UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549




FORM 10-Q



[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2016March 31, 2017

OR

[  ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934or

For the transition period from ________to _________

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number:0-21419

Tiger X Medical,


BioCardia, Inc.

(Exact name of Registrantregistrant as Specifiedspecified in its Charter)charter)

 


Delaware
23-2753988
  (State

Delaware

23-2753988

(State or Other Jurisdictionother jurisdiction of Incorporation

incorporation or Organization) organization)

(I.R.S. Employer

Identification Number)


4400 Biscayne Blvd
Miami, FL   33137

125 Shoreway Road, Suite B 

San Carlos, California 94070

(Address of Principal Executive Officesprincipal executive offices)

(650) 226-0120

Registrant’s telephone number, including Zip Code)

(305) 575-4100
(Registrant's Telephone Number, Including Area Code)area code

N/A

(Former name, former address and former fiscal year, if changed since last report)


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d)15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES   x        NO   ¨    Yes  ☒    No  ☐


Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    YES  x     NO  Yes  ☒    No  ☐¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large“large accelerated filer," "accelerated filer"” “accelerated filer,” and "smaller“smaller reporting company"company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer¨

Accelerated filer¨

Non-accelerated filer¨
(Do

☐  (Do not check if a smaller reporting company)

Smaller reporting companyx

Emerging growth company☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES   ¨        NO   x    Yes  ☐    No  ☒

As

Indicate the number of October 17, 2016, 230,743,141shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

There were 457,682,784 shares of the issuer's common stock, par valueregistrant’s Common Stock issued and outstanding as of $0.001 per share, were outstanding.



May 9, 2017.

TIGER X MEDICAL, INC.


Table of Contents

Part I.   FINANCIAL INFORMATION

Page

1

PART I — FINANCIAL INFORMATION

1

Item 1.

Unaudited Condensed Consolidated Financial Statements

1

Condensed Consolidated Balance Sheets at September 30, 2016 (Unaudited)as of March 31, 2017 and December 31, 20152016

1

Condensed Consolidated Statements of Income (Unaudited) — ThreeOperations for the three months ended March 31, 2017 and Nine Months Ended September 30, 2016 and 2015

2

Condensed Consolidated Statements of Cash Flows (Unaudited) — Nine Months Ended September 30,for the three months ended March 31, 2017 and 2016 and 2015

3

Notes to Unaudited Condensed Consolidated Financial Statements (Unaudited)

4

  4

Item 2.

Management'sManagement’s Discussion and Analysis of Financial Condition and Results of Operations

7

  11

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

11

  15

Item 4.

Controls and Procedures

11

  15

PART II —Part II.  OTHER INFORMATION

11

17

Item 1.

Legal Proceedings

11

  17

Item 1A.

Risk Factors

  17

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

12

  17

Item 3.

Defaults uponUpon Senior Securities

12

  17

Item 4.

Mine Safety Disclosures

12

  17

Item 5.

Other Information

12

  17

Item 6.

Exhibits

12

  17

SIGNATURES

18

Signatures

EXHIBIT INDEX

13

Exhibit Index

19

i


FORWARD-LOOKING INFORMATION

This report contains forward-looking statements within the meaning of the U.S. federal securities laws that involve risks and uncertainties. Certain statements contained in this report are not purely historical including, without limitation, statements regarding our expectations, beliefs, intentions, anticipations, commitments or strategies regarding the future that are forward-looking. These statements include those discussed in Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations, including “Critical AccountingPolicies andEstimates,” “Results of Operations,” “Liquidity and Capital Resources,”and “Future Funding Requirements,” and elsewhere in this report.

In this report, the words “may,” “could,” “would,” “might,” “will,” “should,” “plan,” “ forecast,” “anticipate,” “believe,” “expect,” “intend,” “estimate,” “predict,” “potential,” “continue,” “future,” “moving toward” or the negative of these terms or other similar expressions also identify forward-looking statements. Our actual results could differ materially from those forward-looking statements contained in this report as a result of a number of risk factors including, but not limited to, thoselisted in our Annual Report on Form 10-Kand elsewhere in this report. You should carefully consider these risks, in addition to the other information in this report and in our other filings with the SEC. All forward-looking statements and reasons why results may differ included in this report are made as of the date of this report, and we assume no obligation to update any such forward-looking statement or reason why such results might differ, except as required by law.


PART I —I. FINANCIAL INFORMATION

ITEM 1 —1.UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

TIGER X MEDICAL,BIOCARDIA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

   September 30,  December 31,
   2016  2015
   (Unaudited)   
Assets
       
Current assets      
     Cash $19,437  $13,840 
     Prepaid expenses  46   36 
               Total assets $19,483  $13,876 
       
Liabilities and Stockholders' Equity
       
Current liabilities      
     Accounts payable and accrued expenses $330  $10 
          Total liabilities  330   10 
       
Stockholders' equity      
     Common stock, $0.001 par value, 750,000,000 shares authorized, 230,743,141 and 230,293,141 shares      
          issued and outstanding as of September 30, 2016 (unaudited) and December 31, 2015, respectively  231   230 
     Additional paid-in capital  25,776   25,768 
     Accumulated deficit  (6,854)  (12,132)
          Total stockholders' equity  19,153   13,866 
               Total liabilities and stockholders' equity  $19,483  $13,876 

The

Assets

 

March 31, 2017

  

December 31,

2016

 
  

(unaudited)

     

Current assets:

        

Cash and cash equivalents

 $19,032  21,352 

Accounts receivable, net of allowance for doubtful accounts of $1 and $2 atMarch 31, 2017 and December 31, 2016, respectively

  121   74 

Inventory

  144   135 

Prepaid expenses

  252   356 

Total current assets

  19,549   21,917 

Property and equipment, net

  177   111 

Other assets

  54   54 

Total assets

 $19,780  22,082 

Liabilities and Stockholders’ Equity

        

Current liabilities:

        

Accounts payable

 $291  525 

Accrued liabilities

  720   544 

Deferred revenue

  72   71 

Grant liability

  285   304 

Total current liabilities

  1,368   1,444 

Deferred rent

  62   56 

Total liabilities

  1,430   1,500 

Stockholders’ equity:

        

Preferred stock, $0.001 par value, 50,000,000 shares authorized, no shares issuedand outstanding at March 31, 2017 and December 31, 2016

      

Common stock, $0.001 par value, 750,000,000 shares authorized at March 31, 2017 andDecember 31, 2016, 457,682,784 shares and 457,575,631 shares issued and outstandingat March 31, 2017 and December 31, 2016, respectively

  458   458 

Additional paid-in capital

  80,910   80,266 

Accumulated deficit

  (63,018)  (60,142)

Total stockholders’ equity

  18,350   20,582 

Total liabilities and stockholders’ equity

 $19,780  22,082 

See accompanying notes are an integral part of theseto condensed consolidated financial statements.

1



TIGER X MEDICAL,BIOCARDIA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)
(Unaudited)

   Three Months Ended  Nine Months Ended
   September 30,  September 30,
   2016  2015  2016  2015
             
Royalty income $5,500  $121  $5,791  $382 
             
General and administrative expenses  379   38   515   152 
Income from operations  5,121   83   5,276   230 
Interest income        
Income before income tax provision  5,121   83   5,278   232 
Provision for income taxes        
Net income  $5,121  $83  $5,278  $232 
             
Net income per share:            
Basic and diluted $0.02  $-   $0.02  $-  
             
Weighted average shares outstanding:            
Basic and diluted  230,537,706   230,293,141   230,375,258   230,293,141 

The(unaudited)

  

Three Months ended March 31,

 
  

2017

  

2016

 

Revenue:

        

Net product revenue

 $109  168 

Collaboration agreement revenue

  28   10 

Total revenue

  137   178 

Costs and expenses:

        

Cost of goods sold

  175   226 

Research and development

  1,033   441 

Selling, general and administrative

  1,804   587 

Total costs and expenses

  3,012   1,254 

Operating loss

  (2,875)  (1,076)

Other income (expense):

        

Interest expense, net

     (550)

Change in fair value of convertible preferred stock warrant liability

     53 

Change in fair value of maturity date preferred stock warrant liability

     (1)

Change in fair value of convertible shareholder notes derivative liability

     78 

Other expense

  (1)   

Total other expense, net

  (1)  (420)

Net loss

 $(2,876) (1,496)
         

Net loss per share, basic and diluted

 $(0.01) (0.08)
         

Weighted-average shares used in computing net loss per share, basic and diluted

  457,654,570   18,947,536 

See accompanying notes are an integral part of theseto condensed consolidated financial statements.

