0001493152-24-008948.txt : 20240306 0001493152-24-008948.hdr.sgml : 20240306 20240306083549 ACCESSION NUMBER: 0001493152-24-008948 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20240306 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240306 DATE AS OF CHANGE: 20240306 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Innoveren Scientific, Inc. CENTRAL INDEX KEY: 0001591165 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 463312262 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36763 FILM NUMBER: 24724451 BUSINESS ADDRESS: STREET 1: 151 W4TH ST STREET 2: STE 223 CITY: CINCINNATI STATE: OH ZIP: 45202 BUSINESS PHONE: 844-633-6839 MAIL ADDRESS: STREET 1: 151 W4TH ST STREET 2: STE 223 CITY: CINCINNATI STATE: OH ZIP: 45202 FORMER COMPANY: FORMER CONFORMED NAME: H-CYTE, INC. DATE OF NAME CHANGE: 20190715 FORMER COMPANY: FORMER CONFORMED NAME: Medovex Corp. DATE OF NAME CHANGE: 20140501 FORMER COMPANY: FORMER CONFORMED NAME: SpineZ DATE OF NAME CHANGE: 20131105 8-K 1 form8-k.htm
false 0001591165 0001591165 2024-03-06 2024-03-06 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

Innoveren Scientific Announces 510(k) Submission for SkinDiscTM 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 SkinDiscTM Lite product.

 

SkinDiscTM Lite 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. SkinDiscTM 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 SkinDiscTM 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 SkinDiscTM Lite, allowing us to continue to advance our pipeline and submit a 510(k) submission for SkinDiscTM Ultra in the coming quarters.”

 

Innoveren Scientific is prepared to submit a second 510(k) De Novo submission for SkinDiscTM Ultra should clearance be received for SkinDiscTM Lite. SkinDiscTM 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.

 

 

 

 

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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
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