With well over $4 billion already invested, Angiogenesis Foundation, Inc estimates Angiogenesis as one of the most heavily funded areas of medical research in human history. With the passage of Proposition 71 in 2004 committing $3 billion over 10 years, State of California became the largest single source of funding for stem cell research in the world. Although much of the initial activity has been in cancer research, growing new tissue to replace the functions of a diseased heart­ tipped by some experts as the next big thing in cardiology practice­ has also been an area of substantial investment activity and promise. Despite the magnitude of the investments, the initial euphoria of growing natural bypass to the blocked arteries was dampened by the statistically week or no efficacy reported in some of the FDA approved clinical trials. Major players in regenerative cardiology business who were bullish to begin with, transformed to bears. However, a second wave of clinical trials driven mostly by stem cell approaches to regenerate heart appears to be gathering the momentum. Surprisingly none of the published research reports so far investigates the reasons for the failed clinical trials that places at risk industry’s billion dollars invested in developing a viable neocardiogenesis therapeutic. This study fills that void.

The principal objective of the study is to provide comprehensive analysis of emerging approaches in regenerating/ renewing dysfunctional portions of a diseased heart, identify problems that caused the disappointing clinical trial outcomes, and formulate answers to some of the difficult questions in the context of improving myocardial functions in patients of coronary artery disease.

In the changing paradigm adult heart is now largely seen as a Self-Renewing Organ. Such self-renewal broadly comprises of two anatomically distinguishable and physiologically integrated processes by means of which new blood channels are formed to bypass the blocked coronary arteries (Angiogenesis), and new myocardial tissue is generated to compensate for the portions of the dead infracted myocardium (Myogenesis).

i. The First Wave Lessons
The first wave of clinical trials for growing coronary arteries began in mid nineties with much hype and expectations but ended in disappointment with the end of the millennium. It is the principle goal of the study to identify the problems and ascertain if they are insurmountable.

ii. The Second Wave Issues
The second wave of clinical trials is now gaining momentum. It is an opportune time, and another goal of the study, to shortlist the issues based on the lessons learnt from the initial failures and address them.

iii. Solution
Finally, it is the goal of this study to formulate a strategy that maximizes the probability of achieving significant efficacy in the ongoing and future clinical trials.

Accordingly the report aims at forecasting near term measures based on an assessment of the merits and limitations of the various therapeutic approaches and their clinical development protocols. In essence the primary goal is to evolve a technologically sound strategy that will not only revitalize the currently active or on hold neocardiogenesis programs but also revive those terminated for reasons of insufficient or no efficacy.

This report explains the angiogenesis and myogenesis processes and the cellular mediators involved in their regulation in the context of coronary artery disease. It offers new insights needed to understand regulation of heart´s self-renewal mechanism, which we believe is uniquely different than any of those encountered in any other gene therapy, protein therapy or cell therapy scenario. The report articulates the impact of these novelties on treatment protocols, as well as their affects on the efficacy of the therapeutics in clinical development. Just copying any other protein, gene or cell therapy protocol ditto is not likely to produce the desired results. It is therefore an invaluable tool for business planners, investors and investor consultants, acquisitions specialists, licensing strategists, product managers, market research analysts, expert committees, regulatory approval committees, academicians and physician investigators involved and interested in therapeutic angiogenesis.

This research was neither sponsored by any of the known companies in therapeutic angiogenesis / regenerative medicine business, nor was any part of it funded by any party actively engaged in ongoing regenerative cardiology research. All the resources used for this research were raised and contributed in-house by MetaReports.net.

The scope of this study is limited to application of therapeutic angiogenesis in treating patients of coronary artery disease. More particularly the research delves into ways of resolving the less than desirable outcomes of the clinical trials with several angiogenic agents conducted in the recent past. The format is therefore more akin to scientific exposition rather than to equity research. Any equity valuation is meaningless if the technical foundations on which products are built aren't robust, and the happenings of the recent years have put that robustness into question. Since most forecasts published so far on Neo-Cardiogenesis companies have been so much off from reality, we rather refrain from projecting any hypothetical equity valuations at this time. This report is therefore technology focused rather than company focused. Nevertheless brief profiles of companies in the late stages of development of Neo-Cardiogenesis products are provided.

We deploy a unique patent pending methodology to eliminate all possible sources of biases and prejudices that are inherent with any sponsored or paid research. Pursuant to our proprietary MetaReports technology the research is conducted at our own behest based on popularity, recommendations, unmet need, urgency of the subject matter, and our own in-house expertise. The completed Research Report is presented to the audience in two phases:
    1. Dynamic Phase: During the dynamic phase the report is initially released as a dynamic living document for 90 days. During this dynamic phase all the parties who are mentioned in the report are entitled to an opportunity to edit the contents relevant to them by commenting, updating, modifying, correcting any text they find erroneous or inadequate or incomplete. Such edits are however moderated by the author or the chief editor of the report.
    2. Final Release: The final release of the report includes all the edits received from the initial audience moderated by the moderator of the report. For further details on MetaReports methodology please feel free to contact us at MetaReports@mrilimited.com

Peer reviewed journals are the major source for the scientific information used in this report. The sources for corporate, statistical, administrative and regulatory information on companies, academic institutions, governmental or non-governmental outfits include Internet, press releases, media articles, analyst reports, regulatory filings and disclosures and other sources in public domain such as company annual reports and 10-Ks, minutes of meetings, prospectus etc.

Several related Cardiology research projects are currently underway at MetaReports.net. The following MetaReports are upcoming in the next several months.
    1. Endothelial Dysfunction– The Mother Of All Morbidities
    2. Plaque Regression and Stabilization- The Next Frontier In Coronary Artery Disease
    3. Stents- The Odyssey Continues
    4. Cardiac Monitoring- Changing The Shape Of Cardiac Care

An updated list is also available at www.metareports.net .

The study did achieve its goal of articulating the hitherto unperceived sources of problems facing the clinical development of Neo-Cardiogenesis products and come out with a near term approach that maximizes the probability of achieving significant efficacy in the ongoing and future clinical trials. The study not only achieved its primary goal of evolving a technologically sound strategy that will revitalize the currently active or on hold Neo-Cardiogenesis programs but also holds out promise to revive and salvage hundreds of millions of dollars invested in those programs that were terminated for reasons of insufficient or no efficacy.