Annual report pursuant to Section 13 and 15(d)

Summary of Significant Accounting Policies (Policies)

v3.8.0.1
Summary of Significant Accounting Policies (Policies)
12 Months Ended
Dec. 31, 2017
Accounting Policies [Abstract]  
Principles of Consolidation

i. Principles of Consolidation

 

The consolidated financial statements include the accounts of Pressure BioSciences, Inc., and its wholly-owned subsidiary PBI BioSeq, Inc. All intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

ii. Use of Estimates

 

To prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, we are required to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In addition, significant estimates were made in projecting future cash flows to quantify impairment of assets, deferred tax assets, the costs associated with fulfilling our warranty obligations for the instruments that we sell, and the estimates employed in our calculation of fair value of stock options awarded, beneficial conversion features and derivative liabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from the estimates and assumptions used.

Revenue Recognition

iii. Revenue Recognition

 

Revenue is recognized when realized or when realizable and earned when all the following criteria have been met: persuasive evidence of an arrangement exists; goods were shipped, delivery of service has occurred and risk of loss has passed to the customer; the seller’s price to the buyer is fixed or determinable; and collectability is reasonably assured.

 

Our current instruments, the Barocycler NEP3229 and NEP2320EXT, require a basic level of instrumentation expertise to set-up for initial operation. To support a favorable first experience for our customers, upon customer request and for an additional fee, we will send a highly trained technical representative to the customer site to install Barocyclers that we sell, lease, or rent through our domestic sales force. The installation process includes uncrating and setting up the instrument, followed by introductory user training. Product revenue related to current Barocycler instrumentation is recognized upon shipment of the unit, and in the case where the customer requests installation and training, the completion of the installation and introductory training process of the instrumentation at the customer location, for domestic installations. Product revenue related to sales of PCT instrumentation to our foreign distributors is recognized upon shipment through a common carrier. We provide for the expected costs of warranty upon the recognition of revenue for the sales of our instrumentation. Our sales arrangements do not provide our customers with a right of return. Product revenue related to the HUB440 and our consumable products such as PULSE Tubes, MicroTubes, and application specific kits is recorded upon shipment through a common carrier. Shipping costs are included in sales and marketing expense. Any shipping costs billed to customers are recognized as revenue.

 

The Company applies ASC 845, “Accounting for Non-Monetary Transactions”, to account for products and services sold through non-cash transactions based on the fair values of the products and services involved, where such values can be determined. Non-cash exchanges would require revenue to be recognized at recorded cost or carrying value of the assets or services sold if any of the following conditions apply:

 

  a) The fair value of the asset or service involved is not determinable.
     
  b) The transaction is an exchange of a product or property held for sale in the ordinary course of business for a product or property to be sold in the same line of business to facilitate sales to customers other than the parties to the exchange.
     
  c) The transaction lacks commercial substance.

 

The Company currently records revenue for its non-cash transactions at recorded cost or carrying value of the assets or services sold.

 

We account for our lease agreements under the operating method. We record revenue over the life of the lease term and we record depreciation expense on a straight-line basis over the thirty-six month estimated useful life of the Barocycler instrument. The depreciation expense associated with assets under lease agreement is included in the “Cost of PCT products and services” line item in our consolidated statements of operations. Many of our lease and rental agreements allow the lessee to purchase the instrument at any point during the term of the agreement with partial or full credit for payments previously made. We pay all maintenance costs associated with the instrument during the term of the leases.

 

Revenue from government grants is recorded when qualifying expenses are incurred under the grant in accordance with the terms of the grant award.

 

Deferred revenue represents amounts received from grants and the Company’s service contracts for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying deliverables. Revenue from service contracts is recorded ratably over the length of the contract.

