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EXCEL - IDEA: XBRL DOCUMENT - ARTVENTIVE MEDICAL GROUP, INC. | Financial_Report.xls |
EX-31 - CERTIFICATION - ARTVENTIVE MEDICAL GROUP, INC. | exhibit31.htm |
EX-32 - CERTIFICATION - ARTVENTIVE MEDICAL GROUP, INC. | exhibit32.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 September 30, 2012
[ ]
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
(Registrants 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 issuers classes of common equity, as of the latest practicable date:
As of November 1, 2012, there were 50,448,286 shares of the Companys 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 September 30, 2012
Consolidated Balance Sheets as of September 30, 2012 (unaudited) and December 31, 2011
Statement 1
Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the three and nine month periods ended September 30, 2012 and September 30, 2011;
and for the period from January 23, 2007 (Inception) through September 30, 2012
Statement 2
Consolidated Statements of Cash Flows (unaudited) for the nine month periods ended September 30, 2012
and September 30, 2011; and for the period from January 23, 2007 (Inception)
to September 30, 2012
Statement 3
Notes to Consolidated Financial Statements (unaudited)
Statement 1
ArtVentive Medical Group, Inc.
A Development Stage Company
Consolidated Balance Sheets
September 30, 2012 and December 31, 2011
ASSETS | September 30, |
|
| 2012 (unaudited) | December 31, 2011 |
CURRENT | ||
Cash and cash equivalents Prepaid expenses | $ 92,223 1,048 | $ 98,221 1,048 |
TOTAL CURRENT ASSETS | 93,271 | 99,269 |
PROPERTY, PLANT AND EQUIPMENT |
| |
Office equipment | 1,382 | 1,382 |
Accumulated depreciation | (714) | (506) |
NET PROPERTY, PLANT AND EQUIPMENT | 668 | 876 |
OTHER ASSETS |
|
|
Deposits | 1,048 | 1,048 |
TOTAL OTHER ASSETS | 1,048 | 1,048 |
|
|
|
TOTAL ASSETS | $ 94,987 | $ 101,193 |
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
|
|
CURRENT LIABILITES | ||
Accounts payable | $ 232,187 | $ 374,429 |
Payroll taxes payable | 63 | 21 |
TOTAL CURRENT LIABILITIES | 232,250 | 374,450 |
STOCKHOLDERS EQUITY (DEFICIT) | ||
Common stock, par value $.001, 100,000,000 shares | ||
authorized, 49,948,286 and 49,248,286 shares issued and outstanding at September 30, 2012 and December 31, 2011 respectively after giving effect to 1.65 for 1 split on February 12, 2010 | 49,949 |
49,249 |
Additional paid in capital | 4,214,703 | 3,565,403 |
Deficit accumulated during the development stage | (4,401,915) | (3,887,909) |
TOTAL STOCKHOLDERS EQUITY (DEFICIT) | (137,263) | (273,257) |
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | $ 94,987 | $ 101,193 |
(See accompanying notes)
Statement 2
A ArtVentive Medical Group, Inc.
A Development Stage Company
Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
For the Three and Nine Months Ended September 30, 2012 and September 30, 2011; and for the Period from January 23, 2007 (Inception) to September 30, 2012
| For the three months ended September 30, 2012 | For the three months ended September 30, 2011 | For the nine months ended September 30, 2012 | For the nine months ended September 30, 2011 | For the period from January 23, 2007 (Inception) to September 30, 2012 |
REVENUES | $ NIL | $ NIL | NIL | NIL | $ NIL |
OPERATING EXPENSES |
|
| |||
Exploration costs | - | - |
|
| 45,533 |
Research and development | 60,935 | 600,687 | 215,520 | 1,577,298 | 2,954,912 |
Selling, general and administrative | 118,342 | 166,988 | 298,295 | 463,740 | 1,404,288 |
Depreciation expense | 69 | 69 | 207 | 207 | 1,229 |
OPERATING LOSS BEFORE OTHER ITEMS AND INCOME TAX | (179,346) | (767,744) | (514,022) | (2,041,245) | (4,405,962) |
OTHER INCOME/(EXPENSE) |
|
| |||
INTEREST INCOME | 4 | 130 | 16 | 377 | 4,047 |
Income tax expense (benefit) | - | - | - | - | - |
NET LOSS AVAILABLE TO COMMON STOCKHOLDERS | (179,342) | (767,614) | (514,006) | (2,040,868) | (4,401,915) |
COMPREHENSIVE LOSS FOR THE PERIOD | $ (179,342) | $ (767,614) | (514,006) | (2,040,868) | $ (4,401,915) |
BASIC AND DILUTED LOSS PER COMMON SHARE | (0.00) | (0.02) | (0.01) | (0.04) |
|
WEIGHTED AVERAGE SHARES OUTSTANDING | 49,542,036 | 48,616,315 | 49,351,206 | 47,836,787 |
|
Statement 3
ArtVentive Medical Group, Inc.
