SMTI Sanara MedTech Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): September 10, 2024

 

SANARA MEDTECH INC.

(Exact name of registrant as specified in its charter)

 

Texas		001-39678		59-2219994
(State or other jurisdiction		(Commission		(IRS Employer
of incorporation)		File Number)		Identification No.)

 

1200 Summit Avenue, Suite 414 Fort Worth, Texas		76102
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code: (817) 529-2300

 

(Former name or former address, if changed since last report)

 

Not Applicable

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

	☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
	☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
	☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
	☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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, $0.001 par value		SMTI		The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If 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. ☐

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On September 11, 2024, Sanara MedTech Inc. (the “Company”) issued a press release announcing the Unit Purchase Agreement (defined below). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

The information included under Item 7.01 (including Exhibit 99.1) is furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.

 

Item 8.01 Other Events.

 

On September 10, 2024, Sanara CMP LLC, a wholly owned subsidiary of the Company (“Sanara CMP”), entered into a Unit Purchase Agreement (the “Unit Purchase Agreement”) with ChemoMouthpiece, LLC (“CMp”), pursuant to which Sanara CMP purchased 100,674.72 common units in CMp for $5.0 million, which represents approximately 6.64% of the issued and outstanding membership interests of CMp immediately following such purchase. CMp is a privately held medical device company that develops and commercializes propriety oral cryotherapy products for cancer patients, including, among other things, CMp’s Chemo Mouthpiece^® oral cryotherapy device, which is a 510(k) cleared cryotherapy device designed to reduce the incidence and severity of chemotherapy induced oral mucositis.

 

In connection with the Unit Purchase Agreement, the Company, CMp, certain subsidiaries of CMp, InfuSystem, Inc. (“InfuSystem”) and SI Healthcare Technologies, LLC, a joint venture entity owned 50/50 by the Company and InfuSystem (“SI Technologies”), entered into an Exclusive Distribution Agreement (the “Distribution Agreement”) pursuant to which SI Technologies was appointed as the sole and exclusive U.S. distributor of CMp’s Standard Chemo Regiment Kits, each kit consisting of the Chemo Mouthpiece^® oral cryotherapy device and associated materials used in the treatment of oral mucositis (the “Product”), for a term of five years. In addition, the parties to the Distribution Agreement entered into an Intellectual Property Rights Agreement pursuant to which SI Technologies was granted the exclusive right to use CMp’s intellectual property rights to permit resale and use of the Product in the United States.

 

On September 4, 2024, the Company, pursuant to its option under its previously disclosed Term Loan Agreement with CRG Servicing LLC dated as of April 17, 2024 (the “Loan Agreement”) borrowed an additional $15.5 million under the Loan Agreement (the “Second Borrowing”). As previously disclosed, the Loan Agreement provides for up to a $55.0 million term loan facility, $15.0 million of which was borrowed at closing on April 17, 2024 (the “First Borrowing”). The First Borrowing and the Second Borrowing each have a maturity date of May 30, 2029, unless earlier prepaid, and bear interest at 13.25% per annum rate. Pursuant to the Loan Agreement, prior to June 30, 2025 and subject to the satisfaction of certain conditions, the Company has the right to draw down a third borrowing of up to $24.5 million. The Company used $5.0 million of the proceeds of the Second Borrowing for the investment in CMp and intends to use the remaining proceeds for permitted acquisition opportunities and for general working capital and corporate purposes.

 

The description of the Loan Agreement included in Item 1.01 of the Company’s Current Report on Form 8-K filed on April 18, 2024 (the “April 2024 8-K”), is incorporated herein by reference. The description of the Loan Agreement contained herein does not purport to be complete, and is qualified in its entirety by reference to the complete text of the Loan Agreement filed as Exhibit 10.1 to the April 2024 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release issued September 11, 2024 (furnished pursuant to Item 7.01).
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: September 11, 2024
	Sanara MedTech Inc.
	By:	/s/ Michael D. McNeil
	Name:	Michael D. McNeil
	Title:	Chief Financial Officer

 

 

Exhibit 99.1

 

 

Sanara MedTech Inc. and InfuSystem Holdings, Inc. Announce Exclusive United States Distribution Agreement with, and Minority Investment in, ChemoMouthpiece, LLC

 

FORT WORTH, TX / GlobeNewswire / September 11, 2024 / Sanara MedTech Inc. Based in Fort Worth, Texas, Sanara MedTech Inc. (“Sanara,” the “Company,” “we,” “our” or “us”) (NASDAQ: SMTI), a medical technology company focused on improving clinical outcomes and reducing healthcare expenditures in the surgical, chronic wound and skincare markets, and InfuSystem, Inc. (“InfuSystem”), the operational subsidiary of Sanara’s joint venture partner InfuSystem Holdings, Inc., announced today the execution of an exclusive United States distribution agreement with, and minority investment in, ChemoMouthpiece, LLC (“ChemoMouthpiece”).

