MONTREAL, October 25, 2012 – Thrasos Therapeutics announced that it has completed a $35 Million (U.S.) financing for the development of THR-184, its lead product candidate for the treatment of acute kidney injury (AKI). The round was led by new investor, SR One, with funds coming from the GSK Canada Life Sciences Innovation Fund, part of GlaxoSmithKline’s commitment to advance the development and commercialization of scientific innovation in Canada. Five additional new investors and existing investor, SW Co, joined in the round. The new investors were Advanced Technology Ventures (ATV), Fonds de solidarité FTQ, Lumira Capital, MP Healthcare Venture Management and Pappas Ventures. With the financing, Thrasos plans to advance THR-184 through Phase 2 clinical proof of concept in AKI.

Click here to read the full press release.

FierceMedicalDevices named two Pappas Ventures' portfolio companies to the 2012 Fierce 15 list, the inaugural list of the most innovative and exciting medical device companies. CardioDx is a cardiovascular molecular diagnostics company based in Palo Alto and TyRx is a New Jersey device company developing a range of drug-eluting implantable devices.

Mike Grey will join a panel to discuss the future of venture capital in life sciences investing at a special event hosted by the San Diego Venture Group on September 27 in San Diego, CA.

AIGISRx Antibacterial Envelope for Pacemakers and Defibrillators Recognized by Frost & Sullivan

MONMOUTH JUNCTION, N.J., Sep 14, 2012 (BUSINESS WIRE) -- TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with cardiovascular implantable electronic devices (CIEDs) including pacemakers and implantable defibrillators, announced today that Frost & Sullivan has named the AIGISRx(R) Antibacterial Envelope as the recipient of its prestigious New Product Innovation Award for 2012.

"To date TYRX's AIGISRx is very unique in the fact that it is the first and only antibacterial product of its kind to receive U.S. Food and Drug Administration (FDA) clearance. The product not only helps in stabilizing the pacemaker or ICD, but it also helps reduce infection by delivering antibiotics directly to the surgical site in the first 7 to 10 days following implantation," said Darshana De, IP and Best Practices Analyst from Frost & Sullivan.

The AIGISRx Antibacterial Envelope is designed to address surgical-site infections which are expensive to treat and have a significant impact on patients and hospitals.

Patients suffering from surgical-site infections following CIED procedures:

• spend an average of two extra weeks in the hospital
• undergo repeat surgical procedures to treat the infection
• cost the facility an average of $72,485
• experience significant increases in morbidity & mortality, with 1-year mortality rates of 26.5% to 35.1%, depending on device type

The recipient of the Frost & Sullivan New Product Innovation Award is selected after rigorous analysis of industry's leading companies who demonstrate outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

"Since TYRX was founded, we have been working diligently to research, develop, and commercialize technologies which help reduce surgical-site infections and improve patient outcomes," remarked Robert White, President and CEO of TYRX. "Our team appreciates Frost & Sullivan's acknowledgement of our product leadership and innovation."

About TYRX, Inc.

TYRX, Inc., headquartered in Monmouth Junction, New Jersey, is a pioneer in the development, manufacture, and distribution of innovative, implantable combination drug-device products including the AIGISRx(R) Antibacterial Envelope. The AIGISRx Envelope is specifically designed to aid in the stabilization of CIED placement as well as to help reduce surgical-site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection by organisms representing the majority of the infections reported in CIED-related endocarditis, including "superbugs" or MRSA.

For more information, please visit www.TYRX.com

RALEIGH, N.C.--(BUSINESS WIRE)--September 5, 2012--LipoScience, Inc., an in vitro diagnostic company committed to advancing patient care in cardiovascular, metabolic and other diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vantera® Clinical Analyzer.

The Vantera Clinical Analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology. Ease-of-use and walk-away automation provide efficient workflow to maximize laboratory resources while producing high quality results.

“LipoScience is pioneering a new field of personalized diagnostics based on NMR technology,” said Rick Brajer, Chief Executive Officer of LipoScience. “The FDA clearance of our Vantera Clinical Analyzer is a pivotal event that advances our vision of decentralizing our technology and becoming a clinical standard of care.”

The first assay cleared on this new in vitro diagnostic platform is low density lipoprotein particle number (LDL-P). LDL-P is a key component of LipoScience’s NMR LipoProfile® test, which provides physicians and their patients with actionable information to personalize management of risk for heart disease from a single blood sample. To date, over 8 million NMR LipoProfile tests have been ordered to aid in the management of patients’ heart health.

“Historically, all NMR LipoProfile tests have been performed at LipoScience’s CLIA-certified laboratory in North Carolina,” said Tom Clement, Vice President of Regulatory and Quality Affairs. “The 510(k) clearance of the Vantera Clinical Analyzer will allow us to place Vantera systems in select high-volume national and regional clinical diagnostic laboratories across the U.S., as well as at leading medical centers and hospital outreach laboratories, in order to drive both geographic expansion and the technology adoption necessary for successful execution of our market conversion strategy.”

About LipoScience, Inc. 

LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. Its first proprietary diagnostic test, the NMR LipoProfile® test, measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 8 million NMR LipoProfile tests have been ordered. LipoScience’s automated clinical analyzer, Vantera has recently been cleared by the FDA and will be placed with national and regional clinical laboratories. LipoScience is driving toward a clinical standard of care by decentralizing its technology and expanding its menu of personalized diagnostic tests to address a broad range of metabolic and other diseases. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.

