Healthcare Industry News:  hemodialysis 

Devices FDA

 News Release - January 10, 2006

OmniSonic's Resolution(R) Endovascular System Recieves 510(k) Clearance from FDA

Physicians comment on positive results from initial procedures

WILMINGTON, Mass., Jan. 10 (HSMN NewsFeed) -- OmniSonics Medical Technologies, Inc., announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the Resolution® Endovascular System for treatment of thrombosed synthetic hemodialysis access grafts. Immediately following FDA clearance, the Company commenced shipments of the Resolution Endovascular System. Richard Ganz, President and Chief Executive Officer of OmniSonics said, "This is a major milestone for the Company as it marks the transition of OmniSonics from an engineering focused organization to a fully integrated, commercial health care company. During the past year, OmniSonics has been working to put together a top level sales and marketing team with vast experience in the medical device industry and is now ready to fully support our product launch."

There are approximately 300,000 patients on hemodialysis in the U.S., according to the U.S. Renal Data System (USRDS), and the number is growing at around 5% per year. Every year a large number of these patients suffer occlusions of their grafts. Greater than 90,000 graft thrombectomies are performed on these patients annually to allow patients to continue hemodialysis treatment. "It is useful to have a simple and fast treatment option, such as the Resolution Endovascular System, to reestablish flow on thrombosed access grafts to ensure patients' quick return to the dialysis center," said Dr. Carlo Dall'Olmo (Michigan Vascular Center, Flint, MI) after completing his first series of cases.

Early physician response has been very encouraging for the Company. Dr. John Martin (Anne Arundel Medical Center, Annapolis, MD) was among the first to use the device and commented, "The Resolution Endovascular System rapidly clears the graft and reestablishes flow within minutes. I believe this ultrasonic technology may be ideal for peripheral applications, such as deep vein thrombosis."

The Resolution Endovascular System uses OmniWave(TM) Technology to deliver low power acoustic energy 360 degrees around the active length of the Resolution Therapeutic Wire to rapidly resolve blood clots. "Acoustic energy is unique in that it dissolves the thrombus, but does not damage the surrounding structures," explained Mr. Ganz. "We believe that the OmniWave technology is a leveragable platform with many additional future applications to treat unmet clinical needs in vascular occlusive disease, representing a $2 billion addressable market," he added. OmniSonics is currently developing OmniWave Technology to apply it to deep vein thrombosis (DVT), peripheral arterial limb ischemia and catheter clearance, as well as investigating neurovascular and coronary applications.

About OmniSonics Medical Technologies, Inc.

OmniSonics Medical Technologies, Inc., headquartered in Wilmington, Massachusetts, is a privately held medical device company focused on bringing breakthrough products for vascular occlusive disease to market. The Company's patented OmniWave technology is the first technology that enables the delivery of acoustic energy over an entire active length of a small diameter wire. OmniWave is designed to have broad applications in peripheral and coronary vascular occlusive conditions.

About the Resolution Endovascular System

The Resolution Endovascular System consists of two primary components, the Generator and the Resolution System Kit. The Resolution System Kit consists of a handpiece with attached wire and accessory irrigation tubing. The Generator controls an electrical signal to power the handpiece. The handpiece converts the electronic signal from the generator to low-power ultrasonic energy transmitted down the length of the Resolution Therapeutic Wire. The Resolution Therapeutic Wire distributes ultrasonic energy waves that generate a cavitational streaming effect that breaks the fibrin bonds.

The Resolution Endovascular System is easy to set up; Power-on -- Plug-in -- Prime. Treatment with the Resolution Endovascular System utilizes typical interventional technique and is compatible with common interventional devices (5Fr and .035" wire compatibility).

For more information, please visit the Company's website at http://www.omnisonics.com.


Source: OmniSonics Medical Technologies

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