SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-10-06
Accession Number: 0001493152-25-016953
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225016953/filename1.htm

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mortality. Our goal is for the Revivent System to be the new standard of care for these patients. also have ownership rights to Alginate, a hydrogel-based device treatment for HFrEF patients without anterior scarring. November 2024, we received an investigational device exemption (“IDE”) from the U.S. Food and Drug Administration (the “FDA”) under a Breakthrough Therapy Designation (“BTD”) to begin a pivotal trial of the Revivent System (called the “RELIVE Trial”). We began enrolling patients in the RELIVE Trial in September 2025. An IDE authorizes the use of a significant-risk investigational medical device in a clinical study in order to collect safety and effectiveness data but does not constitute FDA clearance or approval to market or commercialize the device. The FDA grants BTD if preliminary clinical evidence suggests the procedure may improve substantially upon at least one clinically significant endpoint for a serious or life-threatening condition compared to existing therapies.

Our
company, under prior management, previously conducted a clinical trial of the Revivent System (called the “ALIVE Trial”),
which ended in 2023. The ALIVE Trial achieved statistical significance upon secondary analysis on functional status and Quality-of-Life
(“QoL”) measures, three of the five measures in the trial’s primary efficacy endpoint. The functional status and QoL
endpoints included change in 6-minute walk test (“6MWT”), change in Minnesota Living with Heart Failure questionnaire score
(“MLHF”), and change in New York Heart Association (“NYHA”) functional classification assessed at 12 months.
However, as reported in the Journal of the American College of Cardiology (“JACC”) ALIVE Trial publication, the failure of
the other two measures, cardiovascular mortality and heart failure hospitalization, were in part a result of the comparison of our trial
results with a control group that was healthier than the treatment group. This was a result of prior management’s decision to not
randomize the ALIVE Trial. In the JACC ALIVE Trial publication, the authors noted that (i) the control group was healthier than the treated
group as evidenced by heart failure treatments and hospitalizations in the twelve months prior to the trial and better baseline left-ventricle
function; and (ii) the external anchor placement (surgical only approach) produced safer outcomes than the internal right ventricle-left ventricle
(RV-LV) anchor placement (hybrid procedure). The composite primary safety endpoint through 30 days was met. Major adverse events occurred
in 15 of 84 patients (17.9%) of which 12 out of 60 patients (20%) were in the hybrid procedure and 3 out of 23 (13.0%) were in the surgical
only approach. In 1 patient, the device procedure was attempted but aborted before device anchor placement. While the ALIVE trial met
its safety endpoints inclusive of the hybrid procedure and surgical only approach, we have decided to test the surgical only approach
only in the RELIVE trial due to its more favorable safety profile.

Our
current management team is following the JACC article authors’ recommendations by designing a randomized control trial using the
external anchor placement approach. We proposed and were approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients
and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition)
to support our Revivent Therapy Pre-Market Approval (“PMA”) application. We are actively engaged with approximately half
of the sites needed for the RELIVE Trial, providing confidence to management on their estimates on site initiation, recruitment rates,
heart failure specialist referral rates, surgeon experience, and trial expense.

The
Revivent System is classified by the FDA as a Class III medical device and requires PMA approval. In the event we receive FDA PMA approval
for our Revivent System, which we believe could be by mid-2028, we intend to expand from the 20 or more cardiac surgery centers participating
in the trial to the top 336 United States cardiac surgery centers which represent approximately 30% of hospitals performing cardiac surgeries
and 51% of cardiac surgery volume according to data published in The American Journal of Accountable Care. Ultimately, through the approximately
1,545 U.S. heart failure specialist and 1,120 U.S. cardiac surgery centers, our goal is to deploy the Revivent System in the market
to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. based on our estimations.

While
our priority is conducting the RELIVE Trial, we intend to support post-market surveillance to maintain our Revivent System CE mark and may
build a small European commercial organization if funding from this offering or otherwise becomes available in excess of our trial expenses.
In addition, we expect to conduct post-approval studies to support marketing and to satisfy any ongoing regulatory requirements.

There
is no guarantee that the RELIVE Trial will be sufficient for FDA approval, and in such case, we may be required to conduct additional
trials for the Revivent System. See “Risk Factors – If our clinical trials are unsuccessful or significantly delayed,
or if we do not complete our clinical trials, our business may be harmed.” and “Risk Factors – The FDA regulatory
approval, clearance and license process is complex, time-consuming and unpredictable.”

In the event we receive FDA
PMA approval for our Revivent System, which we anticipate could be by mid-2028, we intend to expand from the 20 or more cardiac surgery
centers participating in the trial to the top 336 United States cardiac surgery centers which represent 30% of hospitals performing cardiac
surgeries and approximately 51% of cardiac surgery volume (“Inpatient and 90-Day Postdischarge Outcomes in Cardiac Surgery,”
The American Journal of Accountable Care). Ultimately, through the approximately 1,120 U.S. cardiac surgery centers, our goal is to
serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. Approximately
28,000 Revivent System-eligible patients are added each year to U.S. prevalence, respectively, and a similar number are lost each year
to mortality. The Revivent System is classified by the FDA as a Class III medical device, which is subject to the most stringent
regulatory requirements, including the requirement to demonstrate reasonable assurance of safety and effectiveness through well-controlled
clinical investigations. While we currently anticipate submitting a PMA following completion of the RELIVE trial, FDA approval may not
be obtained on this timeline or at all, and the FDA could require additional clinical trials or other data before granting any approval.
See “Risks Related to Regulatory Approval and Other Governmental Regulations.”

Principal
Factors Affecting Our Financial Performance

Our
operating results are primarily affected by the following factors:

●	the
ability to obtain regulatory approval to market our product candidates;

●	the
timing, costs and results of clinical trials and other development activities versus expectations;

●	the
ability to manufacture product candidates successfully;

●	competition
from product candidates sold or being developed by other companies;

●	the
price of, and demand for, our product candidates once approved;

●	the
ability to negotiate favorable licensing or other manufacturing and marketing agreements for our product candidates;

●	patent
reinforcement and prosecution; and

●	changes
in laws or the regulatory environment affecting our company.

Our
Status as an Emerging Growth Company and Smaller
Reporting Company

qualify as an “emerging growth company” under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions
from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:

●	have
an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

●	comply
with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation
or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e.,
an auditor discussion and analysis);

●	submit
certain executive compensation matters to shareholder advisory votes, such as “say-on-pay” and “say-on-frequency;”
and

●	disclose
certain executive compensation related items such as the correlation between executive compensation and performance and comparisons
of the chief executive officer’s compensation to median employee compensation.

addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period
provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging
growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable
to those of companies that comply with such new or revised accounting standards.