 

Our transactions sometimes involve multiple elements (i.e., products and services). Revenue under multiple element arrangements is recognized in accordance with FASB ASC 605-25 Multiple-Element Arrangements (“ASC 605”). When vendor specific objective evidence or third party evidence of selling price for deliverables in an arrangement cannot be determined, the Company develops a best estimate of the selling price to separate deliverables and allocates arrangement consideration using the relative selling price method. If an arrangement includes undelivered elements that are not essential to the functionality of the delivered elements, we defer the fair value of the undelivered elements to such time as they are delivered. Fair value is determined based upon the price charged when the element is sold separately. If there is not sufficient evidence of the fair value of the undelivered elements the Company uses its best estimate of the value of those items and recognizes revenues based on the relative values of the delivered and undelivered items. We provide certain customers with extended service contracts with revenue recognized ratably over the life of the contract.

Cash and Cash Equivalents

iv. Cash and Cash Equivalents

 

Our policy is to invest available cash in short-term, investment grade interest-bearing obligations, including money market funds, and bank and corporate debt instruments. Securities purchased with initial maturities of three months or less are valued at cost plus accrued interest, which approximates fair value, and are classified as cash equivalents. Restricted cash is included in cash equivalents.

Research and Development

v. Research and Development

 

Research and development costs, which are comprised of costs incurred in performing research and development activities including wages and associated employee benefits, facilities, consumable products and overhead costs that are expensed as incurred. In support of our research and development activities we utilize our Barocycler instruments that are capitalized as fixed assets and depreciated over their expected useful life.

Inventories

vi. Inventories

 

Inventories are valued at the lower of cost (average cost) or net realizable value. The cost of Barocyclers consists of the cost charged by the contract manufacturer. The current year allowance was increased by a $159,600 inventory allowance for the older generation of Barocycler instruments held in stock, the NEP3229. The cost of manufactured goods includes material, freight-in, direct labor, and applicable overhead. The composition of inventory as of December 31, is as follows:

 

    2017     2016  
Raw materials   $ 288,295     $ 326,228  
Finished goods     748,967       599,056  
Inventory reserve     (179,600 )     (20,000 )
Total   $ 857,662     $ 905,284

Property and Equipment

vii. Property and Equipment

 

Property and equipment are stated at cost, less accumulated depreciation. For financial reporting purposes, depreciation is recognized using the straight-line method, allocating the cost of the assets over their estimated useful lives of three years for certain laboratory equipment, from three to five years for management information systems and office equipment, and three years for all PCT finished units classified as fixed assets.

Intangible Assets

viii. Intangible Assets

 

We have classified as intangible assets, costs associated with the fair value of acquired intellectual property. Intangible assets, including patents, are being amortized on a straight-line basis over nine years. We perform an annual review of our intangible assets for impairment. We capitalize any costs to renew or extend the term of our intangible assets. When impairment is indicated, any excess of carrying value over fair value is recorded as a loss. As of December 31, 2017 and 2016, the outstanding balance for intangible assets was $750,000 and $0, respectively.

Long-Lived Assets

ix. Long-Lived Assets

 

The Company’s long-lived assets are reviewed for impairment in accordance with the guidance of the FASB ASC 360-10-05, Property, Plant, and Equipment, whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of an asset to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the asset. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds its fair value. Through December 31, 2017, the Company had not experienced impairment losses on its long-lived assets.

Concentrations

x. Concentrations

 

Credit Risk

 

Our financial instruments that potentially subject us to concentrations of credit risk consist primarily of cash, cash equivalents and trade receivables. We have cash investment policies which, among other things, limit investments to investment-grade securities. We perform ongoing credit evaluations of our customers, and the risk with respect to trade receivables is further mitigated by the fact that many of our customers are government institutions and university labs. Allowances are provided for estimated amounts of accounts receivable which may not be collected. At December 31, 2017, we determined that no allowance against accounts receivable was necessary and wrote off the prior year allowance of $28,169 as unrecoverable.

