Attached files
| file | filename |
|---|---|
| EXCEL - IDEA: XBRL DOCUMENT - ARTVENTIVE MEDICAL GROUP, INC. | Financial_Report.xls |
| EX-32 - CERTIFICATION - ARTVENTIVE MEDICAL GROUP, INC. | exhibit32.htm |
| EX-31 - CERTIFICATION - ARTVENTIVE MEDICAL GROUP, INC. | exhibit31.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C 20549
FORM 10-Q
(Mark One)
[X]
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 201431, 2014rch 31, 2014
[ ]
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
For the transition period from ____ to ____
Commission File No. 333-144226
ARTVENTIVE MEDICAL GROUP, INC.
(Exact name of registrant as specified in its charter)
Nevada
26-0148468
(State or other jurisdiction
(IRS Employer
of incorporation or organization)
Identification No.)
2766 Gateway Road, Carlsbad, California, 92009
(Address of principal executive offices)
(760) 471-7700
(Registrant’s telephone number)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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 [ ]
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 during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes
[X]
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 accelerated filer, “accelerated filer and smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
[ ]
Accelerated filer
[ ]
Non-accelerated filer
[ ]
Smaller reporting company
[ X ]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [x]
State the number of shares outstanding of each of the issuer’s classes of common equity, as of the latest practicable date:
As of March 31, 2014 there were 56,406,286 shares of the Company’s common stock issued and outstanding.
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements.
ArtVentive Medical Group, Inc.
A Development Stage Company
Consolidated Financial Statements (Unaudited)
For the Period from January 23, 2007 (Inception) to March 31, 2014
Consolidated Balance Sheets as of March 31, 2014 (unaudited) and December 31, 2013
Statement 1
Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the three month periods ended March 31, 2014 and March 31, 2013;
and for the period from January 23, 2007 (Inception) through March 31, 2014
Statement 2
Consolidated Statements of Cash Flows (unaudited) for the three month periods ended March 31, 2014
and March 31, 2013; and for the period from January 23, 2007 (Inception)
to March 31, 2014
Statement 3
Notes to Consolidated Financial Statements (unaudited)
Statement 1
ArtVentive Medical Group, Inc.
A Development Stage Company
Consolidated Balance Sheets
March 31, 2014 and December 31, 2013
ASSETS | March 31, |
|
| 2014 (unaudited) | December 31, 2013 |
CURRENT | ||
Cash and cash equivalents | $ 1,087,618 | $ 1,626,521 |
Accounts receivable | 10,165 | - |
Prepaid expenses | 1,048 | 9,098 |
Inventory | 280,145 | 26,903 |
TOTAL CURRENT ASSETS | 1,378,976 | 1,662,522 |
PROPERTY, PLANT AND EQUIPMENT |
| |
Office equipment | 16,380 | 16,380 |
Accumulated depreciation | (3,075) | (2,303) |
NET PROPERTY, PLANT AND EQUIPMENT | 13,305 | 14,077 |
OTHER ASSETS |
|
|
Deposits | 51,048 | 51,048 |
TOTAL OTHER ASSETS | 51,048 | 51,048 |
|
|
|
TOTAL ASSETS | $ 1,443,329 | $ 1,727,647 |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
CURRENT LIABILITES | ||
Accounts payable | $ 144,684 | $ 272,509 |
Accrued expenses | 695,800 | 585,800 |
Notes payable-current portion | 11,417 | - |
TOTAL CURRENT LIABILITIES | 851,901 | 858,309 |
| ||
LONG-TERM LIABILITES | ||
Notes payable | $ 500,000 | $ - |
Less current portion notes payable | (11,417) | - |
TOTAL LONG-TERM LIABILITIES | 488,583 | - |
|
|
|
TOTAL LIABILITIES | $ 1,340,484 | $ 858,309 |
|
(See accompanying notes)
ArtVentive Medical Group, Inc. A Development Stage Company Consolidated Balance Sheets March 31, 2014 and December 31, 2013 | ||
STOCKHOLDERS’ EQUITY (DEFICIT) | ||
Common stock, par value $.001, 100,000,000 shares | ||
authorized, 56,406,286 and 55,306,286 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively | $ 56,406 | $ 55,306 |
Additional paid in capital | 10,045,178 | 9,056,279 |
Deficit accumulated during the development stage | (9,998,739) | (8,242,247) |
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | 102,845 | 869,338 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ 1,443,329 | $ 1,727,647 |
(See accompanying notes)
Statement 2
ArtVentive Medical Group, Inc.
