News releases
September 2008
Come visit Ovalum at Booth 1658 at TCT Conference 2008 in Washington DC.
Dr. Keyur Parikh will be presenting FIM Results of the CiTop™ Coronary Guidewire study at the Chronic Total Occlusions: Basic and Expert Techniques session on Monday October 13th, Room 202A, 5:13PM.
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July 2008
Ovalum Ltd. Announces Success in Coronary Cases Using CiTop™ ExPander™ Guidewire
Following First-in-Man study success, Ovalum Ltd. Launches a multicenter study using the CiTop™ technology in the coronary arteries
Ovalum Ltd. has announced today successful experiences using CiTop™ ExPander™ Guidewire in traversing chronic total occlusions in the coronary arteries.
The company has completed successfully its First-in-Man study in the use of the CiTop™ ExPander™ Guidewire in the coronary arteries. Dr. Keyur H. Parikh, The Heart Care Clinic/Care Cardiovascular Consultants , Principle Investigator of the study has said: “Ovalum with its CiTop™ wire has discovered an approach to a safe and sure way to cross CTOs. Chronic Total Occlusions is one of the last frontiers of the Cardiologists, the CiTop™ wire has shown me an approach towards that last frontier.... ”
Ovalum is launching this July its Multicenter study to evaluate the performance of the CiTop™ ExPander™ Guidewire in crossing CTOs in the coronary arteries. Dr. Farrel Hellig from the Sunninghill Hospital in Johannesburg, South Africa, has concluded that “…the CiTop™ was successful with an excellent result.” after an initial experience with the CiTop™ ExPander™ Guidewire.
The company has submitted the CiTop™ ExPander™ Guidewire to its notified body in the European Economic Area and is expecting to receive its CE marking during the fourth quarter of 2008. In addition, the company has completed the CiTop™ ExPander™ Guidewire 510K application to the FDA which will be submitted next month.
The CiTop™ ExPander™ guidewire provides a simpler and more efficient means to open the Chronic Total Occlusion, thus avoiding the need for coronary bypass surgery. Noam Shamay, Founder and CEO of Ovalum Ltd. Said: “I am enthusiastic about the opportunity to introduce a significantly less invasive therapeutic option for coronary CTO patients “.
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July 2008
Ovalum Ltd. Received Clearance to Market the CiTop™ Product-Line in Israel
Following FDA clearance and CE approval, Revolutionary CiTop™ product-line is now available in Israel
Ovalum Ltd. has announced today the clearance to market of its unique CiTop™ product-line in Israel.
Dr. Alexander Belenky, Head of Interventional Radiology Unit at Rabin Medical Center and chief Radiologist at Assuta Tel-Aviv Medical Center says: " This unique technology greatly assist in rescuing limbs which could not be treated by any other means. Opening an occluded artery is a must for saving the limb from amputation. The CiTop(tm) guidewire system is crossing these occlusions in tremendous ease even in the most complicated cases"
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June 2008
Ovalum Ltd. Announces Sales Launch of CiTop™ Product-Line in Europe
Ovalum Ltd has announced today the launch of sales of its new CiTop™ Guidewire product line for angiographic procedures in the peripheral vasculature.
Following the approval for CE Marking from the European Economic Area, Ovalum has initiated sales of the CiTop™ product line in Europe, with orders totaling Over 400 devices up to date.
Procedures have already been done by Dr. Jaques Clerissi in Italy, Dr Gouvas Konstantinos in Greece by and in Russia by Dr Yakovlev Sergey.
All procedures showed tremendous success and demonstrated the quality and uniqueness of the CiTop™ products in saving limbs from amputation.
Noam Shamay Ovalum`s CEO say: " It is a great joy to see the real fruits after years of hard work. The company and management teem are all united at this launch effort and we know we are at the right track seeing week to week an increase in sales. The response from the market is unbelievable"
Ovalum has signed distribution agreements in Italy (Kardia srl) and Russia (Center of Perinatal Medicine).
