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I've had my eye on this for a few weeks now and just after the bell Friday this PR was released....I think she could be a ripper at da bell.....
Ruff!!!!!
Business Editors
VANCOUVER, British Columbia--(BUSINESS WIRE)--July 8, 2005-- MIV Therapeutics, Inc. (OTCBB:MIVT), a developer of next-generation biocompatible stent coatings and drug delivery technologies for the treatment of cardiovascular disease, has reported significant progress in a report outlining the achievement of numerous key corporate and technological objectives for the first half of 2005. MIVT has systematically reinforced its strategic goal to capitalize on proprietary Hydroxyapatite (HAp) coating technologies, which have demonstrated consistently high levels of safety and biocompatibility in repeated scientific studies. The Company's achievements for the first half of 2005 include execution of a Letter of Intent to acquire India-based Sahajanand Medical Technologies (SMT), the world's third largest manufacturer of drug-eluting stents, and a leading innovator in advanced laser technologies for cost-effective manufacturing of world-class quality cardiovascular stents. During this period, MIVT also successfully acquired SagaX Medical Technologies, a privately held company developing a proprietary Aortic Embolic Protection Device (AEPD), a novel filtration device designed to prevent Cardioembolic Strokes by diverting particles that might otherwise reach the brain. The Sahajanand and SagaX agreements are designed to significantly broaden MIVT's portfolio of technology and expertise, and are expected to provide a major boost to its marketing and commercialization efforts. "We are very pleased to report that in the first six months of this calendar year were marked with outstanding successes that rewarded our endeavors towards meeting our strategic corporate objectives for 2005," said Alan Lindsay, President and CEO of MIVT. "Our concentrated efforts to develop the core strengths of our proprietary medical device coating technologies are approaching a turning point in MIVT's corporate history. Excellent results from porcine animal trials of the proprietary HAp coating technology and novel drug-eluting solutions confirm their outstanding biocompatibility and safety, and bring a promise of unique therapeutic capabilities. Our recent proposed acquisition of Sahajanand, along with our successfully completed acquisition of SagaX Medical Technologies set a firm foundation for accelerated progress of our technologies to the commercialization stage." Arc Rajtar, MIVT Vice President of Operations, added: "It has truly been an exceptional year for us thus far. We have received new and exciting validation of our proprietary coating technologies from many sources in and around the biomedical community. These include such events as the successful results from our latest animal trials, and the renewal of government grants and other official endorsements of the HAp-based technologies and products we're developing at an international scale. It is always gratifying to our team to receive independent positive confirmation of MIVT's next-generation coatings, which represent novel and innovative solutions that consistently demonstrate exceptional safety and biocompatibility, and suggest possibilities for significantly improved treatments for heart and cardiovascular disease."
Research & Development Milestones
-- March 2005 -- MIVT completes a successful pilot preclinical studies performed on different formulations of biocompatible Hydroxyapatite (HAp) nano-film coating specifically designed for cardiovascular stents. Independent histopathology studies confirm excellent biocompatibility and safety of the proprietary HAp coating for vascular applications.
-- April 2005 -- MIVT files two new patent applications for inventions developed by the Company's R&D Team, which are expected to enable the development and manufacture of a novel class of advanced composite drug-eluting coatings capable of delivering multiple drugs from a single implantable medical device.
-- April 2005 -- MIVT reports on positive results from several animal studies of the proprietary ultra-thin HAp coating. Consistent and problem-free performance of stents with MIVT's proprietary coatings confirms exceptional safety and biocompatibility of HAp passive coating technologies.
-- April 2005 -- Cardiovascular stents coated with MIVT's proprietary composite drug-eluting coating demonstrate uncompromised and exceptional biocompatibility and safety. The low amount of neointima ranks with the performance of the best contemporary stents described in literature utilizing a similar experimental setting.
-- May 2005 -- MIVT commences preclinical trials of its Aortic Embolic Protection Device (AEPD), a unique proprietary filtration device developed by SagaX Medical Technologies, a company that has been acquired by MIVT. AEPD is designed to divert particles that might otherwise reach the brain and cause strokes.
