Medical Technology
Stocks and First Patient Enrollment Milestones
November
12, 2024 - Investorideas.com,
a go-to investing platform, releases an industry snapshot looking at the future of medical technology as first patients are
enrolled in potential breakthrough trials, featuring Aethlon Medical, Inc. (Nasdaq:AEMD), a medical
therapeutic company focused on developing products to treat cancer and life-threatening
infectious diseases.
According
to Statista.com,
“The Medical Technology market, which encompasses various markets, including
Medical Devices, is anticipated to witness significant revenue growth in the
coming years.”
“By
2024, the market is projected to reach a staggering US$597.00bn worldwide.
Among these markets, Medical Devices are expected to dominate, with a projected
market volume of US$508.00bn by 2024. Furthermore, the Medical Technology
market is expected to demonstrate a steady annual growth rate of 5.29% from
2024 to 2029.”
As
medical technology companies announce first patient enrollment, they take a
significant step forward to the goal of bringing their technology to market.
Stocks
mentioned in this article include Royal
Philips (NYSE: PHG), Microbot Medical Inc. (Nasdaq: MBOT), BD (Becton, Dickinson and Company) (NYSE: BDX).
Yesterday,
Aethlon Medical, Inc. (Nasdaq:AEMD) announced a key
milestone with enrollment of the first patient in its Australian safety,
feasibility and dose-finding clinical trial of the Hemopurifier® in patients
with solid tumors who have stable or progressive disease during anti-PD-1
monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab)
(AEMD-2022-06 Hemopurifier Study). The patient was enrolled on October 29,
2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit,
CALHN, Royal Adelaide Hospital in Australia.
Paid
news dissemination for Aethlon Medical
Read this article,
featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/11121AEMD-First-Patient-Enrollment-Milestones.asp
The
Hemopurifier is an immunotherapeutic device which is designed to combat cancer
and life-threatening viral infections and for use in organ transplantation. In
human studies, the Hemopurifier has demonstrated the removal of
life-threatening viruses and in pre-clinical studies, the Hemopurifier has
demonstrated the removal of harmful exosomes from biological fluids, utilizing
its proprietary lectin-based technology.
From the news: The
first patient completed screening activities confirming their eligibility on
November 8, 2024, and has now entered a two-month run-in period, receiving
anti-PD-1 therapy. During this time, concentrations of Extracellular vesicles
(EVs) and anti-tumor T cell activity will be measured. If imaging after this
two-month run-in period reveals no improvement in the patient’s tumor, they
will be treated with the Hemopurifier, followed by monitoring to identify
decreases in EV concentrations and improvements in T cell anti-tumor activity.
"Enrollment
of the first patient represents the achievement of a critical milestone for
Aethlon Medical in the clinical development of the Hemopurifier in Oncology,”
stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “We are
thrilled with the pre-screening activity being done to identify patients at
Royal Adelaide, as well as the second site, Pindara Private Hospital in the
Gold Coast. We are grateful to the patient for consenting to be part of this
study. This trial is our initial step in determining if the Hemopurifier
treatment can improve upon the 30-40% response rates to anti-PD-1 therapies
such as Opdivo and Keytruda.”
From the news: Currently,
only approximately 30% of patients who receive pembrolizumab or nivolumab will
have lasting clinical responses to these agents. EVs produced by tumors have
been implicated in the spread of cancers as well as the resistance to anti-PD-1
therapies. The Aethlon Hemopurifier has been designed to bind and remove these
EVs from the bloodstream, which may improve therapeutic response rates to
anti-PD-1 antibodies. In preclinical
studies, the Hemopurifier has been shown to reduce the number of exosomes from
the plasma of cancer patient samples.
The
primary endpoint of the approximately nine to 18-patient, safety, feasibility
and dose-finding trial is the incidence of adverse events and clinically significant
changes in safety lab tests of Hemopurifier treated patients with solid tumors
with stable or progressive disease at different treatment intervals, after a
two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy.
Patients who do not respond to the therapy will be eligible to enter the
Hemopurifier period of the study where sequential cohorts will receive 1, 2 or
3 Hemopurifier treatments during a one-week period. In addition to monitoring
safety, the study is designed to examine the number of Hemopurifier treatments
needed to decrease the concentration of EVs and if these changes in EV
concentrations improve the body’s own natural ability to attack tumor cells.
These exploratory central laboratory analyses are expected to inform the design
of a subsequent efficacy and safety, Premarket Approval (PMA), study required
by regulatory agencies.