 

Ron Nixon, Sanara’s CEO, stated, “Oral mucositis is a debilitating condition impacting hundreds of thousands of oncology patients annually. ChemoMouthpiece has developed a clinically validated product with FDA 510(k) clearance that can bring relief to affected patients. The American Medical Association has recently issued the CPT code (effective July 2024) to be applied for potential reimbursement by physicians and payers for the use of an oral cavity device for a cryotherapy procedure in conjunction with chemotherapy. The product aligns well with Sanara’s skincare strategy, which includes the licensed collagen peptides from Tufts University that focus on radiation dermatitis. We look forward to providing the Chemo Mouthpiece® oral cryotherapy device to oncology patients undergoing chemotherapy.”

 

Transaction Overview

 

●

ChemoMouthpiece owns and manufactures a 510(k) cleared device that uses cryotherapy to reduce the incidence and severity of oral mucositis in patients undergoing stomatotoxic chemotherapy treatments.

 

●

SI Healthcare Technologies, LLC (f/k/a SI Wound Care, LLC) (“SI Technologies”), a 50/50 joint venture between Sanara and InfuSystem, will be the exclusive distributor of ChemoMouthpiece’s kits in the United States.

 

●

SI Technologies plans to market and distribute the product through InfuSystem to approximately 3,000 cancer centers through InfuSystem’s existing sales team.

 

●

SI Technologies will purchase the product kits from ChemoMouthpiece at a fixed price and pay a royalty on net revenues for the use of the product intellectual property.

 

●

Sanara invested $5 million for a 6.6% ownership position in ChemoMouthpiece.

 

●

SI Technologies will have a purchase option that expires on January 31, 2029 to purchase the U.S. business of ChemoMouthpiece, including all U.S. intellectual property related to the product.

 

●

Sanara has drawn $15.5 million on its term loan with CRG Servicing, LLC and will fund this investment as part of that draw.

 

 

Oral Mucositis

 

Oral mucositis causes painful mouth ulcers, which are a common complication of chemotherapy and radiation. In the U.S., there are an estimated 500,000 – 1,000,000 patients who have oral mucositis annually and the estimated market size exceeds $600 million. SI Technologies believes this product will show material cost reductions for oncology treatment centers, improve patient quality of life and allow for continued treatment of cancer therapy for patients. ChemoMouthpiece is planning to publish studies in the future reinforcing the efficacy of their product.

 

Richard Dilorio, InfuSystem’s CEO, stated, “Sanara and InfuSystem entered into our partnership in order to bring together our combined technical, operational and commercial strengths to deliver proprietary efficacious products to patients. We believe this exclusive agreement, which builds on our partnership, will allow us to do that by offering the Chemo Mouthpiece® oral cryotherapy device and bringing potential relief to thousands of cancer patients suffering from oral mucositis.”

 

David Yoskowitz, ChemoMouthpiece’s President and CEO stated, “We are pleased to have selected SI Technologies as our exclusive distribution partner in the United States. We believe that InfuSystem’s experienced team of seasoned oncology professionals currently calling on approximately 3,000 U.S. cancer centers will accelerate the uptake of the Chemo Mouthpiece, bringing a much-needed option for patients that would otherwise suffer from the debilitating effects of oral mucositis.” David added, “We understand that the executive team of SI Technologies has a long history of launching products into the oncology space, and coupled with Sanara’s ownership position in ChemoMouthpiece, we are confident that they will execute the successful launch of the Chemo Mouthpiece® oral cryotherapy device.”

 

Pickwick Capital Partners, LLC, served as the exclusive advisor to ChemoMouthpiece on this transaction.

 

About ChemoMouthpiece, LLC

 

ChemoMouthpiece, LLC is a privately held medical device company that develops and commercializes propriety oral cryotherapy products for cancer patients. The Chemo Mouthpiece® oral cryotherapy device was developed based on the personal experience of inventor, founder and CEO, David Yoskowitz, who when diagnosed with Hodgkin’s Lymphoma, experienced oral mucositis firsthand. His treatment options included ice chips to mitigate and minimize the pain. Yet this caused nausea, was difficult to maintain in his mouth, and did not effectively cool the entire oral cavity which led him to search for a better option. The Chemo Mouthpiece® oral cryotherapy device cools down the entire oral cavity, causing vasoconstriction, which in effect slows and reduces the flow of chemotherapy in the oral cavity, thus greatly reducing the risk of developing oral mucositis. The cryotherapy approach has been positively studied for decades and the Chemo Mouthpiece® oral cryotherapy device has significant and improved advantages over conventional cryotherapy interventions. For more information on ChemoMouthpiece, LLC, please visit its website at www.chemomouthpiece.com.

