InnoVision Report
                                                       DNA Powered Technology Assessment

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Ezassi Report Mitral Valve Replacement[1]
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Ezassi Report Mitral Valve Replacement[1]

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Transcript of "Ezassi Report Mitral Valve Replacement[1]"

  1. 1. InnoVision Report DNA Powered Technology Assessment Owner: CardiAQ Valve Technologies, Inc. Date Generated: Agent/s: N/A May 12, 2009 Inventor/s: Management: Percutaneous Mitral Valve Replacement The following information resulted from the analysis of this innovation by the e-Zassi Innovation Assessment Software Platform. The Percutaneous Mitral Valve Replacement is a biologic and medical device combination product used in the cardiovascular surgery segment of the cardiovascular market. It is designed for long-term use or permanent implantation. It is expected to be used in the hospital (inpatient department) by a specialty practice physician. Improved procedural efficiency has been identified as a benefit resulting from the use of the Percutaneous Mitral Valve Replacement. Human clinical trials are in the planning stage. Nature of Innovation – Summary Table Type of Device: Medical Device with Biologic Learn more Device Regulatory Classification: US: Class III Learn more EU: Class III Regulatory Status: US: A regulatory submission is required, but not yet filed Learn more EU: A regulatory filing is required but has not been submitted Primary Intended Use: Treatment Learn more Primary and Secondary Users: Specialty practice physician,and Surgeon Learn more Key Purchasing Decision Maker: Uncertain Learn more Reimbursement Outlook: Likely Existing Coverage Applies Learn more Intellectual Property Status: No patents are issued. Learn more Patent applications are pending. Clinical Specialty / Market: Cardiovascular Learn more Market Segment / Sub-Segment: Cardiovascular surgery / Prosthetic heart valve (including Learn more heart valve repair devices) Pre-Clinical / Clinical Research Status: Pre-clinical in-vitro testing is started,Pre-clinical animal Learn more testing objectives have been identified Advantages and Benefits: Improved procedural efficiency Increased Safety Shorter Surgical Procedure Time Learn more Reduction in treatment time Reduced Pain Improved Quality of Life Grant Matching Results: 6 Federal/State Grant(s) Learn more Manufacturing Build Status: Three dimensional computer model(s) Learn more Non-functional physical prototype(s) e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved.
  2. 2. InnoVision Report Date Generated: May 12, 2009 Market Landscape The market landscape section includes information on market segment, customers, and competitors, all of which are invaluable in devising an effective sales and marketing plan for the innovation. Initially, this data covers the major geographic segments for the US and the European Union medical device market. Future versions of this report will include world-wide market data. Market Information Market Overview / Environmental Assessment United States Cardiovascular Market The United States (US) market for cardiovascular devices in 2006 was the largest in the world with revenues of between $13.5 billion (Millennium) and $18.5 billion (GMD). The difference between the market estimates may be the result of how each research organization recognizes, places, and/or calculates data and products within the cardiovascular device market segments and categories. By 2011, GMD projects the cardiovascular device market at $37.2 billion in revenues. As in the global market, the largest share of the market in the US is held by cardiac rhythm management (CRM) devices (50%), followed by interventional cardiology devices (27%). (Global Markets Direct, Cardiovascular Device Market Profile, 2008) (Millennium Research Group, US Markets for Cardiac Surgery, 2007) e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 2
  3. 3. InnoVision Report Date Generated: May 12, 2009 The most rapidly growing segments of the US market - interventional cardiology, rhythm management, and prosthetic devices - mirror the global market. By 2011, the interventional cardiology segment will generate a compound annual growth rate (CAGR) of 20% in revenues. Whereas, rhythm management, and prosthetic devices will each generate a CAGR of 12% in revenues. With the exception of cardiovascular monitoring and diagnostic devices, more than 85% of all cardiovascular devices are distributed to hospitals. Rehabilitation centers, clinics, long-term care (LTC) centers, acute care centers, and laboratories receive 25% of the monitoring and diagnostic devices. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 3
  4. 4. InnoVision Report Date Generated: May 12, 2009 Competition The two leading manufacturers of cardiovascular devices in the US, based on market share, are Medtronic and Boston Scientific. Other leading competitors, in descending order of market share, are: St. Jude Medical, Cordis, Terumo Medical Corporation, and Abbott. In the US, some of the cardiovascular device segments have one company as the dominant market share leader, while other segments are lead by a group designated as "others." This designation may represent many companies that individually have a niche product or products in that segment. Market segments and leading shareholders are:  Interventional cardiology, Cordis (33%)  Peripheral vascular devices, Cordis (31%)  Cardiac rhythm management, Medtronic (48%)  Cardiovascular surgery, Others (47%)  Cardiovascular prosthetic devices, Others (39%) In the US, GE Healthcare emerges as the leading manufacturer of cardiovascular monitoring and diagnostic devices with a 34% market share; however, these devices make up only 1% of the total market for cardiovascular devices. (Global Markets Direct, Cardiovascular Device Market Profile, 2008) (Millennium Research Group, US Markets for Cardiac Surgery, 2007) Cardiovascular Surgery & Prosthetic Devices Segment e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 4
  5. 5. InnoVision Report Date Generated: May 12, 2009 It is important to know that statistics and information about the cardiovascular surgery and prosthetic device segments of the cardiovascular marketplace are provided by market research organizations in either a separated or combined format. In order to facilitate identification of the innovation, the segments are combined in this section of the Innovation Diagnostic Tool. Leading products in the current US cardiovascular surgery device market are known as “beating heart surgical systems” that allow surgery to be performed while the heart continues to function. Some heart valve devices and coronary artery bypass graft (CABG) devices, both on and off pump, are also included in this segment. With new innovations and the introduction of less invasive surgical procedures, the population that is treatable is expected to expand. As a result, the current market is expected to grow substantially by 2011 from approximately $2 billion in 2006. Other products within the cardiovascular surgery segment are endoscopic vessel harvesting (EVH) devices, cardiac ablation devices, anastamosis assist devices (AAD)s, and transmyocardial laser revascularization (TMR) devices. Products in the US cardiovascular prosthetic device market segment include tissue and mechanical heart valves, artificial hearts, and cardiac assist devices. Cardiac assist devices provide support to a poorly functioning heart by allowing it to rest and heal, eventually returning the heart to normal function. This device can be a full or total artificial heart (TAH) or a left ventricular assist device (LVAD). This segment also includes intra-aortic balloon pumps (IABP) used most often in emergency situations. In the US, more than five million individuals have been diagnosed with congestive heart failure; of these, 20% are expected to develop disease of the aortic or mitral valve. Treatment involves medical management or surgical intervention. In 2006, the heart valve market was estimated to be over $500 million. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 5
  6. 6. InnoVision Report Date Generated: May 12, 2009 By 2011, market growth in the valve market segment will be enhanced by the highly anticipated introduction of two minimally invasive percutaneous heart valve therapy (PHVT) procedures - percutaneous mitral valve repair (PMVR) and percutaneous aortic valve replacement (PAVR). Both procedures are expected to have an impact on the market providing an alternative for patients who are not suited to the more invasive open-heart surgery procedure. Revenues in the US for cardiovascular prosthetic devices are expected to increase by a compound annual growth rate (CAGR) of over 12% by 2011. Competition The manufacture of cardiovascular surgery devices in the US is led by “others” (47%), indicating there are many companies in this segment. Some of these companies specialize in a particular segment of the surgery device market and/or may own a niche segment of this market. Terumo is second after "others" in this segment (25%), followed by Medtronic (24%) and Boston Scientific with a 4% market share. In the cardiovascular prosthetic device segment, the market is led by a group designated as “others” with 40% of the revenue share. This designation may represent many companies that individually have a niche product or products in that segment. The "others" group is followed by Edwards Lifesciences (19%), St. Jude Medical (13%), Medtronic (8%), Thoratec (8%), Datascope (7%), and Arrow International (5%). Approximately 18 companies participate in the US heart valve marketplace. The leaders in order of market share are Edwards Lifesciences, Medtronic, and St. Jude Medical. (Global Markets Direct, Cardiovascular Devices Market Profile, 2008) e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 6