-- June 2005 -- A three-month follow-up phase of a porcine implantation study of HAp-coated cardiovascular stents demonstrates excellent safety and feasibility of MIVT's HAp-based coating technologies. An interim report on long-term in vivo safety studies performed at the Center for Research in Cardiovascular Interventions at the Methodist Hospital Research Institute in Houston, Texas, confirms earlier predictions of exceptional safety and biocompatibility of the ultra-thin HAp coating technologies at this critical follow-up stage
Business and Financing Achievements
-- March 2005 -- MIVT executes a Letter of Intent to acquire Sahajanand Medical Technologies (SMT), one of the world's largest manufacturers of advanced coronary stents. Based in Surat, India, SMT is a leader in the use of high-precision laser technology, and a leading manufacturer of state-of-the-art drug-eluting and non-drug-eluting stents. Established in 1997, SMT is the largest privately-held producer of coronary drug-eluting stents outside of North America, with its stent products sold in more than 33 countries and used in more than 30,000 implants. The Company expects to cross the benchmark of 50,000 implanted stents this year.
-- March 2005 -- MIVT acquires SagaX Medical Technologies, a privately held company developing a unique Aortic Embolic Protection Device (AEPD). The AEPD is expected to decrease likelihood of strokes and other frequent, serious complications that can result from cardiac procedures, as well as from naturally occurring Cardioembolic Strokes. The market for AEPD is estimated to exceed $1.5 billion by 2009.
-- March 2005 -- MIVT receives governmental Natural Sciences and Engineering Research Council of Canada (NSERC) grant for research program entitled, "Development of Novel Drug-Eluting Composite Coatings for Cardiovascular Stents." The research is being conducted by MIVT subsidiary MIVI Technologies, Inc. in cooperation with scientists from the University of British Columbia.
-- June 2005 -- MIVT exercises the option provided in its Collaborative Research Agreement with the University of British Columbia to license four additional technologies for advanced biocompatible and drug-eluting coatings for cardiovascular stents and other medical devices to further the Company's research and development program.
Industry Recognitions and Scientific Presentations
-- April 2005 -- Dr. Dov Shimon, Chief Medical Officer and Director of MIV Therapeutics Inc. presents MIVT's business and growth strategy based on the Company's unique HAp-based multi-layer/multi-drug delivery systems for vascular stents at the Third Annual Biotechnology Conference in New York, N.Y.
-- April 2005 -- MIVT announces the online availability (http://www.trilogy-capital.com/tcp/mivt/video.html) of a video presentation of the Company's advanced biocompatible and drug-eluting coatings for cardiovascular stents and other medical devices. The unique passive biocompatible features combined with the active drug-elution functionality of the HAp coating are expected to reduce inflammation and eliminate some complications that are often attributable with currently available cardiovascular stents and other implanted medical devices.
-- May 2005 -- Dr. Tom Troczynski, PhD, Vice President of Coatings of MIV Therapeutics Inc., and a Professor of Ceramics at UBCeram in the Materials Engineering Dept. of the University of British Columbia, delivers a public presentation entitled, "Progress in Development of Composite Calcium Phosphate Coatings for Stents," and other MIVT Advanced Coating Technologies at the 4th European Symposium of Vascular Biomaterials in Strasbourg, France.
-- May 2005 -- BiomedDiscoveries.com, an online source for exclusive investor information, announces the availability of an audio interview featuring CEO Alan Lindsay, who discusses the benefits of MIVT's recent acquisition of SagaX Medical Technologies.
-- May 2005 -- MIV Therapeutics makes debut at the Paris Course on Revascularization (PCR2005) in Paris, France, sharing an exposition booth with potential future partner, Sahajanand Medical Technologies, Pvt. Ltd.
-- June 2005 -- MIVT is featured in a recent edition of respected European medical industry publication, Cardiovascular News.
Strengthened Management
-- May 2005 -- Mr. Dhirajlal Kotadia, founder and CEO of India-based advanced stent manufacturer, Sahajanand Medical Technologies, is appointed to the position of Co-Chairman and Managing Director of International Operations for MIVT. Mr. Kotadia pioneered the use of advanced laser cutting technology that transformed the jewelry diamond-cutting industry, founded Sahajanand Medical Technologies in 1998 and has since built the company into the third-largest maker of drug-eluting stents in the world.
About MIV Therapeutics, Inc.
