Pathfinder Cell Therapy (PFND) 10QSB 2007 Q3 Quarterly report (small business)

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-QSB

(Mark One)

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

For the quarterly period ended September 30, 2007

OR

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

For the transition period from  to

Commission file number: 0-20580

SYNTHEMED, INC.

(Exact name of registrant as specified in its charter)

Delaware	14-1745197
(State or other jurisdiction of	(I.R.S. Employer
incorporation or organization)	Identification No.)
200 Middlesex Essex Turnpike, Suite 210 Iselin, New Jersey	08830
(Address of principal executive offices)	(Zip Code)

(732) 404-1117

(Issuer’s telephone number, including area code)

Checkwhether the issuer: (1) has filed all reports required to be filed by Section 13 or 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 þ No o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)

Yes o No þ

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

Common Stock, $.001 Par Value - 87,499,108 shares outstanding at November 2, 2007

Transitional Small Business Disclosure Format (check one):

Yes o No þ

SYNTHEMED, INC.
INDEX
		Page
Part I -	FINANCIAL INFORMATION
Item 1.	Financial Statements
	Condensed Statements of Operations (unaudited) for the three-month	3
	and nine-month periods ended September 30, 2006 and 2007
	Condensed Balance Sheets as of December 31, 2006 and	4
	September 30, 2007 (unaudited)
	Condensed Statements of Cash Flows (unaudited) for the	5
	nine-month periods ended September 30, 2006 and 2007
	Notes to Condensed Financial Statements (unaudited)	6
Item 2.	Management’s Discussion and Analysis or Plan of Operation	11
Item 3.	Controls and Procedures	14
Part II	OTHER INFORMATION
Item 6.	Exhibits	15
	Signature	16

2

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

SYNTHEMED, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

	(In thousands, except share and per share data)
	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2006			2007			2006			2007
Revenue
Product sales	$	62		$	9		$	62		$	93
Revenue		62			9			62			93
Cost of goods sold		9			1			9			17
Gross profit		53			8			53			76
Operating expenses:
Research and development		486			643			1,598			1,807
General and administrative		322			397			1,918			1,825
Sales and marketing		35			298			129			691
Operating expenses		843			1,338			3,645			4,323
(Loss) from operations		(790	)		(1,329	)		(3,592	)		(4,247	)
Other income/(expense):
Interest income		41			24			91			75
Other Income								1
Gain on settlement of debt								22
Interest expense		(1	)					(4	)		(1	)
Reversal of liabilities											44
Other income/(expense)		40			24			110			118
Net loss	$	(750	)	$	(1,306	)	$	(3,482	)	$	(4,129	)
Net loss per common share-basic and diluted	$	(0.01	)	$	(0.02	)	$	(0.05	)	$	(0.05	)
Weighted average shares outstanding		82,821			85,786			77,313			84,314

See Notes to Condensed Financial Statements

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SYNTHEMED, INC.

CONDENSED BALANCE SHEETS

	(In thousands, except per share data)
	December 31,			September 30,
	2006			2007
ASSETS				(unaudited)
Current assets:
Cash and cash equivalents	$	3,722		$	3,507
Accounts receivable		5			10
Inventory		38			156
Prepaid expenses and deposits		158			142
Total current assets		3,923			3,815
Acquired technology, less accumulated amortization		89			38
Furniture and equipment, less accumulated depreciation		166			140
TOTAL	$	4,178		$	3,993
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	138		$	180
Accrued expenses		643			435
Convertible note payable		70
Total current liabilities		851			615
Stockholders' equity:
Preferred stock, $.01 par value; shares authorized - 5,000;
issued and outstanding - none
Common stock, $.001 par value; shares authorized - 150,000
issued and outstanding - 82,945 and 87,404		83			87
Additional paid-in capital		51,389			55,565
Accumulated deficit		(48,145	)		(52,274	)
Total stockholders' equity		3,327			3,378
TOTAL	$	4,178		$	3,993

See Notes to Condensed Financial Statements

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SYNTHEMED, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

