Electro-Optical Sciences: Positive Results for MelaFind

Electro-Optical Sciences (MELA) recently announced positive topline results in a pivotal clinical trial for MelaFind, which was conducted at seven medical centers across the U.S. and included nearly 1,400 patients and over 1,800 pigmented skin lesions. A larger study will also be conducted for MelaFind, with the results planned for submission to the FDA (see the Emerging Diagnostics Index.)

The Company is currently preparing to file a PMA (with a six-month priority review designation and advisory panel meeting expected) for medical device marketing approval from the FDA based on the study findings, which represents the largest prospective study for melanoma detection (see BioMedReports.com's FDA Calendar.)

MelaFind demonstrated 98% sensitivity (correctly identifying the disease when it is actually present) in the detection of melanomas (identifying 125 out of 127 overall melanomas) and 9.5% specificity (ability to rule out the disease when it is not present), compared to 3.6% for the 39 dermatologists who participated in the study.

The major advantage of MelaFind is the ability to examine lesions below the skin surface. The device is meant to aid dermatologists by going beyond skin surface examinations and providing additional data to determine if a more invasive biopsy is required for suspicious lesions.

An estimated 650,000 people in the U.S. visit a dermatologist each year because of a suspicious skin lesion and experts estimate that 4-10 million Americans have risk factors for the development of melanoma. Early diagnosis of melanoma is crucial for effective treatment and survival, as it represents the fastest growing cancer (6% annually) which is responsible for 80% of all skin cancer deaths.

The MelaFind System is an objective diagnostic screening test that incorporates 10 different wavelengths, which was developed and tested on 600 different melanomas. MelaFind works by taking 10 digital images across the different wavelengths, which are processed by algorithms based on a database including 9,000 skin lesions and 600 melanomas. The system provides the clinician with an immediate result to aid in the decision of whether to perform a biopsy.

MELA ended the year with $15.4M in cash, 20.6M fully diluted shares of common stock, a 17.6M net loss over the past 12 months, a market cap of $80M, and an expected cash burn rate of $1.3M per month going forward.

Disclosure: no positions

Comments

[hoopdreamer...:]

So basically this device calls everything melanoma. That way it captures 98% of melanoma correctly but also incorrectly calls non melanoma, melanoma over 90% of the time. Sounds like a winner :)

Mar 18 08:41 AM

[Mike Havrilla:]

not exactly, it represents a screening tool for dermatologists and an improvement over visual screenings which had a 3.6% specificity versus 9.5% for the device. also picks up lesions below the surface


On Mar 18 08:41 AM Jose McIntyre wrote:

> So basically this device calls everything melanoma. That way it captures
> 98% of melanoma correctly but also incorrectly calls non melanoma,
> melanoma over 90% of the time. Sounds like a winner :)

Mar 18 09:22 AM

[hoopdreamer...:]

Mike, the results were horrible. This will never get approved.

Apr 13 11:06 PM

[Mike Havrilla:]

Thats fine, the stock is still up from around 4 bucks to 6 and change in a few weeks so someone disagrees with you in addition to me!


On Apr 13 11:06 PM [e-mail] wrote:

> Mike, the results were horrible. This will never get approved.

Apr 14 04:43 AM

[Mike Havrilla:]

Someone still disagrees with you -- MELA now flirting with 8 bucks from around $4 when I wrote the original article!


On Apr 13 11:06 PM [e-mail] wrote:

> Mike, the results were horrible. This will never get approved.

May 01 12:46 PM

[frankie c:]

watch the daily volume on this one

May 04 11:48 AM