Item 1A.Risk Factors
Our
business and an investment in our common stock are subject to a variety of risks. The following risk factors describe some of the material
factors that could have a material adverse effect upon our business, operating results, financial condition, prospectus, and/or the market
price of our common stock. These disclosures reflect the our beliefs and opinions as to factors that could materially and adversely affect our
Company and our common stock in the future. References to past events are provided by way of example only and are not intended to be a
complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the
future. Many of these risks are outside of our control. If any of these risks actually occur, our business, operating
results, and financial condition may be materially adversely affected. In such case, the market price of our common stock could decline
and investors in our common stock could lose all or part of their investment. In addition, risks and uncertainties not currently known
to us or that we currently deem to be immaterial also may adversely affect our business, operating results, financial condition, prospectus,
and/or stock price.
Risk
Factors Summary
This
summary is not complete and should be read in conjunction with the risk factors set forth below.
Risks
Related to Our Business
● We face intense competition.
● We are highly dependent on the continued availability of our facilities.
● We may be party to product liability litigation that could be expensive.
● Our quarterly operating results are subject to substantial fluctuations.
Risks
Related to Governmental Regulation
● Loss of AATB accreditation would have a material adverse effect on us.
Risks
Related to Human Capital Management
● We have limited staffing and are dependent upon key employees.
Risks
Related to Intellectual Property
Risks
Related to Information Technology, Cybersecurity and Data Protection
Risks
Related to Our Outstanding Indebtedness and Financial Condition
● We may need additional financing to satisfy our future liquidity requirements.
Risks
Related to Our Common Stock
● The market price of our common stock is extremely volatile.
● We may issue additional common stock resulting in dilution.
General
Risk Factors
Risks
Related to Our Business
Although
we generated net income for the year ended December 31, 2025, we historically have incurred significant losses, expect to continue to
incur losses, and despite our focused goal to maintain profitability, we may never achieve sustained profitability.
Although
we generated net income for the year ended December 31, 2025, we have a history of incurring net losses and expect to continue to incur
net losses. Our ability to maintain and achieve sustained profitability will be influenced by many factors, including, among others,
the level and timing of future revenues and expenditures; development, commercialization, market acceptance and availability and supply
of our products; the impact of competing technologies and market developments; our ability to develop and introduce new products; the
impact of regulatory requirements and delays; the strength of our relationships with and the success of our independent sales agents
and distributors; our ability to increase our OEM sales; and our ability to attract and retain key personnel. As a result, despite our
focus on profitability, we may be unsuccessful and incur operating losses. These losses would likely have an adverse impact on our operating
results and financial condition and likely adversely affect our stock price.
We
recognized a significant amount of license revenue in 2025 that likely will not repeat in 2026 and thus the loss of such revenue will
have an adverse impact on our 2026 revenues and other operating results, including gross margins.
During
2025, we recognized $18.7 million in license revenue that likely will not repeat in 2026 due primarily to changes in the reimbursement
environment for our SimpliMaxTM product effective January 1, 2026, which changes also will adversely affect a portion of our product
revenue. The loss of this license and product revenue will have an adverse impact on our 2026 revenues and other operating results, including
in particular our gross margins.
Because
we recently sold certain assets relating to our Coflex and CoFix products and our international hardware business to Companion Spine,
our revenue will be adversely affected in 2026.
On
December 1, 2025, we sold to Companion Spine certain assets relating to our Coflex and CoFix products for
a total purchase price of $17.5 million, and sold Paradigm Spine GmbH, a former wholly owned subsidiary of ours that was engaged in the
operation of our hardware business outside of the United States for a total purchase price of $3.9 million, inclusive of certain cash,
indebtedness and net working capital adjustments. In 2025, we recognized $20.3 million in revenue from sales of our Coflex and CoFix
products and international hardware products which we sold to Companion Spine. The loss of this revenue will adversely affect our 2026
revenue.
A
substantial portion of our hardware product family revenue is conducted through independent sales agents and distributors who we do not
control and our revenue from this channel has declined in recent periods compared to prior periods.
A
substantial portion of our hardware product family revenue is conducted through independent sales agents and distributors. Sales from
certain independent sales agents and distributors have decreased over the past quarters compared to prior quarters and no assurance can
be provided that we will not be able to reverse this trend and increase future sales from this channel. Our success is partially dependent
upon our ability to retain and motivate our independent sales agents and distributors, and their representatives, to sell our products
in certain territories. They may not be successful in implementing our marketing plans. Some of our independent sales agents and distributors
do not sell our products exclusively and may offer similar products from other companies. Our independent sales agents and distributors
may terminate their contracts with us, may devote insufficient sales efforts to our products, or may focus their sales efforts on other
products that produce greater commissions or revenues for them, which could have an adverse effect on our operations and operating results.
In
addition, because the independent sales agent or distributor often controls the customer relationships (and, in certain countries outside
the United States, the regulatory relationship), there is a risk that if our relationship with the independent sales agent or distributor
ends, our relationship with the customer will be lost (and, in certain countries outside the United States, that we could experience
delays in amending or transferring our product registrations). Also, because we do not control the independent sales agent or field sales
agents of a distributor, there is a risk we will be unable to ensure that our sales processes, compliance, and other priorities will
be consistently communicated and executed by the sales agent or distributor. If we fail to maintain relationships with our key independent
sales agents and distributors or fail to ensure that our independent sales agent and distributors adhere to our sales processes, compliance,
and other priorities, this could have an adverse effect on our operations. Changes to or turnover within our independent sales agent
or distributor organization or transitions to direct selling models also could adversely affect our business if these transitions are
not managed effectively. Further, independent sales agents and distributors of companies we have acquired may decide not to renew or
may decide to seek to terminate, change and/or renegotiate their relationships with us. The loss of a significant number of our sales agent
or distributors could have a material adverse effect on our business and results of operations.
