The VELOCITY study will enroll 60 awake patients with ST segment elevation myocardial infarctions (STEMIs) at multiple U.S. and Canadian sites. Patients will be randomized to either primary percutaneous coronary intervention (PCI) or a combination of primary PCI and cooling to therapeutic temperatures before reperfusion.

“The case went very well, with no delay in door-to-balloon time,” said Dr. Shavelle. “Any concerns we had with the peritoneal access are essentially gone and the patient has been doing well since his treatment. If this technology shows the expected benefit for these STEMI patients, I could see it become the standard of care for these patients.”

The study’s primary endpoint is a composite of specific new-onset, serious adverse events during the first thirty days following treatment. Several secondary endpoints will also be collected, including infarct size, myocardial salvage, left ventricular volumes, and left ventricular ejection fraction, assessed by cardiac magnetic resonance imaging (MRI). The study will thus gather initial efficacy information in addition to primary safety data.

Previous studies of therapeutic hypothermia in AMI patients have shown that cooling can significantly reduce the severity of STEMIs only if patients are cooled to temperatures of less than 35°C prior to PCI. The Velomedix approach may be unique in its ability to cool patients to this desired temperature in less than 15 minutes.

“Over the past ten years, we have seen several failed attempts to leverage therapeutic hypothermia to improve AMI patient outcomes. We now realize that a technology must be able to cool a patient to below 35°C without extending door-to-balloon times in order to be effective and adopted into today’s time-sensitive AMI treatment workflows,” said Gregg Stone, M.D., Columbia University Medical Center / New York-Presbyterian Hospital and co-principal investigator of the VELOCITY trial. “Velomedix appears to have developed an ultrafast cooling technology that might be effective without significantly delaying reperfusion.”

About Acute Myocardial Infarction (AMI)

AMI affects 1,255,000 people in the US yearly1, reducing the heart’s ability to pump the needed amount of blood throughout the body. The most severe form of AMI, called ST segment elevation myocardial infarction (STEMI), often leads to heart failure, a substantially debilitating disease and one of the most costly conditions for our healthcare system. While it is extremely important to restore blood flow to the heart as early as possible, the process (called reperfusion) may cause coincidental damage, known as reperfusion injury. Thus, (it is hypothesized that) an approach that not only restores blood flow quickly, but also minimizes reperfusion injury, could further improve AMI patient outcomes and substantially reduce overall healthcare costs.

About the Velomedix mild therapeutic hypothermia system

The Velomedix mild therapeutic hypothermia system incorporates a peritoneal-based approach to rapidly cool patients from their core. Using tools and techniques similar to those for peritoneal dialysis, the physician first accesses the peritoneal cavity and then uses the Velomedix system to circulate cold fluid in the peritoneal cavity. This cavity provides a unique means of very rapidly removing heat (cooling) from the patient due to the fact that the cavity is in contact with a large part of the body’s core and a high percentage of blood flows past it at any one time. This efficient “heat exchanger” enables the system to cool patients to less than 35 degrees C in fewer than 15 minutes on average. For additional information, please visit www.velomedix.com.

Contacts:

Velomedix, Inc. Brian K. Hakim, 650-330-7314 Director of Marketing bhakim@velomedix.com

Note: The Velomedix Automated Peritoneal Lavage System is limited by federal (United States) law to investigational use only and is not available for sale.

References 1. Véronique R. Heart Disease and Stroke Statistics–2012 Update: A Report From the American Heart Association. Circulation. 2012;125:e2-e220.

MENLO PARK, Calif.–(BUSINESS WIRE)–Velomedix, Inc., a venture-backed medical device company advancing the field of therapeutic hypothermia, today announced it has received Health Canada Approval for its VELOCITY pilot study in addition to the previously announced US IDE approval. The study is a prospective, randomized, multi-center study designed to further evaluate the safety and feasibility of the Velomedix rapid therapeutic hypothermia system in patients with acute myocardial infarctions (AMIs or heart attacks). The study will enroll 60 awake patients with anterior ST segment elevation myocardial infarctions (STEMIs) at up to three Canadian sites in addition to US sites. Patients will be randomized to either primary percutaneous coronary intervention (PCI) or a combination of primary PCI and cooling to therapeutic temperatures before reperfusion.

“We are excited by the positive response from Health Canada,” said Griff Tully, M.D., Chief Medical Officer of Velomedix. “The expansion of the VELOCITY study into Canada will provide broader physician and patient experience on the use of therapeutic hypothermia in STEMI patients. We are working with very experienced STEMI centers across Canada to obtain hospital approval and begin enrollment. Once active, we expect these sites will enroll a good percentage of the sixty patients.”
The study’s primary endpoint is a composite of specific new-onset, serious adverse events during the first thirty days following treatment. Several secondary endpoints will also be collected, including infarct size, myocardial salvage, left ventricular volumes, and left ventricular ejection fraction, assessed by cardiac magnetic resonance imaging (MRI). Thus, while primarily a safety trial, the study will also gather initial efficacy information.

