ParaMax device for early Glaucoma detection is awaiting FDA approval.

Paradigm’s (OTC: PDMI) has recently announced that his Italian partner CSO (Costruzione Strumenti Oftalmici) has completed  and submitted all necessary documents to the FDA regarding his lead device candidate ParaMax for Glaucoma early detection.

Paradigm team has been very busy these last months, preparing the release of fantastic new devices.

Paradigm is still in talk with different financial partners but now it seems they are being very selective in selecting the right one that will benefit the company the most.

Paradigm has many products to address the optometrist market but we will focus here on the 3 new products with the biggest potential.

Products:

Corneal topography — also known as videokeratography or corneal mapping — represents a significant advance in the measurement of the corneal curvature. Most corneal topographers evaluate 8,000 to 10,000 specific points across the entire corneal surface. By contrast, the Paravue processes more than 100,000 points. It also offers corneal wave front analysis with 2, 3 or 4 maps available for comparison.

1. Paravue 300 is a corneal topographer, (measures the curvature of cornea). The Paravue is a sophisticated topographer utilizing Placido Disk Technology and an advanced software to provide accurate and detailed analysis of the anterior corneal surface. It is FDA approved and is manufactured by CSO, (Italy).  Paradigm will begin promoting it as soon as funding issues are resolved.

1. Surveyor 500 is also a corneal topographer. The Surveyor has a Scheimpflug rotating camera and includes one of finest topographers with it. Release is same situation as Paravue 300.

According to the World Health Organization, approximately 60 million people suffer from glaucoma, making it one of the leading causes of blindness. It is estimated that the market is growing by approximately 10% per year, and it is expected to reach a value of $4 billion in 2010 (Decision News Media). Steve Davis, CEO of Paradigm believes that they have the product that will capture the bulk of that market with their ParaMax device.

1. Paramax is also from CSO and is being sold as Retimax outside the US. Paradigm has exclusive arrangement to represent this early glaucoma detection device in the US! It is in review by the FDA. Latest information states that all paperwork has been submitted and work completed for submission.

Glaucoma:

Everyone is at risk for glaucoma. According to the Glaucoma Research Foundation, approximately 1 out of every 10,000 babies in the U.S. is born with glaucoma. Certain groups also posses an increased risk, such as senior citizens. In fact, the Glaucoma Research Foundation found that people over the age of 60 are 6 times more likely to develop glaucoma than younger people. This group alone represents a very large number of people, especially as the baby boomer population is reaching these later ages.

About Steve Davis, new CEO of Paradigm:

Mr. Davis brings over 25 years of experience in global healthcare and medical devices markets and over 14 of those in the ophthalmic arena to Paradigm Medical Industries, Inc. Stephen has also served as the President and CEO for Zinetics Medical, Inc. Salt Lake City, Utah for nine years. Stephen was successful in raising over $2.7 million for Zinetics Medical and spearheaded the purchase of Zinetics Medical by Medtronic for over $50 million. He served as Site Director for Medtronic Functional Diagnostics for a year after the conclusion of the sale of Zinetics Medical. Prior to those responsibilities, Stephen was the Western Area Director for Barnes-Hind Hydrocurve and held additional responsibilities as a Regional Vice-President and District Sales Manager. He possesses a stellar background in the areas of strategic planning, start-up ventures, P&L and has a successful record in developing business in preparation for acquisition. Mr. Davis also has an extensive knowledge of the International markets. Stephen has a B.S. from Brigham Young University and additional studies in International Business and Finance.

Conclusion:

Paradigm could soon emerge from their past difficulties and gain investors attraction as soon as ParaMax is approved and a distributor partner is secured.

Clever investors would do their own due diligence and discover that it might be the good time to invest and take a long position on this company poised for a recovery; this could be the real new start for Paradigm.

