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
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"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
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