	(In thousands)
	Nine Months Ended
	September 30,
	2006			2007
Cash flows from operating activities:
Net loss	$	(3,482	)	$	(4,129	)
Adjustments to reconcile net loss to
net cash used in operating activities:
Depreciation		21			42
Amortization of acquired technology		51			51
Reversal of liabilities					(44	)
Stock based compensation		1,298			1,240
Changes in operating assets and liabilities:
(Increase) in accounts rceivable		(47	)		(5	)
(Increase) in inventory		(25	)		(118	)
(Increase)/Decrease in prepaid expenses		(55	)		16
(Decrease)/Increase in accounts payable		(152	)		86
(Decrease) in accrued expenses		(92	)		(208	)
Net cash used in operating activities		(2,483	)		(3,069	)
Cash flows from investing activities:
Purchase of furniture and equipment		(31	)		(16	)
Net cash used in investing activities		(31	)		(16	)
Cash flows from financing activities:
Proceeds from the issuance of common stock		5,766			2,726
Repayment of convertible note payable		(40	)		(70	)
Proceeds from exercise of stock options and warrants		9			214
Net cash provided by financing activities		5,735			2,870
Net increase /(decrease) in cash and cash equivalents		3,221			(215	)
Cash and cash equivalents at beginning of period		735			3,722
Cash and cash equivalents at end of period	$	3,956		$	3,507
Supplemental disclosure of cash flow information
Non-cash investing and financing activities:
Offering costs paid in common shares	$	449

See Notes to Condensed Financial Statements

5

SYNTHEMED, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

A) Basis of Presentation

The accompanying condensed financial statements do not include all of the information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles; but, in the opinion of management, contain all adjustments (which consist of only normal recurring adjustments) necessary for a fair presentation of such financial information. Results of operations and cash flows for interim periods are not necessarily indicative of those to be achieved for full fiscal years. Certain conditions indicate that the Company may be unable to continue as a going concern. The accompanying financial statements do not include any adjustments to the financial statements that might be necessary should the Company be unable to continue as a going concern. These condensed financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2006 included in the Company's Annual Report on Form 10-KSB filed with the Securities and Exchange Commission.

B) Accounts Receivable

Accounts receivable are stated at estimated net realizable value. The Company expects to evaluate its allowance for doubtful accounts based on a combination of historical experience, aging analysis and information on specific accounts. Account balances are written off when collection efforts have been exhausted and the potential for recovery is considered remote. The Company has not recorded an allowance against receivables based upon management’s estimate.

C)  Inventory

 Inventory is stated at the lower of cost or market, as determined by the first-in, first-out method.

	December 31,		September 30,
	2006		2007
Raw materials	$	-	$	62,000
Work in process		35,000		38,000
Finished goods		3,000		56,000
	$	38,000	$	156,000

The Company outsources the production of its inventory which is located at third party facilities in Prince Edward Island, Canada, Ohio and Minnesota.

D) Stock Based Compensation Plans

At September 30, 2007, the Company has three stock-based compensation plans: the 2000 Non-Qualified Stock Option Plan, under which the Company is authorized to issue non-qualified stock options to purchase up to an aggregate of 1,000,000 shares of common stock; the 2001 Non-Qualified Stock Option Plan, under which the Company is authorized to issue non-qualified stock options to purchase up to an aggregate of 10,000,000 shares of common stock and the 2006 Stock Option Plan, under which the Company is authorized to issue incentive stock options and non-qualified stock options to purchase up to an aggregate of 5,000,000 shares of common stock. At September 30, 2007, there were 1,966,000 options available for grant under these plans. The exercise price is determined by the Compensation Committee of the Board of Directors at the time of the granting of an option. Options vest over a period not greater than five years, and expire no later than ten years from the date of grant.

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The Company follows Statement of Financial Accounting Standards (“SFAS”) No. 123R, “Share Based Payment.” SFAS 123R requires all share-based payments to employees, including grants of employee stock options, to be recognized as compensation expense over the requisite service period (generally the vesting period) in the financial statements based on their fair values. For options with graded vesting, the Company values the stock option grants and recognizes compensation expense as if each vesting portion of the award was a separate award. The impact of forfeitures that may occur prior to vesting is also estimated and considered in the amount of expense recognized. In addition, the realization of tax benefits in excess of amounts recognized for financial reporting purposes will be recognized as a financing activity rather than as an operating activity.

