EpiEP, Inc.

What we've been up to



EpiEP, Inc. is a medical device company that has developed an FDA cleared and CE marked epicardial access system, EpiAccess™. This system engages a patent protected pressure-guided needle that is designed to alert physicians of needle tip location during epicardial access procedures.

Entering the pericardial space with a minimally invasive technique is considered the “final frontier” for electrophysiology procedures. EpiEP has devoted itself to developing a specialized instrument that will facilitate an epicardial approach for patients who will benefit from minimally invasive procedures on the surface of the heart.


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Our Mission


An epicardial approach allows the physician to work on the outside surface of the heart muscle rather than on the inside of the heart. While several companies have emerged with epicardial tools for treatment of ventricular tachycardia (VT), atrial fibrillation (AF), and left atrial appendage (LAA) ligation, EpiEP's solution uniquely employs a pressure guided needle in conjunction with standard of care fluoroscopy to provide the physician with safe, precise, real-time guidance confirming access into the pericardial cavity.

During pre-clinical and clinical trials, physicians have expressed satisfaction with the performance of the EpiAccess™ System and its unique ability to display adjunctive data, designed to permit the physician to recognize when the needle tip reaches the pericardial space. This is a technology platform that can be calibrated for other anatomic locations within the body, but to date our focus has been the development and commercialization of the EpiAccess™ System to provide pressure guided access to the pericardial space.





Milestones

  • October 2014
    FDA 510(k) clearance for EpiAccess™ System
  • August 2014
    FDA submission completed
  • March 2014
    EpiAccess™ System CE Marked
  • 2013 - 2014
    Multi-center clinical trial in Europe
    (Prague, Czech Republic; Milan, Italy; Coimbra, Portugal; Bordeaux, France)
  • December 2013
    EpiEP receives ISO 13485 Certification
  • 2012
    Feasibility study completed in Europe
    (Prague, Czech Republic; Debrecen, Hungary)
  • May 2012
    Findings from pre-clinical trial presented at Heart Rhythm Society meeting
    Boston, MA
  • May 2011
    Pre-clinical trial at Mayo Clinic
    Rochester, MN
  • 2010
    First product design
  • December 2008
    Company formed

Management Team

Creating a better future



Pamela Bunes

Chief Executive Officer, Founder

Ms. Bunes has 24 years of medical device history including numerous years with Johnson & Johnson’s Ethicon Endo–Surgery and Biosense Webster, followed by nine years as the senior executive of two start-up companies, one which was a public entity. In 2013 she was a member of the FDA entrepreneur in residence team and currently serves on the operating board of directors for the Yale Entrepreneurial Institute.

Her experience includes sales and sales management, marketing, execution of new product launches, achieving both FDA and CE Mark approval for commercializing new medical technologies, and forming strategic partnerships and alliances through licensing or acquisitions. During the last decade, her market focus has been cardiology and electrophysiology.

She is experienced in raising capital for both private and public companies, and developing innovative medical technologies that improve patient’s lives. Ms. Bunes strives to find a collaborative balance with her team and board of directors, believing that the collective genius of the experience supporting her vision improves the chances of a successful outcome for patients, physicians, and investors.



Colin M. Rolph

Chief Financial Officer

Mr. Rolph has been an angel investor in several start-ups over the past fifteen years. For the past 10 years, Mr. Rolph has been running day to day operations of Tall Oaks Capital, LP and has been CFO of the fund for the past 7 years. Mr. Rolph has also been the CFO of EpiEP, Inc. for the past 3 years and part time CFO of iTiHealth, a start-up out of the University of Virginia for the past two years.

Starting in April of 2014 he is the acting CFO of another start-up out of the University of Virginia, TearSolutions, LLC. Mr. Rolph graduated from the Rochester Institute of Technology in 1982 with a Bachelor of Science.



Michael Theran

VP of Product Development

Mr. Michael Theran is the Vice President of Product Development at EpiEP, Inc. He received his Bachelor of Science in Mechanical Engineering from Boston University.

After starting his career in consumer products as a product designer, product manager then engineering executive, Mr. Theran decided to focus on start-up companies in the life sciences including medical devices. Creating much needed and highly innovative new medical devices from university research has been Mr. Theran’s focus for the last 10 years.





