Form 8-K - Current report

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): March 6, 2024

Innoveren Scientific, Inc.

(Exact Name of Registrant as Specified in Charter)

Nevada

001-36763

46-3312262

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

151 W4th St., Ste 223,

Cincinnati, OH

45202

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code:

(844) 633-6839

201 E Kennedy Blvd, Suite 700 Tampa, FL, 33602

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

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:

☐	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: Common Stock

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 March 6, 2024, Innoveren Scientific, Inc. (the “Company”) issued a press release. A copy of the press release is furnished hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits.

The following exhibits are filed as part of this report:

Item 9.01 Exhibits

Exhibit No.		Description
99.1		Press Release dated March 6, 2024
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.

	Innoveren Scientific, Inc.

Date: March 6, 2024	By:	/s/ Jeremy Daniel
		Jeremy Daniel
		Chief Financial Officer

Exhibit 99.1

Innoveren Scientific Announces 510(k) Submission for SkinDisc^TM Lite

First Commercial Product Submission from Company’s Robust Regenerative Medicine-Based Pipeline

CINCINNATI, OH / ACCESSWIRE / March 6, 2024 -- Innoveren Scientific Inc. (OTCQB: IVRN) (“Innoveren” or the “Company”), a life science company focused on becoming a leading biotech incubator, announced today that it has submitted a 510(k) premarket filing to the U.S. Federal Food and Drug Administration (FDA) for its SkinDisc^TM Lite product.

SkinDisc^TMLite provides an active and protein-rich cellular matrix that is essential for structural support and cellular attachment during the wound-healing process that can be administered in an outpatient setting. The product maintains complete wound contact and depth fill during the healing process, resulting in rapid growth of the host tissue. SkinDisc^TM Lite utilizes autologous platelet-rich plasma (PRP) and platelet poor plasma concentrate, from the patient’s own body, helping to mitigate any potential rejection of the product.

“The FDA submission for SkinDisc^TM Lite represents a significant milestone for Innoveren Scientific in our journey to advance our new medical technologies in areas of unmet need across multiple indications,” said Michael Yurkowsky, Innoveren Scientific’s Chief Executive Officer. “With the use of PRP, which already has predicates in wound care cleared by the FDA, we are hopeful we will also receive clearance for SkinDisc^TM Lite, allowing us to continue to advance our pipeline and submit a 510(k) submission for SkinDisc^TM Ultra in the coming quarters.”

Innoveren Scientific is prepared to submit a second 510(k) De Novo submission for SkinDisc^TM Ultra should clearance be received for SkinDisc^TM Lite. SkinDisc^TM Ultra is an operating room-only product for limb salvage that utilizes bone marrow aspirate (BMA).

The Company is also making progress on advancing its BreatheEasy product, a medical device that helps patients struggling with chronic obstructive pulmonary disease (COPD), as well as other closely related diseases such as chronic bronchitis and emphysema. The Company is on track for a 510(k) De Novo submission later this year once additional clinical work has been completed.

About Innoveren Scientific Inc.

Innoveren Scientific Inc., formerly known as H-CYTE, Inc. is a life science and biotech incubator company, focused on advancing new technologies in areas of unmet need across multiple indications, with the ultimate goal of improving patient lives. The company invests in and fosters innovative technologies that are supported by a strong scientific foundation, which have relatively short timelines and low costs to achieve meaningful value inflection points. For more information about Innoveren, please visit www.InnoverenScientific.com.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Innoveren believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those outlined in Innoveren’s filings with the SEC, including but not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. Innoveren expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Innoveren Investor Contact:

Alpha IR Group

Jackie Marcus or Josh Carroll

IVRN@alpha-ir.com

312-445-2870

Source: Innoveren Scientific Inc.

Cover	Mar. 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 06, 2024
Entity File Number	001-36763
Entity Registrant Name	Innoveren Scientific, Inc.
Entity Central Index Key	0001591165
Entity Tax Identification Number	46-3312262
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	151 W4th St.
Entity Address, Address Line Two	Ste 223
Entity Address, City or Town	Cincinnati
Entity Address, State or Province	OH
Entity Address, Postal Zip Code	45202
City Area Code	(844)
Local Phone Number	633-6839
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false