A Development Stage Company
Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
For the Three Months Ended March 31, 2014 and March 31, 2013; and for the Period from January 23, 2007 (Inception) to March 31, 2014
| For the three months ended March 31, 2014 | For the three months ended March 31, 2013 | For the period from January 23, 2007 (Inception) to March 31, 2014 |
REVENUES | $ 10,165 | $ NIL | $ 10,165 |
COST OF GOODS SOLD | 10,165 | - | 10,165 |
GROSS PROFIT | - | - | - |
| |||
OPERATING EXPENSES | |||
Exploration costs | - | - | 45,533 |
Research and development | 289,522 | 328,374 | 5,306,162 |
Selling, general and administrative | 1,466,676 | 225,247 | 4,648,934 |
Depreciation expense | 771 | 583 | 3,590 |
TOTAL OPERATING EXPENSES | (1,756,969) | (554,204) | (10,004,219) |
OPERATING LOSS BEFORE OTHER ITEMS AND INCOME TAX | (1,756,969) | (554,204) | (10,004,219) |
OTHER INCOME/(EXPENSE) | |||
INTEREST INCOME | 477 | 235 | 5,480 |
Income tax expense (benefit) | - | - | - |
NET LOSS AVAILABLE TO COMMON STOCKHOLDERS | (1,756,492) | (553,969) | (9,998,739) |
COMPREHENSIVE LOSS FOR THE PERIOD | $ (1,756,492) | $ (553,969) | $ (9,998,739) |
BASIC AND DILUTED LOSS PER COMMON SHARE | $ (0.03) | $ (0.01) |
|
WEIGHTED AVERAGE SHARES OUTSTANDING | 56,022,953 | 51,222,598 |
|
(See accompanying notes)
Statement 3
ArtVentive Medical Group, Inc.
A Development Stage Company
Consolidated Statements of Cash Flows (Unaudited)
For the Three Months Ended March 31, 2014 and March 31, 2013; and for the Period from January 23, 2007 (Inception) to March 31, 2014
| For the three months ended March 31, 2014 | For the three months ended March 31, 2013 | For the period from January 23, 2007 (Inception) to March 31, 2014 |
CASH FLOW FROM OPERATING ACTIVITIES | |||
Net loss | $ (1,756,492) | $ (553,969) | $ (9,998,739) |
ADJUSTMENTS TO RECONCILE NET LOSS TO NET CASH USED BY OPERATING ACTIVITIES |
|
|
|
Non-cash expenses | - | 20,169 | 60,805 |
Depreciation expense | 771 | 583 | 3,590 |
Issuance of common stock and options for services | - | - | 103,482 |
|
|
|
|
CHANGES IN OPERATING ASSETS AND LIABILITIES |
|
|
|
Accounts receivable | (10,165) | - | (10,165) |
Prepaid expenses | 8,050 | 5,000 | (1,048) |
Inventory | (253,242) | - | (280,145) |
Deposits | - | - | (51,048) |
Accounts payable | (127,825) | 138,296 | 144,684 |
Payroll taxes payable | - | 392 | - |
Accounts payable – related party | - | - | 39,000 |
NET CASH USED BY OPERATING ACTIVITIES | (2,138,903) | (389,529) | (9,989,584) |
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
Disposal of equipment | - | - | 745 |
Purchase of equipment | - | (3,551) | (17,623) |
NET CASH USED BY INVESTING ACTIVITIES | - | (3,551) | (16,878) |
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
Issuance of common stock for cash | 1,100,000 | 650,000 | 10,444,080 |
Issuance of notes payable | 500,000 | - | 500,000 |
Convertible note payable (see Note 4) | - | - | 150,000 |
NET CASH PROVIDED BY FINANCING ACTIVITIES | 1,600,000 | 650,000 | 11,094,080 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
(538,903) |
256,920 |
1,087,618 |
CASH, BEGINNING OF PERIOD | 1,626,521 | 517,831 | - |
CASH, END OF PERIOD | $ 1,087,618 | $ 774,751 | $ 1,087,618 |
|
|
| |
NON-CASH INVESTING AND FINANCING ACTIVITIES |
|
| |
STOCK ISSUED UPON CONVERSION OF NOTE PAYABLE | $ - | $ - | $ 150,000 |
FORGIVENESS OF RELATED PARTY NOTE; APPLIED TO PAID IN CAPITAL | $ - | $ - | $ 39,000 |
ACCRUAL OF STOCK ISSUANCE COST | $ 110,000 | $ 65,000 | $ 695,800 |
(See accompanying notes)
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
1.
BASIS OF FINANCIAL STATEMENT PRESENTATION
The accompanying unaudited condensed consolidated financial statements have been prepared by ArtVentive Medical Group, Inc. “the Company” pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted in accordance with such rules and regulations. The information furnished in the interim condensed financial statements includes normal recurring adjustments and reflects all adjustments, which, in the opinion of management, are necessary for a fair presentation of such financial statements. Although management believes the disclosures and information presented are adequate to make the information not misleading, it is suggested that these interim condensed consolidated financial statements be read in conjunction with the Company's audited financial statements and notes thereto included in its Form 10-K filed on March 26, 2014. Operating results for the three months ended March 31, 2014 are not necessarily indicative of the results to be expected for the fiscal year ended December 31, 2014.
2.
ORGANIZATION
The Company was originally incorporated under the name of Big Bear Resources, Inc. a USA Company registered in the State of Nevada on January 23, 2007. The Company changed its name to Uranium Plus Resources Inc. on March 21, 2008, and following the acquisition of the assets of ArtVentive, Inc. the Company changed its name on January 26, 2010, to ArtVentive Medical Group, Inc. The accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America, and the Company’s fiscal year end is December 31.
