which has an FDA Breakthrough Device Designation, to the FDA under the De Novo pathway, and Health Canada in the third quarter of 2024.”

 

Also focused on blood purification, Cerus Corporation (Nasdaq: CERS), dedicated solely to safeguarding the world’s blood supply, announced financial results for the first quarter ended March 31, 2024.

 

Highlights included:

 

·        U.S. ReCePI Phase 3 clinical trial successfully met primary endpoint for INTERCEPT Blood System for Red Blood Cells in cardiovascular surgery patients.

 

·        Received FDA approval of extended shelf life for INTERCEPT Platelet Processing Sets to 12 months, doubling the previous shelf life.

 

·        Advanced the LED illuminator program towards the Company’s target commercial launch in the EU in 2025.

 

The Company is reiterating its full-year 2024 annual product revenue guidance range of $172 million to $175 million. Included in this range is full-year 2024 guidance for INTERCEPT Fibrinogen Complex, which is expected to be between $8 million to $10 million.

 

"The Cerus team delivered against our plans for Q1, paving the way for the balance of 2024, with great progress on clinical milestones and a strong return to growth for our commercial business. The positive topline readout from ReCePI, the U.S. Phase 3 clinical trial for INTERCEPT Red Blood Cells, is a significant milestone for the program and for our efforts to potentially bring this product to the market globally," stated William "Obi" Greenman, Cerus’ President and Chief executive Officer. "Red blood cells are the most commonly transfused blood components worldwide, and we are committed to providing the full INTERCEPT portfolio for all transfused blood components to our customers around the globe."

 

The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System of Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding associated with fibrinogen deficiency, including massive hemorrhage.

 

In mid- May, Spectral Medical Inc. (TSX: EDT), a Phase 3 company seeking US FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”), announced its financial results for the first quarter ended March 31, 2024, and provided a corporate update. 

 

PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

 

Spectral has continued its significant progress throughout the first quarter of 2024 both clinically and operationally and year-to-date enrolled 25 patients for a total of 106 patients out of the 150 total patient’s target. The Company is focused on the final push to fully enroll and finish the Tigris trial and believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment and allow Spectral to rapidly reach the 150-patients target, bringing the Company closer to FDA submission and potential FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Baxter. In Q1 2024, Baxter exercised its right to maintain its exclusive distribution for PMX products in the U.S. and Canada and paid Spectral a non-dilutive milestone payment. Additionally, Spectral and Baxter mutually agreed to amend the initial term of their commercial partnership to ten years post-FDA approval of PMX. The Company believes this amendment provides a mutually beneficial runway for the parties to maximize PMX commercial economics, while providing motivation for continued support and allocation of resources to the PMX partnership.

 

Blood Purification technology made headlines during the pandemic when several companies including Baxter International Inc. (NYSE:BAX) received emergency use authorization (EUA) from the US FDA. Baxter’s approval was for the company's Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT). 

 

Separate from its current focus on cancer treatment, Aethlon (Nasdaq: AEMD) investigates the potential for the use of the Hemopurifier® in viral diseases under an open Investigational Device Exemption (IDE) and their FDA Breakthrough Designation for “…the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy.” 

 

Based on our studies to date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV, Sars-CoV-2, and Ebola.”

 

For the companies in this sector, the drive for innovation is ‘in their blood‘, and with the global threats of viruses and future pandemics on the rise, it’s a sector worth watching.

 

Research biotech and medical device/ tech stocks at Investorideas.com

https://www.investorideas.com/BIS/Stock_List.asp

 

About Investorideas.com - Big Investing Ideas

Investorideas.com is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all. Our original branded content includes podcasts such as Exploring Mining, Cleantech, Crypto Corner, Cannabis News, and the AI Eye. We also create free investor stock directories for sectors including mining, crypto, renewable energy, gaming, biotech, tech, sports and more. Public companies within the sectors we cover can use our news publishing and content creation services to help tell their story to interested investors. Paid content is always disclosed.

