Item 1A. Risk Factors
Investing in our common stock is highly speculative
and involves a significant degree of risk. Before you invest in our securities, you should give careful consideration to the following
risk factors, in addition to the other information included in this Annual Report on Form 10-K, including our financial statements and
related notes, before deciding whether to invest in our securities. The occurrence of any of the adverse developments described in the
following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects. In that
case, the trading price of our common stock could decline, and you may lose all or part of your investment.
Risks Related to Our Business and Operations
We have incurred losses in the past, our financial statements
have been prepared on a going concern basis and we may be unable to achieve or sustain profitability in the future.
To date, we have financed our operations primarily
through the issuance of public and private equity and convertible notes. We have devoted substantially all of our resources to research
and development, creating the infrastructure for a publicly traded medical device company, preparing for our national commercial launch,
and clinical and regulatory matters for our products. There can be no assurances that we will be able to generate sufficient revenue from
our existing products or from any future product candidates to transition to profitability and generate consistent positive cash flows.
We expect that our operating expenses will continue to increase as we continue to build our commercial infrastructure, develop, enhance,
and commercialize our existing and new products and incur additional operating and reporting costs associated with being a public company.
As a result, we expect to continue to incur operating losses for the foreseeable future and may never achieve profitability. Furthermore,
even if we do achieve profitability, we may not be able to sustain or increase profitability on an ongoing basis. If we do not achieve
profitability, it will be more difficult for us to finance our business and accomplish our strategic objectives.
Our recurring losses from operations and negative
cash flows raise substantial doubt about our ability to continue as a going concern. As a result, our independent registered public accounting
firm included an explanatory paragraph in its report on our financial statements for the fiscal year ended, December 31, 2023, describing
the existence of substantial doubt about our ability to continue as a going concern. Our expected future capital requirements may depend
on many factors including expanding our clinician base, increasing the rate at which we train clinicians, the number of additional clinical
papers initiated, and the timing and extent of spending on the development of our technology to increase our product offerings. We may
need additional funding to fund our operations but additional funds may not be available to us on acceptable terms on a timely basis,
if at all. We may seek funds through borrowings or through additional rounds of financing, including private or public equity or debt
offerings. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing
into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur
liens or additional debt, pay dividends, repurchase our common stock, make certain investments, and engage in certain merger, consolidation
or asset sale transactions. Any future debt financing or additional equity that we raise may contain terms that are not favorable to
us or our stockholders. Furthermore, we cannot be certain that additional funding will be available on acceptable terms, if at all. If
we are unable to raise additional capital or generate sufficient cash from operations to adequately fund our operations, we will need
to curtail planned activities to reduce costs, which will likely harm our ability to execute on our business plan and continue operations.
Practice trends or other factors, including
the COVID-19 pandemic, may cause procedures to shift from the hospital environment to ambulatory surgical centers (“ASCs”),
where pressure on the prices of our products is generally more acute.
To protect health care professionals involved
in surgical care and their patients, we anticipate that more outpatient eligible procedures will be performed in ASCs during the COVID-19
pandemic, and as its acuity declines and the healthcare system returns to a more normalized state. Since patients do not stay overnight
in ASCs and COVID-19 patients would not otherwise be treated in ASCs, it is likely that the ASC will be viewed as a safer site of service
for patients and health care providers, where the risk of transmission of COVID-19 can be more effectively controlled. Because ASC facility
fee reimbursement is typically less than facility fee reimbursement for hospitals, we typically experience more pressure on the pricing
of our products by ASCs than by hospitals, and the average price for which we sell our products to ASCs is less than the average prices
we charge to hospitals. An accelerated shift of procedures using our products to ASCs as a result of the COVID-19 pandemic could adversely
impact the average selling prices of our products and our revenues could suffer as a result.
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If hospitals, clinicians, and other healthcare
providers are unable to obtain coverage and reimbursement from third-party payors for procedures performed using our products, adoption
of our products may be delayed, and it is unlikely that they will gain further acceptance.
Growing sales of our product depends on the availability
of adequate coverage and reimbursement from third-party payors, including government programs such as Medicare and Medicaid, private insurance
plans, and managed care programs. Hospitals, clinicians, and other healthcare providers that purchase or use medical devices generally
rely on third-party payors to pay for all or part of the costs and fees associated with the procedures performed with these devices.
Adequate coverage and reimbursement for procedures
performed with our products is central to the acceptance of our current and future products. We may be unable to sell our products on
a profitable basis if third-party payors deny coverage, continue to deny coverage or reduce their current levels of payment, or if our
costs for the product increase faster than increases in reimbursement levels.
Many private payors refer to coverage decisions
and payment amounts determined by the Centers for Medicare and Medicaid Services, or CMS, which administers the Medicare program, as guidelines
for setting their coverage and reimbursement policies. By June 30, 2016, all Medicare Administrative Contractors were regularly reimbursing
for minimally invasive and/or open SI-Joint fusion. Private payors that do not follow the Medicare guidelines may adopt different coverage
and reimbursement policies for procedures performed with our products. Private commercial payors have been slower to adopt positive coverage
policies for minimally invasive and/or open SI-Joint fusion, and many private payors still have policies that treat the procedure as experimental
or investigational and do not regularly reimburse for the procedure. Future action by CMS or third-party payors may further reduce the
availability of payments to physicians, outpatient surgery centers, and/or hospitals for procedures using our products.
