What changed in this filing

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Item 1A. Risk Factors

2023-03-20 compared with 2022-03-10 · 813 added, 751 removed, 166 unchanged (90% of the section changed)

Risk Factor Summary

The following summary highlights the material risks

that may affect our business, operating results, financial condition and prospects, as more fully described in the pages that follow this

Risks Related to Our Financial Condition and Capital Requirements

Investing in our securities carries a significant degree of risk.

You should carefully consider the risks described below, together with all of the other information in this Form 10-K, including our consolidated

financial statements and related notes included elsewhere in this Form 10-K, before deciding whether to invest in our securities.

or a combination of the following risks were to materialize, our results of operations, financial condition and prospects could be materially

adversely affected.

If that were to be the case, the market price of our securities could decline, and investors could lose all or part

of their investment.

The risks and uncertainties described below are not the only ones we face.

Additional risks and uncertainties not

presently known to us or that we currently believe to be immaterial may also adversely affect our business.

Risks Related to Our Financial Condition

and Capital Requirements

We are subject to the risks associated with

new businesses.

We entered into a license agreement

with Toray in October 2020 and are effectively a new business with a plan to commercialize our licensed technology.

Our limited operating

history may not be adequate to enable you to fully assess our ability to develop and market our Symphony platform and test cartridges,

assuming we receive regulatory clearances for which there is no assurance, and respond to competition.

Our efforts to date have related

to the organization and formation of our company, research and development and preparation for commencing regulatory trials.

approved products, have not yet generated revenue, and we cannot guarantee we will ever be able to generate revenues.

Therefore, we are,

and expect for the foreseeable future to be, subject to all the risks and uncertainties, inherent in a new business focused on the development

We entered into a License Agreement with Toray

in October 2020 and are effectively a new business with a plan to commercialize our licensed technology.

Our limited operating history

may not be adequate to enable you to fully assess our ability to develop and market our Symphony platform and test cartridges, assuming

we receive regulatory clearances, for which there is no assurance, and respond to competition.

Our efforts to date have related to the

organization and formation of our Company, research and development and performing clinical trials.

We have no approved products, have

not yet generated sustainable revenue, and we cannot guarantee we will ever be able to generate future revenues.

Therefore, we are, and

expect for the foreseeable future to be, subject to all the risks and uncertainties, inherent in a new business focused on the development

and sale of new medical devices.

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assessing and commencing our marketing activities.

Accordingly, you should consider

our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies that have not yet commercialized

their products, particularly those in the medical device field.

Accordingly, you should consider our prospects

in light of the costs, uncertainties, delays and difficulties frequently encountered by companies that have not yet commercialized their

products, particularly those in the medical device field.

In particular, potential investors should consider that there is a significant

risk that we will not be able to:

● implement or execute our current business plan, or that our

business plan is sound;

● maintain our management team and Board of Directors;

● determine that the technologies that have been developed are

commercially viable;

● attract, enter into or maintain contracts with, and retain customers;

● raise any necessary additional funds in the capital markets

or otherwise to effectuate our business plan.

In the event that we do not

successfully address these risks, our business, prospects, financial condition, and results of operations could be materially and adversely

● implement or execute our current

business plan, or that our business plan is sound;

● maintain our management team

and Board of Directors;

● determine that the technologies

that have been developed are commercially viable;

● attract, enter into or maintain

contracts with, and retain customers;

● raise any necessary additional

funds in the capital markets or otherwise to effectuate our business plan.

In the event that we do not successfully address

these risks, our business, prospects, financial condition, and results of operations could be materially and adversely affected.

We have incurred significant losses since

inception and may not be able to achieve significant revenues or profitability.

Since our inception, we have

engaged primarily in development activities.

We have funded our operations primarily through debt and equity financings, and have incurred

losses since inception, including a net loss of $3.5 million and $1.2 million for the years ended December 31, 2021 and 2020, respectively.

We do not know whether or when we will become profitable.

Our ability to generate revenue and achieve profitability depends upon our

ability, alone or with others, to complete the development process of our product candidates, including regulatory approvals, and thereafter

achieve substantial acceptance in the marketplace for our products.

Since our inception, we have engaged primarily

in development activities.

We have funded our operations primarily through debt and equity financings, and have incurred losses since

inception, including a net loss of $9.3 million and $3.5 million for the years ended December 31, 2022 and 2021, respectively.

know whether or when we will become profitable.

Our ability to generate revenue and achieve profitability depends upon our ability, alone

or with others, to complete the development process of our product candidates, including regulatory approvals, and thereafter achieve

substantial acceptance in the marketplace for our products.

We may be unable to achieve any or all of these goals.

We will require substantial additional

funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce

or cease our operations.

To date, we have relied primarily

on private debt and equity financing to carry on our business.

We have limited financial resources, negative cash flow from operations

and no assurance that sufficient funding will be available to us to fund our operating expenses and to further our product development

efforts and pursue clinical trials for FDA approval.

We expect that our current cash position will enable us to fund our operating expenses

and capital expenditure requirements for at least the next twelve months.

Thereafter, unless we achieve profitability, we anticipate

that we will need to raise additional capital to fund our operations while we implement and execute our business plan.

We currently do

not have any contracts or commitments for additional financing.

In addition, any additional equity financing may involve substantial

dilution to our existing shareholders.

There can be no assurance that such additional capital will be available on a timely basis or

on terms that will be acceptable to us.

Failure to obtain such additional financing could result in delay or indefinite postponement

of operations or the further development of our business with the possible loss of such properties or assets.

If adequate funds are not

available or are not available on acceptable terms, we may not be able to fund our business or the expansion thereof, take advantage

of strategic acquisitions or investment opportunities or respond to competitive pressures.

Such inability to obtain additional financing

when needed could have a material adverse effect on our business, results of operations, cash flow, financial condition and prospects.

We will require substantial additional funding,

which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease

our operations.

To date, we have relied primarily on private debt

and equity financing to carry on our business.

We have limited financial resources, negative cash flow from operations and no assurance

that sufficient funding will be available to us to fund our operating expenses and to further our product development efforts and pursue

clinical trials for FDA approval.

Based on these and other factors, in our audited consolidated financial statements for the years ended

December 31, 2022 and 2021, we concluded that this circumstance raised substantial doubt about our ability to continue as a going concern

within one year from the original issuance date of such financial statements.

Similarly, in its report on the consolidated financial statements

for the years ended December 31, 2022 and 2021, our independent registered public accounting firm included an emphasis of matter paragraph

stating that our recurring losses from operations and continued cash outflows from operating activities raised substantial doubt about

our ability to continue as a going concern.

Our consolidated financial statements for the years ended December 31, 2022 and 2021 do not

include any adjustments that may result from the outcome of this uncertainty.

We anticipate that we will need to raise additional capital

to fund our operations while we implement and execute our business plan.

We currently do not have any contracts or commitments for additional

In addition, any additional equity financing may involve substantial dilution to our existing stockholders.

There can be no assurance that such additional

capital will be available on a timely basis or on terms that will be acceptable to us.

Failure to obtain such additional financing could

result in delay or indefinite postponement of operations or the further development of our business with the possible loss of such properties

If adequate funds are not available or are not available on acceptable terms, we may not be able to fund our business or the

expansion thereof, take advantage of strategic acquisitions or investment opportunities or respond to competitive pressures.

