IMAC Holdings, Inc. Announces Opening Enrollment in Its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cel...
November 05 2020 - 9:00AM
IMAC Holdings, Inc. (Nasdaq: IMAC) (“IMAC” or “the Company”), a
provider of innovative medical advancements and care specializing
in regenerative rehabilitation orthopedic treatments without the
use of surgery or opioids, today announces it is opening enrollment
in its Phase 1 clinical trial for its investigational compound
utilizing umbilical cord-derived allogenic mesenchymal stem cells
for the treatment of bradykinesia, or the gradual slowing and loss
of spontaneous body movement, due to Parkinson’s disease.
The Phase 1 clinical trial, consisting of a
15-patient dose escalation safety and tolerability study, will be
conducted at three of IMAC’s clinical centers in Chesterfield,
Missouri, Paducah, Kentucky, and Brentwood, Tennessee. The trial
will be divided into three groups: 1) five patients with
bradykinesia due to Parkinson’s disease will receive a low dose,
intravenous infusion of stem cells, 2) five will receive a medium
intravenous dose, 3) and five will receive a high intravenous dose,
and all groups will be tracked for 12 months. IMAC’s medical
doctors and physical therapists at the clinical sites have been
trained to administer the treatment and manage the therapy. Ricardo
Knight, M.D., M.B.A., who is medical director of the Mike Ditka
IMAC Regeneration Center, is the trial’s principal
investigator.
“This is a pivotal moment in the history of IMAC
as it expands its business beyond that of its regenerative
medicine, physical therapy and rehabilitation model and further
pursues non-opioid, non-surgical, medical solutions for
movement-restricting diseases. This process began with the idea to
apply stem cell treatment to Parkinson’s patients for whom physical
therapy alone was not sufficient to provide restoration of movement
and alleviation of pain. Moreover, utilizing our existing centers
and our knowledge of their communities helps streamline the costs
usually associated with conducting these types of studies,” said
Jeffrey Ervin, IMAC Chief Executive Officer. “The enrollment
process and the subsequent first dose is expected to be
administered by the end of 2020. We have already received
considerable interest from Parkinson’s patients who would like to
participate in the trial and expect to fill enrollment in a
relatively short time. We look forward to the opportunity to share
the outcome from the trial in the coming year.”
The Institute of Regenerative and Cellular
Medicine will serve as the trial’s independent investigational
review board while Regenerative Outcomes will provide management of
the study. Further details of the trial can be found here.
In addition to unusually slow movements and
reflexes, bradykinesia can also lead to limited ability to lift
arms and legs, reduced facial expressions, rigid muscle tone, a
shuffling walk, and difficulty with repetitive motion tasks,
self-care and daily activities. Parkinson’s disease is the typical
culprit of bradykinesia, and as it progresses through its stages, a
person’s ability to move and respond declines.
According to Zion Market Research, the global
Parkinson’s disease therapeutics market was $2.61 billion in 2018
and is expected to grow to $5.28 billion by 2025. The Parkinson’s
Disease Foundation estimates that nearly 10 million people are
suffering from Parkinson’s disease, and almost 60,000 new cases are
reported annually in the U.S.
About IMAC Holdings, Inc.
IMAC Holdings was created in March 2015 to
expand on the footprint of the original IMAC Regeneration Center,
which opened in Kentucky in August 2000. IMAC Regeneration Centers
combine life science advancements with traditional medical care for
movement restricting diseases and conditions. IMAC owns or manages
15 outpatient clinics that provide regenerative, orthopedic and
minimally invasive procedures and therapies. It has partnered with
several active and former professional athletes, opening six Ozzie
Smith IMAC Regeneration Centers, two David Price IMAC Regeneration
Centers, as well as Mike Ditka IMAC Regeneration Centers and a Tony
Delk IMAC Regeneration Center. IMAC’s outpatient medical clinics
emphasize its focus around treating sports and orthopedic injuries
and movement-restricting diseases without surgery or opioids. More
information about IMAC Holdings, Inc. is available at
www.imacregeneration.com.
# # #
Safe Harbor Statement
This press release contains forward-looking
statements. These forward-looking statements, and terms such as
“anticipate,” “expect,” “believe,” “may,” “will,” “should” or other
comparable terms, are based largely on IMAC's expectations and are
subject to a number of risks and uncertainties, certain of which
are beyond IMAC's control. Actual results could differ materially
from these forward-looking statements as a result of, among other
factors, risks and uncertainties associated with its ability to
raise additional funding, its ability to maintain and grow its
business, variability of operating results, its ability to maintain
and enhance its brand, its development and introduction of new
products and services, the successful integration of acquired
companies, technologies and assets, marketing and other business
development initiatives, competition in the industry, general
government regulation, economic conditions, dependence on key
personnel, the ability to attract, hire and retain personnel who
possess the skills and experience necessary to meet customers’
requirements, and its ability to protect its intellectual property.
IMAC encourages you to review other factors that may affect its
future results in its registration statement and in its other
filings with the Securities and Exchange Commission. In light of
these risks and uncertainties, there can be no assurance that the
forward-looking information contained in this press release will in
fact occur.
IMAC Press Contact:
Laura Fristoe
lfristoe@imacrc.com
Investor Relations:
Bret Shapiro
(516) 222-2560
brets@coreir.com
IMAC (NASDAQ:IMAC)
Historical Stock Chart
From Mar 2024 to Apr 2024
IMAC (NASDAQ:IMAC)
Historical Stock Chart
From Apr 2023 to Apr 2024