March 14, 2007
Onset Medical Receives FDA Clearance to Market SoloPath(TM) Percutaneous Transseptal Access Catheter
Onset Medical Corporation announced today that the Food and Drug Administration ("FDA") has granted clearance to begin marketing the Company's SoloPathTM transseptal access catheter in the United States. SoloPath utilizes Onset's patented Controlled Deployment Technology ("CDT") to allow percutaneous access to the chambers of the left heart and surrounding vasculature.
Controlled Deployment Technology
The Company has developed several unique product platforms based on its CDT, which represents a new and different approach to procedures requiring minimally invasive access to remote sites within the body. CDT allows introduction of a dimensionally small catheter to a specific site, which once positioned, can be radially expanded to deploy a semi-rigid sheath to maintain access to the treatment site. The catheter enters the body at a diameter approximately 50% of the size of conventional access devices. Once placed in the body, the device is expanded in a slow and gentle manner, using radial force to create an internal diameter larger than conventional devices. Studies have shown that the CDT can allow the physician to achieve access quicker, easier and with less trauma to the surrounding tissue than with conventional access procedures.
SoloPath, the first cardiovascular application of Controlled Deployment Technology, allows interventional cardiologists and electrophysiologists a novel percutaneous approach to access the left atrium and pulmonary veins through the atrial septum for the diagnosis and treatment of conditions such as atrial fibrillation. Atrial arrhythmias, such as atrial fibrillation and flutter, affect more than 2.2 million people in the United States. Many analysts project this to be the next major market in the treatment of cardiovascular disease.
The rapidly growing number of minimally invasive procedures performed by cardiac and vascular surgeons, as well as interventional cardiologists, electrophysiologists and radiologists, has dramatically increased the need for such percutaneous and minimally invasive access. While many catheter procedures are currently performed via multiple percutaneous access sites, an ever growing number of these procedures will benefit from the SoloPath large lumen catheters which only require a single access site.
The unique SoloPath design provides the access insertion of a small catheter that when positioned in the atrium of the heart can be gently expanded to provide a large working lumen to perform therapeutic procedures. The resulting lumen is large enough to provide access of multiple therapeutic catheters and instruments.
Onset and its Scientific Advisory Board believe that the SoloPath will offer the following advantages:
A single catheter and access site to replace multiple catheters and multiple access sites required during current electrophysiology diagnostic and therapeutic procedures.
Reduced complications resulting from less invasive access.
Time and cost savings compared to conventional electrophysiology procedures.
Easier and reduced physician education and training required to perform complex coronary procedures, thereby increasing the number of trained cardiologists and expanding the market for such procedures.
In January 2007, Onset Medical introduced the SoloPath catheter to the medical community at the Boston Atrial Fibrillation Symposium. In a survey conducted by the Company, physicians polled perceived that this technology would give them a significant advantage over their current access devices in regard to patient safety and reduction in procedure time. Onset is organizing a clinical evaluation at several large centers which will be completed during the first half of 2007.
CDT Product Platforms
Onset initially concentrated the development of CDT on the field of endourology, with emphasis on procedures that reduce trauma, procedure time and cost. Onset has developed the patented PathwayTM Ureteral Access Catheter which allows for minimally invasive ureteral access in a less traumatic manner to both the kidney and the ureteral tract compared to devices currently in use. The primary clinical application for the PathwayTM Ureteral Access Catheter is to perform ureteroscopy procedures for the removal of kidney stones and to manage other conditions within the urinary tract in a minimally invasive fashion.
Onset has also developed the PathwayTM Percutaneous Access Sheath for use in nephrostomy procedures. Percutaneous nephrostomy is a minimally invasive alternative to remove stones from the kidney. By eliminating a number of surgical maneuvers, use of the Pathway for both the ureteroscopy and the nephrostomy procedures reduces procedural time, surgical expense and patient recovery time.
The Pathway products have now been used in over 300 patients in the U.S. In October 2005, Onset completed a distribution agreement providing a large, multi-national medical device manufacturer with worldwide distribution rights of Onset's CDT for urology, endourology and gynecologic applications.
In addition to interventional cardiology, electrophysiology, endovascular, and, endourology, Onset is applying the CDT platform to a variety of clinical applications in large surgical and interventional markets. These applications include new and emerging procedures in minimally invasive cardiac surgery, orthopedic/spinal procedures, neurosurgery and gastroenterology. Each of these applications is expected to lessen trauma, decrease blood loss and result in reduced procedure time and associated cost savings.
Commenting on the FDA market clearance of Onset's SoloPath, Joseph Bishop, Chief Executive Officer, said, "We are very pleased with the FDA clearance of this product. The SoloPath catheter will provide physicians with an exciting new way of accessing the heart that can accommodate multiple devices through a single catheter. It is an enabling technology that we believe will revolutionize the way access and therapy are performed."
Onset's Controlled Deployment Technology is supported by a strong patent portfolio. The Company currently holds three published patents, two of which are licensed and 15 pending patent applications.
Onset Medical Corporation, incubated in 2003 by the MedFocus Fund, is a private medical technology firm located in Irvine, California. Onset is developing the Company's Controlled Deployment Technology to provide clinically superior, minimally invasive and percutaneous access for a wide range of medical procedures.