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MicroMed Cardiovascular, Inc. (MicroMed - MMCV-OTC) is a leading developer of miniaturized implantable ventricular assist devices (VADs) for the treatment of advanced heart failure. The Company's DeBakey VAD® represents the next generation of miniaturized, implantable mechanical support for failing hearts and acts as an auxiliary pump that provides increased blood flow from the left ventricle of the heart throughout the body. Using state-of-the art technology developed by NASA, working with famed heart surgeon Dr. Michael E. DeBakey and Dr. George P. Noon of Baylor College of Medicine, the device is approved for marketing in the European Union for Bridge-to-Transplant Therapy (BTT), Destination Therapy (DT) and for use in children. In the U.S., the DeBakey VAD is in pivotal Phase III trials for BTT and DT indications, and the DeBakey VAD Child is approved for use in children under a Humanitarian Device Exemption. To date, DeBakey VADs have been implanted in approximately 370 adult and pediatric patients worldwide. MicroMed's ISO 9001/13485 certified manufacturing facility is located in Houston, TX.
INVESTMENT HIGHLIGHTS
(MicroMed - MMCV-OTC) A Leading Competitor in Development of Next Generation VAD
First generation VADs have proven to be effective in supporting blood circulation in patients with failing hearts, reversing end-organ dysfunction and improving quality of life while awaiting heart transplantation. However, these first generation devices require a highly invasive surgery, are large in size and carry a high risk of infection. MicroMed's patented DeBakey VAD is a next generation, state-of-the-art device that weighs less than four ounces and is approximately 1/10th the size of other VADs currently on the market in the U.S. Benefits of smaller size and enhanced technology include anticipated reduction in surgical time, the potential for lower risk of infection and improved quality of life. While there are other next generation VADs currently in development by other companies, MicroMed's DeBakey VAD is the only device that has received FDA clearance for use in children in the U.S. It is also the only device in the US with real time measurement of pump flow and operating parameters. In addition, the DeBakey VAD is the next generation VAD with the most implants worldwide to date.
Addressable Market Potential
Congestive heart failure (CHF) is the leading cause of death in the U.S. According to a 2005 statistical update from the American Heart Association (AHA), 4.9 million Americans suffer from CHF, with 550,000 new cases diagnosed annually, and the total cost of treatment is $27.9 billion annually. Of those diagnosed with CHF, there are 70,000 to 100,000 late-stage patients who could benefit from a heart transplant, cardiac assist device or total artificial heart. This group of patients represents the addressable market for VADs, which currently has two segments: Bridge-to-Transplant market (BTT) market and the Destination Therapy (DT) market. The BTT market includes end-stage patients waiting to receive a heart transplant and comprises a small percentage of the potential market. The DT patient population comprises the bulk of the potential market, and includes patients who are ineligible to receive a heart transplant and need a viable long-term alternative to heart transplantation. With widespread adoption of VADs for the DT indication, the potential total market for mechanical support devices in the US alone is estimated to be $2-3 billion.
Phase III Medical Trials in Progress
MicroMed is conducting Phase III clinical trials in the U.S. for both the BTT and DT indications. The BTT therapy trial includes a total of 95 patients in comparison to a historical control (published data on the HeartMate® VE). Based on results to date, the Company has determined that it will not meet the established endpoint for survival in the BTT study, but expects to complete enrollment in 2006 and enter into discussions with the FDA about modifying the trial endpoint. The DT study is larger in scope and is in its early stages.
Reimbursement Approval from Medicare
Medicare and most private insurance companies have already approved reimbursement for VADs used for BTT and DT, including for all implants in MicroMed's clinical trials.
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Overview of the DeBakey VAD
The DeBakey VAD is a next generation, miniaturized heart pump that is designed to increase blood flow from the left ventricle of the heart throughout the body. Designed for patients in advanced heart failure, it has several expected advantages over existing VADs including elimination of valves and air vents, potential for reduced surgical time, lower rate of infection and greater mechanical durability. Unlike larger devices, the miniaturized DeBakey VAD facilitates nutrition to support patient recovery. The device has only one moving part and has been projected to last in excess of five years by third party studies. Because of its small size and light weight, the DeBakey VAD can be implanted in persons with small body sizes, including women and small children. In addition, the design provides for silent operation and increased mobility, which aid in improving the patient's quality of life. The device is comprised of four parts:
- Pump System is a titanium pump with an inducer/impeller, the only moving part of the pump. The components are fully enclosed in a titanium flow tube that has been hermetically sealed.
- Data Acquisition System (DAS) is used to monitor the patient and adjust the operating parameters of the device during surgery and while the patient is in intensive care. The proprietary design of the DAS enables real-time monitoring of critical pump parameters.
- Patient Home Support System (PHSS) provides primary and battery backup power to the DeBakey VAD while the patient is resting for long periods or sleeping in the hospital or at home.
- Controller and two batteries are housed in the VADPAK, an ergonomically designed carrying case. The Controller displays key operating information about the pump, including remaining battery life, flow and other operating conditions. Together, the VADPAK, Controller and batteries weigh approximately five pounds, enhancing patient mobility and the ability to engage in most normal, everyday activities.
Clinical Trials
The Bridge to Transplant trial has been designed as a non-randomized, literature-based fixed performance goal trial of 95 patients with a target of 66% survival to transplant. Early results have been promising; however, MicroMed has determined that its target survival to transplant rate of 66% will not be achieved when the trial is completed (expected in 2006). MicroMed believes the lower survival rate to be principally due to the concern voiced by many of the clinicians participating in the trial that patients receiving VADs today are much sicker than patients included in earlier studies that serve as the control arm. However, the success rates that MicroMed has experienced in the trial are consistent with success rates for all VADs implanted for 2002-2004 as recently reported in the Journal of Heart and Lung Transplantation (2005; 24:1182-7). Accordingly, upon completion of enrollment in the trial, MicroMed intends to ask the FDA to consider its PMA application for the BTT therapy based on lower success rates combined with secondary factors such as quality of life, adverse events and comparison to current results for VADs.
