SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1
Document Type: S-1
Date Filed: 2026-02-12
Accession Number: 0001493152-26-006407
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.htm

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related to patient health information, we could be subject to criminal or civil sanctions and any resulting liability could adversely affect our financial condition. addition, countries around the world have passed or are considering legislation that would impose data breach notification requirements and/or require that companies adopt specific data security requirements. If we experience a data breach that triggers one or more of these laws, we may be subject to breach notification obligations, civil liability and litigation, all of which could also generate negative publicity and have a negative impact on our business. are currently, and in the future may be, subject to various governmental regulations related to the manufacturing of product candidates and their components, and we may incur significant expenses to comply with, experience delays in our product commercialization as a result of and be subject to material sanctions if we or our contract manufacturers violate these regulations.

Our
manufacturing processes and facility are required to comply with the FDA’s QSR, which covers the procedures and documentation of
the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of product candidates.
Although we believe we are compliant with the QSRs, the FDA enforces the QSR through periodic announced or unannounced inspections of
manufacturing facilities. We anticipate in the future being subject to such inspections, as well as to inspections by other federal and
state regulatory agencies. Once we receive FDA regulatory clearance or approval, we are required to register our manufacturing facility
with the FDA and list all devices that are manufactured. We also operate our facility in Massachusetts as an International Organization
for Standardization, or ISO, 13485 certified facility and annual audits are required to maintain that certification. The resuppliers
of our components are also required to comply with the QSR and are subject to inspections. We have limited ability to ensure that any
such third-party manufacturers will take the necessary steps to comply with applicable regulations, which could cause delays in the delivery
of our product candidates. Failure to comply with applicable FDA requirements, or later discovery of previously unknown problems with
our product candidates or manufacturing processes, including our failure or the failure of one of our third-party manufacturers to take
satisfactory corrective action in response to an adverse QSR inspection, can result in, among other things:

●	administrative
or judicially imposed sanctions;

●	injunctions
or the imposition of civil penalties;

●	recall
or seizure of our product candidates;

●	total
or partial suspension of production or distribution;

●	the
FDA’s refusal to grant future clearance or pre-market approval for our product candidates;

●	withdrawal
or suspension of marketing clearances or approvals;

●	clinical
holds;

●	warning
letters;

●	refusal
to permit the import or export of our product candidates; and

●	criminal
prosecution of us or our employees.

Any
of these actions, in combination or alone, could prevent us from marketing, distributing, or selling our product candidates and would
likely harm our business. In addition, a product defect or regulatory violation could lead to a government-mandated or voluntary recall
by us. Regulatory agencies in other countries have similar authority to recall devices because of material deficiencies or defects in
design or manufacture that could endanger health. Any recall would divert management attention and financial resources, could expose
us to product liability or other claims, including contractual claims from parties to whom we sold product candidates and harm our reputation
with customers. A recall involving any of our product candidates would be particularly harmful to our business and financial results
and, even if we remedied a particular problem, would have a lasting negative effect on our reputation and demand for our product candidates.

While Breakthrough Device Designation allows
for increased interaction with FDA reviewers and prioritized submission review, it does not guarantee product approval, faster approval,
or commercial success.

The FDA may grant BDD to
medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. In July
2022, the Revivent TC System received BDD for the treatment of heart failure patients with left ventricular scar. This designation is
intended to expedite development and regulatory review while maintaining the FDA’s statutory standards for premarket approval,
510(k) clearance, or De Novo classification.

While BDD allows for increased
interaction with FDA reviewers and prioritized submission review, it does not guarantee product approval, faster approval, or commercial
success. The Revivent System remains subject to extensive regulatory requirements, including but not limited to premarket approval, manufacturing
quality systems, labeling, and post-market surveillance. Medical devices may only be marketed for uses approved by the FDA, and we must
comply with the FDA’s QSR, covering manufacturing, testing, labeling, and documentation processes.

Our
manufacturing facilities and those of our suppliers are subject to periodic FDA inspections, which may be unannounced. Any failure to
comply with applicable regulations could delay approval, limit commercialization, or lead to enforcement actions that could materially
impact our business.

Risks
Related to Our Securities and this Offering

active trading market for our common stock currently exists, and an active trading market may not develop or be sustained following this
offering.

Prior
to this offering, there has not been an active trading market for our common stock. If an active trading market for our common stock
does not develop following this offering, you may not be able to sell your shares quickly or at the market price. Our ability to raise
capital to continue to fund operations by selling shares of our common stock and our ability to acquire other companies or technologies
by using shares of our common stock as consideration may also be impaired. The initial public offering price of our common stock will
be determined by negotiations between us and the underwriters and may not be indicative of the market prices of our common stock that
will prevail in the trading market.

The
trading price of our common stock may be volatile, and you could lose all or part of your investment.

Prior
to this offering, there has been no public market for shares of our common stock. The initial public offering price of our common stock
will be determined through negotiations between us and the underwriters. This price does not necessarily reflect the price at which investors
in the market will be willing to buy and sell shares of our common stock following this offering. In addition, the trading price of our
common stock following this offering is likely to be volatile and could be subject to fluctuations in response to various factors, some
of which are beyond our control. These fluctuations could cause you to lose all or part of your investment in our common stock as you
might be unable to sell your shares at or above the price you paid in this offering. Factors that could cause fluctuations in the trading
price of our common stock include the following:

●	price
and volume fluctuations in the overall stock market from time to time;

●	volatility
in the trading prices and trading volumes of transportation stocks;

●	changes
in operating performance and stock market valuations of other transportation companies generally, or those in our industry in particular;

●	sales
of shares of our common stock by us or our stockholders;

●	failure
of securities analysts to maintain coverage of us, changes in financial estimates by securities analysts who follow our company,
or our failure to meet these estimates or the expectations of investors;

●	the
financial projections we may provide to the public, any changes in those projections, or our failure to meet those projections;

●	announcements
by us or our competitors of new product candidates, features, or services;

●	the
public’s reaction to our press releases, other public announcements and filings with the SEC;

●	rumors
and market speculation involving us or other companies in our industry;

●	actual
or anticipated changes in our results of operations or fluctuations in our results of operations;

●	actual
or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally;

●	litigation
involving us, our industry, or both, or investigations by regulators into our operations or those of our competitors;

●	developments
or disputes concerning our intellectual property or other proprietary rights;

●	announced
or completed acquisitions of businesses, product candidates, services or technologies by us or our competitors;

●	new
laws or regulations or new interpretations of existing laws or regulations applicable to our business;

●	changes
in accounting standards, policies, guidelines, interpretations or principles;

●	any
significant change in our management; and

●	general
economic conditions and slow or negative growth of our markets.