Such inability

to obtain additional financing when needed could have a material adverse effect on our business, results of operations, cash flow, financial

condition and prospects.

We have received a notification letter

from the Nasdaq Listing Qualifications Staff that our common stock does not satisfy Nasdaq’s $1.00 minimum price per share rule

and we could face delisting by Nasdaq if we are unable to regain compliance with this requirement, which could adversely affect our ability

to sell stock in the public markets, the liquidity of our common stock and our general ability to raise additional capital.

Our common stock currently is listed for quotation

on the Nasdaq Capital Market.

We are required to meet specified financial requirements in order to maintain such listing.

On October 25,

2022, we received a notification letter from the Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”)

notifying us that the closing bid price for our common stock had been below $1.00 for the previous 30 consecutive business days and that

we therefore are not in compliance with the minimum bid price requirement for continued inclusion on the Nasdaq Capital Market under Nasdaq

Listing Rule 5550(a)(2).

The notification has no immediate effect on the listing of our common stock on the Nasdaq Capital Market.

Under the Nasdaq Listing Rules, we have a period

of 180 calendar days to regain compliance.

To regain compliance, the closing bid price of our common stock must be at least $1.00 or higher

for a minimum of ten consecutive business days, and in such case, Nasdaq will provide us with written confirmation of compliance.

do not regain compliance by April 24, 2023, we may be eligible for an additional 180 calendar days, provided that we meet the continued

listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, except the bid price

If we are not eligible or it appears to Nasdaq that we will not be able to cure the deficiency during the second compliance

period, Nasdaq will provide written notice to us that our common stock will be subject to delisting.

In the event of such notification,

we may appeal Nasdaq’s determination to delist its securities, but there can be no assurance that Nasdaq would grant our request

for continued listing.

We intend to take all reasonable measures available

to us to achieve compliance to allow for continued listing on the Nasdaq Capital Market.

However, there can be no assurance that we will

be able to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria.

If our common stock does not regain compliance with the minimum price requirement during the applicable compliance period, we may need

to effect a reverse stock split, whereby shares of our common stock are consolidated so that the per-share trading price becomes greater

than $1.00 per share.

If our common stock is delisted, we may seek to have our common stock quoted on an over-the-counter marketplace,

such as on the OTCQX.

The OTCQX is not a stock exchange, and if our common stock trades on the OTCQX rather than a securities exchange,

there may be significantly less trading volume and analyst coverage of, and significantly less investor interest in, our common stock,

which may lead to lower trading prices for our common stock.

Any potential delisting

of our common stock from the Nasdaq Capital Market may have materially adverse consequences to our stockholders, including:

● A reduced market price and liquidity

with respect to our shares of common stock;

● limited dissemination of the

market price of our common stock;

● limited news coverage;

● limited interest by investors

in our common stock;

● volatility of the prices of

our common stock, due to low trading volume;

● our common stock being considered

a “penny stock,” which would result in broker-dealers participating in sales of our common stock being subject to the regulations

set forth in Rules 15g-2 through 15g-9 promulgated under the Exchange Act;

● increased difficulty in selling

our common stock in certain states due to “blue sky” restrictions;

● limited ability to issue additional

securities or to secure additional financing.

Risks Related to Our Business

The License Agreement with Toray, which

covers the license of the core technology used in our Symphony platform and test cartridge product candidates, contains significant risks

that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.

We have an exclusive license

with Toray for the entire world, excluding Japan, to use their patents and know-how related to our Symphony platform and test cartridges

for the manufacturing, marketing and sale of such products.

We also have a nonexclusive license for the same

purposes in Japan.

We have no contractual rights to the intellectual property covered in the license agreement other than as expressly

set forth therein.

Our plans, business, prospects and viability are substantially dependent on that intellectual property and subject

to the limitations relating thereto as set forth in the license agreement:

● After the receipt of regulatory approval in a country, we are

required to pay Toray a minimum royalty of $60,000 for the initial year that royalties are payable increasing to a minimum of $100,000

thereafter, regardless of the actual amount of sales by us of licensed products.

Accordingly, we could be obligated to pay royalties

even though we have generated no or limited revenue.

Such payments could materially and adversely affect our profitability and could

limit our investment in our business.

● For a period of three years, we are required to purchase test

cartridges from Toray.

Accordingly, we will not have unfettered right to select our suppliers, regardless of whether an unauthorized

supplier could provide products on better pricing, delivery, quality or other terms, thus potentially materially and adversely impacting

those aspects of our business, economies, profitability and prospects.

● The license is non-assignable and non-sublicensable (to third

These restrictions may limit our flexibility to structure our operations in the most advantageous manner.

● At our sole expense, we must file for, prosecute the application

for, and obtain all regulatory approvals for the licensed products and obtain all legal permits necessary for promoting, marketing, offering

or selling each licensed product.

The regulatory approval process can be expensive and time consuming, and there can be no assurances

that we will be able to obtain or maintain any or all required permits.

● We are required to obtain market approval for the products in

the United States and the European Union by October 2023 or the license agreement could be terminated by Toray.

● If we do not generate commercial sales within five years of

the date of the license, Toray has the right to terminate the agreement or make it non-exclusive.

covers the license of the core technology used in our Symphony Cartridges , contains significant risks that may threaten

our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.

We have an exclusive license with Toray for the

entire world, excluding Japan, to use their patents and know-how related to our Symphony test cartridges for the manufacturing, marketing

and sale of such products.

We also have a nonexclusive license for the same purposes in Japan.

We have no contractual

rights to the intellectual property covered in the License Agreement other than as expressly set forth therein.

Our plans, business, prospects

and viability are substantially dependent on that intellectual property and subject to the limitations relating thereto as set forth in

the License Agreement:

● After the receipt of regulatory

approval in a country, we are required to pay Toray a minimum royalty of $60,000 for the initial year that royalties are payable increasing

to a minimum of $100,000 thereafter, regardless of the actual amount of sales by us of licensed products.

Accordingly, we could be obligated

to pay royalties even though we have generated no or limited revenue.

Such payments could materially and adversely affect our profitability

and could limit our investment in our business.

● Toray is only required to supply

cartridges for a three-year period ending in October 2024.

If we are unable to extend this arrangement or activate a new CMO

to produce cartridges, we could be without any cartridge supply in the future.

● Toray may not be able to provide

all necessary know-how related to the test cartridges, increasing the time and cost of remediating product defects or impairing our ability

to timely scale up cartridge manufacturing.

● The license is non-assignable

and non-sublicensable (to third parties).

These restrictions may limit our flexibility to structure our operations in the most advantageous

● At our sole expense, we must

file for, prosecute the application for, and obtain all regulatory approvals for the licensed products and obtain all legal permits necessary

for promoting, marketing, offering or selling each licensed product.

The regulatory approval process can be expensive and time consuming,

and there can be no assurances that we will be able to obtain or maintain any or all required permits.

● We are required to obtain market

approval for the products in the United States and the European Union by October 2023 or the License Agreement could be terminated by

Toray has the right to terminate the License Agreement or make it non-exclusive

if we do not generate commercial sales by October 2025, or by April 2027 if the lack of commercial sales is not directly attributed to

● Except with respect to Toray’s ownership of all intellectual

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These provisions represent a significant risk of a material adverse impact on us, our business and our prospects.

In addition, see the risks

in “ Risks Related to Our Intellectual Property ” below.

In addition, see the risks in “ Risks

Related to Our Intellectual Property ” below.