  7. 7. InnoVision Report Date Generated: May 12, 2009 (Millennium Research Group, US Markets for Cardiac Surgery, 2007) Prosthetic Heart Valve Segment The entire US heart valve device market segment, which includes tissue and mechanical valves and valve repair devices, was valued just under $570 million in 2006. Supported by an aging population, new devices and techniques, and minimally invasive procedures, the market is expected to grow. Heart valve replacement is accomplished with either tissue (biological), or mechanical valves. The use of mechanical valves continues to decline due to issues with safety and long-term management of anticoagulation therapy post surgery. The market for mechanical valves was reported to be slightly under $100 million in 2006. The tissue valve market in 2006 was 50% of the total heart valve market and is expected to grow to $400 million by 2011. However, the introduction of percutaneous heart valve technology (PHVT) procedures may affect the upward momentum of tissue heart valves. The usual choices for tissue heart valve devices are allografts and xenografts, either as stent grafts or stentless grafts. Heart Valve Repair Devices In the current market, heart valve repair devices continue to be preferred over heart valve replacement devices due to positive clinical results and surgeon acceptance. Repair devices are of four types: rigid, semi-rigid, bands, and flexible. This market will continue to grow, but may be negatively influenced by the introduction of percutaneous mitral valve repair (PMVR). In 2006, this market was estimated at just above $70 million. Percutaneous Heart Therapy By 2011, market growth in the heart valve segment will be enhanced by the highly anticipated introduction of two minimally invasive percutaneous heart valve therapy (PHVT) procedures - percutaneous mitral valve repair (PMVR) and percutaneous aortic valve replacement (PAVR). Both procedures are expected to have an impact on the market providing an alternative for patients who are not suited to the more invasive open-heart surgery procedure. Revenues in the US for all cardiovascular prosthetic devices are expected to increase by a compound annual growth rate (CAGR) of over 12% by 2011. Competition Approximately 18 companies participate in the heart valve marketplace. The leaders in the US in order of market share are Edwards Lifesciences, Medtronic, and St. Jude Medical. Each company within this market has its own specialty. Edwards Lifesciences leads in heart valve replacement and repair, while Medtronic is second in the heart valve market alone. St. Jude Medical has the leading share of the mechanical heart valve device market. The entire valve replacement market is expected to grow with the increase in use of biological valves, which last longer and are considered to have less risk of failure. The life of a biological tissue valve replacement is likely to last the life of the recipient. (Millennium Research Group, US Markets for Interventional Cardiology Devices 2008, 2007) e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 7
  8. 8. InnoVision Report Date Generated: May 12, 2009 Market Overview / Environmental Assessment European Cardiovascular Market In 2006, the European market for cardiovascular devices was valued at $9.4 billion. By 2011, this market is projected to generate $16.2 billion in revenues. As in the global market, in Europe, the largest share of the market is held by cardiac rhythm management devices (47%), followed by interventional cardiology devices (21%). The most rapidly growing segments of the market include; interventional cardiology, rhythm management, and prosthetic devices. These device segments closely resemble the growth of the global market, and are expected to exceed a 11% compound annual growth rate (CAGR) for revenues by 2011. The European Cardiovascular Market includes:  Cardiac rhythm management devices (47%)  Interventional cardiology devices (21%)  Cardiovascular surgery (17%)  Cardiovascular prosthetic devices (6%)  Peripheral vascular devices (6%)  Monitoring and diagnostic catheters (3%) Forecast Revenue and Market Share Growth In Europe, cardiovascular devices in the interventional cardiology and peripheral vascular categories are distributed to either hospitals (90%) or to rehabilitation centers (10%). Cardiac rhythm management, cardiovascular surgery, and cardiac prosthetic devices are distributed exclusively to hospitals. Rehabilitation centers, clinics, long-term care, and acute care centers combined, receive 25% of the cardiovascular monitoring and diagnostic devices. The remaining 75% of devices in this category are distributed to hospitals. (Global Markets Direct, Cardiovascular Devices Market Profile, 2008) Competition In Europe, the two leading manufacturers of cardiovascular devices, based on market share are Medtronic and Boston Scientific. Other leading competitors, in declining order of market share, are; St. Jude Medical, Cordis, Sorin, Biotronik, Terumo Medical Corporation, and Guidant. In Europe, some of the cardiovascular device categories have one company as the dominant market share leader, while other categories are led by an “other” companies designation. This designation may represent many companies that individually have a niche product or products in that category. Market category and leading shareholders are:  Interventional cardiology, Others (31%)  Peripheral vascular devices, Cordis (35%)  Vardiac rhythm management, Medtronic (36%)  Vardiovascular surgery, Others (47%)  Cardiac prosthetic devices, and Others (41%). e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 8
  9. 9. InnoVision Report Date Generated: May 12, 2009 In Europe, Philips Medical Systems emerges as the major manufacturer of cardiac monitoring and diagnostic devices with a 32% market share. However, these devices make up only 3% of the total market for cardiovascular devices. (Global Markets Direct, Cardiovascular Devices Market Profile, 2008) (Millennium Research Group, US Markets for Cardiac Surgery 2007, 2007) European Cardiovascular Surgery and Prosthetic Devices Market Segment It is important to know that statistics and information about the cardiovascular surgery and prosthetic device segments of the cardiovascular marketplace are provided by market research organizations in either a separated or combined format. In order to facilitate identification of the innovation, the segments are combined in this section of the Innovation Diagnostic Tool. In 2006, the cardiac surgery device market in Europe was valued at over $400 million. The market is comprised of three main segments: heart valve replacement, coronary assist devices and coronary artery bypass surgery devices. A smaller market exists for vein harvesting, atrial assist devices and surgical ablation devices. In 2011, the market will shift as coronary artery bypass graft (CABG) procedures stabilize and heart valve replacement procedures increase. Endovascular vein harvesting to provide a conduit for bypass grafts, either in the peripheral vascular device sector or for coronary surgery, will show a slight growth as will atrial assist devices. The coronary assist device market will remain constant with small growth. The cardiovascular surgery market may grow for the first time in years due to the failure of coronary stents prompting many clinicians to favor bypass over stenting. The increase includes:  Endoscopic vessel harvesting for the bypass conduits  Anastamosis assist devices to facilitate the bypass around heart blockages  Cardiac assist devices such as the intra-aortic balloon pump and atrial fibrillation ablation devices  Mitral, aortic and tricuspid valve replacement  A small market exists for cardiac revascularization devices. Cardiac revascularization devices are used to help the heart build collateral circulation and new arteries. Lasers are used to bore a hole near the blockage and encourage the blood to move through collateral arteries which grow from the laser opening. This procedure is declining as most of the scientific proof of the benefit has not been definitively or clinically proven. Included in the European cardiovascular surgery market are cardiovascular prosthetic devices such as stent grafts and prosthetic synthetics grafts made from biocompatible materials; two examples are polyurethane and polytetrafluoroethylene (ePTFE). Initial results have been less than successful due to the nature of the artery these devices are meant to replace. An artery has a muscular characteristic that keeps the blood flowing without clotting. The prosthetic devices have a tendency to clot easily. Unless a superior material is found with the ability to address clotting, it is unlikely that the grafts made from non- biological materials will gain increased adoption. Other types of prosthetic devices include mechanical valves and ventricular assist devices. This is a rapidly growing segment as patients are symptomatic before the valve or ventricle fails, providing an opportunity for medical intervention. The mechanical heart valve market in Europe is expected to grow at e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 9