The healthcare industry in the United States has
experienced a trend toward cost containment as government and private insurers seek to control healthcare costs. Payors are imposing lower
payment rates and negotiating reduced contract rates with service providers and being increasingly selective about the technologies and
procedures they choose to cover. There can be no guarantee that we will be able to provide the scientific and clinical data necessary
to overcome these policies. Payors may adopt policies in the future restricting access to medical technologies like ours and/or the procedures
performed using such technologies. Therefore, we cannot be certain that the procedures performed with each of our products will be reimbursed.
There can be no guarantee that, should we introduce additional products in the future, payors will cover those products or the procedures
in which they are used.
If the reimbursement provided by third-party
payors to hospitals, clinicians, and other healthcare providers for procedures performed using our products is insufficient, adoption
and use of our products and the prices paid for our implants may decline.
When a Tenon procedure utilizing the Catamaran
System is performed, both the clinician and the healthcare facility, a hospital (inpatient or outpatient clinic), submit claims for
reimbursement to the patient’s insurer. Generally, the facility obtains a lump sum payment, or facility fee, for SI-Joint fusions.
Our products are purchased by the facility, along with other supplies used in the procedure. The facility must also pay for its own fixed
costs of operation, including certain operating room personnel involved in the procedure, and other medical services care. If these costs
exceed the facility reimbursement, the facility’s managers may discourage or restrict clinicians from performing the procedure in
the facility or using certain technologies, such as the Catamaran System, to perform the procedure.
The Medicare 2022 national average hospital inpatient
payment ranges from approximately $25,000 to approximately $59,000 depending on the procedural approach and the presence of Complication
and Comorbidity (CC)/Major Complication and Comorbidity (MCC).
The Medicare 2022 national average hospital outpatient
clinic payment is $21,897. We believe that insurer payments to facilities are generally adequate for these facilities to offer the Catamaran
System. However, there can be no guarantee that these facility payments will not decline in the future. The number of procedures
performed, and the prices paid for our implants may in the future decline if payments to facilities for SI-Joint fusions decline.
Clinicians are reimbursed separately for their
professional time and effort to perform a surgical procedure. Depending on the surgical approach, the incision size, type and extent of
imaging guidance, indication for procedure, and the insurer, the Catamaran System procedure may be reported by the clinician using any
one of the applicable following CPT® codes 27279, 27280, 27299. The Medicare 2022 national average payment for CPT® 27279 is $807
and $1,325 for 27280. CPT® 27299 has no national valuation. Clinicians, however, can present a crosswalk to another procedure believed
to be fairly equivalent and/or comparison to a code for which there is an existing valuation.
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For some governmental programs, such as Medicaid,
coverage and reimbursement differ from state to state, and some state Medicaid programs may not pay an adequate amount for the procedures
performed with our products, if any payment is made at all. Similar to Medicaid, many private payors’ coverage and payment may differ
from one payer to another as well.
We believe that some clinicians view the current
Medicare reimbursement amount as insufficient for the procedure, given the work effort involved with the procedure, including the time
to diagnose the patient and obtain prior authorization from the patient’s health insurer when necessary. Many private payors require
extensive documentation of a multi-step diagnosis before authorizing SI-Joint fusion for a patient. We believe that some private payors
apply their own coverage policies and criteria inconsistently, and clinicians may experience difficulties in securing approval and coverage
for sacroiliac fusion procedures. Additionally, many private payors limit coverage for open SI-Joint fusion to trauma, tumors or extensive
spine fusion procedures involving multiple levels. The perception by physicians that the reimbursement for SI-Joint fusion is insufficient
to compensate them for the work required, including diagnosis, documentation, obtaining payor approval for the procedure, and burden on
their office staff, may negatively affect the number of procedures performed and may therefore impede the growth of our revenues or cause
them to decline.
We may not be able to convince physicians
that the Catamaran System is an attractive alternative to our competitors’ products and that our procedure is an attractive alternative
to existing surgical and non-surgical treatments of the SI-Joint.
Clinicians play the primary role in determining
the course of treatment in consultation with their patients and, ultimately, the product that will be used to treat a patient. In order
for us to sell the Catamaran System successfully, we must convince clinicians through education and training that treatment with the Catamaran
System is beneficial, safe, and cost-effective for patients as compared to our competitors’ products. If we are not successful in
convincing clinicians of the merits of the Catamaran System, they may not use our product, and we will be unable to increase our sales
and achieve or grow profitability.
Historically, most spine clinicians did not include
SI-Joint pain in their diagnostic work-up because they did not have an adequate surgical procedure to perform for patients diagnosed with
the condition. As a result, some patients with lower back pain resulting from SI-Joint dysfunction are misdiagnosed. We believe that educating
clinicians and other healthcare professionals about the clinical merits and patient benefits of the Catamaran System is an important element
of our growth. If we fail to effectively educate clinicians and other medical professionals, they may not include a SI-Joint evaluation
as part of their diagnosis and, as a result, those patients may continue to receive unnecessary or only non-surgical treatment.
Clinicians may also hesitate to change their medical treatment practices
for other reasons, including the following:
● lack of experience with minimally invasive procedures;
● costs associated with the purchase of new products; and
● time commitment that may be required for training.
