UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

DC 20549

Form

10-K

(Mark

One)

For

the fiscal year ended December 31, 2023

For

the transition period from to

Commission

file number: 001-38797

IMAC

Holdings, Inc.

(Exact

Name of Registrant as Specified in its Charter)

(Address of Principal Executive Offices) (Zip Code)

(844)266-4622

(Registrant’s

Telephone Number, Including Area Code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value $0.001 per share BACK The NASDAQ Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted posted pursuant

to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☒

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The

aggregate market value of the registrant’s voting common stock held by non-affiliates based on the closing stock price on June

30, 2023, was approximately $3.3 million. For purposes of this computation only, all executive officers and directors have been deemed

affiliates.

The

number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of April 16, 2024 was 1,148,321.

DOCUMENTS

INCORPORATED BY REFERENCE

None.

IMAC

HOLDINGS, INC.

FORM

10-K—ANNUAL REPORT

For

the Fiscal Year Ended December 31, 2023

Table

of Contents

Page

PART I 1

Item 1 Business 1

Item 1A Risk Factors 20

Item 1B Unresolved Staff Comments 41

Item 2 Properties 41

Item 3 Legal Proceedings 41

Item 4 Mine Safety Disclosures 41

Item 6 [Reserved] 42

Item 7A Quantitative and Qualitative Disclosures About Market Risk 53

Item 8 Financial Statements and Supplementary Data 54

Item 9A Controls and Procedures 79

Item 9B Other Information 79

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 79

PART III 80

Item 10 Directors, Executive Officers and Corporate Governance 80

Item 11 Executive Compensation 86

Item 14 Principal Accounting Fees and Services 93

Item 15 Exhibits, Financial Statement Schedules 95

Signatures 97

PART

Cautionary

Statement Regarding Forward-Looking Statements

Portions

of this Annual Report on Form 10-K (including information incorporated by reference) include “forward-looking statements”

based on our current beliefs, expectations, and projections regarding our business strategies, market potential, future financial performance,

industry, and other matters. This includes, in particular, “Item 7 — Management’s Discussion and Analysis of Financial

Condition and Results of Operations” of this Annual Report on Form 10-K, as well as other portions of this Annual Report on Form

10-K. The words “believe,” “expect,” “anticipate,” “project,” “could,” “would,”

and similar expressions, among others, generally identify “forward-looking statements,” which speak only as of the date the

statements were made. The matters discussed in these forward-looking statements are subject to risks, uncertainties, and other factors

that could cause our actual results to differ materially from those projected, anticipated, or implied in the forward-looking statements.

The most significant of these risks, uncertainties, and other factors are described in “Item 1A — Risk Factors” of

this Annual Report on Form 10-K. Except to the limited extent required by applicable law, we undertake no obligation to update or revise

any forward-looking statements, whether as a result of new information, future events, or otherwise.

Unless

the context requires otherwise, references herein to “we,” “us,” “our,” “our company,”

“our business” or “IMAC Holdings” are to IMAC Holdings, Inc., a Delaware corporation, and prior to the Corporate

Conversion discussed herein, IMAC Holdings, LLC, a Kentucky limited liability company, and in each case, their consolidated subsidiaries.

ITEM 1. BUSINESS

Overview

were a provider and manager of value-based, conservative medical care combining life science advancements with traditional medical care

for movement-restricting diseases and conditions in IMAC Regeneration Centers and BackSpace clinics. Our Innovative Medical Advancements

and Care (IMAC) Regeneration Centers combine medical and physical procedures to improve patient experiences and outcomes and reduce healthcare

costs as compared to other available treatment options. As of December 31, 2023, we closed or sold our outpatient clinics that provide

regenerative, orthopedic and minimally invasive procedures and therapies. Our treatments were performed by licensed medical practitioners

through our regenerative rehabilitation protocols designed to improve the physical health, to advance the quality of life and to lessen

the pain of our patients. We did not prescribe opioids, but instead offered an alternative to conventional surgery or joint replacement

surgery by delivering minimally invasive medical treatments to help patients with sports injuries, back pain, knee pain, joint pain,

ligament and tendon damage, and other related soft tissue conditions. Our employees focused on providing exceptional customer service

to give our patients a memorable and caring experience.

Our

licensed healthcare professionals have historically provided each patient a custom treatment plan that integrated innovative

regenerative medicine protocols (representing 9% of our revenue) with traditional, minimally invasive (minimizing skin punctures)

medical procedures (representing 63% of our revenue) in combination with physical therapies (representing 22% of our revenue),

chiropractic care (representing 5% of our revenue) and the remaining 1% of our revenue from memberships based on historical averages. We did not use or offer

opioid-based prescriptions as part of our treatment options in order to help our patients avoid the dangers of opioid abuse and

addiction. We have successfully treated patients that were previously addicted to opioids because of joint or soft tissue related

pain. Further, our procedures comply with all professional athletic league drug restriction policies, including the NFL, NBA, NHL

and MLB.

