MIV THERAPEUTICS INC (OTCBB: MIVT)

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For any drug or drug delivery company, approval of its products for use in humans is an enormous corporate development.  But it’s even more significant when said achievement occurs in the world’s second most populous country.  This morning, MIV Therapeutics Inc. (OTCBB:MIVT), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, announced that the Drugs Controller General of India (DCGI), the governmental agency with regulatory authority over medical products, has approved two of the MIV’s bare metal stents for manufacture and sale in India.

This achievement positions MIV in one of the largest stent markets in the world and gives the company manufacturing capability as it advances the clinical development of unique drug-eluting stents using advanced biocompatible coatings and drug delivery technology.  This passage in India is a watershed event for MIV Therapeutics even if it comes through the minute portal of a small stent placed in the heart of an Indian cardiac patient.

MIV Therapeutics, Inc. is focused on commercializing the next generation of fully biocompatible coatings for cardiovascular stents and drug delivery systems to treat coronary artery disease, an estimated $6 billion worldwide market.

Breaking *News* From MIV Therapeutics Inc.

Press Release Source: MIV Therapeutics, Inc.
Monday November 12, 8:30 am ET

ATLANTA, GA--(MARKET WIRE)--Nov 12, 2007 -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB - News) (Frankfurt:MIV.F - News)developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, announces that the Drugs Controller General of India (DCGI), the governmental agency with regulatory authority over medical products, has approved two of the Company's bare metal stents for manufacture and sale in India.

The GenX(TM) Stainless Steel Coronary Stent & Stent System and the GenX(TM) CrCo Chromium Cobalt Coronary Stent & Stent System along with the company's additional angioplasty products will be officially launched into the Indian market at the Cardiological Society of India 59th Annual Meeting beginning December 5th to 9th in Hyderabad and will be available for sale in India through third party distributors.

Dr. Mark Landy, president of MIV Therapeutics, said, "This regulatory achievement permits MIV Therapeutics' entrée into one of the world's fastest growing stent markets with a highly competitive offering, and allows us to continue refining and increasing our manufacturing capability as we advance the clinical development of our unique drug-eluting stents using our advanced biocompatible coatings and drug delivery technology."

Coronary heart disease is a major health problem in India, one of the world's largest markets. According to a global study on cardiac diseases by the World Health Organization (WHO), India has the highest number of deaths from coronary heart disease in the world, exceeding 1.5 million in 2002. The WHO has predicted a cardiac epidemic for India by 2010.

"These two stents are designed to expand in a very controlled manner providing better vessel coverage. By expanding from the center outwards versus from the edges inwards they are designed to help reduce the injury caused during stent deployment and expansion. We believe they will help cardiovascular patients in India lead longer, healthier lives," concluded Dr. Landy.

The two stents are identical in design and performance with the main difference being strut thickness. The GenX(TM) Stainless Steel Coronary Stent has a strut thickness of 105 microns making it one of the thinnest-strut stainless steel stents available today. The GenX(TM) CrCo Chromium Cobalt Coronary Stent has a strut thickness of 65 micron, placing it amongst the thinnest-strut stents available today. Strut thinness has long been regarded as an important stent design feature as it reduces injury and aids re-endothelialization leading to lower restenosis and thrombosis rates.

You may view the entire news release HERE

Press Release Source: MIV Therapeutics, Inc.
Thursday November 8, 8:30 am ET

ATLANTA, GA--(MARKET WIRE)--Nov 8, 2007 -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB - News) (Frankfurt:MIV.F - News) ("the Company"), a leading developer of next-generation coatings and advanced drug-delivery systems for cardiovascular stents and other implantable medical devices, announces that new data from a previously presented animal study comparing the safety and efficacy of the Company's Vestasync hydroxyapatite (HAp) coronary stent coating with low-dose Sirolimus to the Cypher® Stent showed less fibrinoid, a marker for delayed healing and equivalent efficacy. The data were presented at the American Heart Association's Scientific Sessions 2007 in Orlando, Fla. yesterday.