Elsa Abruzzo, RAC, FRAPS

Regulatory Consultant

Elsa has a 25+ year successful regulatory, quality, clinical, and operations track record. Most recently as Founder and CEO of Cygnus Regulatory, her areas of expertise include cardiovascular, neurovascular, orthopedic, CRM, diagnostic imaging, mHealth, Health IT, and point of care diagnostics. Elsa successfully headed numerous project teams at a variety of start-ups. Prior to Cygnus, Ms. Abruzzo worked at companies such as Baxter, Cordis JNJ, CryoLife, Percutaneous Valve Technologies (acquired by Edwards LifeSciences), AtriCure, and Polymer Technology Systems Cardiochek.

Ms. Abruzzo’s regulatory and clinical strategies have resulted in global commercialization of numerous technologies. Some of the disruptive medical solutions Elsa helped bring to market include: transcatheter tissue heart valves, implantable biomaterials, surgical adhesives, embolic agents, stents, atrial fibrillation ablation devices, neuromodulation devices, and point of care analyzers.

Ms. Abruzzo has a B.S. in engineering from the University of Miami (Coral Gables, FL), is regulatory affairs certified (RAC), and a Fellow of the Regulatory Affairs Professional Society (FRAPS). As a thought leader in regulatory, she has been invited to present nationally and was recognized for leadership in Regulatory and Quality by MDDI Magazine 2007.



NOVUS Group LLC

Q.S. Management

NOVUS Management Group is a technology-startup consulting group that specializes in quality assurance, patent protection, marketing, and software development for the medical device industry. Founded in 2010 by Scott D. Wampler, NOVUS Management Group assists early-stage medical device companies in bringing their products to market by supplying all stages of technology development, patent prosecution, quality control, regulatory support and marketing consultation.

In addition Novus has a dedicated software engineering team to conduct UI/UX GUI design as well as full software development and validation. Based in Cincinnati, Ohio, NOVUS Management Group LLC has assisted over 12 clients through 2013.


Board of Directors

Our industry veterans

Jonathan Mark Sackier MD, MB, ChB, FRCS, FACS

Dr. Sackier has 30 years of healthcare experience. Trained in Britain as a surgeon and recruited to the USA in 1989 he helped lead the laparoscopic surgery revolution. As a Professor at George Washington University in Washington, DC, he founded, and funded the Washington Institute of Surgical Endoscopy, a center for education, research & innovation. He is an Adjunct Professor of Surgery at the University of Virginia and his activities in basic and clinical research funded by multiple grants have led to many publications, chapters and books.

Dr. Sackier’s collaborations with the pharmaceutical and medical device industry have led to multiple technologies coming to market with partners like Valleylab, Pfizer, Karl Storz, Applied Medical & Pall. In 1984 his team at Genethics, a company he founded, discovered and patented amniotic stem cells and licensed the rights to a publicly traded British drug discovery company. He helped develop and market the AESOP robot with Computer Motion, who had a successful IPO in 1997 and has also built a research & product design company, a medical contract sales organization, a locum agency and helped found a communications company. He has consulted to healthcare companies and worked with the financial community on enterprise financing and due diligence.

Dr. Sackier has served the Steppenwolf Foundation, is a Trustee of First Star, on the Board of the American College of Surgeons Foundation, the Surgical Fellowships Foundation and chaired the Board of the Larry King Cardiac Foundation. He has sat on the Associate Board of AdvaMed and several corporate governance and scientific advisory boards. He was until recently Chairman of Adenosine Therapeutics and among others, sits on the Board of Clinvue, Hemoshear and Rex Bionics.

Mary Lake Polan, MD, PhD, MPH

Dr. Polan served as the chair of the Department of Obstetrics and Gynecology at Stanford University School of Medicine for over 15 years, and is currently an Adjunct Professor, Department of Obstetrics and Gynecology and Reproductive Sciences at Columbia University School of Medicine.