Previous studies of therapeutic hypothermia in AMI patients have shown that cooling can significantly reduce the severity of STEMIs only if patients are cooled to temperatures of less than 35°C prior to PCI. The Velomedix approach may be unique in its ability to cool patients to this desired temperature in less than 15 minutes.

Concurrent with initiating the VELOCITY trial, Velomedix strengthened its leadership team with the addition of Vicki Bebeau as Vice President of Clinical Affairs. Ms. Bebeau has more than 18 years of experience in the planning and execution of drug and medical device trials across multiple geographies.

From 2005 to 2012, Ms. Bebeau served as Senior Clinical Director for the St Jude Medical cardiovascular and international divisions where she was responsible for several IDEs, PMAs, and post market programs supporting regulatory approvals and physician adoption in the U.S., Canada, Europe, Australia, and Japan. Prior to her tenure at St. Jude Medical, Ms. Bebeau served in various clinical leadership roles at Boston Scientific and Medtronic. Ms. Bebeau holds a BSN from Bethel College and is a licensed registered nurse.

About Acute Myocardial Infarction (AMI)

AMI affects 1,255,000 people in the US yearly1, reducing the heart’s ability to pump the needed amount of blood throughout the body. The most severe form of AMI, called ST segment elevation myocardial infarction (STEMI), often leads to heart failure, a substantially debilitating disease and one of the most costly conditions for our healthcare system.
While it is extremely important to restore blood flow to the heart as early as possible, the process (called reperfusion) may cause coincidental damage, known as reperfusion injury. Thus, (it is hypothesized that) an approach that not only restores blood flow quickly, but also minimizes reperfusion injury, could further improve AMI patient outcomes and substantially reduce overall healthcare costs.

About the Velomedix mild therapeutic hypothermia system

The Velomedix mild therapeutic hypothermia system incorporates a peritoneal-based approach to rapidly cool patients from their core. Using tools and techniques similar to those for peritoneal dialysis, the physician first accesses the peritoneal cavity and then uses the Velomedix system to circulate cold fluid in the peritoneal cavity. This cavity provides a unique means of very rapidly removing heat (cooling) from the patient due to the fact that the cavity is in contact with a large part of the body’s core and a high percentage of blood flows past it at any one time. This efficient “heat exchanger” enables the system to cool patients to less than 35 degrees C in fewer than 15 minutes on average.
For additional information, please visit www.velomedix.com.

Contacts:

Velomedix, Inc.
Brian K. Hakim, 650-330-7314
Director of Marketing
bhakim@velomedix.com

Note: The Velomedix Automated Peritoneal Lavage System is limited by federal (United States) law to investigational use only and is not available for sale.

References
1. Véronique R. Heart Disease and Stroke Statistics–2012 Update: A Report From the American Heart Association. Circulation. 2012;125:e2-e220.

MENLO PARK, Calif.–(BUSINESS WIRE)–Velomedix, Inc., a venture-backed medical device company advancing the field of therapeutic hypothermia, announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to expand the design of its VELOCITY pilot clinical trial. This North American trial will evaluate the use of rapid therapeutic hypothermia in the treatment of patients suffering an acute myocardial infarction (AMI or heart attack). Positive discussions with the FDA resulted in approval to include a control arm for a randomized comparison, thus doubling the number of patients, and to increase the number of U.S. trial sites.

Mild therapeutic hypothermia has been shown to substantially improve outcomes for acute events, such as heart attack and cardiac arrest*. While several technologies are currently being used clinically for hypothermia management, Velomedix’s proprietary technology delivers unparalleled cooling speed, as demonstrated in previous clinical trials*. This form of rapid cooling may enhance clinical outcomes and enable widespread clinical adoption of this promising therapy. “More rapid cooling may be critical to reduce infarct size in patients with heart attacks undergoing angioplasty,” commented Gregg Stone, MD, Columbia University Medical Center / New York-Presbyterian Hospital and co-principal investigator of the VELOCITY trial.

The VELOCITY trial is a 60-patient randomized trial at up to nine U.S. investigational sites to evaluate the Velomedix Automated Peritoneal Lavage System in patients with ST segment elevation myocardial infarction, presenting within six hours of symptom onset. The study will investigate the safety and feasibility of augmenting today’s standard of care (primary PCI) with mild therapeutic hypothermia delivered by the Velomedix system. “We are very excited that collaboration with the FDA resulted in a randomized trial which will likely provide much more clinically useful information than a comparison to historical control,” said Jeff Gold, President and CEO of Velomedix.

