IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem ...
August 05 2020 - 11:58AM
IMAC Holdings, Inc. (Nasdaq: IMAC) (the “Company” or “IMAC”), a
provider of innovative medical advancements and care specializing
in regenerative rehabilitation orthopedic treatments without the
use of surgery or opioids, today announced the United States Food
and Drug Administration (the “FDA”) approved its investigational
new drug application, which IMAC submitted in May 2020, for the use
of umbilical cord-derived allogenic mesenchymal stem cells for the
treatment of bradykinesia, or the gradual loss and slowing down of
spontaneous body movement, due to Parkinson’s disease.
The Company will now initiate enrollment of 15
patients for its Phase 1 trial to evaluate the safety and
tolerability of the stem cell product acquired from technology
developed by a major research university to treat patients with
Bradykinesia due to Parkinson’s utilizing intravenous
administration of Wharton’s jelly-derived mesenchymal stem cells.
The Company believes that the causes of bradykinesia may be related
to an inflammatory response in the body. The Company’s new study is
designed to confirm this belief and support the Company’s long-term
strategy for the use of regenerative medicine in combination with
physical rehabilitation to reduce the effect of
movement-restricting diseases.
“Our regenerative rehabilitation centers have
long focused on the importance of finding and applying non-opioid,
non-surgical solutions to physical ailments in orthopedics. In
2017, our neurosurgeon researched opportunities to apply stem cells
to treating Parkinson’s, and we put a team together to design a
treatment for our neurological patients that simply could not
achieve maximum benefit from physical therapy alone,” commented
Jeffrey Ervin, IMAC’s Chief Executive Officer. “Having received
approval to proceed with our study, IMAC is extremely optimistic
regarding the potential of this stem cell technology. This has the
potential to not only expand proprietary service options for
neurological patients, but also advance the way physically
debilitating inflammatory conditions are managed as a whole. We
would like to thank the FDA for the collaborative process and the
partners who helped us achieve this milestone, including patient
advocate, Doug Oliver and his team at Regenerative Outcomes.”
The Phase 1 trial will consist of three
treatment protocols: five patients with bradykinesia due to
Parkinson’s will receive a low dose intravenous infusion of stem
cells, five patients will receive a medium dose intravenous
infusion of stem cells and five patients will receive a high dose
intravenous infusion of stem cells. The Phase 1 trial will be
conducted over 12 months to determine the incidence and extent of
adverse events, although the Company will also investigate the
efficacy of its stem cell treatment. More information on the
clinical trial, including patient criteria, can be found on
clinicaltrials.gov.
IMAC will enroll participants from its existing
clinics in Illinois, Tennessee, Kentucky and Missouri in its Phase
1 trial. Prospective enrollees may email
fdatrial@imacregeneration.com to be considered for the trial.
IMAC’s medical doctors and physical therapists have been trained to
administer the treatment and manage the therapy for the clinical
trial, which is anticipated to begin in 30 days.
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
16 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 Fristoelfristoe@imacrc.com
IMAC Investor Contact:Bret Shapiro(516)
222-2560brets@coreir.com
Source: IMAC Holdings, Inc.
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