If
we are unable to innovate, develop, introduce, market, sell and license new products and technologies, we may experience a decrease in
market share or revenue if our products become obsolete, and our business and operating results would suffer.
We
may be unable to compete effectively with our competitors unless we can keep up with existing or new products and technologies in the
markets in which we compete. If we do not continue to innovate, develop, introduce, market, sell and license new products and technologies,
or if those products and technologies are not accepted, we may not be successful. Due to limited funding, our research and development
efforts and ability to develop new products have been constrained for several years, although we have increased our development of new
products over the last couple of years, including in particular our amnio and other new biologics products. Research and development
efforts require a substantial investment of time and resources before we are able to determine the commercial viability of a new product,
technology, material, or innovation. We also may experience delays in the research and development process and the marketing and sale
of new products. Demand for our products also could change in ways we may not anticipate due to, among other factors, evolving customer
needs, changes in customer health insurance coverage and reimbursement policies, changing demographics, slow industry growth rates, declines
in our markets, the introduction of new competing products and technologies, evolving surgical philosophies, and evolving industry standards.
Additionally, our competitors’ new products and technologies may beat our products to market, may be more effective or less expensive
than our products, or may render our products obsolete. It is also important that we carefully manage our introduction of new and enhanced
products and technologies. If potential customers delay purchases until new or enhanced products are available, it could negatively impact
our revenue. Our new products and technologies also could reduce demand for or render our existing products obsolete and thus adversely
affect sales of our existing products and lead to increased expense for excess and obsolete inventory.
Biologics
products are inherently difficult and time-consuming to manufacture. In the past, we have experienced and in the future could experience
manufacturing issues, which could negatively impact our business and operating results.
Biologics
products are inherently difficult and time-consuming to manufacture. Our products are manufactured using technically complex processes
requiring specialized equipment and facilities and highly specific raw materials. Other production constraints, including the number
of processors we are able to hire, the number of clean rooms available in our facilities, and our ability to automate certain processes
by implementing labor saving technology also affect the speed and extent of our production. The complexity of these processes, as well
as strict company and government standards for the manufacture and storage of our products, subject us to production risks. A shortage
of the number of processors or clean rooms or inadequate levels of automation may cause us to be unable to operate at full production,
which in the past has and could in the future negatively impact our business and operating results.
Our
biologics business is highly dependent on the availability of human donors and placentas. Any disruptions in the availability of donors
and placentas due to regulatory changes or otherwise could cause our customers to seek alternative providers or technologies and harm
our business and operating results.
Our
mission is “to honor the gift of donation, by allowing our patients to live as full, and complete a life as possible.”
Accordingly, our biologics business is highly dependent on our ability to obtain deceased human donors and placentas as the raw
material for many of our biologics products. The availability of acceptable donors and placentas is relatively limited, and we
compete with many other companies for this limited availability. The availability of donors and placentas is impacted by regulatory
changes, Association for Advancing Tissue Biologics (formerly, American Association of Tissue Banks) requirements, general public
opinion of the donor process, and our reputation for our handling of the donor process. In 2025, the FDA published draft
guidance documents with recommendations to reduce the risk of transmission of disease agents associated with sepsis by human cells,
tissues, and tissue-based products and recommendations to reduce the risk of transmission of Mycobacterium tuberculosis by
HCT/Ps. These new guidelines, if approved, may further reduce the number of acceptable donors and increase competition for
acceptable donors. A disruption in the supply of available donors and placentas could have significant consequences on our ability
to meet anticipated demand for our biologics products, which would adversely affect our revenue and other operating
results.
Some
of our biologics products, including our OsteoVive Plus, involve a heightened inherent risk of transmission of disease, which if materialized,
could adversely affect our business, operating results, financial condition, reputation and stock price.
Our
OsteoVive Plus product is a viable bone allograft produced using a proprietary method designed to preserve native bone components, including
growth factors and viable cells. Similar to other viable or cellular bone matrix products, our OsteoVive Plus product contains viable
cells. Although we and our third-party contractors perform rigorous donor screening and laboratory testing, viable human tissue products
carry an inherent residual risk of transmitting communicable diseases, including but not limited to Human Immunodeficiency Virus (HIV),
Hepatitis B and C viruses (HBV, HCV), Human T-lymphotropic virus (HTLV), treponema pallidum (syphilis), and mycobacterium tuberculosis
(Mtb). Although we process and test our OsteoVive Plus product in accordance with current regulatory standards, there is no current standardized
industrial screening test for tissues to detect Mtb and testing Mtb via culture or other methods does not definitively exclude the presence
of tuberculosis due to the limitations of diagnostic sensitivity, specimen viability, and potential latent infection. While our OsteoVive
Plus product is intended for use by qualified medical professionals who understand the risks associated with transplantation of human
tissues and are responsible for recipient counseling and clinical decision-making, if Mtb were to be transmitted as a result of the use
of one of our products, including our OsteoVive Plus product, this could adversely affect our relationships and reputation throughout
the industry and have a material adverse effect on our business, operating results, financial condition, reputation and stock price.