 

The following table illustrates the level of concentration of the below two groups within revenue as a percentage of total revenues during the years ended December 31:

 

    2017     2016  
Top Five Customers     37 %     29 %
Federal Agencies     14 %     3 %

 

The following table illustrates the level of concentration of the below two groups within accounts receivable as a percentage of total accounts receivable balance as of December 31:

 

    2017     2016  
Top Five Customers     85 %     82 %
Federal Agencies     1 %     1 %

 

Investment in Available-For-Sale Equity Securities

 

As of December 31, 2017, we held 100,250 shares of common stock of Everest, a Polish publicly traded company listed on the Warsaw Stock Exchange. We exchanged 33,334 shares of our common stock for the 100,250 shares from Everest. We account for this investment in accordance with ASC 320 “Investments — Debt and Equity Securities” as securities available for sale. On December 31, 2017, our consolidated balance sheet reflected the fair value of our investment in Everest to be $19,825, based on the closing price of Everest shares of $0.1978 per share on that day. The carrying value of our investment in Everest common stock held will change from period to period based on the closing price of the common stock of Everest as of the balance sheet date. The change in market value since the receipt of stock amounting to $379,751 was determined to be other than temporary and was recorded by us as an impairment loss starting in 2016. We recorded $6,069 as realized losses in 2017 for the changes in market value.

Computation of Loss Per Share

xi. Computation of Loss per Share

 

Basic loss per share is computed by dividing loss available to common shareholders by the weighted average number of common shares outstanding. Diluted loss per share is computed by dividing loss available to common shareholders by the weighted average number of common shares outstanding plus additional common shares that would have been outstanding if dilutive potential common shares had been issued. For purposes of this calculation, convertible preferred stock, common stock dividends, warrants to acquire preferred stock convertible into common stock, and warrants and options to acquire common stock, are all considered common stock equivalents in periods in which they have a dilutive effect and are excluded from this calculation in periods in which these are anti-dilutive. The following table illustrates our computation of loss per share for the years ended December 31:

  

    2017     2016  
Numerator:                
Net loss   $ (10,715,561 )   $ (2,706,984 )
                 
Denominator for basic and diluted loss per share:                
Weighted average common shares outstanding     1,114,225       911,312  
                 
Loss per common share - basic and diluted   $ (9.62 )   $ (2.97 )

 

The following table presents securities that could potentially dilute basic loss per share in the future. For all periods presented, the potentially dilutive securities were not included in the computation of diluted loss per share because these securities would have been anti-dilutive for the years ended December 31:

 

    2017     2016  
Stock options     247,692       175,642  
Convertible debt     947,203       891,132  
Common stock warrants     899,542       881,990  
Convertible preferred stock:                
Series D Convertible Preferred     25,000       25,000  
Series G Convertible Preferred     26,857       28,857  
Series H Convertible Preferred     33,334       33,334  
Series H2 Convertible Preferred     70,000       70,000  
Series J Convertible Preferred     115,267       117,367  
Series K Convertible Preferred     229,334       227,200  
      2,594,229       2,450,522

Accounting for Income Taxes

xii. Accounting for Income Taxes

 

We account for income taxes under the asset and liability method, which requires recognition of deferred tax assets, subject to valuation allowances, and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and income tax purposes. The Company considers many factors when assessing the likelihood of future realization of our deferred tax assets, including recent cumulative earnings experience by taxing jurisdiction, expectations of future taxable income or loss, the carry-forward periods available to us for tax reporting purposes, and other relevant factors. A valuation allowance is established if it is more likely than not that all or a portion of the net deferred tax assets will not be realized. If substantial changes in the Company’s ownership should occur, as defined in Section 382 of the Internal Revenue Code, there could be significant limitations on the amount of net loss carry forwards that could be used to offset future taxable income.

 

Tax positions must meet a “more likely than not” recognition threshold at the effective date to be recognized. At December 31, 2017 and 2016, the Company did not have any uncertain tax positions. No interest and penalties related to uncertain tax positions were accrued at December 31, 2017 and 2016.

