SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: S-1/A
Document Type: S-1/A
Date Filed: 2026-05-15
Accession Number: 0001493152-26-023752
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315226023752/forms-1a.htm

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of our product candidates for which governmental reimbursement may be available, as being in violation of applicable laws. If our relationships with physicians are found to be in violation of the laws and regulations that apply to us, we may be required to restructure the arrangements and could be subject to administrative, civil and criminal penalties, including exclusion from participation in government healthcare programs, imprisonment, and the curtailment or restructuring of our operations, any of which could negatively impact our ability to operate our business and our results of operations. Our company and many of our collaborators and potential collaborators may be required to comply with the Federal Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act and implementing regulations affecting the transmission, security and privacy of health information, and failure to comply could result in significant penalties and reputational harm.

Numerous
federal and state laws and regulations, including HIPAA and the HITECH Act, govern the collection, dissemination, security,
use and confidentiality of health information that identifies specific patients. HIPAA and the HITECH Act require our surgeon and hospital
customers and potential customers to comply with certain standards for the use and disclosure of health information within their companies
and with third parties. The Privacy Standards and Security Standards under HIPAA establish a set of standards for the protection of individually
identifiable health information by health plans, health care clearinghouses and certain health care providers, referred to as Covered
Entities, and the business associates with whom Covered Entities enter into service relationships pursuant to which individually identifiable
health information may be exchanged. Notably, whereas HIPAA previously directly regulated only these Covered Entities, the HITECH Act
makes certain of HIPAA’s privacy and security standards also directly applicable to Covered Entities’ business associates.
As a result, both Covered Entities and business associates are subject to significant civil and criminal penalties for failure to comply
with Privacy Standards and Security Standards.

HIPAA
requires Covered Entities (like many of our customers and potential customers) and their business associates to develop and maintain
policies and procedures with respect to protected health information that is used or disclosed, including the adoption of administrative,
physical and technical safeguards to protect such information. The HITECH Act expands the notification requirement for breaches of patient-identifiable
health information, restricts certain disclosures and sales of patient-identifiable health information and provides for civil monetary
penalties for HIPAA violations. The HITECH Act also increased the civil and criminal penalties that may be imposed against Covered Entities
and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts
to enforce the federal HIPAA laws and seek attorney fees and costs associated with pursuing federal civil actions. Additionally, certain
states have adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA. While we are
not directly subject to HIPAA as a Covered Entity or business associate, we may be required to comply with HIPAA requirements in connection
with the conduct of our clinical trials.

Any
new legislation or regulation in the area of privacy and security of personal information, including personal health information, could
also adversely affect our business operations. If we do not comply with existing or new applicable federal or state laws and regulations
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.