Persistent
inflation, tariffs and supply chain disruptions in the past have resulted in and in the future could result in delayed product launches,
lost revenue, higher costs and decreased profit margins.
Our
products are manufactured and sold within the United States, which increases our exposure to domestic inflation and fuel price increases.
Inflationary pressures and supply chain disruptions resulted in increased fuel, raw material and other costs in recent years. The future
implementation of inflationary policies, such as tariffs, may similarly contribute to increased fuel, raw material and other costs and
also may contribute to higher overall inflation. Additionally, from time to time we have experienced shortages in certain raw materials,
suppliers have been unable to meet delivery schedules due to excess demand and labor shortages, and lead times have lengthened throughout
our supply chain. Our efforts to mitigate supply chain weaknesses through our own vertical integration of manufacturing activities and
other means may not be successful or may have unfavorable effects. For example, efforts to purchase raw materials in advance for product
manufacturing may result in increased storage costs or excess supply and inventory. If our costs rise due to continuing supply chain
disruptions or due to the impact of tariffs, we may not be able to fully offset such higher costs through price increases. In addition,
delays in obtaining materials from our suppliers could delay product launches or result in lost opportunities to sell our products due
to their unavailability. Increased costs and decreased product availability due to supply chain issues could adversely impact our revenue
and/or gross margin, and could thereby harm our business, operating results, and financial condition.
We
face intense competition.
The
markets for our products are highly competitive and subject to rapid and profound technological change. Our success depends, in part,
on our ability to maintain a competitive position in the development of technologies and products for use by our customers. Many of the
companies developing or marketing competitive products enjoy several competitive advantages over us, including greater financial and
human resources for product development and sales and marketing; greater name recognition; established relationships with surgeons, hospitals
and third-party payors; broader product lines and the ability to offer rebates or bundle products to offer greater discounts or incentives
to gain a competitive advantage; and established sales and marketing and distribution networks. Our competitors may develop and patent
processes or products earlier than we do, obtain regulatory clearances or approvals for competing products more rapidly than we do, develop
more effective or less expensive products or technologies that render our technology or products obsolete or non-competitive, or acquire
technologies and technology licenses complementary to our products or advantageous to our business, which could adversely affect our
business and operating results. Not all of our sales and other personnel have non-compete agreements. We also compete with other organizations
in recruiting and retaining qualified sales and management personnel, which may exacerbate the effects of labor shortages we have experienced
in the past, as described elsewhere in these risk factors. If our competitors are more successful than we are in these matters, we may
be unable to compete successfully against our existing or future competitors. Our industry has been subject to increasing consolidation.
Consolidation in our industry not involving our Company could result in existing competitors increasing their market share through business
combinations and result in stronger competitors, which could have a material adverse effect on our business, operating results and financial
condition. We may be unable to compete successfully in an increasingly consolidated industry and cannot predict with certainty how industry
consolidation will affect our competitors or us.
Our
private label and OEM revenue channel involves risks and may be subject to significant fluctuation on a product to product basis from
period to period since we typically do not have long-term purchase agreements covering these sales and our customers could decide to
use other OEMs.
We
expect an increasing amount of our future revenues to be derived from our private label and original equipment manufacturer, or OEM,
revenue channel. This expectation is based on our ability to internally produce all products within our orthobiologics product family
allowing us to make such products available on a private label and OEM basis where compelling opportunities exist. We may not be successful,
however, in retaining or expanding our private label and OEM channel. Our private label and OEM channel, although not subject to commissions,
generally involves lower gross margins relative to comparable products sold through our independent agent channel which, if this business
increases as a percentage of our revenue, will reduce our future gross margins. In addition, our private label and OEM channel involves
other additional risks. For example, we generally do not have long-term supply agreements covering our private label and OEM customers,
so they could periodically decide to use other OEMs based on cost, quality, delivery time, production capacities, competitive and regulatory
considerations, or other factors. Thus, revenues from our private label and OEM customers and the products we provide them are subject
to significant fluctuation on a product to product basis from period to period. The success of our private label and OEM channel is dependent
upon the success of our private label and OEM customers in creating demand for and selling the products that we manufacture for them.
If our private label and OEM channel significantly increases, we may experience difficulties in staffing our manufacturing facility and
meeting demand. Our OEM channel sales also are dependent upon adequate reimbursement and changes in such reimbursement could adversely
affect future sales. For example, a portion of our 2025 OEM channel sales likely will not repeat in 2026 or future years given a change
in the reimbursement environment affecting the product involved, which could adversely affect our 2026 and future revenues.
Our
prior acquisitions and dispositions and any future acquisitions, dispositions or business combinations we complete involve a number of
risks, the occurrence of which could adversely affect our business, operating results and financial condition.