2



BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

TIGER X MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)

   Six Months Ended
   September 30,
   2016  2015
      
Cash flows from operating activities      
     Net income  $5,278  $232 
     Adjustments to reconcile net income to net cash provided by operating activities:      
          Stock-based compensation    
     Changes in operating assets and liabilities:      
          Prepaid expenses   (10)  (14)
          Accounts payable and accrued expenses  320   (1)
Net cash provided by operating activities  5,597   217 
       
       
Net change in cash  5,597   217 
Cash, beginning of period  13,840   13,509 
Cash, end of period $19,437  $13,726 
       
Supplemental disclosure of cash flow information:      
     Interest paid $ $
     Income taxes paid $ $

The

  

Three Months ended March 31,

 
  

2017

  

2016

 

Operating activities:

        

Net loss

 $(2,876) (1,496)

Adjustments to reconcile net loss to net cash used in operatingactivities:

        

Depreciation and amortization

  13   10 

Change in fair value of convertible preferred stock warrant liability

     (53)

Change in fair value of maturity date preferred stock warrant liability

     1 

Change in fair value of convertible shareholder notes derivative liability

     (78)

Share-based compensation

  622   30 

Non-cash interest expense on convertible shareholder notes

     550 

Changes in operating assets and liabilities:

        

Accounts receivable

  (47)  (4)

Inventory

  (9)  42 

Prepaid expenses

  104   28 

Accounts payable

  (249)  103 

Accrued liabilities excluding accrued interest on convertible note

  176   86 

Deferred revenue

  1   40 

Deferred rent

  6   (7)

Grant liability

  (19)   

Net cash used in operating activities

  (2,278)  (748)

Investing activities:

        

Purchase of property and equipment

  (64)   

Net cash used in investing activities

  (64)   

Financing activities:

        

Proceeds from the exercise of stock options

  22    

Net cash provided by financing activities

  22    

Net decrease in cash and cash equivalents

  (2,320)  (748)

Cash and cash equivalents at beginning of period

  21,352   3,557 

Cash and cash equivalents at end of period

 $19,032  2,809 
         
Supplemental disclosures for noncash investing activity:        
Accounts payable recognized for the purchase of equipment $15  $ 

See accompanying notes are an integral part of theseto condensed consolidated financial statements.

3



(1)

Summary of Businessand Basis of Presentation

(a)

Description of Business

TIGER X MEDICAL, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2016
(Unaudited)

NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Tiger X Medical,BioCardia, Inc. ("Tiger X", or the "Company"), formerly known as Cardo Medical, Inc.,Company, is a corporation organizedclinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. Its lead therapeutic candidate is the CardiAMP cell therapy system and existing under and byits second therapeutic candidate is the virtue of the General Corporation Law of the State of Delaware, previously operated as an orthopedic medical device company specializing in designing, developing and marketing high performance reconstructive joint devices and spinal surgical devices.

During 2010,CardiALLO cell therapy system. To date the Company discontinuedhas devoted substantially all of its orthopedic medical deviceresources to research and development efforts relating to its therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and soldprotecting its intellectual property.

The Company has three enabling device product lines: (1) the assets fromCardiAMP cell processing system; (2) the Helix biotherapeutic delivery system, or Helix; and (3) the Morph vascular access product line, or Morph, which offers advanced catheter products for interventional medicine.The Company manages its previous business lines during 2011. Through July 1, 2016, our continuing operations includedas a single segment for the collectionpurposes of assessing performance and management of our royalty income earned in connection with the Asset Purchase Agreement with Arthrex, Inc. ("Arthrex").making operating decisions.

(b)

Reverse Merger

On August 22, 2016, the Company, its wholly-owned subsidiary, Icicle Acquisition Corp., a Delaware corporation and a direct wholly-owned subsidiary of the Company ("Merger Sub"),Corp, and BioCardia Lifesciences, Inc., a Delaware corporation ("BioCardia"or BioCardia Lifesciences (at the time named BioCardia, Inc.), entered into an Agreement and Plan of Merger, (the "Merger Agreement"),or the Merger Agreement. The transactions contemplated by the Merger Agreement closed on October 24, 2016, pursuant to which Merger Sub will mergeIcicle Acquisition Corp. merged with and into BioCardia Lifesciences, with BioCardia Lifesciences continuing as the surviving company, underor the name "BioCardia, Inc." (the "Merger"). The Company expectsMerger. BioCardia Lifesciences was determined to be the accounting acquirer in the Merger based upon the terms of the Merger and other factors, including: (i) former BioCardia Lifesciences security holders owned approximately 54% of the combined company (on a fully diluted basis) immediately following the closing of the Merger, (ii) former BioCardia Lifesciences directors hold the majority of the board seats in the combined company, and (iii) former BioCardia Lifesciences management holds all of the key positions in the management of the combined company. Following the completion of the Merger, the Company changed its name to close in October 2016.BioCardia, Inc.

Basis

Exchange Ratio

Pursuant to the Merger Agreement, each share of PresentationBioCardia Lifesciences common stock issued and outstanding prior to the Merger, including shares of common stock underlying outstanding preferred stock, convertible notes (which converted into common stock immediately prior to the Merger), and stock options were converted into the right to receive 19.3678009 shares of Company common stock, or the Exchange Ratio. The accompanying consolidated financial statements and notes to the consolidated financial statements give retroactive effect to the capital structure as a result of the Merger.

(2)

Significant Accounting Policies

(a)

Basis of Preparation

The accompanying condensed consolidated balance sheetsheets, statements of operations and cash flows as of DecemberMarch 31, 2015, which has been derived from the Company's audited financial statements as of that date, and the unaudited condensed consolidated financial information of the Company as of September 30, 20162017 and for the three and nine months ended September 30,March 31, 2017 and 2016 and 2015, hasare unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles generally accepted in the United States of America ("U.S. GAAP")(U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the instructions to Form 10-Qannual financial statements and, Article 8-03 of Regulation S-X. Inin the opinion of management, such financial information includesreflect all adjustments consideredwhich include only normal recurring adjustments, necessary for a fair presentation of the Company'sto present fairly our financial position at such date and the operatingas of March 31, 2017, results of operations and cash flows for such periods. Operatingthe three months ended March 31, 2017 and 2016. The results for the interim periodthree months ended September 30, 2016March 31, 2017 are not necessarily indicative of the results that mayto be expected for the entireyear ending December 31, 2017 or for any other interim period or for any other future year.

Certain information and footnote disclosure normally included in financial statements in accordance with U.S. GAAP have been omitted pursuant to the rules of the United States Securities and Exchange Commission ("SEC").

These unauditedcondensed consolidated financial statements should be read in conjunction with ourthe audited financial statements and accompanyingrelated notes included in the Company'sCompany’s Annual Report on Form 10-K for the year ended December 31, 20152016, filed with the SEC on March 25,30, 2017.


(b)

Liquidity

The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $63.0 million as of March 31, 2017. Management expects operating losses and negative cash flows to continue through at least the next several years.

Upon closing of the Merger Agreement, the combined company had approximately $24.0 million in cash, including $19.0 million of cash acquired as part of the Merger and $4.4 million in net proceeds from the issuance of convertible notes in October 2016. Management believes cash of $19.0 million as of March 31, 2017 is sufficient to fund the Company for at least the next twelve-month period following the date of issuance of these financial statements. The Company also plans to raise other additional capital, potentially including debt and equity arrangements, to finance its future operations. If adequate funds are not available, the Company may be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that may require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations. While the Company believes in the viability of its strategy to raise additional funds, there can be no assurances to that effect. 

(c)

Use of Estimates

The preparation of the financial statements in accordance with U.S. GAAP requires Company management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include the useful lives of property and equipment; allowances for doubtful accounts and sales returns; inventory valuation; fair value of the convertible preferred stock warrant liability; fair value of the maturity date preferred stock warrant liability; fair value of the convertible shareholder notes derivative liability; and share-based compensation.