  10. 10. InnoVision Report Date Generated: May 12, 2009 approximately 20% in the next five years and is a viable use of non- biologic devices to treat a growing market segment. Competition The manufacture of cardiovascular surgery devices in Europe is led by "others" (37%), indicating there may be many companies in this category. Some of these companies specialize in a particular area of the surgery device market and/or may focus on a niche product or products. Terumo (22%) is followed by Medtronic (16%), Sorin (14%), Edwards Lifesciences (5%), Boston Scientific (5%) and Guidant (1%). The cardiovascular prosthetic device market segment is also led by “others” (41%), followed by Edwards Lifesciences (18%), St. Jude Medical (14%), Sorin (9%), Medtronic (7%), Datascope (7%), and Thoratec (4%). (Global Markets Direct, Cardiovascular Devices Market Profile, 2008) (Millennium Research, European Markets for Cardiac Surgery Devices, 2007) Prosthetic Heart Valve Segment The European market for heart valve devices in 2006 was over $150 million. This includes tissue valves, mechanical valves and valve repair annuloplasty devices. Heart valve replacement is accomplished with either tissue, biological, or mechanical valves. The use of mechanical valves continues to decline due to issues with safety and long term management of anticoagulation therapy following surgery. The introduction of percutaneous heart valve technology (PHVT) procedures may affect the upward momentum of tissue heart valves. The usual choices for tissue heart valve devices are allografts and xenografts, either as stent grafts or stentless grafts. Heart Valve Repair Devices In the current market, heart valve repair devices continue to be preferred over heart valve replacement devices due to positive clinical results and surgeon acceptance. Repair devices are of four types: rigid, semi-rigid, bands, and flexible. Percutaneous Heart Therapy By 2011, market growth in the heart valve segment will be enhanced by the highly anticipated introduction of two minimally invasive percutaneous heart valve therapy (PHVT) procedures - percutaneous mitral valve repair (PMVR) and percutaneous aortic valve replacement (PAVR). Both of these procedures are expected to have an impact on the market providing an alternative for patients who are not suited to the more invasive open heart surgery procedure. Competition Sorin controls approximately 25% of the cardiac surgery device and prosthetic market segment in Europe. Along with Sorin, Medtronic, Edwards Lifesciences, and St. Jude Medical comprise the top four companies that supply the cardiac surgery device market. There are over 30 smaller competitors whose entry into this market segment may include niche products. (Millennium Research Group, European Markets for Cardiac Surgery Devices, 2007) e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 10
  11. 11. InnoVision Report Date Generated: May 12, 2009 Additional information related to the minimally invasive surgery products market is located in the appendix. Key Purchasing Decision Maker The Percutaneous Mitral Valve Replacement decision maker is unknown at this time. It is extremely important to direct a strong marketing plan toward the person most likely to have a buying influence. Therefore, if this person is unknown, it is critical to spend some time researching who this might be before selecting a marketing partner. Device Primary Intended Use Treatment and Management Products The intended use of the Percutaneous Mitral Valve Replacement has a direct impact on where a product is sold, the patient population, and overall marketing strategy. Planning for sufficient marketing and/or sales power to reach the potential users of the product is a critical marketing consideration. Treatment and management products may be used in a wide variety of settings, including; acute care facilities, outpatient clinics, physician offices, and to a lesser extent, long-term care facilities, rehabilitation facilities, and/or home care. Many companies have employed successful segmentation strategies, which involve focusing marketing resources on only one segment of the potential market at a time. Product Profile Marketing Implants An implant is a medical device that is designed to replace a missing biological structure, such as a breast or a joint. Implants are typically inserted surgically. The decision to select a specific surgical implant usually rests with the surgeon, however more and more frequently patients play a role in selecting the implant that will be used. This is particularly true with breast implants, but the patient is often consulted for other types of implants, including joint replacements and tissue implants. Patients have enough input in the decision that some companies are using direct-to –consumer advertising, including television ads, to influence their opinions. In an institutional setting, the use of a specific implant is likely to require approval by the product committee. Significant clinical and safety and efficacy data is critical to the ability to make inroads in the implant market. Regulatory e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 11
  12. 12. InnoVision Report Date Generated: May 12, 2009 The medical device industry is regulated by government agencies around the world to help ensure public safety. These agencies monitor the distribution, marketing, design, and manufacturing of medical devices sold in the country of the agency. In the US, the government agency that is responsible for this regulation is the Food and Drug Administration (FDA). In the European Union, each country has its own government agency known as a Competent Authority. This section of the report includes the likely US and EU regulatory parameters and classifications for the innovation. US Regulatory US Regulatory Status: A regulatory submission is required, but not yet filed FDA Submission No.: Not Applicable FDA Clearance/Approval Date: Not Applicable FDA Regulation / Device Classification / Predicate Product Code / Regulatory Pathway: The following information resulted from the analysis of the Percutaneous Mitral Valve Replacement by the e-Zassi Innovation Assessment Platform and represents the likely US FDA Regulatory parameters for the Percutaneous Mitral Valve Replacement, i.e., a potential predicate regulation number or product code(s) for the innovation, and the regulatory parameters associated with the predicate. Note that product codes represent generic types of legally marketed devices. When preparing a 510(k) submission, the submission must demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. 510(k) submitters must compare their device to one or more similar legally marketed devices to make and support their substantial equivalency claims. The following product code(s) may be utilized to navigate the FDA Product Classification database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm in order to access and evaluate a list of potential predicate devices against which substantial equivalency claims may be drawn. FDA Regulation No: No Regulations Found FDA Regulation Name: No Regulations Found Product Code Product Code Title Classification Regulatory Pathway LWR Heart-Valve, Non-Allograft Tissue Class III PMA The FDA assigns devices to one of three regulatory classes based on the level of control necessary to assure safety and effectiveness of the device. The Percutaneous Mitral Valve Replacement may be considered a Class III medical device, which means at least one of its characteristics may present a significant risk. It is good practice to review the proposed device classification directly with the FDA. Class III is the most stringent regulatory classification where the devices have an insufficient amount of information in existence to assure their safety and effectiveness, solely through general or special controls. Class III devices are usually those that support or sustain human life, are of significant importance in preventing impairment of human health, or which present a potential and unreasonable risk of illness or injury. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 12
  13. 13. InnoVision Report Date Generated: May 12, 2009 Because a significant amount of risk may be associated with the Percutaneous Mitral Valve Replacement, the FDA will likely require performance testing or bench testing, or both, and clinical data to support the safety and efficacy of the device. Confirm the Percutaneous Mitral Valve Replacement classification with the FDA by submitting a 513(g). The 513(g) request should include the following: 1. Cover letter stating the submission is a 513(g) request for information concerning the Percutaneous Mitral Valve Replacement, including; device status, classification, and regulatory requirements 2. Detailed description of the Percutaneous Mitral Valve Replacement 3. Concise indication(s) for Use Statement 4. The Percutaneous Mitral Valve Replacement proposed labeling or labeling of a marketed similar device 5. If no labeling is available, note this in the cover letter 6. Contact person's name, address, telephone number, and fax number on the cover letter 7. Copy of the Medical Device User Fee Payment sheet (MDUFP) Send the 513(g) request to: 513(g) Coordinator c/o Document Mail Center (HFZ-401) Office of Device Evaluation Center for Devices and Radiological Health 9200 Corporate Boulevard Rockville, MD 20850 Classification as a Combination Product and FDA Primary Mode of Action: European Union (EU) Regulatory EU Regulatory Status: A regulatory filing is required but has not been submitted EU Device Classification / Regulatory Pathway: The following information resulted from the analysis of the Percutaneous Mitral Valve Replacement by the e-Zassi Innovation Assessment Platform and represents the likely EU Regulatory parameters for the Percutaneous Mitral Valve Replacement. Classification Regulatory Pathway e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 13