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May 2008
Come visit Ovalum at Booth A01 at EuroPCR 2008 in Barcelona
Ovalum’s medical director, Dr. Amit Segev, will be presenting at the Late Breaking Trials session, Wednesday, May 14th, Room 2, 13:30-14:00
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March 2008
TraVerse™ Microcatheter receives CE and FDA permission to market
Ovalum Ltd. releases for marketing the TraVerse™ micro-catheter in the US and Europe. The TraVerse™ micro-catheter is a unique stainless steel helically laser cut support and exchange catheter used to aid guide wire manipulation in complex angiographic procedures.
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February 2008
FIM Coronary FIM final results presented at CTO Summit in New York
Ovalum’s FIM Coronary Study final results were presented at the CTO Summit held at the Marriott hotel in New-york by study PI, Dr. Keyur Parikh, director, Department Of CardioVascular Medicine, Sheth V.S.Hospital, India
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February 2008
Come visit Ovalum at Booth 308 at the CRT08 at the Omni Shoreham hotel, Washington DC
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January 2008
Come visit Ovalum at the International Symposium on Endovascular Therapy (ISET2008) held in Miami
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October 2007
Outstanding Coronary Clinical results with the CiTop™ Guidewire
CiTop™ guidewire has successully crossed chronic total occlusions in the coronary arteries.
The cases were performed by Dr. Keyur Parikh, director, Department Of CardioVascular Medicine, Sheth V.S.Hospital, India.
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October 2007
CiTop™ Guidewire system receives FDA clearance
CiTop™ Guidewire was cleared for commercial use in the US for the peripheral vasculature indication.
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October 2007
Come visit Ovalum at Booth 1028 at TCT2007
Dr.Keyur H Parikh will present The Ovalum CiTop Guide Wire System
Date: Sun Oct 21 Time: 4:12 PM - 4:22 PM
Event Title: Chronic Total Occlusions: Basic and Expert Techniques
Section Title: CTO Imaging and Novel Device Approaches
Lecture Title: Blunt Microdissection Revisited: The Ovalum CiTop Guide Wire System
Lecturer: Dr.Keyur H Parikh,MD(USA)FCSI,FACC,FESC,FSCAI
Room: 145AB
Location: Washington Convention Center
Date: Sun Oct 21 Time: 4:12 PM - 4:22 PM
Event Title: Chronic Total Occlusions: Basic and Expert Techniques
Section Title: CTO Imaging and Novel Device Approaches
Lecture Title: Blunt Microdissection Revisited: The Ovalum CiTop Guide Wire System
Lecturer: Dr.Keyur H Parikh,MD(USA)FCSI,FACC,FESC,FSCAI
Room: 145AB
Location: Washington Convention Center
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September 2007
CiTop™ guidewire system is CE Approved
CiTopTM guidewire system has received CE approval for the peripheral indication
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April 2007
Come Visit Ovalum at Booth A4 at EuroPCR 2007
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January 2007
Ovalum Ltd. presents its third product Derigo™ a superior all purpose steerable guidewire.
Ovalum Ltd. presents its third product DerigoT a superior all purpose steerable guidewire.
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January 2007
Ovalum Ltd. submitted 510K application for the CiTop™ guidewire system.
Ovalum Ltd. has submitted 510K application for the CiTopTM guidewire system.
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January 2007
Ovalum Ltd. will present its first clinical trial results at the CTO summit in NY Feb 21.
Ovalum Ltd. will present its first clinical trial results at the CTO summit in NY Feb 21.
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December 2006
Ovalum Ltd. presents the CiTop™ guidewire system at the ICI meeting in Israel.
Ovalum Ltd. presents the CiTop™ guidewire system at the ICI meeting in Israel, for the first time the CiTop™ guidewire system was presented to the public.