(d)

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Tiger X Medical, Inc., Accelerated Innovation, Inc. ("Accelerated"), Uni-Knee LLC ("Uni")the Company and Cervical Xpand LLC ("Cervical").its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated during the consolidation process.

(e)

Significant Accounting Policies

The Company’s significant accounting policies are described in consolidation.Note 2 of the notes to the financial statements included in the 2016 Form 10-K. There have been no changes to those policies except as described below.

4


(f)

Recently Adopted Accounting Pronouncement

In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (ASU 2016-09). The standard is intended to simplify several areas of accounting for share-based compensation arrangements, including the income tax impact, classification in the statement of cash flows and forfeitures. The Company adopted ASU 2016-09 effective January 1, 2017.

Royalty Agreement

On January 24, 2011,The impact of adopting ASU 2016-09 resulted in the following:

We will classify the excess income tax benefits from stock-based compensation arrangement as a discrete item within income tax expense, rather than recognizing such excess income tax benefits in additional paid-in capital. The adoption of this guidance had no material impact to our condensed consolidated financial statements due to a full valuation allowance recognized against our deferred tax assets.

We elected to recognize forfeitures as they occur. The cumulative effect adjustment as a result of the adoption of this guidance on a modified retrospective basis was insignificant.

We applied the change in classification of cash flows resulting from excess tax benefits and cash paid by us when directly withholding shares for tax-withholding purposes on a retrospective basis. The adoption of these provisions did not result in changes in our condensed consolidated statements of cash flow.

There were no other material impacts to our condensed consolidated financial statements as a result of adopting this updated standard.


(g)

Recently Issued Accounting Pronouncements

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides comprehensive guidance for revenue recognition. ASU 2014-09 affects any entity which either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets. The core principle of the guidance provides that a company should recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The new standard can be applied retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of the change recognized at the date of the initial application in retained earnings.

In August 2015, the FASB issued ASU 2015-14 Revenue from Contracts with Customers, which deferred the effective date for implementation of the standard. Public entities are to apply the new standard for annual and interim reporting periods beginning after December 15, 2017 and earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. The Company has not elected early adoption and has not concluded on an adoption method. The Company has formed a task force that is beginning to assess the Company’s customer contracts and the potential impacts the standard may have on previously reported revenues and future revenues. Given the relatively small volume of revenue arrangements, the Company believes that the analysis will be completed in sufficient time to adopt the new standard when required.

In February 2016, the FASB issued ASU 2016-02 Leases (Topic 842), which supersedes existing guidance on accounting for leases in “Leases (Topic 840)” and generally requires all leases to be recognized in the consolidated balance sheet. ASU 2016-02 is effective for annual and interim reporting periods beginning after December 15, 2018; early adoption is permitted. The Company does not plan to elect early adoption. The provisions of ASU 2016-02 are to be applied using a modified retrospective approach. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not or are not believed by management to have a material impact on the Company’s financial statement presentation or disclosures.

(3)     Fair Value Measurement

The fair value of financial instruments reflects the amounts that the Company estimates to receive in connection with the sale of an asset or paid in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). The Company follows a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels:

Level 1 – quoted prices in active markets for identical assets and liabilities

Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities

Level 3 – unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table sets forth the fair value of our financial assets measured on a recurring basis as of March 31, 2017 and indicates the fair value hierarchy utilized to determine such fair value (in thousands).

  

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets:

                

Cash and cash equivalents

 $19,032  $  $  $19,032 

The following table sets forth the fair value of our financial assets measured on a recurring basis as of December 31, 2016 and indicates the fair value hierarchy utilized to determine such fair value (in thousands).

  

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets:

                

Cash and cash equivalents

 $21,352  $  $  $21,352 

As discussed in Note 7, in 2015, the Company issued warrants to purchase preferred stock in connection with the note agreements to various shareholders as described below. The warrant liabilities were recorded at the fair value on the date of issuance and were remeasured each subsequent balance sheet date and as of the warrant exercise date, with fair value changes recognized as income (decrease in fair value) or expense (increase in fair value) in other income (expense) in the consolidated statements of operations.  No warrants are outstanding as of March 31, 2017.


In May 2015, the Company entered into note agreements with various stockholders of the Company and other lenders for a total of $7.2 million, or the 2015 Notes. As discussed more fully in Note 7, the 2015 Notes include embedded derivative features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The Company estimated the fair value of the compound embedded derivative utilizing a Monte Carlo simulation model from inception through June 30, 2016. The inputs used to determine the estimated fair value of the compound embedded derivative instrument include the probability of an Asset Purchase Agreementunderlying event triggering the redemption event and its timing prior to the maturity date of the 2015 Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgment. Upon the completion of the Merger, the valuation of the compound embedded derivative was determined based on the settlement value of the common stock exchanged for the notes on October 24, 2016.  No notes are outstanding as of March 31, 2017.

(4)

Inventories

Inventories are stated at the lower of cost or net realizable value using the average cost method. Inventories consist of the following (in thousands):

  

March 31,

2017

  

December 31,

2016

 

Raw materials

 $53  59 

Work in process

  48    

Finished goods

  43   76 

Total

 $144  135 

Write downs for excess or expired inventory are based on management’s estimates of forecasted usage of inventories and are included in cost of goods sold. A significant change in the timing or level of demand for certain products as compared to forecasted amounts may result in recording additional write downs for excess or expired inventory in the future. Charges to cost of goods sold for inventory write-downs, scrap, shrinkage and expired inventories totaled approximately $9,000 and $18,000 for the three months ended March 31, 2017 and 2016, respectively.

(5)

Property and Equipment, Net

Property and equipment, net consist of the following (in thousands):

  

March 31,

2017

  

December 31,

2016

 

Computer equipment and software

 $172  143 

Laboratory and manufacturing equipment

  415   366 

Furniture and fixtures

  48   48 

Leasehold improvements

  326   325 

Property and equipment, gross

  961   882 

Less accumulated depreciation

  (784)  (771)

Property and equipment, net

 $177  111 

Depreciation expense totaled approximately $13,000 and $10,000 for the three months ended March 31, 2017 and 2016, respectively.


(6)

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

  

March 31,

2017

  

December 31,

2016

 

Accrued expenses

 $572  478 

Accrued clinical trial costs

  86    

Customer deposits

  62   66 

Total

 $720  544 

(7)

Convertible Notes

In May 2015, BioCardia Lifesciences entered into note agreements with Arthrex (the "Arthrex Asset Purchase Agreement"),various stockholders of BioCardia Lifesciences and other lenders for a total of $7.2 million, or the 2015 Notes. The 2015 Notes accrued 8% annual simple interest, matured 18 months from the issue date and were callable after the maturity date by written demand of a majority of the holders of the outstanding note principle. If BioCardia Lifesciences closed an effective registration statement filed under the Securities Act of 1933, as amended, covering the sale of BioCardia Lifesciences common stock (an IPO) prior to maturity, the outstanding principle and accrued interest would have automatically converted into shares of common stock at 80% of the price of the shares of common stock purchased in the IPO. If at any time prior to the maturity date, the Company closed a private placement of the Company’s preferred stock for aggregate sales proceeds of at least $5.0 million excluding note conversions, at the note holder’s option, or the Optional Conversion Right, the outstanding principle and interest may have been converted into shares of the preferred stock at a conversion price equal to 80% of the price of the preferred shares sold in such financing, plus preferred stock warrant coverage equal to 8% with an exercise price equal to the purchase price of the preferred stock sold in such financing. If the notes were held to maturity, subject to BioCardia Lifesciences authorizing sufficient shares of a new class of preferred stock, or the Maturity Date Preferred Stock, the holder would have had the option to convert the outstanding principle and interest to this new class of Maturity Date Preferred Stock at an exercise price of $0.07 per share, plus 8% warrant coverage.