Furthermore, we believe clinicians may not widely
adopt the Catamaran System unless they determine, based on experience, clinical data, and published peer-reviewed publications, that surgical
intervention provides benefits or is an attractive alternative to non-surgical treatments of SI-Joint dysfunction. In addition, we believe
support of our products relies heavily on long-term data showing the benefits of using our product. If we are unable to provide that data,
clinicians may not use our product. In such circumstances, we may not achieve expected sales and may be unable to achieve profitability.
Clinicians and payors may not find our clinical
evidence to be compelling, which could limit our sales, and on-going and future research may prove our product to be less safe and effective
than initially anticipated.
All of the component parts of the Catamaran System
have either received premarket clearance under Section 510(k) of the U.S. federal Food, Drug, and Cosmetic Act, or FDCA, or are exempt
from premarket review. The 510(k) clearance process of the U.S. Food and Drug Administration, or FDA, requires us to document that our
product is “substantially equivalent” to another 510(k) -cleared product. The 510(k) process is shorter and typically requires
the submission of less supporting documentation than other FDA approval processes, such as a premarket approval, or PMA, and does not
usually require pre-clinical or clinical studies. Additionally, to date, we have not been required to complete clinical studies in connection
with the sale of our product. For these reasons, clinicians may be slow to adopt our product, third-party payors may be slow to provide
coverage, and we may be subject to greater regulatory and product liability risks. Further, future patient studies or clinical experience
may indicate that treatment with our product does not improve patient outcomes. Such results would slow the adoption of our product by
clinicians, significantly reduce our ability to achieve expected sales, and could prevent us from achieving profitability. Moreover, if
future results and experience indicate that our product causes unexpected or serious complications or other unforeseen negative effects,
we could be subject to mandatory product recalls, suspension, or withdrawal of FDA clearance.
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Pricing pressure from our competitors, changes
in third-party coverage and reimbursement, healthcare provider consolidation, payor consolidation and the proliferation of “physician-owned
distributorships” may impact our ability to sell our product at prices necessary to support our current business strategies.
If competitive forces drive down the prices we
are able to charge for our product, our profit margins will shrink, which will adversely affect our ability to invest in and grow our
business. The SI-Joint fusion market has attracted numerous new companies and technologies. As a result of this increased competition,
we believe there will be continued and increased pricing pressure, resulting in lower gross margins, with respect to our product.
Even to the extent our product and procedures
using our product are currently covered and reimbursed by third-party private and public payors, adverse changes in coverage and reimbursement
policies that affect our product, discounts, and number of implants used may also drive our prices down and harm our ability to market
and sell our product.
We are unable to predict what changes will be
made to the reimbursement methodologies used by third-party payors. We cannot be certain that under current and future payment systems,
in which healthcare providers may be reimbursed a set amount based on the type of procedure performed, such as those utilized by Medicare
and in many privately managed care systems, the cost of our product will be justified and incorporated into the overall cost of the procedure.
In addition, to the extent there is a shift from inpatient setting to outpatient settings, we may experience pricing pressure and a reduction
in the number of the Catamaran System procedures performed.
Consolidation in the healthcare industry, including
both third-party payors and healthcare providers, could lead to demands for price concessions or to the exclusion of some suppliers from
certain of our markets, which could have an adverse effect on our business, results of operations, or financial condition. Because healthcare
costs have risen significantly over the past several years, numerous initiatives and reforms initiated by legislators, regulators, and
third-party payors to curb these costs have resulted in a consolidation trend in the healthcare industry to aggregate purchasing power.
As the healthcare industry consolidates, competition to provide products and services to industry participants has become and will continue
to become more intense. This in turn has resulted and will likely continue to result in greater pricing pressures and the exclusion of
certain suppliers from important market segments as group purchasing organizations, independent delivery networks, and large single accounts
continue to use their market power to consolidate purchasing decisions for hospitals. We expect that market demand, government regulation,
third-party coverage, and reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting
in further business consolidations and alliances among our customers, which may reduce competition, exert further downward pressure on
the price of our product, and adversely impact our business, results of operations, or financial condition. As we continue to expand into
international markets, we will face similar risks relating to adverse changes in coverage and reimbursement procedures and policies in
those markets.
We operate in a very competitive business
environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results
may be negatively affected and we may not grow.
The Catamaran System is subject to intense competition.
Many of our competitors are major medical device companies that have substantially greater financial, technical, and marketing resources
than we do, and they may succeed in developing products that would render our product obsolete or non-competitive. In addition, many of
these competitors have significantly longer operating histories and more established reputations than we do. Our field is intensely competitive,
subject to rapid change and highly sensitive to the introduction of new products or other market activities of industry participants.
Our ability to compete successfully will depend on our ability to develop proprietary products that reach the market in a timely manner,
receive adequate coverage and reimbursement from third-party payors, and are safer, less invasive, and more effective than alternatives
available for similar purposes as demonstrated in peer-reviewed clinical publications. Because of the size of the potential market, we
anticipate that other companies will dedicate significant resources to developing competing products.