 

Disclaimer/Disclosure: This news article featuring AEMD is a paid for news release on Investorideas.com -Our site does not make recommendations for purchases or sale of stocks, services or products.  This is not investment opinion: Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services and prices on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp

 

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Blood Purification Medical Devices Stocks in the News (NASDAQ: $AEMD) (NASDAQ: $CTSO) (NASDAQ: $CERS) (NYSE: $BAX) (TSX: $EDT.TO) @CytoSorbents @SpectralMedical @baxter_intl

 

Blood Purification Medical Devices Stocks in the News (NASDAQ: $AEMD) (NASDAQ: $CTSO) (NASDAQ: $CERS) (NYSE: $BAX) (TSX: $EDT.TO) @CytoSorbents @SpectralMedical @baxter_intl

 

Revolutionizing the Future of Health from Cancer to COVID

 

June 3, 2024 - Investorideas.com, a go-to investing platform, releases the first of a two-part series looking at medical device advancements for blood purification, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.

 

According to Straits Research ”The global blood purification equipment market size was valued at USD 17,755.6 million in 2021. It is expected to reach USD 29242.21 million by 2030.”

 

Aethlon Medical, Inc. (Nasdaq: AEMD), with a long history of development for its patented Hemopurifier® blood purification device, just released an update on its planned phase 1 safety, feasibility and dose-finding clinical trials of its Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

 

This news is paid advertisement/ news disseminated on behalf of/issued on behalf of Aethlon Medical

 

Read this article, featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/06031Blood-Purification-Medical-Devices.asp

 

"We continue to make progress preparing for our planned, safety, feasibility and “dose finding” oncology trials in Australia and India, and want to provide our shareholders and other constituents with an update”, stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “In early May, we announced new data showing the in vitro removal of exosomes from cancer patient plasma using a miniature version of our Hemopurifier®. This data has been quickly integrated into the required documentation for Ethics Committees at our potential clinical sites. On May 17, 2024, we provided these documents to the Contract Research Organizations for these planned clinical trials. Subsequently, on May 24, 2024, one potential site submitted the documents to its Ethics Board.  An additional site in Australia and another in India are currently assembling the packages for submission to their Ethics Committees.”

 

“Once we receive the expected Ethics Committee approvals, we will finalize the Clinical Trial Agreements. After this, hospitals can begin recruiting patients for the trials.”

 

As a reminder, the target patient population for these safety, feasibility, and dose finding trials is oncology patients with solid tumors who are failing their anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

 

The Aethlon Hemopurifier® is a first-in-class technology designed for the rapid depletion of cancer-promoting exosomes and circulating viruses. The United States Food and Drug Administration (FDA) has designated the Hemopurifier® as a “Breakthrough Device” for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and life-threatening viruses that are not addressed with approved therapies.

 

Zach’s Research recently commented on Aethlon following positive data from an in vitro binding study it had implemented of the potential for the Hemopurifier® to remove extracellular vesicles (EVs) directly from plasma of cancer patients.

 

“The data from this in vitro study is a critical element enabling the company to move the Hemopurifier forward in clinical oncology studies towards potential regulatory approval and commercialization. The company next intends to add this data to its Clinical Investigator Brochure, which will then be submitted to the Ethics Committees at clinical sites that are interested in participating in the planned phase 1 oncology trials in Australia and India. We expect AEMD to submit the Clinical Investigator Brochure this month.”

 

“AEMD will then seek to obtain approval by the respective Ethics Boards of interested sites in India. The company has a strong clinical working relationship with Medanta Medicity Hospital in Delhi, India, which is currently participating in a study of the Hemopurifier in COVID patients and it would not surprise us if Medanta Medicity Hospital had interest in participating in the oncology study.”

 

“Depending on how long it takes for the sites to review and potentially approve moving forward to participate in Aethlon’s phase 1 trial, we believe clinical efforts could begin in 2H24. If Aethlon can demonstrate the ability of the Hemopurifier to improve outcomes of cancer patients suffering from a variety of different cancer types, we would anticipate strong commercial prospects for the Hemopurifier.”

 

In early May, CytoSorbents Corporation (NASDAQ: CTSO), a pioneer in critical care and cardiac surgery blood purification technologies, announced unaudited financial and operating results for the quarter ended March 31, 2024. The Company reported a robust 14% increase in product sales year over year and a sequential quarterly increase of 22%.

 

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We are pleased to announce a strong start to 2024, driven by significant sales growth and operational efficiencies. First quarter 2024 product sales were $9.0 million, marking the highest quarter for core CytoSorb sales in nearly 3 years. We expanded our product gross margins to 76%, exclusive of a non-recurring inventory adjustment, up an absolute 8% from Q1 2023, which we believe highlights the scalability and efficiency of our state-of-the-art manufacturing facility and processes.”