The Company is a medical device corporation, focused on developing, manufacturing and marketing a family of Endoluminal Occlusion Devices (EOS). Through its innovative, proprietary technology the Company has developed unique minimally invasive occlusion devices and procedures, bringing the current interventional, image guided techniques to a new level of sophistication, potentially resolving significant and unaddressed health issues. The EOS device being developed by the Company targets a substantive market demand in several major clinical areas, including women's health, peripheral and neurological vascular disorders, and interventional cardiology procedures.
To date, the Company’s activities have been committed to the development of the EOS, intellectual property, animal studies, human studies, patent filings, and developing a regulatory strategy for initial clinical indications pertinent to European and FDA
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
submissions and approvals, corporate operations and the raising of equity capital. The Company conducted the required human clinical studies during 2011 achieving 100% clinical and procedural success, validating the safety and efficiency of the ArtVentive EOSTM device. The Company received its CE Mark certification for the ArtVentive EOS™ Peripheral device on May 30, 2013. In 2014 the Company began commercialization and commenced shipping to its European distributors and preparing the foundation for marketing and sales into the US markets following regulatory approval.
On August 3, 2011, the Company incorporated ArtVentive Women’s Health Group, Inc., a wholly owned subsidiary of the Company.
3.
SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the transactions of the Company and its subsidiary.
All inter-company accounts and transactions have been eliminated in consolidation.
DEVELOPMENT STAGE COMPANY
The Company is considered to be in the development stage as defined in FASC 915-10-05, “Development Stage Entity”. The Company is devoting substantially all of its efforts to the execution of its business plan.
USE OF ESTIMATES
The preparation of the Company’s financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimates. The Company’s periodic filings with the Securities and Exchange Commission include, where applicable, disclosures of estimates, assumptions, uncertainties and markets that could affect the financial statements and future operations of the Company.
COMMON STOCK ISSUED FOR OTHER THAN CASH
Services purchased and other transactions settled in the Company’s common stock and stock options are recorded at the estimated fair value of the stock issued and options granted if that value is more readily determinable than the fair value of the consideration received.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
EARNINGS PER SHARE OF COMMON STOCK
In accordance with accounting guidance now codified as FASB ASC Topic 260, “Earnings per Share,” basic earnings (loss) per share is computed by dividing net income (loss) by weighted average number of shares of common stock outstanding during each period.
Diluted earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock, common stock equivalents and potentially dilutive securities outstanding during the period.
The Company had the following potential common stock equivalents at March 31, 2014:
Common stock warrants
4,808,000
Common stock options
105,000
Total common stock equivalents
4,913,000
Since the Company reflected a net loss as of March 31, 2014 and December 31, 2013, the effect of considering any common stock equivalents, if outstanding, would have been anti-dilutive. A separate computation of diluted earnings (loss) per share is not presented.
The following table sets forth the computation of earnings per share:
March 31, 2014 March 31, 2013
Net income (loss) $ (1,756,492) $ (553,969)
Weighted average common shares outstanding 56,022,953 51,222,598
Net (loss) per share $ (0.03) $ (0.01)
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
PROPERTY AND EQUIPMENT
The Company records property and equipment at cost and uses straight-line depreciation methods.
| Estimated Useful Lives | March 31, 2014 | December 31, 2013 |
Computer equipment Office furniture | 5 years 7 years | $ 11,634 4,746 | $ 11,634 4,746 |
|
|
|
|
Less accumulated depreciation |
| (3,075) | (2,303) |
|
|
|
|
Net property and equipment |
| $ 13,305 | $ 14,077 |
FOREIGN CURRENCY TRANSLATIONS
The Company’s functional and reporting currency is the US dollar. All transactions initiated in other currencies are translated into US dollars using the exchange rate prevailing on the date of transaction. Monetary assets and liabilities denominated in foreign currencies are translated into the US dollar at the rate of exchange in effect at the balance sheet date. Unrealized exchange gains and losses arising from such transactions are deferred until realization and are included as a separate component of stockholders’ equity (deficit) as a component of other comprehensive income or loss. Upon realization, the amount deferred is recognized in income in the period when it is realized.
The Company recorded an unrealized foreign currency translation gain, totaling $0 for the period from January 23, 2007 (Inception) to March 31, 2014, in accumulated other comprehensive income.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents consist of funds on deposit with banks. The Company has no cash equivalents. The Company had funds on deposit of $1,087,618 at March 31, 2014.
CONCENTRATION OF RISK
Certain financial instruments, which subject the Company to concentration of credit risk, consist of cash. The Company maintains cash balances at financial institutions which, from time to time, may exceed Federal Deposit Insurance Corporation insured limits of $250,000. As of March 31, 2014 and December 31, 2013, the Company had $862,638 and $1,415,194, respectively, in deposits in excess of federally insured limits in its US bank. The Company has not experienced any losses with regard to its bank accounts and believes it is not exposed to any risk of loss on its cash in bank accounts.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
4.