Dr. Polan served on the board of Wyeth Pharmaceuticals prior to it’s acquisition by Pfizer and currently serves on the board of Quidel Corp, San Diego, CA as well as on the boards of several privately held life sciences companies. She is also a Managing Director of Golden Seeds, an angel investing group which invests in women led companies. In addition, she chairs an SAB in Women’s Health for Proctor and Gamble.

Dr. Polan’s research has involved ovarian and urologic function with many publications in both areas. She is a member of the Institute of Medicine of the National Academy of Sciences and has served on a number of NIH and university committees. She has a long-standing interest in women’s health research and has been actively involved in international public health. She initiated The Eritrean Women’s Project in 2001 and has maintained this surgical project in Eritrea to repair fistulas resulting from traumatic births.

She received her bachelor’s degree from Connecticut College and her Ph.D. in Molecular Biophysics and Biochemistry and M.D. from Yale University and completed her residency and Reproductive Endocrine Fellowship in the Department of Obstetrics and Gynecology at the Yale University School of Medicine. Dr. Polan received her M.P.H. (Maternal and Child Health Program) from the University of California, Berkeley.

Konstantine Drakonakis, Director, Launch Capital

Konstantine is an experienced early stage investor focused on proprietary technologies in the tri-state NY region. As an "Entrepreneurial Engineer", Konstantine gravitates to technology companies within the software, med-tech and green-tech markets. He holds a Masters in Environmental Management from Yale University and a Civil and Environmental Engineering degree from the University of Vermont.

He is a board certified Professional Engineer and is a member of the National Civil Engineering Honors Society. Konstantine lives in New Haven with his wife, 3 year old son and new baby girl. When he can, he finds a Zen moment in his garden.



Thomas K. Brooks

Tom started his medical career at Ethicon Endo Surgery in Sales and moved up into Sales Management in the New York area. He moved to a startup, Meditech, known today as Boston Scientific and held positions in Sales, Sales Management and Business Development.

A few years after the company went public, he left to move to Atlanta as employee number 7 at Novoste Corporation, which went public in 1996. In 2001, Tom moved out to Menlo Park, California to become the President of Conor Medsystems who was developing a novel drug eluding coronary stent and raised over $30 million in capital.

The Company went public in 2004 and was sold to Johnson & Johnson in 2007 for $1.4 billion. In 2003, he formed a venture capital fund, Healthcare Capital Partners, whose primary focus was making seed and early-stage investments in medical device companies.

In 2009 he went back to the west coast to run Mast BioSurgery in San Diego. He returned to Atlanta 2013 and is working on his next start-up company, Vein Closure Systems based in Georgia.

Russell Tweedale

Russell has invested in more than 50 companies during his tenure as Managing Director of Investments at Connecticut Innovations. He has led CI’s investments in bioscience companies including Affomix Corporation, Cardiopulmonary Corporation, Genaissance Pharmaceuticals, Ipsogen and Metagenomix, Inc. Russell has also led CI’s investments in I-Mark and LiveClips, and serves on a number of boards.

Seven of the current or former CI portfolio companies that Russell has worked with have had successful initial public offerings. Russell has considerable experience in economic and venture analysis, engineering cost accounting, systems analysis, scientific and commercial programming, math analysis, EDP auditing and computer modeling.

He was previously with United Technologies Corp., Wolf Research and Development, Scientific Leasing and the Robert E. Nolan Co. Russell holds a B.S. in Electrical Engineering and an M.B.A. from the University of Hartford.


Scientific Advisors & Investigators

Our Medical Experts

Principle Investigator and Scientific Advisor


Andrea Natale, MD

FACC, FHRS, FESC, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas


Scientific Advisors


Vivek Reddy, MD

Mount Sinai School of Medicine, Mount Sinai Hospital, New York, New York, Director of Cardiac Arrhythmia Services, Professor of Medicine, Cardiology, The Leona M. and Harry B Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology

Mitchell Krucoff, MD

Duke University Medical Center, Durham, NC, Duke Clinical Research Organization,Co-Director, Cardiovascular Devices Group Director, Electrocardiology Core Lab, Professor of Medicine, Cardiology

Moussa Mansour, MD

Director of Cardiac Electrophysiology Laboratory, Mass General Hospital; Director Atrial Fibrillation Program, Mass General Hospital; Assistant Professor of Medicine, Harvard Medical School