The study’s primary endpoint is a composite of specific new-onset, serious adverse events during the first thirty days following treatment. Several secondary endpoints will also be collected, including infarct size, myocardial salvage, and left ventricular ejection fraction. Thus, while primarily a safety trial, it will also gather meaningful efficacy information.

Graham Nichol, MD, University of Washington – Harborview Center for Pre-Hospital Emergency Care, will be working with Dr. Stone as the other co-principal investigator for this study. The trial is set to begin enrollment before the end of 2012. More information on this trial can be found at www.clinicaltrials.gov, study NCT01655433.

About Velomedix, Inc.

Velomedix is a private medical device company in Menlo Park, CA created to realize the clinical potential of mild therapeutic hypothermia in patients suffering from acute vascular insults. These include heart attack, cardiac arrest, and ischemic stroke.
Therapeutic hypothermia (TH) has been shown to reduce the ischemic and reperfusion effects in these costly and debilitating conditions.

Unlike other cooling approaches, Velomedix’s unique technology can rapidly reduce patient temperatures to therapeutic levels. In clinical studies outside the U.S., the system has achieved therapeutic temperatures in less than 15 minutes on average*. This rapid cooling rate may therefore make TH an effective enhancement to the time-sensitive treatments of these patients.

For additional information, please visit www.velomedix.com.

Note: The Velomedix Automated Peritoneal Lavage System Investigational Device is limited by Federal (United States) Law to Investigational Use.

* References available upon request

Contacts:

Velomedix, Inc.
Brian K. Hakim, 650-330-7314
Director of Marketing
bhakim@velomedix.com

Company’s Proprietary Approach Expected To Further Advance The Practical Application and
Clinical Benefits Of Therapeutic Hypothermia

MENLO PARK, CA – February 14, 2012 – Velomedix, Inc., a clinical stage medical device company advancing the field of therapeutic hypothermia , announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to evaluate the use of rapid therapeutic hypothermia for the treatment of patients suffering an acute myocardial infarction (AMI or heart attack.) The conditional approval allows the company to initiate a clinical trial at select sites in the U.S.

Therapeutic hypothermia has been shown to significantly improve outcomes for several acute events such as cardiac arrest, heart attack, and acute ischemic stroke. It has also been used with great success for spinal cord injury. While there are several technologies currently being marketed for hypothermia management, Velomedix’s proprietary technology delivers unparalleled cooling speed and procedural efficiency that is expected to result in enhanced clinical outcomes and enable more widespread clinical adoption of this promising therapy. “While current technologies can reach a therapeutic target temperature of 33C in 1-2 hours, the Velomedix system has shown the ability to achieve 33C in less than 15 minutes,” commented Jeff Gold, President and CEO of Velomedix. “For AMI patients requiring an intervention to open a blocked artery, the ability to deliver rapid cooling is crucial to optimizing the protective benefits of therapeutic hypothermia while still complying with mandated hospital ‘time-to-treatment’ standards,” added Griff Tully, MD, Velomedix’s Vice-President & Chief Medical Officer.

The recently approved IDE study will build upon limited, yet significant, data developed over the last 8 years for the use of therapeutic hypothermia for heart attack victims. Though the early randomized studies clearly pointed to the potential benefits of therapeutic hypothermia in this patient population, the effectiveness of the therapy was limited by the slow cooling times of the technologies employed and, as such, failed to meet the primary clinical endpoints. More recent studies have shown that rapid cooling, as enabled by Velomedix’s proprietary system, can result in clinical results that rival the best data extracted from earlier studies. Study patients who were rapidly and effectively treated with therapeutic hypothermia showed up to a 50% reduction in the amount of heart muscle lost during a major heart attack. This reduction is expected to correlate with improved survival rates and enhanced quality of life post-infarct.
It is anticipated the Velomedix IDE study will begin enrolling patients in the second half of 2012.