Lead researcher Helena M. van Beusekom of Erasmus MC in Rotterdam, The Netherlands, made an oral presentation entitled, "Hydroxy apatite coating eluting low dose sirolimus shows less delayed healing but equal efficacy to Cypher in Porcine Coronary Arteries." The data presented showed a statistically significant difference between an increase in Sirolimus and an increase in fibrinoid material, which is a strong indicator of delayed healing. In the presentation, the researchers concluded that "Hydroxyapatite is a safe coating and effectively releases Sirolimus. All dosages were equivalent to Cypher at 28 days, even at a four-fold lower dose and shows significantly less fibrinoid." The data are derived from an earlier study in porcine coronary arteries presented last year that concluded that HAp is a safe coating and effective in releasing Sirolimus.

Dr. Mark Landy, president of MIV Therapeutics, said, "Our VESTASYNC stent utilizes significantly less Sirolimus than the Cypher and we believe that our 55 µg dosage form is by far the lowest dose Sirolimus stent either available or in development. All three doses of Sirolimus tested in this animal study, produced significantly less fibrinoid material than Cypher. In our recent First-In-Man trial, we went one step further and demonstrated both safety and efficacy of the VESTASYNC in humans at four months, and look forward to starting a larger study shortly."

"Applying the findings from this study could help patients experience faster healing. This is another benefit of inert non-polymeric coatings such as HAp, compared with conventional drug-eluting stents that use polymers to attach the drug to the stent. It is our goal to develop a drug-eluting stent that does not produce the same response as the current generation of stents. These data are another confirmatory point in our endeavor to develop the safest possible drug eluting stent and clearly support the further development of our technology," concluded Dr. Landy.

Delayed healing is a well documented problem of the current generation of approved drug-eluting stents and could lead to an increase in thrombosis rate or an increased need for revascularization. In the study, there was a clear correlation between the amount of Sirolimus eluted and fibrinoid material.

Cypher is a registered trademark of Cordis Corporation.

You may view the entire news release HERE
 

About MIV Therapeutics Inc.

MIV has recently acquired Biosync Scientific in India and earlier, SagaX in Israel to significantly expand product offerings, as well as design, manufacturing and distribution capabilities.

Working since 2001 in close collaboration with The University of British Columbia (UBC), MIVT has developed a unique biocompatible nano-film coating that eliminates the side-effects attributed to current stent technology. This is a major breakthrough, which utilizes Hydroxyapatite (HAp), a mineral and major component of human bones and teeth, to protect surrounding arterial tissue from direct contact with bare metal stent. Comprehensive animal studies demonstrated Hydroxyapatite improves the performance of bare metal stents by inhibiting inflammatory responses, a common cause of restenosis, a re-growth of vascular tissue following stent implantation. 

MIVT announced the first ever human implantation of a hydroxyapatite-coated stent and the launch of the MIVT Pilot Trial.  The MIVT Pilot Trial will evaluate the safety and efficacy of MIVT’s polymer-free nanoscale microporous hydroxyapatite drug-eluting stent for the treatment of single de novo lesions in native coronary arteries.  The first procedure was conducted by Dr. Alexandre Abizaid of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil. Dr. Abizaid and Institute Dante Pazzanes of Cardiology are among the world’s foremost experts in conducting clinical trials researching both new and existing drug-eluting stents.  

MIV Therapeutics announced on May 31, 2007: 

Start of Clinical Trial Marking First Ever Human Implantation of A Hydroxyapatite Coated Stent

The trial to study safety and efficacy of one of the company’s proprietary polymer – free drug eluting stent technologies

The beginning of human implantation represents the culmination of extensive research and development and a successful animal trial program. Human implantation represents a crucial milestone in MIVT’s strategic plan to develop a new class of polymer-free drug-eluting stents that could provide patients with superior outcomes.  "We are very pleased to announce that our human trials are underway in-line with our previous guidance," said Dr. Mark Landy, president of MIV Therapeutics. "We have worked diligently to create a new, novel technology that we expect will be an excellent alternative for millions of patients around the world suffering from coronary artery disease.

