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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suppliers that could make or provide any one of our externally-sourced components, we seek to manage single-source supplier risk by regularly assessing the quality and capacity of its suppliers, implementing supply and quality agreements where appropriate and actively managing lead times and inventory levels of sourced components. We generally seek to maintain sufficient supply levels to help mitigate any supply interruptions and enable it to find and qualify another source of supply. For certain components, we estimate that it would take up to six months to find and qualify a second source. Order quantities and lead times for externally sourced components are based on our forecasts, which are derived from historical demand and anticipated future demand. Lead times for components may vary depending on the size of the order, time required to fabricate and test the components, specific supplier requirements and current market demand for the materials, sub-assemblies and parts.

Suppliers
are evaluated, qualified and approved as part of our supplier quality program, which includes verification and monitoring procedures
to ensure that our suppliers comply with FDA and ISO standards, as well as our own specifications and requirements. We inspect and verify
externally-sourced components under strict processes supported by internal policies and procedures. We maintain a rigorous change control
policy to assure that no product or process changes are implemented without prior review and approval. Our finished product candidates
are sterilized via gamma radiation by an approved supplier.

Regulatory
Pathway

Our
regulatory pathway for the Revivent System is strategically structured to facilitate clinical validation and eventual market approval,
following the FDA’s guidelines for Class III medical devices. The Revivent System, designed to treat ischemic heart failure through
minimally invasive ventricular remodeling, has been granted BDD status that underscores its potential to meet a critical unmet medical
need. This designation provides us with FDA priority review and enhanced guidance on regulatory submissions, with the goal of
expediting patient access to the device.

The
regulatory process for the Revivent System began with the completion of the ALIVE Trial, a PMA study that served as the basis for an
IDE. An IDE was granted by the FDA to initiate the pivotal RELIVE Trial, which is structured as the definitive study supporting PMA submission.
The RELIVE Trial, which began in 2025, evaluates the Revivent System’s safety and efficacy through a comprehensive
clinical protocol, including patient-specific endpoints such as left ventricular volume reduction, quality-of-life metrics, and device-related
adverse events. We anticipate completing the study and submitting the results to the FDA as part of its PMA application by 2028.

support regulatory compliance, we have conducted extensive preclinical studies, including biocompatibility testing, device fatigue assessments,
and animal model evaluations in alignment with FDA guidelines and ISO 13485 standards. These preclinical studies seek to validate
the durability and safety of the device’s External Anchor configuration (any such determinations would be made by the FDA),
designed to improve procedural outcomes and reduce adverse events compared to traditional cardiac surgery. We continue to engage with
the FDA through formal meetings and ongoing data submissions to streamline the regulatory process and align trial protocols with FDA
expectations.

addition to U.S. regulatory progress, we have initiated regulatory applications for the Revivent System in the European
Union, where it has achieved CE Mark approval for clinical use. This approval serves as a basis for the system’s potential expansion
to additional global markets and provides supportive evidence for its efficacy and safety in treating heart failure patients with severe
left ventricular scarring.

Through
its coordinated regulatory strategy, we aim to meet all FDA requirements for PMA submission while concurrently expanding its global market
presence. The Breakthrough Device Designation, combined with an IDE for the pivotal RELIVE Trial, along with
the already obtained CE Mark, positions us to bring the Revivent System to market as an innovative solution for ischemic heart failure,
with the potential to transform therapeutic standards in cardiac care.

and when the RELIVE trial is fully funded, we plan to use excess capital to fund Alginate’s clinical and regulatory development
through catheter development, a new or revised IDE submission, and a new trial. The earliest we expect to commence an Alginate trial
is 2028 and the earliest possible commercialization year for Alginate is estimated to be 2032.