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December 2006
Ovalum Ltd. continues to demonstrate outstanding results in its first clinical trial.
Ovalum Ltd. continues to demonstrate outstanding results in its first clinical trial.
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October 2006
Ovalum Ltd. presents the CiTop™ technology at the TCT 2006 in Washington DC US.
Ovalum Ltd. presents the CiTop™ technology at the TCT 2006 in Washington DC US.
Ovalum Ltd. presents the CiTop™ technology at the TCT 2006 in Washington DC, USA, at the New CTO Devices and Novel Approaches Chronic Total Occlusions: Exploring the Final Frontier Event Tue Oct 24, 11:40 AM.
Ovalum‘s CEO, Noam Shamay, will present the CiTop™ guidewire system. Lecture Title: "The Ovalum Device for CTO Recanalization"
Location: Washington Convention Center,147 AB.
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October 2006
Ovalum presents the first human case at the TCT meeting.
Ovalum presents the first human case at the TCT meeting : The procedure was performed by Dr. Alexander Belenky head of interventional radiology Rabin medical center Israel and Dr. Zlatko Cacic from central hospital Zagreb. The Guidewire successfully traversed a very difficult occluded lesion in the SFA peripheral artery, the patient suffered from chronic CLI for the last two years.
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September 2006
Ovalum Ltd. first design review of novel guiding catheter system Support-x™
Ovalum Ltd. first design review of a novel guiding catheter system the Support-x™
This new pipeline product emerging from successful R&D project will complete the OVALUM line for CTO by providing superior guiding catheter support in complex minimally invasive procedures. Animal studies showed the support-X™ guiding catheter can double the support in the coronary arteries of pigs.
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September 2006
Ovalum Ltd. receives clearance to start the coronary CTO Trial of the CiTop
Ovalum Ltd. has received clearance to start the first in-man coronary CTO Trial of the CiTop™ guidewire system. The study is titled "A feasibility, multicenter multinational randomized open label study, to evaluate the safety and performance of the CiTop™ Active Guidewire for crossing total occlusion in coronary arteries". The study is led by Dr. Belenky Alexander, MD Head of Interventional Radiology at Belinson medical center Israel.
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September 2006
Ovalum Ltd presents its latest solution for guidewire extension system.
Ovalum Ltd presents its latest solution for guidewire extension system.
The solution will enable a quick connection and release of a guidewire extension system to be incorporated in the CiTop™ guidewire system for a more convenient operation when rapid exchange catheter systems are used with the CiTop™ guidewire system.
The solution will enable a quick connection and release of a guidewire extension system to be incorporated in the CiTop™ guidewire system for a more convenient operation when rapid exchange catheter systems are used with the CiTop™ guidewire system.
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September 2006
Ovalum Ltd. presents the CiTop™ technology at the CCT 2006 in Kobe Japan.
Ovalum Ltd. presents the CiTop™ technology at the CCT 2006 in Kobe Japan.
The presentation was carried by Dr. Mickey Scheinowitz, PhD and titled: "Recanalization of chronic total occlusion using the self propelled, channel propagation CiTop active guidewire"
The study was conducted by: Scheinowitz M, Amrami I, Oppenhaim U, Dahan A, Schwartz O, Belenky A, Shamay N, Ziv-Ner Z, Neufeld Cardiac Research Institute & Department of Biomedical engineering; Department for Rehabilitative Orthopedics, Sheba Medical Center; Department of Vascular Radiology, Rabin Medical Center; Tel-Aviv University, Israel.
The presentation was carried by Dr. Mickey Scheinowitz, PhD and titled: "Recanalization of chronic total occlusion using the self propelled, channel propagation CiTop active guidewire"
The study was conducted by: Scheinowitz M, Amrami I, Oppenhaim U, Dahan A, Schwartz O, Belenky A, Shamay N, Ziv-Ner Z, Neufeld Cardiac Research Institute & Department of Biomedical engineering; Department for Rehabilitative Orthopedics, Sheba Medical Center; Department of Vascular Radiology, Rabin Medical Center; Tel-Aviv University, Israel.