Accounting for Stock-Based Compensation

xiii. Accounting for Stock-Based Compensation

 

We maintain equity compensation plans under which incentive stock options and non-qualified stock options are granted to employees, independent members of our Board of Directors and outside consultants. We recognize equity compensation expense over the requisite service period using the Black-Scholes formula to estimate the fair value of the stock options on the date of grant. Employee awards are accounted for under ASC 718 where the awards are valued at grant date. Awards given to nonemployees are accounted for under ASC 505 where the awards are valued at earlier of commitment date or completion of services.

 

Determining Fair Value of Stock Option Grants

 

Valuation and Amortization Method - The fair value of each option award is estimated on the date of grant using the Black-Scholes pricing model based on certain assumptions. The estimated fair value of employee stock options is amortized to expense using the straight-line method over the vesting period, which generally is over three years.

 

Expected Term - The Company uses the simplified calculation of expected life, described in the FASB ASC 718, Compensation-Stock Compensation, as the Company does not currently have sufficient historical exercise data on which to base an estimate of expected term. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted.

 

Expected Volatility - Expected volatility is based on the Company’s historical stock volatility data over the expected term of the award.

 

Risk-Free Interest Rate - The Company bases the risk-free interest rate used in the Black-Scholes valuation method on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent remaining term.

 

Forfeitures - As required by FASB ASC 718, Compensation-Stock Compensation, the Company records stock-based compensation expense only for those awards that are expected to vest. The Company estimated a forfeiture rate of 5% for awards granted based on historical experience and future expectations of options vesting. We used this historical rate as our assumption in calculating future stock-based compensation expense.

 

The following table summarizes the assumptions we utilized for grants of stock options to the three sub-groups of our stock option recipients during the year ended December 31, 2017:

 

Assumptions   Non-Employee
Board Members
    CEO, other
Officers and Employees
 
Expected life     6.0 (yrs     6.0 (yrs )
Expected volatility     92.85%-104.83     105.71 %
Risk-free interest rate     1.01%-1.53 %     1.63 %
Forfeiture rate     5.00 %     5.00 %
Expected dividend yield     0.0 %     0.0 %

 

We recognized stock-based compensation expense of $406,427 and $379,964 for the years ended December 31, 2017 and 2016, respectively. The following table summarizes the effect of this stock-based compensation expense within each of the line items within our accompanying consolidated statements of operations for the years ended December 31:

 

    2017     2016  
Research and development   $ 92,055     $ 65,500  
Selling and marketing     54,404       42,315  
General and administrative     259,968       272,149  
Total stock-based compensation expense   $ 406,427     $ 379,964  

 

During the years ended December 31, 2017 and 2016, the total fair value of stock options awarded was $487,964 and $0, respectively.

 

As of December 31, 2017, total unrecognized compensation cost related to the unvested stock-based awards was $392,590, which is expected to be recognized over weighted average period of 1.66 years.

Advertising

xiv. Advertising

 

Advertising costs are expensed as incurred. We incurred $5,899 in 2017 and $19,125 in 2016 for advertising.

Fair Value of Financial Instruments

xv. Fair Value of Financial Instruments

 

Due to their short maturities, the carrying amounts for cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their fair value. Short-term and long-term liabilities are primarily related to liabilities transferred under contractual arrangements with carrying values that approximate fair value.

Fair Value Measurements

xvi. Fair Value Measurements

 

The Company follows the guidance of FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”) as it related to financial assets and financial liabilities that are recognized or disclosed at fair value in the consolidated financial statements on a recurring basis.

 

The Company generally defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company uses a three-tier fair value hierarchy, which classifies the inputs used in measuring fair values. These tiers include: Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

 

Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company has determined that its financial assets are currently classified within Level 1 and that its financial liabilities are currently all classified within Level 3 in the fair value hierarchy.

 

 The Company changed its method of accounting for the Debentures and Warrants through the early adoption of ASU 2017-11 during the year ended December 31, 2017 on a modified retrospective basis. Accordingly, the Company reclassified the warrant derivative and conversion option derivative liabilities to additional paid in capital on its January 1, 2017 consolidated balance sheets totaling approximately $2.6 million, reduced debt discount by approximately $0.9 million and recorded the cumulative effect of the adoption to the beginning balance of accumulated deficit of approximately $2.5 million.

