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

Chunk 42 of 87
Word Count: 1384
Character Count: 9303

Document Content:

position our Revivent System as a compelling option for patients, who currently face 50-60% mortality rates over five years. Figure 2. Typical HF Patient Progression and Treatment Options believe that we are well-positioned to serve a substantial, underserved global addressable market of approximately $16 billion in eligible and appropriate patients (prevalence) and once served, $2.4 billion of annually recurring patients (incidence). Assuming we achieve similar reimbursement to Barostim and Impella devices, which we believe are similar treatment devices for HFrEF, the U.S. would represent an approximate $10 billion addressable market. This addressable market based on our assumptions for U.S. prevalence in 2024 is 192,000, U.S. incidence of 28,000. To obtain the global addressable market, we divide the U.S. market by 60% based on the average U.S. revenue share of Boston Scientific and Edwards Lifesciences, companies whose revenue is primarily cardiovascular medical devices, as the Revivent System is. The Revivent System

The
Revivent System is a novel and proprietary medical device engineered to plicate (fold) and exclude non-functional scar tissue in the
left ventricular (“LV”), enabling healthy myocardial tissue to restore efficient cardiac function. Cardiothoracic surgeons
can perform the procedure on a beating heart in under ninety minutes through a mini-thoracotomy incision, making it significantly
less invasive than open heart surgery. As a point of comparison, a similar procedure using open heart surgery requires a sternotomy (cutting
through the breastbone to access the heart and lungs), cardiopulmonary bypass, cardioplegic arrest, frequent procedural complications,
as well as long recovery times.

The
Revivent System procedure places external left-ventricle to left-ventricle (“LV-LV”) anchors with or without external
right ventricle to left ventricle anchors (“RV-LV”). The anchoring system is composed of two polyester covered titanium anchors
(5 x 25 mm) mounted on a polyethylene ether ether ketone (PEEK) tether. The anchors are drawn together to appose the LV free wall to
the septum in the case of RV anchors as well as plicating the anterior wall onto itself in the case of LV-LV anchors, thereby excluding
the nonviable anteroseptal scar.

Plicated
Non-Functional Scar Revivent
System Anchors

Figure
3. Plicated Non-Functional Scar (Left) and Revivent System Anchors (Right).

Figure
4. Comparison of Healthy Heart, Dilated & Scarred Heart post-MI scarring, and Revivent Heart Post-Procedure.

reducing LV volume and wall tension, the Revivent System is designed to hopefully enhance the performance of the remaining functional
myocardium (or heart muscle), if successful, this may effectively address the core pathology of heart failure in patients with substantial
LV scarring. The principles of Laplace’s Law guide the remodeling process. Based on Laplace’s Law, wall tension in the LV
is proportional to the chamber’s size and inversely proportional to wall thickness. The Revivent System will potentially
exclude scarred tissue from the functional myocardium, and we anticipate this reduces LV size, decreasing wall tension and thereby improving
cardiac function.

Alginate

addition to the Revivent System, we also own an unapproved and investigatory alginate-based hydrogel product (“Alginate”)
to potentially treat heart failure patients with reduced ejection fraction (“HFrEF”) who may not be appropriate for the Revivent
System due to a non-anterior scar or non-ischemic cardiomyopathy. U.S. prevalence of HRrEF in 2024 was approximately 3.3 million adults.
Presumed labeling would include an indication that therapeutic procedures would be limited to those with moderate symptoms (NYHA III;
25-35%) or severe symptoms (NYHA IV; 5-10%). We anticipate 1.0 to 1.5 million of moderate to severe HFrEF adults less the 322,000 appropriate
for Revivent, suggests 0.7 million to 1.2 million adults may be appropriate for Alginate. Further clinical work will provide greater
precision in determining the target market size. Like the Revivent System, Alginate is theorized to reduce LV wall stress to enhance
heart performance and we believe this does so by increasing wall thickness. Alginate was CE-marked in Europe and had an approved IDE
for the U.S. While we could resubmit and, subject to approval, start trials using a surgical approach to apply Alginate, we now believe
the better procedure is to deliver Alginate via catheter. If and when the RELIVE trial is fully funded, we plan to use any excess
capital to fund catheter development, a new or revised IDE submission (as the prior IDE for Alginate has expired), and a new Alginate
trial. The earliest we expect to commence an Alginate trial is 2028 and the earliest possible commercialization year is estimated to
be 2032. We estimate that reimbursement for Alginate will be similar to the Revivent System, since the prognosis and therapeutic alternatives
are similar to those eligible for the Revivent System. The addition of Alginate aligns with and complements our strategic objective to
address broader heart failure populations through targeted, innovative therapies.