These risks are not the only risks inherent in the License Agreement.

You are encouraged to read the complete text of the license agreement, which is filed as an exhibit to this annual report.

You are encouraged

to read the complete text of the License Agreement, which is filed as an exhibit to this Form 10-K.

We have not yet launched any products and

the ability to do so will depend on the acceptance of our Symphony platform in the healthcare market.

We have not yet launched or

received regulatory approvals in any country or territory for our Symphony platform or test cartridges.

Even if we receive regulatory

approvals, we are faced with the risk that our Symphony platform will not be accepted over competing products and that we will be unable

to enter the marketplace or compete effectively.

We have not yet launched or received regulatory

approvals in any country or territory for our Symphony platform or test cartridges.

Even if we receive regulatory approvals, we are faced

with the risk that our Symphony platform will not be accepted over competing products and that we will be unable to enter the marketplace

or compete effectively.

We cannot assure you that our Symphony platform or test cartridges will gain market acceptance.

If the market for our future products fails to develop or develops more slowly than expected, or if any of the technology and standards

supported by us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

If the market

for our future products fails to develop or develops more slowly than expected, or if any of the technology and standards supported by

us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

We cannot accurately predict the volume

or timing of any sales, making the timing of any revenues difficult to predict.

We may be faced with lengthy

and unpredictable customer evaluation and approval processes associated with our Symphony platform.

Consequently, we may incur substantial

expenses and devote significant management effort and expense in developing customer adoption of our Symphony platform, which may not

result in revenue generation.

We must also obtain regulatory approvals of our Symphony platform and test cartridges in jurisdictions in

which we pursue approvals, which is subject to risk and potential delays.

The same risks apply to other tests we may develop based on

our Symphony platform.

We may be faced with lengthy and unpredictable

customer evaluation and approval processes associated with our Symphony platform.

Consequently, we may incur substantial expenses and

devote significant management effort and expense in developing customer adoption of our Symphony platform, which may not result in revenue

We must also obtain regulatory approvals of our Symphony platform and test cartridges in jurisdictions in which we pursue

approvals, which is subject to risk and potential delays.

The same risks apply to other tests we may develop based on our Symphony platform.

As such, we cannot accurately predict the volume, if any, or timing of any future sales.

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and reimbursement for the use of our platform, our business and prospects may be negatively impacted.

Third-party payors, whether

governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.

In addition, in certain

countries, no uniform policy of coverage and reimbursement for medical device products and services exists among third-party payors.

coverage and reimbursement for medical device products and services can differ significantly from payor to payor.

In addition, payors

continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures.

As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific

and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement

will be obtained.

Third-party payors, whether governmental or commercial,

are developing increasingly sophisticated methods of controlling healthcare costs.

In addition, in certain countries, no uniform policy

of coverage and reimbursement for medical device products and services exists among third-party payors.

Therefore, coverage and reimbursement

for medical device products and services can differ significantly from payor to payor.

In addition, payors continually review new technologies

for possible coverage and can, without notice, deny coverage for these new products and procedures.

As a result, the coverage determination

process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our

products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

Our Symphony platform, including its software

and systems, may contain undetected errors, which could limit our ability to provide our products and diminish the attractiveness of our

Our Symphony platform may contain

undetected errors, defects, or bugs.

As a result, our customers or end users may discover errors or defects in our products, software

or systems, or our products, software or systems may not operate as expected.

We may discover significant errors or defects in the future

that we may not be able to fix.

Our inability to fix any of those errors could limit our ability to provide our products and services,

impair the reputation of our brand and diminish the attractiveness of our product and service offerings to our customers.

In addition, we may utilize

third party technology or components in our products, and we rely on those third parties to provide support services to us.

The existence

of errors, defects, or bugs in third party technology or components, or the failure of those third parties to provide necessary support

services to us, could materially adversely impact our business.

Our Symphony platform may contain undetected errors,

defects, or bugs.

As a result, our customers or end users may discover errors or defects in our products, software or systems, or our

products, software or systems may not operate as expected.

We may discover significant errors or defects in the future that we may not

be able to fix.

Our inability to fix any of those errors could limit our ability to provide our products and services, impair the reputation

of our brand and diminish the attractiveness of our product and service offerings to our customers.

In addition, we may utilize third party technology

or components in our products, and we rely on those third parties to provide support services to us.

The existence of errors, defects,

or bugs in third party technology or components, or the failure of those third parties to provide necessary support services to us, could

materially adversely impact our business.

We will rely on the proper function, security

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or competitive position.

We will depend on sophisticated

software and other information technology systems to operate our business, including to process, transmit and store sensitive data, and

our future products and services may include information technology systems that collect data regarding patients.

We could experience

attempted or actual interference with the integrity of, and interruptions in, our technology systems, as well as data breaches, such as

cyber-attacks, malicious intrusions, breakdowns, interference with the integrity of our products and data or other significant disruptions.

Furthermore, we may rely on third-party vendors to supply and/or support certain aspects of our information technology systems.

third-party systems could also become vulnerable to cyber-attack, malicious intrusions, breakdowns, interference, or other significant

disruptions, and may contain defects in design or manufacture or other problems that could result in system disruption or compromise the

information security of our own systems.

If in the future we pursue

foreign jurisdictions, such international operations will mean that we are subject to laws and regulations, including data protection

and cybersecurity laws and regulations, in many jurisdictions.

Furthermore, there has been a developing trend of civil lawsuits and class

actions relating to breaches of consumer data held by large companies or incidents arising from other cyber-attacks.

Any data security

breaches, cyber-attacks, malicious intrusions or significant disruptions could result in actions by regulatory bodies and/or civil litigation,

any of which could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation, or

competitive position.

In addition, our information

technology systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop

new systems to keep pace with continuing changes in information processing technology, evolving legal and regulatory standards, the increasing

need to protect patient and customer information, changes in the techniques used to obtain unauthorized access to data and information

systems, and the information technology needs associated any new products and services.

There can be no assurance that our process of

consolidating, protecting, upgrading and expanding our systems and capabilities, continuing to build security into the design of our products,

and developing new systems to keep pace with continuing changes in information processing technology will be successful or that additional

systems issues will not arise in the future.

We will depend on sophisticated software and other

information technology systems to operate our business, including to process, transmit and store sensitive data, and our future products

and services may include information technology systems that collect data regarding patients.

We could experience attempted or actual

interference with the integrity of, and interruptions in, our technology systems, as well as data breaches, such as cyber-attacks, malicious

intrusions, breakdowns, interference with the integrity of our products and data or other significant disruptions.

Furthermore, we may

rely on third-party vendors to supply and/or support certain aspects of our information technology systems.

These third-party systems

could also become vulnerable to cyber-attack, malicious intrusions, breakdowns, interference, or other significant disruptions, and may

contain defects in design or manufacture or other problems that could result in system disruption or compromise the information security

of our own systems.

If in the future we pursue foreign jurisdictions,

such international operations will mean that we are subject to laws and regulations, including data protection and cybersecurity laws

and regulations, in many jurisdictions.

Furthermore, there has been a developing trend of civil lawsuits and class actions relating to

breaches of consumer data held by large companies or incidents arising from other cyber-attacks.

Any data security breaches, cyber-attacks,

malicious intrusions or significant disruptions could result in actions by regulatory bodies and/or civil litigation, any of which could

materially and adversely affect our business, results of operations, financial condition, cash flows, reputation, or competitive position.

