CytoSorbents Corporation (“CTSO” or the “Company”), which has seen its share price more than triple
since we initiated coverage in January 2014, is based in Monmouth Junction, NJ, and is a publicly
traded, critical care immunotherapy focused company using blood purification to treat life-threatening
illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can
actively remove toxic substances from blood and other bodily fluids by pore capture and surface
adsorption. Each polymer bead contains millions of pores and channels that can be modified to remove
substances as small as drugs, to substances as large as antibodies. The Company is on the “ground floor”
of commercialization and positioned to potentially create significant value with their product, CytoSorb®,
which has the potential to revolutionize critical care medicine; save lives, and reduce healthcare costs.
CytoSorb is as an extracorporeal cytokine adsorber, and can be used with standard hemodialysis
machines in any situation where cytokines are elevated. This includes a diverse range of conditions
where cytokines are driving a potentially dangerous inflammatory response, including acute critical
illnesses such as sepsis and infection, burn injury, trauma, acute respiratory distress syndrome, severe
acute pancreatitis, liver failure, influenza, and complications of cardiac surgery, as well as in other more
chronic diseases such as cancer, cancer cachexia, autoimmune diseases, and others.
CytoSorbents began trading on the Nasdaq on Dec. 23, 2014. This up-listing to NASDAQ is a significant
corporate milestone for CytoSorbents, and is the latest in a series of important accomplishments for the
Pluristem a leading developer of placenta-based cell therapy products, announced today that it has been granted a patent in both Australia and New Zealand for the use of a specified population of placental cells for treating several medical indications. The patent, titled “Adherent cells from placenta and use of same in disease treatment” has been issued in Australia, Patent No. 2010322808, and in New Zealand, Patent No. 600651.
The patents’ claims include the use of the population of placental cells in the treatment of muscle trauma, muscle defect, neuropathic pain, peripheral nerve injury, and neurodegenerative diseases.
“These patents, which cover multiple indications and bring the Company’s total to 32 granted patents, are timely, as we’ve demonstrated Pluristem’s ability to use its technology platform to develop distinct cell therapy product lines for the potential treatment of different conditions. We continue to evaluate additional indications for PLX-PAD and PLX-RAD, our first two cell therapy products,” stated Pluristem CEO Zami Aberman.
Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease and cancer, announced today that officials at Frankfurt University Hospital have reported undetectable virus in an ebola patient previously disclosed to have received Hemopurifier® therapy. In an article entitled: "Ugandan Doctor Cured of Ebola in Germany," The Wall Street Journal has reported that hospital officials indicated the patient is no longer infected with ebola virus and is heading toward a full recovery.
The Aethlon Hemopurifier® is a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans. According to the World Health Organization (WHO), more than 5,000 deaths have been attributed to the current ebola virus epidemic. The patient at Frankfurt University Hospital was administered Hemopurifier® therapy through special approval from The Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte, BfArM), an independent federal higher authority within the portfolio of the Federal Ministry of Health of Germany.
"It is truly wonderful that the patient, who was reported to be suffering from multiple organ failure, is now recovering from ebola infection," stated Aethlon founder and CEO, Jim Joyce. "In the coming days, we will disclose the venue of a public presentation that will report treatment data including the quantification of viral load reduction and viruses captured by our Hemopurifier during the treatment of this patient."
CNQR - currently around $107 a share, 34,400 percent from their lows
TRLG - traded as low as .67 a share bought out at $32 a share
BJRI - closed at $1 in 1997, today around $30
QSII - up 17000 percent from their .11 cent lows
MNST - $1 in 1995, today $110
I'd go on, but I have things to do....
Mr Ravindra Limaye, President, Marketing, Biocon, said: "CytoSorb®has been embraced by physicians as a safe and well-tolerated therapy for managing sepsis in critically-ill patients.Our expanded partnership with CytoSorbents will now enable us to address the huge unmet needs of patients experiencing a Systemic Inflammatory Response Syndrome (SIRS) as a result of burns, lung injury, liver failure, pancreatitis, post-cardiac surgery complications, and tropical diseases like malaria and dengue fever."
