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IMAC Holdings Completes First Infusion of Stem Cells in Clinical Study for the Treatment of Bradykinesia Due to Parkinson’s Disease

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IMAC Holdings, Inc. (Nasdaq: IMAC) announced the completion of the first infusion of its investigational compound using umbilical cord-derived allogenic mesenchymal stem cells in a Phase 1 clinical trial targeting bradykinesia due to Parkinson’s disease. This milestone occurred on December 29, 2020, and marks a significant step in IMAC's development as a regenerative rehabilitation company. The trial will include 15 patients in a dose escalation study, with full enrollment expected by February 2021 and tracking of participants for 12 months.

Positive
  • First infusion of investigational compound completed, indicating progress in clinical trial.
  • Anticipated full patient enrollment by end of February 2021, demonstrating strong interest.
  • Trial will provide data on safety and tolerability over 12 months, potentially leading to future treatments.
Negative
  • None.

BRENTWOOD, Tenn., Dec. 30, 2020 (GLOBE NEWSWIRE) -- 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, announces it completed the first infusion of its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells in its Phase 1 clinical trial for the treatment of bradykinesia, or the gradual slowing and loss of spontaneous body movement, due to Parkinson’s disease.

“The first infusion of our proprietary compound is a significant milestone in its development, as well as in the development of IMAC, expanding our capabilities as a regenerative rehabilitation company,” said Jeffrey Ervin, Chief Executive Officer of IMAC. “We have already received significant interest from patients across our regenerative medicine centers to participate in the trial, and we are actively screening these inquiries to identify those who fit the inclusion criteria of the trial. We anticipate full patient enrollment by the end of February 2021, with subsequent infusions continuing in early 2021.”

The first infusion was delivered on December 29, 2020, by trial lead investigator Ricardo Knight, M.D., M.B.A. at the Company’s Brentwood, Tennessee facility. 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 patients will receive a medium intravenous dose, and (3) five patients will receive a high intravenous dose. 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.

About IMAC Holdings, Inc.

IMAC 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


FAQ

What is the purpose of IMAC's Phase 1 clinical trial?

The trial aims to evaluate the safety and tolerability of umbilical cord-derived stem cells for treating bradykinesia in Parkinson's disease.

When was the first infusion in IMAC's clinical trial completed?

The first infusion was completed on December 29, 2020.

How many patients will be involved in IMAC's clinical trial?

The trial will involve 15 patients divided into three dosage groups.

What is the projected timeline for patient enrollment in the trial?

IMAC anticipates full patient enrollment by the end of February 2021.

What key locations are conducting IMAC's clinical trial?

The trial is being conducted at clinical centers in Chesterfield, Missouri; Paducah, Kentucky; and Brentwood, Tennessee.

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