No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for substantially all net deferred tax assets. We elected to adopt the alternative method of calculating the historical pool of windfall tax benefits as permitted by FASB Staff Position (FSP) No. SFAS 123R-3, “Transition Election Related to Accounting for the Tax Effects of Share-Based Payment Awards.” This is a simplified method to determine the pool of windfall tax benefits that is used in determining the tax effects of stock compensation in the results of operations and cash flow reporting for awards that were outstanding as of the adoption of SFAS 123R.

The Company uses the Black-Scholes option pricing model to determine the weighted average fair value of options. The fair value of options at date of grant and the assumptions utilized to determine such values are indicated in the following table:

	Nine Months Ended September 30,
	2007		2006
Weighted average fair value at date of grant for options granted during the period		$.84		$1.05
Risk-free interest rates		4.51%-4.73%		4.59%
Expected option life in years		2-10		7-10
Actual vesting terms in years		3		2
Expected stock price volatility		95.7%		98.5%
Expected dividend yield		-0-		-0-

The following summarizes the activity of the Company’s stock options for the nine months ended September 30, 2007 (shares in thousands):

	Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
Number of shares under option plans:
Outstanding at January 1, 2007		13,437		$	0.39		3.1 Years*
Granted		1,715			0.84		9.2 Years
Exercised		(930	)		0.15
Canceled or expired		(954	)		1.31
Outstanding at September 30, 2007		13,268		$	0.40		5.3 Years*	$	4,928,372
Exercisable at September 30, 2007		12,310		$	0.36		4.9 Years*	$	4,880,372

* During the three months ended March 31, 2006, the Company extended the expiration date of various options by one year, with exercise prices ranging from $0.05 to $4.75 and expiration dates ranging from March 31, 2006 through December 27, 2006, granted to employees, directors, consultants and former employees and directors. As a result of this option modification, the Company recorded an expense of approximately $384,000. The Company calculated the incremental value based on the excess of the fair value of the modified award over the fair value of the original option measured immediately before its terms were modified based on current circumstances using the Black Scholes option pricing model.

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The total intrinsic value of options exercised during the nine months ended September 30, 2007 was $653,000.

The following summarizes the activity of the Company’s stock options that have not vested as of September 30, 2007 (shares in thousands):

	Shares			Weighted Average Exercise Price
Nonvested at January 1, 2007		1,069		$	0.75
Granted		1,715			0.84
Canceled or expired		(150	)		0.80
Vested		(1,676	)		0.76
Nonvested at September 30, 2007		958		$	0.89

As of September 30, 2007, there was approximately $451,000 of unrecognized stock compensation related to unvested awards (net of estimated forfeitures) expected to be recognized over the next 32 months.

The Company granted 1,660,000 and 1,715,000 options in the periods ended September 30, 2006 and 2007, respectively. The Company has recorded a charge of $295,000, $700,000 and $97,000 in research and development, general and administrative and sales and marketing expense, respectively, for the fair value of the options granted for the nine months ended September 30, 2007.

Under SFAS 123R forfeitures are estimated at the time of valuation and reduce expense ratably over the vesting period. This estimate is adjusted periodically based on the extent to which actual forfeitures differ, or are expected to differ, from the previous estimate.

At September 30, 2007, the Company had 405,000 options outstanding which vest upon the achievement of certain FDA-related milestones associated with REPEL-CV and other product development programs. These options have a term ranging from 4-10 years from date of grant and an exercise price range of $0.26 to $2.00. Based on the recommendation of the Circulatory System Devices Advisory Panel of the FDA to approve REPEL-CV Adhesion Barrier for use in pediatric patients (21 and younger) who are likely to need secondary open heart surgery, the Company has concluded that 220,000 of such options will likely vest, and the Company has recorded an estimated $113,000 in research and development expense and $36,000 in general and administrative expense associated with such options. Upon FDA approval, the Company will true up the fair value charge and record the change in the estimate.