In 2023, we acquired Surgalign SPV, certain assets and liabilities of Surgalign
Holdings, and certain assets of RTI. In December 2025, we sold certain assets relating to our Coflex and CoFix products and our international
hardware business to Companion Spine. Our ability to complete future acquisitions, dispositions and business combinations will depend,
in part, on the availability of suitable acquisition candidates or buyers at acceptable prices, terms, and conditions; our ability to
compete effectively for acquisition candidates or buyers; and the availability of capital and personnel to complete such acquisitions
and run the acquired business effectively. Any acquisition, disposition or business combination could impair our business, operating results
and financial condition. The benefits of an acquisition, disposition or business combination may take more time than expected to develop
or, in the case of an acquisition, integrate into our operations, and we cannot guarantee that prior or future acquisitions, dispositions
or business combinations will, in fact, produce any benefits. Acquisitions, dispositions and business combinations may involve a number
of risks, the occurrence of which could adversely affect our business, operating results and financial condition, including:
● diversion of management’s attention;
● possibility of not receiving any earnout or milestone payments;
Also, some transactions may require the consent of the lenders under our
credit agreements, and we cannot predict whether such consent would be forthcoming or the terms on which the lenders would approve future
transactions.
These
risks, among others, could be heightened if we complete a large acquisition or other business combination or multiple transactions within
a relatively short period of time or, if such approvals are not obtained, could prevent us from completing acquisitions that we believe
would be beneficial to our business.
Negative
publicity concerning methods of tissue recovery and screening of donor tissue in our industry could reduce demand for our biologics products
and impact the supply of available donor tissue.
Media
reports or other negative publicity concerning both alleged improper methods of tissue recovery from donors and disease transmission
from donated tissue could limit widespread acceptance of some of our biologics products and reduce demand for our biologics products. Unfavorable reports of improper or illegal
tissue recovery practices, both in the United States and internationally, as well as incidents of improperly processed tissue
leading to the transmission of disease, may broadly affect the rate of future tissue donation and market acceptance of technologies
incorporating human tissue. In addition, such negative publicity could cause the families of potential donors to become reluctant to
agree to donate tissue to for-profit tissue processors.
We
depend on a limited number of third-party suppliers for products, components and raw materials and losing any of these suppliers, or
their inability to provide us with an adequate supply of materials that meet our quality and other requirements or our failure to order
a sufficient supply of products, components and raw materials, could harm our business and operating results.
Outside
suppliers, some of whom are sole-source suppliers, provide us with products and raw materials and components used in manufacturing
our orthobiologics and spinal implant products. We strive to maintain sufficient inventory of products, raw materials and components
so that our production will not be significantly disrupted if a particular product, raw material or component is not available to us
for a period of time, including as a result of a supplier’s loss of its ISO or other certification, long required lead times,
or other reasons. Despite our efforts, we sometimes experience an insufficient inventory of products, raw materials and/or
components. If we fail to plan our procurement accordingly or are unable to obtain sufficient quantities of raw materials and
components used in manufacturing our orthobiologics and spinal implant products that meet our quality and other requirements on a
timely basis for any reason, we may not produce sufficient quantities of our products to meet market demand until a new or
alternative supply source is identified and qualified and, as a result, we could lose sales and customers, our reputation could be
harmed, and our business could suffer. Furthermore, an uncorrected defect or supplier’s variation in a component or raw
material that is incompatible with our manufacturing, unknown to us, could harm our ability to manufacture products.
Although
we believe there are alternative supply sources, replacing our suppliers may be impractical or difficult in many instances. For example,
we could have difficulty obtaining similar products from other suppliers that are acceptable to the FDA or other foreign regulatory authorities.
In addition, if we are required to transition to new suppliers for certain components or raw materials of our products, the use of components
or materials furnished by these alternative suppliers could require us to alter our operations, and if we are required to change the
manufacturer of a critical component of our products, we will have to verify that the new manufacturer maintains facilities, procedures
and operations that comply with our quality and applicable regulatory requirements, which could further impede our ability to manufacture
our products in a timely manner. Transitioning to a new supplier could be time-consuming and expensive, may result in interruptions in
our operations and product delivery, could affect the performance specifications of our products or could require that we modify the
design of those systems.
We
are highly dependent on the continued availability of our facilities and would be harmed if they were unavailable for any prolonged period
of time.
Any
failure in the physical infrastructure of our facilities could lead to significant costs and disruptions that could reduce our revenues
and harm our business, operating results, and reputation. We are highly reliant on our Belgrade, Montana facilities. Any natural or man-made
event that impacts our ability to utilize these facilities could have a significant impact on our operating results, reputation and ability
to continue operations. The regulatory process for approval of facilities is time-consuming and our ability to rebuild facilities would
take a considerable amount of time and expense and cause a significant disruption in service to our customers. Further, the FDA or some
other regulatory agency could identify deficiencies in future inspections of our facilities or our supplies that could disrupt our business
and harm our operating results.
We
may be party to product liability litigation that could be expensive, and our insurance coverage may not be adequate in a catastrophic
situation.
The
manufacture and sale of medical devices and biologics expose us to significant risk of product liability claims, which are made against
us from time to time. We may incur material liabilities relating to product liability claims, including product liability claims arising
out of the use of our products, if the liabilities exceed or are not covered under our insurance program. No assurance can be provided
that any amounts that we may be required to pay to resolve such matters in the future will be within our insurance limits.
We
also could experience a material design or manufacturing failure in our products, a quality system failure, other safety issues, or heightened
regulatory scrutiny that would warrant a recall of some of our products. Product liability lawsuits and claims, safety alerts and product
recalls, regardless of their ultimate outcome, could result in decreased demand for our products, injury to our reputation, significant
litigation and other costs, substantial monetary awards to or costly settlements with patients, product recalls, loss of revenue, increased
regulatory scrutiny, and the inability to commercialize new products or product candidates, and otherwise have a material adverse effect
on our business and reputation and on our ability to attract and retain customers.