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August 2006
Ovalum Ltd. completed 3.4 M $ investment round.
Ovalum Ltd. completed 3.4 M $ investment round.
The investment was led by MEDITECH ADVISORS LLC. which include Israeli VC – PONTIFAX, US based VC SMITHFIELD FIDUCIARY LLC and the US based VC ZIEGLER MEDITECH EQUITY PARTNERS LP. This investment willsupport the completion of the company‘s clinical trials and the regulatory submissions expected this year for the CiTop™.
The investment was led by MEDITECH ADVISORS LLC. which include Israeli VC – PONTIFAX, US based VC SMITHFIELD FIDUCIARY LLC and the US based VC ZIEGLER MEDITECH EQUITY PARTNERS LP. This investment willsupport the completion of the company‘s clinical trials and the regulatory submissions expected this year for the CiTop™.
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July 2006
Ovalum Ltd. completed the design cycle of the Traverse™ support system.
Ovalum Ltd. completed the design cycle of the Traverse™ support system.
The product will be marketed as part of the CiTop™ guidewire system and as a stand-alone support platform. The Traverse™support system enables the pre-shaping and controlled stiffness of guidewires. Manufacturing of the Traverse™ utilizes advance laser cutting process.
The product will be marketed as part of the CiTop™ guidewire system and as a stand-alone support platform. The Traverse™support system enables the pre-shaping and controlled stiffness of guidewires. Manufacturing of the Traverse™ utilizes advance laser cutting process.
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July 2006
Ovalum Ltd. announces the completion of technology transfer to production.
Ovalum Ltd. announces the completion of technology transfer to production.
Ovalum Ltd. announces the completion of technology transfer to production of the CiTop™ guidewire in a new clean room built in Rehovot, Israel. The product is manufactured in-house according to GMP practices, utilizing the top of the line technologies and automatic controlled processes, according to strict quality assurance standards.
Ovalum Ltd. announces the completion of technology transfer to production of the CiTop™ guidewire in a new clean room built in Rehovot, Israel. The product is manufactured in-house according to GMP practices, utilizing the top of the line technologies and automatic controlled processes, according to strict quality assurance standards.
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June 2006
Ovalum Ltd. Received clearance to start the first in-man peripheral CTO Trial of the CiTop
Ovalum Ltd. Received clearance to start the first in-man peripheral CTO Trial of the CiTop™ guidewire system.
Ovalum Ltd. has received clearance to start the first in-man peripheral CTO Trial of the CiTop™ guidewire system. The study is titled "A feasibility, multicenter multinational randomized open label study, to evaluate the safety and performance of the CiTop™ Active Guidewire for crossing total occlusion in Peripheral arteries". The study is led by Dr. Belenky Alexander, MD Head of Interventional Radiology Dpt. at Belinson medical center Israel, PI-Prof. Dr. Ivana Tonković, M.D. Ph.D., Chief of the Vascular Surgery Department and President of the Surgical Croatian Association, Dr. Zlatko Fiolić, M.D., vascular surgeon and Dr. Zlatko Čačić, M.D., interventional radiologist.
Medical Center; Tel-Aviv University, Israel.
Ovalum Ltd. has received clearance to start the first in-man peripheral CTO Trial of the CiTop™ guidewire system. The study is titled "A feasibility, multicenter multinational randomized open label study, to evaluate the safety and performance of the CiTop™ Active Guidewire for crossing total occlusion in Peripheral arteries". The study is led by Dr. Belenky Alexander, MD Head of Interventional Radiology Dpt. at Belinson medical center Israel, PI-Prof. Dr. Ivana Tonković, M.D. Ph.D., Chief of the Vascular Surgery Department and President of the Surgical Croatian Association, Dr. Zlatko Fiolić, M.D., vascular surgeon and Dr. Zlatko Čačić, M.D., interventional radiologist.