E)    Acquired Technology

In March 2003, the Company purchased certain polymer technology from Phairson Medical, Ltd., a private medical technology company based in the United Kingdom, for approximately 6,896,000 shares of restricted common stock of the Company. These assets comprise a series of United States and foreign patent applications as well as scientific and clinical documentation. In connection with this transaction, the Company recorded $344,000 as the fair value of this technology which includes (i) $330,000, representing the deemed value of the shares issued (approximately $0.0478 per share) paid by investors in the contemporaneous private placement of Series C Convertible Preferred Stock and related warrants; (ii) $11,000 in transaction-related costs and (iii) $3,000 representing the fair value of the options issued as a finder’s fee. A useful life of 5 years was assigned to the acquired technology considering the stage of product development, the estimated period during which patent protection could be enforced, which would go well beyond five years from the acquisition date, the development cycle time for medical devices of the type envisioned by the Company based on such technology, as well as potential technology obsolescence over time. For each of the nine month periods ended September 30, 2006 and 2007, the Company recorded amortization of $51,000 in research and development expense relating to these assets.

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F)    Convertible Promissory Notes

On February 22, 2007, a $70,000 5-year, 5% convertible promissory note matured and was repaid.

G)    Net Loss Per Common Share

Basic and diluted net loss per common share is computed using the weighted average number of shares outstanding during each period, which excludes 14,953,166 potential common shares issuable upon the exercise of outstanding options and warrants since their inclusion would have been be anti-dilutive.

H)   Exercise of Warrants

In March 2007, the Company received proceeds of approximately $71,000 from the exercise of warrants to purchase 594,000 shares of the Company’s common stock. The warrants were issued to the placement agent in the Series C Convertible Preferred Stock private placement in March 2003.

At September 30, 2007, the Company has 1,685,000 warrants outstanding. (See note J).

I)     Exercise of Options

For the nine month period ended September 30, 2007, the Company received proceeds of approximately $143,000 from the exercise of options to purchase 854,318 shares of the Company’s common stock.

On April 27, 2007, the Company amended 75,148 options for two of its officers to include a cashless exercise feature. In exchange, the employees have agreed that upon exercise, these shares will be subject to forfeiture and non-transferable for a period of one year from the date of exercise. These options were simultaneously fully exercised on a cashless basis on April 27, 2007, resulting in the issuance of an aggregate of 40,014 shares of the Company’s common stock. The Company has accounted for this transaction as a cancellation of an award accompanied by a replacement award and has recorded the incremental value over the vesting period.

J)    Common Stock

In August and September 2007, the Company sold an aggregate of 3,000,000 shares of common stock at a purchase price of $1.00 per share in a private placement, resulting in gross cash proceeds of $3,000,000. The private placement occurred in two closings, the first on August 14, 2007 for total proceeds of $2,800,000 and the second on September 7, 2007 for $200,000. In connection with the financing, the Company paid a placement agent a commission of $210,000 in cash, representing 7% of the proceeds raised by the agent, and issued to or at the direction of the placement agent warrants to purchase an aggregate of 210,000 shares of common stock, representing 7% of the number of shares sold by the agent in the financing. The warrants are exercisable at an exercise price equal to $1.10 per share at any time until August 13, 2011. The Company incurred certain financing-related expenses totaling $64,000 including legal fees.

In connection with the above noted financing, the Company entered into subscription agreements and an investor rights agreement with the investors, as well as an agency agreement with the placement agent. One of our directors, Mr. Joerg Gruber, is Chairman and a director of the placement agent. Pursuant to the investor rights agreement, the Company filed a registration statement with the United States Securities and Exchange Commission covering resale of the securities sold in the private placement. The registration statement was declared effective by the SEC on October 16, 2007.

In April 2006, the Company sold an aggregate of 15,000,000 shares of common stock in a private placement at a purchase price of $.40 per share, resulting in gross cash proceeds of $6,000,000. In connection with the financing, the Company paid a placement agent a commission equal to $590,000, representing 10% of the proceeds raised by the agent ($449,840 of which was paid, at the agent’s election, by issuance of 1,124,600 shares of common stock at the offering price of $0.40 per share, and the balance of which was paid in cash) and the Company issued to or at the direction of the placement agent warrants to purchase an aggregate of 1,475,000 shares of common stock, representing 10% of the number of shares sold by the agent in the financing. The warrants are exercisable at an exercise price equal to $.60 per share at any time until April 3, 2010. The Company paid offering costs of $78,000 including amounts to the placement agent for certain financing-related expenses including legal fees.