In addition, our information technology systems

require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep

pace with continuing changes in information processing technology, evolving legal and regulatory standards, the increasing need to protect

patient and customer information, changes in the techniques used to obtain unauthorized access to data and information systems, and the

information technology needs associated any new products and services.

There can be no assurance that our process of consolidating, protecting,

upgrading and expanding our systems and capabilities, continuing to build security into the design of our products, and developing new

systems to keep pace with continuing changes in information processing technology will be successful or that additional systems issues

will not arise in the future.

If our information technology systems, products

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technology outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to our reputation.

Our future performance will depend on the

continued engagement of key members of our management team.

Our future performance depends

to a large extent on the continued services of members of our current management.

In the event that we lose the continued services of

such key personnel for any reason, this could have a material adverse effect on our business, operations and prospects.

If we are not able to attract and retain

highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully.

We believe that our management

team must be able to act decisively to apply and adapt our business model in the markets in which we will compete.

In addition, we will

rely upon technical and scientific employees or third-party contractors to effectively establish, manage and grow our business.

Consequently,

we believe that our future viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific

and technical personnel.

In order to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently

expect, and such higher compensation payments would have a negative effect on our operating results.

Competition for experienced, high-quality

personnel is intense and we cannot assure that we will be able to recruit and retain such personnel.

We may not be able to hire or retain

the necessary personnel to implement our business strategy.

Our failure to hire and retain such personnel could impair our ability to

develop new products and manage our business effectively.

We believe that our management team must be able

to act decisively to apply and adapt our business model in the markets in which we will compete.

Our future performance depends to a large

extent on the continued services of members of our current management.

In addition, we will rely upon technical and scientific employees

or third-party contractors to effectively establish, manage and grow our business.

Consequently, we believe that our future viability

will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical personnel.

to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently expect, and such higher compensation

payments would have a negative effect on our operating results.

Competition for experienced, high-quality personnel is intense and we

cannot assure that we will be able to recruit and retain such personnel.

We may not be able to hire or retain the necessary personnel

to implement our business strategy.

Our failure to hire and retain such personnel could impair our ability to develop new products and

manage our business effectively.

In the event that we lose the continued services of such key personnel for any reason, this could have

a material adverse effect on our business, operations and prospects.

If we or our manufacturers fail to comply

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and our operating results would suffer.

We and any third-party manufacturers

and suppliers of ours will be required, to the extent of applicable regulation, to follow the quality system regulations of each jurisdiction

we will seek to penetrate and also will be subject to the regulations of these jurisdictions regarding the manufacturing processes.

we or any third-party manufacturers or suppliers of ours are found to be in significant non-compliance or fail to take satisfactory corrective

action in response to adverse regulatory findings in this regard, regulatory agencies could take enforcement actions against us and such

manufacturers or suppliers, which could impair or prevent our ability to produce our products in a cost-effective and timely manner in

order to meet customers’ demands.

We and any third-party manufacturers and suppliers

of ours will be required, to the extent of applicable regulation, to follow the quality system regulations of each jurisdiction we will

seek to penetrate and also will be subject to the regulations of these jurisdictions regarding the manufacturing processes.

third-party manufacturers or suppliers of ours are found to be in significant non-compliance or fail to take satisfactory corrective action

in response to adverse regulatory findings in this regard, regulatory agencies could take enforcement actions against us and such manufacturers

or suppliers, which could impair or prevent our ability to produce our products in a cost-effective and timely manner in order to meet

customers’ demands.

Accordingly, our operating results would suffer.

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These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our insurance

If our Symphony platform or

test cartridges, or any future tests based on our Symphony platform, are defectively designed or manufactured, contain defective components

or are misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly

Misusing our devices or failing to adhere to the operating guidelines or our devices producing inaccurate readings could cause

significant harm to patients.

If our Symphony platform or test cartridges, or

any future tests based on our Symphony platform, are defectively designed or manufactured, contain defective components or are misused,

or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation.

our devices or failing to adhere to the operating guidelines or our devices producing inaccurate readings could cause significant harm

In addition, if our operating guidelines are found to be inadequate, we may be subject to liability.

liability claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage

awards against us.

While we expect to maintain product liability insurance, we may not have sufficient insurance coverage for all future

Any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or

prevent us from securing continuing coverage, could harm our reputation in the industry and could reduce revenue.

Product liability claims

in excess of our insurance coverage would be paid out of cash reserves harming our financial condition and adversely affecting our results

of operations.

could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us.

While we expect to maintain product liability insurance, we may not have sufficient insurance coverage for all future claims.

liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing

continuing coverage, could harm our reputation in the industry and could reduce revenue.

Product liability claims in excess of our insurance

coverage would be paid out of cash reserves harming our financial condition and adversely affecting our results of operations.

If we are found to have violated laws protecting

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and harm our reputation or our business.

There are a number of laws

around the world protecting the confidentiality of certain patient health information, including patient records, and restricting the

use and disclosure of that protected information.

Privacy rules protect medical records and other personal health information by limiting

their use and disclosure, giving individuals the right to access, amend and seek accounting of their own health information and limiting

most use and disclosures of health information to the minimum amount reasonably necessary to accomplish the intended purpose.

difficulties in holding such information in compliance with applicable law.

If we are found to be in violation of the privacy rules, we

could be subject to civil or criminal penalties, which could increase our liabilities, harm our reputation and have a material adverse

effect on our business, financial condition and results of operations.

Significant raw material shortages, supplier capacity constraints,

supplier disruptions, and sourcing issues may adversely impact or limited our products sales and or impact our product margins.

In connection with effects

related to the COVID-19 pandemic, we are operating in a supply-constrained environment and are facing, and may continue to face, supply-chain

shortages, inflationary pressures, logistics challenges and manufacturing disruptions that impact our revenues, profitability, and timeliness

in fulfilling customer orders.

In addition, our key contract manufacturers are limited- or sole-source suppliers.

Disruptions in deliveries,

capacity constraints, production disruptions up- or down-stream, price increases, or decreased availability of raw materials or commodities,

including as a result of war, natural disasters (including the effects of climate change such as sea level rise, drought, flooding, wildfires

and more intense weather events), actual or threatened public health emergencies or other business continuity events, adversely affect

our operations and, depending on the length and severity of the disruption, can limit our ability to meet our commitments to customers

or significantly impact our operating profit or cash flows.

Risks Related to Product Development and Regulatory Approval

There are a number of laws around the world protecting

the confidentiality of certain patient health information, including patient records, and restricting the use and disclosure of that protected

Privacy rules protect medical records and other personal health information by limiting their use and disclosure, giving

individuals the right to access, amend and seek accounting of their own health information and limiting most use and disclosures of health

information to the minimum amount reasonably necessary to accomplish the intended purpose.

We may face difficulties in holding such information

in compliance with applicable law.

If we are found to be in violation of the privacy rules, we could be subject to civil or criminal penalties,

which could increase our liabilities, harm our reputation and have a material adverse effect on our business, financial condition and

results of operations.

Significant raw material shortages, supplier

capacity constraints, supplier disruptions, and sourcing issues may adversely impact or limited our products sales and or impact our product

In connection with effects related to the COVID-19

pandemic, we are operating in a supply-constrained environment and are facing, and may continue to face, supply-chain shortages, inflationary

pressures, logistics challenges and manufacturing disruptions that impact our revenues, profitability, and timeliness in fulfilling customer

In addition, our key suppliers are limited- or sole-source suppliers.