Medical Center; Tel-Aviv University, Israel.
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June 2006
Ovalum Ltd. Has completed the design cycle of the CiTop™ coronary 0.014
Ovalum Ltd. Has completed the design cycle of the CiTop™ coronary 0.014" guidewire.
The announcement represents a 6 months early delivery of this major milestone. The revolutionary 0.014" platform will allow the usage of the CiTop™ as a primary guidewire in interventional procedures with no need of exchanging it for a standard guidewire after crossing. The 0.014" platform will substantially increase the marketability of the CiTop™ CTO solution as it is specifically suited to the common clinical practice with no need for extra procedures.
The announcement represents a 6 months early delivery of this major milestone. The revolutionary 0.014" platform will allow the usage of the CiTop™ as a primary guidewire in interventional procedures with no need of exchanging it for a standard guidewire after crossing. The 0.014" platform will substantially increase the marketability of the CiTop™ CTO solution as it is specifically suited to the common clinical practice with no need for extra procedures.
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May 2006
Ovalum Ltd. Announces scientific collaboration with the Israeli company, Nano Materials Ltd
Ovalum Ltd. Announces scientific collaboration with the Israeli company, Nano Materials Ltd.
The main objective of the project is to test a revolutionary nano-material coating for the CiTop™ guidewire and other interventional pipeline devices.
The main objective of the project is to test a revolutionary nano-material coating for the CiTop™ guidewire and other interventional pipeline devices.
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March 2006
feasibility report for the CiTop
Ovalum Ltd. presents the human peripheral CTO‘s amputation model feasibility report for the CiTop™
Excellent results for the CiTop™ guidewire were reported by the Neufeld Cardiac Research Institute, Sackler Faculty of Medicine, and Department of Biomedical Engineering, Faculty of Engineering, Tel-Aviv University, Israel. The study was led by Dr. Mickey Scheinowitz, senior researcher at the Neufeld Cardiac Research Institute, in collaboration with Dr Ziv-ner Tchaki, MD Head of rehabilitation department Sheba medical center Israel, and Dr. Belenky Alexandr, MD Head of interventional radiology at Belinson medical center Israel. In this study the CiTop™ has successfully crossed the most difficult to cross Chronic total occlusions in human peripheral arteries. The limbs used for the study were amputated after all other treatments had failed to save the limbs. Success rates were more than 90%.
Excellent results for the CiTop™ guidewire were reported by the Neufeld Cardiac Research Institute, Sackler Faculty of Medicine, and Department of Biomedical Engineering, Faculty of Engineering, Tel-Aviv University, Israel. The study was led by Dr. Mickey Scheinowitz, senior researcher at the Neufeld Cardiac Research Institute, in collaboration with Dr Ziv-ner Tchaki, MD Head of rehabilitation department Sheba medical center Israel, and Dr. Belenky Alexandr, MD Head of interventional radiology at Belinson medical center Israel. In this study the CiTop™ has successfully crossed the most difficult to cross Chronic total occlusions in human peripheral arteries. The limbs used for the study were amputated after all other treatments had failed to save the limbs. Success rates were more than 90%.
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December 2005
Ovalum Ltd. completed 1M $ investment round.
De
Ovalum Ltd. completed 1M $ investment round.
The investment was led by MEDITECH ADVISORS LLC. which include the Israeli VC - PONTIFAX and the USA based VC SMITHFIELD FIDUCIARY LLC. The investment is intended to help the company develop the coronary version of the CiTop™ and complete the study on the human peripheral amputation model.
The investment was led by MEDITECH ADVISORS LLC. which include the Israeli VC - PONTIFAX and the USA based VC SMITHFIELD FIDUCIARY LLC. The investment is intended to help the company develop the coronary version of the CiTop™ and complete the study on the human peripheral amputation model.
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