•  
•  
•  
•  
•  
•  

CHF SOLUTIONS INC. & AQUADEX™ – acquired by Gambro

2.2 million hospital admissions per year in the U.S. are due to congestive heart failure with fluid overload. Coridea invented a new therapy now known as Aquapheresis, that allows for the safe and expedient removal of large volumes of fluid. Patients receiving Aquapheresis showed a remarkable 50% reduction in the number of re-hospitalizations for heart failure over standard care in trials. CHF Solutions Inc. obtained FDA approval of the Aquadex™ System, which is now standard care for drug resistant fluid overload. Gambro AB acquired CHF Solutions in 2010 and retained it as an independent business unit and a brand.

PLC MEDICAL & RenalGuard™

When PLC Medical Systems Inc. found the market space shrinking for their ground-breaking transmural laser revascularization, they sought out Coridea to identify a new market direction for their company. Coridea recognized an unmet clinical need in the area of Contrast-Induced Nephropathy (CIN) – a form of Acute Renal Failure caused by exposure to contrast media during image-guided cardiology and radiology procedures. CIN is a devastating and costly complication in patients with baseline renal dysfunction, hypertension or diabetes. While previous drug studies and devices failed to prevent CIN, Coridea discovered that a balanced high volume infusion of IV fluid flushes the patient’s kidneys and reduces damage from radiocontrast. The device based on Coridea’s discovery was named RenalGuard.

RenalGuard is approved in the EU for a broad range of clinical indications. The Centro Cardiologico Monzino at the University of Milan and Clinica Mediterranea in Naples, Italy, completed randomized clinical trials of RenalGuard in the prevention of Contrast-Induced Nephropathy (CIN) in high-risk patients undergoing catheterization procedures. The results conclusively demonstrated reduction of CIN by 50–80% in high risk patients as well as the reduction of in-hospital dialysis.

ARDIAN INC. & SYMPLICITY™ – acquired by Medtronics

Hypertension is the most common contributor to death worldwide. Only 35 percent of hypertensive patients are controlled with medication. It was long suspected that a major contributor to hypertension is hyperactivation of the sympathetic nervous system.

Coridea identified renal nerve traffic to and from the kidney as a target for a new, previously unexplored device development. After successful preclinical studies and IP development, Coridea licensed the renal denervation technology – now marketed as Symplicity™ – to The Foundry, the premier medical device company incubator in the San Francisco Bay Area, and Ardian Inc. was formed. Ardian Inc. has raised more than $60 million from Advanced Technology Ventures, Morgenthaler Ventures and Split Rock Partners and from Medtronic Inc. and successfully demonstrated sustained reduction of hypertension by a safe and simple cathlab procedure.

Medtronic Inc. acquired Ardian in November 2010 for $800 million with a potential upside of $500 million more in milestone payments. The price was the highest ever paid for a venture capital-backed medical device company, still at the pre-commercialization stage.

Symplicity^® Catheter System™ by Medtronic Ardian named the 2011 Edison Awards Silver Winner. The Gold Award went to Abbott's MitraClip^® system partially based on the initial patented research of Coridea's Dr. Levin.

CARDIAC CONCEPTS & CENTRAL SLEEP APNEA

We identified a new device opportunity in the little known field of Central Sleep Apnea (CSA). CSA afflicts 50 percent of patients with heart failure. There is scientific evidence that CSA accelerates the deterioration of heart failure patients and contributes to early mortality. Until now, CSA resisted all attempts of treatment.

In collaboration with Dan Sachs, M.D., Coridea formed Cardiac Concepts, Inc. as an early stage medical device company developing neurostimulation technology to treat Congestive Heart Failure patients with CSA. Three Arch Partners, Polaris Venture Partners, Versant Ventures and others participated in the $30 million early stage financing. Today, the first series of U.S. clinical implants of the RespiCardia® System at the Wroclaw Medical University Hospital in Poland and at The Ohio State University Medical Center have been implanted. Experienced pacemaker industry professionals in the Minneapolis area now lead the company.