In the United States, we believe that our primary
competitors are currently SI-bone, Inc., Globus Medical, Inc., Medtronic plc, XTant Medical Holdings, Inc., and RTI Surgical, Inc. At
any time, these or other industry participants may develop alternative treatments, products or procedures for the treatment of the SI-Joint
that compete directly or indirectly with our product. If alternative treatments are, or are perceived to be, superior to our product,
sales of our product and our results of operations could be negatively affected. Some of our larger competitors are either publicly traded
or divisions or subsidiaries of publicly traded companies. These competitors may enjoy several competitive advantages over us, including:
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● significantly greater name recognition;
● large and established sales and marketing and distribution networks;
● more expansive portfolios of intellectual property rights; and
New participants have increasingly entered the
medical device industry. Many of these new competitors specialize in a specific product or focus on a particular market segment, making
it more difficult for us to increase our overall market position. The frequent introduction by competitors of products that are or claim
to be superior to our product or that are alternatives to our existing or planned products may make it difficult to differentiate the
benefits of our product over competing products. In addition, the entry of multiple new products and competitors may lead some of our
competitors to employ pricing strategies that could adversely affect the pricing of our product and pricing in the market generally.
As a result, without the timely introduction of
new products and enhancements, our product may become obsolete over time. If we are unable to develop innovative new products, maintain
competitive pricing, and offer products that clinicians and other physicians perceive to be as reliable as those of our competitors, our
sales or margins could decrease, thereby harming our business.
We currently manufacture (through third
parties) and sell products used in a single procedure, which could negatively affect our operations and financial condition.
Presently we do not sell any products other than
the Catamaran System and related tools and instruments. Therefore, we are solely dependent on widespread market adoption of the Catamaran
System and we will continue to be dependent on the success of this single product for the foreseeable future. There can be no assurance
that the Catamaran System will gain a substantial degree of market acceptance among clinicians, patients or healthcare providers. Our
failure to successfully increase sales of the Catamaran System or any other event impeding our ability to sell the Catamaran System, would
result in a material adverse effect on our results of operations, financial condition and continuing operations.
We have a limited operating history and
may face difficulties encountered by early-stage companies in new and rapidly evolving markets.
Even though we were formed in 2012 we have just
built the infrastructure necessary to commercially launch the Catamaran System. Accordingly, we have a limited operating history upon
which to base an evaluation of our business and prospects. In assessing our prospects, you must consider the risks and difficulties frequently
encountered by early-stage companies in new and rapidly evolving markets, particularly companies engaged in the development and sales
of medical devices. These risks include our inability to:
● obtain coverage by third-party, private, and government payors;
● establish and increase awareness of our brand and strengthen customer loyalty;
● attract and retain qualified personnel;
● commercialize new products and enhance our existing product;
● manage rapidly changing and expanding operations;
● implement and successfully execute our business and marketing strategy;
● respond effectively to competitive pressures and developments.
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We can also be negatively affected by general
economic conditions. Because of our limited operating history, we may not have insight into trends that could emerge and negatively affect
our business. As a result of these or other risks, our business strategy might not be successful.
Our sales volumes and our operating results
may fluctuate over the course of the year.
Since we had our first sales in April 2021 and
our official national launch commenced in October 2022, we have limited history with respect to how rapidly adoption of the Catamaran
System will occur. Sales growth could be slower than we have projected. Our sales and results of operations will be affected by numerous
factors, including, among other things:
● payor coverage and reimbursement;
● maintaining our training schedule with clinicians;
● the evolving product offerings of our competitors;
● ability of clinicians to do our procedure given possible COVID restrictions;
● interruption in the manufacturing or distribution of our product;
● the effect of competing technological, industry and market developments;
● our ability to expand the geographic reach of our sales and marketing efforts;
● the number of selling days in the quarter; and
● impairment and other special charges.
Some of the products we may seek to develop and
introduce in the future will require FDA clearance or approval before commercialization in the United States. As a result, it will be
difficult for us to forecast demand for these products with any degree of certainty. In addition, we will be increasing our operating
expenses as we expand our commercial capabilities. Accordingly, we may experience significant, unanticipated quarterly losses. If our
quarterly or annual operating results fall below the expectations of investors or securities analysts, the price of our common stock could
decline substantially. Furthermore, any quarterly or annual fluctuations in our operating results may, in turn, cause the price of our
common stock to fluctuate substantially. Quarterly comparisons of our financial results may not always be meaningful and should not be
relied upon as an indication of our future performance.
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If we do not successfully implement our
business strategy, our business and results of operations will be adversely affected.
Our business strategy was based on assumptions
about the market that might prove wrong. We believe that various demographics and industry-specific trends will help drive growth in the
market and our business, but these demographics and trends have been and will continue to be uncertain. Actual demand for our product
could differ materially from projected demand if our assumptions regarding these factors prove to be incorrect or do not materialize,
or if alternative treatments to those offered by our product gains widespread acceptance. Also, our strategy of focusing exclusively on
the SI-Joint market may limit our ability to grow. In addition, in order to increase our sales, we will need to identify and contract
with independent sales representatives in existing and new regions as well, and in the future, commercialize new products. Moreover, we
may decide to alter or discontinue aspects of our business strategy and may adopt different strategies due to business or competitive
factors not currently foreseen, such as new medical technologies that would make our product obsolete. Any failure to implement our business
strategy may adversely affect our business, results of operations, and financial condition.
Our business could suffer if we lose the
services of key members of our senior management, key advisors or personnel.
We are dependent upon the continued services of
key members of our senior management and a number of key advisors and personnel. The loss of members of our senior management team, key
advisors or personnel, or our inability to attract or retain other qualified personnel or advisors, could have a material adverse effect
on our business, results of operations, and financial condition. We do not maintain “key person” insurance for any of our
executives or employees. In addition, several of the members of our executive management team are not subject to non-competition agreements
that restrict their ability to compete with us. Accordingly, the adverse effect resulting from the loss of certain executives could be
compounded by our inability to prevent them from competing with us.