(Public, OTC:PDMI.PK)

The Medical device industry has been one of the most successful industries within 2008 and 2009, and 2010 should continue that trend. StocksHaven Investments profiles Paradigm Medical Industries, Inc., a promising company who will soon begin to introduce the first of its four new ophthalmic diagnostic devices, the Paravue, during the remainder of 2009. Plagued by lawsuits, financial woes, and poor management — the company has made a vast array of changes during late 2008 and 2009 leading to an invigorated interest in past and present shareholders. The company named Stephen Davis the new president, an individual with an impeccable ability to attain funds and grants for struggling institutions, alongside 20 years experience in the ophthalmic industry. Paradigm also has the only patented technology utilizing photon lasers for cataract removal and is poised to capture a niche market within the glaucoma and ultrasound microscopy fields. The glaucoma market alone is estimated to reach $4 billion in 2010. With a portfolio consisting of a total of 15 devices currently available, and 4 pending release with one expect by end of 2009, Paradigm seems to have positioned itself nicely for a rebound in the near future.

About Paradigm Medical Industries, Inc.

Paradigm Medical Industries, Inc. develops, manufactures, sources, markets and sells ophthalmic surgical and diagnostic instrumentation and related accessories, including disposable products. The Company’s surgical equipment is designed for minimally invasive cataract treatment. Its cataract removal system, the Photon laser system, is a laser cataract surgery system designed to be marketed as the next generation of cataract removal. The Company’s diagnostic products include a P2000 pachymetric analyzer, a P37 Ultrasonic A/B Scan, P40, P45 and P60 UBM Ultrasound Biomicroscopes, a P37 A/B Scan, two perimeters, the Blood Flow Analyzer, and the Glaid. The diagnostic ultrasonic products, including the P2000 pachymetric analyzer, the P37 Ultrasonic A/B Scan and the P40 UBM Ultrasound Biomicroscope were acquired from Humphrey Systems, a division of Carl Zeiss.

Products

P2700 A/B Scan

10 MHz A-Scan and 10 MHz B-Scan with 10 inch integrated monitor and foldup keyboard, making the P2700 very portable for moving from room to room. 8 image memory and optional printer available.  Product Details…

P37-II A/B Scan

10 MHZ A-Scan and 10 MHz B-Scan with a flat color monitor, integrated key board and trackball. High resolution imaging with precise biometry incorporating the necessary formulas.  Product Details…

P60 UBM

P60 Ultrasound BioMicroscope® provides sulcus–to-sulcus imaging and three interchangeable probes including the new self-contained water path probe. Probe frequencies include 12.5 MHz, 20 MHz, 35 MHz, and 50 MHz. Available in single pulse frequency or  Product Details…

P37 A/B Scan

Ultrasound A and B Scan for precise biometry and high resolution retinal imaging. Designed for clinical application. Includes printer. Optional cart.  Product Details…

P40 Ultrasound BioMicroscope (UBM)

The Gold Standard in Ultrasound Biomicrosopy. The P40 Ultrasound BioMicroscope® provides a 50 MHz transducer frequency. Extreme high resolution ultrasound imaging with the resolution of a microscope.   Product Details…

P45 Ultrasound BioMicroscope (UBM)

The Gold Standard in a multi frequency UBM. Ultrasound BioMicroscope® with A and B Scan capabilities provided with a 10 MHz A Scan probe, a 10 MHz B Scan probe, and an 8 MHz diagnostic A Scan probe. The P45 UBM features a 50 MHz transducer, video printe  Product Details…

P50 Ultrasound BioMicroscope (UBM)

Paradigm’s high frequency Ultrasound BioMicroscope featuring 50 MHz and/or 35 MHz high frequency probe. The P50 provides high resolution image of the anterior chamber of the eye with unique measurement and database capabilities. Ideal for ICL measurement  Product Details…

LD400 AutoPerimeter

A unique, kinetic, voice-based, price effective, computer AutoPerimeter capable of threshold, fast threshold and suprathreshold testing exams. Patented kinetic fixation with voice response technology provides a price effective and unique AutoPerimeter. Fu  Product Details…

