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U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 16, 2007
ONCOLOGIX TECH, INC.
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(Name of Small Business Issuer as Specified in Its Charter)
0-15482
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(Commission File Number)
Nevada 86-1006416
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
3725 Lawrenceville-Suwanee Rd., Suite B-7
Suwanee, GA 30024
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(Address of principal executive offices)
(770) 831-8818
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(Issuer's telephone number)
Check the appropriate box below if the Form 8-K is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01 Other Events.
On July 16, 2007, we discovered, during additional testing of our
Oncosphere product, more rigorous than our original feasibility testing, a rate
of radiation leaching from the microsphere surface higher than anticipated.
"Leaching" refers to the amount of radiation physically released from the
microspheres that had been previously thought to be bound. We believe that the
level of leaching observed is high enough that future progress with the product
requires further investigation into process and material modifications to reduce
or eliminate the leaching. We believe that in accomplishing this, we will need
to replace one or more of the constituent components of the Oncosphere with
similar or new components. We have already begun to explore and test several
alternative processes and materials that we believe would meet the performance
conditions expected in the human body and the requirements of the FDA. Testing
that simulates the conditions of the body is required by medical device
standards and the FDA.
Subject to further review, we believe that there is sufficient cash on
hand to enable us to develop and test a new design within approximately two
months. There is no assurance that the necessary re-design can be accomplished
with those funds and within that time or even at all. Our previous estimate that
approximately $5,000,000 will be required to complete the pre-clinical testing
phase and the clinical approval phase, has been revised to a requirement of
approximately $6,000,000.
Our ability to complete any new development is dependent on our
ability, which is uncertain, to raise additional funds from the proceeds of new
loans or the sale of additional equity. As with any development stage medical
device product, there can be no guarantee that even with sufficient funds the
product design will be successful or that the FDA will ultimately provide
approval for its clinical or commercial use.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Title
99 Press release issued by Oncologix Tech, Inc., dated July 19,
2007.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
Dated: July 19, 2007 ONCOLOGIX TECH INC.
By: /s/ Andrew M. Green
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Andrew M. Green,
Chief Executive Officer
and President
By: /s/ Michael A. Kramarz
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Michael A. Kramarz,
Chief Financial Officer