LONG-TERM DEBT
The details concerning long-term debt for the three months ended March 31, 2014, and the year ended December 31, 2013, follow:
| March 31, 2014 | December 31, 2013 |
Note payable to private party, with interest at 3.0%, with interest only payments due December 31, 2014 and June 30, 2015, with the balance, interest and principal, due December 31, 2015 | $ 250,000 | $ - |
Note payable to private party, with interest at 3.0%, with interest only payments due December 31, 2014 and June 30, 2015, with the balance, interest and principal, due December 31, 2015 | 250,000 | - |
Total | 500,000 | - |
Less current maturities of long-term debt | (11,417) | - |
Noncurrent maturities of long-term debt | $ 488,583 | $ - |
The Principal Maturities of Notes Payable, by year, are as follows:
2013 | $ - |
2014 | - |
2015 | $ 500,000 |
| $ 500,000 |
5.
SHARE CAPITAL
Effective April 22, 2008, the Company forward-split its issued capital stock on a ratio of 5.8 shares for each prior share. As a result of this transaction, 11,078,000 shares were issued. Effective February 12, 2010, the Company forward-split its issued capital stock on a ratio of 1.65 a share for each 1 old share. As a result of this transaction 8,442,200 shares were issued. Effective February 19, 2010, 3,767,051 shares were issued in a private placement. Consideration for the issue of additional shares has been charged against additional paid in capital. The forward stock splits adjustments have been reflected retroactively.
Effective April 16, 2010, the Board of Directors of the Company authorized issuance of 20,000 shares to the members of its Scientific Board at a deemed value per share of $.90.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
Effective June 2, 2011, and December 30, 2011, the Board of Directors of the Company authorized issuance of 3,888 and 13,611 shares to the former consultants at a deemed value per share of $.90.
Effective June 26, 2012, 200,000 shares were issued in a private placement for the receipt of $200,000.
Effective July 5, 2012, the Company’s subscription agreement was amended to include finder’s fee of 10% of the amount raised in the future in the form of shares of restricted common stock.
Effective September 12, 2012, 500,000 shares were issued in a private placement for the receipt of $500,000.
On October 3, 2012, October 12, 2012, November 5, 2012, and December 12, 2012, 250,000 shares each were issued in a private placement for the total receipt of $1,000,000.
Effective February 7, 2013, 500,000 shares were issued in a private placement for the receipt of $500,000.
Effective March 5, 2013, 150,000 shares were issued in a private placement for the receipt of $150,000.
Effective April 22, 2013, 100,000 shares were issued in a private placement for the receipt of $100,000.
Effective June 4, 2013, 308,000 shares were issued in a private placement for the receipt of $308,000.
Effective July 16, 2013, 300,000 shares were issued in a private placement for the receipt of $300,000.
Effective August 30, 2013, 200,000 shares were issued in a private placement for the receipt of $200,000.
Effective September 11, 2013, 200,000 shares were issued in a private placement for the receipt of $200,000.
Effective September 22, 2013, 300,000 shares were issued in a private placement for the receipt of $300,000.
Effective October 4, 2013, 300,000 shares were issued in a private placement for the receipt of $300,000.
Effective November 8, 2013, 400,000 shares were issued in a private placement for the receipt of $400,000.
Effective December 2, 2013, 400,000 shares were issued in a private placement for the receipt of $400,000.
Effective December 10, 2013, 400,000 shares were issued in a private placement for the receipt of $400,000.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
Effective December 30, 2013, 400,000 shares were issued in a private placement for the receipt of $400,000.
Effective January 7, 2014, 400,000 shares were issued in a private placement for the receipt of $400,000.
Effective February 11, 2014, 400,000 shares were issued in a private placement for the receipt of $400,000.
Effective March 6, 2014, 300,000 shares were issued in a private placement for the receipt of $300,000.
6.
GOING CONCERN AND LIQUIDITY CONSIDERATIONS
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. As of March 31, 2014, the Company has a working capital balance of $527,075 and an accumulated deficit of $9,998,739. The Company intends to fund operations through equity financing arrangements, which should be sufficient to fund its capital expenditures, working capital and other cash requirements for the next twelve months.
The ability of the Company to emerge from the development stage is dependent upon, among other things, obtaining additional financing to continue operations, research, development and production of its product.
In response to these challenges, management intends to raise additional funds through public or private placement offerings.
The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.
7.
RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
Accounting Standards Updates (“ASU”) ASU No. 2014-08 which contain technical corrections to existing guidance or affect guidance to specialized industries or entities were recently issued. These updates have no current applicability to the Company or their effect on the financial statements would not have been significant.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
8.
