Dear Bioheart Shareholders and Friends,
As the 3rd quarter winds down, Bioheart continues to announce new strategic business efforts as well as the progression of our unique stem cell technology.
We recently announced early phase I data from the ANGEL Study being conducted in Mexico at the Hospital Angeles which has far exceeded our expectations. The strong safety profile will allow us to expand this study to additional clinical sites and enroll more patients in the US and around the world. Patients showed an average improvement in exercise capacity (or six-minute walk test) of 47 meters and 60% of the patients are walking greater than 65 meters farther at 3 months post stem cell injection. The patients are also reporting an average improvement of 13 points in their Minnesota Living with Heart Failure questionnaire. An improvement of 5 points or greater is considered “clinically meaningful” and 80% of the patients in the trial had a greater than 5 point improvement.
We are contacted often by potential investors in Asia and Latin America interested in investing in the Company. I have recently completed the prerequisite training and the vetting process is underway to take advantage of the EB5 investor visa program for immigrant investors. This visa provides a method of obtaining a green card for foreign nationals who invest money in the US. To obtain the visa, individuals must invest $1,000,000 or at least $500,000 in a “Targeted Employment Area” creating or preserving at least 10 jobs for U.S. workers excluding the investor and their immediate family. We cannot solicit investors for the program but we are certainly preparing to better answer questions and potentially take advantage of the obvious benefits for all involved. As you know, besides an advocate for regenerative medicine, I am a fervent supporter of talent development, economic development and job creation in our STEM field and our state. In that vein, I was recently appointed by Florida Governor Rick Scott to sit on the state’s board of directors of Workforce Florida, the statewide business-led workforce policy board.
We have entered into an agreement with Invitrx Therapeutics to license their adipose derived stem cell products. The team at Invitrx has been working with adipose derived stem cells for over 10 years and this experience will contribute to the development and commercialization of AdipoCell™ (Bioheart’s adipose stem cell product). We are hoping to integrate some of the techniques utilized by the team at Invitrx into our existing adipose stem cell program as we expand the ANGEL trial to additional clinical sites.
We continue to enhance our resources with the addition of two service providers — Outside Eyes and Mitrani, Rynor, Adamsky& Toland, P.A. Outside Eyes, led by Ben Porritt, is a marketing strategist who worked in the White House and has a clear understanding of both private markets and public policy. They have been engaged to support the company’s marketing plan and investor relations efforts. The marketing plan includes developing additional lines of business and revenue generators involving human and animal stem cell products. The commercial litigation law firm of Mitrani, Rynor, Adamsky & Toland, P.A. Miami and Fort Lauderdale has been hired to assist us with the protection of intellectual property rights, libel, slander and privacy protection.
I truly appreciate the ongoing flood of support of your letters and emails. I will continue to keep you posted of ongoing efforts via public filings, press releases, social media and this monthly blog. We believe that all of the above efforts will prove to be invaluable in the coming months as we prepare the market for upcoming milestones and we too realize that ongoing communication with you, our shareholders and friends of the firm, is important and key.
Thank you for your continued support and as always please reach out to me via phone or email with your comments or questions.
Warm regards,
Mike Tomas and the Bioheart Team