  14. 14. InnoVision Report Date Generated: May 12, 2009 Class III CE Mark / Design Dossier / Full Quality Management System The Percutaneous Mitral Valve Replacement may be classified as a Class III device according to the European Union (EU) Medical Device Directive. Class III devices typically involve the most risk to patients; they include devices that contact the central nervous system or heart, or are absorbed by the body. Class III device manufacturers are required to develop a full Quality Management System in compliance with ISO 13485: 2003. A Notified Body is required for certification of Class III devices. A Notified Body will ensure that the documentation and quality system that are developed are in accordance with EU Regulations. The following steps must be followed in order for the Percutaneous Mitral Valve Replacement to be shipped to Europe.  Locate a Notified Body o This is an outside service that will be responsible for auditing the Technical File and Quality Management System (QMS) to ensure that they meet the requirements of the directive. This service will cost around $15,000-$30,000 o Examples of Notified Bodies include TUV, BSi, Intertek  Implement a Quality Management System (QMS) o Full QMS in compliance with ISO 13485: 2003  Prepare Design Dossier o This provides detailed information intended to demonstrate compliance with the health and safety requirements stipulated in the directive o This is a detailed set of documents which provides information from design and development through manufacturing  Appoint an Authorized Representative (EC REP) o There must be a physical address in Europe which is identified on the product labeling o There must be a person at that address that can handle regulatory issues, e.g., product complaints, recalls, Customs issues  Register with Competent Authority (if applicable) o A Competent Authority is the equivalent of the FDA in the U.S.; each country has its own government agency that regulates medical devices o Must be located in the same country as the Authorized Representative o Note: Not all countries require registration  Obtain CE Certificate o This will be issued by the Notified Body after successfully passing the registration audit and technical file review o Follow-up audits are required to keep CE Certificate e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 14
  15. 15. InnoVision Report Date Generated: May 12, 2009  Prepare Declaration of Conformity o A legally binding document that certifies all of the requirements of CE Marking have been met o Work with the Notified Body to complete this  Notified Body must certify the declaration Clinical Research Requirements Based on the device classification, the United States (US) approval or clearance process for medium to high risk medical devices is very different from the European Union (EU), especially in terms of the scope and size of clinical trials required for high risk devices. In general, to receive approval to market a device in the EU, the manufacturer must demonstrate that the device is safe and that it performs in a manner consistent with the manufacturer’s intended use. To receive approval or clearance to market a high-risk device (Class III and some Class II) in the US, the manufacturer must demonstrate the device to be effective as well as safe, thus requiring prospective, randomized clinical trials often involving hundreds of human subjects. Further, additional clinical data may be required for Class IIb devices in the EU. Regardless of the regulatory body (US or EU), it is important for the innovator to discuss the scope and size of clinical trials required for medium to high risk devices with the appropriate regulatory body. This regulatory assessment was generated -by the e-Zassi Regulatory Innovation Assessment Engine using information provided to e-Zassi by the user. The information presented within this report does not represent or intend to be an opinion, a suggestion, a comment, or a decision from the FDA, or any of its authorities, agents, employees, or third party representatives. This information is an estimate and is intended as preparation for conversations with the appropriate regulatory authority or regulatory consultant. All aspects of the innovation must be evaluated in order to make an accurate classification. The regulatory authority or regulatory consultant can assist in fully assessing the innovation. Ultimately, the regulatory authority reserves responsibility for classifying a new medical device. Clinical Pre-Clinical Research Status In the US and in Europe, pre-clinical trials that involve the use of animals must be implemented based on regulatory requirements, local laws, and quality standards for animal testing. In addition, in Europe, due to the concern regarding animal use in the cosmetic industry, it is also important to contact the EU Regulatory Authority to determine whether or not animal testing is required for the device under investigation. The Percutaneous Mitral Valve Replacement may benefit from animal studies used to meet biocompatibility testing requirements, establish safety and tolerance guidelines, or to provide other clinical outcomes that will support the overall product development process. In addition, animal testing data should adequately demonstrate that the device is relatively safe and that it functions as intended. In the US and in Europe, pre-clinical trials that involve in vitro bench testing must be implemented based e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 15
  16. 16. InnoVision Report Date Generated: May 12, 2009 on regulatory requirements, local laws, and quality standards. In vitro bench testing should provide adequate data to demonstrate that the device is relatively safe and that it functions as intended. The innovation may use testing parameters, such as the following, to demonstrate optimal device operation:  Hazard analysis  Temperature ranges  Humidity ranges  Pressure (e.g., altitude) Table I – Overview of Pre-Clinical Research Status In-Vitro Bench Testing Status: Animal Testing Status: Pre-clinical in-vitro testing is started Pre-clinical animal testing objectives have been identified Human Clinical Research Status Clinical trials that involve the participation of human subjects may be conducted anywhere in the world. However, each country or region has specific regulatory requirements for conducting clinical research and for the transporting of investigational device(s) into that country or region. The US, Europe, Canada, and Japan accept the International Conference on Harmonisation Good Clinical Practices (ICH/GCP) guidelines for designing, conducting, recording, and reporting the findings of the clinical trial. The clinical trial sponsor must ensure compliance with ICH/GCP and regulatory requirements prior to conducting clinical device trial(s) in a given country or region. The Percutaneous Mitral Valve Replacement clinical trial(s) must include qualified research professionals with the prerequisite education, training, and experience to support the quality systems requirements (QSRs) ICH/GCP, and regulatory requirements. These qualified research professionals include (but are not limited to) a medical director, a clinical monitor, a project manager, a data manager, a biostatistician, a quality assurance manager, and a regulatory affairs representative. Additionally, clinical conduct standard operating procedures (SOPs) must be either written and maintained by the medical device developer, and/or manufacturer, or transferred to a Clinical Research Organization (CRO). The developer or manufacturer, however, is ultimately responsible for compliance. Table II – Overview of Human Clinical Research Status Types of Human Clinical Research Conducted: Pilot Trial Results (US, EU): Not Identified Not Identified Clinical Trials Location: Pivotal Trial Results (US, EU): Not Identified Not Identified Clinical Data Available to Support Claims: Regulatory Confirmation of US/EU GCP Not Identified Compliance: Not Identified Clinical Research Published: Which regulatory body confirmed GCP Not Identified Compliance? Not Identified e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 16
