IRIDEX Corporation (IRIX) - 500 Beiträge pro Seite

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Profile:IRIDEX Corporation develops, manufactures, markets, sells and services semiconductor-based medical laser systems used to treat eye diseases in ophthalmology and skin conditions in dermatology. The Company treats serious eye diseases by ophthalmology products that include the causes of irreversible blindness, age-related macular degeneration, diabetic retinopathy and glaucoma. Its dermatology products are used in the treatment of vascular and pigmented lesions and the removal of unwanted hair. Each ophthalmic and dermatology laser system includes a console, which generates the laser energy and a number of interchangeable peripheral delivery devices, including disposable delivery devices for use in specific clinical applications.

http://www.iridex.com

[Catchup]

Aha, und jetzt?

catchup

[Allure]

Market Cap (intraday): 30.24M




Total Cash (mrq): 18.12M
Total Cash Per Share (mrq): 2.46
Total Debt (mrq)²: 0
Total Debt/Equity (mrq): 0
Current Ratio (mrq): 5.471
Book Value Per Share (mrq): 4.245



ich bin gerade eingestiegen!

iridex ist ganz klar unterbewertet!

grüße

[Macros]

Warum ist das teil von 7$ auf 4$ gefallen? Weiss das jemand... ging ja ruckzuck.

Grüße
Macros

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@macros



IRIDEX Announces Presentation of Preliminary Results of TTT4CNV Clinical Trial for Patients With Age-related Macular Degeneration
Friday October 22, 10:50 am ET


MOUNTAIN VIEW, Calif., Oct. 22 /PRNewswire-FirstCall/ -- IRIDEX Corporation (Nasdaq: IRIX - News) announced today that Dr. Elias Reichel presented preliminary two-year results from the TTT4CNV Clinical Trial for occult neovascular (wet) age-related macular degeneration (AMD). A total of 303 patients were enrolled in the study. Patients who were treated in the study with the Transpupillary Thermotherapy (TTT) laser protocol were compared to sham treatment. Results were presented today at the Retina Subspecialty Day Program during the annual meeting of the American Academy of Ophthalmology and that the intent-to-treat evaluation of the primary visual outcome data showed that TTT, as applied in this trial, did not result in a significant beneficial effect relative to sham.
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Dr. Elias Reichel, Study Chairman of the TTT4CNV Clinical Trial and Associate Professor of Ophthalmology at the New England Eye Center, Tufts University School of Medicine, presented the data. At two years 47% of eyes avoided modest or severe vision loss compared to 43% of sham eyes, which was not statistically significant. Follow-up at 18 and 24 months showed an advantage of approximately 4 letters in TTT treated eyes; though this trend was not significant.

Additionally, it was reported that 11% of patients who were treated with TTT compared to 3% of patients who received sham showed improvement (greater or equal to 2 lines increase) from baseline when evaluated at one year. This secondary outcome was statistically significant.

Dr. Reichel stated, "Further analysis of this subgroup of patients who improved vision may yield information regarding those patients who respond to TTT. Specifically this subgroup of patients may have certain characteristics that result in a high likelihood of improvement or stabilization over time."

Safety results were also presented. Some patients, both in the treatment and sham groups, showed severe loss of vision at the one-month follow-up visit. This occurred in 5% of TTT treated eyes compared to 1% of sham eyes. This finding was not statistically significant.

Dr. Reichel concluded, "Given the fact that the Executive Committee was unmasked to the outcome data only recently, there are a number of questions for which analyses remain to be done. Specifically, careful inspection of baseline characteristics between groups and a per protocol analysis that evaluates the subset of enrolled patients who met all key eligibility criteria needs to be done."

Theodore A. Boutacoff, President and CEO of IRIDEX said, "We are disappointed that these preliminary results did not demonstrate a significant difference compared to sham when these patients were treated following the TTT4CNV dosing protocol. We are encouraged that a number of patients experienced a significant improvement in vision and look forward to the comprehensive analysis of the study data that may provide clarity into the patients who responded well to TTT. We remain optimistic about this therapy in light of the difficulties and inconsistencies in treating this devastating condition and the economic burden given the large numbers of newly affected patients."

About the TTT4CNV Clinical Trial

The TTT4CNV Clinical Trial is a multi-center, prospective, double-masked, placebo-controlled clinical trial conducted at 22 centers in the United States. The trial was designed to look at eyes with wet AMD and randomized eyes with small (less than or equal to 3 mm diameter) subfoveal occult membranes and symptomatic vision (ETDRS visual acuity between 20/50 and 20/400). In all TTT treated eyes laser energy was applied at 800 mW with a 3 mm spot size for 60 seconds with the IRIS Medical® OcuLight® SLx 810 nm laser and Large Spot Slit Lamp Adapter. Results were compared to sham treated (placebo) eyes. One retreatment was permitted at 3 months during the follow-up period at the physician`s discretion. The trial was physician initiated, supported by IRIDEX and performed within the FDA cleared indications for the OcuLight infrared laser system.

About IRIDEX

IRIDEX Corporation is a leading worldwide provider of semiconductor-based laser systems for the ophthalmology and dermatology markets. IRIDEX products are sold in the United States through a direct sales force and internationally through a network of independent distributors into more than 100 countries. For further information, visit the Company`s website at www.iridex.com.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Act of 1934 relating to the outcome of any further analysis of the study data, further validation in treating wet AMD with TTT, the size of the patient population that can benefit from the TTT procedure and the effectiveness of TTT. These statements are subject to risks and uncertainties and actual results could differ materially from those projected in the forward-looking statements based on, among other things, further analysis of the study data may not yield any statistically significant identifiable group that improved from the TTT treatment. For additional risks that may affect the Company, please see a detailed description of these risks contained in our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K for the year ended January 3, 2004 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.




