IMAC Holdings, Inc. Announces Initiation of Third and Final Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease

Rhea-AI Summary

IMAC Holdings, Inc. (Nasdaq: IMAC) has announced the initiation of the third cohort in its Phase 1 clinical trial of an investigational compound using umbilical cord-derived allogenic mesenchymal stem cells, aimed at treating bradykinesia due to Parkinson's disease. This trial, taking place at multiple IMAC Regeneration Centers, involves a total of 15 patients across three dosing groups. The global Parkinson’s disease therapeutics market is projected to grow from $2.61 billion in 2018 to $5.28 billion by 2025, highlighting the potential market opportunity for IMAC's treatment.

Positive

• Initiation of the third cohort in the Phase 1 clinical trial, advancing towards potential treatment options.
• The global Parkinson’s disease therapeutics market is expected to grow, indicating a favorable market environment.

Negative

• Risks associated with retaining necessary personnel and protecting intellectual property, which could impact trial outcomes.

BRENTWOOD, Tenn, March 24, 2022 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: IMAC) (“IMAC” or “the Company”), today announces it has initiated the third and final cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s disease.

About IMAC’s Phase 1 Clinical Trial

The Phase 1 clinical trial, consisting of a 15-patient dose escalation safety and tolerability study, is being conducted at IMAC Regeneration Centers in Chesterfield, Missouri, Paducah, Kentucky, and Brentwood, Tennessee. The trial is divided into three groups: 1) five patients with bradykinesia due to Parkinson’s disease received a low dose, intravenous infusion of stem cells which was completed February 26, 2021, 2) five patients received a medium dose intravenous infusion which was completed February 16, 2022, 3) and five patients will receive a high concentration dose intravenous infusion. 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.

About Bradykinesia Due to Parkinson’s Disease

In addition to unusually slow movements and reflexes, bradykinesia may 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 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 over 15 outpatient medical clinics that provide regenerative, orthopedic and minimally invasive procedures and therapies. It has partnered with several active and former professional athletes including Ozzie Smith, David Price, Mike Ditka and Tony Delk to emphasize its focus treating sports and orthopedic injuries and movement-restricting diseases without surgery or opioids. IMAC also operates the BackSpace retail spine health and wellness treatment centers. More information about IMAC Holdings, Inc. is available at www.imacholdings.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 retain personnel who possess the skills and experience necessary to meet trial 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

FAQ

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

The trial focuses on using umbilical cord-derived allogenic mesenchymal stem cells to treat bradykinesia due to Parkinson's disease.

What are the key stages of IMAC's Phase 1 clinical trial?

The trial consists of three cohorts with 15 patients total, each receiving varying doses of stem cells.

What is the significance of the global Parkinson's disease therapeutics market?

The market is projected to grow from $2.61 billion in 2018 to $5.28 billion by 2025, indicating potential opportunities for IMAC's treatment.

Who is overseeing the clinical trial at IMAC?

The clinical trial is led by Ricardo Knight, M.D., M.B.A., the medical director at the Mike Ditka IMAC Regeneration Center.