A Development Stage Company
Consolidated Statements of Cash Flows (Unaudited)
For the Nine Months Ended September 30, 2012 and September 30, 2011; and for the Period from January 23, 2007 (Inception) to September 30, 2012
| For the nine months ended September 30, 2012 | For the nine months ended September 30, 2011 | For the period from January 23, 2007 (Inception) to September 30, 2012 |
CASH FLOW FROM OPERATING ACTIVITIES | |||
Net loss | $ (514,006) | $ (2,040,868) | $ (4,401,915) |
ADJUSTMENTS TO RECONCILE NET LOSS TO NET CASH USED BY OPERATING ACTIVITIES |
| ||
Non-cash expenses | - | - | 60,805 |
Depreciation expense | 208 | 207 | 1,230 |
Issuance of common stock and options for services | - | 3,499 | 78,749 |
CHANGES IN OPERATING ASSETS AND LIABILITIES Prepaid expenses | - | 6,516 |
(1,048) |
Deposits | - | (1,048) | (1,048) |
Accounts payable | (192,242) | 166,463 | 182,187 |
Payroll taxes payable | 42 | - | 63 |
Accounts payable related party | - | - | 39,000 |
NET CASH USED BY OPERATING ACTIVITIES | (705,998) | (1,865,231) | (4,041,977) |
CASH FLOWS FROM INVESTING ACTIVITIES |
| ||
Disposal of equipment | - | - | 745 |
Purchase of equipment | - | - | (2,625) |
NET CASH USED BY INVESTING ACTIVITIES | - | - | (1,880) |
CASH FLOWS FROM FINANCING ACTIVITIES |
| ||
Issuance of common stock for cash | 700,000 | 1,800,000 | 3,986,080 |
Convertible note payable (see Note 4) | - | - | 150,000 |
NET CASH PROVIDED BY FINANCING ACTIVITIES | 700,000 | 1,800,000 | 4,136,080 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (5,998) | (65,231) |
92,223 |
CASH, BEGINNING OF PERIOD | 98,221 | 176,425 | - |
CASH, END OF PERIOD | $ 92,223 | $ 111,194 | $ 92,223 |
| |||
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 |
SHARES ISSUED FOR NET ASSETS OF ARTVENTIVE | $ - | $ - | $ 21,430 |
ACCRUAL OF STOCK ISSUANCE COST | $ 50,000 | $ - | $ 50,000 |
(See accompanying notes)
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
September 30, 2012
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 28, 2012. Operating results for the nine months ended September 30, 2012 are not necessarily indicative of the results to be expected for the fiscal year ended December 31, 2012.
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 Companys 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 Companys activities have been limited 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 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.
On August 3, 2011, the Company incorporated ArtVentive Womens Health Group, Inc., a wholly owned subsidiary of the Company.
3.
SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES OF CONSOLIDATION
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
September 30, 2012
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 state 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 Companys 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 Companys 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.
FOREIGN CURRENCY TRANSLATIONS
The Companys 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 September 30, 2012, 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 $92,223 as at September 30, 2012.
4.
CONVERTIBLE NOTE PAYABLE
The Company borrowed $150,000 (all funds are in US dollars) pursuant to an agreement dated April 29, 2008.
The note was converted into 166,666 shares at a deemed value per share of $.90 effective February 22, 2010.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
September 30, 2012
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.
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.
During the period that the options were issued, the Company had no public trading activity for the Companys common stock. However, the majority shareholder sold in private transactions shares at $.90 per share. In order to value the Companys 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.
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 Companys subscription agreement was amended to include finders 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.
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 September 30, 2012, the Company has a negative working capital balance of $138,979 and an accumulated deficit of $4,401,915. 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.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
September 30, 2012
7.
RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
Accounting Standards Update (ASU) ASU No. 2009-05 (ASC Topic 820), which amends Fair Value Measurements and Disclosures Overall, ASU No. 2009-13 (ASC Topic 605), Multiple-Deliverable Revenue Arrangements, ASU No. 2009-14 (ASC Topic 985), Certain Revenue Arrangements that include Software Elements, and various other ASUs No. 2009-2 through ASU No. 2012-07 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.