In August 2016, the Company and the holders of the 2015 Notes amended the 2015 Notes, pursuant to which the Company agreed to selloutstanding principal amount and all accrued interest through August 31, 2016 automatically converted into shares of BioCardia Lifesciences common stock at 80% of the assetsconversion price of its joint arthroplasty division, referred to as the Reconstructive Division, to Arthrex. The Arthrex Asset Purchase Agreement also providedconvertible notes issued in October 2016. In addition, the amendment eliminated the payment of interest for the Companyperiod subsequent to receive royalty payments equal to 5% of net sales of the Company's products made by Arthrex on a quarterly basis for a term up toAugust 31, 2016, and including the 20th anniversary of the June 10, 2011 closing date. These amounts were reflected as royalty income on the accompanying condensed consolidated statements of income.

On May 5, 2016, the Company entered into a Royalty Settlement and Release Agreement (the "Royalty Settlement and Release Agreement") with Arthrex, whereby Arthrex agreed to pay the Company $5,642,302 (the "Royalty Payment") in full satisfaction of all amounts due or payable, or which could become payable under the Arthrex Asset Purchase Agreement. Of the Royalty Payment, $142,302 of the amount represented royalty income due to the Company under the Arthrex Asset Purchase Agreement through the date of the Royalty Settlementclosing of the Merger. Upon the completion of the Merger, the 2015 Notes and Release Agreement,accrued interest converted into shares of BioCardia Lifesciences common stock, which were then exchanged at the Exchange Ratio into 67,443,988 shares of the Company’s common stock.

The 2015 Notes had redemption features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The changes in the estimated value are reflected in the change in fair value of convertible shareholder notes derivative liability in the consolidated statements of operations. We estimated the fair value of the compound embedded derivative utilizing a Monte Carlo simulation model. The inputs used to determine the estimated fair value of the compound embedded derivative instrument include the probability of an underlying event triggering the redemption event and its timing prior to the maturity date of the 2015 Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgment. Immediately prior to the closing of the Merger, the compound embedded derivative was remeasured based on the settlement value of the common stock exchanged for the notes, and we reclassified the balance of the convertible shareholder notes derivative liability to additional paid-in capital.

The Company recognized interest expense, including amortization of the debt discount of approximately $0 and $550,000 for the three months ended March 31, 2017 and 2016, respectively. 

(8)

Share-Based Compensation

BioCardia Lifesciences adopted, and the remaining $5,500,000 representedBioCardia Lifesciences shareholders approved, the settlement2002 Stock Plan in 2002, or the 2002 Plan, and the Company assumed the 2002 Plan in the Merger. We will not grant any additional awards under the 2002 Plan following the Merger. In 2016, BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2016 Equity Incentive Plan, or the 2016 Plan, and the Company assumed the 2016 Plan in the Merger. We will grant awards, including incentive stock options and nonstatutory stock options, under the 2016 Plan following the Merger.


Stock compensation attributable to manufacturing operations was not significant and was expensed directly to cost of future royalties. goods sold in the condensed consolidated statements of operations. Share-based compensation expense for the three months ended March 31, 2017 and 2016 was recorded as follows (in thousands):

  

Three Months ended March 31,

 
  

2017

  

2016

 

Cost of goods sold

 $41  $1 

Research and development

  172   1 

Selling, general and administrative

  409   28 

Share-based compensation expense

 $622  $30 

The Royalty Settlementfollowing table summarizes the activity of stock options and Release Agreement became effectiverelated information:

  

Options outstanding

 
         
      

Weighted

 
      

average

 
  

Number of

  

exercise

 
  

shares

  

price

 
         

Balance, December 31, 2016

  41,903,728  0.15 

Stock options granted

  4,413,930   0.90 

Stock options exercised

  (107,153)  0.20 

Stock options cancelled

  (407,382)  0.04 

Balance, March 31, 2017

  45,803,123  0.22 

The weighted average grant-date fair value of options granted during the three months ended March 31, 2017 was $0.72 per share.

EmployeeShare-Based Compensation (Stock Options)

During the three months ended March 31, 2017, the Company granted stock options to certain non-employee directors and employees to purchase 2,466,147 shares of common stock. The fair value of each option grant is estimated on July 1, 2016 upon the receipt of the Royalty Payment.

Use of Estimates

Financial statements prepared in accordance with U.S. GAAP require management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statementsgrant using the BSM option pricing model with the weighted average assumptions in the table below.  

Risk-free interest rate

  2.052.07% 

Volatility

  8889% 

Dividend yield

   None  

Expected terms (in years)

  6.006.25 

Unrecognized share-based compensation for employee options granted through March 31, 2017 is approximately $4.1 million to be recognized over a remaining weighted average service period of 3.4 years.

EmployeeShare-Based Compensation (RSUs)

During the three months ended March 31, 2017, the Company granted to certain non-employee directors 736,000 restricted stock units, or RSUs. The fair value of each RSU is estimated on the closing market price on the grant date.  

The following summarizes the activity of non-vested RSUs:

      

Weighted

 
      

average

 
      

grant date

 
  

Number of

  

fair value

 
  

shares

  

per share

 

Non-vested units, December 31, 2016

       

RSUs granted

  736,000  $0.92 

RSUs vested

       

RSUs forfeited

       

Non-vested units, March 31, 2017

  736,000  $0.92 


Unrecognized share-based compensation for employee RSUs granted through March 31, 2017 is approximately $630,000 to be recognized over a remaining weighted average service period of 2.8 years.

Nonemployee Share-Based Compensation

During the three months ended March 31, 2017, the Company granted options to purchase 1,947,783 shares of common stock to consultants. These options were granted in exchange for consulting services to be rendered and vest over the term specified in the grant, which correlates to the period the services are rendered. The Company recorded approximately $233,000 and $1,000 for the three months ended March 31, 2017 and 2016, respectively, as nonemployee share-based compensation expense.

The Company accounts for share-based compensation arrangements with nonemployees, using the BSM option pricing model, based on the fair value as these instruments vest. Accordingly, at each reporting date, the Company revalues the unearned portion of the share-based compensation and the reported amounts of revenues and expenses during the reporting period. Among other things, management makes estimates relating to share- based payments and deferred income tax assets. Actual results could differ from those estimates.

Revenue Recognition

The Company's revenue consists of royalty income from Arthrex pursuant to the Arthrex Asset Purchase Agreement. Royalty incomeresulting change in fair value is recognized in the consolidated statements of operations over the period the related services are rendered. The following assumptions were used to value the awards as the amount becomes known and collectability is reasonably assured.of March 31, 2017:

Net Income Per

Risk-free interest rate

  2.372.40% 

Volatility

   89%  

Dividend yield

   None  

Expected terms (in years)

  9.49.8% 

(9)

Net Loss per Share

Basic net incomeloss per share is computed by usingdividing net loss by the weighted-average number of common shares outstanding duringfor the period. DilutedSince we were in a loss position for all periods presented, diluted net incomeloss per share is computed giving effect tothe same as basic net loss per share for all dilutiveperiods as the inclusion of all potential common shares using various methods such as the treasuryoutstanding would have been anti-dilutive.  

The following outstanding common stock or modified treasury stock method in the determination of diluted shares outstanding at each reporting period. Dilutive potential common shares consist of incremental common shares issuable upon exercise of stock options. No dilutive potential common shares are included inequivalents were excluded from the computation of any diluted net loss per share amount because their impact was anti-dilutive.

Income Taxes

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences betweenperiods presented because including them would have been antidilutive:

  

March 31,

 
  

2017

  

2016

 

Stock options to purchase common stock

  45,803,123   12,595,578 

Unvested restricted stock units

  736,000   - 

Total

  46,539,123   12,595,578 

(10)     Income Taxes

During the financial statement carrying amounts of existing assetsthree months ended March 31, 2017 and liabilities and their respective tax bases as well as operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable2016, there was no income in the years in which those temporary differences are expected to be recovered or settled. The likelihood of realizing the tax benefits related to a potential deferred tax asset is evaluated, and a valuation allowance is recognized to reduce that deferred tax asset if it is more likely than not that all or some portion of the deferred tax asset will not be realized. Deferred tax assets and liabilities are calculated at the beginning and end of the year; the change in the sum of the deferred tax asset, valuation allowance and deferred tax liability during the year generally is recognized as a deferred tax expense or benefit. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date.