MIV Therapeutics Inc. is developing a next generation line of advanced biocompatible coatings for passive and drug-eluting application on cardiovascular stents and other implantable medical devices. The Company's ultra-thin coating formulation is designed primarily to protect surrounding tissue from the chemical interaction with metal stents. The Company's unique ultra-thin coating has been derived from a biocompatible material called hydroxyapatite (HAp) that during in-vivo animal trials demonstrated excellent safety and superior healing properties pursued by the science in the field of advanced implantable drug delivery systems. Hydroxyapatite is a bioactive porous material that makes up the bone mineral and matrix of teeth. It is widely used as a bone substitute material and for coating implantable fixation devices in orthopedic, dental and other applications. The Company's novel drug eluting technology provides an alternative solution to polymer-based drug eluting coatings currently in the stent market. The Company's drug eluting coating is designed to suit a broad range of implantable medical devices which may benefit from a highly customizable drug release profile. MIVT reached a Collaborative Research Agreement (CRA) with the University of British Columbia and supported a research and development grant from the Natural Sciences and Engineering Research Council of Canada (NSERC) in 2002 for the development of Hydroxyapatite as a drug eluting coating. In December 2004 MIVT received a Government grant for the research program titled "Development of Novel Drug Eluting Composite Coatings for Cardiovascular Stents" under the National Research Council -- Industrial Research Assistance Program (NRC-IRAP). Under this sponsorship the Company will progress to the development stage, which is expected to finalize the drug-eluting research and development Program. For more information, please visit http://www.trilogy-capital.com/tcp/mivt/website.html. To read or download MIV Therapeutics' Investor Fact Sheet, visit http://www.trilogy-capital.com/tcp/mivt/factsheet.html. To obtain daily and historical Company stock quote data, and recent Company news releases, visit http://www.trilogy-capital.com/tcp/html/mivt.htm.
MIVT - MIV THERAPEUTICS INC (OTCBB) Date Open High Low Last Change Volume % Change 07/08/05 0.6700 0.7500 0.6600 0.7300 +0.0800 1258384 +12.31%
Composite Indicator Trend Spotter TM Buy
Short Term Indicators 7 Day Average Directional Indicator Buy 10 - 8 Day Moving Average Hilo Channel Buy 20 Day Moving Average vs Price Buy 20 - 50 Day MACD Oscillator Buy 20 Day Bollinger Bands Buy
Short Term Indicators Average: 100% - Buy 20-Day Average Volume - 252780
Medium Term Indicators 40 Day Commodity Channel Index Buy 50 Day Moving Average vs Price Buy 20 - 100 Day MACD Oscillator Buy 50 Day Parabolic Time/Price Buy
Medium Term Indicators Average: 100% - Buy 50-Day Average Volume - 270180
Long Term Indicators 60 Day Commodity Channel Index Buy 100 Day Moving Average vs Price Buy 50 - 100 Day MACD Oscillator Buy
Long Term Indicators Average: 100% - Buy 100-Day Average Volume - 440432
Overall Average: 100% - Buy
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Introducing Traders Nation Television and Streetcast Television Partnership Tuesday July 5, 1:05 pm ET
PHOENIX, July 5, 2005 (PRIMEZONE) -- Traders Nation Network and Traders Nation(TM), the largest syndicated 'live' radio talk show for smallcap stocks under the parent company of Desert Son Media Corp., is pleased to announce its television debut, in partnership with Streetcast Television, a simulcast televised version of its popular radio show. The show will debut July 18, 2005 at http://www.tradersnation.com/radio.shtml and http://www.streetcast.tv.
Kurt Schemers, creator of Traders Nation(TM) and President of Desert Son Media Corp., says, ``Fans of Traders Nation(TM) now can watch the show via the internet and when announced, millions of additional viewers through cable stations across the country.'' Schemers further states, ``Going to television is a natural progression for us, the demand for quality smallcap financial content is strong and Traders Nation(TM), the leader in this space, will meet that demand. In coordination, we look forward to growing our television presence with our new partner Streetcast Television -- they share the same professional broadcasting ideals we have.''
Aaron Henderson, CEO of Streetcast Television stated, ``We are always interested in providing our viewers with the best content on Streetcast Television. Traders Nation(TM) offers our viewers live and interesting commentary each day and we are pleased to introduce them to our broadcast team.''
About Streetcast Television:
Streetcast Television is a Television Broadcaster providing current financial news and content on the Equities Markets. Our mandate is to provide various strategic advertising services to companies to increase their investment appeal amongst the financial community and Main Street. Partnering with America One Cable, a 24-hour broadcast network that provides programming to over 30 million households via 127 broadcast affiliate stations located in 40 states, the Streetcast Television broadcast is currently seen 4 days each week on the America One Network and has a viewing audience upwards of 500,000 respondents.