CardioDx Completes $58 Million Equity FinancingProceeds to Support Commercial Expansion of Corus CAD and New Product Development

PALO ALTO, Calif. – August 27, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced the completion of a $58 million two-tranche equity financing. The financing included Temasek, an Asia investment company based in Singapore; and existing investors Longitude Capital; Artiman Ventures; Kleiner, Perkins, Caufield & Byers; J.P. Morgan; Mohr Davidow Ventures; TPG Biotech; Intel Capital; Acadia Woods Partners; Bright Capital; the venture arm of RU-COM; Pappas Ventures; DAG Ventures; Asset Management Group; and GE Capital. All previous investors participated in the round.

Proceeds from the financing will be used to support the commercial expansion of Corus® CAD, the only clinically validated gene expression test for obstructive coronary artery disease, and to develop additional genomic diagnostics in the field of cardiovascular disease.

“This funding positions CardioDx well to capitalize on the significant opportunity to improve the diagnosis of the millions of patients who visit their physicians with symptoms suggestive of obstructive coronary artery disease each year,” said David Levison, the company’s President and Chief Executive Officer. “The favorable Medicare coverage decision that we received earlier this month is a significant milestone that further validates the clinical benefit of and economic rationale for Corus CAD. This additional capital will help us expand our sales force in the U.S., further broaden reimbursement coverage, and support continued investments in research and development of new products.”

CardioDx recently announced that Palmetto GBA, a national contractor that administers Medicare benefits, has established coverage for the Corus CAD gene expression test for the evaluation of patients presenting with typical and atypical symptoms suggestive of coronary artery disease. With this decision, the Corus CAD gene expression test is now a covered benefit for more than 40 million Medicare enrollees in the U.S.

Studies have shown that typical and atypical presentations of stable chest pain account for up to two percent of outpatient office visits each year in the U.S., which equates to up to three million patients per year in the Corus CAD intended-use population. However, a study of nearly 400,000 patients published in The New England Journal of Medicine in 2010 reported that as many as 62 percent of stable patients who undergo elective invasive angiographic procedures are found to have no obstructive coronary artery blockage, despite broad usage of prior noninvasive imaging. The authors concluded that current modalities used to identify patients for elective invasive angiography to diagnose obstructive coronary artery disease have limitations, and that better methods are needed for patient risk stratification.

As much as $5 billion is spent on noninvasive testing, imaging and elective invasive angiography in the Corus CAD intended-use population annually in the U.S.

Monmouth Junction, NJ (August 20, 2012): Medicare’s decision to stop reimbursing hospitals for the treatment of potentially avoidable surgical site infections following cardiac implantable electronic device (CIED) procedures, including pacemaker and defibrillator implants, will significantly impact hospital practices according to a new national survey of hospital chief financial officers (CFOs).

The Centers for Medicare and Medicaid Services (CMS) recently released its Hospital Inpatient Prospective Payment System (IPPS) Final Rule for Fiscal Year 2013 which adds Surgical Site Infection following CIED implantation as a condition subject to the Hospital Acquired Condition (HAC) payment provision. CMS considers these infections to be reasonably preventable and has classified them as complicating conditions that would otherwise result in higher payment to the hospital. Under the new policy, CMS will pay for the original implantation surgery, but will not reimburse hospitals at a higher rate for treating the infection. 

The survey polled 50 hospital CFOs at academic health centers and community hospitals across the United States to determine how hospital practices are likely to change as the result of the new CMS rule. Findings included:

• 62% of CFOs consider the financial impact of the HAC on their hospital’s operations to be “very important.”

• Nearly all CFOs had adopted or plan to adopt new technologies to help reduce the risk of CIED infections; half those surveyed specifically cited increased use of the AIGISRx®Antibacterial Envelope.

• 82% of CFOs plan to use internal reporting measures to reduce the incidence of the CIED infections.

• 74% of CFOs believe their facilities may reduce the use of CIEDs when alternative therapies are available.

• Only 6% of hospital CFOs said their organization had not taken any actions to reduce the incidence of existing HACs.

Patients with surgical site infections following CIED procedures spend an average of two extra weeks in the hospital, undergo repeat surgical procedures to treat the infection, and cost the facility an average of $72,485. Additionally, such patients experience significant increases in morbidity and mortality, with 1-year mortality rates of 26.5 – 35.1%, depending on device type.

“Surgical site infections are expensive to treat and have a significant financial impact on hospitals as well as on patients’ health and wellbeing,” stated Robert White, Chief Executive Officer of TYRX, Inc., the leader in the commercialization of implantable medical devices intended to help reduce surgical site infections (SSIs). “New technologies, such as the AIGISRx® Antibacterial Envelope, can play an important role in reducing the incidence of such infections and thus lowering hospital costs.”

The survey, conducted by Epocrates, was sponsored by TYRX, Inc.

Art Pappas joins a Venture Capital Panel at Mid-Atlantic Bio on September 28 in Bethesda, MD.

Art Pappas joins a Venture Capital Panel at BioContactQuébec 2012 on October 3 in Quebec City.

In a bid to help control health care costs, on October 1, 2012, the Centers for Medicare and Medicaid Services (CMS) will stop paying hospitals for treating potentially avoidable surgical site infections following Cardiac Implantable Electronic Device (CIED) procedures including pacemaker and defibrillator implants. CMS just released its Hospital Inpatient Prospective Payment System (IPPS) Final Rule for Fiscal Year 2013 which adds Surgical Site Infection following CIED implantation as a condition subject to the Hospital Acquired Condition payment provision. CMS considers these infections to be reasonably preventable and has classified them as complicating conditions that would otherwise result in higher payment to the hospital. Under the new policy, CMS will pay for the original surgery, but will not reimburse hospitals at a higher rate for treating the infection.