  17. 17. InnoVision Report Date Generated: May 12, 2009 FDA Clinical Strategy Meeting: Not Identified E6 Good Clinical Practice Consolidate Guidance (ICH/GCP) Section 8, essential documents are those documents that individually and collectively permit evaluation of the trial, and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, and/or sponsor; and that the trial and data have been monitored in accordance with Good Clinical Practice (GCP) standards and all applicable regulatory requirements. Essential documents are collected before (ICH/GCP 8.2), during (ICH/GCP 8.3), and after (ICH/GCP 8.4) the clinical trial. Table III – Overview of Essential Documents Collected for Clinical Trial(s) Type of Essential Documents Collected for Clinical Specific Essential Documents Collected During Trial(s): the Trial(s) (ICH GCP 8.3]*: Not Identified Not Identified Specific Essential Documents Collected After the Specific Essential Documents Collected Before the Trial(s) were completed/terminated (ICH GCP Trial(s) Began [ICH GCP 8.2]*: 8.4]*: Not Identified Not Identified Note: The above table illustrates only a small sample of the essential documents collected before, during, and/or after a clinical trial(s). Further review of all essential documents collected for a clinical trial(s) should be conducted to ensure compliance with ICH/GCP section 8, essential documents. Reimbursement Coverage and payment for new, innovative devices in the global health care system is a complex process. Each country has a distinct set of criteria, coding system, and decision making process. A well designed plan is essential to success in obtaining global reimbursement for the Percutaneous Mitral Valve Replacement. Currently, e-Zassi data only includes US and German reimbursement content. Additional content for the other countries is coming soon. US Reimbursement The US reimbursement process requires both coverage and coding. Coverage is determining the eligible benefit and the criteria that must be met to obtain a specific covered service by various organizations involved in reimbursement for a new device, technology, or service. Coding is used to define medical conditions, to identify medical services and devices used in various clinical settings, and by who is using the new device. The following brief overview describes US codes used for identification of diseases, surgical procedures, diagnostic procedures, medical services, devices, supplies, and drugs. The following table describes the likelihood of the innovation having existing reimbursement coverage in the US: Overall Coverage: Likely Existing Coverage Applies e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 17
  18. 18. InnoVision Report Date Generated: May 12, 2009 International Classification of Diseases 9th Revision, Clinical Modification (ICD-9-CM) codes identify the reason for the health encounter (medical diagnosis, specific injury, or other health care reason). The codes are use to process billing and to track health statistics. They are used in-hospital, out-patient clinic, and specialty facilities. (Nursing homes and physician offices) The Center of Disease Control, National Center for Health Statistics (NCHS) manages the process for new ICD-9-CM codes. The following table describes the likelihood of an existing ICD-9-CM code being associated with the innovation: ICD-9-CM: An ICD-9-CM code is identified Current Procedural Terminology (CPT) codes are uniform codes of descriptive terms that are used primarily to identify medical services and procedures furnished by physicians and other health care professionals. The clinical settings include a physician office, the out-patient clinic or surgical center, and other unique specialty facilities. The American Medical Association (AMA) manages the process for new CPT codes. The following table describes the likelihood of an existing CPT code being matched with the use of the innovation: CPT: An associated CPT code is expected to exist Healthcare Common Procedure Coding System (HCPCS) codes are alpha-numeric codes that describe categories of products, medical supplies, certain drugs and biologics, certain devices, and some procedures not covered by CPT codes. The HCPCS code is used for devices in a person’s home, the physician office, an out-patient clinic, or a surgery center. The Center for Medicaid and Medicaid Services HCPCS Workgroup manages the process for a new HCPCS code. The following table describes the likelihood of an existing HCPS code matching a description of the innovation: HCPCS: The HCPCS codes status is not known German Reimbursement The German health system requires that all its citizens be provided health care coverage. The majority of its population (85%) is covered under the mandatory statutory health insurance (SHI) and the remainder by a mix of private and public providers. The system is funded by the statutory health insurance (Pflegekasse) contributions, private funds, and government social security (sickness) funds. Employed citizens must contribute, along with their employers, into the SHI and the long term care (LTC) insurance which covers community-based services. Individuals choose their mandatory health plan from one of more than 230 health insurance companies. The range of covered services and products is defined in the German Code of Social Law. In Germany there are two different reimbursement systems I; the German Diagnostic Related Group system and the doctor’s fee scale reimbursement system. The German Diagnostic Related Group system (G-DRG) includes codes used for treatments in hospitals. Each Federal member state (of which there are 16) establishes the base-rate for hospitals within their e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 18
  19. 19. InnoVision Report Date Generated: May 12, 2009 State, which is then calculated with the G-DRG mix-weight to determine the overall payment for a patient encounter in the hospital. The following table describes the likelihood of a G-DRG code matching the innovation: G-DRG: An associated G-DRG code is expected to exist In the doctor’s fee scale reimbursement system, EBM-Code: (Einheitlicher Bewertungsmaßstab = EBM) is the doctor’s fee scale reimbursement system for office-based physicians. Physicians are organized in Regional Physicians’ Associations (of which there are 17) with budgets set by the federal member state for management of the population base. Physicians are paid per service they provide. All insurance (SHI) fees are standardized throughout Germany. Private Insurance fees vary. The following table describes the likelihood of an EBM-code being available for the innovation: EBM-Code: An associated EBM-Code is expected to exist Other supporting codes used in the German health system include: Operation Procedure Codes (OPS) identify surgical treatments. Operation Procedure Codes are determined by the location of treatment. In a hospital or a clinic treatments are categorized under a G- DRG, or under an EBM-Code for treatment in a doctor’s office. The following table describes the status of an OPS code associated with the innovation: OPS: An associated OPS code is expected to exist German Health System (GHS) Therapeutic Appliances List (Hilfsmittelverzeichnis) includes categories of devices used in the community for in home use. The likelihood of whether or not the innovation is included is identified in the following table: Therapeutic An associated Therapeutic Appliannces List code is expected to Appliance List: exist International Statistical Classification of Diseases (ICD) and Related Health Problems; 10th revision (ICD- 10) codes track the diagnosis for utilization of services for health statistics and are used to process payment in a hospital and other facilities. The following table describes whether or not it is likely that an ICD-10 code identifies the clinical reason for the innovation: ICD-10: An associated ICD-10-CM code is expected to exist Intellectual Property e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 19
  20. 20. InnoVision Report Date Generated: May 12, 2009 Intellectual property considerations are a critical part of the due diligence required when determining the potential for commercializing an innovation. The following information characterizes the intellectual property status of the Percutaneous Mitral Valve Replacement. Patent Status Patents are generally granted on a nation by nation basis. In the US, patent grants are effective for 20 years from the date of filing, and protect an invention only within the United States, and in its territories and possessions. Under US law, when a patent is granted, the grant provides the right to exclude others from making, using, offering for sale, selling, or importing the invention. When the patent is issued in the US, the patentee has the burden of enforcing the patent, not the United States Patent and Trademark Office (USPTO). The Percutaneous Mitral Valve Replacement patent status is: No patents are issued., Patent applications are pending. A written opinion from a patent attorney evaluating the patentability of the Percutaneous Mitral Valve Replacement was rendered. Assuming the opinion is favorable, this is a useful piece of information for potential investors or other interested parties. It should be noted that any disclosure of such an opinion is usually done only under a confidentiality disclosure agreement (CDA). Intellectual Property Ownership and Encumbrances At this time, and based on the provided information, others do not have rights to the Percutaneous Mitral Valve Replacement. If others do have rights to the Percutaneous Mitral Valve Replacement, it would be important to ensure that all patents are properly filed, and to indicate all of the inventors involved with the Percutaneous Mitral Valve Replacement. These precautions will help ensure the parties that hold rights to the invention are properly represented during subsequent license or sale negotiations. It is uncertain if encumbrances or contractual obligations for the Percutaneous Mitral Valve Replacement exist. More information is needed to determine if such obligations exist for the Percutaneous Mitral Valve Replacement. Public Disclosure and Public Use The protection of intellectual property is important to innovators and partners. Public disclosure and/or public use of innovations may jeopardize intellectual property protection. The following table provides information on the status of public disclosure and public use for the Percutaneous Mitral Valve Replacement. Public Disclosure and Use Status Date of Occurrence Public Use: No Public Use has occurred None Identified Public Disclosure has not Public Disclosure: None Identified occurred e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 20