Dr Abhijit Barve, President, Research & Development, Biocon, said: "While our initial focus has been on sepsis, physicians are increasingly identifying conditions where very high levels of cytokines are known to cause multiple organ failure. We also believe there is a significant unmet medical need to manage high risk patients undergoing cardiac surgery by using CytoSorb® to control inflammation. We are excited about working together with CytoSorbents and look forward to playing an important role in advancing the clinical development of this product."
Dr. Phillip Chan, Chief Executive Officer and President, CytoSorbents, stated: "We are very pleased to expand our relationship with Biocon, which has been an exceptional partner in launching CytoSorb® in India. We take deep pride in the opportunity to potentially help more people in this part of the world by addressing a broader array of conditions. Moreover, Biocon is a world-class clinical development organization with strong capabilities in advancing new therapies. We look forward to working closely with Biocon as they generate clinical evidence to support the widespread use of CytoSorb®."
Sentiment: Strong Buy
Cytosorbents Corp (OTCBB:CTSO)declared consolidation of its SEC and international legal counsel with the global law firm, DLA Piper LLP. DLA Piper is one of the largest international business law firms with offices in major markets around the world and legal expertise across a broad range of areas including corporate and finance, litigation and arbitration, Sarbanes Oxley compliance, government affairs, labor law, intellectual property and technology, and tax.
Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease and cancer, disclosed today that it will provide Hemopurifier® therapy under FDA compassionate use access provisions to support potential requests by qualified physicians and institutes that may seek to treat ebola virus infection in the United States.
The Aethlon Hemopurifier® is a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans. According to the World Health Organization (WHO), nearly 5,000 deaths have been attributed to the current ebola virus epidemic.
Based on guidance from FDA, the treatment of ebola virus infection provides for a unique circumstance where a physician or health care provider may wish to pursue the compassionate use of Hemopurifier® therapy based on the serious nature of the disease and absence of alternative therapies. Compassionate use provisions are typically approved by FDA on an individual patient basis, but may be expanded to include a small group.
Aethlon also disclosed that it plans to submit its first ebola treatment data to the FDA as a means to support the goal of further expanding treatment access through emergency use regulatory pathways.
New York, NY / ACCESSWIRE / November 18, 2014 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced that it has issued a company note on Aethlon Medical, Inc. (AEMD), a medical device company focused on creating innovative devices that address unmet medical needs in cancer, infectious disease and other life-threatening conditions. In the note, SeeThruEquity is raising its price target price to $0.74 from $0.52.
"Aethlon Medical's announcement that its Hemopurifier device was used to treat an Ebola patient in Germany is encouraging. We believe the Hemopurifier will be shown to be an advanced, broad-spectrum countermeasure against pandemic threats like Ebola. It is significant that the Chief of Nephrology at Frankfurt University Hospital reported that 242 million Ebola viruses were captured within the Hemopurifier(R) during the treatment, resulting in a 400-fold reduction in viral load. In light of these developments, we are increasing our price target to $0.74 per share," stated Ajay Tandon, Chief Executive Officer of SeeThruEquity.
The note is available here: AEMD Company Note. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack's. The report will also be available on these platforms.
Highlights from the note are as follows:
The Aethlon Hemopurifier® was used in the successful treatment of a critically-ill Ebola-infected patient in Frankfurt, Germany, according to data presented today at the American Society of Nephrology (ASN) Annual Meeting by Helmut Geiger, M.D., Chief of Nephrology at Goethe University, Frankfurt University Hospital. Geiger reported that 242 million Ebola viruses were captured within the Aethlon Hemopurifier® during treatment, a number verified by a post-treatment elution protocol. The patient is no longer infected with Ebola virus and is expected to make a full recovery.
Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to treat infectious disease, created the Hemopurifier®, a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals.
The Frankfurt University Hospital patient, a Ugandan physician, who was infected with Ebola in Sierra Leone where he was treating Ebola patients, was not administered Hemopurifier® therapy until 12 days after being diagnosed.
At the time of Hemopurifier® administration, Dr. Geiger reported that the Ebola patient was unconscious and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications.
The patient's viral load prior to the administration of a single 6.5-hour Hemopurifier® treatment was measured 400,000 virus copies per milliliter of blood (copies/ml). Post-treatment viral load was measured at 1,000 copies/ml and never again rose above that level. The treatment was well tolerated with no adverse events reported.