About Velomedix, Inc.
Velomedix is a venture capital backed clinical stage company located in Menlo Park, CA. Founded in 2007, the company has completed an initial human trial in the European Union (EU) that showed improved survival rates and neurological outcomes for patients suffering a cardiac arrest. In both the EU and the United States, awareness of the benefits of therapeutic hypothermia is growing and, in 2010, the American Heart Association (AHA) elevated the recommendation for therapeutic hypothermia for out-of-hospital cardiac arrest to a Class I. Yet clinical adoption of the therapy continues to be burdened by the insufficiencies of current approaches. Velomedix feels its rapid cooling approach has the potential to expand the clinical application and practical adoption of therapeutic hypothermia for the management of cardiac arrest patients as well as those suffering from a heart attack, stroke, traumatic brain injury, and spinal cord injury.
For additional information, please visit www.velomedix.com

Corporate and Media Contact:
Jeffrey G. Gold
President & CEO
Velomedix, Inc.
(650) 330-7314
jgold@velomedix.com

Company’s Unique Approach to Therapeutic Hypothermia
Provides Unparalleled Cooling Speed for Enhanced Clinical Outcomes

MENLO PARK, CA – February 8, 2012 – Velomedix, Inc, a development stage medical device company advancing the clinical field of Therapeutic Hypothermia, announced the closing of $10.2 million in Series B financing and the appointment of medical device veteran Jeffrey (Jeff) Gold as the company’s Chief Executive Officer and Michael Moore as the Vice-President of Operations.

Velomedix is accelerating the paradigm shift in the management of patients suffering from cardiac arrest and, potentially, those suffering from acute myocardial infarction (AMI or heart attack) and stroke. The company’s initial clinical trial, CAMARO, enrolled cardiac arrest patients at multiple sites in the European Union (EU). The clinical results demonstrated unprecedented positive neurologic outcomes in patients surviving cardiac arrest, as compared to clinical data published in peer-reviewed papers. Proceeds from the company’s recent financing will be used to initiate a post-CE Mark trial in support of EU commercialization and obtain U.S. Food and Drug Administration approval for a clinical study in the United States.

“Without question, I feel Velomedix’s technology is the most exciting device I have worked with,” stated Kees Polderman, MD, CAMARO Principal Investigator and Medical Director of Neurocritical Care Services at the University of Pittsburgh Medical Center. “It definitely has the potential to significantly change and broaden the scope of hypothermia treatment to much larger patient groups, specifically myocardial infarct and stroke patients, but perhaps also patients with traumatic brain injury.”

“The therapeutic benefits of induced hypothermia are well documented in clinical literature,” commented Mr. Gold. “However, market adoption of hypothermia devices has lagged because, until now, there has been no single technology that could solve the thermodynamic challenge of therapeutic cooling to 33°C in a safe, user-friendly and effective manner, while simultaneously fitting within mandated hospital “time-to-treatment” standards associated with cardiac arrest, AMI, and stroke. With a solid technology platform, funding from premiere venture capital firms, and an experienced leadership team, I am optimistic about the role Velomedix will play in accelerating the use of Therapeutic Hypothermia in these growing underserved markets.”

“By offering rapid cooling and significantly improved set-up times, we feel we are well positioned to excel in the cardiac arrest market and unlock the AMI market”, added Griff Tully, MD, Velomedix’s Vice-President & Chief Medical Officer.

Concurrent with the closing of its Series B financing, Velomedix’s Board of Directors appointed Mr. Gold as the company’s President & CEO on a permanent basis. Previously Mr. Gold was the Interim CEO of Velomedix and a Venture Partner of Longitude Capital. As Interim CEO, Mr. Gold played a critical role in strengthening Velomedix’s position in the emerging Therapeutic Hypothermia market.

Prior to Velomedix, Mr. Gold has held numerous senior executive positions including CEO of CryoVascular Systems which was acquired by Boston Scientific Corporation and COO and Executive Vice President of CardioThoracic Systems which was acquired by Guidant Corporation. Previous to CTSI, Mr. Gold spent 18 years with Cordis Corporation and was the Co-founder and President of Cordis Endovascular Systems. Mr. Gold holds an M.B.A. from the University of Florida and a B.S. in Engineering from Northeastern University, and is a graduate of GE’s Manufacturing Management Program.

Joining Mr. Gold, Velomedix is pleased to also announce the addition of Michael Moore as Vice President of Operations. Mr. Moore has 18 years of experience in medical device development and product realization. Most recently, Mr. Moore served as VP of Operations for MRI Interventions (formally SurgiVision), prior to which he was the Chief Technical Officer for Bolton Medical, Inc. Previously, Mr. Moore served as Director of R&D and Operations for AVE, Peripheral Vascular, a division of Medtronic, Inc., and held various operations and product development roles at Cordis Corporation and DePuy Orthopedics. He holds a BSME from Purdue University.

About Velomedix, Inc.

Based in Menlo Park, California, Velomedix, Inc. is a development stage medical device company created to realize the clinical potential of mild Therapeutic Hypothermia in benefiting patients suffering from ischemic and reperfusion injury effects of cardiac arrest, heart attack, stroke, and trauma brain injury.

For additional information, please visit www.velomedix.com

Corporate and Media Contact:
Jeffrey G. Gold
President & CEO
Velomedix, Inc.
(650) 330-7314
jgold@velomedix.com