  21. 21. InnoVision Report Date Generated: May 12, 2009 Trademark and Copyright Status Trademarks and copyrights are valuable Intellectual Property (IP) components. The following table provides information on the trademark and copyright status of the Percutaneous Mitral Valve Replacement. Trademarks and Copyrights Status Type Trademarks: No trademark NA Copyrights: No copyright NA Innovation Litigation Status The Percutaneous Mitral Valve Replacement is not involved in litigation or a legal dispute. Technology Platform Considerations Some medical innovations are considered technology platform innovations and may offer clinical benefit across medical specialties. When this occurs, additional intellectual property review is recommended to insure that all IP rights are protected. At this point, the Percutaneous Mitral Valve Replacement is not reported to include such a DNA technology platform. This conclusion means that the Percutaneous Mitral Valve Replacement may note only one clinical application within the patent application. Product Development and Manufacturing Successful medical device development of the Percutaneous Mitral Valve Replacement requires a core development team of individuals with expertise in; Project Management, Intellectual Property, Design, Process Development, Manufacturing, Procurement, Quality, Regulatory, Reimbursement, Medical Affairs, Clinical Affairs, and Marketing. Product development requires a broad range of knowledge about the market in which the innovation will participate, including current products, requirements, key features, and claims. The successful developer will also be very familiar with customers and competitors. Most importantly, the developer will have a clear understanding of user needs, the development process, and risks (patient, technical, safety, business, schedule, and cost). The following analysis includes invaluable information in devising an effective development plan for the medical device innovation. The selection of a regulatory-compliant, competent manufacturer is a key consideration for all medical product innovators. The innovator has reported the following about the Percutaneous Mitral Valve Replacement manufacturing facility:  manufacturer not selected or being considered e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 21
  22. 22. InnoVision Report Date Generated: May 12, 2009 Quality System Regulations (QSRs) Global quality system regulations require that a medical device be designed, developed, and manufactured under design controls as defined by 21 CFR 820.30(h) for US and International Standards Organization (ISO) 13485 section 7.3 for International design control requirements. The quality system of a medical device company must contain procedures that define how the manufacturer will address design control elements and design transfer regulations. Both the design and manufacturing company must have a compliant quality system in place. This is true even when the design company does not plan to manufacture the medical device. The design history file (DHF) must contain a comprehensive record of the design process as defined by the applicable design control requirements. An executive summary is created in the Phase IV Design Transfer process that contains references to specified critical required documentation. The clinical evaluation phase is only used if the clinical evaluation (clinical trials) are required or implemented. Note: The manufacturer must have procedures in place and must maintain documentation in the design history file to demonstrate compliance with the design control requirements of §820.30 and completion of the activities identified in the design plan. The design history file must be made available for FDA inspection. The FDA will conduct routine quality system inspections of all classes of devices subject to design to evaluate the manufacturer’s compliance with design control requirements. Medical Device Design Control Development Phase The innovator has reported the following for the Percutaneous Mitral Valve Replacement: Business Plan, Design/Development Plan, High Level Level of planning: Plan (25 to 100 lines), Resource Planning Level of documentation: Formal dimensioned sketches Three dimensional computer model(s), Non- Product build status: functional physical prototype(s) Not confirmed to be in compliance to Good Design control system: Manufacturing Practices (GMP) Development stage: R&D (Pre Design Control) The following chart depicts the typical formal design control process phase with the current phase of development (R&D (Pre Design Control)) highlighted. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 22
  23. 23. InnoVision Report Date Generated: May 12, 2009 Design control deliverables status at the time of this report: Phase I Design Input The concept document complete and released to formal documentation Incomplete control The marketing/user needs specification complete and released to formal Incomplete document control The design specification complete and released to formal document control Incomplete The hazard analysis complete and released to formal document control Incomplete The design failure mode and effects analysis (DFMEA) complete and released Incomplete to formal document control The process failure mode and effects analysis (PFMEA) drafted Incomplete The phase I design input design review conducted and approved Incomplete Phase II Design Output The design input document updated and under formal document control Incomplete The device master record (DMR) complete, updated, and under formal Incomplete document control The risk analysis updated and under formal document control Incomplete The master design verification and validation plan established Incomplete The suppliers selected and qualifications in process Incomplete The initial transfer cost of goods sold (TCOGS) drafted Incomplete The phase II design output design review conducted and approved. The minutes from the design I input design review examined and all action items Incomplete sufficiently closed out. Phase III Design Verification and Validation e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 23
  24. 24. InnoVision Report Date Generated: May 12, 2009 The design specification testing including all label performance claims Incomplete complete The biocompatibility and accelerated aging and/or ship testing complete Incomplete The manufacturing and quality procedures under formal document control and Incomplete training initiated The process validation (PV) protocols drafted, installation qualifications (IQs) and/or operational qualifications (OQs) complete, and the process Incomplete qualifications (PQs) and product performance qualifications (PPQs) approved The final manufacturing plan and the transfer cost of goods sold (TCOGS) Incomplete established and up to date The regulatory submission, clinical investigational exemption (IDE), or the Incomplete institution review board (IRB) protocols and preparation fully complete The phase III design verification and validation design review conducted and approved. The minutes from the phase II design output design review Incomplete examined and all action items sufficiently closed out. Phase IV Design Transfer The process validation (PV), installation qualification (IQ), operational qualification (OQ), process qualification (PQ), product performance Incomplete qualifications (PPQs), and supplier qualifications approved The device master record (DMR) complete, updated, and under formal Incomplete document control The training and pertinent documentation updated and complete Incomplete The design-related material review boards (MRB) closed and corrective action Incomplete requests (CAR) implemented The bill of materials (BOM) successfully transferred to manufacturing and/or the procurement specialist. Also, ownership of tools, machines, and gauges Incomplete documented The initial build order submitted and the forecast updated Incomplete The phase IV design transfer design review conducted and approved. The minutes from the phase III design verification and validation design review Incomplete examined and all action items closed. Material Biocompatibility Considerations and Status All submissions for regulatory approval of medical devices must include a biocompatibility assessment of the device and the materials use therein as one of the assurances the device is safe for its intended use. The guidance documents used to determine what testing may be required are: In Europe, refer to ISO 10993, “Biological Evaluation of Medical Devices”. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 24