The Show named ``Traders Nation(TM)'':
Multiple segments make up the 'LIVE' hour-long program where listeners gather daily to hear the latest smallcap news of the day and scheduled guests, from industry experts and CEOs. Traders also share investing, trading strategies and potential hot stock plays swirl throughout the call-in portion of the show.
-- Traders Nation(TM) broadcasts are fed on the New York ABC's Starguide Satellite System which can be received by over 4,000 radio stations across the United States. Our station affiliates capture Traders Nation(TM) for either a simulcast or rebroadcast of the show. http://www.tradersnation.com/program_clock.shtml
-- Traders Nation(TM) is currently syndicated online with 119 sites carrying the show and is broadcasted on WTAN 1400AM & WZHR 1340AM in Tampa, Florida and KWAI 1080AM in Hawaii.
-- Traders Nation(TM) is heard by tens of thousands of end users via QuoteStream online financial software.
-- Traders Nation(TM) is Apple's iTunes only pre-select financial talk show listed.
-- TradersNation.com is the developer of ProXstream, a media player for the active trader. Traders can now access alerts, news, quotes, SEC filings, charts, free level II, and a variety of interviews and live radio talk shows that are fresh right from the Traders Nation(TM) studios. http://www.tradersnation.com/proxstream.shtml
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MIV Therapeutics Announces Availability of Research Report Projecting 300% Share Value Increase in 12 Months Tuesday June 28, 5:10 pm ET Report by SISM Research & Investment Services Affirms 'Speculative Buy' Recommendation and Stock Price of $1.50
VANCOUVER, British Columbia--(BUSINESS WIRE)--June 28, 2005--MIV Therapeutics, Inc. (OTCBB:MIVT - News), a developer of next-generation biocompatible stent coatings and drug delivery technologies, has announced the availability of an extensive research and investment report by SISM Research & Investment Services that projects a 300% increase in share appreciation, and reaffirms a Speculative Buy/4 recommendation of the Company's stock with a 12-month target price of $1.50.
The SISM "Company Insight!" report, authored by leading market analyst Ernest C. Schlotter, concludes that the company's fully biocompatible, ultra-thin HAp coating technology positions it to become a world leader in the coated medical device market.
The report provides a detailed overview of MIVT's proprietary Hydroxyapatite (HAp)-based biocompatible stent coatings and novel drug-delivery solutions designed to address known weaknesses of current drug-eluting systems. The report outlines MIVT's intellectual property portfolio, which was strengthened recently through exclusive licensing of four additional technologies from the University of British Columbia. It also reviews key research milestones achieved to date.
For example, the report states: "In June 2004, MIVT commissioned Toxikon Corp., of Bedford, MA, to complete a full range of twelve biocompatibility studies on its proprietary HAp coating technology. All twelve studies were successful and confirmed HAp's exceptional biocompatibility."
The report adds: "MIVT's HAp stent coating also demonstrated excellent performance and biocompatibility in all key areas at three-month follow-up of porcine trials, paving the way for MIVT to enter the lucrative drug-eluting stent market."
The report also expands on MIVT's key investment and business highlights, including the completed acquisition of SagaX Medical Technologies and an agreement to acquire advanced stent manufacturer Sahajanand Medical Technologies, one of the world's largest manufacturers of advanced coronary stents outside of the U.S. The pending acquisition of Sahajanand is expected to bring MIVT approximately $20 million in revenues in its first year, as well as immediate access to Sahajanand's world-class production facilities and well-established distribution network.
The report concludes: "Based on the Company's strong management team and outstanding proprietary coating technology, MIVT is clearly undervalued, and we reaffirm our Speculative Buy/4 recommendation for the stock of MIV Therapeutics with a 12-month target price of $1.50."
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MIV Therapeutics Reports on Successful Progress of Animal Studies of Hydroxyapatite in Preparation for Clinical Trials Thursday June 23, 3:30 am ET HAp-Coated Cardiovascular Stents Demonstrate Excellent Safety and Feasibility at 3-Month Follow-up after Porcine Implantation
VANCOUVER, British Columbia--(BUSINESS WIRE)--June 23, 2005--MIV Therapeutics, Inc. (OTCBB:MIVT - News), a developer of next-generation biocompatible stent coatings and drug delivery technologies, has announced that its proprietary Hydroxyapatite (HAp) stent coating has demonstrated excellent performance and biocompatibility in key areas assessed at the three-month follow-up stage of an ongoing study in which HAp-coated stents were implanted in pig cardiovascular arteries. The results of the study, conducted at The Methodist Hospital Research Institute in cooperation with Texas Heart Institute, pave the way for upcoming human clinical trials of HAp coatings for stents.
