Changing the Paradigm for Treating Ischemic Heart Disease with
Regenerative Medicine
Drug Development for Restoring Blood Flow
Within Damaged Heart Muscle
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An opportunity to invest in a clinical trial-focused drug development company.
The main business goal is to generate favorable clinical data, the primary path to substantially increase valuation. The company is preparing its lead candidate, Sonic Hedgehog Protein (Shh), for clinical trials to treat heart attacks that result from blockage of blood vessels that supply the heart (termed "ischemic heart disease" or "coronary artery disease"). Many will develop chronicheart failure (CHF), a progressive disease with high mortality (so-called "No Option" patients).
A key therapeutic and market differentiator for Shh protein is the ability to generate both smaller (capillary) and larger (arterial) blood vessels within the heart, leading to a stronger heart muscle and better pumping action, which should improve patient quality-of-life
and extend survival. Ischemic heart disease remains a major unmet need and with the aging of the baby boomers there is a large and increasing patient population of approx 16.8 million total in the USA; of which almost 8 million have experienced heart attacks. For patients older than 65 years, CHF is the leading indication for hospitalization and is the largest Medicare Diagnosis-Related Group (DRG) with estimated direct costs of over $33.7 billion (American Heart Assoc.). Both heart attack and CHF are potential indications for FDA approval.
Over a four year period, the company is seeking $6,200,000 to fund its primary business goal and exit strategy, which is acquisition after increasing its value ~5-10X over the 4 years via the generation of compelling Phase I clinical trial safety data and Phase IIa clinical
trial efficacy data. The projected valuation with favorable clinical data may be in the range of $20-$30 million. The company is also seeking early pharma partnerships to support the acquisition exit strategy.
Depending upon the clinical data, investors could also opt to support a broader Phase II trial to achieve a higher ROI, especially if the probability of Fast Track status increases (a more rapid path for FDA approval). The potential market is very large: if peak sales only
reached a 5% of the ~1.1M annual heart attack patient market (assuming cost of ~$10K/patient/yr), annual revenue would be approximately $500,000,000. If CHF were also approved as an indication and peaksales reached only 5% of the ~3M patient market, the annual revenue would be approximately $1.5 Billion.
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