 

Adoption of ASU 2017-11

 

The Company changed its method of accounting for the Debentures, Debenture Warrants and Series D Warrants through the early adoption of ASU 2017-11 during the year ended December 31, 2017 on a modified retrospective basis. Accordingly, the Company reclassified the warrant derivative and conversion option derivative liabilities to additional paid in capital on its January 1, 2017 consolidated balance sheets totaling approximately $2.6 million, reduced debt discount by approximately $0.9 million and recorded the cumulative effect of the adoption to the beginning balance of accumulated deficit of approximately $2.4 million. This resulted to an increase in stock warrants by $2.6 million and additional paid-in capital by $1.4 million. The following table provides a reconciliation of the warrant derivative liability, convertible debt, conversion option derivative liability, stock warrant, additional paid-in capital and accumulated deficit on the consolidated balance sheet as of December 31, 2016:

 

    Convertible debt, current portion     Convertible debt, long term portion     Warrant Derivative Liability     Conversion Option Liability     Warrants to acquire common stock     Additional Paid-in Capital     Accumulated deficit  
Balance, January 1, 2017 (Prior to adoption of ASU 2017-11)   $ 4,005,702     $ 529,742     $ 1,685,108     $ 951,059     $ 6,325,102     $ 27,544,265     $ (42,264,190 )
Reclassified derivative liabilities and cumulative effect of adoption     769,316       154,152     $ (1,685,108 )     (951,059 )     2,636,236       1,446,011       (2,369,548 )
Balance, January 1, 2017 (After adoption of ASU 2017-11)   $ 4,775,018     $ 683,894     $ -     $ -     $ 8,961,338     $ 28,990,276     $ (44,633,738 )

 

The following tables set forth the Company’s financial assets and financial liabilities that were accounted for at fair value on a recurring basis as of December 31, 2017 and December 31, 2016. The development of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s management.

 

          Fair value measurements at December 31, 2017 using:  
    December 31, 2017     Quoted prices in
active markets
(Level 1)
    Significant other
observable inputs
(Level 2)
    Significant
unobservable inputs
(Level 3)
 
Available-For-Sale Equity Securities     19,825       19,825       -       -  
Total Financial Assets   $ 19,825     $ 19,825     $ -     $ -  

 

          Fair value measurements at December 31, 2016 using:  
    December 31, 2016     Quoted prices in
active markets
(Level 1)
    Significant other
observable inputs
(Level 2)
    Significant
unobservable inputs
(Level 3)
 
Available-For-Sale Equity Securities     25,865       25,865       -       -  
Total Financial Assets   $ 25,865     $ 25,865     $ -     $ -  

 

    December 31, 2016     Quoted prices in
active markets
(Level 1)
    Significant other
observable inputs
(Level 2)
    Significant
unobservable
inputs (Level 3)
 
Series D Preferred Stock Purchase Warrants   $ 23,313       -       -     $ 23,313  
Warrants Issued with Convertible Debt     1,661,795       -       -       1,661,795  
Conversion Option Derivative Liabilities     951,059       -       -       951,059  
Total Derivatives   $ 2,636,167     $ -     $ -     $ 2,636,167  

 

The following table provides a summary of the changes in fair value, including net transfers in and/or out, of the derivative financial instruments, measured at fair value on a recurring basis using significant unobservable inputs:

 

    January 1, 2016     Issuance
fair value
    Change in
fair value
    December 31, 2016  
Series D Preferred Stock Purchase Warrants   $ 173,526     $ -     $ (150,213 )   $ 23,313  
Warrants Issued with Convertible Debt     3,122,450       1,094,432       (2,555,087 )     1,661,795  
Conversion Option Derivative Liabilities     3,940,791       1,547,127       (4,536,859 )     951,059  
Total Derivatives   $ 7,236,767     $ 2,641,559     $ (7,242,159 )   $ 2,636,167  

 

The issuance fair values for 2016 include the “day 1” derivative losses on the conversion option derivative liabilities of $1,337,510, which are included in “change in fair value of derivative liabilities” in the consolidated statements of operations. There were no derivative liabilities as of December 31, 2017.