Dr.

Matthew Wallis, DC, our former President, opened the first IMAC Regeneration Center in Paducah, Kentucky in August 2000, which was our

flagship location. Dr. Jason Brame, DC joined Dr. Wallis in 2008. In 2015, Drs. Wallis and Brame hired Jeffrey S. Ervin as our Chief

Executive Officer to collectively create and implement their growth strategy. The result was the formal creation of IMAC Holdings, Limited

Liability Company (“LLC”) to expand IMAC clinics outside of western Kentucky, with such facilities to remain owned or operated

under the group using the IMAC Regeneration Center name and services. In June 2018, we completed a corporate conversion in which IMAC

Holdings, LLC was converted to IMAC Holdings, Inc. to consolidate ownership of existing clinics and implement our growth strategy. In

February 2019, we completed an initial public offering and our shares commenced trading on the Nasdaq Capital Market.

focused on providing natural, non-opioid solutions to pain as consumers increasingly demand conservative treatments for an aging population.

The demand for our services grew fueled by consumer preferences for organic healthcare solutions over traditionally invasive orthopedic

practices. We believed that our regenerative rehabilitation treatments were provided to patients at a much lower price than our primary

competitors, including orthopedic surgeons, pain management clinics and hospital systems targeting invasive joint reconstruction. Surgical

joint replacements cost several times more than our therapies initially treating the same condition. The U.S. government has recently

adopted strict surgery pre-approval initiatives to reduce the cost for CMS and limit the proliferation of opioids since they accompany

substantially all joint replacement surgeries.

believed patient satisfaction was driven by our five fundamental beliefs:

● We believe a medical setting should be comforting.

are led by senior executive officers who together have more than 100 years of combined experience in the healthcare services industry.

Jeffrey S. Ervin, co-founder of IMAC Holdings and our Chief Executive Officer, joined us in March 2015. Mr. Ervin has a history of sourcing

private equity investments and managing private equity operations in the healthcare and other growth industries. Mr. Ervin earned an

M.B.A. degree from Vanderbilt University. The founder of our company, Matthew C. Wallis, DC, a licensed chiropractor, was our President

through November 2023. Dr. Wallis had implemented strategies in the company to create consistent operating efficiencies for our sales,

marketing and service delivery operations. Sheri F. Gardzina serves as our Chief Financial Officer and joined the company in November

2017. Mrs. Gardzina earned an M.B.A. and M.S. from Northeastern University and is a licensed Certified Public Accountant. Ben Lerner,

DC, a licensed chiropractor, joined the team in February 2022 as our Chief Operating Officer. Dr. Lerner left the company in February

2023 to pursue other opportunities.

Recent

Developments

May 23, 2023, IMAC Holdings, Inc., a Delaware corporation (Nasdaq: BACK) (the “Company”) entered into an Agreement and Plan

of Merger (the “Merger Agreement”) with Theralink Technologies, Inc. (OTC: THER), a Nevada corporation (“Theralink”),

and IMAC Merger Sub, Inc., a Delaware corporation and a newly formed, wholly owned subsidiary of the Company (“Merger Sub”).

Upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Theralink (the “Merger”),

with Theralink continuing as the surviving entity (the “Surviving Entity”) and a wholly owned subsidiary of the Company.

On May 22, 2023, the board of directors of the Company, and the board of directors of Theralink unanimously approved the Merger Agreement.

the effective time of the Merger (the “Effective Time”), each share of Theralink’s common stock (“Theralink Common

Stock”) and each share of Theralink’s preferred stock (together with the Theralink Common Stock, “Theralink Shares”)

issued and outstanding as of immediately prior to the Effective Time will be converted into and will thereafter represent the right to

receive a portion of a share of the Company’s common stock (the “Company Shares”) such that the total number of Company

Shares issued to the holders of Theralink Shares shall equal 85% of the total number of Company Shares outstanding as of the Effective

Time (the “Merger Consideration”).

the Effective Time, each award of Theralink stock options (each, a “Theralink Stock Option”), whether or not then vested

or exercisable, that is outstanding immediately prior to the Effective Time, will be assumed by the Company and converted into a stock

option relating to a number of Company Shares equal to the product of: (i) the number of shares of Theralink Common Stock subject to

such Theralink Stock Option; and (ii) the ratio which results from dividing one share of Theralink Common Stock by the portion of a Company

Share issuable for such share as finally determined at the Effective Time (the “Exchange Ratio”), at an exercise price per

Company Share (rounded up to the nearest whole cent) equal to the quotient obtained by dividing (A) the exercise price per share of Theralink

Common Stock of such Theralink Stock Option by (B) the Exchange Ratio.