  25. 25. InnoVision Report Date Generated: May 12, 2009 In the US, refer to the FDA Blue Book Memorandum #G95-1, “Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices’ – Part 1: Evaluation and Testing”. The specific biocompatibility tests required for any given device are dependent upon where the device or component contacts the patient and for how long. The user provided the following information for the innovation during the interview process: Device Type: Surgical Implant Direct patient contact with breached or compromised surfaces, Patient Contact Type: tissue, tissue fluid, bone or dentin, blood, directly (circulating) for more than 30 days Sterility Requirements: Sterile when used Accordingly, the e-Zassi assessment engine has identified the following biocompatibility tests for consideration when planning development of the Percutaneous Mitral Valve Replacement: Initial Evaluation Tests for Consideration:  Cytotoxicity  Sensitization  Irritation or Intracutaneous Reactivity  System Toxicity (Acute) and Pyrogenicity  Sub-chronic toxicity (sub-acute)  Genotoxicity  Implantation  Haemocompatibility Supplemental Evaluation Tests for Consideration:  Chronic Toxicity  Carcinogenicity Consider additional FDA material testing beyond the above ISO requirements to meet the FDA requirements including: Initial Evaluation Tests for Consideration:  None Identified Supplemental Evaluation Tests for Consideration:  None Identified Biocompatibility test sample lot builds must be completed under formal design control using final manufacturing (production not prototype) processes and materials, and maximum sterilization dosage. These builds add considerable cost and lead time to those previously noted. It is advisable to use materials and processes with a proven history in similar medical devices when considering biocompatibility testing. Minimize risk with minimal informal testing wherever needed. Use a marketing partner and delay formal biocompatibility testing to Phase III or IV of formal design controls to minimize costly retesting. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 25
  26. 26. InnoVision Report Date Generated: May 12, 2009 Biocompatibility Test: Current Status: Cytotoxicity Considering Sensitization Considering Irritation or Intracutaneous Reactivity Considering System Toxicity (Acute) and Pyrogenicity Considering Sub-chronic Toxicity (Sub-acute) Considering Biocompatibility Genotoxicity Test Status Considering Biocompatibility Implantation Test Status Considering Haemocompatibility Considering Chronic Toxicity Considering Carcinogenicity Considering Reproductive Developmental Not Required Biodegradable Not Required Grant Eligibility The e-Zassi grant matching engine utilizes a proprietary innovation model record designed to match medical device innovations to International and US federal, state, and local grant programs. Initially, the grant database will include the National Institute of Health (NIH) current federal grant program parent announcement/omnibus solicitation PHS 2009-2 SBIR/STTR program descriptions and research topics as well as the current US state grant/loan programs available. The e-Zassi grant matching engine searches the state and NIH solicitations on a regular basis. A key feature of the e-Zassi algorithm is that it does not require confidential information to be disclosed when calculating the best NIH SBIR/STTR grant and US state grant matched to the Percutaneous Mitral Valve Replacement. The following grant opportunities have been identified as potential matches for the Percutaneous Mitral Valve Replacement. The table below provides a brief description of each grant, as well as contact information where further information can be obtained. Grant Name Description Contact Info National Institute of Health SBIR Biomaterials. Development of new or Mr. Todd Merchak 301-496-8592 2008 - 2009 National Institute of novel biomaterials that can be used Tm311u@nih.gov Biomedical Imaging and for a broad spectrum of biomedical Bioengineering applications such as implantable http://www.nibib.nih.gov devices; drug and gene delivery; tissue engineering; imaging agents; and biosensors and actuators. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 26
  27. 27. InnoVision Report Date Generated: May 12, 2009 Research that is National Institute of Health SBIR Cardiovascular implants (heart J. Timothy Baldwin, Ph.D. Pothur R. 2008 - 2009 National Heart, Lung, valves, vascular grafts, stents, Srinivas, PhD 301-435-0513, 301- and Blood Institute Division of pacemakers, defibrillators, etc) 435-0550 baldwint@nhlbi.nih.gov; Cardiovascular Diseases srinivap@nhlbi.nih.gov http://www.nhlbi.nih.gov National Institute of Health SBIR Cardiovascular Medical Implants- J. Timothy Baldwin, Ph.D. Pothur R. 2008 - 2009 National Heart, Lung, Preservation methods Srinivas, PhD 301-435-0513, 301- and Blood Institute Division of 435-0550 baldwint@nhlbi.nih.gov; Cardiovascular Diseases srinivap@nhlbi.nih.gov; http://www.nhlbi.nih.gov National Institute of Health SBIR Cardiovascular Medical Implants- J. Timothy Baldwin, Ph.D. Pothur R. 2008 - 2009 National Heart, Lung, Quality assurance and quality control Srinivas, PhD 301-435-0513, 301- and Blood Institute Division of 435-0550 baldwint@nhlbi.nih.gov; Cardiovascular Diseases srinivap@nhlbi.nih.gov; http://www.nhlbi.nih.gov National Institute of Health SBIR Cardiovascular Medical Implants- J. Timothy Baldwin, Ph.D. Pothur R. 2008 - 2009 National Heart, Lung, Reference biomaterials for Srinivas, PhD 301-435-0513, 301- and Blood Institute Division of evaluation of biocompatibility 435-0550 baldwint@nhlbi.nih.gov; Cardiovascular Diseases srinivap@nhlbi.nih.gov; http://www.nhlbi.nih.gov National Institute of Health SBIR Cardiovascular Medical Implants- J. Timothy Baldwin, Ph.D. Pothur R. 2008 - 2009 National Heart, Lung, Reliability Srinivas, PhD 301-435-0513, 301- and Blood Institute Division of 435-0550 baldwint@nhlbi.nih.gov; Cardiovascular Diseases srinivap@nhlbi.nih.gov; http://www.nhlbi.nih.gov For your consideration e-Zassi is providing the following information on both federal and state grant programs. There are certain criteria the innovator should remember when applying for a US state grant program:  The business must be owned 51% or more by a US citizen  Only small to medium-sized businesses (500 employees or fewer) are eligible for US state grant funding programs  Most states require that at least 50% of business operations and/or employees be located within the state, with the exception of angel networks or venture capital firms  If a funding program includes multiple states, then it is a grant program in which the business operation location rules may include different criteria When the innovator prepares an SBIR proposal and submission, the following links may prove to be very helpful: 1. Tutorial and Advice on applying for NIH SBIR grants (http://www.niaid.nih.gov/ncn/sbir/pres.htm) e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 27
  28. 28. InnoVision Report Date Generated: May 12, 2009 2. PHS-2009-2 Small Business Innovation Research Program Parent Announcement (SBIR [R43/R44]) (http://grants.nih.gov/grants/guide/pa-files/pa-09-080.html) 3. Small Business Technology Transfer Program Parent Announcement (STTR [R41/R42]) (http://grants.nih.gov/grants/guide/pa-files/pa-09-081.html) It is important to note that if Venture Capital is listed as a source of capital in the following Innovator Objectives section then, the innovation may not be eligible as an NIH SBIR grant funded project. Check with the contact source to confirm eligibility. Innovator Objectives Objectives:  Financial success  Reduce the cost of healthcare  Improve quality of life for patients and their families Desired Role in Development/Commercialization: Seat on the Board of Directors CEO Key management position Active participation in capital formation Active participation in the market creation activities Sources of Capital Acquired for the Percutaneous Mitral Valve Replacement: Friends and Family Angel investor(s) Institutional funding The following table summarizes the level of decision-making authority desired by the innovator: Share responsibility for the Others make the decision Activity Make all the decisions decision without me Core Technology  Decisions Major  Expenditures Hiring of Key  Employees Resource  Allocation e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 28
  29. 29. InnoVision Report Date Generated: May 12, 2009 Strategic  Partnerships Selection of  Board Members and Key Executives Capital  Formation Appendix Additional Marketing Information Global Cardiovascular Market The cardiovascular medical devices market exceeds the growth of all other medical device market segments. Future markets, influenced by the changes that accompany a more affluent lifestyle, are expected to show an increase in cardiovascular disease, the leading cause of death on a global basis. Growth in this market is also attributed to an increase in the elderly population. This population is expected to benefit from innovative products that utilize new technology and deliver exceptional treatment outcomes. Currently, the United States leads the cardiovascular devices global market, followed by Western Europe. The fastest growing global markets are Latin America and Asia Pacific. Cardiovascular devices include those that treat the heart and the heart’s circulatory system. These devices are used in the following major treatment areas: interventional cardiology, peripheral vascular disease treatments, cardiac rhythm management, cardiovascular surgery, cardiovascular prosthetics, cardiovascular monitoring, and diagnosis. Worldwide revenues for cardiovascular devices (GDM 2008 reports) were greater than $36.5 billion in 2006, and are projected to generate over $66.5 billion in revenues by 2011. (Global Markets Direct, Cardiovascular Device Market Profile, 2008) Cardiovascular device segments in market share in percentage of compound annual growth rate (CAGR) in declining order, include:  Cardiac rhythm management (CRM) devices (49%)  Interventional cardiology (IC) devices (25%)  Cardiovascular surgery devices (12%)  Cardiovascular prosthetic devices (6%)  Peripheral vascular (PV) devices (6%)  Cardiovascular monitoring and diagnostic devices (2%) e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 29