Disruptions in deliveries, capacity constraints, production

disruptions up- or down-stream, price increases, or decreased availability of raw materials or commodities, including as a result of war,

natural disasters (including the effects of climate change such as sea level rise, drought, flooding, wildfires and more intense weather

events), actual or threatened public health emergencies or other business continuity events, adversely affect our operations and, depending

on the length and severity of the disruption, can limit our ability to meet our commitments to customers or significantly impact our operating

profit or cash flows.

Risks Related to Product Development and Regulatory

The regulatory approval process which we

may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for our planned

We intend to market our Symphony

platform or test cartridges following regulatory approval.

We intend to market our Symphony platform or test

cartridges following regulatory approval.

To date, we have not received regulatory approval in any jurisdiction.

research, design, testing, manufacturing, labeling, selling, marketing, and distribution of medical devices are subject to extensive regulation

by country-specific regulatory authorities, which regulations differ from country to country.

There can be no assurance that, even after

such time and expenditures, we will be able to obtain necessary regulatory approvals for clinical testing or for the manufacturing or

marketing of any products.

In addition, during the regulatory process, other companies may develop other technologies with the same intended

use as our products.

We also will be subject to

numerous post-marketing regulatory requirements, which may include labeling regulations and medical device reporting regulations, which

may require us to report to different regulatory agencies if our device causes or contributes to a death or serious injury, or malfunctions

in a way that would likely cause or contribute to a death or serious injury.

In addition, these regulatory requirements may change in

the future in a way that adversely affects us.

If we fail to comply with present or future regulatory requirements that are applicable

to us, we may be subject to enforcement action by regulatory agencies, which may include, among others, any of the following sanctions:

● warning letters, fines, injunctions, consent decrees and civil

customer notification, or orders for repair, replacement, or refunds;

● voluntary or mandatory recall or seizure of our products;

imposing operating restrictions, suspension, or shutdown of production;

● refusing our requests for clearance or pre-market approval of

new products, new intended uses or modifications to any products;

● rescinding clearance or suspending or withdrawing pre-market

approvals that have already been granted;

The research, design,

testing, manufacturing, labeling, selling, marketing, and distribution of medical devices are subject to extensive regulation by country-specific

regulatory authorities, which regulations differ from country to country.

There can be no assurance that, even after such time and expenditures,

we will be able to obtain necessary regulatory approvals for clinical testing or for the manufacturing or marketing of any products.

addition, during the regulatory process, other companies may develop other technologies with the same intended use as our products.

We also will be subject to numerous post-marketing

regulatory requirements, which may include labeling regulations and medical device reporting regulations, which may require us to report

to different regulatory agencies if our device causes or contributes to a death or serious injury, or malfunctions in a way that would

likely cause or contribute to a death or serious injury.

In addition, these regulatory requirements may change in the future in a way

that adversely affects us.

If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject

to enforcement action by regulatory agencies, which may include, among others, any of the following sanctions:

● warning letters, fines, injunctions,

consent decrees and civil penalties;

● customer notification, or orders

for repair, replacement, or refunds;

● voluntary or mandatory recall

or seizure of our products;

● imposing operating restrictions,

suspension, or shutdown of production;

● refusing our requests for clearance

or pre-market approval of new products, new intended uses or modifications to any products;

● rescinding clearance or suspending

or withdrawing pre-market approvals that have already been granted;

● criminal prosecution.

The occurrence of any of these

events may have a material adverse effect on our business, financial condition and results of operations.

Product clearances and approvals can often be denied or significantly

Under FDA regulations, unless

exempt, a new medical device may only be commercially distributed after it has received 510(k) clearance, is authorized through the de

novo classification process, or is the subject of an approved PMA.

The FDA will clear marketing of a medical device through the 510(k)

process if it is demonstrated that the new product is substantially equivalent to another legally marketed product not subject to a PMA.

Sometimes, a 510(k) clearance must be supported by preclinical and clinical data.

The PMA process typically is

more costly, lengthy, and stringent than either the 510(k) process or the de novo classification process.

Unlike a 510(k) review, which

determines “substantial equivalence,” a PMA requires that the applicant demonstrate reasonable assurance that the device is

safe and effective by producing valid scientific evidence, including data from preclinical studies and human clinical trials.

to obtain regulatory clearance or approvals, we typically must, among other requirements, provide the FDA and similar foreign regulatory

authorities with preclinical and clinical data that demonstrate to their satisfaction that our products satisfy the criteria for approval.

Preclinical testing and clinical trials must comply with the regulations of the FDA and other government authorities in the United States

and similar agencies in other countries.

We may be required to obtain

PMAs, PMA supplements, de novo classification, or additional 510(k) pre-market clearances to market modifications to our products once

they are approved and commercialized.

The FDA requires device manufacturers to make and document a determination of whether a device modification

requires approval or clearance;

The occurrence of any of these events may have

a material adverse effect on our business, financial condition and results of operations.

Product clearances and approvals can often

be denied or significantly delayed.

Under FDA regulations, unless exempt, a new medical

device may only be commercially distributed after it has received 510(k) clearance, is authorized through the de novo classification process,

or is the subject of a PMA.

The FDA will clear marketing of a medical device through the 510(k) process if it is demonstrated that the

new product is substantially equivalent to another legally marketed product not subject to a PMA.

Sometimes, a 510(k) clearance must be

supported by preclinical and clinical data.

The PMA process typically is more costly, lengthy,

and stringent than either the 510(k) process or the de novo classification process.

Unlike a 510(k) review, which determines “substantial

equivalence,” a PMA requires that the applicant demonstrate reasonable assurance that the device is safe and effective by producing

valid scientific evidence, including data from preclinical studies and human clinical trials.

Therefore, to obtain regulatory clearance

or approvals, we typically must, among other requirements, provide the FDA and similar foreign regulatory authorities with preclinical

and clinical data that demonstrate to their satisfaction that our products satisfy the criteria for approval.

Preclinical testing and

clinical trials must comply with the regulations of the FDA and other government authorities in the United States and similar agencies

in other countries.

We may be required to obtain PMAs, PMA supplements,

de novo classification, or additional 510(k) pre-market clearances to market modifications to our products once they are approved and

commercialized.

The FDA requires device manufacturers to make and document a determination of whether a device modification requires approval

or clearance;

however, the FDA can review a manufacturer’s decision.

The FDA may not agree with our decisions

not to seek approvals or clearances for particular device modifications.

If the FDA requires us to obtain PMAs, PMA supplements or pre-market

clearances for any modification to a previously cleared or approved device, we may be required to cease manufacturing and marketing of

the modified device and perhaps also to recall such modified device until we obtain FDA clearance or approval.

We may also be subject

to significant regulatory fines or penalties.

The FDA may not clear or approve

our product submissions or applications on a timely basis or at all.

Such delays or refusals could have a material adverse effect on our

business, financial condition, and results of operations.

The FDA may also change its

clearance and approval policies, adopt additional regulations, or revise existing regulations, or take other actions which may prevent

or delay approval or clearance of our products under development or impact our ability to modify our currently approved or cleared products

on a timely basis.

Any of these actions could have a material adverse effect on our business, financial condition, and results of operations.