MIV Therapeutics is focused on commercializing the next generation of fully biocompatible coatings for cardiovascular stents and drug delivery systems to treat coronary artery disease, an estimated $6 billion worldwide market. The company's technologies are expected to offer a safer alternative to current drug-eluting stents and hope to solve the issues of late thrombosis.

MIVT’s polymer-free nanoscale microporous hydroxyapatite drug-eluting stent uses the Company’s GenX coronary stent system. The GenX stent is coated with one of MIVT’s proprietary hydroxyapatite polymer-free drug eluting systems that is 700 nanometers thin. 

This technology is not limited to stents and can be used on any implantable medical device including those in the orthopedic field. MIV also has a number of Non-Polymeric drug eluting coatings currently under development that are expected to offer a safer and possibly more effective solution to current products on the market. Human implantation of these technologies is also expected in 2007. 

MIVT’s current product portfolio encompasses the following preclinical development projects:

HAp-nano-film coating technology. MIVT's lead product in development is an HAp-coated coronary stent with a nano-film coating. HAp is naturally found in bone and tooth enamel and demonstrates complete biocompatibilty with the human body. As such, it may inhibit a variety of adverse and inflammatory reactions and potentially help reduce restenosis, a recurrence of CAD, Coronary Artery Disease, a re-blocking of arteries following angioplasty. It is also believed that HAp-coated cardiovascular stents, unlike their counterparts available at the global markets at the present time, will not trigger late adverse thrombogenic reactions. 

Drug-eluting stents. MIVT is expected to enter the drug-eluting stent market by using a thicker coating of HAp loaded with a suitable drug, i.e. anti-inflammatory. The technology has a variety of potential applications in cardiovascular and non-cardiovascular drug/device combination products, including peripheral stents, biodegradable implants, gene therapy, and delivery systems for release of chemotherapeutic agents. 

• Statistically, heart disease is the number one cause of mortality in North America
• 64 million-plus Americans suffer from cardiovascular disease
• Americans suffer over 1,000,000 known heart attacks each year
• Heart Disease and related care account for $329.2 billion and growing
• Women believe the greatest threat to their health is breast cancer (In reality, they are five times more likely to die of heart disease).

Other Recent News From MIVT

Press Release Source: MIV Therapeutics, Inc.
Tuesday October 23, 7:30 am ET

ATLANTA, Oct. 23, 2007 (PRIME NEWSWIRE) -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB - News) (Frankfurt:MIV.F - News), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, announces that Alexandre Abizaid, M.D., Ph.D., Chief of Coronary Intervention of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, performed one live four-month follow-up case from the MIVT pilot trial at the Transcatheter Cardiovascular Therapeutics (TCT) 2007 conference yesterday, during which angiographic, IVUS and OCT studies were conducted. This patient represented the 14th follow-up patient in the 15-patient First-in-Man pilot study with the VESTASYNC Polymer-Free HAp-Coated Sirolimus-Eluting Stent. The 15th patient, who was a back-up patient, if required for this live case in the event that the 14th patient was unable to undergo the procedure, will be followed up shortly, bringing to a close the four-month follow-up of the study.

You may view the entire news release HERE

Press Release Source: MIV Therapeutics, Inc.
Monday October 22, 6:30 am ET

ATLANTA, GA--(MARKET WIRE)--Oct 22, 2007 -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB - News) (Frankfurt:MIV.F - News), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, announced positive results from the four-month follow up of its First-In-Man study with its VESTASYNC stent. In a presentation titled "The MIV Polymer-Free Hydroxyapatite-Coated Sirolimus-Eluting Stent: First-in-Man Angiographic and IVUS Follow-Up Results," Principal Investigator Alexandre Abizaid, M.D., Ph.D., Chief of Coronary Intervention of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, noted excellent safety data with no Major Adverse Coronary Events (MACE), and good efficacy data.