Our
quarterly operating results are subject to substantial fluctuations, and you should not rely on them as an indication of our annual or
future results.
Our
quarterly revenue and operating results have varied and in the future may vary significantly, and period-to-period comparisons of our
results of operations are not necessarily meaningful and should not be relied upon as indications of our annual results or future performance.
Any shortfalls in revenue or earnings from levels expected by industry analysts or investors, as a result of such quarterly fluctuations
or otherwise, could have an immediate and significant adverse effect on the market price of our common stock in any given period. Our
quarterly operating results may vary significantly due to a combination of factors, many of which are beyond our control. These factors
include, among others:
● demand for our products;
● the level of competition;
● changes in pricing policies by us and our competitors;
● changes in the treatment practices of our customers;
● the number of selling days;
● the availability and cost of components and materials;
● the timing of orders and shipments;
● work stoppages or strikes in our industry;
● changes in accounting standards, policies, estimates, and treatments;
● restructuring, impairment, and other special charges;
● costs associated with pending and any future litigation;
● income tax fluctuations and changes in tax rules;
● general economic, social and other external factors; and
We
strive to maintain a sufficient inventory of products, raw materials and components so that our production and revenues will not be significantly
disrupted, especially with respect to new products. This practice, however, consumes a significant amount of our resources, reduces our
cash flows, and in the past has led to, and in the future could lead to, inventory impairment charges.
A
feature of our orthopedic hardware and implant business is the high level of product inventory required, some of which is located at
customer premises and is available for customers’ immediate use (referred to as consignment inventory). Complete sets of
products, including large and small sizes, have to be made available for customers; and often, certain sizes are used less
frequently than standard sizes and towards the end of the product life cycle are inevitably in excess of requirements. Under
applicable accounting rules, we are required to review and make adjustments to the carrying value of our inventory to anticipate
this situation. We typically calculate such adjustments in accordance with a formula based on levels of inventory compared with
historical and forecast usage and apply this formula on an individual product line basis, typically after a product group has been
on the market for two years. While we believe based on our experience that this method of calculation is appropriate in most
circumstances under applicable accounting rules, it involves management judgments on forecasted sales, effectiveness of inventory
deployment, length of product lives, phase-out of old products, and efficiency of manufacturing planning systems. In the event a
substantial portion of our inventory becomes obsolete, the resulting costs associated with the inventory impairment charges and
costs required to replace such inventory could have a material adverse effect on our operating results and cash flows. In addition,
as we introduce new products, new implant and instrument sets may be required, with a significant initial investment required to
accommodate the launch of the product. If we overestimate the projected future sales of the new product or if the launch of the new
product is not successful, we may be required to record inventory impairment charges, which could be significant. For example,
during fourth quarter of 2025, we recorded a $1.3 million charge related to excess and obsolete inventory associated with the launch
of our Cortera® Fixation System, which was launched in the second half of 2024. Depending upon future sales of this product and
other new products we may launch, we may be required to record additional excess and obsolete inventory charges, which would
adversely impact our operating results.
Our
ability to use our net operating loss carry-forwards and other tax attributes to offset future taxable income is limited.
At
December 31, 2025, we had total domestic federal and state net operating loss carryovers of approximately $34.1 million and $36.7 million,
respectively. Federal net operating losses generated prior to 2018 and state net operating loss carryovers expire at various dates between
2026 and 2045. Federal net operating losses generated after 2017 have an indefinite carryforward and are only available to offset 80%
taxable income beginning in 2021. Foreign net operating losses begin expiring in 2026.
Section
382 of the Internal Revenue Code of 1986, as amended (“Code”), imposes restrictions on the use of a corporation’s net
operating losses, as well as other tax attributes including capital loss carryforwards and other losses and credits, after an “ownership
change” occurs. A Section 382 “ownership change” occurs if one or more stockholders or groups of stockholders who own
at least 5% of our stock (including certain “public groups” deemed created for Section 382 purposes) increase their ownership
by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. When an “ownership
change” occurs, Section 382 imposes an annual limit on the amount of pre-change net operating losses and other tax attributes we
can use to reduce our taxable income generally equal to the product of the total value of our outstanding equity immediately prior to
the “ownership change” (subject to certain adjustments) multiplied by the applicable federal long-term tax-exempt interest
rate for the month of the “ownership change.”
We
have completed studies to assess whether ownership changes, as defined by Section 382 of the Code, have occurred from our formation through
December 31, 2025. Based upon these studies, we determined that an ownership change occurred during 2018 and again in 2025. Accordingly,
we reduced our deferred tax assets related to the federal net operating loss carryforwards that are anticipated to expire unused as a
result of these ownership changes. These tax attributes were excluded from deferred tax assets with a corresponding reduction of the
valuation allowance with no net effect on income tax expense or the effective tax rate. Future ownership changes may further limit our
ability to utilize our remaining tax attributes. Any future ownership change may result in the imposition of additional limitations on
our ability to utilize our NOLs existing at the time of the ownership change. Future regulatory changes could also limit our ability
to utilize our NOLs. To the extent we are not able to offset future taxable income with our NOLs, our cash flows may be adversely affected.
We have recorded a full valuation allowance against our U.S. deferred tax assets, which includes net operating loss carryforwards.
