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March 2008
Rafael Medical Completes Multicenter Clinical Study
Rafael Medical is pleased to announce that it has completed all enrollment and follow-up in its SafeFlo Vena Cava Filter clinical study. The study, which commenced in July 2003, evaluated 117 patients in 8 medical centers in the U.S., Austria, Scotland, Greece, South Africa and Israel. The results of the study have been submitted to FDA and are currently under review. Presentations which will review the study data are expected at a number of conferences over the coming months.
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Feb. 2007
Rafael Medical in the Press
Rafael Medical has recently been profiled in a number of industry publications including the March 2007 issue of Cardiovascular Innovations (Biba Publishing) as well as in a Frost & Sullivan issue of Technical Insights.
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Jan. 2007
EZDployTM Deployment Handle
Representatives of Rafael Medical were on hand at the recent ISET conference in Miami, FL in order to present the new SafeFlo® delivery concept to potential end user physicians. Feedback from the physicians to the EZDployTM deployment handle was enthusiastic. The handle will provide simple and repeatable deployment of SafeFlo®'s spiral filter element while providing for full repositioning of the double ring anchoring system which facilitates the achievement of optimal filter positioning.
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Dec. 2006
Possis Invests in Rafael Medical
Deal, with Option to Purchase, Expands Endovascular Thrombus Management Focus
MINNEAPOLIS--(BUSINESS WIRE)--Dec. 13, 2006--Possis Medical, Inc. (NASDAQ: POSS) a developer, manufacturer and marketer of pioneering medical devices for the cardiovascular and vascular treatment markets, today announced that it has closed a $2.5 million equity investment in Rafael Medical Technologies, Inc. The deal gives Possis 15 percent ownership in Rafael Medical with a three-year option to purchase the company, together with an obligation to provide up to $1.5 million of secured debt financing and one seat on Rafael's board of directors. Rafael Medical is developing its proprietary SafeFlo(R) inferior vena cava (IVC) filter. It is estimated that by 2010, the U.S. market for IVC filters will total nearly $200 million.
The inferior vena cava (IVC) is the large vein that carries de-oxygenated blood from the lower body back to the heart and then to the lungs for re-oxygenation. In certain individuals, the formation of blood clots in the deep veins of the legs, a condition known as deep vein thrombosis (DVT), can lead to the migration of blood clots to the lungs causing a pulmonary embolism (PE), an often fatal condition. The U.S. patented SafeFlo(R) IVC filter is a minimally invasive and retrievable filter designed to prevent the migration of thrombus to the lungs and the potentially devastating effects of PE.
"More than 600,000 people suffer from DVT annually in the United States and the most feared complication of DVT is PE," said Robert Dutcher, chairman, president and CEO of Possis Medical. "As part of our broader endovascular focus, we secured an option to acquire Rafael Medical -- the developer of the SafeFlo(R) filter. The retrievable design of the SafeFlo(R) filter allows it to be placed in the patient temporarily and then later removed when the risk of a PE has passed. This device is synergistic with our strategy to expand the use of our industry-leading AngioJet(R) Thrombectomy System to treat both DVT and PE thrombus. The combination of the SafeFlo(R) filter and AngioJet thrombectomy may revolutionize the treatment of DVT and prevention of PE."
Rafael Medical is conducting a clinical trial of the SafeFlo(R) filter at multiple sites in the United States and Europe; a 510(k) submission to the FDA is expected within 12 to 18 months.
The purchase option may be exercised by Possis at any time, at the discretion of Possis, prior to the earlier of 60 days after Rafael receives U.S. FDA marketing clearance, or November 29, 2009. If Possis determines to exercise the option, it will pay Rafael Medical shareholders an initial purchase price of $12 million in cash, less any debt outstanding, and will be obligated to make earn-out payments based on a multiple of revenue generated from the SafeFlo(R) IVC filter during the three years commencing six months after closing of the transaction. Total payments, including the $2.5 million initial equity investment, will not exceed $54 million.
