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CryoFluor Raises Trial Money From Endocare, Temple

CryoFluor Therapeutics LLC, a medical device startup with operations in Irvine and Tucson, has landed a $2.5 million investment.

The money allows CryoFluor to complete a feasibility trial for a device it’s developing to treat abnormal uterine bleeding.

Endocare Inc., an embattled Irvine-based device company, made the investment along with Research Corporation Technologies, a Tucson-based investor, and Pennsylvania’s Temple University.

Endocare, which makes devices for freezing and removing tissue and tumors, is providing engineering, production, regulatory and marketing support to CryoFluor.

For the past few years, Endocare has dealt with a regulatory probe of its financial results, as well as shareholder revolts, management changes and the fall of its stock from Nasdaq to the low-profile Pink Sheets.

CryoFluor’s device is designed to treat uterine bleeding by ablating,removing or destroying,the uterine lining, which is known as the endometrium.

Abnormal uterine bleeding is responsible for more than 1 million doctor visits yearly in the U.S.

“The data from this trial will allow the company to conduct a multicenter trial in U.S. so we can bring improved care for patients with abnormal uterine bleeding,” said David Jackson, CryoFluor’s president and chief operating officer.

CryoFluor has no relation to Aliso Viejo-based engineering services company Fluor Corp.

Research Corporation Technologies and Temple University formed CryoFluor to develop the work of three researchers at the school. Jackson previously was an investment professional with Research Corporation Technologies.


Ista Ups Sales Staff for Drug

Irvine-based Ista Pharmaceuticals Inc. plans to expand its sales force from 28 people to 50 in the current quarter as part of the U.S. launch of its long-awaited Vitrase drug.

The company hopes that by expanding its sales force, Ista could extend its reach to more than 7,000 eye doctors across the country,

said Chief Executive Vicente Anido Jr.

Vitrase is set to be available in two vials for use as a spreading agent to help with the absorption and dispersion of other injected drugs. It also can be used for hypodermoclysis, a method of infusing fluid into the eye.

The drug debut is Ista’s second product launch in the past six months. The eye drug maker came out with Istalol, a once-a-day drug for treating glaucoma, in July.

Ista has spent several years trying to get Vitrase to the market, overcoming a 2002 setback that happened when the drug, which was being tested for vitreous hemorrhage, or internal bleeding of the eye, failed to meet its main goal during clinical testing on patients.

The drug maker later sought to develop Vitrase as a spreading agent for other drugs.

Ista has fashioned itself as a smaller, specialized player in the eye drug market. In a 2003 presentation, Anido described Irvine-based Allergan Inc. and Nestle SA’s Alcon Laboratories Inc., which has operations in Irvine, as the “big gorillas.” But he said there was room for the Istas of the world.


AMDL Files Application

AMDL Inc. of Tustin submitted an application with the Food and Drug Ad-

ministration to market its DR-70 test as an aid in monitoring patients who previously were diagnosed with progressing colorectal cancer. AMDL, a publicly traded company on the American Stock Exchange, submitted the application through Diagnostic Oncology Clinical Research Organization, its consultant.

In a release, AMDL said that its consultant submitted data showing that by using DR-70 with the carcinoembryonic antigen test, the standard colorectal cancer diagnostic test, there was a 24% positive gain in monitoring the disease status’ clinical progression.

AMDL said that the carcinoembryonic antigen test’s sensitivity varies from 40% to 70%.

DR-70 is a noninvasive blood test. Scientific journals have published data showing DR-70 was shown to detect at least 13 different types of cancer, including breast, ovarian and cervical.

Besides DR-70, AMDL also owns a combination immunogene therapy technology that’s a potential treatment for people already diagnosed with cancer. It eventually could be used as a vaccine to protect those known to be at risk because of a family history for certain types of cancer.


Company Sues NFL Star

Formulated Sciences Inc. of Laguna Hills recently sued Terrell Owens, the colorful and controversial Philadelphia Eagles wide receiver who currently is on injury rehabilitation, for $35 million.

Formulated Sciences alleges that Owens failed to follow the terms of an endorsement deal he signed while he played for the San Francisco 49ers in 1999.

The company said Owens was hired to promote a nutritional supplement and muscle pain reliever it made, but didn’t wyear clothes on TV that it provided to him.

In published reports, Jason Knight, Owens’ attorney, said his client was taking the complaint seriously.

“We feel very strongly about our legal position,” he said.

Formulated Sciences is one of several companies whose products have been banned by the National Football League since Minnesota Vikings offensive tackle Korey Stringer died in 2001. Formulated Sciences sued the NFL over its ban.

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