We
identified a material weakness in our internal control over financial reporting as of December 31, 2025, and cannot provide assurances that this weakness
will be effectively remediated or that additional material weaknesses will not occur in the future.
If
our internal control over financial reporting or disclosure controls and procedures are not effective, we may not be able to accurately
report our consolidated financial results, which may cause investors to lose confidence in our reported financial information and may
lead to a decline in our stock price. Our management is responsible for establishing and maintaining adequate internal control over our
financial reporting, as defined in Rule 13a-15(f) under the Exchange Act, which is designed to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally
accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that (i) pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
(ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with U.S. generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations
of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of our assets that could have a material effect on the financial statements.
We
identified certain control deficiencies in the design and implementation of our internal control over financial reporting as of
December 31, 2025, which constitute a material weakness. A material weakness is a deficiency, or a combination of deficiencies, in
internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or
interim financial statements will not be prevented or detected on a timely basis. More specifically, our controls surrounding our
evaluation of inventory net realizable value were insufficient and did not operate at an appropriate level of precision. Our review
and evaluation of inventory failed to identify specific items not assessed for net realizable value under our existing control,
which constitutes material weakness as of December 31, 2025. While we are taking steps to remediate the material weakness, we cannot provide any assurance
that such remedial measures, or any other remedial measures we take, will be effective. If we fail to maintain effective internal
control over financial reporting, we may not be able to accurately report our financial results, which may, among other adverse
consequences, cause investors to lose confidence in our reported financial information and lead to a decline in our stock price. In
addition, a material weakness will not be considered remediated until the applicable controls operate for a sufficient period of
time and management has concluded, through testing, that these controls are designed and operating effectively.
Risks
Related to Governmental Regulation
If
we or our suppliers fail to comply with regulations pertaining to human cells, tissues, and cellular and tissue-based products or if
any of our cellular or tissue-based products are deemed to be biological products requiring approval of a BLA, drug products requiring
approval of a new drug application (“NDA”) or medical devices requiring clearance, authorization or approval prior to being
marketed, these products could be subject to withdrawal from the market or other enforcement action.
Certain
of our products are regulated as HCT/Ps. Section 361 of the PHSA authorizes the FDA to issue regulations to prevent the introduction,
transmission or spread of communicable disease. HCT/Ps regulated as “361” HCT/Ps are subject to requirements relating to
registering facilities and listing products with the FDA; screening and testing for tissue donor eligibility; and current Good Tissue
Practice (“cGTPs”), when processing, storing, labeling, and distributing HCT/Ps, including required labeling information,
stringent record keeping, and adverse event reporting, among other applicable requirements and laws. The FDA regulations also have additional
requirements that address sub-contracted tissue services, tracking, and donor records review. If a tissue-based product is considered
human tissue, the FDA requirements focus on preventing the introduction, transmission and spread of communicable diseases. A product
regulated solely as a 361 HCT/P is not required to undergo 510(k) premarket clearance, de novo classification or PMA nor approval of
a BLA or NDA.
The
FDA may inspect facilities engaged in manufacturing 361 HCT/Ps and may issue untitled letters, warning letters, or otherwise authorize
orders of retention, recall, destruction and cessation of manufacturing if the FDA has reasonable grounds to believe that an HCT/P or
the facilities where it is manufactured are in violation of applicable regulations. There also are requirements relating to the import
of HCT/Ps that allow the FDA to make a decision as to the HCT/Ps’ admissibility into the United States.
An
HCT/P is eligible for regulation solely as a 361 HCT/P if it is: (i) minimally manipulated; (ii) intended for homologous use as reflected
by labeling, advertising or other indications of the manufacturer’s objective intent; (iii) the manufacture does not involve the
combination of the HCT/P with another article, except for water, crystalloids or a sterilizing, preserving, or storage agent (not raising
new clinical safety concerns for the HCT/P); and (iv) it does not have a systemic effect and is not dependent upon the metabolic activity
of living cells for its primary function or, if it has a systemic effect or is dependent upon the metabolic activity of living cells
for its primary function, it is intended for autologous use or allogeneic use in a first or second degree relative or for reproductive
use. If any of these requirements are not met, then the HCT/P is also subject to applicable biologic, device, or drug regulation under
the FDCA or the PHSA. These biologic, device or drug HCT/Ps must comply with the requirements exclusively applicable to 361 HCT/Ps and,
in addition, with requirements applicable to biologics under the PHSA and FDCA, or devices or drugs under the FDCA, including licensure,
clearance or approval, as the case may be.
Over
the course of several years, the FDA issued regulations that address manufacturer activities associated with HCT/Ps. The first requires
that companies that manufacture HCT/Ps register with the FDA. This set of regulations also includes the criteria that must be met in
order for the HCT/P to be eligible for regulation solely under Section 361 of the PHSA and the regulations in 21 CFR Part 1271, rather
than under the drug or device provisions of the FDCA or the biological product licensing provisions of the PHSA. The second set of regulations
provides criteria that must be met for donors to be eligible to donate tissues and is referred to as the “Donor Eligibility”
rule. The third rule governs the processing and distribution of the tissues and is often referred to as the cGTP rule. The cGTP rule
covers all stages of allograft processing, from procurement of tissue to distribution of final allografts. Together these regulations
are designed to ensure that sound, high quality practices are followed to reduce the risk of tissue contamination and of communicable
disease transmission.