LD700 AutoPerimeter

The Paradigm LD 700 is our third generation compact and affordable autoperimter to join the Paradigm family. The small 10-lf4″x11-3f4″footprint makes the Paradigm LD700 ideal for areas where space is limited. With its optional carrying case, this 111b a  Product Details…

Ocular Blood Flow Analyzer

A unique Tonometer designed to measure intraocular pressure and specifically designed to measure and evaluate pulsatile blood flow. Clinically proven measurement designed to improve detection of glaucoma suspects and aid in managing the disease.  Product Details…

P-2000 Biometric Analyzer A-Scan

10 MHz A-Scan with probe fixation light, built-in LCD monitor and built-in printer in a unique compact design. Includes foot switch. Weighing less than 4lbs.  Product Details…

P2200 Pachymeter

20 MHz probe with built-in LCD monitor and build in printer in a unique compact design. Includes foot switch for easy operation. Weighing less than 4lbs.  Product Details…

P-2500 A-Scan/Pachymeter Combination

10 MHz A-Scan with fixation light and 20 MHz Pachymeter. Our unique design includes a with built-in monitor, built in printer and foot switch, all weighing less than 4lbs.  Product Details…

P55 Pachymeter

12 MHz solid tip probe for ease of use, compact and durable designed for clinical application. Optional Printer..  Product Details…

TKS 5000 AutoPerimeter

Full field autoperimetry system capable of optional testing beyond 60 degrees.  Product Detail

Financial Analysis ( From 3/31/09 10-Q )

Sales of the Blood Flow Analyzer TM decreased due in part from the reorganization of the Company’s sales force. The Company anticipates continuing the upward trend in Blood Flow Analyzer TM sales through additional efforts by the Company to gain more wide spread support from the Blood Flow Analyzer TM through increased clinical awareness, product development and improved marketing plans.

Sales of surgical products are at a standstill pending FDA approval of the Photon TM laser system. In the twelve month period ended December 31, 2008, the Company realized no sales in the surgical line consisting of the Photon TM laser system. There were also no sales in the surgical line for the comparable period of 2007.

The Company anticipates reversing the downward trend in sales through additional efforts by the Company to gain more widespread support for the P60 UBM Ultrasound Biomicroscope, the Blood Flow Analyzer™, the LD400 Antoperimetry System, the P37-II Ocular Ultrasound Diagnostic A/B Scan, the 2200 and 2500 Pachymetric Analyzers, the P2000 A-Scan Biometric Ultrasound Analyzer, the new agreement with the Costrugione Srumenti Oftalmici (“CSO”) organization and its ophthalmic products, and through increased clinical awareness, ongoing product development, improved marketing plans and strategic product replacement, and ongoing development of the LD400 perimeter. The Blood Flow Analyzer™ is expected to have a new CPT reimbursement code for Medicare insurance providers issued by the end of 2009, reversing the downward sales trend it has experienced.

Gross profit for the three months ended March 31, 2009 increased by 15% to 53% of total revenues, compared to 38% of total revenues for the same period in 2008. This increase in gross profit was mainly due to reductions in corporate expenditures as a result of improved operating efficiencies during the three months ended March 31, 2009. There was no increase to cost of sales as a result of a charge to the reserve for obsolete inventory in 2008.

Marketing and selling expenses decreased by $137,000, or 75%, to $46,000, for the three months ended March 31, 2009, from $183,000 for the comparable period in 2008. This decrease was due primarily to a reduction in overall marketing expenses, related travel expenses and a general reduction in staff.

General and administrative expenses decreased by $94,000, or 42%, to $128,000 for the three months ended March 31, 2009, from $222,000 for the comparable period in 2008. This decrease was due primarily to a reduction in overall general and administrative expenses, including a reduction in salaries and hours worked by employees and travel expenses. The bad debt allowance remained same from December 31, 2008 to $75,000 for the first three months ended December 31, 2008.

Also, during the three months ended March 31, 2009, the Company collected $58,000 in receivables that were previously allowed in the allowance for doubtful accounts.