PROVISION FOR INCOME TAXES
The Company recognizes the tax effects of transactions in the year in which such transactions enter into the determination of net income, regardless of when reported for tax purposes. Deferred taxes are provided in the financial statements under ASC Topic 740 to give effect to the resulting temporary differences which may arise from differences in the bases of fixed assets, depreciation methods, allowances, and start-up costs based on the income taxes expected to be payable in future years. Minimal exploration stage deferred tax assets arising as a result of net operating loss carry forwards have been offset completely by a valuation allowance due to the uncertainty of their utilization in future periods. The Company adopted the provisions of ASC Topic 740 Accounting for Uncertainty in Income Taxes, on January 23, 2007 (inception date). As a result of the implementation of ASC 740, the Company recognized no increase in the liability for unrecognized tax benefits.
Operating loss carry-forwards generated during the period of January 23, 2007 (date of inception), through March 31, 2014, of approximately $9,895,257, will begin to expire in 2027. Accordingly, deferred tax assets of approximately $4,159,911 related to net operating loss carry-forwards, and $44,332 related to stock-based compensation were offset by the valuation allowance in the same amount. For the three months ended March 31, 2014 and 2013, the allowance increased by approximately $752,481 and $235,537, respectively.
The Company has no tax positions at March 31, 2014, or December 31, 2013, for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility.
The Company recognizes interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses. The Company had no accruals for interest and penalties since inception.
The statute of limitation is three years for Federal tax returns and four years for California state returns.
9.
CONTRACTUAL OBLIGATIONS
Effective March 1, 2010, the Company entered into Management Agreements with Dr. Leon Rudakov and H. James Graham.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
Under the terms of the Employment Agreement with its then Chief Executive Officer (CEO) and Chief Technology Officer (CTO), Dr. Rudakov was compensated with an annual salary of $120,000, plus benefits. As of February 1, 2011, the base salary was amended to $170,000 per annum to reflect his current positions as the President and CTO. The agreement includes other employment benefits. Effective June 1, 2013, the agreement was amended to reflect a term to December 31, 2018, with an annual salary of $250,000 per annum.
Under the terms of a consulting Agreement, effective March 1, 2010, Mr. Jim Graham was compensated with annual base fee of $100,000 per annum, plus benefits. As of February 1, 2011, the agreement was amended to reflect Mr. Graham’s current positions of Chief Executive Officer, Chief Financial Officer and Chairman of the Board of Directors to reflect a base annual fee of $180,000 per annum. Effective June 1, 2013, the agreement was amended to reflect a term to December 31, 2018, with an annual fee of $260,000 per annum.
Effective September 2013, the Company (“Supplier”) executed revised Amended and Restated Distribution Agreements (the “Agreements”) with its current European Distributors (“Distributors”) in the Netherlands, Germany, Austria, Switzerland and Italy. The Agreements grant the Distributor the exclusive right to offer for sale and sell the EOS Systems in the respective territories covered by each of the Agreement. There is a minimum purchase of products included in each of the Agreements. The new Agreements incorporate a quality agreement provision as apart of the original Distribution Agreement.
10.
PURCHASE AGREEMENT
On January 8, 2010, the Company entered into an asset purchase agreement with Artventive, Inc. a privately held company. The Company purchased substantially all of the assets of Artventive, Inc. which consisted entirely of patents. The patents were accounted for under SAB Topic 5G using the historical cost basis of zero. The combination was accounted for under ASC 805 as a business combination.
11.
WARRANTS AND OPTIONS
During the fiscal year ended December 31, 2013, the Company has granted 4,358,000 warrants to purchase shares of Common Stock which all have a 1 year exercise term, of which 3,708,000 remain outstanding at March 31, 2014. During the quarter ended March 31, 2014, 1,100,000 warrants were issued. The issuance of outstanding warrants is detailed below.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
Effective April 22 2013, 100,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective June 4, 2013, 308,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective July 16 2013, 300,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective August 30 2013, 200,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective September 11, 2013, 200,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective September 22, 2013, 300,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective October 4 2013, 300,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective October 25, 2013, 400,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective November 8, 2013, 400,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective December 2, 2013, 400,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective December 10, 2013, 400,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective December 30, 2013, 400,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
Effective January 7, 2014, 400,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective February 11, 2014, 400,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
Effective March 6, 2014, 300,000 warrants were issued. The warrants allow the purchase of common shares at an exercise price of $1.50. There is no vesting period, and the warrants expire in 1 year
The Company valued all warrants utilizing a Black-Scholes option-pricing model and the fair value was recorded in additional paid-in capital.