  30. 30. InnoVision Report Date Generated: May 12, 2009 The most rapidly growing segments of the market are interventional cardiology, rhythm management, and prosthetic devices. Each of these segments is expected to exceed a CAGR of 12% in revenues by 2011, led by interventional cardiology with a 20% CAGR. Interventional cardiology as a segment of the total global market is expected to grow by 5%, taking 1% to 2% of the market share from the other cardiovascular device segments. Cardiac rhythm management is expected to maintain a segment share of 49%. More than 75% of all cardiovascular devices worldwide are distributed to hospitals. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 30
  31. 31. InnoVision Report Date Generated: May 12, 2009 Global Cardiovascular Competition Leading competitors in the global cardiovascular device market, in order of declining market share, include Medtronic, Boston Scientific, St. Jude Medical, Cordis, Biotronik, Terumo Medical Corporation, and Guidant. In the global market, one company is the dominant market share leader in each of the individual cardiovascular device segments as follows:  Interventional cardiology, Cordis (30%)  Peripheral vascular devices, Cordis (33%)  Cardiac rhythm management, Medtronic (40%)  Cardiovascular surgery, Terumo (29%)  Cardiovascular prosthetic devices, Edwards (22%)  Cardiovascular monitoring/diagnostic devices, Phillips (33%) In four of the segments, a group designated as “other” holds the second highest market share. This designation may represent many companies that individually have a niche product or products in that segment. Market segments where “others” are the second largest shareholder include: Interventional cardiology others (26%), peripheral vascular devices others, (21%), cardiovascular surgery others, (39%), and cardiovascular prosthetic devices others,(33%). (Global Markets Direct, Cardiovascular Device Market Profile, 2008) Minimally Invasive Surgery (MIS) Devices and Equipment Overview e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 31
  32. 32. InnoVision Report Date Generated: May 12, 2009 Minimally invasive surgery is defined as surgery that is conducted with a minimum of trauma to the patient, without making a large incision in the body. The MIS market includes devices for a wide variety of anatomical uses and that fall into a number of different technological categories. The following chart illustrates the Major US MIS Application Segments, 2005 and 2011 (% of Total Sales).1 Minimally invasive surgical procedures (closed or local surgery) are less invasive and traumatic to the body than open invasive surgery. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device, and are carried out through the skin or through a body cavity or anatomical opening. This may result in shorter hospital stays, or allow outpatient treatment. Special medical equipment may be used, such as fiber optic cables, miniature video cameras, and special surgical instruments handled via tubes inserted into the body through small openings in its surface. The images of the interior of the body are transmitted to an external video monitor and the surgeon has the possibility of making a diagnosis, visually identifying internal features, and then performing surgery based on these findings. The following chart illustrates the US Forecast for MIS Devices and Equipment Market Sales by Application through 2011 ($ millions) 1. The global MIS devices and instrument market is estimated at $14.9 billion in 2008, with an average annual growth rate (AAGR) of 7.5%. Revenues in 2018 are expected to top $30 billion1. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 32
  33. 33. InnoVision Report Date Generated: May 12, 2009 Minimally invasive devices and equipment includes1:  Monitoring/visualization equipment o Robotics/computer-assisted surgery o Electrosurgical and auxiliary equipment o Endosurgical instruments o Surgical devices (stents, catheters, guidewires, etc.) The following table identifies the US Forecast for MIS Equipment Types Through 2011 ($ Millions).10 US MIS Market Overview In the United States, about 4.9 million MIS procedures are performed annually. Cardiac procedures (mainly angioplasties and other heart catheterization procedures) account for the largest number, (e.g., more than 1.5 million or 31%% of all MIS procedures) Orthopedic is the fastest-growing anatomical segment, with an anticipated average annual growth rate of 8.7% through 2011, followed by cardiac surgery (7.9%) and vascular surgery (6.8%). The remaining segments all have projected average 2006 to 2011 growth rates below the US market average of 7.2%1. In the United States MIS device and equipment market, cardiac was the largest anatomical segment in 2005, with 69% of the total market, followed by orthopedic (20%), gastrointestinal (18%), and gynecology (6%). The remaining anatomical segments were all relatively small1. The following table identifies catheterization (including angioplasty) as the largest annual number of minimally invasive cardiac procedures performed in the US annually1. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 33
  34. 34. InnoVision Report Date Generated: May 12, 2009 Surgical Devices Overview The surgical device market is projected to grow at an average rate of 7.8% per year between 2006 and 2011, compared with an average growth rate of 7.2% for the market as a whole. The surgical device market share is projected to grow from 68.6% in 2005 to 70.9% in 2011, while the remaining segments are expected to experience a slight drop in market share10. The chart below identifies the Major US MIS Equipment Segments, 2005 and 2011 (% of Total Sales). In 2011, the surgical devices segment is projected to hold 70.9% of the total sales10. The following table identifies the US Forecast for MIS Surgical device segment by application, through 2011 ($ Millions)10 e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 34
  35. 35. InnoVision Report Date Generated: May 12, 2009 Surgical devices used in minimally invasive surgery include stents, guidewires, and catheters. Contemporary Trends Stents1 Coronary artery disease is the leading cause of death in the United States for both men and women.  Endeavor® Drug-Eluting Stent System is designed to treat artery disease by opening clogged arteries and restoring blood flow. The stent provides support to the artery after angioplasty. The system also releases medication to limit excess cell growth while the artery heals.  Driver® Coronary Stent System is designed to treat coronary artery disease. It increases blood flow by opening up your artery and keeping it open. The stent acts as a scaffolding to provide permanent support to the artery wall after angioplasty.  Micro-Driver® is specifically designed to work in small vessels2. e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 35
  36. 36. InnoVision Report Date Generated: May 12, 2009 Guidewires A guidewire is a thin, usually flexible wire that can be inserted into a confined or tortuous space to act as a guide for subsequent insertion of a stiffer or bulkier instrument. Coronary Products  Vascular Cougar Guidewire3  Zinger Guidewire used for advanced steerability and torque control4  Persuader Guidewire used to access and cross difficult lesions5 Catheters  A catheter is a hollow flexible tube for insertion into a body cavity, duct, or vessel to allow the passage of fluids or distend a passageway. The Optitorque catheter includes the ‘Tiger Catheter’ and ‘Jacky Catheter’ designed in such a way as to allow a full coronary angiogram and left ventriculogram to be performed with a single catheter. Reduced catheter exchanges and movements result in less radial artery spasm, radiation exposure and procedure time6.  Balloon-tipped Catheter As many as 15-50% of end-stage kidney disease patients are on peritoneal dialysis (PD). The likelihood of peritonitis limits its more widespread use. Sinusitis is an inflammation or infection of the air-filled cavities that surround the nose and eyes, which can cause swelling and facial pain, severe headache, and nasal congestion with discharge. In balloon sinuplasty, in conjunction with minimally invasive functional endoscopic sinus surgery (FESS), the balloon device is inflated and stretches the sinus opening back to its original size or a little bigger, allowing for drainage of the sinus. The balloon is then deflated and removed7.  Catheter-based interventions are being used in increasing numbers to treat severe leg blood-vessel blockages. This painful condition known as lower extremity arterial vascular disease effects an estimated eight million Americans8. Competitors (Not an all inclusive list)  United States Surgical (USS)10 Medtronics9 e-zassi.com | © 2009 e-Zassi, Inc. LLC. All Rights Reserved. 36

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