Berlin Heart Inc. (Private)
August 27, 2012 Issue
The Most Powerful Name In Corporate News and Information
As the Only Company Worldwide that Has a Mechanical Circulatory Support Option for Patients of Every Age and Body Size and a Ventricular Assist Device Approved by the FDA for Infants and Children, Berlin Heart Inc. is Well Positioned for Growth
Berlin Heart is the only
company worldwide that develops, manufactures and distributes ventricular
assist devices for patients for every age and body size, and leads the
global market in circulatory support for the pediatric population. Berlin
Heart’s product portfolio includes INCOR®, EXCOR® Adult and EXCOR®
Pediatric, devices that support failing hearts short-, mid- and long-term
and therefore offer a life-saving therapy. INCOR® and EXCOR® Adult are not
FDA-approved, but widely used outside of the US. EXCOR® Pediatric, approved
for use in the US under HDE regulations by the FDA is widely used worldwide.
President and Chief Executive Officer (CEO), Berlin Heart Inc.
Robert Kroslowitz is responsible for Berlin Heart’s North American Operations. He joined Berlin Heart Inc. in 2005 as Vice President Clinical Affairs, and was appointed President and CEO in 2011.
Previously, he held both clinical and research positions in the cardiovascular space having served as director of several clinical departments in well-known US medical centers.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – August 27, 2012
Mr. Kroslowitz: Berlin Heart Incorporated, a wholly owned subsidiary of its parent company, Berlin Heart GmbH, is the North American representative for Berlin Heart. We are responsible for the company’s operations in the US, Canada, and Mexico. Berlin Heart Inc. was established in 2005 to support the North American market and to secure FDA approval of the EXCOR® Pediatric. EXCOR® Pediatric is the first-ever ventricular assist device (VAD) developed to provide long-term circulatory support for infants and children awaiting heart transplants. In the past, these children were given little hope of survival, but now, there is a lifesaving option for children with heart failure and immediate need for support.
Mr. Kroslowitz: The EXCOR® Pediatric Ventricular Assist Device is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or bi-ventricular dysfunction who are candidates for cardiac transplantation and require circulatory support may be treated using the device. The EXCOR® Pediatric VAD system incorporates paracorporeal pneumatic pumps that are available in different sizes that are patient specific and capable of providing cardiac support for both uni-ventricular and bi-ventricular failure in infants and children. The device is a smaller, redesigned subset of the much larger adult EXCOR® Adult.
The adult population has the option of being bridged to heart
transplantation with a variety of FDA approved adult ventricular assist
devices (VAD’s). Unfortunately, size and physiologic considerations preclude
the safe use of these devices in the pediatric population. In lieu of an
appropriate pediatric VAD, the primary default option for children failing
optimal medical therapy has long been extra-corporeal membrane oxygenation (ECMO),
the past standard of care for pediatric mechanical circulatory support in
for children for up to 1 – 2 weeks. However, ECMO is not suitable for
providing the kind of reliable long term circulatory support that is
necessary to bridge children to cardiac transplant, 4 - 6 months or more,
especially when the wait time is long, and the therapy is associated with a
complex support method and high complication rates. Serious complications
such as bleeding, infection, stroke, and multi-organ failure predictably
develop during the first week on ECMO limiting the overall effectiveness of
ECMO for long-term circulatory support. Several institutions have published
their single center experiences using ECMO as a bridge to transplant, with
reports that suggest that ECMO is effective in bridging roughly half of
eligible children to cardiac transplantation. Berlin Heart understood the
unmet need for children with end stage cardiac failure and has worked
towards providing a solution with the EXCOR® Pediatric.
Not only have the waiting list mortalities for pediatric transplant
candidates been significantly reduced, but the quality of life that these
patients enjoy while waiting for a transplant is unmatched when compared to
the historical options available for this population. The possibilities of
simple pleasures such as freedom from sedation, breathing tubes, feeding
tubes, are not feasible with ECMO. Additionally, the application Berlin
Heart submitted to the FDA for approval of the device included a report
detailing a successful outcome for 90% of the patients who received the
device, far more effective than the ECMO option, with successful support
times of more than one year, and with much lower complication rates.