The

Company and Theralink have each agreed, subject to certain exceptions with respect to unsolicited proposals, not to directly or indirectly

solicit competing acquisition proposals or to enter into discussions concerning, or provide confidential information in connection with,

any unsolicited alternative acquisition proposals. However, if such party receives an unsolicited, bona fide acquisition proposal that

did not result from a material breach of the non-solicitation provisions of the Merger Agreement and the Company’s or Theralink’s

board of directors, or any committee thereof, as applicable, concludes, after consultation with its financial advisors and outside legal

counsel, that such unsolicited, bona fide acquisition proposal constitutes, or could reasonably be expected to result in, a superior

offer, such party may furnish non-public information regarding it or any of its subsidiaries and engage in discussions and negotiations

with such third party in response to such unsolicited, bona fide acquisition proposal; provided that each party provides notice

and furnishes any non-public information provided to the maker of the acquisition proposal to each party substantially concurrently with

providing such non-public information to the maker of the acquisition proposal.

The

completion of the Merger is subject to the satisfaction or waiver of customary closing conditions, including: (i) adoption of the Merger

Agreement by holders of a majority of the outstanding Theralink Shares; (ii) approval of the issuance of Company Shares in connection

with the Merger by a majority of the outstanding shares of the Company’s common stock; (iii) absence of any court order or regulatory

injunction prohibiting completion of the Merger; (iv) expiration or termination of (a) all waiting periods under the Hart-Scott-Rodino

Antitrust Improvements Act of 1976, as amended (the “HSR Act”) and (b) any agreement with any governmental entity not to

consummate the transactions contemplated by the Merger Agreement; (v) effectiveness of the Company’s registration statement on

Form S-4 to register the Company Shares to be issued in the Merger; (vi) subject to specified materiality standards, the accuracy of

the representations and warranties of the other party; (vii) the authorization for listing of Company Shares to be issued in the Merger

on Nasdaq; (viii) compliance by the other party in all material respects with its covenants; and (ix) the completion of satisfactory

due diligence by both parties.

The

Company and Theralink have each made customary representations and warranties in the Merger Agreement. The Merger Agreement also contains

customary covenants and agreements, including covenants and agreements relating to (i) the conduct of each of the Company’s and

Theralink’s business between the date of the signing of the Merger Agreement and the closing date of the Merger and (ii) the efforts

of the parties to cause the Merger to be completed, including actions which may be necessary to cause the expiration or termination of

any waiting periods under the HSR Act.

In furtherance of the proposed business combination

with Theralink, on April 12, 2024 we entered into a credit agreement, secured by the assets of Theralink and its subsidiaries, pursuant

to which Theralink may borrow from the Company up to an aggregate of $1,000,000 with an initial borrowing of $350,000. While we remain

committed to acquiring the business of Theralink, we continue to evaluate all options with respect to the structuring of the business

combination, including the Merger. We cannot give any assurance that the business combination will be consummated in accordance with the

previously disclosed terms, as opposed to other alternative structures. See Note 14 – Subsequent Events.

On April 10, 2024, we entered into a series of transactions including the

exchange of the Company’s outstanding Series B-1 Convertible Preferred Stock, par value $0.001 per share (the “Series B-1

Preferred Stock”) and Series B-2 Convertible Preferred Stock, par value $0.001 per share (the “Series B-2 Preferred Stock”

and, collectively with the Series B-1 Preferred Stock, the “Series B Preferred Stock”), for new preferred stock, the exchange

of the Company’s outstanding warrants (the “Existing Warrants”) for new warrants, and the sale of new preferred stock

and warrants. All such transactions were consummated on April 11, 2024 and resulted in gross proceeds to the Company of $900,000. See

Note 14 – Subsequent Events.

Our

Operations

of December 31, 2023, we had closed or sold our outpatient medical clinics and BackSpace locations. Given the Company’s financial position, during 2023, the Company decided to close its underperforming locations and sold The BackSpace, LLC operations and physical assets of certain locations in an effort to raise sufficient capital

to support on-going operations. Management has been actively exploring various strategic alternatives since July 2022.

