|Monday, 23 March 2009 17:37|
Since I last wrote about Electro-Optical Sciences (MELA) positive results for MelaFind as a new diagnostic screening device for melanoma, the Company presented at the buy cialis online without prescription Cowen and non prescription viagra substitute Company Healthcare conference. Below is a summary of the presentation, including the razor/razor blade business model and brand name cialis overnight targeted commercialization plans on a regional basis for MelaFind.
The pivotal Phase 3 trial for MelaFind achieved statistically significant results for the pre-specified clinical outcomes agreed upon with the FDA and it is the largest prospective study ever conducted for melanoma screening. MELA expects to file for FDA approval of MelaFind as a new medical device once the final statistical report is prepared and becerenotel.com/proscar-vs-propecia/ integrated into a PMA filing. The PMA filing will be given a priority, expedited 180-day review and buy viagra germany canadian meds a FDA Advisory Panel meeting is expected to occur around the mid-point of the review cycle.
MelaFind offers dermatologists the ability to examine lesions below the surface at a very high resolution down to the cellular level (a three-cell resolution) to uncover cases of disorganized growth which are characteristic of melanoma and buy levitra are not always evident upon visual inspection at the surface level. MelaFind is a point-of-care screening device which assists dermatologists in the clinical decision of whether to perform a biopsy for suspicious lesions.
MELA expects to commercialize MelaFind on a regional basis starting with the Northeast based upon the number of dermatologists and purchase cialis overnight delivery the incidence of melanoma. MelaFind requires a low upfront investment, which is expected to be around $5,000 as a placement cost while MELA retains title to the device while offering additional software licensing and cialis dose upgrade fees. A card will be sold for each procedure, with expected pricing of $100 (split 50/50 with MELA and the dermatologist).
Based on average dermatologist practice volumes of 30-50 patients per day, MELA expects about one MelaFind exam per hour to occur. This equates to 40 cards per week or $100,000 (2,000 cards used) per year in income to the company and buy pfizer viagra the dermatologist for each MelaFind placement. The Company expects to market the device through patient/dermatologist education and soft cialis direct-to-consumer advertising. Patients have expressed positive opinions about MelaFind in marketing studies and buy clomid online it is hoped that the device will increase awareness of melanoma detection and www.stepspa.com/buy-flagyl-online/ drive new patients to see a dermatologist.
The financing history for MELA includes a November 2005 IPO at $5/share ($21.3M), November 2006 PIPE at $5.70/share ($13.2M), August 2007 PIPE at $5.75/share ($11.5M), August 2008 Registered Direct Offering at $5.68 per share ($11.9M). In total, MELA has raised $57.9M in equity financing at a weighted average price of $5.45 per share, which is well above the current share price around 4 bucks.
The Company ended 2008 with a cash balance of about $15.4M and has 20.6M fully diluted shares of common stock outstanding. Cash burn rate has been reduced significantly with the conclusion of the pivotal Phase 3 trial for MelaFind. Additional money will be required at some point to fund commercialization plans, but the CEO stated it would not occur at this time, as evidenced by a current stock price which is about 25% below the historical, weighted-average of $5.45 per share in the four equity financings outlined above.