SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: EX-1.1
Date Filed: 2026-03-18
Accession Number: 0001493152-26-010642
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226010642/ex1-1.htm

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disclosures to users or customers required by applicable laws and regulatory rules or requirements, and none of such disclosures made or contained in any Policy have, to the knowledge of the Company, been inaccurate or in violation of any applicable laws and regulatory rules or requirements in any material respect. The Company further certifies that neither it nor any Subsidiary: (i) has received notice of any actual or potential liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is a party to any order, decree, or agreement that imposes any obligation or liability under any Privacy Law.

Healthcare Regulatory Matters. The research, preclinical tests and studies, or clinical trials or studies conducted by or on behalf
of the Company that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus (the “Company
Studies and Trials”) were and, if still pending, are being, conducted in all material respects with all applicable federal,
state and foreign laws, rules, orders and regulations, including without limitation the current Good Clinical Practices (“cGCP”)
as well as in accordance with experimental protocols that were submitted to the relevant Regulatory Authority (defined below) in the
relevant jurisdiction; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, the
Pricing Disclosure Package and the Prospectus are accurate and not misleading in all material respects; the Company has no knowledge
of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results
of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing
Disclosure Package and the Prospectus; and, except as set forth in the Registration Statement, the Pricing Disclosure Package and the
Prospectus, the Company has not received any written notices or correspondence with the FDA or with or from any foreign, federal, state
or local regulatory authority performing functions similar to those performed by the FDA (collectively “Regulatory Authorities”),
requiring or threatening the termination, suspension or material modification of any Company Studies or Trials that are described in,
or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, that would
reasonably be expected to result in a Material Adverse Change and, to the Company’s knowledge, there are no reasonable grounds
for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated
in the Company Studies and Trials. Neither the Company, nor its Subsidiaries or any of their respective directors, officers, employees
or, to the Company’s knowledge, agents is or has been debarred, suspended or excluded, or has been convicted of any crime or, to
the knowledge of the Company or its Subsidiaries, engaged in any conduct that would result in a debarment, suspension or exclusion from
any U.S. federal or state government health care program or human clinical research. To the Company’s knowledge, none of the Company
Studies and Trials involved any investigator, as such term is defined in Title 21, Section 50.3 of the U.S. Code of Federal Regulations,
who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s
knowledge, the manufacturing facilities and operations of it and its suppliers, as applicable, are operated in compliance in all material
respects with all applicable statutes, rules and regulations of the FDA and any foreign, federal, state or local regulatory authority
performing functions similar to those performed by the FDA to which the Company is subject. The Company has not, either voluntarily or
involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall of any clinical trial materials
related to any of the Company Studies and Trials. Further, the Company and its Subsidiaries have not received written notice of any claim,
action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental
or regulatory authority or third party alleging that any of the Company Studies and Trials is in violation of any Applicable Laws nor,
to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other
action threatened, except as would not, singularly or in the aggregate, reasonably be expected to result in a Material Adverse Change.

Health Care Products Manufacturing. The manufacture of the Company’s products by or on behalf of the Company is being conducted
in material compliance with all Applicable Laws, including, without limitation, the FDA’s current good manufacturing practice regulations
at 21 CFR Part 820 and in compliance with all facility registration regulations, and, to the extent applicable, the respective counterparts
thereof promulgated by any other Regulatory Authorities. The Company has had no manufacturing site (whether Company-owned or to the Company’s
knowledge, that of a third party manufacturer for the Company’s products) subject to an FDA or other Regulatory Authority shutdown
or import or export prohibition, nor received any unresolved written notice of adverse finding, warning letter, untitled letter, requests
to make material changes to the Company’s products, processes or operations, or similar written correspondence or notice from the
FDA or any other Regulatory Authority alleging or asserting material noncompliance with any Applicable Laws or any governmental licenses
required by any such Applicable Laws. To the Company’s knowledge, neither the FDA nor any other Regulatory Authority is considering
such action.

No Safety Notices. Except as would not, singularly or in the aggregate, result in a Material Adverse Change: (i) there have been
no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters,
investigator notices, import alert, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory
compliance of the Company’s products (collectively, “Safety Notices”) and (ii) there are no facts that would
be reasonably likely to result in (x) a Safety Notice with respect to the Company’s products or services, or (y) a material change
in labeling of any of the Company’s products or (z) a termination or suspension of marketing, testing or distribution of any of
the Company’s products or services.

Forward-Looking Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section
21E of the Exchange Act) included in any of the Registration Statement, the Pricing Disclosure Package or the Prospectus has been made
or reaffirmed without a reasonable basis or has been disclosed other than in good faith, based on the information available to the Company
as of the Effective Date.

Covenants of the Company. The Company covenants and agrees as follows:

Amendments to Registration Statement. The Company shall deliver to the Representative, prior to filing, any amendment or supplement
to the Registration Statement or Prospectus proposed to be filed after the Effective Date and not file any such amendment or supplement
to which the Representative shall reasonably object in writing.

Federal Securities Laws.