SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS
Document Type: DRS
Date Filed: 2025-08-05
Accession Number: 0001641172-25-022123
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000164117225022123/filename1.htm

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particular to the transaction. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Those estimated values do not necessarily represent the amounts that may be ultimately realized due to the occurrence of future circumstances that cannot be reasonably determined. Because of the inherent uncertainty of valuations, those estimated values may be materially higher or lower than the values that would have been used had a ready market for the assets or liabilities existed. Research and Development Costs and expenses that can be clearly identified as research and development are charged to expense as incurred in accordance with FASB ASC 730-10. Research and development costs are charged to expense as incurred and include the cost of wages, equipment, materials, and laboratory fees paid in conducting scientific research on product candidates. Stock-Based Compensation

account for stock-based compensation to employees and non-employees in conformity with the provisions of FASB ASC Topic 718, Compensation
- Stock Based Compensation. We expense stock-based compensation to employees and non-employees over the requisite service
period based on the estimated grant-date fair value of the awards. We estimate the fair value of options granted using the Black
Scholes Merton model. We estimate when and if performance-based awards will be earned. If an award is not considered probable
of being earned, no amount of equity-based compensation expense is recognized. If the award is deemed probable of being earned, related
equity-based compensation expense is recorded. The fair value of an award ultimately expected to vest is recognized as an expense, net
of forfeitures, over the requisite service, which is generally the vesting period of the award. Options forfeitures are recorded as they
occur.

The
Black Scholes Merton model requires the input of certain subjective assumptions and the application of judgment in determining the fair
value of the awards. The most significant assumptions and judgments include the following:

●	Expected
volatility - The expected price volatility is based on the historical volatilities of peer group companies as we do not have
a sufficient trading history. Industry peers consist of several public companies in the bio-tech industry similar in size, stage
of life cycle, and capital structure. We also blend in historical data on the volatility of its own equity, increasing in
proportion as the period of historical data on our data becomes more representative.

●	Risk-free
interest rate - The risk-free rate was determined based on yields of U.S. Treasury Bonds of comparable terms.

●	Expected
dividend yield - We have not previously issued dividends and do not anticipate paying dividends in the foreseeable future.
Therefore, we used a dividend rate of zero based on our expectation of additional dividends.

●	Expected
term -The expected term of the options was estimated using the simplified method.

Shares
of common stock issued to third parties for services provided are valued at fair value of our common stock.

Recently
Adopted Accounting Pronouncements

The
Financial Accounting Standards Board (FASB) has issued several new accounting standards that are not yet effective for us, including
ASU 2023-01 (Leases – Common Control Arrangements), ASU 2023-02 (Equity Method Investments), ASU 2023-05 (Joint Venture Formations),
and ASU 2023-07 (Segment Reporting).

have evaluated these new standards and does not
expect them to have a material impact on its financial position, results of operations, or cash flows upon adoption.

BUSINESS

Overview

We are a clinical-stage
medical device company focused on developing, manufacturing and commercializing proprietary devices to restore left ventricular function
in heart failure patients with reduced ejection fraction (“HFrEF”). In HFrEF patients with left ventricular dilation due
to large anterior heart attack scars, cardiac surgeons elect to utilize our product, the Revivent system (the “Revivent System”),
in order to restore left ventricular function by reducing the size of the left ventricle. The Revivent System does so by folding the
scar onto itself and fastening it together in a less invasive mini-thoracotomy procedure. Absent the Revivent System, patients suffer
the grim prognosis of 50-60% five-year mortality rates when treated with the standard of care, currently consisting of a combination
of medications used to treat HFrEF.

In November 2024, we received an investigational device exemption (“IDE”) from the U.S. Food and Drug Administration
(the “FDA”) under Breakthrough Therapy Designation (“BTD”) to begin a pivotal trial (the “RELIVE Trial”).
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 prior trial, which was completed 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 our primary efficacy endpoint. However, the failure of the other two measures 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 Journal of the American College of Cardiology (“JACC”)
ALIVE Trial publication, the authors noted that (1) 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 (2) the external
anchor placement (surgical only approach) was safer than the internal RV-LV anchor placement (hybrid procedure).

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 for approval. 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, surgeon experience, and trial expense. We anticipate first subject treatment in August 2025. 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 340 United States (“US”) cardiac surgery centers which represent 30% of hospitals performing cardiac
surgeries and 51% of cardiac surgery volume. Ultimately, through the approximately 1,120 U.S. cardiac surgery centers, we will
seek to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. Based
on leading cardiac surgery device companies averaging 60% of their total revenue in the U.S., we estimate an additional 213,000
identifiable and appropriate patients which have similar unmet needs outside the U.S. Approximately 28,000 and 32,000 Revivent
System-eligible patients are added each year to U.S. and ex-U.S. prevalence, respectively, and a similar number are lost
each year to mortality.

Background
on ST Elevated Myocardial Infarction (“STEMI”)

Annually,
approximately 322,000 individuals in the U.S. suffer a STEMI event, of which approximately 35% have scarring in the heart’s
anterior wall, and of these approximately 25% have scarring greater than 30% of the anterior wall, which provides the 28,000 annual and
new eligible patient population for the Revivent System. These 28,000 patients encounter a grim prognosis, with a 50-60% mortality
rate over five years and continuous health deterioration marked by frequent acute events. In the U.S., cardiologists monitor 192,000
existing eligible patients. We estimate that internationally, an additional 213,000 eligible and identifiable patients have similar grim
prognoses.

heart attack, also known as a myocardial infarction, occurs when blood flow to the heart is blocked, preventing the heart muscle from
getting enough oxygen. When a heart attack occurs, it causes the heart muscle that lost blood supply to be damaged. The amount of damage
to the heart muscle depends on the size of the area supplied by the blocked artery and the time between injury and treatment. The risk
of recurrent myocardial infarction, death and heart failure increases rapidly when the time between the heart attack and a PCI treatment
exceeds one hour. Nearly half of U.S. patients receive their PCI treatment an hour or more after their heart attack. Heart muscle
damaged by a heart attack heals by forming scar tissue. While PCI treatment in heart attack patients quickly restores heart blood flow
to the coronary artery and heart, a PCI procedure does not repair the already damaged tissue caused by the heart attack. As a result
of the scarred tissue, the heart enlarges and the left ventricle remodels. When the left ventricle remodels due to scar damage, it undergoes
structural changes in size, shape, and thickness, which can lead to impaired pumping ability and potentially progress to heart failure
if left untreated. Essentially, the left ventricle becomes enlarged and thinner (dilated), affecting its ability to efficiently pump
blood throughout the body.

Figure
1. Cardiovascular Post-MI Remodeling Imaging