Below

is a description of each of our outpatient medical clinics as of December 31, 2023 along with each location’s current status:

Kentucky

Market

November 2015, we relocated our Paducah, Kentucky operations into a 10,200 square foot build-to-suit facility. This facility serves

as an anchor clinic for the western Kentucky market of roughly 50,000 residents. The clinic performs medical evaluations with x-ray,

fluoroscopic spine, joint and appendage injections, regenerative medicine and physical medicine. This clinic discontinued patient

care in November 2023 upon the sale of assets to The Regenerative Center. The value of the sale of assets and assumption of lease liability exceeded $450,000.

March 2018, we purchased a medical practice building in Lexington, Kentucky, for $1.2 million. The Lexington, Kentucky clinic was

our seventh IMAC outpatient medical clinic, which we named the Tony Delk Center, and opened on July 2, 2018. This building was sold

in June 2020 and we then entered into a lease for the building that expires in July 2025. This clinic discontinued patient care in

January 2023 and lease obligations were settled in May 2023.

opened a 4,700 square foot facility in Murray, Kentucky, a town of nearly 15,000 residents near the Tennessee border in February

2017. This facility provides medical evaluations, fluoroscopic joint and appendage injections, and physical medicine and refers

patients to Paducah for regenerative PRP medical procedures. This clinic discontinued patient care in October 2023 upon the sale of

assets and assumption of liabilities to two former providers.

Missouri

Market, St. Louis

In January 2016, IMAC of St. Louis, LLC, executed a lease for a 13,300

square foot facility in Chesterfield, Missouri, a suburb 18 miles west of downtown St. Louis. The clinic opened in May 2016. The clinic

performs medical evaluations with x-ray, fluoroscopic spine, joint and appendage injections, regenerative PRP medicine and physical medicine.

This clinic discontinued patient care in October 2023 upon the sale of assets to JWB Chiropractic, PC. JWB Chiropractic, PC is owned by

our co-founder, Jason Brame, DC. The Company agreed to maintain the security deposit for the facility through 2026 as part of the transition

of lease liability, resulting in the sale of assets and liabilities valued over $600,000.

IMAC

of St. Louis opened a satellite facility in St. Peters, Missouri to assist with demand from suburbs west of the Missouri River. The

St. Peters clinic opened for business in July 2017. The facility offered patient medical

evaluations with x-ray, fluoroscopic joint and appendage injections, and physical medicine. This clinic discontinued patient care in

December 2021. The lease expired in August 2022.

IMAC

of St. Louis acquired the chiropractic clinic Lockwood Chiropractic in Webster Groves, Missouri, a suburb of St. Louis, in

November 2020. The clinic relocated to a new medical facility in January 2022, to expand medical

services to broaden our patient base while expanding into neighboring suburbs. This clinic discontinued patient care in September

2023. The lease expires in January 2029.

Missouri

Market, Springfield

August 2018, we acquired the physical and occupational therapy provider, Advantage Therapy, which operated four locations in the Springfield,

Missouri metropolitan area. The South Springfield location originally occupied 5,000 square feet, until it was relocated in September

2019 to a 7,520 square feet location which has a lease that expires in June 2024. The North Springfield, Monett and Ozark locations function

as satellite locations. The North Springfield location functions within 2,400 square feet with a lease that expired in May 2022. The

Monett location occupied 2,200 square feet pursuant to a lease that expired in February 2021. The Ozark location operated in approximately 1,000 square feet, until it was

relocated in 2019 to a 2,740 square foot location with a lease that expires in May 2024. The North Springfield and Ozark locations discontinued patient

care in 2022 and the Springfield location discontinued patient care in May 2023. Lease obligations for Springfield and Ozark were settled in 2023, and assets

in the facilities were sold to former non-executive employees.

Tennessee

Market

The

David Price Center opened in Brentwood, Tennessee in May 2017, however, this clinic discontinued patient care in April 2022. The 7,500

square foot location is leased through July 2024 and was being used as corporate office space through January 31, 2023. The lease obligation was retired and settled in 2023.

November 2017, a 5,500 square foot facility was opened in Murfreesboro, Tennessee however, this clinic discontinued patient care in February

2021.

Chicago

Market

April 2019, we acquired the non-medical assets of, and management agreements for, a regenerative medicine and physical medicine

practice operating in three locations in the Chicago, Illinois metropolitan area. The Arlington Heights location occupies 3,390

square feet and has a lease which expires in July 2023. The Elgin location occupies 3,880 square feet and has a lease which expires

in October 2023. The Elgin location was sold in November 2022. The Arlington Heights location discontinued patient care April 2023

upon the sale of assets and operations to an external buyer.

November 2019, we entered into a management agreement for an occupational and physical therapy practice in Rockford, Illinois. This location

occupies 3,056 square feet and has a lease that expires in July 2023. This management agreement was terminated in 2021.