 

Furthermore, Principal Investigator Dr. Michael Mack presented the results of the U.S. and Canada pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized controlled trial at the Annual Meeting of the American Association for Thoracic Surgery (AATS) and at the KOL and Investor/Analyst Day we hosted earlier this week (replay available) that we believe support a favorable benefit-to-risk profile of the DrugSorb-ATR system* in the perioperative bleeding risk of patients undergoing isolated coronary artery bypass graft (CABG) surgery within 2 days of receiving Brilinta® (ticagrelor, AstraZeneca). We received positive and encouraging feedback on the importance of these data and the continued unmet medical need from cardiothoracic surgeons. Looking ahead, we expect to submit marketing applications for DrugSorb-ATR, which has an FDA Breakthrough Device Designation, to the FDA under the De Novo pathway, and Health Canada in the third quarter of 2024.”

 

Also focused on blood purification, Cerus Corporation (Nasdaq: CERS), dedicated solely to safeguarding the world’s blood supply, announced financial results for the first quarter ended March 31, 2024.

 

Highlights included:

 

·        U.S. ReCePI Phase 3 clinical trial successfully met primary endpoint for INTERCEPT Blood System for Red Blood Cells in cardiovascular surgery patients.

 

·        Received FDA approval of extended shelf life for INTERCEPT Platelet Processing Sets to 12 months, doubling the previous shelf life.

 

·        Advanced the LED illuminator program towards the Company’s target commercial launch in the EU in 2025.

 

The Company is reiterating its full-year 2024 annual product revenue guidance range of $172 million to $175 million. Included in this range is full-year 2024 guidance for INTERCEPT Fibrinogen Complex, which is expected to be between $8 million to $10 million.

 

"The Cerus team delivered against our plans for Q1, paving the way for the balance of 2024, with great progress on clinical milestones and a strong return to growth for our commercial business. The positive topline readout from ReCePI, the U.S. Phase 3 clinical trial for INTERCEPT Red Blood Cells, is a significant milestone for the program and for our efforts to potentially bring this product to the market globally," stated William "Obi" Greenman, Cerus’ President and Chief executive Officer. "Red blood cells are the most commonly transfused blood components worldwide, and we are committed to providing the full INTERCEPT portfolio for all transfused blood components to our customers around the globe."

 

The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System of Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding associated with fibrinogen deficiency, including massive hemorrhage.

 

In mid- May, Spectral Medical Inc. (TSX: EDT), a Phase 3 company seeking US FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”), announced its financial results for the first quarter ended March 31, 2024, and provided a corporate update. 

 

PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

 

Spectral has continued its significant progress throughout the first quarter of 2024 both clinically and operationally and year-to-date enrolled 25 patients for a total of 106 patients out of the 150 total patient’s target. The Company is focused on the final push to fully enroll and finish the Tigris trial and believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment and allow Spectral to rapidly reach the 150-patients target, bringing the Company closer to FDA submission and potential FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Baxter. In Q1 2024, Baxter exercised its right to maintain its exclusive distribution for PMX products in the U.S. and Canada and paid Spectral a non-dilutive milestone payment. Additionally, Spectral and Baxter mutually agreed to amend the initial term of their commercial partnership to ten years post-FDA approval of PMX. The Company believes this amendment provides a mutually beneficial runway for the parties to maximize PMX commercial economics, while providing motivation for continued support and allocation of resources to the PMX partnership.

 

Blood Purification technology made headlines during the pandemic when several companies including Baxter International Inc. (NYSE:BAX) received emergency use authorization (EUA) from the US FDA. Baxter’s approval was for the company's Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT). 

 

Separate from its current focus on cancer treatment, Aethlon (Nasdaq: AEMD) investigates the potential for the use of the Hemopurifier® in viral diseases under an open Investigational Device Exemption (IDE) and their FDA Breakthrough Designation for “…the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy.” 

 

Based on our studies to date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV, Sars-CoV-2, and Ebola.”

 

For the companies in this sector, the drive for innovation is ‘in their blood‘, and with the global threats of viruses and future pandemics on the rise, it’s a sector worth watching.

 

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