The following is a summary of the Company’s warrant activity:
|
| Warrants |
| Weighted Average Exercise Price |
Exercisable – December 31, 2012 |
| 1,500,000 |
| $ 1.50 |
Granted-2013 |
| 4,358,000 |
| $ 1.50 |
Exercised-2013 |
| - |
| - |
Forfeited-2013 |
| (1,500,000) |
| $ 1.50 |
Outstanding – December 31, 2013 |
| 4,358,000 |
| $ 1.50 |
Exercisable – December 31, 2013 |
| 4,358,000 |
| $ 1.50 |
|
|
|
|
|
|
| Warrants |
| Weighted Average Exercise Price |
Granted-2014 (at March 31, 2014) |
| 1,100,000 |
| $ 1.50 |
Exercised-2014 (at March 31, 2014) |
| - |
| - |
Forfeited-2014 (at March 31, 2014) |
| (650,000) |
| $ 1.50 |
Outstanding – March 31, 2014 |
| 4,808,000 |
| $ 1.50 |
Exercisable – March 31, 2014 |
| 4,808,000 |
| $ 1.50 |
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
March 31, 2014
Warrants outstanding and exercisable at March 31, 2014 are as follows:
Warrants Outstanding |
| Warrants Exercisable | |||||||||||||||
| Range of Exercise Price |
| Number Outstanding |
| Weighted Average Remaining Contractual Life (in Years) |
| Weighted Average Exercise Price |
|
| Number Exercisable |
|
| Weighted Average Exercise Price |
| |||
$ | 1.50 |
| 100,000 |
| 0.06 years |
| $ | 1.50 |
|
|
| 100,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 308,000 |
| 0.18 years |
| $ | 1.50 |
|
|
| 308,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 300,000 |
| 0.29 years |
| $ | 1.50 |
|
|
| 300,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 200,000 |
| 0.42 years |
| $ | 1.50 |
|
|
| 200,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 200,000 |
| 0.45 years |
| $ | 1.50 |
|
|
| 200,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 300,000 |
| 0.48 years |
| $ | 1.50 |
|
|
| 300,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 300,000 |
| 0.51 years |
| $ | 1.50 |
|
|
| 300,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 400,000 |
| 0.56 years |
| $ | 1.50 |
|
|
| 400,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 400,000 |
| 0.61 years |
| $ | 1.50 |
|
|
| 400,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 400.000 |
| 0.66 years |
| $ | 1.50 |
|
|
| 400,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 400.000 |
| 0.68 years |
| $ | 1.50 |
|
|
| 400,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 400.000 |
| 0.73 years |
| $ | 1.50 |
|
|
| 400,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 400.000 |
| 0.76 years |
| $ | 1.50 |
|
|
| 400,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 400.000 |
| 0.85 years |
| $ | 1.50 |
|
|
| 400,000 |
|
| $ | 1.50 |
|
$ | 1.50 |
| 300.000 |
| 0.93 years |
| $ | 1.50 |
|
|
| 300,000 |
|
| $ | 1.50 | |
Effective November 2, 2010 the Board of Directors of the Company granted 50,000 non-statutory stock options to a former consultant at an exercise price of $.001 per share with the vesting date of November 2, 2013 and an expiration date of November 2, 2016.
Effective February 1, 2013 the Board of Directors of the Company granted 20,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of February 1, 2013 and an expiration date of February 1, 2018.
Effective February 1, 2013 the Board of Directors of the Company granted 5,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of February 1 2013 and an expiration date of February 1, 2018.
Effective February 1, 2013 the Board of Directors of the Company granted 10,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of February 1 2013 and an expiration date of February 1, 2018.
Effective March 1, 2013 the Board of Directors of the Company granted 10,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of March 1, 2013 and an expiration date of March 1, 2018.
ArtVentive Medical Group, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
For the Year Ended December 31, 2013
Effective December 27, 2013 the Board of Directors of the Company granted 10,000 non-statutory stock options to a current consultant at an exercise price of $1.00 per share with the vesting date of December 27, 2013 and an expiration date of December 27, 2018.
During the period that the options were issued, the Company had no public trading activity for the Company’s common stock. However, the majority shareholder sold in private transactions shares at $.90 per share. In order to value the Company’s options, the Company chose to use the minimum value method, even though the Company is a public company since there was no measurable trading activity. The fair value of the options was recorded in additional paid-in capital.
Options outstanding and exercisable at March 31, 2014 are as follows:
|
| Options |
| Weighted Average Exercise Price |
Exercisable – December 31, 2012 |
| 50,000 |
| $ 0.001 |
Granted-2013 |
| 55,000 |
| $ 1.00 |
Exercised-2013 |
| - |
| - |
Forfeited-2013 |
| - |
| - |
Outstanding – December 31, 2013 |
| 105,000 |
| $ 0.524 |
Exercisable – December 31, 2012 |
| 105,000 |
| $ 0.524 |
|
| Options |
| Weighted Average Exercise Price |
Granted-2014 (at March 31, 2014) |
| - |
| $ - |
Exercised-2014 (at March 31, 2014) |
| - |
| - |
Forfeited-2014 (at March 31, 2014) |
| - |
| $ - |
Outstanding – March 31, 2014 |
| 105,000 |
| $ 0.524 |
Exercisable – March 31, 2014 |
| 105,000 |
| $ 0.524 |
Options outstanding and exercisable at March 31, 2014 are as follows:
Options Outstanding |
| Options Exercisable | ||||||||||||||||||||||
| Range of Exercise Price |
| Number Outstanding |
| Weighted Average Remaining Contractual Life (in Years) |
| Weighted Average Exercise Price |
|
| Number Exercisable |
|
| Weighted Average Exercise Price |
| ||||||||||
$ | 0.001 |
| 50,000 |
| 1.59 years |
| $ | 0.001 |
|
|
| 50,000 |
|
| $ | 0.001 | ||||||||
$ | 1.000 |
| 35,000 |
| 3.84 years |
| $ | 1.000 |
|
|
| 35,000 |
|
| $ | 1.000 | ||||||||
$ | 1.000 |
| 10,000 |
| 3.92 years |
| $ | 1.000 |
|
|
| 10,000 |
|
| $ | 1.000 | ||||||||
$ | 1.000 |
| 10,000 |
| 4.74 years |
| $ | 1.000 |
|
|
| 10,000 |
|
| $ | 1.000 | ||||||||
ArtVentive Medical Group, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
For the Year Ended December 31, 2013
During the period that the options were issued, the Company had no public trading activity for the Company’s common stock. However, the majority shareholder sold in private transactions shares at $.90 per share. In order to value the Company’s options, the Company chose to use the minimum value method, even though the Company is a public company since there was no measurable trading activity. The fair value of the options was recorded in additional paid-in capital.