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Source: IRIDEX Corporation

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IRIDEX Announces Favorable TTT4CNV Clinical Trial Sub-Group Results
Thursday February 24, 6:00 am ET
Company to Host Conference Call to Discuss Results on Monday, February 28, 1:30 p.m. ET, 10:30 a.m. PT


MOUNTAIN VIEW, Calif., Feb. 24 /PRNewswire-FirstCall/ -- IRIDEX Corporation (Nasdaq: IRIX - News) today announced a significant clinical benefit in a subset of patients with wet age-related macular degeneration (AMD) who were treated with the transpupillary thermotherapy (TTT) laser protocol when compared to the sham treated control group in the TTT4CNV Clinical Trial. The results showed that in a subgroup of patients with baseline visual acuity of 20/100 or worse, 22% of treated eyes improved vision by one or more lines compared with none of the eyes in the untreated control group. Furthermore, at 18 months, there was a 2 line benefit in preserving vision in this subgroup when compared to sham treated eyes. Specifically, TTT treated eyes on average lost 2 lines of visual acuity while sham treated eyes lost 4 lines. Both of these findings were statistically significant.
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Dr. Elias Reichel, Study Chairman of the TTT4CNV Clinical Trial and Associate Professor of Ophthalmology at the New England Eye Center, Tufts University School of Medicine, will be presenting these results Friday, February 25 at The Macula Society Meeting in Key Biscayne, Florida.

Dr. Reichel commented, "These subgroup results are very important. TTT clearly benefits patients with vision that is 20/100 or worse. Within the TTT4CNV Clinical Trial about 42% of the patients enrolled had baseline vision of 20/100 or worse. On average, in this group of patients, the TTT treated patients lost two lines less than the sham treated group at 18 months. Remarkably, at 18 months, one-fifth of treated patients showed some improvement in vision compared to their vision prior to the TTT treatment. This compares to no vision improvement for patients in the sham treated control group. These results support a role for TTT in the treatment of a significant fraction of patients with occult wet AMD worldwide."

Theodore A. Boutacoff, President and CEO of IRIDEX said, "We are excited about these results and the significant contribution they can make in the clinical care of patients with occult wet AMD. TTT has the potential to offer physicians a clinically effective, cost efficient procedure that is easily incorporated into practice and can benefit many patients since it targets the early occult stage of the disease."

Conference Call

IRIDEX and Dr. Reichel will conduct a conference call to discuss the TTT4CNV Clinical Trial results on Monday, February 28 at 1:30 p.m. ET, 10:30 a.m. PT. Interested parties may access the live conference call via telephone by dialing 800-265-0241 US or 617-847-8704 International and entering code 85535615 or visit the Company`s website at www.iridex.com. A telephone replay will be available beginning on February 28, 2005 through March 7, 2005 by dialing 888-286-8010 US or 617-801-6888 International and entering code 37300186. In addition, an archived version of the webcast will be available later in the day on February 28, 2005 on the Company`s website at www.iridex.com.

About the TTT4CNV Clinical Trial

The TTT4CNV Clinical Trial is a multi-center, prospective, double-masked, placebo-controlled clinical trial conducted at 22 centers in the United States. The trial was designed to look at eyes with wet AMD and randomized eyes with small (less than or equal to 3 mm diameter) subfoveal occult membranes and symptomatic vision (ETDRS visual acuity between 20/50 and 20/400). In all TTT treated eyes laser energy was applied at 800 milliWatts with a 3 mm spot size for 60 seconds with the IRIS Medical(R) OcuLight(R) SLx 810 nm laser and Large Spot Slit Lamp Adapter. Results were compared to sham treated (placebo) eyes. One retreatment was permitted at 3 months during the follow-up period at the physician`s discretion. The trial was physician initiated, supported by IRIDEX and performed within the FDA cleared indications for the OcuLight infrared laser system. TTT is a large spot size, low irradiance, long exposure, infrared (810 nm) laser photocoagulation protocol. The protocol uses the Company`s IRIS Medical OcuLight SLx laser and Large Spot Slit Lamp Adapter.

About IRIDEX

IRIDEX Corporation is a leading worldwide provider of semiconductor-based laser systems for the ophthalmology and dermatology markets. IRIDEX products are sold in the United States through a direct sales force and internationally through a network of independent distributors into more than 100 countries. For further information, visit the Company`s website at www.iridex.com.

Safe Harbor

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Act of 1934, as amended, relating to the role of TTT in the treatment of occult wet AMD, the potential to incorporate its use in patient care and the potential benefits of its use. These statements are subject to risks and uncertainties and actual results could differ materially from those projected in the forward-looking statements based on, among other things, the clinical rate of adoption of TTT for treatment of occult wet AMD, the experience of ophthalmologists in treating patients with TTT, the potential for variation in TTT treatment results across other patient populations or other studies, government regulatory procedures, and market acceptance of the Company`s products. For additional risks, please see those contained in our Quarterly Reports on Form 10-Q and Annual Report on Form 10-K for the fiscal year ended January 3, 2004 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.




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Source: IRIDEX Corporation