Crux Biomedical’s Vena Cava Filter Presented at Society of Interventional Radiology (SIR) Meeting

Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical Enrolls First Patient in Its Retrieve 2 U.S. Pivotal Trial

Crux Biomedical Named One of Top 50 Companies to Watch

Crux Biomedical Awarded Patent for Its Novel Blood Filter

	Crux Biomedical’s Vena Cava Filter Presented at Society of Interventional Radiology (SIR) Meeting: 98% Success Rate Shown in Trial to Prevent Recurrent Pulmonary Embolism
	Menlo Park, Calif., March 26, 2012. Crux Biomedical announced that a recently completed pivotal trial of its innovative Crux Vena Cava Filter (VCF) System with bi-directional retrieval was presented at the 2012 Society of Interventional Radiology (SIR) Annual Scientific Meeting (March 24-29, San Francisco). Vena cava filters are designed to trap blood clots that can lead to potentially fatal pulmonary embolisms (PE) among patients at risk. In the study, deployment and retrieval each were achieved with a 98% success rate. By obstructing the blood flow through the lungs, PE cause difficulty breathing, chest pain and palpitations. Each year in the United States, approximately 600,000 patients develop PE and an estimated 200,000 deaths occur. The primary means of prevention and therapy of PE is systemic administration of anticoagulant agents, but is contraindicated in many patients. These patients require alternate treatments to reduce the ongoing PE risk, including vena cava filters – small devices that are inserted in the inferior vena cava, the main blood vessel returning blood from the lower part of the body to the heart, to prevent blood clots from reaching the lungs. The Crux Biomedical VCF was designed to address the limitations of currently available VCFs, including perforation, migration and inability to retrieve. "Crux designed a device that is both more versatile and simple to use," stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical. “The Crux device demonstrated an excellent safety profile,” stated Robert R. Mendes, M.D., Principal Investigator of the study; Associate Professor of Surgery, University of North Carolina; and Chief of Vascular Surgery, Rex UNC Healthcare. “The clinical study evaluation has demonstrated the Crux VCF System device can be used safely for the prevention of recurrent PE.” The recently completed pivotal trial, known as the RETRIEVE Clinical Study, was a prospective, single-arm, multinational investigational study to assess the safety, performance, and efficacy of the Crux VCF System as both a retrievable and a permanent device. The trial included 125 patients at high risk for PE and was performed at 22 centers in the United States, Australia, New Zealand and Belgium. In the study, the technical success rate of filter deployment was 98 percent; filter retrieval success was also 98 percent. The average retrieval time was 7 minutes, with the femoral approach used for retrieval in 70% of cases. By the 6-month follow up of the study, no embolizations, migrations, or fractures were observed. The presentation at the SIR 2012 Annual Scientific Meeting, titled “The Results of the Crux Vena Cava Filter RETRIEVE Trial” was authored by Robert R. Mendes, M.D., and was presented on Sunday, March 25 at 11:50 am Pacific Time during the IVC Filters Scientific Session in the Moscone Center, Room 122. The Crux VCF has received CE Mark approval for commercial use in the European Union. The System is being studied in the United States under an approved Investigational Device Exemption (IDE) Study. 510(k) Clearance for commercial distribution in the U.S. is pending. Crux Biomedical is located in Menlo Park, California and is focused on developing improved therapies for the human vasculature. It is funded by Alloy Ventures, Three Arch Partners, Emergent Medical Partners and Thomas Fogarty, M.D. # # #
	Crux Biomedical’s IVC Filter Receives CE Mark Approval :
	Menlo Park, Calif., January 23, 2012. Crux Biomedical announced it has received CE mark approval for their revolutionary inferior vena cava filter (IVCF) with bi-directional retrieval (BDR). Vena cava filters are designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE). Each year in the United States, approximately 600,000 patients develop a PE and an estimated 200,000 deaths occur. The Crux Biomedical IVCF was designed to address the limitations of currently available vena cava filters including perforation, migration and inability to retrieve. “Crux was able to design a device that is both more versatile and simple to use”, stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical. “We are extremely pleased with the results from the recently completed pivotal trial performed at 22 centers of excellence in the United States, Australia, New Zealand and Belgium. Our device demonstrated an excellent safety profile. The Crux device could be retrieved with a 98% success rate,” stated Mel Schatz, CEO of Crux Biomedical. The Company anticipates submission to the FDA in January and U.S. approval in 2012. Crux Biomedical is located in Menlo Park, California and is focused on developing improved therapies for the human vasculature. It is funded by Alloy Ventures, Three Arch Partners, Emergent Medical Partners and Thomas Fogarty, M.D.
	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.
	R. Lindholm Named to Crux Biomedical Board:
	Menlo Park, Calif – March 15: 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.
	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. For more information, contact mschatz@cruxbiomedical.com or at (650)321-9903.