Various factors outside our direct control
may adversely affect manufacturing and distribution of our product.
The manufacture and distribution of our product
is challenging. Changes that our contract manufacturers may make outside the purview of our direct control can have an impact on our processes,
quality of our product, and the successful delivery of products to our customers. Mistakes and mishandling are not uncommon and can affect
supply and delivery. Some of these risks include:
● failure to manufacture in compliance with the required regulatory standards;
● transportation risk;
If any of these risks were to materialize, our
ability to provide our product to customers on a timely basis would be adversely impacted.
We are dependent on a limited number of
contract manufacturers, some of them single-source and some of them in single locations, for our product, and the loss of any of these
contract manufacturers, or their inability to provide us with an adequate supply of products in a timely and cost-effective manner, could
materially adversely affect our business.
We rely on contract manufacturers to supply our
product. For us to be successful, our contract manufacturers must be able to provide us with product in substantial quantities, in compliance
with regulatory requirements, in accordance with agreed upon specifications, at acceptable prices, and on a timely basis. We have a limited
history with our current contract manufacturers and do not have long-term supply contracts with them. We are in the process of identifying
and evaluating new contract manufacturers for our product. The inability to find the required contract manufacturers or the time required
to switch contract manufacturers could adversely affect sales.
In addition, our anticipated growth could strain
the ability of our contract manufacturers to deliver an increasingly large supply of product. Contract manufacturers often experience
difficulties in scaling up production, including financial issues, or problems with production yields and quality control and assurance.
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We use a small number of contract manufacturers
for our instruments. Our dependence on such a limited number of contract manufacturers exposes us to risks, including, among other things:
If any one or more of these risks materialize,
it could significantly increase our costs and impact our ability to meet demand for our product. If we are unable to satisfy commercial
demand for our product in a timely manner, our ability to generate revenue would be impaired, market acceptance of our product could be
adversely affected, and customers may instead purchase or use our competitors’ products. Additionally, we could be forced to seek
alternative sources of supply.
Because of the nature of our internal quality
control requirements, regulatory requirements, and the custom and proprietary nature of our product, we may not be able to quickly engage
additional or replacement contract manufacturers for our product and accessories. We may also be required to assess any potential new
contract manufacturer’s compliance with all applicable regulations and guidelines, which could further impede our ability to obtain
our product in a timely manner. As a result, we could incur increased product costs, experience delays in deliveries of our product, suffer
damage to our reputation, and experience an adverse effect on our business and financial results. Failure of any of our contract manufacturers
to meet our product demand level would limit our ability to meet our sales commitments to our customers and could have a material adverse
effect on our business.
We may also have difficulty obtaining similar
product from other contract manufacturers that are acceptable to the FDA and the failure of our contract manufacturers to comply with
strictly enforced regulatory requirements could expose us to delays in obtaining clearances or approvals, regulatory action including
warning letters, product recalls, termination of distribution, product seizures, civil, administrative, or criminal penalties. We could
incur delays while we locate and engage qualified alternative contract manufacturers, and we may be unable to engage alternative contract
manufacturers on favorable terms or at all. Any such disruption or increased expenses could harm our commercialization efforts and adversely
affect our ability to generate sales.
In addition, we expect that most of our contract
manufacturers will operate at a facility in a single location and substantially all their inventory of component supplies and finished
goods will be held at these locations. We, and our contract manufacturers, will take precautions to safeguard facilities, including acquiring
insurance, adopting health and safety protocols, and utilizing off-site storage of computer data. However, vandalism, terrorism, or a
natural or other disaster, such as an earthquake, fire, or flood, could damage or destroy equipment or component supplies or finished
product, cause substantial delays in our operations, result in the loss of key information, and cause us to incur additional expenses.
Our insurance may not cover our losses in any particular case. In addition, regardless of the level of insurance coverage, damage to our
or our contract manufacturers’ facilities could harm our business, financial condition, and operating results.
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As our sales grow, our contract manufacturers
may encounter problems or delays in the manufacturing of our product or fail to meet certain regulatory requirements which could result
in an adverse effect on our business and financial results.
To become profitable, our contract manufactures
must manufacture our product in adequate quantities in compliance with regulatory requirements and at an acceptable cost. Increasing their
capacity to manufacture and inspect our product may require them to improve internal efficiencies or require us to re-design or change
the specifications of our product. Our contract manufacturers may encounter several difficulties in increasing this capacity, including:
● managing production yields;
● maintaining quality control and assurance;
● providing component and service availability;
● maintaining adequate control policies and procedures;
● hiring and retaining qualified personnel; and
● complying with state, federal, and foreign regulations.
If we are unable to satisfy commercial demand
for the Catamaran System due to our contract manufacturer’s inability to manufacture and inspect our product, our ability to generate
revenue would be impaired, market acceptance of our product could be adversely affected and customers may instead purchase or use our
competitors’ products.
The size and future growth in the market
for the SI-Joint fixation market have not been established based on market reports and our estimates are based on our own review and analysis
of public information and may be smaller than we estimate, possibly materially. In addition, our estimates of cost savings to the economy
and healthcare system as a result of the Catamaran System procedure are based on our internal estimates and market research and could
also be smaller than we estimate, possibly materially. If our estimates and projections overestimate the size of this market or cost savings,
our sales growth may be adversely affected.