Research, development and service expenses decreased by $24,000, or 27%, to $64,000 for the three months ended March 31, 2009, compared to $88,000 in the same period in 2008. This decrease was mainly due to a reduction of funding available for the marketing of new products and a reduction in staff.

Gain and loss of derivative valuation for the three months ended March 31, 2009 decreased by $113,000, or 93%, to $8,000 as compared to $121,000 for the same period in 2008.

Interest expense–accretion of debt discount for the three months ended March 31, 2009 decreased by $123,000, or 66%, to $62,000 as compared to $185,000 for the same period in 2008.

Interest expense for the three months ended March 31, 2009 decreased by $5,000, or 6%, to $72,000 as compared to $77,000 for the same period in 2008.

News & Announcements

Paradigm Medical Announces Plans to Release Its New Corneal Topographer, the Paravue, in the United States Market

ALT LAKE CITY, UT–(Marketwire – June 1, 2009) – Paradigm Medical Industries, Inc. (OTCBB: PDMI) announced today that the Company will soon begin to introduce the first of its four new ophthalmic diagnostic devices, the Paravue, during the remainder of 2009. The Paravue is a sophisticated topographer utilizing Placido Disk Technology and an advanced software to provide accurate and detailed analysis of the anterior corneal surface.

Corneal topography — also known as videokeratography or corneal mapping — represents a significant advance in the measurement of the corneal curvature. Most corneal topographers evaluate 8,000 to 10,000 specific points across the entire corneal surface. By contrast, the Paravue processes more than 100,000 points. It also offers corneal wave front analysis with 2, 3 or 4 maps available for comparison. Source

Paradigm Medical Industries Plans to Begin Clinical Work to Upgrade Its CPT Code for Its Blood Flow Analyzer From an Investigational to a Reimbursable Level

SALT LAKE CITY, UT–(Marketwire – May 26, 2009) – Paradigm Medical Industries, Inc. (OTCBB: PDMI) announced today that the Company plans to begin the important process of upgrading its CPT code (0189T) for its Blood Flow Analyzer from the American Medical Association from an investigational level (Class III) to one that will enable public and private medical centers to be reimbursed by their regional medical insurance companies for testing patients using the Blood Flow Analyzer. The Blood Flow Analyzer is used to detect glaucoma and aid in managing the disease. Source

PDMI has spent the past six months consolidating after a significant change in price back in April and now appears ready to climb. The current price channel has been in control for most of this year and the price action has respected the channel lines (Blue lines on the chart) very well. Today, the price clearly exceeded the ¼-level trend-line.  This move is backed-up by an enormous increase in volume (almost 150%).  Now, the stock seems to be headed for the middle trend-line around the .0042 cent level.  What is interesting is the fact that the daily 200 SMA (Yellow line on the chart) is currently at .0037 cents.  As we have seen with numerous stocks over the past six months, the trend is to jump the 200 SMA and use it as support while the daily 100 SMA (Orange line on the chart) starts to trend up looking for the Bullish cross over.  The increase in volume indicates the interest in this company’s recent activity seems very positive and this stock is ready to swing in a positive direction and carry on into the upper level of the conservative price channel and beyond. It’s good to keep in mind that the price has reached well above the top trend-line, trading over .015 cents back in January (over a 350% increase from today’s closing price).

Overall Sentiment

For Paradigm Medical Industries, Inc., it is easy to see why the company’s market cap has suffered, thus generating an all-time low price per share, leaving investors to scratch their heads questioning the future potential. This company has been beaten down and battered, in every sense of the word the last couple of years. They’ve endured financial failures, inability to generate sales, incoherent management, irresponsible leadership by the past CEO, and to top it all off lawsuits, as if this cupcake really needed the cherry on the icing. With a renewed sense of optimizing within the coming weeks due to the 4 new products, this play represents the perfect scenario for a high risk, high rewards style of investment.

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Disclosure: Short term position in PDMI

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