At
the time they came into effect approximately 20 years ago, these regulations increased regulatory scrutiny within the industry in which
we operate and have led to increased enforcement action which affects the conduct of our business. In addition, these regulations can
increase the cost of tissue recovery activities. The FDA periodically inspects tissue processors to determine compliance with these requirements.
Allegations of violations of applicable regulations noted by the FDA during facility inspections could adversely affect the continued
marketing of our products. We believe we comply with all aspects of 21 CFR Part 1271 that we are required to comply with, although there
can be no assurance that we will be deemed by FDA to be in compliance. Entities that provide us with allograft bone tissue are responsible
for performing donor recovery, donor screening and donor testing and our compliance with those aspects of the cGTP regulations that regulate
those functions are dependent upon the actions of these independent entities. If our suppliers fail to comply with applicable requirements,
our products and our business could be negatively affected. If the FDA determines that we have failed to comply with applicable regulatory
requirements, it can impose a variety of regulatory actions, or enforcement actions from public warning letters, fines, injunctions,
consent decrees and civil penalties to suspension or delayed issuance of approvals, seizure of our products, total or partial shutdown
of our production, withdrawal of approvals, and criminal prosecutions. If any of these events were to occur, it could materially adversely
affect us.
In
addition, the FDA could disagree with our conclusion that one or more of our HCT/Ps meet the criteria for marketing solely under Section
361 of the PHSA, and therefore that one or more of the HCT/Ps require licensure, approval or clearance of a marketing application. The
FDA could conclude that the tissue is more than minimally manipulated, that the product is intended for a non-homologous use, that the
product is combined with another article, or that the product has a systemic effect or is dependent on the metabolic activity of living
cells for its primary function. The FDA could also determine that a modification to an HCT/P makes it ineligible for regulation solely
as a 361 HCT/P. If the FDA were to draw these conclusions, it would likely require clinical studies conducted pursuant to an investigational
new drug application (“IND”) or Investigation Device Exemption (“IDE”) and the submission and licensure, approval,
authorization, or clearance of a marketing application in order for us to continue to market the product. Such an action by the FDA could
cause negative publicity, decreased or discontinued product sales, and significant expense in obtaining required marketing licensure,
approval, authorization, or clearance.
Other
regulatory entities with authority over our products and operations include state agencies enforcing statutes and regulations covering
tissue banking. Regulations issued by Florida, New York, California, Colorado, Georgia and Maryland are particularly relevant to our
business. Most states do not currently have tissue banking regulations. It is possible that others may make allegations against us or
against donor recovery groups or tissue banks about non-compliance with applicable FDA regulations or other relevant statutes or regulations.
Allegations like these could cause regulators or other authorities to take investigative or other action or could cause negative publicity
for our business and the industry in which we operate.
Loss
of AATB accreditation would have a material adverse effect on us.
We
are accredited with the Association for Advancing Tissue and Biologics (formerly American Association of Tissue Banks), a private non-profit
organization that accredits tissue banks and sets industry standards. Although AATB accreditation is voluntary and not required by law,
as a practical matter, many of our customers would not purchase our products if we failed to maintain our AATB accreditation. Although
we make every effort to maintain our AATB accreditation, the accreditation process is somewhat subjective and lacks regulatory oversight.
There can be no assurance that we will continue to remain accredited with the AATB and any loss of our AATB accreditation would adversely
affect our business and operating results.
U.S.
governmental regulation could restrict the use of our tissue products or our procurement of tissue.
In
the United States, the procurement and transplantation of allograft bone tissue is subject to federal law pursuant to the National Organ
Transplant Act (“NOTA”), a criminal statute which prohibits the purchase and sale of human organs used in human transplantation,
including bone and related tissue, for “valuable consideration.” NOTA permits reasonable payments associated with the removal,
transportation, processing, preservation, quality control, implantation and storage of human bone tissue. We provide services in all
of these areas in the United States, with the exception of removal and implantation, and receive payments for all such services. We make
payments to certain of our clients and tissue banks for their services related to recovering allograft bone tissue on our behalf. If
NOTA is interpreted or enforced in a manner which prevents us from receiving payment for services we render, or which prevents us from
paying tissue banks or certain of our clients for the services they render for us, our business could be materially and adversely affected.
We
are engaged through our marketing employees, independent sales agents and sales representatives in ongoing efforts designed to educate
the medical community as to the benefits of our products, and we intend to continue our educational activities. Although we believe that
NOTA permits payments in connection with these educational efforts as reasonable payments associated with the processing, transportation
and implantation of our products, payments in connection with such education efforts are not exempt from NOTA’s restrictions and
our inability to make such payments in connection with our education efforts may prevent us from paying our sales representatives for
their education efforts and could adversely affect our business and prospects. No federal agency or court has determined whether NOTA
is, or will be, applicable to every allograft bone tissue-based material which our processing technologies may generate. Assuming that
NOTA applies to our processing of allograft bone tissue, we believe that we comply with NOTA, but there can be no assurance that more
restrictive interpretations of, or amendments to, NOTA will not be adopted in the future, which would call into question one or more aspects
of our method of operations.
In
May 2025, the FDA published a draft guidance document, which when finalized would contain recommendations to reduce the risk of transmission
of Mycobacterium tuberculosis by HCT/Ps. If finalized, this guidance would identify Mtb as a relevant communicable
disease agent or disease (“RCDAD”) and provide recommendations for tissue banks for screening and testing of donors for Mtb
prior to processing. The impact of this change would dramatically slow down the production of our viable bone matrix products. We currently
employ several actions to mitigate potential Mtb exposure, including a comprehensive review of the donor’s medical and social history.