Aethlon Medical, Inc. (AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today announced that James A. Joyce, Chief Executive Officer, will present at the Biotech Showcase 2015 Conference on Wednesday, January 14, 2015. Details of Aethlon Medical's presentation are as follows:
Biotech Showcase 2015
Wednesday, January 14, 2015
4:00 p.m. Pacific Time / 7:00 p.m. Eastern Time
Parc 55 Wyndham Union Square, San Francisco, CA
A live audio webcast of the presentation will be available on the Company's website in the Investor Relations section on the Events and Presentations . The webcast replay will be available approximately two hours after the presentation ends and will be accessible for one month.
About Biotech Showcase 2015
The Biotech Showcase 2015 conference takes place January 12-14, 2015, at the Parc 55 Wyndham Hotel located in Union Square, San Francisco, California. Biotech Showcase is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies an opportunity to present to, and meet with, investors and pharmaceutical executives during the course of one of the industry's largest annual healthcare investor conferences. Now in its seventh year, Biotech Showcase is expected to attract upwards of 1,500 attendees.
The Company continues to advance their business through the ongoing commercial ramp of CytoSorb®
in 28 countries worldwide and a planned pivotal cardiac surgery trial in the U.S. On Dec 30th, the
Company announced, it has submitted an Investigational Device Exemption (IDE) application to the U.S.
Food and Drug Administration (FDA) to conduct its proposed clinical trial using CytoSorb® intraoperatively
in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine.
The goal of CytoSorb® treatment is to reduce inflammatory mediators and proteins such as cytokines
and plasma free hemoglobin generated during surgery that can lead to serious post-operative
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "The submission of this IDE
application represents a major milestone for the Company, initiating the clinical trial process needed to
seek approval of CytoSorb® in the United States. With approximately half a million cardiac surgery
procedures such as valve replacement and coronary artery bypass graft surgeries each year in the U.S.
alone, and another one million in the rest of the world annually, we believe this represents a significant
potential commercial opportunity for the Company."Vista Partners LLC - January 2015
CytoSorb®, and the other products in the Company’s pipeline, may have significant upside considering
the massive markets they seek to address. CTSO has received validation of their technologies potential
from many large organizations in the form of research grants and other agreements including: BioCon,
DARPA, U.S. Army, U.S. Air Force, NIH/NHLBI, scientific advisors & analysts. The Company enjoys a
unique, high margin product and pipeline with little to no current competition and is currently selling
their flagship product CytoSorb® in Europe and the Middle East.
Aethlon will soon begin the first U.S. clinical Hemopurifier® studies following the United States Food and Drug Administration's (FDA)'s approval of an Investigational Device Exemption (IDE). The study will contribute safety data to advance the device as a broad-spectrum countermeasure against bioterror and pandemic threats, including Ebola and chronic viral pathogens such as HIV and Hepatitis C (HCV).
CytoSorbents Corporation a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation in critically-ill and cardiac surgery patients, announced the receipt of $385,642, net of transaction costs, in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority (NJEDA). Funds will be used to help expand manufacturing of CytoSorb® and support sales of CytoSorb® internationally.
The New Jersey Technology Business Tax Certificate Transfer Program enables approved Technology and Biotechnology Businesses with Net Operating Losses to sell their Unused Net Operating Loss Carryover (NOL) and Unused Research and Development Tax Credits (R&D Tax Credits) for at least 80% of the value of the tax benefits to a profitable corporate taxpayer in the State of New Jersey that is not an Affiliated Business. This allows Technology and Biotechnology Businesses with Net Operating Losses to turn their tax losses and credits into cash to buy equipment or facilities, or for other Allowable Expenditures. The New Jersey Economic Development Authority (NJEDA) determines eligibility, and the New Jersey Division of Taxation determines the value of the tax benefits (NOL and R&D Tax Credits).
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "As a high growth, international therapeutics company with distribution of CytoSorb® in 28 countries around the world, and continued expansion of our manufacturing, R&D and administrative facility in New Jersey, we thank the continued support of the NJEDA. Over the past 6 years, we have obtained nearly $7.5 million in non-dilutive government grants, contracts and other funding, an important part of our overall financing strategy."