Mauricio Scanavacca, MD

InCor, University of São Paulo, Professor of Medicine, São Paulo University Medical School and supervisor of the Electrophysiology Lab


Clinical Investigators


Petr Neužil, MD

Na Holmolce Hospital, Prague, Czech Republic

David Burkhardt, MD

St. David’s Medical Center, Austin, Texas

Luigi Di Biase, MD, PhD

Montefiore Medical Center, New York, New York

Zoltan Csansadi, MD

University of Debrecen, Debrecen, Hungary



Claudio Tondo, MD

Centro Cardiologico Monzino, Milan, Italy

Coronado Carrbucchio, MD

Centro Cardiologico Monzino, Milan, Italy

Antonio Dello Russo, MD

Centro Cardiologico Monzino, Milan, Italy

Miguel Ventura, MD

IdealMed Unidade Hospitalar de Coimbra, Coimbra, Portugal



Douglas Packer, MD

Mayo Clinic, Rochester, Minnesota

Matthew Swale, MD

Mayo Clinic, Rochester, Minnesota

Frédéric Sacher

Hôpital Haut-Lévêque, Bordeaux, France

Pierre Jaïs, MD

Hôpital Haut-Lévêque, Bordeaux, France


Technology

Introducing the The EpiAccess™ System

The real-time guidance and confirmation capability of the EpiAccess™ system are based on both disposable and hardware components. The disposable is an access needle that is used to provide single-use access to the pericardial cavity; the capital component contains the host computer and relevant algorithms.


FDA 510(k) clearance & CE Mark approval have been granted.




The EpiAccess™ Needle

The system includes a proprietary, tuohy-style needle with a fiber optic pressure sensor mounted permanently at the distal tip. The real-time pressure signal in combination with standard of care fluoroscopy is designed to provide the physician position guidance and needle tip position confirmation.

EpiAccess™ “SMART” Needle pictured during epicardial access.

Product being used as part of the EASe Clinical trial conducted in Europe.


Real-Time Feedback

Our instrumentation captures the pressure signal from the sensor and displays the signals on a monitor. The graphical user interface is easy to read, allowing physicians to understand the real-time pressure waveform intuitively.

The data provides guidance to the physician on the position of the needle so they can know when the needle has reached the desired location. The needle tip pressure wave form is designed to confirm access to the pericardial space.


EpiAccess™ screen capture showing typical pericardial signal.


The Control Unit

The control unit is designed to be easy to use, flexible and durable. Data capture equipment and a touch screen monitor are housed in a mobile cart that allows the user to position the system as desired.

Its design features allow quick and convenient transition from a “Secured” mode for storage to “Procedure Ready” mode. When in “Secured” mode, the control unit is more protected.

The control unit can be used as a stand alone monitor or integrated into most existing monitors; see below.


Stand Alone

The EpiAccess™ unit can be used as a stand alone device, as shown above. The monitor can be conveniently rolled into place and raised or lowered to the clinicians preferred position, typically adjacent to the fluoroscopy monitor.

Integrated System

The EpiAccess™ system can also connect to other monitors, such as a monitor within a monitor bank. Many clinicians prefer to position the EpiAccess™ system display adjacent to the fluoroscopy monitor, as shown above.

Product being used as part of the EASe Clinical trial conducted in Europe.

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News

The latest from EpiEP

EpiEP, Inc. Receives FDA 510(k) Clearance for EpiAccess System™

Pressure-guided epicardial access system enables electrophysiologists to perform challenging procedures on the surface of the heart

New Haven, Conn. - Nov. 10, 2014 – EpiEP, Inc. (EpiEP), today announced that its EpiAccess™ system, a pressure-guided epicardial access system designed to help physicians perform procedures on the surface of the heart, has received 510(k) clearance from U.S. Food and Drug Administration (FDA), a step that will allow EpiEP to commercially distribute the device.

EpiEP is a research and development medical device company with a portfolio of innovative epicardial technologies initially targeting minimally-invasive epicardial access for electrophysiology procedures such as ventricular tachycardia (VT), atrial fibrillation (AF), and left atrial appendage occlusion (LAA), which in some instances require access to the surface of the heart.