June 2021, we completed an asset purchase in Naperville, Illinois. The clinic provides a wide variety of orthopedic treatments for various

conditions through a combination of medical and physical rehabilitation services. This location occupies 2,153 square feet and has a

lease that expires in July 2025. This clinic was sold in July 2022 and the lease terminated effective December 1, 2022.

Florida

Market

January 2020, we acquired the assets and assumed the building lease liability of Chiropractic Health of Southwest Florida, Inc. in Bonita

Springs, Florida. The acquisition of this practice expanded our presence into a new market

where we have extended our service offering to incorporate medical procedures to the existing physical therapy, chiropractic care and

soft tissue therapies. This clinic discontinued patient care in March 2022. The lease liability was settled in 2022.

February 2021, we acquired the business of Willmitch Chiropractic, P.A. in Tampa, Florida. This location provides chiropractic care and

occupies 3,613 square feet with a lease that expires in April 2026. This clinic discontinued patient care in January 2023.

March 2021, we completed an asset purchase in Orlando, Florida. The clinic operates in 2,500 square feet with a lease that expires in

September 2023. This clinic discontinued patient care in March 2022.

June 2021, we completed an asset purchase in Fort Piece, Florida. The clinic provides chiropractic care and will be incorporating

medical procedures. This clinic occupies 3,368 square feet and discontinued

patient care in January 2023. The lease liability was settled in 2023.

IMAC

Medical of Louisiana

October 2021, we acquired the assets and management agreement of IMAC Medical of Louisiana in Baton Rouge, Louisiana. The location occupies

9,000 of square feet with a lease that expires in December 2026. This clinic was sold in January 2023.

BackSpace

Starting

in June 2021, the Company introduced BackSpace clinics located in Walmart. They provided chiropractic adjustments, nerve and muscle stimulation,

and percussion tool therapies for soft tissue recovery, muscle relaxation, and spinal wellness. The BackSpace operations were sold in

February 2023.

Our

Services (prior to dispositions)

The

licensed healthcare professionals at our clinics work with each patient to create a protocol customized for each patient by utilizing

a combination of the following traditional and innovative treatments:

Medical

Treatments. Our specialized team of doctors work together to provide the latest minimally invasive, prescription-free treatments

for movement challenges or pain related to orthopedic conditions. The treatments are customized to treat the underlying condition instead

of addressing the challenge with prescriptions or surgeries.

Regenerative

Medicine. Regenerative therapy at IMAC Regeneration Centers utilizes undifferentiated cellular tissue to regenerate damaged tissue.

The majority of our procedures utilize cells from the patient, harvested under minimal manipulation, and applied during the same visit

to the clinic. These autologous cells help to heal degenerative soft tissue conditions, which cause pain or compromise the patient’s

quality of life. Platelet therapies comprise the greatest percentage of regenerative procedures. Independent studies in this area, including

a recent safety and feasibility study published by Dr. Peter B. Fodor, “Adipose Derived Stromal Cell Injections for Pain Management

of Osteoarthritis in the Human Knee Joint” (Aesthetic Surgery Journal, February 2016), have supported claims that autologous cell

treatments using adipose and bone marrow lead to improved function and decreased pain within joints, muscles and connective tissue and

can help alleviate osteoarthritis and degenerative disease. We believe that we have followed the increasingly accepted protocols described

in this and other similar studies in connection with our regenerative therapies.

Physical

Medicine. Our team of medical practitioners start by collaboratively building a personalized physical medicine treatment plan designed

to help patients get back to living the life they deserve.

Physical

Therapy. With a combination of biomechanical loading and tissue mobilization, our licensed physical rehabilitation therapists

work with each patient to help the body restore skill within the joint or soft tissue.

Spinal

Decompression. During this treatment, the spine is stretched and relaxed intermittently in a controlled manner, creating a negative

pressure in the disc area that can pull herniated or bulging tissue back into the disc. Whether caused by trauma or degeneration, we

realize the impact a spinal injury can have on the quality of one’s life and are committed to providing the most innovative, minimally

invasive medical technology and care to relieve back pain and restore function.

Chiropractic

Manipulation. Common for spine conditions, manual manipulation is used to increase range of motion, reduce nerve irritability

and improve function.

FDA

Clinical Trial

November 2017, we engaged a medical consulting group to advise us on current regenerative medicine therapy protocols and to organize

a clinical trial towards an investigational new drug application (IND) with the FDA, while pursuing a voluntary Regenerative Medicine

Advanced Therapy (RMAT) designation. This process is defined under Section 3033 of the 21st Century Cures Act. We intend to conduct an

investigator-initiated trial utilizing regenerative advancements to alleviate symptoms of debilitating, neurological conditions and diseases.

