Incorporated in 2005 and headquartered in Hackensack, New Jersey, Amorcyte, Inc. is a development stage cellular therapies company focused on developing cell therapeutics for cardiovascular disease. Currently, the company is developing its first product, AMR–001, which is a bone marrow-derived, CD 34 positive selected stem cell product for the treatment of damaged heart muscle following Acute Myocardial Infarction (AMI). The company is currently assessing the safety and efficacy of AMR–001 in treating patients who have suffered a severe AMI and who are at risk for further adverse events.

There are approximately 160,000 patients per year who have a ST-Elevation MI (STEMI) resulting in a reduced Left Ventricular Ejection Fraction (LVEF) of less than 50%. These patients are at significant risk of downstream adverse events including Congestive Heart Failure, Re-current MI, Significant Arrhythmias, premature Death or Acute Coronary Syndrome, and are the target population for AMR-001. This population represents an accessible market of over $1.2 Billion annually for AMR–001.

AMR-001 was recently evaluated in 31 patients (16 treatment, 15 control) in a Phase I study. We have shown that AMR–001 is safe, and have isolated the threshold dose for efficacy: Patients receiving 10 million cells or more showed improvement in perfusion/RTSS (statistically significant) and cardiac function measures (non–significant trends in improvement) as compared to those receiving 5 million cells or none. We have also recently verified the mechanism of action of AMR–001 in animal models, set to be published within the year.

Based on the success of Phase I, we expect a Phase II trial to be approved. The Phase II trial will include 230 patients (125 Treatment, and 105 Control) in approximately 30 sites. We are poised to have all of our clinical sites enrolling patients within 6 months of closing Series B Financing, and expect to complete the trial within 18 months after the trial starts. The company has commitments from leading research hospitals to participate in the Phase II trial, including Emory, Vanderbilt, the Mayo Clinic. We anticipate that the efficacy data from the Phase II trial will result in the sale of the company or a strategic partnership.

In addition to strong underlying science, Amorcyte has a strong position in the market place. We have a large total potential market of $5.6 Billion, a strong patent portfolio, and a written a Freedom to Operate Opinion. Amorcyte has a capital efficient business model, which will require a moderate number of full time employees through product approval. We have a strong existing venture group which is committed to participating in our series B financing. We maintain a close, strategic relationship with one of our founding corporate partners, Progenitor Cell Therapy, LLC, which continues to provide GMP contract manufacturing services, as well as clinical, regulatory and administrative support.

We work with cells derived from adult tissue sources and do not plan to develop embryonic stem cells for therapeutic use. We are not involved in any activity directed toward human cloning; our work is exclusively directed toward the use of adult tissue-derived cells for the treatment of cardiovascular diseases. We believe that such stem cell technologies, when successfully developed, may provide the basis for effective therapies. The long-term aim of the Company is to help patients return to productive lives and significantly reduce the substantial health care costs often associated with cardiovascular disease.