Crux Successfully Completes Funding for Advanced Filter for PE Prevention:
(Menlo Park, Ca.) – Crux Biomedical Inc., a developer of an advanced implantable vena cava filter (VCF), announced the successful completion of a $12.0MM investment round.  The round was led by Three Arch Partners, which was joined by current investors, Alloy Ventures and Emergent Medical Partners.

Vena cava filters, which were first introduced in the late 60’s, are designed to trap blood clots that can lead to a potentially fatal pulmonary embolism, (PE). During the last 10 years, VCF’s have been designed to be placed on a permanent basis or  retrieved  at a later date. The Crux vena cava filter has been designed to address the complications seen with current VCF’s. “The Crux device represents the first significant design innovation since vena cava filters were introduced. Its design represents a radical departure from the traditional conical design and for the first time combines ease of placement with enhanced retrievability”, stated Bill Harrington, M.D. and partner at Three Arch Partners.

Crux Biomedical initiated its pivotal Retrieve 2 U.S. clinical trial at 18 centers of excellence in the second half of 2010.  The Company is simultaneously conducting clinical evaluations in both Europe and Australia/New Zealand and expects to complete patient enrollment shortly. “We are very pleased with the interim success of our ongoing clinicals in both the U.S. and abroad,” states Crux CEO, Mel Schatz. He continued, “ It has been rewarding to see the physician enthusiasm for our filter and their belief it will prove to be an advance in the management of patients at risk for a PE.” Crux anticipates commercial availability in the first half of 2012.

Recent reports have cited safety concern  with currently available VCF’s related to both the incidence of filter fracturing and associated challenges of retrieving the filters. The Crux VCF has been designed to minimize these problems. “We are very excited to be part of the clinical development of a novel VCF that offers a potential safety advantage over current technologies, with the flexibility of bidirectional placement and retrieval, “stated Doug Kelly, M.D. and partner at Alloy Ventures.

There are an estimated 200,000 deaths attributed to PE in the United States alone each year. The American Public Health Association and the CDC have pointed out that deaths attributed to PE exceed the combined deaths per annum due to breast cancer, AIDS and highway fatalities.  Experts cite the increase in PE incidence to more complex surgeries, trauma, expanded use of chemotherapeutics and an aging population.

Crux is a privately held medical device company, founded in 2004 by Tom Fogarty, M.D. and specializes in minimally invasive vascular devices. The Company is headquartered in Menlo Park, California.

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R. Lindholm Named to Crux Biomedical Board:

Menlo Park, Calif – March 15/PR Newswire – Crux Biomedical, developer of an advanced implantable vena cava filter (IVCF) to prevent pulmonary embolisms, announced the appointment of Randy Lindholm to its Board of Directors. Mr. Lindholm is a widely respected advisor to the medical device field. He was previously Chairman and CEO of Vidamed,  a maker of minimally invasive medical devices to treat benign prostate hyperplasia until it was acquired by Medtronic in 2002.  Prior to Vidamed, Randy held senior positions at Nellcor Puritan Bennett and GE Medical Systems. “ I am excited to join Crux Biomedical. They are well positioned to take advantage of the current interest in a better performing retrievable IVC filter”, stated Mr. Lindholm. He currently serves as director of publically held Omnicell (MLCL), Barrx Medical, Tibion Bionic Technologies, Estech and Novasys Medical.

“We are very pleased to have Randy’s operating experience at Crux,” states Mel Schatz, CEO of Crux Biomedical. He continued, “Randy  has assisted numerous firms in securing venture backed funding”.  Crux Biomedical is currently enrolling patients in its pivotal IDE study in the United States and several sites internationally. It expects to complete the U.S. study in 2011 and launch internationally  later this year.

Crux Biomedical was founded in 2004 by Thomas Fogarty, M.D, to target the development of an advanced implantable inferior vena cava filter (IVCF) to prevent the occurrence of potentially fatal pulmonary embolisms. Although routinely used in the United States, currently cleared IVC filters are associated with a variety of complications. “We recognized current IVC filters did not meet the needs of clinicians and designed a filter that provided better retrievability”, stated Tom Fogarty, M.D.

Each year in the United States approximately 600,000 patients develop a PE and an estimated 200,000 deaths occur. Pulmonary embolisms are recognized as the most frequent cause of death among hospitalized patients.

Crux Biomedical is located in Menlo Park, California and is funded by Alloy Ventures and Emergent Medical Partners.

 

New Device to Prevent Pulmonary Embolisms Introduced at CIRSE Meeting:

Munich, Germany, September 10, 2011:

A revolutionary new blood filter to prevent the occurrence of a life threatening pulmonary embolism (PE), was introduced at Munich’s Cardiovascular and Interventional Radiological Society of Europe , (CIRSE) symposium. A PE occurs when blood clots migrate from the lower limbs of the body to the pulmonary arteries.

It is estimated that as many as 200,000 deaths occur each year in Europe due to the occurrence of a PE.  Current treatments to prevent the occurrence of a PE include the administration of oral anticoagulants or in cases where drug therapy is contraindicated, placement of a filter in the vena cava. Vena cava filters (VCF), first introduced in the late 60’s are designed to trap potentially fatal blood clots.

The Crux Biomedical Vena Cava Filter with BDR (bi-directional retrieval) represents a significant design innovation in IVC filter technology.  The unique, self centering design of the Crux VCF is the first device to provide bidirectional placement and retrieval, thus providing the physician more choice in the implantation and retrieval of the device.

Crux Biomedical initiated a clinical trial of its new VCF at 24 centers of excellence in the United States, Belgium, Australia and New Zealand. It has successfully completed  patient enrollment and anticipates clearance to launch its new device internationally later this year. CIRSE is the world’s largest meeting for the field of Interventional Radiology. It is held annually and attracts some 5,000 participants.

For more information on Crux Biomedical, contact: Mel Schatz, President at mschatz@cruxbiomedical.com