“This clearance marks a significant advance for EpiEP and our lead product,” said Pamela Bunes, CEO of EpiEP. “The EpiAccess™ system is positioned to immediately impact the growing field of epicardial electrophysiology procedures. We look forward to launching the EpiAccess™ system to full commercialization in the U.S. and providing physicians with a unique device that allows them to access the pericardial space, which surrounds the heart.”

The EpiAccess™ system is the flagship product, which provides electrophysiologists a pressure guided access needle. Pressure guidance allows the physician to know where the needle tip is located when it is advanced under fluoroscopic guidance to the virtual space between the pericardial sac and the surface of the heart without injuring the heart. It was CE Mark (Conformité Européenne) approved for sale in Europe in March 2014, and has been used in a post-market study in Prague, Czech Republic, Milan, Italy, Bordeaux, France, and Coimbra, Portugal.

“Despite the growing importance of epicardial access during ablation procedures, it is recognized that the fear of potential complications has limited the use of an epicardial approach,” said Andrea Natale, M.D., and Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. “The EpiAccess™ system is the first product designed and approved for use in Europe and FDA 510(k) cleared in the United States that will offer physicians more confidence to use this approach whenever it could be beneficial to the patient.”

About EpiEP, Inc.

EpiEP, Inc. has licensed, a portfolio of patent protected epicardial medical devices from the University of Virginia. These products will impact the growing field of electrophysiology by providing physicians with novel tools to access and treat various cardiac conditions. The EpiAccess™ system is the flagship product, which provides electrophysiologists with a pressure guided access needle so the physician knows where the tip of the needle is located when it is being advanced to the virtual space between the pericardial sac and the surface of the heart without injuring the heart. The EpiAccess™ system is designed to result in better patient outcomes by reducing unintended puncture in the heart muscle. The system provides real time feedback for physicians so they can know when the needle has reached the desired location.

Editor’s Note: The EpiAccess™ system is not available for sale or use in all countries. For additional information, please visit www.epiep.com.

Media Contact:
Pamela Bunes
EpiEP, Inc.
Phone: 864-423-2526
Email: pbunes@epiep.com




Pamela Bunes: a Business New Haven Rising Star

October 6, 2011 Congratulations, Pamela Bunes, on being named a Business New Haven Rising Star for 2011! We are proud that New Haven-based EpiEP Inc., the company you founded and now lead, is a member of our Connecticut Innovations portfolio.
Read More »


U.Va. Start-Up EpiEP Receives $1.5 Million Investment

July 8, 2010 — EpiEP Inc., a medical device company spun out of the University of Virginia, has received $1.5 million in investments and commitments for the development of its novel EpiAccess system, which shows promise to improve and expand the treatment of cardiac arrhythmia and other heart conditions.
Read More »


Press Inquiries?



PRIVACY STATEMENT


Last Updated: November 8, 2014

This privacy statement ("Privacy Statement"), together with the Terms of Use and other published guidelines, governs any interaction with us at our website at www.epiep.com (the "Site"), including how EpiEP, Inc. ("EpiEP" or “we” or “us”) collects, uses, discloses, transfers or stores personal information that you may provide to us through the Site, including email communications. Please take a moment to get acquainted with our policies and let us know if you have any questions.

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Last Updated: November 8, 2014

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If any term or condition of the Terms of Use shall be held illegal, invalid or unenforceable, the remaining terms and conditions of the Terms of Use shall not be affected thereby and such terms and conditions shall be valid and enforceable to the fullest extent permitted by law. This Site is controlled and operated by EpiEP from the United States.

EpiEP makes no representation that materials in the Site are appropriate or available for use in other locations, and access to them from territories where their contents are illegal is prohibited. Those who choose to access this Site from other locations do so on their own initiative and are responsible for compliance with applicable local laws.

Any claim relating to, and the use of, this Site and the materials contained herein shall be governed by the laws of the United States of America and state of Massachusetts. By accessing or using this Site, you consent to exclusive jurisdiction and venue in such federal and state courts in the State of Massachusetts.

EpiEP may terminate or suspend the Site or your access to the Site at any time without notice, including upon any breach by you of any provision of these Terms of Use.