5


The Company evaluates the accountingbenefit for uncertainty infederal or state income tax recognized in its financial statements and determines whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit is recorded in its financial statements. For those tax positions where it is "not more likely than not" that a tax benefit will be sustained, no tax benefit is recognized. Where applicable, associated interest and penalties are also recorded. The Company has not accrued for any such uncertain tax positions as of September 30, 2016 (unaudited) or December 31, 2015.

Concentration of Credit Risk

The cash and cash equivalents held in the Company's business money market and other bank accounts are with local and national banking institutions and subjected to FDIC insurance limits of $250,000 per banking institution. As of September 30, 2016, the Company's balances in these bank accounts exceeded the insured amount by $19,187,000.

Recent Accounting Pronouncements

There are no recently issued accounting pronouncements that the Company has yet to adopt that are expected to have a material effect on its financial position, results of operations, or cash flows.

NOTE 2 - SHARE BASED PAYMENT

The Company has outstanding stock options issued to employees and board members which are exercisable at $0.23 per share. The options vest 20% each year over a five year period and expire after ten years. As of September 30, 2016, there were no unvested options. There was no stock option expense recognized for the nine months ended September 30, 2016 or 2015taxes in the accompanying condensed consolidated statementsstatement of income.operations due to the Company’s net loss and a full valuation allowance on the resulting deferred tax assets.

A summary

As of stock option activityMarch 31, 2017, the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The realization of the Company’s deferred tax assets depends primarily on its ability to generate future taxable incomewhich is uncertain. The Company does not believe that its deferred tax assets are realizable on a more-likely-than-not basis; therefore, the net deferred tax assets have been fully offset by a valuation allowance.

(11)     Grant Funding

In June 2016, the Company entered into a grant agreement with Maryland Technology Development Corporation, or TEDCO. TEDCO was created by the Maryland State Legislature in 1998 to facilitate the transfer and commercialization of technology from Maryland’s research universities and federal labs into the marketplace. TEDCO administers the Maryland Stem Cell Research Fund to promote State funded stem cell research and cures through financial assistance to public and private entities operating within the State. Under the agreement, TEDCO has agreed to provide the Company an amount not to exceed $750,000 to be used solely to finance the costs to conduct the research project entitled “Heart Failure Trial” over a period of three years. 

In the fourth quarter of 2016, the Company received approximately $312,000 under the grant which will be accounted for as a reduction to research and development expenses as the related qualifying costs are incurred. Approximately $27,000 of the qualifying costs had been incurred as of September 30, 2016, and changes duringMarch 31, 2017. The remaining $285,000 is recorded as grant liability on the period then endedcondensed consolidated balance sheet at March 31, 2017. The amount is presented below.

       Weighted-   
     Weighted- Average   
     Average Remaining  Aggregate
     Exercise Contractual  Intrinsic
  Options  Price Life (Years)  Value
           
Outstanding at December 31, 2015 385,000  $0.23  2.66  $
Granted   -   -    
Exercised   -   -    
Forfeited (305,000)  0.23     
Outstanding at September 30, 2016 (unaudited) 80,000  $0.23  1.91  $
           
Vested and expected to vest          
     at September 30, 2016 (unaudited) 80,000  $0.23  1.91  $
           
Exercisable at September 30, 2016 (unaudited) 80,000  $0.23  1.91  $

6


recorded as a liability as the amounts are refundable, should a default by the Company, as defined in the agreement, occur prior to incurring the qualifying costs.

On(12)     Related Party Transactions

In August 11, 2016, the Company granted an aggregate of 450,000 shares of restricted stockoption to its directors and a consultant. Pursuant to the stock award agreement, the grant of restricted stock of the Company vests in full on August 11, 2017 (the "Vesting Date"), subject to the recipient's continued service with the Company; provided, however, to the extent the recipient's service with the Company is terminated for any reason within thirty (30) days prior to or upon a Change in Control (as defined in the Agreement) prior to the Vesting Date, this grant of restricted stock will immediately and automatically vest in full. The Company recorded stock based compensation of approximately $9,000 related to this grant during the three and nine months ended September 30, 2016. Total unrecognized expense related to the restricted stock grant amounted to approximately $54,000, which will be recognized through the Vesting Date.

NOTE 3 - STOCKHOLDERS' EQUITY

Our authorized capital consists of 750,000,000purchase 5,027,726 shares of common stock, with 4-year vesting period and 50,000,000the exercise price of $0.15 per share, to OPKO Health, Inc., or OPKO, as consideration for consulting services to be provided by OPKO in accordance with the consulting agreement entered into between the Company and OPKO. The unearned portion of the share-based compensation related to the OPKO option was revalued at March 31, 2017, and the Company recorded $122,000 as expense during the three months ended March 31, 2017. The term of the consulting agreement is 4 years and will be automatically renewed for successive one year periods. The chairman and chief executive officer of OPKO is a beneficial owner of more than 5% of the outstanding shares of preferredthe Company’s common stock and OPKO itself is also a beneficial owner of more than 5% of the outstanding shares of the Company’s common stock. Our preferred stock may be designated into series pursuant to authority granted by our Certificate of Incorporation, and on approval from our Board of Directors. As of September 30, 2016 and December 31, 2015, we did not have any preferred stock issued.


ITEM 2 - MANAGEMENT'S2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains certain forward-looking statements that involve risk and uncertainties. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those listed in our Annual Report on Form 10-K and elsewhere in this report. Historical results are not necessarily indicative of future results.

Special Note Regarding Smaller Reporting Company Status

We are filing this Quarterly Report on Form 10-Q as a “smaller reporting company” (as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended) based on our public float (the aggregate market value of our common equity held by non-affiliates of the Company) as of the last business day of our second fiscal quarter of 2016. As a result of being a smaller reporting company, we are allowed and have elected to omit certain information, including tabular disclosure of contractual obligations, from this Management’s Discussion and Analysis of Financial Condition and Results of Operations; however, we have provided all information for the periods presented that we believe to be appropriate and necessary.

Overview

We are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. Our lead therapeutic candidate is the CardiAMP Cell Therapy System, or CardiAMP. We have initiated our U.S. Food and Drug Administration, or FDA, accepted Phase III pivotal trial for CardiAMP in ischemic systolic heart failure, began treating patients in February 2017 and expect to obtain top-line data in 2019. If our trial is successful, we believe we will be the first company to reach the market with a cell-based therapy to treat heart failure. An Investigational Device Exemption submission to FDA for CardiAMP in the indication of post myocardial indication is anticipated in 2017. Our second therapeutic candidate is the CardiALLO Cell Therapy System, or CardiALLO. We anticipate preparation of an Investigational New Drug, or IND, application for submission to the FDA for a Phase II trial for CardiALLO for the treatment of ischemic systolic heart failure. This IND is expected to have improved Chemistry Manufacturing Controls, or CMC, in the IND relative to our previous co-sponsored investigations. We are committed to applying our expertise in the fields of autologous and allogeneic cell-based therapies to improve the lives of patients with cardiovascular conditions.

To date, we have devoted substantially all of our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems, including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property. We have also generated modest revenues from sales of our approved products. We have funded our operations primarily through the sales of equity and convertible debt securities, and certain government and private grants. All convertible debt securities were converted into shares of our Common Stock in connection with the Merger.

We have incurred net losses in each year since our inception. Our net losses were approximately $2.9 million and $1.5 million for the three months ended March 31, 2017 and 2016, respectively. As of March 31, 2017, we had an accumulated deficit of approximately $63.0 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs, clinical trials, intellectual property matters, building our manufacturing and sales capabilities, and from general and administrative costs associated with our operations.

Financial Overview

Revenue

We currently have a portfolio of enabling and delivery products, from which we have generated modest revenue.

Cost of Goods Sold

Cost of goods sold includes the costs of raw materials and components, manufacturing personnel and facility costs and other indirect and overhead costs associated with manufacturing our enabling and delivery products.


Research and Development Expenses

Our research and development expenses consist primarily of:

salaries and related overhead expenses, which include share-based compensation and benefits for personnel in research and development functions;

fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial material management and statistical compilation and analysis;

costs related to acquiring and manufacturing clinical trial materials;

costs related to compliance with regulatory requirements; and

payments related to licensed products and technologies.

