• Increase font size
  • Default font size
  • Decrease font size

FDA Clears Expanded Label Claim for Oculus Innovative Sciences’ Lead Microcyn® Wound Care Product

Print E-mail
Thursday, 04 June 2009 08:15

PETALUMA, Calif.--Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), a healthcare company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, today announced that it has received an expanded 510(k) label clearance from the U.S. Food and Drug Administration (FDA) to market its Microcyn® Skin and Wound Cleanser with preservatives as both a prescription and over-the-counter formulation. The new Rx product is indicated for use by health care professionals to manage the debridement of wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first- and second-degree wounds, grafted and donor sites.

Microcyn® Skin and Wound Cleanser with preservative demonstrated rapid activity against a broad spectrum of gram-positive, gram-negative and yeast species with the following in vitro time kill method results in solution:

Name of Organism

Time to Kill

Percent Reduction

MRSA - Staphylococcus aureus

30 seconds 99.9999%

VRE - Enterococcus faecalis

30 seconds 99.9999%

Staphylococcus aureus

30 seconds 99.9999%

Escherichia coli

30 seconds 99.9997%

Acinetobacter baumannii

30 seconds 99.9999%

Bacteroides fragilis

30 seconds 99.9999%

Candida albicans

30 seconds 99.9999%

Enterobacter aerogenes

30 seconds 99.9999%

Enterococcus faecium

30 seconds 99.9999%

Haemophilus influenzae

30 seconds 99.9993%

Klebsiella oxytoca

30 seconds 99.9999%

Klebsiella pneumoniae

30 seconds 99.9999%

Micrococcus luteus

30 seconds 99.9999%

Proteus mirabilis

30 seconds 99.9999%

Pseudomonas aeruginosa

30 seconds 99.9998%

Serratia marcescens

30 seconds 99.9999%

Staphylococcus epidermidis

30 seconds 99.9998%

Staphylococcus haemolyticus

30 seconds 99.9999%

Staphylococcus homins

30 seconds 99.9996%

Staphylococcus saprophyticus

30 seconds 99.9999%

Streptococcus pyogenes

30 seconds 99.9999%

“We believe these impressive kill times further validate the Microcyn Technology’s unique and proprietary mode of action. At the same time, the Microcyn solution is safe as saline,” said Hoji Alimi, founder and CEO of Oculus. “This safety profile in combination with the FDA-reviewed rapid kill times simply can’t be equaled by silver-based products or even dated and toxic home remedies such as diluted bleach or Dakin’s solution, which impede wound healing. This is scientific fact.”

Last week, Oculus announced FDA clearance of a new Microcyn® Skin and Wound HydroGel, which is reimbursable by both Medicare and Medicaid. The original Microcyn-based solution, branded as Microcyn Wound Care in the United States, Microdacyn60™ in Mexico, Dermacyn™ Wound Care in Europe and China and Oxum in India, has treated over one million patients worldwide without a report of a single serious adverse effect.

Oculus, in partnership with its North American contract sales organization, Advocos, will market and sell the Microcyn® Skin and Wound Cleanser with preservative along with the Microcyn® Skin and Wound HydroGel to the North American medical community beginning in June 2009. Medical professionals interested in more information should contact Advocos at 678-213-0649 or email info@advocos.com.

There will be expanded discussion of these latest FDA clearances during the company’s Q4 2009 earnings conference call at 1:30 p.m. PDT (4:30 p.m. ET) on Thursday, June 11, 2009. Individuals interested in participating in the conference call may do so by dialing 877-397-0292 for domestic callers or 719-325-4907 for international callers.

About Oculus

Oculus Innovative Sciences develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, which includes new formulations designed to significantly reduce the need for antibiotics as it reduces infections. The Microcyn Technology platform features a biocompatible, shelf-stable solution that is currently commercialized in the United States, Europe, India, China and Mexico and select Middle East countries. Several solutions derived from this platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores, increase blood flow to the wound site, reduce both inflammation and pain while assisting in faster wound closure. The company’s headquarters are in Petaluma, California, with operations in Europe and Latin America. More information can be found at www.oculusis.com.




BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 
about 9 hours ago Watson Provides Update on Generic Lidoderm® Application; Gilead Soars On "Striking" Clinical Trial Data: Below i... http://t.co/IbLYNqgb
about 18 hours ago Shares of $IDIX drop slightly after compelling new data from rival Gilead ($GILD) puts prospects for IDIX's hepatitis C drug in question.
about 1 day ago Medgenics has Key to Protein Therapy Market: Medgenics (NASDAQ: MDGN) has what I believe to be the most disrupti... http://t.co/c3IBIWYR
about 1 day ago Stocks Vacillate To Mixed Finish; Some Leaders Rally http://t.co/dtOQTRgh
about 1 day ago Myriad's Prolaris Test Shown to Significantly Predict Biochemical Recurrence Risk; FDA Approves JANUMET XR: Belo... http://t.co/a7IlIvbS
about 1 day ago Athersys $ATHX gets grant to study traumatic brain injury http://t.co/mnZTsxXx
about 1 day ago Watching: San Antonio patients help test new 'spray-on skin' for burns http://t.co/fzKA9B23
about 1 day ago OncoSec's President and CEO explains his firm's ambitious list of milestones for 2012: During the past few sessi... http://t.co/fKOMc1TM

navigation

Free Phone Trade Alerts