SEC Filing Document

Company: BIOVENTRIX, INC.
Ticker: 
CIK: 1283259
Filing Type: DRS/A
Document Type: DRS/A
Date Filed: 2025-12-12
Accession Number: 0001493152-25-027406
Exchange: 
SIC Code: 3841
SIC Description: Surgical & Medical Instruments & Apparatus
URL: https://www.sec.gov/Archives/edgar/data/1283259/000149315225027406/filename1.htm

Chunk 40 of 89
Word Count: 1415
Character Count: 9314

Document Content:

Valuations based on inputs that are unobservable. These valuations require significant judgment. The availability of valuation techniques and observable inputs can vary and is affected by a wide variety of factors, including the type of asset or liability, whether the asset or liability is new and not yet established in the marketplace, and other characteristics 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 the Company,
including ASU 2023-06 (Disclosure Improvements), ASU 2023-09 (Income Taxes), ASU 2024-03 (Expense Disaggregation Disclosures),
and ASU 2025-03 (VIE Business Combinations).

The Company has 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

are a 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”).

Our
lead device program, the Revivent System, has a CE mark in Europe and is in its pivotal trial in the United States. In Europe
(where we have obtained approval but are currently not commercially operating in order to preserve capital) or through an authorized
U.S. clinical site (as we have not received FDA approval), heart failure specialists refer HFrEF patients with left ventricular dilation
due to large anterior heart attack scars to cardiac surgeons who elect to utilize our product to restore left ventricular function by
reducing the size of the left ventricle. The Revivent System accomplishes this reduction by folding the scar onto itself and fastening
it together in a less invasive mini-thoracotomy procedure.

Based on our analysis of publicly available data and according to a 2016
New England Journal of Medicine article, patients with heart failure with HFrEF continue to face poor outcomes under the current standard
of care, with multiple studies reporting an approximately 50–60% five-year 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.

Our
Past and Current Clinical Trials in the United States

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 fewer major adverse events 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 one 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 the fact that fewer major adverse events could indicate that it has
a more favorable safety profile, which would ultimately be determined by the FDA.

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.