We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and clinical sites. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and the services are performed.

We plan to increase our research and development expenses for the foreseeable future as we continue to develop CardiAMP, and subject to the availability of additional funding, further advance the development of CardiALLO and any other therapeutic candidates for additional indications. We typically use our employee and infrastructure resources across multiple research and development programs, and accordingly we have not historically allocated resources specifically to our individual programs.

The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our therapeutic candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our therapeutic candidates.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, sales, corporate development and administrative support functions, including share-based compensation expenses and benefits. Other significant selling, general and administrative expenses include sales commissions, rent, accounting and legal services, obtaining and maintaining patents, the cost of consultants, occupancy costs, insurance premiums and information systems costs.

We expect that our selling, general and administrative expenses will increase as we advance our Phase III pivotal heart failure trial for CardiAMP, and subject to the availability of additional funding, conduct our Phase II trial for CardiALLO and prepare for commercialization. We believe that these increases will likely include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel to support product commercialization efforts and operations and increased fees for outside consultants, attorneys and accountants. We also expect to incur increased costs to comply with corporate governance, internal controls, investor relations and disclosures, and similar requirements applicable to public companies.

Other Income (Expense)

Other income and expense consists primarily of interest income we earn on our cash and cash equivalents, interest charges we incurred in periods when we have convertible debt outstanding, and changes in the fair value of our warrant and convertible shareholder note derivative liabilities in periods when we have warrants or convertible debt outstanding. Subsequent to the Merger we have no interest charges related to the convertible debt and changes in the fair value of our warrant and convertible shareholder note derivative liabilities as such instruments were converted, cancelled or exchanged as part of the Merger. We expect our interest income to increase following the completion of the Merger as we invest our cash on hand pending its use in our operations.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations areis based on our financial statements, which we have prepared in accordance with generally accepted accounting principles generally accepted in the United States, of America.or U.S. GAAP. The preparation of these condensed consolidatedour financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidatedour financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, weperiods presented. We evaluate these estimates and judgments including those described in greater detail below.on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

As used


Other than below, there were no material changes in this "Management'sour critical accounting estimates or accounting policies described in “Management’s Discussion and Analysis of Financial Condition and Results of Operation," except whereOperations” in our 2016 Form 10-K during the context otherwisethree months ended March 31, 2017.

Share-Based Compensation 

We measure and recognize share-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. We use the Black-Scholes-Merton option-pricing model, or BSM, to calculate the fair value of stock options. Restricted stock units (RSUs) are measured based on the fair market values of the underlying stock on the dates of grant. Share-based compensation expense recognized in the statements of operations is based on awards at the time of grant, and is reduced for actual forfeitures at the time that the forfeitures occur. Compensation cost for employee share-based awards will be recognized over the vesting period of the applicable award on a straight-line basis. 

For options granted to nonemployees, we revalue the unearned portion of the share-based compensation and the resulting change in fair value is recognized in the statements of operations over the period the related services are rendered.

The BSM option-pricing model requires the term "we," "us," "our,"input of subjective assumptions, including the "Company," or "Tiger X" refers torisk-free interest rate, the business of Tiger X Medical, Inc.

The following discussion should be read together with the information containedexpected volatility in the unaudited condensed consolidated financial statements and related notes included in Item 1, "Financial Statements," in this Form 10-Q.

Overview

Tiger X Medical, Inc. ("Tiger X" or the "Company"), formerly known as Cardo Medical, Inc., previously operated as an orthopedic medical device company specializing in designing, developing and marketing high performance reconstructive joint devices and spinal surgical devices. During 2010, the Company discontinued its orthopedic medical device operations and sold the assets from its previous business lines during 2011. Through July 1, 2016, our continuing operations included the collection and managementvalue of our royalty income earned in connection withCommon Stock, and the Asset Purchase Agreement with Arthrex. 

On August 22, 2016, the Company, Icicle Acquisition Corp., a Delaware corporation and a direct wholly-owned subsidiaryexpected term of the Company ("Merger Sub"), and BioCardia, Inc., a Delaware corporation ("BioCardia"), entered into an Agreement and Plan of Merger (the "Merger Agreement"), pursuant to which Merger Sub will merge with and into BioCardia, with BioCardia continuing as the surviving company under the name "BioCardia, Inc." (the "Merger"). The Company expects the Merger to close in October 2016.

7


We are headquartered in Miami, Florida. Our common stock is quoted on the National Association of Securities Dealers, Inc.'s, Over-the-Counter Bulletin Board, or the OTC Bulletin Board, with a trading symbol of CDOM.OB.

Critical Accounting Policies

Use of Estimates

Financial statements prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") require management to makeoption. These estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statementsinvolve inherent uncertainties and the reported amountsapplication of revenuesmanagement’s judgment. If factors change and expenses duringdifferent assumptions are used, our share-based compensation expense could be materially different in the reporting period. Among other things, management makes estimates relating to share-based payments, and deferred income tax assets. Given the short operating history of Tiger X, actual results could differ from those estimates.

Royalty Agreementfuture. 

On January 24, 2011, the Company entered into an Asset Purchase Agreement with Arthrex (the "Arthrex Asset Purchase Agreement"), pursuant to which the Company agreed to sell the assets of its arthroplasty division, referred to as the Reconstructive Division, to Arthrex. The Arthrex Asset Purchase Agreement also provided for the Company to receive royalty payments equal to 5% of net sales of the Company's products made by Arthrex on a quarterly basis for a term up to and including the 20th anniversary of the June 10, 2011 closing date. These amounts were reflected as royalty income on the accompanying condensed consolidated statements of income.

On May 5, 2016, the Company entered into a Royalty Settlement and Release Agreement (the "Royalty Settlement and Release Agreement") with Arthrex, whereby Arthrex agreed to pay the Company $5,642,302 (the "Royalty Payment") in full satisfaction of all amounts due or payable, or which could become payable under the Arthrex Asset Purchase Agreement. Of the Royalty Payment, $142,302 of the amount represented royalty income due to the Company under the Arthrex Asset Purchase Agreement through the date of the Royalty Settlement and Release Agreement, and the remaining $5,500,000 represented the settlement of future royalties. The Royalty Settlement and Release Agreement became effective on July 1, 2016 upon the receipt of the Royalty Payment.

Revenue Recognition

The Company's revenue consists of royalty income from Arthrex pursuant to the Arthrex Asset Purchase Agreement. Revenue is recognized as the amount becomes known and collectability is reasonably assured.

Recent Accounting Pronouncements

There are no recently issued accounting pronouncements that we have yet to adopt that are expected to have a material effect on our financial position, results of operations, or cash flows.

8


Results of Operations for the Three Months Ended September 30, 2016 as Compared to the Three Months Ended September 30, 2015.

The following is a comparison of the condensed consolidatedtable summarizes our results of operations for Tiger X for the three months ended September 30,March 31, 2017 and 2016 (in thousands):

  

Three Months Ended

March 31,

 
         
  

2017

  

2016

 

Revenue:

        

Net product revenue

 $109  $168 

Collaboration agreement revenue

  28   10 

Total revenue

  137   178 
         

Cost and expenses:

        

Cost of goods sold

  175   226 

Research and development

  1,033   441 

Selling, general and administrative

  1,804   587 

Total cost and expenses

  3,012   1,254 
         

Operating loss

  (2,875

)

  (1,076

)

Interest expense

  -   (550

)

Other (expense) income

  (1

)

  130 

Net loss

 $(2,876

)

 $(1,496

)

Revenue.    Revenue decreased by approximately $41,000 in the three months ended March 31, 2017 compared to the three months ended March 31, 2016 primarily due to a reduction in sales volumes. We expect net product revenue for 2017 to be relatively consistent with 2016.

Cost of Goods Sold.    Cost of goods sold decreased by approximately $51,000 in the three months ended March 31, 2017 compared to the three months ended March 31 2016 consistent with the reduction in revenue. We expect cost of goods sold for 2017 to be relatively consistent with 2016.

Research and 2015.