9

In connection with the April 2006 financing, the Company entered into subscription agreements and an investor rights agreement with the investors, as well as an agency agreement with the placement agent. Pursuant to the investor rights agreement, the Company filed a registration statement with the United States Securities and Exchange Commission covering resale of the securities sold in the private placement. The registration statement was declared effective by the SEC on August 1, 2006.

K)   Recent Accounting Pronouncements

The Company adopted Financial Standards Board Interpretation No. 48 Accounting for Uncertainty in Income Taxes (“FIN 48”) an interpretation of FASB Statement 109 (“SFAS 109”) on January 1, 2007. As a result of the implementation of FIN 48, we recognized no material adjustment to unrecognized tax benefits. At the adoption date of January 1, 2007, we had $16,908,000 of unrecognized tax benefits, all of which would affect our effective tax rate if recognized. At September 30, 2007 we have $ 21,037,000 of unrecognized tax benefits.

We recognize interest and penalties related to uncertain tax positions in general and administrative expense. As of September 30, 2007, we have not recorded any provisions for accrued interest and penalties related to uncertain tax positions.

By statute, tax years 2003-2006 remain open to examination by the major taxing jurisdictions to which we are subject.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” to define fair value, establish a framework for measuring fair value in accordance with generally accepted accounting principles, and expand disclosures about fair value measurements. SFAS No. 157 will be effective for fiscal years beginning after November 15, 2007, the beginning of our 2008 fiscal year. We are assessing the impact of the adoption of SFAS No. 157 will have on our financial position and results of operations.

In February, 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities”. SFAS No. 159 permits entities to choose to measure many financial assets and financial liabilities at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. SFAS No. 159 is effective for fiscal years beginning after November 15, 2007. We are currently assessing the impact of SFAS No. 159 on our financial position and results of operations.

L)    Reversal of Liabilities

For the nine month period ended September 30, 2007, we reversed liabilities of $44,000 primarily relating to trade transactions with former vendors. The underlying transactions occurred during or before March 31, 2001 and there has been no communication with the parties regarding these transactions since that time. Accordingly, we believe, based on advice of our counsel, that any claim for these amounts at this time would be barred by applicable statutes of limitations.

M)   Revenue Recognition Policy

The Company recognizes revenue when the amounts become fixed and determinable. Revenue is recognized when product is shipped to customers. Terms of sale are “f.o.b. shipping point” with the customer covering all costs of shipment and insurance. All sales are final with no right of return except for defective product. All sales were outside the United States of America.

N)   Cost of Goods Sold

The initial quantities of finished goods sold do not have the cost of raw materials factored in as this cost was previously expensed as research and development in prior periods. We estimate that remaining raw material that was previously expensed as research and development will be depleted through December 31, 2007.

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The following table illustrates the effect on cost of goods sold and gross profit if the cost of the raw material had been included in finished goods inventory for the interim periods ended September 30, 2007 (in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2007				September 30, 2007
Reported Net Sales	$	9	100	%	$	93	100	%
Pro forma COGS		3	29	%		29	31	%
Pro forma Gross Profit	$	6	71	%	$	64	69	%

O)   Retirement Plan

In March 2007, the Company adopted a defined contribution retirement plan which qualifies under section 401(k) of the Internal Revenue Code. The plan allows employees to voluntarily contribute amounts not exceeding the maximum allowed under the Internal Revenue Code. The Company will make a matching contribution equal to 100% of the salary deferral contributions made up to the first 4% of total compensation. During the nine months ended September 30, 2007, the Company made a matching contribution in the amount of $15,000 to the plan.

P)    Subsequent Event

Subsequent to September 30, 2007, the Company received gross proceeds of approximately $5,000 upon the exercise of options to purchase 65,833 shares of common stock.

Item 2. Management's Discussion and Analysis or Plan of Operation.

