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

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IMAC Holdings, Inc. (NASDAQ: BACK) announced the completion of the third cohort in its Phase 1 clinical trial of an investigational compound using umbilical cord-derived allogenic mesenchymal stem cells targeting bradykinesia due to Parkinson’s disease. This cohort included five patients receiving a high concentration stem cell treatment. The trial, conducted in three clinical centers, involved 15 patients across different dosage groups. The safety and tolerability study is set to track participants for 12 months, with potential implications for the growing Parkinson’s therapeutics market, projected to reach $5.28 billion by 2025.

Positive
  • Completion of third cohort in Phase 1 clinical trial indicates progress in drug development.
  • Targeted innovative treatment for bradykinesia due to Parkinson’s disease may meet an unmet medical need.
  • Potential market growth with Parkinson’s disease therapeutics expected to reach $5.28 billion by 2025.
Negative
  • None.

BRENTWOOD, Tenn., Sept. 09, 2022 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: BACK) (“IMAC” or “the Company”), today announces it has completed the third 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.

The third cohort consists of five patients with bradykinesia due to Parkinson’s disease receiving an intravenous infusion of a high concentration stem cell treatment. The third and final cohort of the Phase 1 clinical trial was completed on Tuesday, September 6, 2022.

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 three of IMAC’s clinical 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 concentration dose, intravenous infusion of stem cells, 2) five received a medium concentration intravenous dose, 3) and five received a high concentration intravenous dose. All groups will be subsequently 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 IMAC Regeneration Center of Chicago, is the trial’s principal investigator.

The Institute of Regenerative and Cellular Medicine serves as the trial’s independent investigational review board, while Regenerative Outcomes provides management of the study. Further details of the trial can be found at clinicaltrials.gov.

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 Holdings owns and manages health and wellness centers that deliver sports medicine, orthopedic care, and restorative joint and tissue therapies for movement restricting pain and neurodegenerative diseases. IMAC is comprised of three business segments: outpatient medical centers, The Back Space, and a clinical research division. With treatments to address both young and aging populations, IMAC Holdings owns or manages outpatient medical clinics that deliver regenerative rehabilitation services as a minimally invasive approach to acute and chronic musculoskeletal and neurological health problems. IMAC’s The Back Company retail spinal health and wellness treatment centers deliver chiropractic care within Walmart locations. IMAC’s research division is currently conducting a Phase I clinical trial evaluating a mesenchymal stem cell therapy candidate for bradykinesia due to Parkinson’s disease. For more information visit www.imacholdings.com.

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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


FAQ

What was announced in IMAC's press release dated September 6, 2022?

IMAC announced the completion of the third cohort of its Phase 1 clinical trial for a stem cell therapy targeting bradykinesia due to Parkinson’s disease.

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

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

What are the next steps following the completion of the trial cohort?

All 15 trial participants will be tracked for 12 months to assess the therapy's effects and safety over time.

What are the implications of the trial results for the stock BACK?

Successful trial results could enhance investor confidence and potentially increase the stock value by demonstrating progress in addressing a significant medical need.

IMAC Holdings, Inc.

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