  Three Months Ended   
  September 30,   
(In thousands) 2016  2015  $ Change
         
Royalty income$5,500  $121  $5,379 
         
General and administrative expenses 379   38   341 
Income from operations 5,121   83   5,038 
Interest income     
Income before income tax provision 5,121   83   5,038 
Provision for income taxes     
Net income $5,121  $83  $5,038 

Royalty incomeDevelopment Expenses.    Research and development expenses increased by approximately $592,000 in the three months ended March 31, 2017 compared to the three months ended March 31, 2016 primarily due to expenses incurred in the planning, preparation and inception of the CardiAMP Phase III pivotal heart failure trial. We expect research and development expenses to increase as we continue to enroll and treat patients in the trial and incur additional development expenses related to CardiALLO therapeutic program. 

Royalty income amounted

Selling, General and Administrative Expenses.    Selling, general and administrative expenses increased by approximately $1.2 million in the three months ended March 31, 2017 compared to $5,500,000the three months ended March 31, 2016 primarily due to the additional expense of operating as a public company, including additional salary expenses, stock compensation costs, legal, accounting, tax and other corporate expenses. We expect selling, general and administrative expenses for the quarterremaining quarters to increase moderately from the three month period ended September 30,March 31, 2017 as we continue to build the supporting staff and infrastructure to support the CardiAMP Phase III pivotal trial and public company operations.  

Interest Expense.   Interest expense for the three months ended March 31, 2016 consisted primarily of interest expense related to convertible notes which are no longer outstanding.

Other Income (Expense).Other income (expense) for the three months ended March 31, 2016 consisted primarily of the changes in value of the convertible preferred stock warrant liabilities and the change in value of the convertible shareholder note derivative liability.

Liquidity and Capital Resources

We have incurred net losses each year since our inception and as of March 31, 2017, we had an accumulated deficit of approximately $63.0 million. We anticipate that we will continue to incur net losses for at least the next several years.


We have funded our operations principally through the sales of equity and convertible debt securities as well as the cash acquired through the Merger. As of March 31, 2017, we had cash and cash equivalents of approximately $19.0 million.

The following table shows a summary of our cash flows for the periods indicated (in thousands):

  

Three Months EndedMarch 31,

 
  

2017

  

2016

 

Net cash provided by (used in):

        

Operating activities

 $(2,278

)

 $(748

)

Investing activities

  (64

)

  - 

Financing activities

  22   - 
         

Net decrease in cash and cash equivalents

 $(2,320

)

 $(748

)

Cash Flows from Operating Activities.    The increase in overall spending for operating activities of approximately $1.5 million in the three months ended March 31, 2017 compared to $121,000 for the quarterthree months ended September 30, 2015. Revenues represented royalties receivedMarch 31, 2016 relates primarily to increased cash outflows to conduct the CardiAMP Phase III pivotal trial, further develop the CardiAMP and CardiALLO programs and to build the supporting infrastructure to sustain these efforts and support operations as a public company.   

Cash Flows from ArthrexInvesting Activities.     Net cash used in connection with the Arthrex Asset Purchase Agreement. We entered into a Royalty Settlement and Release Agreement with Arthrex on May 5, 2016 and effective on July 1, 2016, whereby we agreed to receive approximately $5,642,000 (including approximately $142,000investing activities of royalty income recorded$64,000 during the three months ended June 30, 2016) in full satisfaction of all amounts due or payable, or which become payable under the Arthrex Asset Purchase Agreement. The remaining $5,500,000 was recorded as revenue upon the closingMarch 31, 2017 consists of the agreement on July 1, 2016. Other than this amount recorded on July 1, 2016 underpurchase of property and equipment.

Cash Flows from Financing Activities.     Net cash provided by financing activities of $22,000 during the termsthree months ended March 31, 2017 consists of the Royalty Settlement and Release Agreement,proceeds from the exercise of stock options.

Future Funding Requirements

To date, we have generated modest revenue from sales of our approved products. We do not know when, or if, we will have no further royalty income.

Generalgenerate any revenue from our development stage biotherapeutic programs. We do not expect to generate any revenue from sales of our CardiAMP or CardiALLO therapeutic candidates unless and Administrative Expenses

Generaluntil we obtain regulatory approval. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and administrativeclinical trials of, and seek regulatory approval for, our therapeutic candidates. In addition, subject to obtaining regulatory approval for any of our therapeutic candidates and companion diagnostic, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need additional funding in connection with our continuing operations.  

Based upon our current operating plan, we believe that the quarter ended September 30, 2016 increased by $341,000cash on hand of $19.0 million as comparedof March 31, 2017 will enable us to fund our operations for at least 12 months from the same period in 2015 due primarilydate of issuance of these financial statements. We have based our estimates on assumptions that may prove to increased legalbe wrong, and professional expenses duringwe may use our available capital resources sooner than we currently expect. Because of the quarter ended September 30, 2016numerous risks and uncertainties associated with the Royalty Settlementdevelopment and Release Agreementcommercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.  

Our future capital requirements will depend on many factors, including:

the progress, costs, results and timing of our CardiAMP and CardiALLO clinical trials;

FDA acceptance of our CardiAMP and CardiALLO therapies for heart failure and for other potential indications;

the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

the costs associated with Arthrex, along with securing, establishing and maintaining commercialization and manufacturing capabilities;

the Merger Agreement with BioCardia.

9


Resultsnumber and characteristics of Operations for product candidates that we pursue, including our product candidates in preclinical development;

the Nine Months Ended September 30, 2016 as Comparedability of our product candidates to progress through clinical development successfully;

our need to expand our research and development activities;

the Nine Months Ended September 30, 2015.

The following is a comparisoncosts of acquiring, licensing or investing in businesses, products, product candidates and technologies;


our ability to maintain, expand and defend the condensed consolidated resultsscope of operations for Tiger X forour intellectual property portfolio, including the nine months ended September 30, 2016amount and 2015.

  Nine Months Ended   
  September 30,   
(In thousands) 2016  2015  $ Change
         
Royalty income$5,791  $382  $5,409 
         
General and administrative expenses 515   152   363 
Income from operations 5,276   230   5,046 
Interest income     
Income before income tax provision 5,278   232   5,046 
Provision for income taxes     
Net income $5,278  $232  $5,046 

Royalty income

Royalty income amountedtiming of any payments we may be required to $5,791,000 for the nine months ended September 30, 2016 as compared to $382,000 for the nine months ended September 30, 2015. Revenues represented royalties received from Arthrexmake, or that we may receive, in connection with the Arthrex Asset Purchase Agreement. We entered intolicensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

the general and administrative expenses related to being a Royalty Settlementpublic company;

our need and Release Agreement with Arthrex on May 5, 2016ability to hire additional management and effective on July 1, 2016, wherebyscientific, medical and sales personnel;

the effect of competing technological and market developments; and

our need to implement additional internal systems and infrastructure, including financial and reporting systems.

Until such time that we agreedcan generate meaningful revenue from the sales of approved therapies and products, if ever, we expect to receive approximately $5,642,000 in full satisfactionfinance our operating activities through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances and licensing arrangements or a combination of all amounts duethese approaches. To the extent that we raise additional capital through the sale of equity or payable, or which become payable underconvertible debt securities, the Arthrex Asset Purchase Agreement. Other than this amount recorded on July 1, 2016 underownership interests of our Common Stock holders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the Royalty Settlementrights of our Common Stock holders. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and Release Agreement,distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we willmay have no further royalty income.

Generalto relinquish valuable rights to our technologies, future revenue streams, research programs, products or therapeutic candidates or to grant licenses on terms that may not be favorable to us. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research and Administrative Expensesdevelopment programs or the commercialization of any approved therapies or products or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially adversely affect our business, financial condition and results of operations.

General and administrative expenses for

Off-Balance Sheet Arrangements

During the nine months ended September 30, 2016 increased by $363,000periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as compared todefined under the same period in 2015 due primarily to increased legal and professional expenses associated with the Royalty Settlement and Release Agreement with Arthrex, along with the Merger Agreement with BioCardia.

Liquidity and Capital Resources

Net cash provided by operating activities was $5,597,000 for the nine months ended September 30, 2016 compared to net cash provided by operating activities of $217,000 for the same period in 2015. The change between the nine months ended September 30, 2016 and the same period in 2015 was primarily due to an increase in royalty income in 2016.

