-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RcInV2G3fwZmhkYB7IU48J0sw2Fu3PlAEHDKrP3bT/PbEgvMNLbKD5YPj4XcGlZy zTOfhTjXnnortjCXasXjWA== 0001108890-07-000163.txt : 20070719 0001108890-07-000163.hdr.sgml : 20070719 20070719161659 ACCESSION NUMBER: 0001108890-07-000163 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070716 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070719 DATE AS OF CHANGE: 20070719 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Oncologix Tech Inc. CENTRAL INDEX KEY: 0000799694 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 861006416 STATE OF INCORPORATION: NV FISCAL YEAR END: 0831 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15482 FILM NUMBER: 07989379 BUSINESS ADDRESS: STREET 1: 3725 LAWRENCEVILLE-SUWANEE ROAD STREET 2: SUITE B-7 CITY: SUWANEE STATE: GA ZIP: 30024 BUSINESS PHONE: 770-831-8818 MAIL ADDRESS: STREET 1: 3725 LAWRENCEVILLE-SUWANEE ROAD STREET 2: SUITE B-7 CITY: SUWANEE STATE: GA ZIP: 30024 FORMER COMPANY: FORMER CONFORMED NAME: BESTNET COMMUNICATIONS CORP DATE OF NAME CHANGE: 20001219 FORMER COMPANY: FORMER CONFORMED NAME: WAVETECH INTERNATIONAL INC DATE OF NAME CHANGE: 19980225 FORMER COMPANY: FORMER CONFORMED NAME: WAVETECH INC DATE OF NAME CHANGE: 19920703 8-K 1 oncologix8k071907.txt PERIOD ENDED 07-16-07 ================================================================================ 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. --------------------------------------------------------- (Name of Small Business Issuer as Specified in Its Charter) 0-15482 ---------------------- (Commission File Number) Nevada 86-1006416 ------------------------------ ----------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 3725 Lawrenceville-Suwanee Rd., Suite B-7 Suwanee, GA 30024 -------------------------------------- (Address of principal executive offices) (770) 831-8818 ------------------------- (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)) ================================================================================ 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 -------------------------------- Andrew M. Green, Chief Executive Officer and President By: /s/ Michael A. Kramarz -------------------------------- Michael A. Kramarz, Chief Financial Officer EX-99 2 oncologixexhib99-071907.txt PRESS RELEASE DATED 07-16-07 EXHIBIT 99 ONCOLOGIX TECH ANNOUNCES THAT ADDITIONAL DESIGN AND TESTING OF THE ONCOSPHERE SYSTEM IS REQUIRED FOR CLINICAL ACCEPTABILITY SUWANEE, Georgia.--(Market wire) July 19, 2007 - Oncologix Tech Inc. (OTC BB: OCLG.OB) announced today that recent testing of its Oncosphere product, more rigorous than the original feasibility testing, has revealed 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. Oncologix believes 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. Oncologix further believes that in accomplishing this, it will need to replace one or more of the constituent components of the Oncosphere with similar or new components. Exploration and testing have already begun on several alternative processes and materials that it is believed 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, the announcement stated the Company's belief that there is sufficient cash on hand to enable it 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. The 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. Andrew Green, President and CEO of Oncologix stated, "Our objective will be to continue to design, test, and provide medical products that meet the highest standards for safety and effectiveness. We are optimistic about our new approach and believe that if successful, we will have a product that has expanded possibilities for diagnostic and therapeutic applications." About Oncologix Tech Inc. and its subsidiary, Oncologix Corporation: - -------------------------------------------------------------------- Oncologix Tech Inc. (formerly BestNet Communications Corp.) was previously a provider of long distance telephone communication services but disposed of that business in January 2007. The Company is developing a brachytherapy (radiation therapy) device, the Oncosphere System, for the advanced medical treatment of soft tissue cancers. It is based on radioactive microparticles designed to deliver therapeutic radiation directly to a tumor site by introducing the microparticles into the artery that feeds the tumor tissue. This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the "safe harbor" created thereby. These statements include the plans and objectives of management for future operations, including plans and objectives. The forward-looking statements herein are based on current expectations that involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond control of the company. Although the company believes that the assumptions underlying the forward-looking statements are reasonable, any one of the assumptions could be inaccurate, and therefore it can provide no assurance that the forward-looking statements included in this release will prove to be accurate. # # # -----END PRIVACY-ENHANCED MESSAGE-----