Mark, MIVT .795 +.065 has news in AH here that may get it rocking toward it's high of the year tomorrow: MIV Therapeutics Successfully Completes Animal Feasibility Studies of Stroke-Prevention Devices
Wednesday July 13, 4:01 pm ET
Positive Experimental Results Speed MIVT's SagaX Subsidiary Toward Human Trials of Novel Aortic Embolic Protection Device
VANCOUVER, British Columbia--(BUSINESS WIRE)--July 13, 2005--MIV Therapeutics, Inc. (OTCBB:MIVT - News), 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.
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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.
About MIV Therapeutics
MIV Therapeutics 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 of metal stents. The Company's ultra-thin coating has been derived from a unique 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. A broader spectrum of synthetic parameters allows The Company's drug-eluting coating easily and widely applicable to various implantable devices with a pre-designed drug release profile to meet desirable clinical performance. MIVT reached a Collaborative Research Agreement (CRA) with the University of British Columbia. For more information, please visit trilogy-capital.com. To read or download MIV Therapeutics' Investor Fact Sheet, visit trilogy-capital.com. To obtain daily and historical Company stock quote data, and recent Company news releases, visit trilogy-capital.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements. Such statements are indicated by words or phrases such as "believe," "will," "breakthrough," "significant," "indicated," "feel," "revolutionary," "should," "ideal," "extremely" and "excited." These statements are made under "Safe Harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those described in forward-looking statements and are subject to risks and uncertainties. See the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's recent Form 10-K and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Copyright © 2005 MIV Therapeutics Inc. All rights reserved.
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Contact:
MIV Therapeutics Inc.
Investors:
604-301-9545
Fax: 604-301-9546
inverstor@mivtherapeutics.com
or
SagaX Inc. Product Inquiries:
Dov Shimon, M.D., 011-972-9-950-8089
dov@sagaxmed.com
or
Trilogy Capital Partners (Investor Relations)
Paul Karon, 800-342-1467
paul@trilogy-capital.com
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Source: MIV Therapeutics, Inc. |