Stem cell therapy is emerging as a potentially revolutionary new way to treat disease and injury, with wide-ranging medical benefits.

It aims to repair damaged and diseased body parts with Healthy new cells provided by stem cell transplants.

The

medical consulting group has assisted us in conducting research, establishing patient engagement tools and developing clinical strategies

to achieve the IND and RMAT. We executed a technology transfer agreement with a research university to license an FDA Phase I approved

mesenchymal stem cell drug candidate. We submitted an IND application with the FDA using this therapeutic product in May 2020, and the

FDA Office of Tissues and Advanced Therapies authorized the Phase I clinical trial in August 2020. IMAC physicians were trained to administer

treatments within IMAC facilities and the FDA approved opening enrollment for the trial in November 2020. The first enrollee was treated

in December 2020, utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s

disease. The Phase 1 clinical trial consists of a 15-patient dose escalation safety and tolerability study. The trial is divided into

three groups: (1) five patients with bradykinesia due to Parkinson’s disease received a low intravenous dose, (2) five patients

received a medium intravenous dose, (3) and five patients received a high intravenous dose. Each trial participant received an intravenous

infusion of stem cells and will be tracked for 12 months for data collection. The final patient was dosed on September 6, 2022.

assurance can be given that the FDA will approve advancement beyond a Phase I study or the RMAT designation. We believe the RMAT designation

may be helpful in differentiating our services and gaining a broader collaborative connection with the FDA. Failure to earn the RMAT

designation will result in unfulfilled research expenses, but should not have a materially adverse effect on our operations or financial

condition.

Protection

of Proprietary Information

own various U.S. federal trademark registrations and applications, and unregistered trademarks, including the registered mark “IMAC

Regeneration Center.” We rely on trademark laws in the United States, as well as confidentiality procedures and contractual provisions,

to protect our proprietary information and brand. We cannot assure you that existing trademark laws or contractual rights will be adequate

for protecting our intellectual property and proprietary information. Protection of confidential information, trade secrets and other

intellectual property rights in the markets in which we operate and compete is highly uncertain and may involve complex legal questions.

We cannot completely prevent the unauthorized use or infringement of our confidential information or intellectual property rights as

such prevention is inherently difficult. Costly and time-consuming litigation could be necessary to enforce and determine the scope of

our confidential information and intellectual property protection.

are not aware of any claims of infringement or other challenges to our rights in our trademarks. We do not expect to need any additional

intellectual property rights to carry out our growth and expansion strategy.

For

years ended December 31, 2023 and 2022, we did not incur any material time or labor for the development of the technology we use in our

operations.

Government

Regulation

Numerous

federal, state and local regulations regulate healthcare services and those who provide them. Some states into which we may expand have

laws requiring facilities employing health professionals and providing health-related services to be licensed and, in some cases, to

obtain a certificate of need (that is, demonstrating to a state regulatory authority the need for, and financial feasibility of, new

facilities or the commencement of new healthcare services). None of the states in which we currently operate require a certificate of

need for the operation of our physical therapy business functions. Our healthcare professionals and/or medical clinics, however, are

required to be licensed, as determined by the state in which they provide services. Failure to obtain or maintain any required certificates,

approvals or licenses could have a material adverse effect on our business, financial condition and results of operations.

Regulations

Controlling Fraud and Abuse. Various federal and state laws regulate financial relationships involving providers of healthcare

services. These laws include Section 1128B(b) of the Social Security Act (42 U.S. C. § 1320a-7b(b)) (the “Fraud and Abuse

Law”), under which civil and criminal penalties can be imposed upon persons who, among other things, offer, solicit, pay or receive

remuneration in return for (i) the referral of patients for the rendering of any item or service for which payment may be made, in whole

or in part, by a Federal health care program (including Medicare and Medicaid); or (ii) purchasing, leasing, ordering, or arranging for

or recommending purchasing, leasing, ordering any good, facility, service, or item for which payment may be made, in whole or in part,

by a Federal health care program (including Medicare and Medicaid). We believe that our business procedures and business arrangements

are in compliance with these provisions. However, the provisions are broadly written and the full extent of their specific application

to specific facts and arrangements to which we are a party is uncertain and difficult to predict. In addition, several states have enacted

state laws similar to the Fraud and Abuse Law, which may be more restrictive than the federal Fraud and Abuse Law.

