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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operation of our business. Litigation is inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse effect on our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers’ confidence and reduce long-term demand for our product candidates, even if the regulatory or legal action is unfounded or not material to our operations. we experience significant disruptions in our information technology systems, our business may be adversely affected.

depend on our information technology systems for the efficient functioning of our business, including the manufacture, distribution and
maintenance of our product candidates, as well as for accounting, data storage, compliance, purchasing and inventory management. Our
information technology systems may be subject to computer viruses, ransomware or other malware, attacks by computer hackers, failures
during the process of upgrading or replacing software, databases or components thereof, power outages, damage or interruption from fires
or other natural disasters, hardware failures, telecommunication failures and user errors, among other malfunctions. We could be subject
to an unintentional event that involves a third party gaining unauthorized access to our systems, which could disrupt our operations,
corrupt our data or result in release of our confidential information. We address these data security concerns in more detail below.
Technological interruptions would disrupt our operations, including our ability to timely ship and track product orders, project inventory
requirements, manage our supply chain and otherwise adequately service our customers or disrupt our customers’ ability use our
product candidates for treatments. In the event we experience significant disruptions, we may be unable to repair our systems in an efficient
and timely manner. Accordingly, such events may disrupt or reduce the efficiency of our entire operation and have a material adverse
effect on our business, financial condition and results of operations. Currently, we carry business interruption coverage to mitigate
certain potential losses but this insurance is limited in amount, and we cannot be certain that such potential losses will not exceed
our policy limits. We are increasingly dependent on complex information technology to manage our infrastructure. Our information systems
require an ongoing commitment of significant resources to maintain, protect and enhance our existing systems. Failure to maintain or
protect our information systems and data integrity effectively could have a material adverse effect on our business, financial condition
and results of operations.

we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary
or confidential data, employee data or personal data, or if customers, patients and other partners are reluctant to use our devices because
of concerns about the privacy or security of their data, we may face additional costs, loss of revenue, significant liabilities, harm
to our brand, decreased use of our platform and business disruption.

connection with various facets of our business, we may collect and use a variety of personal data, such as name, mailing address, email
addresses, mobile phone number, location information and clinical trial information. Any failure to prevent or mitigate security breaches
or improper access to, use of, or disclosure of our data or consumers’ personal data could result in significant liability under
state, federal (e.g., HIPAA and the HITECH Act and international law (e.g., the European Union’s General Data Protection Regulation (“GDPR”)). Such an incident may
also cause a material loss of revenue from the potential adverse impact to our reputation and brand, affect our ability to retain or
attract new users and potentially disrupt our business. We may also rely on third-party service providers to host or otherwise process
some of our data and that of users, and any failure by such third party to prevent or mitigate security breaches or improper access to
or disclosure of such information could have similarly adverse consequences for us.

Because
the techniques used to obtain unauthorized access, disable or degrade service or sabotage systems change frequently and often are not
recognized until launched against a target, we and our service providers may be unable to anticipate these techniques or to implement
adequate preventative measures. Our servers and platforms may be vulnerable to computer viruses or physical or electronic break-ins that
our security measures may not detect. Individuals able to circumvent our security measures may misappropriate our confidential or proprietary
information, disrupt our operations, damage our computers or otherwise damage our reputation and business. We may need to expend significant
resources and make significant capital investment to protect against security breaches or to mitigate the impact of any such breaches.
If we are unable to prevent or mitigate the impact of such security breaches, our ability to attract and retain new customers, patients
and other partners could be harmed, and we could be exposed to litigation and governmental investigations, which could lead to a potential
disruption to our business.

we are unable to develop additional, high-quality manufacturing capacity, our growth may be limited and our business could be seriously
harmed.

be successful in the long-term, we will need to increase our manufacturing capacity to support continued demand for our product candidates.
We may encounter difficulties in scaling up manufacturing of our product candidates, including problems related to product yields, quality
control and assurance, component and service availability, dependable sources of supply, adequacy of internal control policies and procedures,
ability to automate certain manufacturing processes and lack of skilled personnel.

we cannot hire, train and retain enough experienced and capable scientific, technical, and manufacturing employees, we may not be able
to manufacture sufficient quantities of our existing or future product candidates on time and at an acceptable cost, which could limit
market acceptance of our product candidates or otherwise damage our business. In order to meet the expected demand for our Revivent System,
we have continued to implement process improvements on the production line at our manufacturing facilities in Mansfield, MA to increase
the output that we can produce at these facilities. We continue to work on initiatives to expand our Revivent System manufacturing capacity.
We are also working with our existing suppliers and new suppliers to ensure we are able to have sufficient inventory as we increase our
manufacturing capability to support growing demand. We are and will continue outsourcing certain sub-assembly production to third-party
suppliers. We are also working on process improvements to allow us to manufacture our product candidates more efficiently as much of
our manufacturing process is labor dependent. If we are unable to implement these process improvements on a timely basis in order to
meet customer demand, it could inhibit our future revenue growth.

Each
of our product candidates is currently manufactured utilizing a combination of in-house manufacturing and outsource manufacturing, and
any significant disruption in production could impair our ability to deliver our product candidates.

currently utilize a combination of in-house manufacturing and outsource manufacturing to assemble our Revivent System. In-house manufacturing
occurs at a 12,000 square foot ISO 13485 certified facility in Mansfield, Massachusetts. Events such as fire, flood, loss of electricity
or other disasters could prevent us from manufacturing our product candidates in compliance with applicable FDA and other regulatory
requirements, including current Good Manufacturing Process (“cGMP”) and QSR, which could result in significant delays before
we restore production or commence production at another site. These delays may result in lost sales. Our insurance may not be adequate
to cover our losses resulting from disasters or other business interruptions. Any significant disruption in the manufacturing of our
product candidates could seriously harm our business 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.