"We are greatly encouraged with the interim results of this porcine study, which confirm our earlier observations about the superb biocompatibility and safety of our proprietary coating technologies based on Hydroxyapatite," said Alan Lindsay, CEO and Chairman of MIVT. "Successful completion of this critical arm of the animal study marks another decisive step toward the technology's readiness for human trials, and ultimately the realization of its full business potential in several multi-billion-dollar biomedical segments. Our HAp-based coating technology's unique, long-term biocompatibility and safety is among its major advantages over conventional but outdated polymer-based coatings currently available on the market."
"MIVT's D4080 Hydroxyapatite coating had no impact whatsoever on the acute operational characteristics of the stent In-vivo, including pushability, trackability, flexibility, retention on the balloon in transit and ease of deployment and removal of the delivery system," said Dr. Greg L. Kaluza, Scientific Director of the Center for Research in Cardiovascular Interventions at the Methodist Hospital Research Institute in Houston, TX, who coordinates the porcine study. "These were all on par with leading stents on the market. No elevated inflammatory response was seen in any stents coated with Hydroxyapatite in comparison to bare metal stents, suggesting excellent biocompatibility. The favorable qualitative impression on biocompatibility was complemented by low neointimal thickness and percent area stenosis," he added.
The porcine study focuses on non-drug-eluting, or "passive," HAp coating technologies. MIVT, however, also plans to apply its coating technology to other medical device products in development, as well as to other kinds of coatings, including "active" drug-eluting coatings.
"The study offers for the first time important insights into the mid-to-long-term porcine performance of MIVT's non-drug eluting, or "passive," Hydroxyapatite coating technologies applied to the cardiovascular stents and studied in an in-vivo environment," said Dr. Arc Rajtar, Vice President of Operations and coordinator of MIVT's research program. "The latest results reinforce our strategy of using this highly innovative HAp coating technology as both a drug-eluting and non-drug eluting option, and moreover, not only for cardiovascular stents, but for a variety of additional medical devices, to meet the demands for safety and long-term performance of implantable medical devices. We have a number of solutions at advanced stages of development that will combine highly controllable drug-eluting profile of novel composites with exemplary long-term biocompatibility, excellent safety and unique properties of HAp. We expect this combination of highly desirable properties to meet demands of implantable medical devices that may act also as effective drug delivery systems with minimized or completely eliminated risks and weaknesses attributable to the similar devices available at the present time."
About the Methodist Hospital Research Institute, Houston
The Methodist Hospital Research Institute is a cornerstone of The Methodist Hospital's strategic vision for its future as a top-ranked academic medical center. The Research Institute is committed to moving the latest discoveries in the laboratory to the bedside in order to provide a new standard of care for our patients in Houston and in other parts of the country. For more information on The Methodist Hospital and the Methodist Hospital Research Institute, see www.methodisthealth.com.
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MIV Therapeutics Exercises Option to License Additional Proprietary Technologies for Biocompatible Drug-Eluting Coatings Wednesday June 8, 3:30 am ET New Licenses from U. of British Columbia will Strengthen Intellectual Property Portfolio in Novel Coatings for Medical Devices
VANCOUVER, British Columbia--(BUSINESS WIRE)--June 8, 2005--MIV Therapeutics, Inc. (OTCBB:MIVT - News), a developer of next-generation biocompatible stent coatings and drug delivery technologies, announced it has exercised the option provided in its Collaborative Research Agreement with the University of British Columbia (UBC) to license two additional technologies for advanced biocompatible and drug-eluting coatings for cardiovascular stents and other medical devices.
The announcement of the latest patent licensing comes in the wake of the MIVT's announcement of the licensing of two other proprietary technologies from UBC that relate to the use of Hydroxyapatite (HAp) medical device coatings. Together, these four recently licensed technologies considerably broaden and intensify the Company's research and development initiatives towards the creation of unique and improved solutions for biocompatible and drug-elution products in the multi-billion-dollar medical device industry.