Stark

Law. Provisions of the Omnibus Budget Reconciliation Act of 1993 (42 U.S.C. §1395nn) (the “Stark Law”) prohibit

referrals by a physician of “designated health services” which are payable, in whole or in part, by Medicare or Medicaid,

to an entity in which the physician or the physician’s immediate family member has an investment interest or other financial relationship,

subject to several exceptions. Unlike the Fraud and Abuse Law, the Stark Law is a strict liability statute. Proof of intent to violate

the Stark Law is not required. Physical therapy services are among the “designated health services.” Further, the Stark Law

has application to our management contracts with individual physicians and physician groups, as well as, any other financial relationship

between us and referring physicians, including medical advisor arrangements and any financial transaction resulting from a clinic acquisition.

The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral. Several states have enacted laws similar

to the Stark Law. These state laws may cover all (not just Medicare and Medicaid) patients. As with the Fraud and Abuse Law, we consider

the Stark Law in planning our outpatient clinics, establishing contractual and other arrangements with physicians, marketing and other

activities, and believe that our operations are in substantial compliance with the Stark Law. If we violate the Stark Law or any similar

state laws, our financial results and operations could be adversely affected. Penalties for violations include denial of payment for

the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs.

HIPAA.

In an effort to further combat healthcare fraud and protect patient confidentially, Congress included several anti-fraud measures

in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). HIPAA created a source of funding for fraud

control to coordinate federal, state and local healthcare law enforcement programs, conduct investigations, provide guidance to the healthcare

industry concerning fraudulent healthcare practices, and establish a national data bank to receive and report final adverse actions.

HIPAA also criminalized certain forms of health fraud against all public and private payers. Additionally, HIPAA mandates the adoption

of standards regarding the exchange of healthcare information in an effort to ensure the privacy and electronic security of patient information

and standards relating to the privacy of health information. Sanctions for failing to comply with HIPAA include criminal penalties and

civil sanctions. In February of 2009, the American Recovery and Reinvestment Act of 2009 (“ARRA”) was signed into law. Title

XIII of ARRA, the Health Information Technology for Economic and Clinical Health Act (“HITECH”), provided for substantial

Medicare and Medicaid incentives for providers to adopt electronic health records (“EHRs”) and grants for the development

of health information exchange (“HIE”). Recognizing that HIE and EHR systems will not be implemented unless the public can

be assured that the privacy and security of patient information in such systems is protected, HITECH also significantly expanded the

scope of the privacy and security requirements under HIPAA. Most notable are the mandatory breach notification requirements and a heightened

enforcement scheme that includes increased penalties, and which now apply to business associates as well as to covered entities. In addition

to HIPAA, a number of states have adopted laws and/or regulations applicable in the use and disclosure of individually identifiable health

information that can be more stringent than comparable provisions under HIPAA.

believe that our operations comply with applicable standards for privacy and security of protected healthcare information. We cannot

predict what negative effect, if any, HIPAA/HITECH or any applicable state law or regulation will have on our business.

Cybersecurity.

We are a medical provider and comply with HIPAA and data sensitivity requirements as regulated by local and federal authorities.

Our patient data is hosted, managed and secured with an approved Electronic Medical Record vendor. Cybersecurity is of paramount importance

and our executive officers have implemented routine cyber breach insurance policies to protect our company from potential predatory initiatives

to access patient and company data. See “Risk Factors – Our reputation and relationships with patients would be harmed if

our patients’ data, particularly personally identifying data, were to be subject to a cyber-attack or otherwise by unauthorized

persons.”

FDA

Drug Approval Process

the United States, pharmaceutical products are subject to extensive regulation by the Food and Drug Administration (the “FDA”).

The Federal Food, Drug, and Cosmetic Act (“FDC Act”) and other federal and state statutes and regulations, govern, among

other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution,

post-approval monitoring and reporting, sampling and import and export of pharmaceutical products. Failure to comply with applicable

U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending

new drug applications (“NDAs”), warning or untitled letters, product recalls, product seizures, total or partial suspension

of production or distribution, injunctions, fines, civil penalties and criminal prosecution. As a result of these regulations, pharmaceutical

product development and approval are very expensive and time consuming.

Pharmaceutical

product development for a new product or certain changes to an approved product in the United States typically involves preclinical laboratory

and animal tests, the submission to the FDA of an investigational new drug (“IND”), which must become effective before clinical

testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each

indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes many years and the

actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

Clinical

trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase

1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess pharmacological actions,

side effects associated with increasing doses and, if possible, early evidence on effectiveness. For dermatology products, Phase 2 usually

involves trials in a limited patient population to determine metabolism, pharmacokinetics, the effectiveness of the drug for a particular

indication, dosage tolerance and optimum dosage, and to identify common adverse effects and safety risks. If a compound demonstrates

evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 clinical trials are undertaken to obtain the

additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical

trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for

the labeling of the drug. In most cases the FDA requires two adequate and well-controlled Phase 3 clinical trials with statistically

significant results to demonstrate the efficacy of the drug. A single Phase 3 clinical trial with other confirmatory evidence may be

sufficient in rare instances where the study is a large multicenter trial demonstrating internal consistency and a statistically very

persuasive finding of an effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and

confirmation of the result in a second trial would be practically or ethically impossible.