We are not aware of an independent third-party
study that reliably reports the potential market size for the SI-Joint fixation market. Therefore, our estimates of the size and future
growth in the market for the Catamaran System product, including cost savings to the economy overall, including patients and employers,
and to the healthcare system and the number of people currently suffering from lower back pain who may benefit from and be amenable to
our procedure, is based on a number of internal and third-party studies, surveys, reports, and estimates. While we believe these factors
have historically provided and may continue to provide us with effective tools in estimating the total market for our product and procedures
and health cost savings, these estimates may not be correct and the conditions supporting our estimates may change at any time, thereby
reducing the predictive accuracy of these underlying factors. For example, we have consulted with our clinical advisors and utilized public
information as the basis for our market projections. Additionally, the surveys we have conducted are based on a small number of respondents
and are not statistically significant and may have other limitations. The actual incidence of lower back pain, and the actual demand for
our product or competitive products, could differ materially from our projections if our assumptions and estimates are incorrect. As a
result, our estimates of the size and future growth in the market for our product may prove to be incorrect. In addition, actual health
cost savings to the healthcare system as a result of the Catamaran System procedure may materially differ from those presented in this
report. If the actual number of people with lower back pain who would benefit from the Catamaran System and the size and future growth
in the market and related costs savings to the healthcare system is smaller than we have estimated, it may impair our projected sales
growth and have an adverse impact on our business.
In the future our product may become obsolete,
which would negatively affect operations and financial condition.
The medical device industry is characterized by
rapid and significant change. There can be no assurance that other companies will not succeed in developing or marketing devices, and
products that are more effective than the Catamaran System or that would render the Catamaran System obsolete or non-competitive. Additionally,
new surgical procedures, medications and other therapies could be developed that replace or reduce the importance of our product. Accordingly,
our success will depend in part on our ability to respond quickly to medical and changes through the development and introduction of new
products. Product development involves a high degree of risk and there can be no assurance that our new product development efforts will
result in any commercially successful products.
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If we experience significant disruptions
in our information technology systems, our business, results of operations, and financial condition could be adversely affected.
The efficient operation of our business depends
on our information technology systems. We will rely on our information technology systems to effectively manage:
● sales and marketing, accounting, and financial functions;
● inventory management;
● engineering and product development tasks; and
● our research and development data.
Our information technology systems are vulnerable
to damage or interruption from:
● earthquakes, fires, floods, and other natural disasters;
● terrorist attacks and attacks by computer viruses or hackers;
● power losses; and
● computer systems, or Internet, telecommunications, or data network failures.
The failure of our information technology systems
to perform as we anticipate or our failure to effectively implement new systems could disrupt our entire operation and could result in
decreased sales, increased overhead costs, excess inventory and product shortages, and legal liability issues, all of which could have
a material adverse effect on our reputation, business, results of operations, and financial condition.
We may seek to grow our business through
acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or
investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.
From time to time, we expect to consider opportunities
to acquire or make investments in other technologies, products, and businesses that may enhance our capabilities, complement our current
product, or expand the breadth of our markets or customer base. Potential and completed acquisitions and strategic investments involve
numerous risks, including:
● issues maintaining uniform standards, procedures, controls, and policies;
● unanticipated costs and liabilities associated with acquisitions;
● diversion of management’s attention from our core business;
● potential loss of key employees of acquired businesses; and
● increased legal and accounting compliance costs.
We have no current commitments with respect to
any acquisition or investment. We do not know if we will be able to identify acquisitions, we deem suitable, whether we will be able to
successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired
business, product, or technology into our business or retain any key personnel, suppliers, or distributors. Our ability to successfully
grow through acquisitions depends upon our ability to identify, negotiate, complete, and integrate suitable target businesses and to obtain
any necessary financing. These efforts could be expensive and time consuming and may disrupt our ongoing business and prevent management
from focusing on our operations. If we are unable to successfully integrate any acquired businesses, products, or technologies effectively,
our business, results of operations, and financial condition will be materially adversely affected.
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We may enter into collaborations, in-licensing
arrangements, joint ventures, strategic alliances, or partnerships with third-parties that may not result in the development of commercially
viable products or the generation of significant future revenue.
In the ordinary course of our business, we may
enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, partnerships, or other arrangements to develop
products and to pursue new markets. We have not entered into any collaboration arrangements to date. Proposing, negotiating, and implementing
collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships may be a lengthy and complex process.
Other companies, including those with substantially greater financial, marketing, sales, technology, or other business resources, may
compete with us for these opportunities or arrangements. We may not identify, secure, or complete any such transactions or arrangements
in a timely manner, on a cost-effective basis, on acceptable terms or at all. We have limited institutional knowledge and experience with
respect to these business development activities, and we may also not realize the anticipated benefits of any such transaction or arrangement.
These collaborations may not result in the development of products that achieve commercial success or result in significant revenue and
could be terminated prior to developing any products.
Additionally, we may not be able to exercise sole
decision-making authority regarding the transaction or arrangement, which could create the potential risk of creating impasses on decisions,
and our future collaborators may have economic or business interests or goals that are, or that may become, inconsistent with our business
interests or goals. It is possible that conflicts may arise with our collaborators, such as conflicts concerning the achievement of performance
milestones, or the interpretation of significant terms under any agreement, such as those related to financial obligations or the ownership
or control of intellectual property developed during the collaboration. If any conflicts arise with any future collaborators, they may
act in their self- interest, which may be adverse to our best interest, and they may breach their obligations to us. In addition, we may
have limited control over the amount and timing of resources that any future collaborators devote to our or their future products.