Concluded Dutcher, "This strategic initiative will allow us to expand our leadership position in thrombus management, and leverages our strengths and proven technology to provide customers with a broader portfolio of endovascular treatment options."
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Aug. 2006
FDA Approves Expansion of U.S. Clinical Study; Additional U.S. Centers to Join SafeFlo® Clinical Study
Following the receipt of conditional IDE approval from the U.S. Food and Drug Administration in February 2006 and initial enrollment of U.S. patients at two New York City medical centers, Rafael Medical announced that it would expand the number of U.S. centers participating in the study. New York University Medical Center and Beth Israel Medical Center will be joining the two sites currently enrolling patients, Montefiore Medical Center and Mount Sinai Medical Center.
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Feb. 2006
Rafael Medical Technologies Receives Conditional IDE Approval For SafeFlo® Retrievable Vena Cava Filter Trial
Company Press Release
Boston, MA, (February 2, 2006) - Rafael Medical Technologies, Inc. announced today that it has received conditional IDE (Investigational Device Exemption) approval from the U.S. Food and Drug Administration (FDA) to begin the first phase of its U.S. clinical investigation of its SafeFlo® Retrievable Vena Cava Filter for the prevention of pulmonary embolism. The trial is designed to evaluate the safety and efficacy of the SafeFlo® filter in both permanent and temporary indications. The trial is expected to commence shortly at two medical centers in New York City. A second phase of the trial will commence after completion of the first ten patients in the initial phase of the U.S. study.
European clinical studies conducted to date at several outside-U.S. sites including the University of Vienna under Prof. Johannes Lammer and Queen Margaret Hospital in Edinburgh under Dr. Kieran McBride indicate the potential versatility and safety of the filter as well as its retrievability up to 23 days post implantation. The additional U.S. clinical data will be used to support the company's final device clearance submission to the FDA.
The SafeFlo® filter is based on shape-memory nitinol wires and a design that provides an alternative anchoring mechanism to the standard strut-based designs of filters currently available on the market. SafeFlo®'s low-profile design is intended to be vessel-friendly and to afford simple and safe filter implantation with the ability to fully deploy, retrieve and reposition prior to detachment. These potential attributes are intended to provide the physician with full control of the implantation procedure.
According to Dr. Elchanan Bruckheimer, Rafael Medical's medical director, the clinical data presented to date is very encouraging. "By oversizing the vessel with the filter's double ring anchoring mechanism the SafeFlo® filter has the potential for a high level of stability within the cava. A safe and fully repositionable retrievable filter could provide the needed protection at the critical risk stages for patients potentially at risk for developing pulmonary embolism such as hip and knee replacement, trauma and morbid obesity," he stated.
SafeFlo®, which is CE marked and commercially available in select European markets, is expected to expand the use of vena cava filters on a prophylactic basis among the more than two million patients worldwide who are potentially at risk of developing pulmonary emboli each year.
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Aug. 2005
Rafael Medical Adds New Clinical Sites
Leveraging the growing patient enrollment as part of the SafeFlo® multi-center clinical trial in several non-U.S. centers, Rafael Medical has recently added two major Israeli hospitals to its study sites. The Tel Aviv Sourasky Medical Center and Rabin Medical Center, both leading medical institutions, have already begun enrollment. Data obtained from these sites are expected to further support the company's submission for U.S. marketing clearance.
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July 20, 2005
Rafael Medical Secures Health Ministry Approval to Market SafeFlo in Israel
Rafael Medical announced that it has received approval from the Israel Ministry of Health to market its SafeFlo vena cava filter in Israel. With this approval in hand, the company plans to add Israel as one of the selected markets the device will be made available as part of its initial product launch. Over the coming months, the product will be marketed through one of the leading local distributors of cardiovascular devices. Rafael Medical looks forward to rapid acceptance of the device within the Israeli medical community with its emphasis on high quality, patient-driven care and innovation.