"Expansion of our worldwide exclusive licensing rights to these HAp coating technologies licensed from the University of British Columbia puts MIVT in a firm position to explore the superb biocompatibility and drug-eluting properties of HAp as a coating of choice for cardiovascular stents and other medical devices," said Alan Lindsay, CEO of MIVT. "Acquisition of the latest technologies from UBC deepens and broadens the Company's scientific and marketplace leadership in the creation of the next generation of biocompatible drug-eluting coatings."
All four of these technologies involve novel applications of HAp, a ceramic material that has demonstrated excellent biocompatibility in a range of research studies, as well as in already-commercialized dental and orthopedic products. The new license will complete MIVT's exclusive rights to advanced methods developed under the Collaborative Research Agreement with UBC for the processing of HAp and its application to implantable medical devices. The patent applications will be filed with the U.S. Patent and Trademark Office.
MIVT expects to commence animal testing of its HAp biocompatible drug-eluting cardiovascular stents by the end of the year. MIVT's research and development program for Hydroxyapatite-based drug delivery system received a grant from the National Research Council - Industrial Research Assistance Program (NRC-IRAP) in December 2004.
The first of these two patents applications, "BioPolymer-BioCeramic Composite Coatings and Process for Making the Same," discloses a novel process in which porous HAp coatings are combined with bio-polymer for improved functionality. These composite coatings can be used as drug delivery vehicles for the controlled release of the bioactive agents on implanted medical devices. The other patent application, "Process for In-Situ Synthesis of Organo-Ceramic Composites," describes a similarly innovative process for nano-scale synthesis of bioceramic such as HAp with organic compounds such as biopolymers or drugs. This process results in homogenous nano-composites suitable for tissue engineering, coatings, and controlled drug delivery.
"From its earliest concept stage, the HAp coating technologies were conceived and developed by MIVT as a multiplatform solution," said Dr. Tom Troczynski, Vice President of Coatings at MIVT and Professor of Ceramics at the University of British Columbia. "The two new technologies for bioceramic-biopolymer composites with capability to provide controlled, gradual drug release will bring to market fundamental advantages that other coating technologies do not offer." The two new patent applications were co-authored by Dr. Troczynski.
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MIV Therapeutics Featured in Respected Europe-Based Medical Industry Publication 'Cardiovascular News' Monday June 6, 3:30 am ET Article Discusses Company's Planned Acquisition of Advanced Stent Manufacturer Sahajanand Medical Technologies
VANCOUVER, British Columbia--(BUSINESS WIRE)--June 6, 2005--MIV Therapeutics, Inc. (OTCBB:MIVT - News), a developer of next-generation biocompatible stent coatings and drug delivery technologies, announced that the Company has been featured in a recent edition of respected European medical industry publication, Cardiovascular News. The article discussed the Company's recently announced agreement to acquire Sahajanand Medical Technologies (SMT), a manufacturer of advanced drug-eluting coronary stents based in Surat, India.
The successful execution of the acquisition will position MIVT as the world's third largest manufacturer of drug-eluting stents. The Cardiovascular News article notes that SMT, based in Surat, India, is the largest privately held producer of coronary drug-eluting stents outside of North America, with more than 25,000 implants sold in more than 33 countries. MIVT expects SMT to generate approximately $20 million in revenues in the next year.
MIVT develops advanced biocompatible coatings based on its proprietary Hydroxyapatite (HAp) technology, designed for use in both passive and drug-eluting applications on cardiovascular stents and other medical devices. The Company believes the acquisition of SMT will position it to become a global technology leader in the stent marketplace.
"This acquisition creates powerful synergies that will immediately make MIVT a world-class drug-eluting stent company, uniting our pipeline of proprietary future technology with SMT's advanced manufacturing and distribution capabilities," said MIVT's CEO Alan Lindsay.
The article also discusses a separate strategic agreement that MIVT has signed with Saga X Medical Technologies, a developer of advanced proprietary solutions that decrease the likelihood of strokes and other frequently-occurring, serious complications that can result from cardiac procedures, as well as naturally occurring Cardioembolic Strokes.
Cardiovascular News, a respected source of English-language medical news, is published by London-based BIBA Publishing.
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I hope everyone took advantage of the dip on MIVT......
VANCOUVER, British Columbia, Jul 13, 2005 (BUSINESS WIRE) -- MIV Therapeutics, Inc. (OTCBB:MIVT), a developer of next-generation biocompatible stent coatings and drug delivery technologies, has successfully completed Phase I animal feasibility studies in sheep of a novel implantable arterial filtration device designed to prevent strokes by diverting embolic particles flowing through the bloodstream. The Aortic Embolic Protection Device (AEPD) is designed to be implanted in the aorta, one of the body's main arteries, during heart surgery to divert particles that might otherwise reach the brain, where they could trigger embolic strokes, an extremely serious complication that can occur during cardiac surgery.