International regulatory approval

processes may take more or less time than the FDA clearance or approval process.

If we fail to comply with applicable FDA and comparable

The FDA may not agree with our decisions not to seek approvals

or clearances for particular device modifications.

If the FDA requires us to obtain PMAs, PMA supplements or pre-market clearances for

any modification to a previously cleared or approved device, we may be required to cease manufacturing and marketing of the modified device

and perhaps also to recall such modified device until we obtain FDA clearance or approval.

We may also be subject to significant regulatory

fines or penalties.

The FDA may not clear or approve our product submissions

or applications on a timely basis or at all.

Such delays or refusals could have a material adverse effect on our business, financial condition,

and results of operations.

The FDA may also change its clearance and approval

policies, adopt additional regulations, or revise existing regulations, or take other actions which may prevent or delay approval or clearance

of our products under development or impact our ability to modify our currently approved or cleared products on a timely basis.

these actions could have a material adverse effect on our business, financial condition, and results of operations.

International regulatory approval processes may

take more or less time than the FDA’s clearance or approval process.

If we fail to comply with applicable FDA and comparable non-U.S.

regulatory requirements, we may not receive regulatory clearances or approvals or may be subject to FDA or comparable non-U.S.

enforcement actions.

We may be unable to obtain future regulatory clearance or approval in a timely manner, or at all, especially if existing

regulations are changed or new regulations are adopted.

For example, the FDA clearance or approval process can take longer than anticipated

We may be unable to obtain future regulatory clearance or approval in a timely manner, or at all, especially if existing regulations

are changed or new regulations are adopted.

For example, the FDA’s clearance or approval process can take longer than anticipated

due to requests for additional clinical data and changes in regulatory requirements.

A failure or delay in obtaining necessary regulatory

clearances or approvals would materially adversely affect our business, financial condition, and results of operations.

Our Symphony IL-6 product candidate is

currently being distributed as a research use only product.

The FDA could disagree with this distribution strategy and subject the

product to regulation as a regulated medical device, which could increase our costs and delay our commercialization efforts, thereby

materially and adversely affecting our business and results of operations.

In the United States, our Symphony IL-6 is currently

labeled and sold for research use only, and not for the diagnosis or treatment of disease.

Our future product candidates also may

follow this same pathway to market.

Because such products are not intended for use in clinical practice in diagnostics, and the products

cannot include clinical or diagnostic claims, they are exempt from many regulatory requirements otherwise applicable to medical devices.

In particular, while the FDA regulations require that RUO products be labeled, “For Research Use Only.

Not for use in diagnostic

procedures,” the regulations do not otherwise subject such products to the FDA’s pre- and post-market controls for medical

A significant change in the

laws governing RUO products or how they are enforced may require us to change our business model in order to maintain compliance.

instance, in November 2013 the FDA issued a guidance document entitled “Distribution of In Vitro Diagnostic Products Labeled for Research

Use Only or Investigational Use Only” (the “RUO Guidance”) which highlights the FDA’s interpretation that

distribution of RUO products with any labeling, advertising or promotion that suggests that clinical laboratories can validate the test

through their own procedures and subsequently offer it for clinical diagnostic use as a laboratory developed test is in conflict with

The RUO Guidance further articulates the FDA’s position that any assistance offered in performing clinical validation

or verification, or similar specialized technical support, to clinical laboratories, conflicts with RUO status.

If we engage in any activities

that the FDA deems to be in conflict with the RUO status held by the products that we sell, we may be subject to immediate, severe and

broad FDA enforcement action that would adversely affect our ability to continue operations.

Accordingly, if the FDA finds that we are

distributing our RUO products in a manner that is inconsistent with its regulations or guidance, we may be forced to stop distribution

of our RUO tests until we are in compliance, which would reduce our revenue, increase our costs and adversely affect our business, prospects,

results of operations and financial condition.

In addition, the FDA’s proposed implementation for a new framework for the regulation

of LDTs may negatively impact the LDT market and thereby reduce demand for RUO products.

In addition, the changing landscape related to the

COVID-19 pandemic also could lead to delays in obtaining clinical data.

The declining number of COVID patients with respiratory deterioration

may impact our ability to meet the primary endpoint in our Symphony IL-6 Expanded Clinical Study.

We are currently working with the FDA

to expand this endpoint to better reflect the current standard of care and to make the number of study subjects more realistic in light

of the decreasing number of COVID positive subjects needed in the study.

Any failure or delay in obtaining necessary regulatory clearances

or approvals would materially adversely affect our business, financial condition, and results of operations.

Our Symphony platform may be sold as a research

use only product.

The FDA could disagree with this strategy and subject the product to regulation as a regulated medical device,

which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results

of operations.

In the United States, we may decide to label and

sell our Symphony platform for research use only, and not for the diagnosis or treatment of disease.

Our future product candidates

also may follow this same pathway to market.

Because such products are not intended for use in clinical practice in diagnostics, and the

products cannot include clinical or diagnostic claims, they are exempt from many regulatory requirements otherwise applicable to medical

In particular, while FDA regulations require that RUO products be labeled, “For Research Use Only.

Not for use in

diagnostic procedures,” the regulations do not otherwise subject such products to the FDA’s pre- and post-market controls

for medical devices.

A significant change in the laws governing RUO

products or how they are enforced may require us to change our ability to consider generating revenue via this path in order to maintain

For instance, in November 2013 the FDA issued a guidance document entitled “Distribution of In Vitro Diagnostic Products

Labeled for Research Use Only or Investigational Use Only” (the “RUO Guidance”) which highlights the FDA’s

interpretation that distribution of RUO products with any labeling, advertising or promotion that suggests that clinical laboratories

can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as a laboratory developed test

is in conflict with RUO status.

The RUO Guidance further articulates the FDA’s position that any assistance offered in performing

clinical validation or verification, or similar specialized technical support, to clinical laboratories, conflicts with RUO status.

we engage in any activities that the FDA deems to be in conflict with the RUO status held by the products that we sell, we may be subject

to immediate, severe and broad FDA enforcement action that would adversely affect our ability to continue operations.

Accordingly, if

the FDA finds that we are distributing our RUO products in a manner that is inconsistent with its regulations or guidance, we may be forced

to stop distribution of our RUO tests until we are in compliance, which would reduce our revenue, increase our costs and adversely affect

our business, prospects, results of operations and financial condition.

In addition, the FDA’s proposed implementation for a new

framework for the regulation of LDTs may negatively impact the LDT market and thereby reduce demand for RUO products.

Clinical data obtained in the future may

not meet the required objectives, which could delay, limit or prevent any regulatory approval.

There can be no assurance that

we will successfully complete any clinical evaluations necessary to receive regulatory approvals.

While preliminary results have been

encouraging and indicative of the potential performance of our Symphony platform and test cartridges, data already obtained, or in the

future obtained, from clinical studies do not necessarily predict the results that will be obtained from later clinical evaluations.

failure to adequately demonstrate the performance characteristics of the device under development could delay or prevent regulatory approval

of the device, which could prevent or result in delays to market launch and could materially harm our business.

There can be no assurance

that we will be able to receive approval for any potential applications of our principal technology, or that we will receive regulatory

clearances from targeted regions or countries.

There can be no assurance that we will successfully

complete any clinical evaluations necessary to receive regulatory approvals.