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June 2004
Rafael Medical Technologies Receives CE Mark Approval For SafeFlo® Retrievable Vena Cava Filter for Prevention of Pulmonary Embolism
Company Press Release
DOVER, DE, (May 25, 2004) – Rafael Medical Technologies, Inc. announced today that it has received CE Mark approval for the SafeFlo® Retrievable Vena Cava Filter for the prevention of pulmonary embolism as well as for the VascuGrasp® Retrieval System, a foreign body retrieval device used to remove the SafeFlo® Filter from the vena cava. This approval allows the company to begin selling these devices in the European Community.
Rafael Medical’s SafeFlo® filter is based on shape-memory Nitinol wires and a unique design that provides an alternative anchoring mechanism to the standard strut-based designs of filters currently available on the market. SafeFlo®’s unique low-profile, vessel-friendly design affords simple and safe filter implantation with the ability to fully deploy, retrieve and reposition prior to detachment. These attributes provide the physician with full control of the implantation procedure. As a retrievable or “optional” filter, SafeFlo® has been demonstrated to be fully retrievable up to 21 days post implantation.
Clinical studies conducted to date at the University of Vienna under Prof. Johannes Lammer have demonstrated the filter’s versatility and safety. According to Rafael Medical’s medical director, Dr. Elchanan Bruckheimer, SafeFlo®’s unique features have been shown to provide real advantages in the clinical setting. “The ability to straddle the filter across the renal veins, to access the vena cava from all approaches with the same low-profile delivery system, to reposition the filter after complete deployment as well as retrieval via a 7F retrieval system reduce the overall complexity associated with IVC filter use,” explains Dr. Bruckheimer.
SafeFlo® and VascuGrasp® are expected to be launched in selected European markets later this year. “We are currently setting up our distributor network and will focus on selected distributors of leading interventional cardiology and radiology devices,” explains Aaron Feldman, Rafael Medical’s president and CEO.
SafeFlo® is expected to expand the use of vena cava filters on a prophylactic basis among the more than two million patients worldwide who are potentially at risk of developing pulmonary emboli each year. “The enthusiastic response of the medical community to the SafeFlo® Filter over the past year indicates to us that the market is ready for a versatile and safe optional filter for providing protection to a larger patient population at risk of developing pulmonary embolism,” stated Feldman.
ABOUT RAFAEL MEDICAL
Founded in 2000, Rafael Medical has developed a novel anchoring system for safely implanting and retrieving a wide range of intra-vascular devices in a minimally invasive manner. Based on the technology, diagnostic and therapeutic devices can be delivered into small and large blood vessels alike by way of a small-sized delivery system. Following the completion of the SafeFlo® Filter the company is now developing additional devices geared to the interventional cardiology market.
Use of SafeFlo® and VascuGrasp® in the U.S. is restricted by Federal Law to investigational use only.
For further information contact Aaron Feldman at +972-4-6270375.
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September ţ2004
Rafael Medical Participates in the Annual Meeting of the Cardiovascular and Interventional Radiology Society of Europe
For the second year, Rafael Medical participated in the annual meeting of the Cardiovascular and Interventional Radiology Society of Europe (CIRSE), held this year in Barcelona. The company’s booth was visited by a large number of physicians from around the world as well as by industry representatives, providing significant exposure for the CE-marked SafeFlo® filter. Prof. Johannes Lammer, of University Hospital, Vienna presented updated clinical data for the filter as part of the conference’s vena cava filter session. Rafael Medical will continue to participate in leading conferences and exhibitions.
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November 2004
SafeFlo® Filter Presented at Filter Workshop
The SafeFlo® filter was recently presented as part
of a workshop dedicated to retrievable vena cava filters at the Advanced Interventional
Management (AIM) Symposium in New York City. The workshop, moderated by Dr. David Trost
and Dr. Anthony Venbrux, focused on the issues surrounding the use of newly available
retrievable vena cava filters. Attendees from the medical community and industry were
invited to participate in hands-on demonstrations of a number of available filters
including the SafeFlo® filter which was conducted by Rafael Medical’s CEO, Aaron Feldman.
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