Sentiment: Strong Buy
Must be expecting something big:
On November 13, 2014, Aethlon Medical, Inc. (the "Company") entered into an Office Lease (the "Lease") with T-C Stonecrest LLC. Pursuant to the Lease, the Company agreed to rent approximately 2,600 square feet of executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego, California 92123 at an initial base rental rate of $6,054 per month. The Lease has a term of 39 months and an estimated commencement date of December 1, 2014, and provides for the rate to increase to a maximum rate of $6,620 per month over the term of the Lease. Notwithstanding the foregoing, the Lease also provides that, so long as the Company is not in default under the Lease, the base rate for months 2, 3 6 and 7 will be partially abated to a rate of $3,027 per month and the base rate for months 13 and 14 will be partially abated to a rate of $3,117 per month.
Both good companies doing slightly different things, but if you think AEMD is a one trick ebola pony, you are sadly mistaken. It can be used to remove any virus from the blood. They're currently working on Hep C and HIV in addition to cancer exosome removal. AEMD's success can only help CTSO as it brings blood filtration devices to the peoples attention.
CytoSorbents Corporation (CTSO), a critical care immunotherapy company commercializing its European Union approved CytoSorb® cytokine adsorber to treat critically-ill patients in multiple countries worldwide, was awarded the Beacon of Light Award at last night's New Jersey Tech Council Annual Awards Celebration.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "It is an honor to be recognized by the New Jersey Tech Council and the judging committee as the winner of the Beacon of Light award. At the company, we are all driven by the desire to help give critically-ill patients a fighting chance to survive life-threatening illnesses such as sepsis, trauma, lung injury, burn injury, and pancreatitis. To shine a guiding light and offer hope to physicians, patients and their families, where today there is still so much darkness."
Dr. Chan continued, "We are grateful that CytoSorb® is being used by a growing number of physicians in many hospitals around the world to help stabilize patients in the intensive care unit and during high risk cardiac surgery. The goal is to prevent or treat multiple-organ failure, the leading cause of death in the ICU for which there is little to no effective treatment. This award is dedicated to the tireless efforts of the CytoSorbents team - from its internal leadership to its manufacturing, research and development, quality control, and sales and marketing departments - as well as to the Company's shareholders, distributors, and strategic partners whose support we truly appreciate."
Sentiment: Strong Buy
Some people wanted to lock in a profit, and some scared they'd lose theirs. Long term believers scooping up, new believers scooping up, probably a bunch of doctors fresh out of the conference scooping up....
With a consistent streak of setting new records in product sales, accelerating adoption of CytoSorb (CTSO), case studies supporting efficacy of the device in several applications and certain near-term catalysts to further expand the already burgeoning commercial footprint, we view this as an opportunistic entry point for investors. We believe CTSO remains highly undervalued and are reiterating our Outperform rating and $0.50/share price target. See below for free access to our updated report and financial model on CTSO.
CytoSorbents (CTSO) reported results for the third quarter ending September 30, 2014. The streak of setting a new record in product revenue was extended to seven straight quarters with Q3 product revenue coming in at $1.0 million, an increase of 276% and 56% from Q3 2013 (i.e. - yoy) and Q2 2014 (i.e. - sequentially), respectively. Also consistent are the catalysts of the product revenue growth - those being increasing re-order volumes and expansion of the customer base. Sales through Biocon, the company's distributor in India, also were indicated as a particular catalyst in driving product sales in Q3 and which continue to build steam.
We reiterate, that while there remains the potential for short-term variability in product sales, that we continue to believe that a certain base of business has been established whereby follow-on orders should provide a solid floor. This, coupled with broadening the geographic footprint and customer base - both of which the company has had early successes in doing from internal sales efforts and distribution relationships - should provide for near-to-long term product sales growth and improving operating leverage.
Aethlon Medical Inc said the U.S. Food and Drug Administration approved testing of the company's experimental device in Ebola patients.
Patients will be administered for six to eight hours daily with the company's device, Hemopurifier, until the Ebola viral load drops below 1000 copies/ml, Aethlon said on Friday.
Aethlon's Hemopurifier selectively filters viruses and toxins from blood.
The approved protocol allows for a study to be conducted in up to 20 subjects in the United States, the company said.