The
anticipated Alginate procedure, hydrogel beads are delivered percutaneously through a catheter to specific areas of the heart muscle
to prevent further LV enlargement. The presumed action of the beads, which are inert and believed to be well tolerated by the local tissue,
are designed to remain in the left ventricle muscle wall as a string of permanent implants that form a ring around the ventricle (hydrogel
beads implants in figure 3 below). The implant ring acts as a permanent prosthetic scaffold, is thought to increase wall thickness, and
changes the LV geometry to prevent further LV enlargement. If successful in our clinical trials, we believe that treated patients may
benefit from improved LV systolic function without negatively impacting LV relaxation or filling.

Figure
5. Illustration of Alginate Implant Mechanism. The image shows the placement of alginate implants on a heart model strategically
positioned to support the ventricular walls and improve overall heart function.

Historical
and Planned Clinical Trials

have made considerable advancements in the clinical development of the Revivent System through a structured sequence of trials aimed
at establishing the safety and efficacy of this minimally invasive intervention for heart failure patients with severe left ventricular
scarring. We obtained our CE mark, the regulatory approval necessary for European commercial sales, in 2016 and followed up with a long
term results study in 2019. We completed the ALIVE trial in 2023 and based on its findings and FDA granting the IDE in November 2024
are now expecting to launch the RELIVE trial in 2025.

Mark in Europe

obtain our Revivent System CE mark, we conducted a CE-mark study evaluating the Revivent System, the results of which
were published by Dr. Patrick Klein in 2019 (the publication was titled Single Center Long-Term Results with LIVE Therapy)., This
study successfully met its primary safety endpoint of serious adverse events (“SAEs”) during a 12-month follow-up period
as compared to historical surgical ventricular reconstruction (SVR). In the 86-patient study, major adverse events occurred in 7 patients
(8.1%) within 30 days, with an in-hospital mortality rate of 4.5% (4 patients). Ventricular arrhythmias were the most frequently observed
peri-procedural complication but were generally manageable with standard therapies. Emergent surgical conversion was required in a small
number of patients, most often due to bleeding or perforation; importantly, no patient requiring emergent surgery died within 12 months
of follow-up. The observed 12-month survival of 90.6% was also comparable to SVR outcomes. The study met the primary efficacy endpoint
of a measurable decrease in LV volume by either an echocardiography or a cardiac magnetic resonance (“CMR”) imaging
at six months and one year. Specifically, the left ventricular end-systolic volume index (“LVESVi”) was reduced
by a statistically significant 27% reduction and left ventricular ejection fraction (“LVEF”) was increased
by 16% on a relative basis, underscoring the effectiveness of the Revivent System while maintaining a favorable safety profile.
Based on these results, the study authors concluded that treatment with the Revivent System in the enrolled patients
with symptomatic heart failure resulted in statistically significant and sustained reduction of LV volumes and improvement of LV function,
symptoms, and quality-of-life. While a Single Center investigator initiated study and non-randomized, the study findings appear to suggest
that the therapy could extend life and improve the quality-of-life that is extended.

currently have “NUB Status” in Germany, which is the German acronym for „Neue Untersuchungs-und Behandlungsmethode”
which can be translated as “new examination and treatment method.” It provides a mechanism for reimbursement for innovative
devices and procedures. While our priority is the RELIVE Trial, we plan to build a small European commercial organization if funding
from our initial public offering in excess of our trial expenses becomes available.

ALIVE
Trial