Disputes between us and our collaborators may
result in litigation or arbitration which would increase our expenses and divert the attention of our management. Further, these transactions
and arrangements will be contractual in nature and will generally be terminable under the terms of the applicable agreements and, in such
event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights
at a premium. If we enter into in-bound intellectual property license agreements, we may not be able to fully protect the licensed intellectual
property rights or maintain those licenses. Future licensors could retain the right to prosecute and defend the intellectual property
rights licensed to us, in which case we would depend on the ability of our licensors to obtain, maintain and enforce intellectual property
protection for the licensed intellectual property. These licensors may determine not to pursue litigation against other companies or may
pursue such litigation less aggressively than we would. Further, entering into such license agreements could impose various diligence,
commercialization, royalty, or other obligations on us. Future licensors may allege that we have breached our license agreement with them,
and accordingly seek to terminate our license, which could adversely affect our competitive business position and harm our business prospects.
We are increasingly dependent on information
technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.
Significant disruptions to our information technology
systems or breaches of information security could adversely affect our business. In the ordinary course of business, we will collect,
store and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality
and integrity of such information. We have also outsourced significant elements of our information technology infrastructure; as a result,
we manage independent vendor relationships with third parties who are responsible for maintaining significant elements of our information
technology systems and infrastructure and who may or could have access to our confidential information. The size and complexity of our
information technology systems, and those of our third-party vendors, make such systems potentially vulnerable to service interruptions
and security breaches from inadvertent or intentional actions by our employees, partners or vendors. These systems are also vulnerable
to attacks by malicious third parties and may be susceptible to intentional or accidental physical damage to the infrastructure maintained
by us or by third parties. Maintaining the secrecy of confidential, proprietary and/or trade secret information is important to our competitive
business position. While we have taken steps to protect such information and have invested in systems and infrastructures to do so, there
can be no guarantee that our efforts will prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent
wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination
or misuse of critical or sensitive information. The increasing sophistication and frequency of cybersecurity threats, including targeted
data breaches, ransomware attacks designed to encrypt our data for ransom and other malicious cyber activities, pose a significant risk
to the integrity and confidentiality of our data systems. A breach our security measures or the accidental loss, inadvertent disclosure,
unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information or other confidential information, whether
as a result of theft, hacking, fraud, trickery or other forms of deception, or for any other cause, could enable others to produce competing
products, use our proprietary technology or information, and/or adversely affect our business position. Further, any such interruption,
security breach, loss or disclosure of confidential information could result in financial, legal, business and reputational harm to us
and could have a material adverse effect on our business, financial position, results of operations and/or cash flow.
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Geopolitical conditions,
including trade disputes and direct or indirect acts of war or terrorism, could have an adverse effect on our operations and financial
results.
Our operations could be disrupted by geopolitical
conditions, political and social instability, acts of war, terrorist activity or other similar events. In February 2022, Russia initiated
significant military action against Ukraine. In response, the U.S. and certain other countries imposed significant sanctions and export
controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial
organizations, and the U.S. and certain other countries could impose further sanctions, trade restrictions, and other retaliatory actions
should the conflict continue or worsen. It is not possible to predict the broader consequences of the conflict, including related geopolitical
tensions, and the measures and retaliatory actions taken by the U.S. and other countries in respect thereof as well as any counter measures
or retaliatory actions by Russia or Belarus in response, including, for example, potential cyberattacks or the disruption of energy exports,
is likely to cause regional instability, geopolitical shifts, and could materially adversely affect global trade, currency exchange rates,
regional economies and the global economy. In addition, the ongoing conflicts in the Middle East may further impact global economic conditions
and market sentiments. This, in turn, could adversely affect the trading price of our shares of common stock and investor interest in
us. The outcome of the Russia-Ukraine war and conflicts in the Middle East remain uncertain, and while it is difficult to predict the
impact of any of the foregoing, the conflict and actions taken in response to the conflict could increase our costs, disrupt our supply
chain, reduce our sales and earnings, impair our ability to raise additional capital when needed on acceptable terms, if at all, or otherwise
adversely affect our business, financial condition, and results of operations.
Inflation may adversely
affect our operations and financial results.
In periods of rising inflation, the cost of raw
materials, components and labor essential for manufacturing the Catamaran System may increase and as a consequence, our overall profit
margin may be adversely affected. In addition, inflation may result in limitations on healthcare spending, specifically for procedures
that are deemed elective or non-critical, which may include treatments utilizing the Catamaran System. A decrease in demand for these
procedures may significantly impact our financial condition and results of operations.
The failure of
Silicon Valley Bank could cause us to lose our deposits in excess of the federally insured bank deposit limitation.
