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

Chunk 21 of 94
Word Count: 1212
Character Count: 8214

Document Content:

and results of operations. we cannot obtain FDA authorization to utilize product candidates manufactured from our cGMP manufacturing center on a timely basis or at all, we could experience supply constraints that could delay our clinical trials. Any disruption in the supply of our product candidates could result in delays in our clinical trials, which would materially adversely affect our business, financial condition, results of operations and growth prospects. we fail to identify, acquire and develop other product candidates, we may be unable to grow our business. a significant part of our growth strategy, we intend to develop and commercialize additional product candidates through our research and development program or by licensing or acquiring additional product candidates and technologies from third parties. The success of this strategy depends upon our ability to identify, select and acquire the right to product candidates and technologies on terms that are acceptable to us.

Any
product we identify, license or acquire may require additional development efforts prior to commercial sale, including extensive clinical
testing and approval or clearance by the FDA and applicable foreign regulatory authorities. All product candidates are prone to the risks
of failure inherent in medical device product development, including the possibility that the product will not be shown to be sufficiently
safe and effective for approval or clearance by regulatory authorities. In addition, there is a risk that any such product candidates
that are approved or cleared will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace.

Proposing,
negotiating and implementing an economically viable product or technology acquisition or license is a lengthy and complex process. Other
companies, including those with substantially greater financial, marketing and sales resources, may compete with us for the acquisition
or license of approved or cleared product candidates. We may not be able to acquire or license the rights to additional approved or cleared
product candidates on terms that we find acceptable, or at all. If we are unable to develop suitable potential product candidates through
internal research programs or by obtaining rights from third parties, it could have a material adverse effect on our business, financial
condition and results of operations.

may acquire other businesses which could require significant management attention, disrupt our business, dilute stockholder value and
adversely affect our results of operations.

part of our business strategy, we may in the future make acquisitions or investments in complementary companies, product candidates or
technologies that we believe fit within our business model and can address the needs of our customers and potential customers. In the
future, we may not be able to acquire and integrate other companies, product candidates or technologies in a successful manner. We may
not be able to find suitable acquisition candidates, and we may not be able to complete such acquisitions on favorable terms, if at all.
In addition, the pursuit of potential acquisitions may divert the attention of management and cause us to incur additional expenses in
identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated. If we do complete acquisitions, we
may not ultimately strengthen our competitive position or achieve our goals, including increases in revenue, and any acquisitions we
complete could be viewed negatively by our customers, investors and industry analysts.

Future
acquisitions may reduce our cash available for operations and other uses and could result in amortization expense related to identifiable
assets acquired. We may have to pay cash, incur debt or issue equity securities to pay for any such acquisition, each of which could
adversely affect our financial condition or the value of our common stock. The sale or issuance of equity to finance any such acquisitions
would result in dilution to our stockholders. The incurrence of indebtedness to finance any such acquisition would result in fixed obligations
and could also include covenants or other restrictions that could impede our ability to manage our operations. In addition, our future
results of operations may be adversely affected by the dilutive effect of an acquisition, performance earn-outs or contingent bonuses
associated with an acquisition. Furthermore, acquisitions may require large, one-time charges and can result in increased debt or contingent
liabilities, adverse tax consequences, additional stock-based compensation expenses and the recording and subsequent amortization of
amounts related to certain purchased intangible assets, any of which items could negatively affect our future results of operations.
We may also incur goodwill impairment charges in the future if we do not realize the expected value of any such acquisitions.

Also,
the anticipated benefit of any strategic alliance, joint venture or acquisition may not materialize, or such strategic alliance, joint
venture or acquisition may be prohibited. Additionally, future acquisitions or dispositions could result in potentially dilutive issuances
of our equity securities, the incurrence of debt, contingent liabilities or amortization expenses or write-offs of goodwill, any of which
could harm our financial condition. We cannot predict the number, timing or size of future joint ventures or acquisitions, or the effect
that any such transactions might have on our operating results.

General
economic conditions may adversely affect our business.

Adverse
worldwide economic conditions may negatively impact our business. A significant change in the liquidity or financial condition of our
customers could cause unfavorable trends in their purchases and also in our receivable collections, and additional allowances may be
required, which could adversely affect our business, financial condition and results of operations. Adverse worldwide economic conditions,
including tariff and trade wars, may also adversely impact our suppliers’ ability to provide us with materials and components,
which could have a material adverse effect on our business, financial condition and results of operations.

Business
disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

Our
operations could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons,
fires, extreme weather conditions, medical epidemics and other natural or man-made disasters or business interruptions, for which we
are predominantly self-insured. We rely on third-party manufacturers to produce our product candidates. Our ability to obtain clinical
supplies of our product candidates could be disrupted if the operations of these suppliers were affected by a man-made or natural disaster
or other business interruption. The occurrence of any of these business disruptions could seriously harm our operations and financial
condition and increase our costs and expenses.

Risks
Related to Our Intellectual Property and Technology

will be required to comply with our obligations in our intellectual property licenses and other agreements with third parties.

we fail to comply with our obligations in our intellectual property licenses and other agreements with third parties, we could lose license
rights that are important to our business. We are not currently party to any intellectual property license agreement with any third parties,
but we anticipate that in-licensing and co-development will be strategies that we utilize as we continue to pursue our growth strategy.
We expect to enter into licenses and co-development and other agreements in the future, and we expect these agreements to impose, various
diligences, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with these obligations, the licensor
may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed
patents.