12. SUBSEQUENT EVENTS
The Company evaluated all events or transactions that occurred after March 31, 2014, up through the date these consolidated financial statements were issued.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
ArtVentive Medical Group, Inc. (the “Company”), is a Nevada Corporation traded on the OTCQB (symbol AVTD). On March 21, 2008, the Company changed its name from Big Bear Resources Inc. to Uranium Plus Resource Corporation and subsequently, on January 26, 2010, the Company changed its name to ArtVentive Medical Group, Inc. On January 9, 2010, the Company completed the acquisition of all of the assets of ArtVentive Medical Inc., a California company.
The Company is focused on developing, manufacturing and marketing a family of Endoluminal Occlusion devices (EOS). The Company, through its proprietary technology has developed minimally invasive occlusion devices and procedures, allowing for the current interventional, image guided techniques to resolve potentially significant and unaddressed health issues. The ArtVentive EOS™ Peripheral device was developed by the Company to target the arterial and venous embolization peripheral vasculature markets. The Company is currently expanding its EOS™ development to encompass several additional major clinical areas, including, but not limited to neurological vascular disorders, interventional cardiology, interventional oncology and women's health procedures.
The Company is expanding its product portfolio to include a proprietary Catheter-Assisted Endovascular Tumor Treatment (CAETT™) system to deliver drugs and agents for minimally invasive, controlled and localized treatment of tumors as the Company enters the interventional oncology arena.
The Company has contracted, and expects to continue contracting with specific American and European corporations and consulting groups to assist in the implementation of an ongoing strategic plan for the successful international launch, market development, commercialization and manufacturing of the Company’s products. The Company entered into an agreement with Chicago, Illinois based Medical Murray Inc., a leader in the field of medical device development and manufacturing. Medical Murray Inc. is recognized as being ISO certified and FDA registered.
The Company entered into an agreement with the Northwest Clinical Research Group, Inc. (NCRG), located in Seattle, Washington. NCRG has played an intricate role in building the complex infrastructure and support necessary for outlining the regulatory and clinical strategy, in addition to providing a platform of quality controls parallel and synergistic to what Medical Murray is providing. Their responsibility also extends to encompass communication with the FDA and the European Notified Body (FDA counterpart).
The Company implemented its Quality Management System (QMS), based on the requirements of, and is intended to comply with, the following regulations and international standards:
·
US FDA Quality System Regulation, 21 CFR 820
·
EU Medical Device Directive (MDD), EEC 93/42
·
Canada Medical Devices Regulations (CMDR), SOR/98-282
·
ISO 13485:2003 Medical Devices – Quality Management Systems - Requirements Regulatory Purposes
Document Control System and Design History File for the EOS project are in a continuous process of implementation. The highly secured system utilizes Egnyte software and is hosted on the NCRG’s server.
Following the successful completion of the ArtVentive Medical Group Inc. “Concept Design Phase” of the Endoluminal Occlusion System (EOS) in January 2011, the Company moved forward in executing the second Phase of its planned ArtVentive EOS™ development, “the Regulatory Phase.” This Phase required capital increases in research and development, prototyping, testing and documentation for meeting quality standards including, but not limited to regulatory submissions in preparation for the Company’s projected timeline for commercialization in Europe. During this Phase of development, the Company manufactured in excess of seven hundred and fifty devices required to meet international standards and guidelines, bench testing, regulatory animal studies, clinical (First in Man) studies, and all other aspects necessary to confirm the device’s safety and high standard of production quality.
Following the conclusion of the Company’s successful animal studies, the management carried out its First in Man clinical study in Paraguay during June and July, 2011 using the ArtVentive EOS peripheral device. The study achieved 100% clinical and procedural success.
The Company completed a comprehensive ISO Certification audit performed by BSI Product Services. BSI is an international ISO 9000/ISO Registrar and CE Mark Notified Body required for the European Regulatory approval and subsequent CE Mark certification. The audit confirmed that the Company’s Document and Quality control systems were up to ISO standards and in compliance with an international requirements for the maintaining quality of the products without non-conformities.