In addition, we have validated a post-processing Mtb test of our viable bone matrix products. Unless and until this draft guidance is
finalized, Mtb is not an RCDAD, and we can rely on our processes for mitigating Mtb exposure. If this guidance is finalized, the FDA
will expect compliance with the regulatory requirements for donor screening and testing for Mtb as an RCDAD and may take enforcement
action in the event of noncompliance.
Our
manufacturing operations are required to comply with the FDA’s and other governmental authorities’ laws and regulations regarding
the manufacture and production of medical devices, which is costly and could subject us to enforcement action.
We
and certain of our third-party manufacturers and suppliers are required to comply with the FDA’s current Good Manufacturing
Practices requirements the Quality Management System Regulation, which covers, among other things, the methods of documentation of
the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our
products. We and certain of our suppliers also are subject to the regulations of foreign jurisdictions regarding the manufacturing
process for our products marketed outside of the United States. The FDA enforces the QMSR through periodic announced (routine) and
unannounced (for cause or directed) inspections of manufacturing facilities. The failure by us or one of our third-party
manufacturers or suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies,
or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in,
among other things, any of the following enforcement actions:
● operating restrictions or partial suspension or total shutdown of production;
● refusal to grant export certificates for our products; or
● criminal prosecution.
Any
of these actions could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’
demands. We also may be required to bear other costs or take other actions that may have a negative impact on our future revenue and
other operating results. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all
applicable regulatory requirements, which could result in our failure to produce our products on a timely basis and in the required quantities,
if at all.
If
our products cause or contribute to a death or serious injury, or malfunction in certain ways, we will be subject to reporting regulations,
which can result in voluntary corrective actions or agency or other governmental enforcement actions.
Under
the FDA’s reporting regulations applicable to HCT/Ps, we are required to report all adverse reactions involving a communicable
disease if it is fatal, life threatening, results in permanent impairment of a body function or permanent damage to body structure, or
necessitates medical or surgical intervention, including hospitalization. Under the FDA medical device reporting regulations and similar
foreign governmental regulations, medical device manufacturers are required to report to the FDA or other governmental agencies information
that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause
or contribute to a death or serious injury if the malfunction of the device or one of our similar devices were to recur. If we fail to
report these events to the FDA within the required timeframes, or at all, the FDA could take enforcement action against us. Any such
adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications,
or agency action, such as mandatory recalls, destruction, cessation of manufacturing, inspection or other enforcement action. Any corrective
action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, would require the dedication of our time and capital,
distract management from operating our business, and may harm our reputation and financial results. We are currently subject to certain
product liability litigation, which could harm our business, financial condition or results of operations, especially if this litigation
requires payments in amounts that exceed our product liability insurance coverage.
Any
future product recall or voluntary market withdrawal of a product due to defects, enhancements and modifications or other reasons would
significantly increase our costs.
The
FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products. In addition, foreign
governmental bodies have the authority to require the recall of our products in the event of material deficiencies or defects in design
or manufacture. Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found or for
other reasons. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of, among other things,
component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products
would divert managerial and financial resources and could have an adverse effect on our financial condition and results of operations.
The FDA requires that certain recalls undertaken to reduce a risk to health be reported to the FDA within 10 working days after the recall
is initiated. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. We may initiate
voluntary recalls involving our products in the future that we determine do not require notification of the FDA. If the FDA disagrees
with our determinations, they could require us to report those actions as recalls. In addition, the FDA could take enforcement action
for failing to report the recalls when they were conducted.
Our
business is subject to extensive regulation, including requirements for regulatory clearances, authorizations, or approvals prior to
commercial distribution of our products. If we fail to maintain regulatory clearances, authorizations, and approvals, or are unable to
obtain, or experience significant delays in obtaining, FDA clearances, authorizations, or approvals for our future products or product
enhancements, our ability to commercially distribute and market these products could suffer.
Our
products and operations are subject to extensive regulation by the FDA and various other federal, state and foreign governmental authorities.
Government regulation of our products is meant to ensure their safety and effectiveness, and may include regulation of, among other things:
● design, development and manufacturing;
● clinical trials;
● product safety;
● premarket clearance, authorization and approval;
● marketing, sales and distribution (including making product claims);
● advertising and promotion;
● product modifications;
● recordkeeping procedures;
● product import and export.
While
a product regulated solely as a 361 HCT/P is not required to undergo 510(k) premarket clearance, de novo classification or PMA, before
a new medical device, including most of our hardware products, or a new use of, or claim for, an existing product can be marketed in
the United States, it must first receive either premarket clearance under Section 510(k) of the FDCA, a de novo classification or a PMA
from the FDA, unless an exemption applies. The process of obtaining regulatory clearances, authorizations, or approvals to market a medical
device can be costly and time-consuming, and we may not be able to obtain these clearances, authorizations or approvals on a timely basis,
if at all. Most of our currently commercialized hardware products have received premarket clearances under Section 510(k) of the FDCA.
In the future, the FDA may determine that more of our products will require the more costly, lengthy and uncertain de novo or PMA processes.
In the process of obtaining PMA, the FDA must determine that there is a reasonable assurance that a proposed device is safe and effective
for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical study, manufacturing