After

completion of the required activities, including clinical testing, a NDA is prepared and submitted to the FDA. FDA approval of the NDA

is required before marketing of the product may begin in the United States.

The

FDA also may refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to

an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to

whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows

such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with the

FDA’s good clinical practice requirements. Additionally, the FDA typically inspects the facility or the facilities at which the

drug is manufactured and may inspect the sponsor company and investigator sites that participated in the clinical trials. The FDA will

not approve the product unless compliance with current good manufacturing practice (“cGMP”) is satisfactory and the NDA contains

data that provide substantial evidence that the drug is safe and effective for the stated indication.

After

the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete

response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information,

in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction

following FDA review of a resubmission of the NDA, the FDA will issue an approval letter.

approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition

of NDA approval, the FDA may require a risk evaluation and mitigation strategy (“REMS”), to help ensure that the benefits

of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals and elements

to assure safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing

or dispensing, dispensing only under certain circumstances, special monitoring and the use of patient registries. The requirement for

a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval

testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance

with regulatory standards is not maintained or problems are identified following initial marketing.

Changes

to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes

or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement

for a new indication typically requires clinical data similar to that in the original application, and the FDA generally uses the same

procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

Section

505(b)(2) New Drug Applications

Most

drug products obtain FDA marketing approval pursuant to an NDA filed under section 505(b)(1) of the FDC Act. An alternative is a special

type of NDA, commonly referred to as a Section 505(b)(2) NDA (“505(b)(2) NDA”), which enables the applicant to rely, in part,

on the FDA’s previous approval of a similar product, or published literature, in support of its application.

505(b)(2)

NDAs often provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products. Section

505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted

by, or for, the applicant and for which the applicant has not obtained a right of reference. If the 505(b)(2) NDA applicant can establish

that reliance on the FDA’s previous approval is scientifically appropriate, it may eliminate the need to conduct certain preclinical

or clinical studies of the new product. The FDA may also require companies to perform additional studies or measurements to support the

change from the approved product. The FDA may then approve the new product candidate for all, or some, of the label indications for which

the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) NDA applicant.

Biologics

Biological

products used for the prevention, treatment or cure of a disease or condition of a human being are subject to regulation under the FDC

Act, except the section of the FDC Act which governs the approval of NDAs. Biological products are approved for marketing under provisions

of the Public Health Service Act (“PHSA”), via a Biologics License Application (“BLA”). However, the application

process and requirements for approval of BLAs and BLA supplements, including review timelines, are very similar to those for NDAs and

NDA supplements, and biologics are associated with similar approval risks and costs as other drugs.

Post-Approval

Requirements

Once

a NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval

marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored

scientific and educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved

indications and in accordance with the provisions of the approved labeling.

Adverse

event reporting and submission of periodic safety reports is required following FDA approval of a NDA. The FDA also may require post-marketing

testing, known as Phase 4 testing, REMS and surveillance to monitor the effects of an approved product, or the FDA may place conditions

on an approval that could restrict the distribution or use of the product. In addition, quality-control, drug manufacture, packaging

and labeling procedures must continue to conform to cGMPs after approval. Drug manufacturers and certain of their subcontractors are

required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic

unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMPs. Accordingly,

manufacturers must continue to expend time, money and effort in the areas of production and quality-control to maintain compliance with

cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory

standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

Pediatric

Information

Under

the Pediatric Research Equity Act, NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the drug for

the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation

for which the drug is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data.

The

Best Pharmaceuticals for Children Act (“BPCA”) provides NDA holders a six-month extension of any exclusivity, patent or non-patent,

for a drug if certain conditions are met. Conditions for exclusivity include the FDA’s determination that information relating

to the use of a new drug in the pediatric population may produce health benefits in that population, the FDA making a written request

for pediatric studies and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe.

Applications under the BPCA are treated as priority applications, with all of the benefits that designation confers.

Disclosure

of Clinical Trial Information

BACK US Equity

BACK · 10-K · period ended 2023-12-31

ITEM 1. BUSINESS

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BACK · 10-K · period ended 2023-12-31

ITEM 1. BUSINESS

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