 

The fair value of the derivative liabilities was determined using a binomial pricing model. The assumptions for the binomial pricing model are represented in the table below for the warrants issued in the Series D private placement reflected on a per share common stock equivalent basis.

 

Assumptions   November 10, 2011     Warrants revalued at
December 31, 2016
 
Expected life (in months)     60.0       5.0  
Expected volatility     104.5 %     83.5 %
Risk-free interest rate     0.875 %     0.62 %
Exercise price   $ 24.30     $ 7.50  
Fair value per warrant   $ 16.20     $ 0.60  

 

The assumptions for the binomial pricing model are represented in the table below for the warrants issued with the Convertible Debt in 2016 reflected on a per share common stock equivalent basis.

 

Assumptions   At Issuance
Fair value
    Warrants revalued at
December 31, 2016
 
Expected life (in months)     60.0       43.0-51.0  
Expected volatility     118.3-120.1 %     110.0-116.0 %
Risk-free interest rate     1.48-1.69 %     1.93 %
Exercise price   $ 12.00     $ 12.00  
Fair value per warrant   $ 5.70-$6.30     $ 3.60-4.20  

 

The assumptions for the binomial pricing model are represented in the table below for the conversion options reflected on a per share common stock equivalent basis.

 

Assumptions   At Issuance fair value     At Settlement fair value     Conversion options revalued at
December 31, 2016
 
Expected life (in months)     6.0-24.0       0-18.0       6.0-15.0  
Expected volatility     104.2-153.8 %     86.9%-142.2 %     84.4-94.8 %
Risk-free interest rate     0.05-0.99 %     0.01-0.72 %     0.62-0.85 %
Exercise price   $ 3.00-$10.50     $ 3.00-$7.50     $ 8.40  
Fair value per conversion option   $ 2.70-$8.40     $ 2.10-$7.80     $ 0.90-$1.80

Reclassifications

xvii. Reclassifications

 

Certain prior year amounts have been reclassified to conform to our current year presentation.

Recently Issued Accounting Standards

xviii. Recently Issued Accounting Standards

 

In November 2016, the Financial Accounting Standards Board (the FASB) issued Accounting Standards Update (ASU) No. 2016-18 (ASU 2016-18). ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017. As early adoption of this amendment is permitted, the Company has adopted the update retrospectively to each period presented. The adoption of this guidance did not have a material impact on the company’s consolidated Financial Statements.

 

In March 2016, the FASB issued ASU 2016-09, which simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 became effective for the Company on January 1, 2017. The adoption of this guidance did not have a material impact on the Company’s consolidated Financial Statements.

 

In February 2016, the FASB issued ASU 2016-02, which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases, along with additional qualitative and quantitative disclosures. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating the effect this standard will have on its consolidated Financial Statements.

 

In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. (“ASU 2015-14”). Under the new standard, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. This standard was adopted by the Company at January 1, 2017. See Note 2.

 

 In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) which amended the existing accounting standards for revenue recognition. ASU 2014-09 establishes principles for recognizing revenue upon the transfer of promised goods or services to customers, in an amount that reflects the expected consideration received in exchange for those goods or services. In July 2015, the FASB deferred the effective date for annual reporting periods beginning after December 15, 2017 (including interim reporting periods within those periods). The amendments may be applied retrospectively to each prior period (full retrospective) or retrospectively with the cumulative effect recognized as of the date of initial application (modified retrospective). The Company will adopt ASU 2014-09 in the first quarter of 2018 and apply the modified retrospective approach. The Company’s primary source of revenues is from instrument sales which are considered distinct performance obligations and are recognized upon shipment, the Company does not expect the impact on its consolidated financial statements to be material.