The Company received its CE Mark certification for the ArtVentive EOS™ Peripheral device on May 30, 2013, and implemented the planned EOS™ peripheral device transfer from Research and Development to commercialization, marketing, and distribution throughout Europe, simultaneous to making its FDA application.
The Company filed additional patent applications expanding its patent reach of the ArtVentive EOS™ device to 25 patents or patent applications.
The Company launched a Post Market Human Surveillance initiative throughout Europe, Australia and New Zealand. This clinical program is designed to collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System – EOS™. Additional post market studies will commence in the US following FDA approval and commercialization.
The Company currently has agreements encompassing five European countries. Management is in the process of executing similar distribution agreements for several other European countries in addition to Australia and New Zealand during the second and third quarters of 2014.
On August 3, 2011, the Company incorporated the ArtVentive Women’s Health Group, Inc., a wholly owned subsidiary of the Company.
Management first debuted the ArtVentive EOS™ peripheral device at the Cardiovascular and Interventional Radiological Conference (CIRSE) in Munich, Germany in 2011, and again in Lisbon Portugal in 2012. Management also showcased the ArtVentive EOS™ through its distribution partners, when it attended the 17th European Vascular Conference in Maastricht, the Netherlands during March 2013, Charing Cross International Symposium (CX) in London during April 2014. The Company continued its directive to expand its reach as it prepares to launch into the US and global markets following regulatory approval by participating in the US Society of Interventional Radiology (SIR) conference in San Diego, California in March 2014.
Limited Operating History
There is no historical financial information about the Company upon which to base an evaluation of its performance. The Company is a development stage corporation and has not generated significant revenues from its business operations. The Company cannot guarantee that it will be successful in its business operations. The Company’s business is subject to risks inherent in the establishment of a new business enterprise, including limited capital resources and possible cost overruns due to price and cost increases in services and products.
The Company gives no assurance that future financing will be available on acceptable terms. If financing is not available on such terms, the Company may be unable to continue, develop or expand its operations. Additionally, equity financing could result in additional dilution to existing shareholders.
Results of Operations
During the second quarter of 2013, Management amended Research and Development expenditures in line with its final phase of development and regulatory submission of the ArtVentive EOS Peripheral device. The Company continued its focus on the European CE Mark application for the EOS device and raising additional financing for the next phase of its planned business development, including reimbursement, sales, distribution, upcoming clinical studies and commercialization of the device.
Liquidity and Capital Resources
As of the date of this report, the Company has generated revenues from its business operations. However, since inception the Company’s main source of cash has been the sale of its equity securities.
As of March 31, 2014, cash and total assets were $1,087,618 and $1,443,329 respectively, and the Company’s total liabilities were $1,340,484 as compared to cash and total assets of
$1,626,521 and $1,727,647 respectively, and the Company’s total liabilities of $858,309 as of December 31, 2013. The Company is focused on raising additional funds through private or public placement offerings. (See 5 of the Notes to Financial Statements included herewith.)
Item 3. Quantitative and Qualitative Disclosure about Market Risk
Not required by smaller reporting companies.
Item 4. Controls and Procedures
As of the end of the period covered by this report, AVTD carried out an evaluation of the effectiveness of the Company’s disclosure controls and procedures (as defined by Rule 13-15(f) and 15d-15(f) under the Securities Exchange Act of 1934) under the supervision and with the participation of ArtVentive Medical Group’s President and Principal Financial Officer. Based on and as of the date of such evaluation, the aforementioned officers have concluded that ArtVentive Group’s disclosure controls and procedures were effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by us in the reports that we file or submit under the Exchange Act.
There were no significant changes in AVTD’s internal controls or in other factors that could significantly affect these controls during the first quarter ended March 31, 2014. There were no significant deficiencies or material weaknesses, and therefore there were no corrective actions taken. It should be noted that any system of controls, however well designed and operated, can provide only reasonable, and not absolute, assurance that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of future events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.
PART II – INFORMATION
Item 1. Legal Proceedings
None
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None
Item 4. Mine Safety Disclosures
Not Applicable.
Item 5. Other Information
None
Item 6. Exhibits
Exhibit No. | Document | Location |
31 | Rule 13a-41(a)/15d-14(a) Certifications | Included |
32 | Section 1350 Certifications | Included |
101.INS(1) | XBRL Instance Document | Included |
101.SCH(1) | XBRL Taxonomy Schema Document | Included |
101.CAL(1) | XBRL Taxonomy Calculation Linkbase | Included |
101.DEF(1) | XBRL Taxonomy Definition Linkbase Document | Included |
101.LAB(1) | XBRL Taxonomy Label Linkbase Document | Included |
101.PRE(1) | XBRL Taxonomy Label Presentation Linkbase Document | Included |
(2)
XBRL information is furnished and not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended and otherwise is not subject to liability under the sections.
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ARTVENTIVE MEDICAL GROUP, INC.
May 19, 2014
/s/ H. James Graham
H. James Graham
Chief Executive Officer
Chief Financial Officer
/s/ Leon Rudakove
Dr. Leon Rudakov
President