Certain statements in this Report under this Item 2 and elsewhere constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding future cash requirements, the success of any pending or proposed clinical trial, the timing or ability to achieve necessary regulatory approvals or market launch of REPEL-CV. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of our company, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include but are not limited to (i) potential adverse developments regarding our efforts to obtain required FDA and other approvals; (ii) potential inability to secure funding as and when needed to support our activities and (iii) unanticipated delays associated with manufacturing and marketing activities. Reference is made to our Annual Report on Form 10-KSB for the year ended December 31, 2006 for a description of some of these risks and uncertainties. Without limiting the foregoing, the words “anticipates”, “plans”, “intends”, “expects” and similar expressions are intended to identify such forward-looking statements that speak only as of the date hereof. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

General

We are a biomaterials company engaged in the development and commercialization of innovative and cost-effective medical devices for therapeutic applications. Products under development, all of which are based on our licensed proprietary, bioresorbable polymer technology, are primarily surgical implants designed to prevent or reduce the formation of adhesions (scar tissue) following a broad range of surgical procedures. Our commercialization efforts are currently focused on our lead product, REPEL-CV Adhesion Barrier, for use in cardiac surgery. REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of surgery to reduce the formation of post-operative adhesions (scar tissue).

 In September 2006, we reported positive efficacy results from the multi-center, randomized, masked pivotal clinical trial of REPEL-CV in neonatal patients who underwent staged, open-heart surgical procedures. The pivotal trial was conducted at 15 pediatric cardiac surgery centers throughout the United States, and enrolled 144 neonatal patients who had undergone staged, open-heart surgical procedures. In this trial, surgeons used a four point grading system to determine the extent and severity of adhesions in the patients. Over 70% of the REPEL-CV treated patients were completely free of clinically-significant adhesions, the most severe grade of adhesions measured, as compared to less than 30% in the control patients, with a p value < 0.0001. In the primary clinical endpoint assessment, the mean extent of clinically-significant adhesions in the control patients was 2.5 times greater than in the REPEL-CV patients, with a p value = 0.0005. We have incorporated the results of this trial into the Premarket Approval (“PMA”) submission documentation for the United States Food and Drug Administration (“FDA”) as a basis for obtaining approval to market REPEL-CV in the United States for use in all cardiothoracic surgical procedures. Our PMA submission was formally accepted for review by the FDA in March 2007.

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 In September 2007, we reported that the Circulatory System Devices Advisory Panel of the FDA recommended approval of REPEL-CV Adhesion Barrier for use in pediatric patients (21 and younger) who are likely to need secondary open heart surgery. The panel also recommended the development of additional safety data as a basis for expanding the indicated use to include adult patients. We are maintaining a dialogue with the FDA which we are hopeful will lead to approval of the PMA for the pediatric indication by the end of this year as well as clarification of the additional data requirements to support approval of the PMA for use in adults. The timing and scope of any FDA approval of the PMA, as well as the nature and extent of additional data required to expand any approved indication, will materially impact our plan of operations during the next twelve months.

 In June 2006, we announced the successful completion of a multi-center clinical study for REPEL-CV involving several leading cardiac surgery centers in Europe. At the point of the second surgical procedure, 13 of the 15 patients in the study were free of clinically-significant adhesions representing a significant improvement over the typical experience among patients who have undergone secondary open heart procedures. In August, 2006 we received the CE Mark approval to market REPEL-CV for use in cardiac surgery within the European Union (EU) and in other international markets. In September 2006, we launched REPEL-CV for sale in the EU and certain southeast Asian markets through a network of independent distributors, all of whom are experienced at selling devices and medical equipment to cardiac surgeons.

 In anticipation of the above-referenced PMA approval, we are assessing product opportunities outside of cardiac surgery in which we can leverage our polymer film technology through other surgical product applications. Our initial focus is on the possible marketing of bioresorbable film-based products for use in spine and ENT surgical procedures

 Our bioresorbable polymer technology is based on a proprietary group of polymers. We believe that these polymers display desirable properties, which enable them to be tailored to a wide variety of applications. These properties include bioresorbability, flexibility, strength and biocompatibility. Potential applications for products derived from these polymers are in medical areas such as the prevention of post-operative adhesions, sutures, stents, implantable device coatings and drug delivery.

 The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our interim financial statements and notes thereto appearing elsewhere herein.

Results of Operations

Revenue for the three and nine months ended September 30, 2007 totaled $9,000 and $93,000, respectively, compared to $62,000 in each of the comparable prior year periods. Revenue is attributable to product sales of REPEL-CV in the European Union and in other international markets. Should the FDA approve the PMA for the Advisory Panel recommended indication of use in pediatric patients, we anticipate achieving increased revenue in future periods, though, given the more limited market, at lower levels than had the approval included use in the broader adult population. Revenue for the three months ended September 30, 2007 as compared to the prior year decreased as a result of higher initial customer purchases required to fill the product pipeline during the prior year. The increase in revenue for the nine months ended September 30, 2007 as compared to the prior year resulted from no product revenue being recorded for the first eight months of 2006 as we had no products approved for sale at that time.

Cost of goods sold totaled $1,000 and $17,000 for the three and nine months ended September 30, 2007, respectively, compared to $9,000 in each of the comparable prior year periods. Cost of goods sold reflects costs to process and package REPEL-CV into saleable form. Raw material costs are not included as part of cost of goods sold as these were previously expensed as research and development expense in prior periods. Had raw material costs been included in cost of goods sold, costs of goods sold for the 2007 three and nine month periods would have been $3,000 and $29,000, respectively. Cost of goods sold will include raw material costs in future periods once the amounts previously expensed as research and development expense have been fully depleted. (See Note N of Notes to Condensed Financial Statements.)

We incurred research and development expenses of $643,000 and $1,807,000 for the three and nine months ended September 30, 2007, respectively, compared to $486,000 and $1,598,000 for the comparable prior year periods. The increase over the three month periods is primarily attributable to higher regulatory and new product development costs of $263,000, partially offset by lower consulting, legal, insurance and clinical trial costs of $216,000. The increase over the nine month periods is primarily attributable to higher regulatory costs associated with the PMA submission and new product development costs for products that leverage our polymer technology of $516,000 and higher non-cash charges in the current year of $168,000 as the result of SFAS 123R, stock-based compensation expense, partially offset by lower manufacturing development and clinical trial costs for REPEL-CV of $525,000.

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General and administrative expenses totaled $397,000 and $1,825,000 for the three and nine months ended September 30, 2007, respectively, compared to $322,000 and $1,918,000 for the comparable prior year periods. The increase over the three month periods is primarily attributable to higher compensation expense in the current year. The decrease over the nine month periods is primarily attributable to a decrease in non-cash charges of $322,000 as the result of SFAS 123R, stock-based compensation expense, partially offset by increases in compensation expense, insurance and investor relations expenses associated with recent growth in the business. (See Note D of Notes to Condensed Financial Statements.)

We incurred sales and marketing expenses of $298,000 and $691,000 for the three and nine months ended September 30, 2007, respectively, compared to $35,000 and $129,000 for the comparable prior year periods. The increase over the three month periods is primarily attributable to increased consulting costs of $86,000 associated with REPEL- CV post-launch marketing in the European Union and other international markets, sales compensation cost of $77,000, meetings and travel related expenses of $70,000 and sales training expenses of $28,000. The increase over the nine month periods is primarily attributable to increased stock-based compensation expense of $96,000, consulting costs of $187,000 associated with REPEL- CV post-launch marketing in the European Union and other international markets, sales compensation cost of $137,000 and meetings and travel related expenses of $81,000. During the remainder of 2007, we anticipate an increased level of sales and marketing expense as we prepare for a US launch of REPEL-CV.

There was interest income of $24,000 and $75,000 for the three and nine months ended September 30, 2007, respectively, compared to $41,000 and $91,000 for the comparable prior year periods. The decreases were primarily attributable to lower average cash balances during the current year.

Interest expense was $1,000 for the nine months ended September 30, 2007, compared to $1,000 and $4,000 for the three and nine months ended September 30, 2006, respectively. No interest expense was incurred for the three months ended September 30, 2007. The decrease for the 2007 periods was attributable to the repayment of an interest bearing convertible promissory note in the principal amount of $70,000 on February 22, 2007.

 We realized other income from the reversal of liabilities of $44,000 for the nine months ended September 30, 2007; there were no comparable amounts recorded during the prior year period.  The reversal of liabilities during the current year period related to trade and other business transactions which were due and payable on or before March 31, 2001. The reversals were made due to the passage of time and our belief that the underlying claims would be barred by applicable statutes of limitations if recovery actions were asserted at the time of the respective reversals.

A gain on settlement of debt of $22,000 was recorded in the nine months ended September 30, 2006 associated with the settlement of outstanding trade payables; there were no comparable amounts recorded during the current year periods.

Our net loss was $1,306,000 and $4,129,000 for the three and nine months ended September 30, 2007, respectively, compared to $750,000 and $3,482,000 for the corresponding prior year periods. We expect to incur losses in future periods.

Liquidity and Capital Resources

At September 30, 2007, we had a cash balance of $3,507,000 and working capital of $3,201,000.

Net cash used in operating activities was $3,069,000 for the nine months ended September 30, 2007, as compared to $2,483,000 for the prior year period. Net cash used in operating activities for the current year period was primarily due to a net loss of $4,129,000, a decrease in accrued expenses of $208,000 and increases totaling $168,000 in accounts receivable, inventory and reversal of liabilities, partially offset by the impact of SFAS 123R, stock-based compensation expenses, of $1,240,000, an increase in accounts payable of $86,000 and a decrease in prepaid expenses of $16,000. Net cash used in operating activities for the prior year period of $2,483,000 was primarily due to a net loss of $3,482,000 and decreases totaling $244,000 in accounts payable and accrued expenses, partially offset by the impact of $1,298,000 in non-cash expenses comprised of stock-based compensation expenses, primarily due to the adoption of SFAS 123R and the modification of options which extended the exercise period by one year.

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 Net cash used in investing activities was $16,000 for the nine months ended September 30, 2007, as compared to $31,000 for the corresponding prior year period. Net cash used in investing activities was associated with the acquisition of computer equipment and office furniture in both the current and prior year periods.

 Net cash provided from financing activities for the nine months ended September 30, 2007 was $2,870,000, as compared to $5,735,000 for the prior year period. The current year amount was comprised of $2,726,000 of net proceeds from the sale of common stock, $214,000 from the exercise of stock options and warrants offset by the repayment of a $70,000 convertible promissory note that matured in February 2007; the prior year amount was comprised of $5,766,000 of net proceeds from the sale of common stock and $9,000 from the exercise of stock options offset by the repayment of a $40,000 convertible promissory note that matured in August 2006.

The balance of cash and cash equivalents as of September 30, 2007 is not sufficient to meet our anticipated cash requirements through September 30, 2008, based on our present plan of operation. As a result, we are seeking to raise additional capital. Additional capital may not be available as and when needed or on terms favorable or acceptable to us. Equity financings may be dilutive to existing stockholders. Insufficient funds may require us to delay, scale back or eliminate some or all of our research and development programs and commercialization plans, or require us to license to third parties certain products or technologies that we would otherwise seek to commercialize independently. 

 As of September 30, 2007, we had employment agreements with five individuals that expire as follows: two in September 2008, one in March 2009, one in May 2009 and one in May 2010. Pursuant to these agreements, our commitment regarding cash severance benefits aggregates $624,000 at September 30, 2007. We have also entered into change of control agreements with our three executive officers pursuant to which, upon the occurrence of events described therein, we could become obligated, in addition to certain other benefits, to pay either 150% or 200%, depending on the executive, of such executives’ annual base salaries plus the greater of the prior year’s cash bonus or current year’s target bonus. Any severance payments under the employment agreements would offset amounts required to be paid under the change of control agreements.

Item 3.  Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The chief executive officer who is also the chief financial officer, after evaluating the effectiveness of the Company's "disclosure controls and procedures" (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e); collectively, “Disclosure Controls”) as of the end of the period covered by this quarterly report (the "Evaluation Date") has concluded that as of the Evaluation Date, our Disclosure Controls were effective to provide reasonable assurance that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified by the SEC, and that material information relating to our company and any consolidated subsidiaries is made known to management, including the chief executive officer and chief financial officer, particularly during the period when our periodic reports are being prepared to allow timely decisions regarding required disclosure.

In connection with the evaluation referred to in the foregoing paragraph, we have identified no change in our internal control over financial reporting that occurred during the quarter ended September 30, 2007 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

The Company’s management, including the chief executive officer and chief financial officer, who are the same person, does not expect that our Disclosure Controls or our internal control over financial reporting will prevent or detect all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.

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PART II - OTHER INFORMATION

Item 6.Exhibits

31.1	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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SIGNATURE

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

SyntheMed, Inc.

By: /s/ Robert P. Hickey

Robert P. Hickey

President, CEO and CFO

Date: November 5, 2007

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EXHIBIT INDEX

ITEM

31.1	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1	Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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