Government
Regulation

Our
operations are governed by comprehensive regulatory requirements enforced by the FDA, state authorities, and comparable regulatory bodies
worldwide. The Revivent System is classified as a Class III medical device under the Federal Food, Drug, and Cosmetic Act (“FDCA”),
subjecting it to rigorous oversight to ensure safety and effectiveness. These regulations impact every stage of the product lifecycle,
from development, non-clinical and clinical research, manufacturing, quality assurance, and labeling to post-market surveillance. We
are committed to strict compliance with all applicable regulatory frameworks to ensure its product candidates meet FDA and international
standards for safety and efficacy.

FDA
Pre-market Approval (“PMA”) Application

a Class III medical device, the Revivent System requires Pre-market Approval from the FDA before it can be legally marketed in the United
States. The PMA process is highly rigorous, requiring the sponsor to present comprehensive data establishing the device’s safety
and effectiveness for its intended use. Our PMA application for the Revivent System is structured to include extensive non-clinical
and clinical data, as well as information on manufacturing, quality control systems, device labeling, and intended use.

The
PMA process involves multiple stages of review, beginning with the submission of detailed device design, testing protocols, and clinical
trial results. The FDA initially reviews the application for completeness before entering a substantive review phase, where the device’s
safety and efficacy data are evaluated. The FDA is statutorily required to complete this review within 180 days; however, the review
process may extend beyond this timeframe based on factors such as the complexity of data or additional information requests. If the FDA
deems the data to demonstrate a reasonable assurance of safety and effectiveness, the device may be approved for commercial distribution.
As part of PMA approval, the FDA may impose post-approval requirements, including patient follow-up, additional clinical studies, or
surveillance to gather long-term safety and efficacy data. Any significant modification to the Revivent System following PMA approval
requires a PMA supplement or, if the modification substantially changes the device’s intended use or design, an entirely new PMA
application.

Quality
System Regulation and Current Good Manufacturing Practices (“cGMP”)

Our
manufacturing activities for the Revivent System comply with FDA’s QSR, a comprehensive set of requirements governing the design,
production, and distribution of medical devices. Contract manufacturers used by us must adhere to QSR, including cGMP, to maintain
high standards of product quality, consistency, and regulatory compliance. QSR encompasses detailed standards for quality assurance,
including device design, raw material selection, production testing, labeling, and packaging, as well as stringent recordkeeping requirements
to ensure traceability.

Compliance
with QSR and cGMP is enforced by the FDA through periodic inspections of our contract manufacturing facilities. These inspections
assess adherence to FDA standards and identify any deficiencies, which could result in warning letters, civil penalties, or other enforcement
actions if not addressed promptly. Non-compliance may lead to more severe regulatory actions, including restrictions on device production
or distribution. We maintain a continuous monitoring program with its manufacturing partners to ensure that all production and
quality control processes meet QSR and cGMP standards, safeguarding the integrity and safety of the Revivent System.

Post-market
Surveillance and Reporting Obligations

Having
obtained CE Mark and after obtaining clearance or approval in other geographical areas including the U.S., we must fulfill
extensive post-market requirements to ensure the Revivent System continues to meet safety and performance standards. These obligations
include, but are not limited to, compliance with Medical Device Directive (“MDD”) and Medical Device Reporting (“MDR”)
regulations, which require us to report incidents in which the device may have contributed to or caused a death, serious injury,
or significant malfunction. In addition, we must remain in compliance with FDA post-market requirements to be determined at time
of approval. Proper agreed upon compliance and reporting is crucial for ongoing FDA oversight and enables proactive risk management for
both us and the FDA.

Additionally,
we are subject to FDA requirements for field actions, including recalls or corrective actions. If we identify or are informed
of any issues posing potential health risks, it must report these to the FDA and undertake corrective actions, which may include product
recalls, notifications to healthcare providers, or technical adjustments to the device. The FDA retains authority to initiate or mandate
additional post-market surveillance, such as long-term clinical studies or patient registries, to gather data on the device’s safety
and effectiveness in larger, real-world populations. We proactively monitor all post-market data and incident reports, using
this information to improve product performance and align with FDA post-market expectations.

Foreign
Regulatory Compliance and CE Mark Approval