This successful first phase of the animal studies pave the way for further animal studies, and then for human clinical trials -- the last major testing milestones as the Company prepares the stroke-preventing technology for FDA approval and potential commercialization. The AEPD filtration devices are being developed by wholly-owned MIVT subsidiary SagaX Medical Technologies Inc.
"We fully expect that this new technology, once ready for the market, will have the capacity to save countless cardiac patients from the devastating effects of embolic stroke," said Dr. Dov Shimon, founder and CEO of SagaX, and Chief Medical Officer and Director of MIVT. "We look forward to proceeding to the next phases of animal studies, which are the next milestones in readying this technology for human trials."
Embolic particles that reach the brain are among the chief causes of strokes, which are the third-leading cause of death and the leading cause of disability in the world. AEPD is one of the latest innovations in the field of filter-based embolic protection devices and is the only filter being developed for use in the aorta.
MIVT estimates that the global market for AEPD devices could exceed $1.5 billion by 2009. The Company believes AEPD will be particularly useful during invasive heart procedures such as electrophysiology, valve dilatations and valve repair through angioplasty. But the technology may also find broad preventative applications, Dr. Shimon noted, such as during minimally invasive alternatives to open surgery.
MIV Therapeutics' CEO Alan Lindsay said he was greatly encouraged with the results. "The feasibility studies confirm earlier observations in the laboratory showing excellent efficacy and function of AEPD," he said. "This continued progress in our development of both prototypes of the AEPD is essential in our realization of the devices' full business potential in multi-billion-dollar neurovascular segments."
Two prototypes of the AEPD devices were tested in the feasibility studies. The AEPD I version is a self-expanding nitinol stent-based filter in the aorta. AEPD II is a braided self-expanding Elgiloy stent deployed in the innominate artery, the major branch of the aortic arch that prevents brain emboli from causing acute strokes. Both AEPD I and AEPD II were inserted through a small catheter from the sheep's femoral artery and were passed retrogradely under fluoroscopy to the aortic arch.
"The study demonstrated excellent hemodynamics, ample X-ray visibility and easy drivability through a 2.3mm-diameter catheter," said Dr. Shimon. "Direct echocardiography also demonstrated good location and no significant flow disturbances. In addition, AEPD I is deployed, recaptured, relocated and removed using a proprietary delivery system designed to make it an ideal solution for embolic protection for heart surgery and invasive trans-catheter procedures in the heart."
The studies are being conducted at the world-renowned Hadassah University Hospital Cardiology Research Institute in Jerusalem, Israel, under the stewardship of cardiac specialists, Dr. Chaim Danenberg and Dr. Ronen Beeri.
The SagaX AEPD filter employs patented stent based filter-deflector technology that can be used during Trans-Catheter Cardiology procedures, as well as during heart surgery, to minimize the risk of stroke. Cardioembolic Stroke, a grave post-procedural complication, is most frequently experienced by patients with a number of risk factors. These risk factors include: previous strokes; rhythm irregularities, such as atrial fibrillation (which is present in 1-2% of the adult population and 7-10% of the people above 70); congenital malformations of the heart, such as patent Foramen Ovale (PFO); heart valve disease, and previous heart valve surgery. AEPD is one of the latest innovations in the field of filter-based embolic protection devices, and is the only filter developed for use in the aorta. Preliminary evaluation of prototype devices confirmed effectiveness of AEPD in an in-vitro model.
About SagaX Medical Technologies, Inc.
SagaX develops a range of proprietary solutions, primarily endovascular interventional products, which decrease the likelihood of strokes and other serious complications that may result from cardiac procedures, as well as from naturally occurring Cardioembolic strokes. The Company's R&D center is located in Herzlya, Israel, directed by Dr. Dov V. Shimon, M.D., the founder and CEO of SagaX Inc., and MIV Therapeutics director and Chief Medical Officer. In March 2005, MIVT completed its acquisition of SagaX. One of the flagship technologies from SagaX is its Aortic Embolic Protection Device (AEPD), which employs patented stent based filter-deflector technology that can be used during Trans-Catheter Cardiology procedures, as well as during heart surgery, to minimize the risk of stroke.