Mr. Kroslowitz: Though there were many challenges to designing and successfully implementing a pediatric VAD, the rewards are abundant. Children are not small adults and it is not easy to take an adult sized device and make it smaller. Additionally the current adult technology offers a one-size fits all solution. With the pediatric population, we are treating patients from infancy up to teenagers, so the one-size fits all solution was not an option and multiple sizes were required. Not only are pediatric VADs ambitious for the amount of surface area exposed to the blood and the length of time implanted, but these devices until recently have been reserved for implant into some of the sickest patients. The pioneering development of this complex device was truly a collaborative effort between industry and academia, involving clinicians and researchers across many institutions. Until there are more donor organs or other long-term treatment options become available, Berlin Heart will continue to bridge the gap between pediatric heart failure and hope for the future.
Mr. Kroslowitz: Absolutely. The EXCOR® Pediatric requires significant clinical and technical training across several different levels and disciplines within our implanting sites. We provide a very rigorous training program and have an extremely active Clinical Affairs Team that supports all of the implantations in North America and provides telephone support 24 hours per day, 365 days per year.
Mr. Kroslowitz: It is quite interesting. The first use of the device in North America was in 2000. Between 2000 and 2004, we implanted only three patients in the US. In 2004, we implanted a patient in California who was featured on the front page of the New York Times and demand for the device immediately grew. At the time, there were no other options available for the pediatric population and the EXCOR® Pediatric was not approved for use by the FDA, a small number of sites were able to access the device under the compassionate use regulations with approval by the FDA granted on a case by case basis. Between 2004 and 2005, the number of requests for the device had grown so rapidly that both Berlin Heart and the FDA realized that there was a need for a formal approval process. After much discussion with the FDA and a clinical trial, the device was approved in 2011. We have now implanted the device in nearly 50 pediatric centers in North America. With the approval, sites are now able to purchase the device and keep it readily available in their centers, which we believe will lead to more patients benefiting from the device. Additionally, with our treating physicians, we believe that we will identify expanded indications that will allow us to serve a larger portion of the population.
Obviously, for Berlin Heart, any recognition of our efforts is important to
us. We are a small company that serves a very specific market that includes
a finite population. Berlin Heart is honored to have been chosen as a
finalist for the Prix Galien award, which recognizes technical scientific
research skills and achievements of companies that are developing innovative
medicines and devices. The award is considered one of the industry’s highest
accolades. We are very fortunate to have been nominated for this award. We
see this recognition as a clear indicator of the importance of our work and
the potential that our innovative products have to make a life-saving
difference for pediatric patients with severe heart failure.
Mr. Kroslowitz: Initially, Berlin Heart had no intention of coming to the US, our presence was driven by the demand for our pediatric device. Outside of the US, the EXCOR® system is used for both the adult and the pediatric population. We have another implantable device that is similar to other devices that are currently on the market in the US, which is an implantable adult device, the INCOR® System that is also available outside of the United States. We have chosen at this point not to come to the US with our adult devices for several reasons primarily, the nearly prohibitive cost of bringing the devices to the US market, there are approved device options available for the population, and there are several devices that are currently in clinical trials on their way to approval. This is not to say that we never will come to the US with an adult device, but at the current time, we have chosen to concentrate our efforts on the adult population outside of the US.
CEOCFO: Why should investors pay attention to Berlin Heart?
We provide a service that is not only lifesaving but very worthwhile. As the
population that we are treating is completely underserved with a need that
will continue to grow as we learn more about the patients that are
benefiting from our technology and we expand the therapy indications and
options, we are well positioned for growth.
Berlin Heart is the only company worldwide that has a mechanical circulatory
support option for patients of every age and body size, and that has a
ventricular assist device that is approved by the FDA for infants and
We provide a service that is not only lifesaving but very worthwhile. As the population that we are treating is completely underserved with a need that will continue to grow as we learn more about the patients that are benefiting from our technology and we expand the therapy indications and options, we are well positioned for growth. Finally, Berlin Heart is the only company worldwide that has a mechanical circulatory support option for patients of every age and body size, and that has a ventricular assist device that is approved by the FDA for infants and children. - Robert Kroslowitz
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