November 15, 2012
To our investors and friends:
We are pleased to provide you with updated information about MyoCardioCare, Inc. If you’ve reviewed our materials in the recent past, or if you’ve been in contact with any of our corporate officers, advisors or directors, you may already be “up to speed” on what we’re doing. To ensure that you have the latest information, let us summarize several key points.
Sudden cardiac arrest in a hospital setting continues to challenge physicians. Despite the substantial advances in preventive medicine, the arsenal of pharmaceuticals and various medical devices, in-hospital sudden cardiac arrest results in death in about 80% of all cases. Only a small minority of the 20 percent that do survive are able to participate in their former lives without some amount of physical or mental impairment. Unfortunately, survivors frequently become long-term users of numerous medications, consumers of costly out-patient medical services, and a burden to their family members because of their debilitation.
Sadly, the statistics for in-hospital cardiac arrest have not changed significantly over the past 30 years because treatment options are limited. Treatment choices include closed-chest compressions, combined with drugs and defibrillation.
MyoCardioCare’s MCC-3000 cardiac support system for in-hospital cardiac arrest is the only medical device with a chance to change the treatment paradigm in a significant way, allowing hope to increase the percentage of survivors, while decreasing their debilitation. To put this in perspective, CPR (cardiopulmonary resuscitation, or chest compressions) provides roughly one liter per minute of blood flow, at best if performed properly, which is about 20 percent of typical output in a healthy heart. In contrast, the MCC-3000 is able to return blood flow to five liters per minute, ensuring that the body and all its essential organs are optimally perfused, keeping the patient alive and reducing chances for post-cardiac arrest problems, complications, and debilitation.
Let us consider the future of MyoCardioCare and the MCC-3000. Based on discussions with the members of our Scientific Advisory Board and experts from the medical industry, we have planned to undertake a limited First-In-Man patient study outside the United States. What is this study and why is it needed? Although a predecessor of our device was successfully used at Duke University Medical Center (DUMC) many years ago, both the technology and cost curve have improved dramatically in the intervening years. When the predecessor device was used at DUMC, five patients were implanted and all five were successfully supported. Two survived to “walk out” of the hospital while the other three died from non-device-related complications.
It is important to note that the device used at DUMC was a rigid cup that was inserted over the heart, requiring a large incision and removal of a rib. In addition, at that time, the external drive unit needed to be constantly manual adjustment, necessitating 24/7 physician monitoring. At that time, patient trauma and the cost of the procedure were substantial.
As technology has advanced, so has the design of the MCC-3000. The cup that is inserted over the heart is composed of a strong, flexible polymer, reducing incision size by more than two-thirds and the need to remove any ribs. The external console, in addition to being substantially smaller and lighter, has programmable interactive software that eliminates the need for full-time attendance by medical personnel. In terms of the procedure and use of our device, patient trauma and cost will both be reduced dramatically.
Unlike most start-up companies, we have years of data and past clinical experience to validate the present configuration of the MCC-3000. To move to the next step, however, we must demonstrate that all of the current technological improvements and enhancements are clinically significant. To accomplish this, we will perform a First-In-Man Study that will take approximately one year to complete and will cost less than $2.5 million. Preparation for this study will begin upon completion of our next round of financing.
Following the successful completion of our First-In-Man study, we will perform one or more European and/or U.S. clinical trials of our device to demonstrate its success and efficacy in a clinical setting. We estimate funding for this part of our growth to be less than $25 million.
Given the success rate in the past and our current improvements in technology, we are optimistic that our positive data will enable us to rapidly move forward into the clinical setting. Initially, we will introduce the MCC-3000 into European and/or U.S. hospitals that have dedicated cardiac care centers; in the U.S. there are between 400-500 cardiac care centers. Over time, as our device becomes established and more medical practitioners are trained in its use, it will be introduced into the larger hospital base. In the U.S. there are approximately 5,000 community hospitals. Our Scientific Advisory Board has confirmed that our device can be quickly installed by Emergency Room physicians, so its use in community hospitals will benefit the vast majority of individuals that suffer with acute cardiac arrest. And looking towards the future, we plan to pursue the use of MCC-3000 for multiple cardiac problems, including congestive heart failure, myocarditis, bridge-to-transplant, and remote cardiac resuscitation and transportation to a medical center, using a compact and portable drive unit. Our device provides cardiac support without damage to the heart tissue itself, so we are confident that it will find even greater use over time.
The MyoCardioCare Board
Helping hearts…saving lives
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