The Destination Therapy trial includes 360 patients and is randomized against Thoratec Corporation's HeartMate® XVE. Enrollment in the study has been slower than expected due to restrictive inclusion/exclusion criteria and reluctance of clinicians and patients to participate in a randomized trial. MicroMed is in the process of developing new clinical trial parameters and protocols with its clinical consultants and will request FDA approval for a redesigned trial in the near future.
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Next Generation VAD Competitor Matrix
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Strategy for Growth
The market for VADs is dominated by Thoratec Corporation which has a market capitalization of approximately $1 billion and has implanted its commercialized HeartMate XVE VAD in over 10,000 patients worldwide. This is a small percentage of the total addressable population, which includes 70,000 to 100,000 patients that could benefit from either Bridge-to-Transplant Therapy or Destination Therapy. MicroMed believes that its next generation, miniaturized DeBakey VAD has the potential to garner a sizable portion of both these markets. In addition, the smaller size of next generation VADs will expand the number of eligible patients to include more women and children.
Revenue Growth in Europe and in the U.S.
MicroMed has been marketing its products in Europe since 2001, and has an experienced international sales and marketing distributor network in place. The Company generated $1.0 million in revenues during the first half of 2005 from sales of its products in six European countries and Singapore, and plans to continue to expand the international market going forward. In the U.S., the DeBakey VAD Child was approved for use under a Humanitarian Device Exemption in 2004. In addition, MicroMed receives payment for all products implanted in its U.S. clinical trials, generating $2.5 million in U.S. revenues in the first half of 2005. The Company expects a dramatic increase in U.S. revenues upon approval of its PMA by the FDA.
Future Indications for Next Generation VADs
Human studies in the U.K. and Germany have demonstrated that a significant number of CHF patients could potentially benefit from being implanted with a VAD at an earlier stage of the disease. Additional data suggest a possible therapeutic role of the VAD to allow an extended period of time for the heart to rest and then with planned removal of the device, or Bridge to Recovery. These studies suggest that there is the possibility to delay, prevent or even reverse the progression of heart disease.
Leverage Relationships to Promote Use of DeBakey VAD
MicroMed has strong relationships with cardiologists and cardiac surgeons at major international heart centers in Europe and plans to leverage these relationships to promote the use of the DeBakey VAD in high volume transplant centers around the world. In addition, the Company has relationships with U.S. clinical trial investigators and with Dr. DeBakey, Dr. Noon, Dr. Eric Rose and Dr. Matthias Loebe that can be utilized to promote the DeBakey VAD once it is approved for use in the U.S.
Medical Advisory Board
Michael E. DeBakey, MD, Chairman, Co-Principal Investigator of the Bridge-to-Transplant trial. Chancellor Emeritus, Baylor College of Medicine; Director of the DeBakey Heart Center of Baylor and the Methodist Hospital, Houston, TX. A world-famous pioneer in the development of an artificial heart, Dr. DeBakey was the first to use a heart pump successfully in a patient and has been at the forefront of numerous advances in cardiology in recent decades. Dr. DeBakey is a recipient of the Medal of Freedom (the highest honor the President can award to a civilian), the Medal of Science and the Lasker Award, U.S. counterpart of the Nobel Prize.
George P. Noon, MD, Co-Principal Investigator, Bridge-to-Transplant Trial. Executive Director, Multi-Organ Transplant Center, Methodist Hospital; Chief, Division of Transplant and Assist Devices/ Professor of Surgery, Baylor College of Medicine. A key member of the DeBakey VAD development team since inception.
Matthias Loebe, MD, Clinical Consultant. Multi-Organ Transplant Center, Methodist Hospital; Division of Transplant and Assist Devices/ Assistant Professor of Surgery, Baylor College of Medicine.
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Summary Financial Data
Selected Statement of Operations Data *
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|
Year ended December 31, 2005 |
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|
Year ended December 31, 2004 |
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| Revenue |
$ |
5.2MM |
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$ |
5.9MM |
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| Net loss |
$ |
(8.9MM |
) |
$ |
(8.9MM |
) |
* Selected data only - please refer to Company filings with the SEC for full data and notes thereto
This profile may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to vary materially from anticipated results, including, without limitation, market acceptance of products, changes in political and general market conditions, increased competition and other factors as discussed in the Company's filings with the Securities & Exchange Commission. Information presented here is based on sources that we believe to be reliable, but is not guaranteed as being accurate and does not purport to be complete. Opinions expressed herein are those of MicroMed Cardiovascular, Inc. management as of the date of publication and are subject to change without notice.
MicroMed Cardiovascular, Inc. reserves the right to change specifications without notice. Information regarding Indications, contra-indications and precautions are on file with MicroMed Cardiovascular, Inc. Contact MicroMed Cardiovascular Inc. for more information.
The DeBakey VAD® is a registered trademark of MicroMed Cardiovascular, Inc. The DeBakey VAD and DeBakey VAD Child have been awarded the CE Mark for distribution in the European Union.
Caution: Federal (USA) law restricts the DeBakey VAD to investigational use only. The DeBakey VAD Child is available for use under a Humanitarian Device Exemption. © 2005 MicroMed Cardiovascular, Inc.
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