– CardiaLen, Inc. receives $735,000 in funding from Broadview Ventures, Inc. –

ST. LOUIS, MO, March 31, 2011 — CardiaLen, Inc., a medical device company focused on providing pain-free internal cardioversion therapy for atrial fibrillation (AF) with a low-energy implantable atrial cardioverter plus pacing device received $735,000 in funding from Broadview Ventures, Inc. (broadviewventures.org). The financing will be used as working capital and will help fund the completion of CardiLen’s preclinical animal studies in atrial fibrillation as well as finalize the development of the company’s external low-energy pain-free atrial cardioversion device to be used in First-in-Man studies. The funds will not only help the company complete its current studies, but help develop the complete protocol for its First-In-Man studies.

“Clinical evaluation and the development of our cardioverters can be difficult and expensive. We are thankful for Broadview Ventures financing, and look forward to the successful completion of studies in atrial fibrillation utilizing this low-energy cardioversion technology,” said Bob Calcaterra, CEO of CardiaLen. “We continue to reach milestones at CardiaLen, and are confident that our pain-free cardioverter-defibrillators will offer significant patient benefits.”

CardiaLen also received a future commitment from Broadview Ventures for additional dollars upon achievement of certain research milestones. These additional funds will allow the company to begin and complete much of its First-in Man studies. Broadview Ventures, a company associated with Paris-based Fondation Leducq, has a mission to accelerate the development of technology in cardiovascular and neurovascular disease through targeted investment.

The most common cardiac arrhythmia (abnormal heart rhythm) is atrial fibrillation (AF or A-fib) and involves the two upper chambers (atria) of the heart. CardiaLen is developing implantable low-energy (low voltage) pain-free atrial cardioverters to help address the major unmet needs of this condition. AF has been estimated to affect more than three million people in the United States and over twenty million people worldwide. Pain-free operation is essential since AF patients typically remain conscious during episodes and since the condition is not immediately life threatening.

Formed in 2009 and co-located in St. Louis, MO, and St. Paul, MN, CardiaLen’s low-energy cardioversion technology is based on breakthrough work by Professor Igor Efimov, PhD, a world leader in cardiac arrhythmia research, currently at Washington University in St. Louis Biomedical Engineering School and previously at Case Western Reserve University.  Professor Efimov and his research colleagues discovered that very low-voltage shock, applied in proprietary algorithms, induces virtual electrode polarization (VEP) at cardiac heterogeneities and opens a new approach to the long sought after goal of pain-free defibrillation.

CardiaLen holds rights to its low-energy cardioversion technology under an exclusive global joint license from Washington University in St. Louis and Case Western Reserve University to develop and commercialize certain intellectual property developed by Professor Igor Efimov, Ph.D.  This technology has the potential to provide pain-free cardioversion-defibrillation therapy for both atrial and ventricular arrhythmias, conditions where major unmet needs exist.

For more information, visit: www.cardialen.com.

Cardiac arrhythmia start-up awarded $216,027 grant to develop a novel low-energy system for atrial defibrillation

CardiaLen, Inc is pleased to announce that it was notified by the National Heart, Lung, and Blood Institute of a $216,027 Phase I SBIR award to develop an enhanced system for atrial defibrillation (AF). AF is the most frequent arrhythmia in clinical practice and a major contributor to morbidity and mortality.  It is estimated that 3 to 5 million Americans are afflicted by atrial fibrillation and are at risk for thromboembolic stroke, congestive heart failure (CHF), and cognitive dysfunction.  According to a recent report by the AF Stat^TM working group, AF costs Medicare more than $15.7 billion annually due to costly complications.

Qun Sha, M.D., the Chief Medical officer, will be the Principal Investigator for the grant. This funded research will involve design, fabrication, and testing of electrical stimulation equipment capable of generating novel waveforms to further reduce the energy required to achieve atrial defibrillation.

This grant follows the October, 2010 receipt of a Qualifying Therapeutic Discovery Project grant totaling $231,013. These funds were awarded to small firms that showed significant potential to produce new and cost-saving therapies, support U.S. jobs, and increase U.S. competitiveness.

CardiaLen holds rights to its low-energy cardioversion technology under an exclusive global joint license from Washington University in St. Louis and Case Western Reserve University to develop and commercialize certain intellectual property developed by Professor Igor Efimov, Ph.D.  This technology has the potential to provide pain-free cardioversion-defibrillation therapy for both atrial and ventricular arrhythmias, conditions where major unmet needs exist.  CardiaLen will focus primarily on atrial fibrillation, a serious and growing condition worldwide, and secondarily on ventricular fibrillation.  It will work in strategic alliances with industry partners, as appropriate.  Pain-free cardioverter-defibrillators will offer significant patient benefits but will require extensive preclinical testing, clinical trials and regulatory approval prior to entering the market.

CardiaLen is jointly located in St. Louis, MO, where it maintains its headquarters and clinical affairs office, and Minneapolis-St. Paul, MN, where it conducts contract product development.

For more information, visit: www.cardialen.com.

Cardialen, Inc.

4041 Forest Park Avenue, St. Louis, Missouri  63108

Cardiac arrhythmia start-up advances novel low-energy cardioversion therapy: reports successful first studies

CardiaLen, Inc is pleased to advise that on September 2, 2010, it completed an initial close of its second private equity financing.  St. Louis Arch Angels and BioGenerator, key investors from the company’s first financing in July 2009, were joined in this round by a number of new angel investors.  CardiaLen expects this financing will enable it to complete its current preclinical animal studies in atrial fibrillation.  It expects to raise additional financing in the fall enabling the completion of third-party preclinical animal studies in atrial and ventricular fibrillation. It also anticipates a Phase 1 SBIR grant in late 2010 for preparatory work in connection with first-in-humans trials planned for 2011.

Milestones supporting the current financing round included successful completion of initial acute animal studies in atrial fibrillation utilizing low-energy cardioversion technology and the filing of further patent claims arising from these trials.  The company expects that study findings will be presented by researchers from Washington University Biomedical Engineering School at the American Heart Association Scientific Sessions in Chicago, IL, November, 2010.

CardiaLen holds rights to its low-energy cardioversion technology under an exclusive global joint license from Washington University in St. Louis and Case Western Reserve University to develop and commercialize certain intellectual property developed by Igor Efimov, Ph.D.  This technology has the potential to provide pain-free cardioversion-defibrillation therapy for both atrial and ventricular arrhythmias, conditions where major unmet needs exist.  CardiaLen will focus primarily on atrial fibrillation, a serious and growing condition worldwide, and secondarily on ventricular fibrillation.  It will work in strategic alliances with industry partners, as appropriate.  Pain-free cardioverter-defibrillators will offer significant patient benefits but will require extensive preclinical testing, clinical trials and regulatory approval prior to sale.

The company also advises that Robert J. Calcaterra D.Sc., a CardiaLen Board member and investor, has taken over as interim CEO, effective August 1, 2010.  The company thanks Graeme Thomas, its initial President and CEO, for leading it from formation to its most recent milestone achievements and wishes him well as he moves to his next early-stage venture commitment.

CardiaLen is jointly located in St. Louis, MO, where it maintains its headquarters and clinical affairs office, and Minneapolis-St. Paul, MN, where it conducts contract product development.

For more information, visit: www.cardialen.com.

Cardialen, Inc.

4041 Forest Park Avenue, St. Louis, Missouri  63108