We had no cash flows from investing or financing activities during the nine months ended September 30, 2016 or 2015.

We believe our cash and cash equivalents as of September 30, 2016 are adequate to meet our cash needs for the next twelve months and beyond.

10


Forward-Looking Statements

Somerules of the Securities and Exchange Commission.

Recent Accounting Pronouncements

See Note 2 of our notes to condensed consolidated financial statements in this Quarterly Report on Form 10-Qfor information regarding recent accounting pronouncements that are "forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "may," "will," "should," "anticipate," "estimate," "expect," "plan," "believe," "predict," "potential," "project," "target," "forecast," "intend," "assume," "guide," "seek" and similar expressions. Forward-looking statements do not relate strictlysignificance or potential significance to historical or current matters. Rather, forward-looking statements are predictive in nature and may depend upon or refer to future events, activities or conditions. Although we believe that these statements are based upon reasonable assumptions, we cannot provide any assurances regarding future results. We undertake no obligation to revise or update any forward- looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.us.

Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. Information regarding our risk factors appears in Part I, Item 1A, "Risk Factors," in our Annual Report on Form 10-K for the year ended December 31, 2015 filed on March 25, 2016.

ITEM 3 -3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable for smaller reporting companies.applicable.

ITEM 4 -4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are designed to ensure that information required to be disclosed in ourthe Company’s reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the Commission'sSEC’s rules and forms, and that such information is accumulated and communicated to our management, including our interim principal executive officerChief Executive Officer and our interim principal financial officer,Vice President of Finance, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as the Company’s controls are designed to do, and management necessarily was required to apply its judgment in evaluating the risk related to controls and procedures.

We carried out

In connection with the preparation of this Quarterly Report on Form 10-Q, as of March 31, 2017, an evaluation was performed under the supervision and with the participation of our management, including our interim principal executive officerthe Chief Executive Officer and interim principal financial officer,Vice President of Finance, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d- 15(e) under the Exchange Act) as of. Due to the material weakness in internal control over financial reporting described in our Annual Report on 10-K for the fiscal year end of the period covered by this quarterly report. Based on this evaluation,dated December 31, 2016, our Interim Chief Executive Officer and Interim Chief Financial OfficerVice President of Finance concluded that our disclosure controls and procedures were not effective as of September 30, 2016.March 31, 2017. These conclusions were communicated to the Audit Committee. Notwithstanding the existence of this material weakness, management has concluded that the condensed consolidated financial statements in this Form 10-Q fairly present, in all material respects, the Company’s financial position, results of operations and cash flows for all periods and dates presented.


Changes in Internal Control Overover Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2016three month period covered by this Quarterly Report on Form 10-Q that have materially affected or areis reasonably likely to materially affect, our internal control over financial reporting.


PART II -II. OTHER INFORMATION

ITEM 1 -1. LEGAL PROCEEDINGS

We know

The Company may be subject to various claims, complaints, and legal actions that arise from time to time in the normal course of business. Management does not believe that the Company is party to any currently pending legal proceedings. There can be no material,assurance that existing or pendingfuture legal proceeding against our Company, nor are we involved as a plaintiffproceedings arising in any material proceedingthe ordinary course of business or pending litigation. There are no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial shareholder, is an adverse party or hasotherwise will not have a material interest adverse effect on the Company’s business, financial position, results of operations, or cash flows.

ITEM 1A. RISK FACTORS

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our interest.Annual Report on Form 10-K for the year ended December 31, 2016, which could materially affect our business, financial condition, or future results. The risks described in this report and in our Annual Report on 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

11


ITEM 2 -2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None

None.

ITEM 3 -3. DEFAULTS UPON SENIOR SECURITIES

None

None.

ITEM 4 -4. MINE SAFETY DISCLOSURES

Not applicableapplicable.

ITEM 5 -5. OTHER INFORMATION

None

None.

ITEM 6 - EXHIBITS6. EXHIBIT INDEX

The following exhibits listed in the Exhibit Index to this Quarterly Report on Form 10-Q are filed as part of, or incorporated herein by reference into this Report:

Exhibit
Number

Exhibit Description

2.1

Agreement and Plan of Merger dated as of August 22, 2016, by and among the Company, BioCardia, Merger Sub, Jay Moyes, as the representative of BioCardia Securityholders, and Steven Rubin, as initial representative of the Company (incorporated by reference to Exhibit 2.1 to the Company's Current Report on 8-K filed on August 25, 2016).

31.1

Certification of Interim Chief Executive Officer of Tiger X Medical, Inc., as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *

31.2

Certification of Interim Chief Financial Officer of Tiger X Medical, Inc., as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *

32.1

Certification of Interim Chief Executive Officer of Tiger X Medical, Inc. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**

32.2

Certification of Interim Chief Financial Officer of Tiger X Medical, Inc. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**

101.INS

XBRL Instance Document*

101.SCH

XBRL Taxonomy Extension Schema Document*

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document*

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document*

101.LAB

XBRL Taxonomy Extension Label Linkbase Document*

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document*

*

Filed herewith

**

Furnished herewith

12


reference.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrantregistrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

TIGER X MEDICAL,BIOCARDIA, INC.

(Registrant)

 

October 17, 2016

By: 

/s/ Steven Rubin 

Steven Rubin

Interim Chief Executive Officer and Interim Chief Financial Officer
(Principal Executive Officer)

(Principal Financial and Accounting Officer)

 

 

 

Date:     May 11, 2017  

By:

/s/Peter Altman

Peter Altman

President and Chief Executive Officer

(Principal Executive Officer)


13


EXHIBIT INDEX

INDEX TO EXHIBITS

Exhibit

Number

Exhibit Description

3.1(1)  

Exhibit DescriptionAmended and Restated Certificate of Incorporation.

2.13.2(2)  

Amended and Restated Bylaws.

31.1*

Agreement and Plan of Merger dated as of August 22, 2016, by and among the Company, BioCardia, Merger Sub, Jay Moyes, as the representative of BioCardia Securityholders, and Steven Rubin, as initial representative of the Company (incorporated by reference to Exhibit 2.1 to the Company's Current Report on 8-K filed on August 25, 2016).

31.1

Certification of ChiefPeriodic Report by Principal Executive Officer of Tiger X Medical, Inc., as adopted pursuant tounder Section 302 of the Sarbanes-Oxley Act of 2002.*

31.231.2*

Certification of Interim ChiefPeriodic Report by Principal Financial Officer of Tiger X Medical, Inc., as adopted pursuant tounder Section 302 of the Sarbanes-Oxley Act of 2002.*

32.132.1**

Certification of ChiefPrincipal Executive Officer of Tiger X Medical, Inc. pursuantPursuant to 18 U.S.C. Section 1350, as adopted pursuant toRule 13a-14(b) and Section 906 of the Sarbanes-Oxley Act of 2002.**2002 (Subsections (a) and (b) of Section 1350, Title 18, United States Code).

32.232.2**

Certification of Interim ChiefPrincipal Financial Officer of Tiger X Medical, Inc. pursuantPursuant to 18 U.S.C. Section 1350, as adopted pursuant toRule 13a-14(b) and Section 906 of the Sarbanes-Oxley Act of 2002.**2002 (Subsections (a) and (b) of Section 1350, Title 18, United States Code).

 101.INS+

 XBRL Instance Document

101.INS 101.SCH+

XBRL Instance Document*

101.SCH

XBRL Taxonomy Extension Schema Document*Document

101.CAL 101.CAL+

XBRL Taxonomy Extension Calculation Linkbase Document*Document

101.DEF 101.DEF+

XBRL Taxonomy Extension Definition Linkbase Document*Document

101.LAB 101.LAB+

XBRL Taxonomy Extension Label Linkbase Document*Document

101.PRE 101.PRE+

XBRL Taxonomy Extension Presentation Linkbase Document*Document

*

Filed herewithherewith.

**

Furnished herewith.

+

Furnished herewithThe financial information contained in these XBRL documents is unaudited and is furnished, not filed with the Securities and Exchange Commission.

(1)

Previously filed as an exhibit to the Current Report on Form 8-K filed by us on April 11, 2017.

(2)

Previously filed as an exhibit to the Current Report on Form 8-K filed by us on April 11, 2017.

 

 

19