On March 10, 2023, the
Federal Deposit Insurance Corporation (the “FDIC”) took control of Silicon Valley Bank (“SVB”) and created the
National Bank of Santa Clara to hold the deposits of SVB after SVB was unable to continue their operations. SVB’s deposits are insured
by the FDIC in amount up to $250,000 for any depositor and any deposit in excess of this insured amount could be lost. As of March 10,
2023, we had approximately $585,000 on deposit with SVB, of which approximately $335,000 will not be insured by the FDIC (the “Uninsured
Amount”). We expect to have access to the insured portion of our SVB deposit in the coming days, but do not know when, if ever,
we will have access to the Uninsured Amount. The loss of all or a significant portion of the Uninsured Amount would not have an adverse
effect on our ability to pay our operational expenses or make other payments, but may require the Company to move our accounts to another
bank which could cause a temporary delay in making payments to our vendors and employees and cause other operational inconveniences.
Risks Related to Our Legal and Regulatory Environment
We and our contract manufacturers are subject
to extensive governmental regulation both in the United States and abroad, and failure to comply with applicable requirements could cause
our business to suffer.
The medical device industry is regulated extensively
by governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies. The FDA and other U.S. and foreign
governmental agencies regulate, among other things, with respect to medical devices:
● design, development, and manufacturing;
● testing, labeling, content, and language of instructions for use and storage;
● clinical trials;
● product safety;
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● marketing, sales, and distribution;
● premarket clearance and approval;
● conformity assessment procedures;
● record keeping procedures;
● advertising and promotion;
● compliance with good manufacturing practices requirements;
● recalls and field safety corrective actions;
● post-market approval studies; and
● product import and export.
The regulations to which we are subject are complex
and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand
our operations, difficulties achieving new product clearances, higher than anticipated costs or lower than anticipated sales.
Before we can market or sell a new regulated product
or make a significant modification to an existing product in the United States, with very limited exception, we must obtain either clearance
under Section 510(k) of the FDCA for Class II devices or approval of a premarket approval application from the FDA for a Class III
device. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a
device legally on the market, known as a “predicate” device, with respect to intended use, technology, and safety and effectiveness,
in order to clear the proposed device for marketing. Clinical data is sometimes required to support substantial equivalence. The PMA pathway
requires an applicant to demonstrate the safety and effectiveness of the device based, in part, on extensive data, including, but not
limited to, technical, preclinical, clinical trial, manufacturing, and labeling data. The PMA process is typically required for devices
that are deemed to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices. Products that are approved
through a PMA application generally need FDA approval before they can be modified. Similarly, some modifications made to products cleared
through a 510(k) may require a new 510(k). Both the 510(k) and PMA processes can be expensive and lengthy and require the payment of significant
fees, unless exempt. The FDA’s 510(k) clearance process usually takes from three to 12 months but may last longer. The process of
obtaining a PMA is much more costly and uncertain than the 510(k) clearance process and generally takes from one to three years, or even
longer, from the time the application is submitted to the FDA until an approval is obtained. The process of obtaining domestic and international
regulatory clearances or approvals to market a medical device can be costly and time consuming, and we may not be able to obtain these
clearances or approvals on a timely basis, if at all.
In the United States, all of the components to
the Catamaran System have either received premarket clearance under Section 510(k) of the FDCA or are exempt from premarket review.
If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to existing products
than we had expected, our product introductions or modifications could be delayed or canceled, which could cause our sales to decline.
In addition, the FDA may determine that future products will require the more costly, lengthy, and uncertain PMA process. Although we
do not currently market any devices under PMA, the FDA may demand that we obtain a PMA prior to marketing certain of our future products.
In addition, if the FDA disagrees with our determination that a product, we currently market is subject to an exemption from premarket
review, the FDA may require us to submit a 510(k) or PMA in order to continue marketing the product. Further, even with respect to those
future products where a PMA is not required, we cannot assure you that we will be able to obtain the 510(k) clearances with respect to
those products.
The FDA can delay, limit or deny clearance or
approval of a device for many reasons, including:
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In addition, the FDA may change its clearance
and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay clearance
or approval of our product under development or impact our ability to modify our currently approved or cleared product on a timely basis.
Any delay in, or failure to receive or maintain,
clearance or approval for our product under development could prevent us from generating revenue from these products or achieving profitability.
In addition, even after we have obtained the proper
regulatory clearance or approval to market a product, the FDA has the power to require us to conduct post-market surveillance on our product.
These studies can be very expensive and time consuming to conduct. Failure to comply with those studies in a timely manner could result
in the revocation of the 510(k) clearance for a product that is subject to such surveillance and the recall or withdrawal of the product,
which could prevent us from generating sales from that product in the United States.
Additionally, as part of the conformity assessment
process, medical device manufacturers must carry out a clinical evaluation of their medical devices to verify that they comply with the
relevant Essential Requirements covering safety and performance. A clinical evaluation includes an assessment of whether a medical device’s
performance is in accordance with its intended use and that the known and foreseeable risks linked to the use of the device under normal
conditions are minimized and acceptable when weighed against the benefits of its intended purpose. The clinical evaluation conducted by
the manufacturer must also address any clinical claims, the adequacy of the device labeling and information (particularly claims, contraindications,
precautions/ warnings) and the suitability of related Instructions for Use. This assessment must be based on clinical data, which can
be obtained from (i) clinical studies conducted on the devices being assessed; (ii) scientific literature from similar devices
whose equivalence with the assessed device can be demonstrated; or (iii) both clinical studies and scientific literature.
The FDA and other regulatory authorities have
broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some clinicians from
using our product and adversely affect our reputation and the perceived safety and effectiveness of our product.
Failure to comply with applicable regulations
could jeopardize our ability to sell our product and result in enforcement actions such as: