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

 

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

Delaware		68-0423298
(State or other jurisdiction of incorporation or organization)		(I.R.S Employer Identification No.)

Large accelerated filer	Accelerated filer	Non-accelerated filer	Smaller reporting company
o	o	(Do not check if a smaller reporting company)   o	þ

 

 

 

 

 

 

 

1)

moistening and lubricating absorbent wound dressings for traumatic wounds requiring a prescription;

2)

moistening and debriding acute and chronic dermal lesions requiring a prescription;

3)

moistening absorbent wound dressings and cleaning minor cuts as an over-the-counter product;

4)

management of exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically debridement of wounds in a gel form and required as a prescription;

5)

debridement of wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites as a preservative, which can kill listed bacteria such as MRSA & VRE and required as a prescription; and

6)

as a hydrogel, for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue as a prescription.  As an over-the-counter product, the hydrogel is intended to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. It is also indicated for management of irritation and pain from minor sunburn.

 

 

 

 

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We could move forward into the pivotal phase of our U.S. clinical program for Microcyn Technology;

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There were no safety issues relative to moving into this next clinical phase immediately, and carcinogenicity studies would not be required for product approval; and

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Clinical requirements for efficacy and safety for a new drug application, or NDA, would be appropriately accounted for within the agreed upon pivotal trial designs.

 

 

 

 

 

 

 

 

 

 

	·	net proceeds of $21,936,000 raised in our initial public offering on January 30, 2007;
	·	net proceeds of $9,124,000 raised in a private placement of common shares on August 13, 2007;
	·	net proceeds of $12,613,000 raised through a registered direct placement from March 31, 2008 to April 1, 2008;
	·	net proceeds of $1,514,000 raised through a private placement on February 6, 2009;
	·	net proceeds of $948,000 from a private placement on February 24, 2009;
	·	net proceeds of $2,000,000 from a private placement on June 1, 2009;
	·	net proceeds of $5,411,000 from a registered direct offering on July 30, 2009; and
	·	proceeds of $4,239,000 received from the exercise of common stock purchase warrants and options.

 

 

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the scope, rate of progress and cost of our clinical trials and other research and development activities;

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future clinical trial results;

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the terms and timing of any collaborative, licensing and other arrangements that we may establish;

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the cost and timing of regulatory approvals;

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the cost and delays in product development as a result of any changes in regulatory oversight applicable to our products;

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the cost and timing of establishing sales, marketing and distribution capabilities;

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the effect of competing technological and market developments;

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the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and

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the extent to which we acquire or invest in businesses, products and technologies.