On November 4th, Royal Philips (NYSE: PHG) (AEX: PHIA), a global leader in health
technology, announced
enrollment of the first patient in
the US THOR IDE clinical trial, which will study an innovative combined laser
atherectomy and intravascular lithotripsy catheter developed by Philips, that
integrates two critical PAD treatments into a single device. Procedures that
previously required the use of two different devices can now be performed in a
single procedure using a single device, simplifying workflows and procedures
and potentially reducing the risk and improving outcomes for patients who might
otherwise face multiple complex interventions.
From the news: The
Cardiovascular Institute of the South in Louisiana recently completed the first
case using the new laser catheter. The care team there successfully treated a
78-year-old male with peripheral vascular disease using the Philips device.
“Developing and driving clinical evidence is crucial
to improving care and guiding the adoption of new technologies like the Philips
laser atherectomy and lithotripsy system,” said Drs. Craig Walker, Pradeep
Nair, and McCall Walker of Cardiovascular Institute of the South in Louisiana.
“This trial will provide essential data to demonstrate how this combined
approach can optimize procedural efficiency and patient outcomes in treating
challenging calcified lesions.”
From the news: This
ground-breaking first procedure not only marks the launch of the THOR IDE
trial. It also showcases how this innovative new technology, which resulted
from Philips’ powerful in-house development capabilities, can ease the patient
experience by streamlining complex interventions into a single procedure,
potentially reducing the need for multiple interventions and hospital visits.
From the news: The goal of this
pivotal study is to evaluate the safety and efficacy of using this unique laser
device — a first-of-its-kind solution that integrates laser atherectomy and
intravascular lithotripsy in a single device to treat complex, calcified
lesions in a single procedure for patients with peripheral artery disease
(PAD), restoring blood flow to their legs.
On October 15th, Microbot Medical Inc. (Nasdaq: MBOT), a developer of the innovative LIBERTY®
Endovascular Robotic Surgical System, announced that it has successfully completed enrollment
and follow up for all patients in its ACCESS-PVI human clinical trial. The
Company remains on track to file its 510(k) submission with the U.S. Food and
Drug Administration (FDA) by of the end of 2024.
The Company also announced that it is accelerating
its go-to-market strategy. It expects to begin building out the commercial
infrastructure, including the hiring of a seasoned healthcare executive to lead
its sales efforts, upon the FDA clearance, which is expected during 2Q 2025.
This news follows up on developments since its first
patient announcement
in July when Microbot announced the
completion of the first procedure in a patient utilizing its LIBERTY®
Endovascular Robotic Surgical System. The procedure took place at Brigham and
Women’s Hospital (BWH), a leading academic medical center located in Boston,
Massachusetts, as part of the Company’s pivotal human clinical trial.
From the news: The clinical
trial at BWH was led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division
of Angiography & Interventional Radiology, who also performed this first
human case. The trial is part of the Investigational Device Exemption (“IDE”)
for LIBERTY®, and the Company expects its results will support the future
submission to the FDA and subsequent commercialization.
“Enrolling the first patient in our pivotal human
clinical trial is a significant milestone for the Company, and an important
step on our journey to bring LIBERTY® to U.S. physicians,” commented Juan
Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical. “We are very
pleased with the rapid pace of site activation, and I’m looking forward to
enrolling additional patients in the near future.”
Earlier this year BD (Becton, Dickinson and Company)
(NYSE: BDX), a leading global medical technology
company, announced
the enrollment of the first patient
in the investigational device exemption (IDE) study, "AGILITY," which
will assess the safety and effectiveness of the BD Vascular Covered Stent for
the treatment of Peripheral Arterial Disease (PAD).
The investigational Vascular Covered Stent is a
self-expanding, low profile, polytetrafluoroethylene encapsulated nitinol
implant. It is deployed from a delivery system that provides controlled stent
release.
"When we're addressing advanced PAD, a
self-expanding covered stent can play an important role," said Dr. Sean
Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and
National Principal Investigator of the AGILITY study. "We need a stent
that can track to the lesion, apposes the vessel wall and ultimately provides
long-term durability. We're excited to see how this technology performs."
From the news: According to BD,
the global, prospective, multi-center, single-arm, non-randomized AGILITY
clinical study will include 315 patients at up to 40 clinical study sites
across the United States, Europe, Australia and New Zealand. Follow-up for all
treated patients will be performed at various points after treatment — starting
at one month and ending at 36 months.
Medical technology and devices offer a different
approach to health than pharmaceuticals, and as is the case with Aethlon Medical, Inc. (Nasdaq:AEMD, and its Hemopurifier in Oncology, it offers a potential solution when other treatment has
failed.
Research biotech and medical device/ tech
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