At the Transcatheter Cardiovascular Therapeutics (TCT) 2007 conference being held this week at the Washington Convention Center in Washington, D.C., Dr. Abizaid presented four-month follow-up efficacy data on 13 patients in the 15-patient study, which by angiography showed average late-lumen loss of 0.27 mm (+/-0.27) in-stent and 0.18 mm (+/-0.31) in-lesion, and zero percent restenosis. IVUS analysis showed volumetric obstruction of only 2.8% (+/-2.4). All patients were thrombosis-free.

"These are excellent data, and they compare very favorably with FIM data generated by the currently available drug eluting stents both in the U.S. and abroad," commented Dr. Abizaid. "We are looking forward to completing our patient follow up and to further reporting on angiographic and IVUS data at nine months."

Dr. Mark Landy, president of MIV Therapeutics, said, "Based on this pilot trial, our VESTASYNC polymer-free HAp sirolimus-eluting stent system is sufficiently safe and effective to warrant testing in a larger human study. We are very pleased to be developing our protocol for further testing in the first half of 2008."

You may view the entire news release HERE

Press Release Source: MIV Therapeutics, Inc.
Tuesday October 16, 8:30 am ET

ATLANTA, GA--(MARKET WIRE)--Oct 16, 2007 -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB - News) (Frankfurt:MIV.F - News), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, announces that results of the first-in-man safety study with the Company's drug-eluting stent will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2007 conference, to be held October 20-25 at the Washington Convention Center in Washington, D.C.

Principal investigator Alexandre Abizaid, M.D., Ph.D., Chief of Coronary Intervention of Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, will make the presentation titled, "The MIV Polymer-Free Hydroxyapatite-Coated Sirolimus-Eluting Stent: First-in-Man Angiographic and IVUS Follow-Up Results." Dr. Abizaid's presentation will take place on Sunday, October 21 in Room 152A at 3:03 p.m. Eastern time. It is part of a practical workshop titled "First-In-Man Experiences With Drug-Eluting Stents I and Passive and Active Stent Coatings" within the scientific symposia "Innovative Devices and Futuristic Concepts I: Novel Bare Metal and Drug-Eluting Stents."

"We are very pleased the findings of this important first-in-man study will be presented at such a prestigious medical conference. This 15-patient study was conducted very efficiently, and began with the first human implantation of our low dose polymer-free hydroxyapatite-coated drug-eluting stent in May of this year, and each patient was followed for four months," said Dr. Mark Landy, President of MIV Therapeutics. "We are looking forward to the largest-ever presence for MIV Therapeutics at the TCT conference, we believe that acceptance to present at this conference is an important recognition of the significance of our proprietary technology."

You may view the entire news release HERE

Press Release Source: MIV Therapeutics, Inc.
Thursday September 27, 2:00 am ET

ATLANTA, GA--(MARKET WIRE)--Sep 27, 2007 -- MIV Therapeutics (OTC BB:MIVT.OB - News) (Frankfurt:MIV.F - News), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, today announced a research collaboration with contributions in kind from both Smith & Nephew and MIV Therapeutics to develop new coatings and drug delivery systems for orthopedic devices.

"We are honored to be working with Smith & Nephew, an established market leader in orthopedics and look forward to a long and prosperous relationship," said Mark Landy, President of MIV Therapeutics. "We have worked diligently to develop a product pipeline with multiple applications in multiple therapeutic disciplines and this collaboration is proof thereof. We now have programs in cardiology and orthopedics, and will continue to evaluate additional opportunities in different therapeutics areas."

You may view the entire news release HERE
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Financial Highlights For  MIVT

MIVT is a fully reporting company, to view the company filings at the SEC web site, click HERE

To Contact MIV Therapeutics

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