While preliminary results have been encouraging and indicative

of the potential performance of our Symphony platform and test cartridges, data already obtained, or in the future obtained, from clinical

studies do not necessarily predict the results that will be obtained from later clinical evaluations.

The failure to adequately demonstrate

the performance characteristics of the device under development could delay or prevent regulatory approval of the device, which could

prevent or result in delays to market launch and could materially harm our business.

There can be no assurance that we will be able to

receive approval for any potential applications of our principal technology, or that we will receive regulatory clearances from targeted

regions or countries.

We may be unable to complete required clinical

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our targeted product launch timeframe and impair our viability and business plan.

The completion of any future

clinical evaluations of our Symphony platform or test cartridges, or other studies that we may be required to undertake in the future,

could be delayed, suspended, or terminated for several reasons, including:

● we may fail to or be unable to conduct the clinical evaluation

in accordance with regulatory requirements;

● sites participating in the trial may drop out of the trial,

which may require us to engage new sites for an expansion of the number of sites that are permitted to be involved in the trial;

● patients may not enroll in, remain in or complete, the clinical

evaluation at the rates we expect;

● clinical investigators may not perform our clinical evaluation

on our anticipated schedule or consistent with the clinical evaluation protocol and good clinical practices.

If our clinical evaluations

are delayed it will take us longer to ultimately launch our Symphony platform and test cartridges in the market and generate revenues.

Moreover, our development costs will increase if we have material delays in our clinical evaluation or if we need to perform more or larger

clinical evaluations than planned.

The completion of any future clinical evaluations

of our Symphony platform or test cartridges, or other studies that we may be required to undertake in the future, could be delayed, suspended,

or terminated for several reasons, including:

● we may fail to or be unable

to conduct the clinical evaluation in accordance with regulatory requirements;

● sites participating in the trial

may drop out of the trial, which may require us to engage new sites for an expansion of the number of sites that are permitted to be

involved in the trial;

● patients may not enroll in,

remain in or complete, the clinical evaluation at the rates we expect;

● clinical investigators may not

perform our clinical evaluation on our anticipated schedule or consistent with the clinical evaluation protocol and good clinical practices.

The declining number of COVID patients with respiratory

deterioration may impact our ability to meet the primary endpoint in our Symphony IL-6 Expanded Clinical Study.

We are currently working

with the FDA to expand this endpoint to better reflect the current standard of care and to make the number of study subjects more realistic

in light of the decreasing number of COVID positive subjects needed in the study.

If our clinical evaluations are delayed it will

take us longer to ultimately launch our Symphony platform and test cartridges in the market and generate revenues.

Moreover, our development

costs will increase if we have material delays in our clinical evaluation or if we need to perform more or larger clinical evaluations

than planned.

We and our suppliers may not meet regulatory quality standards

applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations.

As a medical device manufacturer, we will need to

regulatory agencies, and will be are subject to periodic inspection by the FDA and foreign

regulatory agencies, for compliance with certain Good Manufacturing Practices (“cGMP”), including design controls, product

validation and verification, in process testing, quality control and documentation procedures.

Compliance with applicable regulatory requirements

is subject to continual review and is rigorously monitored through periodic inspections by the FDA and foreign regulatory agencies.

product and component suppliers may also be required to meet certain standards applicable to their manufacturing processes.

As a medical device manufacturer, we will need

to register with the FDA and various non-U.S.

regulatory agencies and will be subject to periodic inspection by the FDA and foreign regulatory

agencies, for compliance with certain Good Manufacturing Practices, including design controls, product validation and verification, in

process testing, quality control and documentation procedures.

Compliance with applicable regulatory requirements is subject to continual

review and is rigorously monitored through periodic inspections by the FDA and foreign regulatory agencies.

Our product and component

suppliers may also be required to meet certain standards applicable to their manufacturing processes.

We cannot assure you that we or our products or

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that we have engaged in the off-label promotion of our products.

Our promotional materials

and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of the

off-label use of our products.

Once our products are cleared or approved for clinical use, healthcare providers may use our products for

off-label uses, as the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine.

if the FDA determines that our promotional, or training materials for sales representatives or physicians constitute promotion of an off-label

use, the FDA could request that we modify our training, promotional materials and/or subject us to regulatory or enforcement actions,

including the issuance of an untitled letter, a warning letter, injunction, seizure, disgorgement of profits, significant penalties, including

civil fines and criminal penalties.

Other federal, state or foreign governmental authorities also might take action if they consider our

promotion, reimbursement or training materials to constitute promotion of an off-label use, which could result in significant fines or

penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

In those possible events, our reputation

could be damaged, and adoption of the products would be impaired.

Our promotional materials and training methods

must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of the off-label use of our

Once our products are cleared or approved for clinical use, healthcare providers may use our products for off-label uses, as

the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine.

However, if the FDA determines

that our promotional, or training materials for sales representatives or physicians constitute promotion of an off-label use, the FDA

could request that we modify our training, promotional materials and/or subject us to regulatory or enforcement actions, including the

issuance of an untitled letter, a warning letter, injunction, seizure, disgorgement of profits, significant penalties, including civil

fines and criminal penalties.

Other federal, state or foreign governmental authorities also might take action if they consider our promotion,

reimbursement or training materials to constitute promotion of an off-label use, which could result in significant fines or penalties

under other statutory authorities, such as laws prohibiting false claims for reimbursement.

In those possible events, our reputation could

be damaged, and adoption of the products would be impaired.

Our products may be subject to recalls after receiving FDA or

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situations and cause customers to delay purchase decisions or cancel orders and would harm our reputation.

In addition, we will be subject

to medical device reporting regulations that will require us to report to the FDA or similar foreign governmental authorities if one of

our products may have caused or contributed to a death or serious injury or if we become aware that it has malfunctioned in a way that

would likely cause or contribute to a death or serious injury if the malfunction recurred.

Failures to properly identify reportable events

or to file timely reports, as well as failure to address each of the observations to the FDA’s satisfaction, can subject us to sanctions

and penalties, including warning letters and recalls.

Physicians, hospitals, and other healthcare providers may make similar reports to

regulatory authorities.

Any such reports may trigger an investigation by the FDA or similar foreign regulatory bodies, which could divert

managerial and financial resources, harm our reputation, and have a material adverse effect on our business, financial condition and results

of operations.

Any adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer

notifications, or agency action, such as inspection or enforcement action.

Any corrective action, whether voluntary or involuntary, as

well as defending ourselves in a lawsuit, would require our time and capital, distract management from operating our business and may

harm our reputation and have a material adverse effect on our business, financial condition, and results of operations.

In addition, we will be subject to medical device

reporting regulations that will require us to report to the FDA or similar foreign governmental authorities if one of our products may

have caused or contributed to a death or serious injury or if we become aware that it has malfunctioned in a way that would likely cause

or contribute to a death or serious injury if the malfunction recurred.

Failures to properly identify reportable events or to file timely

reports, as well as failure to address each of the observations to the FDA’s satisfaction, can subject us to sanctions and penalties,

including warning letters and recalls.

Physicians, hospitals, and other healthcare providers may make similar reports to regulatory authorities.

Any such reports may trigger an investigation by the FDA or similar foreign regulatory bodies, which could divert managerial and financial

resources, harm our reputation, and have a material adverse effect on our business, financial condition and results of operations.

adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications,

or agency action, such as inspection or enforcement action.