 

About Sanara MedTech Inc.

 

Sanara MedTech Inc. is a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical, chronic wound and skincare markets. The Company markets, distributes and develops surgical, wound and skincare products for use by physicians and clinicians in hospitals, clinics and all post-acute care settings and offers wound care and dermatology virtual consultation services via telemedicine. Sanara’s products are primarily sold in the North American advanced wound care and surgical tissue repair markets. Sanara markets and distributes CellerateRX^® Surgical Activated Collagen, FORTIFY TRG^® Tissue Repair Graft and FORTIFY FLOWABLE^® Extracellular Matrix as well as a portfolio of advanced biologic products focusing on ACTIGEN^TM Verified Inductive Bone Matrix, ALLOCYTE^® Plus Advanced Viable Bone Matrix, BiFORM^® Bioactive Moldable Matrix, TEXAGEN^® Amniotic Membrane Allograft, and BIASURGE^® Advanced Surgical Solution to the surgical market. In addition, the following products are sold in the wound care market: BIAKOS^® Antimicrobial Skin and Wound Cleanser, BIAKOS^® Antimicrobial Wound Gel, and BIAKOS^® Antimicrobial Skin and Wound Irrigation Solution. Sanara’s pipeline also contains potentially transformative product candidates for mitigation of opportunistic pathogens and biofilm, wound re-epithelialization and closure, necrotic tissue debridement and cell compatible substrates. The Company believes it has the ability to drive its pipeline from concept to preclinical and clinical development while meeting quality and regulatory requirements. Sanara is constantly seeking long-term strategic partnerships with a focus on products that improve outcomes at a lower overall cost.

 

 

About InfuSystem Holdings, Inc.

 

InfuSystem Holdings, Inc. (NYSE American: INFU), is a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers. INFU services are provided under a two-platform model. The first platform is Patient Services, providing the last-mile solution for clinic-to-home healthcare where the continuing treatment involves complex durable medical equipment and services. The Patient Services segment is comprised of Oncology, Pain Management and Wound Therapy businesses. The second platform, Device Solutions, supports the Patient Services platform and leverages strong service orientation to win incremental business from its direct payer clients. The Device Solutions segment is comprised of direct payer rentals, pump and consumable sales, and biomedical services and repair. Headquartered in Rochester Hills, Michigan, the Company delivers local, field-based customer support and also operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada.

 

Information about Forward-Looking Statements

 

The statements in this press release that do not constitute historical facts are “forward-looking statements,” within the meaning of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. These statements may be identified by terms such as “aims,” “anticipates,” “believes,” contemplates,” “continue,” “could,” “estimates,” “expect,” “forecast,” “guidance,” “intend,” “may,” “plan,” “possible,” “potential,” “predicts,” “preliminary,” “projects,” “seeks,” “should,” “targets,” “will” or “would,” or the negatives of these terms, variations of these terms or other similar expressions. These forward-looking statements include, among others, statements regarding the ability to market and distribute the Chemo Mouthpiece device. These items involve risks, contingencies and uncertainties such as the ability to penetrate oncology hospitals and clinics, the extent of product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, uncertainties associated with the development and process for obtaining regulatory approval for new products, the ability to consummate and integrate acquisitions, and other risks, contingencies and uncertainties detailed in the Company’s SEC filings, which could cause the Company’s actual operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements.

 

All forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to revise any of these statements to reflect the future circumstances or the occurrence of unanticipated events, except as required by applicable securities laws.

 

Investor Contact:

 

Callon Nichols, Director of Investor Relations

713-826-0524

CNichols@sanaramedtech.com

 

SOURCE: Sanara MedTech Inc.

 

 

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Cover	Sep. 10, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Sep. 10, 2024
Entity File Number	001-39678
Entity Registrant Name	SANARA MEDTECH INC.
Entity Central Index Key	0000714256
Entity Tax Identification Number	59-2219994
Entity Incorporation, State or Country Code	TX
Entity Address, Address Line One	1200 Summit Avenue
Entity Address, Address Line Two	Suite 414
Entity Address, City or Town	Fort Worth
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	76102
City Area Code	(817)
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Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	SMTI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

---