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 September 30, 2012, of approximately $4,323,166, will begin to expire in 2027. Accordingly, deferred tax assets of approximately $1,833,965 related to net operating loss carry-forwards, and $33,736 related to stock-based compensation were offset by the valuation allowance in the same amount. For the nine months ended September 30, 2012 and 2011, the allowance increased by approximately $220,200 and $875,000, respectively.
The Company has no tax positions at September 30, 2012, or December 31, 2011, 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 February 27, 2010, the Company entered into employment agreements for a Chief Executive Officer (CEO) and Chairman of the Board. The CEO agreement is for a five year term commencing March 1, 2010 at a base salary of $120,000 per annum. As of February 1, 2011 the base salary was amended to $170,000 per annum. The agreement includes other employment benefits. The Chairman is engaged under a consulting agreement with a base fee of $100,000 per annum. As of February 1, 2011 the agreement was amended to reflect a base fee of $180,000 per annum.
ArtVentive Medical Group, Inc.
A Development Stage Company
Notes to Consolidated Financial Statements (Unaudited)
September 30, 2012
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
Effective September 12, 2012, the Company has granted 500,000 warrants to purchase shares of Common Stock which all have a 1 year term.
Warrants outstanding and exercisable at September 30, 2012 are as follows:
Exercise price | Number Outstanding | Remaining Contractual Life (in years) |
|
|
|
|
|
$1.50 | 500,000 | 1 year |
|
12.
SUBSEQUENT EVENTS
The Company evaluated all events or transactions that occurred after September 30, 2012, up through the date these consolidated financial statements were issued.
On October 3, 2012, the Company issued 250,000 shares in a private placement for a receipt of $250,000.
On October 15, 2012, the Company issued 250,000 shares in a private placement for a receipt of $250,000.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
ArtVentive Medical Group, Inc. (AVTD or the Company), is a Nevada Corporation listed 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.
Prior to January 26, 2010, the Company had focused on exploration within the resource industry in Peru. 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, bringing the current interventional, image guided techniques to added sophistication, resolving potentially significant and unaddressed health issues. The ArtVentive EOS device is being developed by the Company to target the market demand in several major clinical areas, including, but not limited to peripheral and neurological vascular disorders, interventional cardiology and women's health procedures.
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 Companys 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 Northwest Clinical Research Groups 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 significant 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 Companys projected timeline for commercialization in Europe. This Regulatory Phase is critical to the EOS device submission for European Regulatory approval (CE Mark) and subsequent commercialization. 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 devices safety and high standard of production quality.
Following the conclusion of the Companys 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.
In preparation for the Companys launch into the European markets, management participated in on-going meetings throughout Europe in preparation for all aspects of its European launch. To this end, the Company designed and constructed a corporate booth for industry shows and conferences, in addition to generating marketing materials including targeted industry literature, brochures, educational and medical videos.
On March 3, 2011, the Company incorporated ArtVentive Womens Health Group, Inc., a wholly owned subsidiary of the Company.
During 2012, Management participated in the EuroMedTech Conference in Grenoble, France, and debuted the ArtVentive EOS peripheral device at the Cardiovascular and Interventional Radiological Conference (CIRSE) in in Lisbon, Portugal. In addition, management continued its directive in preparing a solid foundation from which to launch into the European markets by working with European clinics, physicians, international distributors and potential partners.
The Companys Regulatory, Clinical, Research and Development and Scientific Advisory Board made strides in completing the first draft of the documentation required to achieve the CE Mark. The Company is now working on the comprehensive final document to complete the formal CE Mark application for commercialization within Europe and abroad.
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 any revenues from its business operations. The Company cannot guarantee that it will be successful
in its business operations. The Companys 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 third quarter of 2012 Management reduced 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 yet to generate any revenues from its business operations. Since inception the Companys main source of cash has been the sale of its equity securities.
As of September 30, 2012, cash and total assets were $92,223 and $94,987 respectively, and the Companys total liabilities were $232,250 as compared to cash and total assets of $98,221 and $101,193 respectively, and the Companys total liabilities of $374,450 as of December 31, 2011. The Company is focused on raising additional funds through private or public placement offerings. (See 6 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 Companys 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 Groups President and Principal Financial Officer. Based on and as of the date of such evaluation, the aforementioned officers have concluded that ArtVentive Groups 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 AVTDs internal controls or in other factors that could significantly affect these controls during the third quarter ended September 30, 2012. 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.
November 7, 2012
/s/ H. James Graham________________________________
H. James Graham
Chief Executive Officer
Chief Financial Officer
/s/ Dr. Leon Rudakov________________________________
Dr. Leon Rudakov
President