Any corrective action, whether voluntary or involuntary, as well as defending

ourselves in a lawsuit, would require our time and capital, distract management from operating our business and may harm our reputation

and have a material adverse effect on our business, financial condition, and results of operations.

Legislative or regulatory reforms may make

it more difficult and costly for us to obtain regulatory clearance or approval of any future products and to manufacture, market and distribute

our products after clearance or approval is obtained.

From time to time, legislation is drafted and

introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing

of regulated products or the reimbursement thereof.

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 approval or clearance of our future products

under development or impact our ability to modify our currently cleared products on a timely basis.

Any new regulations or revisions or

reinterpretations of existing regulations may impose additional costs or lengthen review times of planned or future products.

It is impossible

to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, and what the impact of

such changes, if any, may be.

FDA regulations and guidance are often revised

or reinterpreted by the FDA in ways that may significantly affect our business and our products.

Any new statutes, regulations or revisions

or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more

difficult to obtain clearance or approval for, manufacture, market or distribute our products.

We cannot determine what effect changes

in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the

Such changes could, among other things, require additional testing prior to obtaining clearance or approval;

changes to manufacturing

recall, replacement or discontinuance of our products;

or additional record keeping.

Any change in the laws or regulations that govern

the clearance and approval processes relating to our current, planned and future products could make it more difficult and costly to obtain

clearance or approval for new products or to produce, market and distribute existing products.

Significant delays in receiving clearance

or approval or the failure to receive clearance or approval for any new products would have an adverse effect on our ability to expand

our business.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or

if we are not able to maintain regulatory compliance, we may lose any marketing clearance that we may have obtained and we may not achieve

or sustain profitability.

Risks Related to Our Intellectual Property

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from Toray, and any dispute over the license would significantly harm our business.

We are dependent on the intellectual

property licensed from Toray.

We are dependent on the intellectual property

licensed from Toray.

Disputes may arise between us and Toray regarding intellectual property subject to the License Agreement.

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements

on acceptable terms, or are insufficient to provide us the necessary rights to use the intellectual property, we may be unable to successfully

develop and launch our Symphony platform and our other product candidates.

If we or Toray fail to adequately protect this intellectual

property, our ability to launch our products in the market also could suffer.

For so long as we are dependent on the intellectual property

covered by the license agreement for the pursuit of our business, any such disputes relating to the license agreement or failure to protect

the intellectual property could threaten our viability.

over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable

terms or are insufficient to provide us the necessary rights to use the intellectual property, we may be unable to successfully develop

and launch our Symphony platform and our other product candidates.

If we or Toray fail to adequately protect this intellectual property,

our ability to launch our products in the market also could suffer.

For so long as we are dependent on the intellectual property covered

by the License Agreement for the pursuit of our business, any such disputes relating to the License Agreement or failure to protect the

intellectual property could threaten our viability.

We will depend primarily on Toray to file,

prosecute, maintain, defend and enforce intellectual property that we license from it and that is material to our business.

The intellectual property relating

to our Symphony platform is owned by Toray.

Under the license agreement, Toray generally has the right to file, prosecute, maintain and

defend the intellectual property we have licensed from Toray.

If Toray fails to conduct these activities for intellectual property protection

covering any of our product candidates, our ability to develop and launch those product candidates may be adversely affected and we may

not be able to prevent competitors from making, using or selling competing products.

In addition, pursuant to the terms of the license

agreement, Toray generally has the right to control the enforcement of our licensed intellectual property and the defense of any claims

asserting the invalidity of that intellectual property.

We cannot be certain that Toray will allocate sufficient resources to and otherwise

prioritize the enforcement of such intellectual property or the defense of such claims to protect our interests in the licensed intellectual

In the absence of action by Toray, we may be unable to protect and enforce the proprietary rights on which our business relies.

Even if we are not a party to these legal actions, an adverse outcome could harm our business because it might prevent us from continuing

to use the licensed intellectual property that we need to operate our business.

In addition, even if we take control of the prosecution

of licensed intellectual property and related applications, enforcement of licensed intellectual property, or defense of claims asserting

the invalidity of that intellectual property, we may still be adversely affected or prejudiced by actions or inactions of Toray and its

counsel that took place prior to or after our assuming control, and we cannot ensure the cooperation of Toray in any such action.

if we take action to protect, enforce or defend the licensed intellectual property, we may incur significant costs and the attention of

our management may be diverted from our normal business operations.

As a result, our business, results of operations and financial condition

could be materially and adversely affected.

The intellectual property relating to our Symphony

platform is owned by Toray.

Under the License Agreement, Toray generally has the right to file, prosecute, maintain and defend the intellectual

property we have licensed from Toray.

If Toray fails to conduct these activities for intellectual property protection covering any of

our product candidates, our ability to develop and launch those product candidates may be adversely affected and we may not be able to

prevent competitors from making, using or selling competing products.

In addition, pursuant to the terms of the License Agreement, Toray

generally has the right to control the enforcement of our licensed intellectual property and the defense of any claims asserting the invalidity

of that intellectual property.

We cannot be certain that Toray will allocate sufficient resources to and otherwise prioritize the enforcement

of such intellectual property or the defense of such claims to protect our interests in the licensed intellectual property.

In the absence

of action by Toray, we may be unable to protect and enforce the proprietary rights on which our business relies.

Even if we are not a

party to these legal actions, an adverse outcome could harm our business because it might prevent us from continuing to use the licensed

intellectual property that we need to operate our business.

In addition, even if we take control of the prosecution of licensed intellectual

property and related applications, enforcement of licensed intellectual property, or defense of claims asserting the invalidity of that

intellectual property, we may still be adversely affected or prejudiced by actions or inactions of Toray and its counsel that took place

prior to or after our assuming control, and we cannot ensure the cooperation of Toray in any such action.

Furthermore, if we take action

to protect, enforce or defend the licensed intellectual property, we may incur significant costs and the attention of our management may

be diverted from our normal business operations.

As a result, our business, results of operations and financial condition could be materially

and adversely affected.

We and Toray may be unable to protect or

enforce the intellectual property rights licensed to us, which could impair our competitive position.

In order for our business to

be viable and to compete effectively, the proprietary rights with respect to the technologies and intellectual property used in our products

must be developed and maintained.

Toray relies primarily on patent protection and trade secrets to protect its technology and intellectual

property rights.

There are significant risks associated with Toray’s ability (or our ability, in the absence of action by Toray)

to protect the intellectual property licensed to us, including:

● pending intellectual property applications may not

be approved or may take longer than expected to result in approval in one or more of the countries in which we operate;

● Toray’s intellectual property rights may not provide

meaningful protection;

● other companies may challenge the validity or extent of Toray’s

patents and other proprietary intellectual property rights through litigation, oppositions and other proceedings.

These proceedings can

be protracted as well as unpredictable;

● other companies may have independently developed (or may

in the future independently develop) similar or alternative technologies, may duplicate Toray’s technologies or may design their

technologies around Toray’s technologies;

● enforcement of intellectual property rights is complex, uncertain

and expensive, and may be subject to lengthy delays.

In the event we take control of any such action under the license agreement, our

ability to enforce our intellectual property protection could be limited by our financial resources;

● the other risks described in “— Risks Related

to Our Intellectual Property.”

If any of Toray’s patents

or other intellectual property rights fail to protect the technology licensed by us, it would make it easier for our competitors to offer

What changed 10-K

Item 1A. Risk Factors