First and foremost, THANK YOU from the bottom of my heart for the incredible outpouring of support during my time away from the office. As you know by now, just before the end of the year I was surprised with an aneurysm and dissection of the aorta that required emergency open heart surgery. I am pleased to report that I am well and on my way to making a full recovery—THANKS in great measure to the most exemplary team of doctors, scientists, friends and associates at Miami’s Baptist Cardiac and Vascular Institute (BCVI, led by world renowned medical director and longtime Bioheart Scientific Advisory Board member, Dr Barry Katzen). I will forever be grateful to cardio thoracic surgeons Dr Niberto Moreno and Dr Lisardo Garcia Covarrubias—as well as the entire team of friends and family at Baptist Health South Florida that made it a point to make sure it was not my time!
It is paramount to note that during my absence, Bioheart Inc. has not missed a beat, continuing to make great progress towards strengthening our strategic relationships, fortifying our laboratory and operational systems, launching a variety of clinical studies and fervently working to bring our cellular therapies to market.
Our Chief Scientific Officer, Kristin Comella, has been making great strides in the war against cardiovascular related diseases by utilizing Bioheart’s cellular biologics. The 6-month data released this week from the Phase I ANGEL trial shows statistically significant improvements in the accepted industry standard measurements, including exercise capacity, quality of life, and ejection fraction. The improvements in the quantitative measurements used–such as the ejection fraction measurement (EFM) by echocardiogram– demonstrate the power of this biological treatment. As a result of the positive 6-month data, the Phase I ANGEL trial has been garnering a rather large interest in the sector of regenerative medicine, as well as institutional investors. The complete 6-month data will be presented by Ms. Kristin Comella at the upcoming Age Management Medicine Group conference in Orlando on April 25th 2014. (www.agemed.org). Additionally, Ms. Comella recently participated in the American Academy of Cosmetic Surgery’s (AACS) scientific pre-conference discussion entitled, ‘Regenerative Stem Cell Therapies’. The AACS program is fully accredited and its pre-conference discussion provided attendees the opportunity to discuss the latest treatments in orthopedic, cosmetic, neurologic, cardiac, pulmonary, and anti-aging treatments utilizing cell therapies.
Bioheart also launched a clinical study for dry macular degeneration with Shareen Greenbaum, M.D., the principal investigator for the study. The study will enroll up to 100 patients and will determine the safety and efficacy of adipose derived stem cells or AdipoCell™ in patients with dry macular degeneration.
In other trials news, Bioheart also announced plans to commence adipose derived stem cell clinical trials for the treatment of Erectile Dysfunction (ED) with Perito Urology in Coral Gables. Perito Urology and the principal investigator of the trial, titled, “An Open-label, Non-randomized, Single-center Study to Assess the Safety and Effects of Autologous Adipose-derived Stromal Cells Delivered into the Corpus Cavernosum in Patients with Erectile Dysfunction,” aims to assess the safety and efficacy of stem cell implantation in patients with ED. The cell therapy in this study will be composed of autologous stem cells derived from a patient’s own adipose (fat) tissue, harvested by syringe liposuction. The adipose derived stem cells will then be delivered into the corpus cavernosum of the penis. The principal investigator is Paul Perito, MD and the trials are being sponsored by Global Stem Cells Group and Bioheart. The study will enroll up to 20 patients. Fort Myers Florida-based Emcyte Corporation, a leading provider of biotechnology products, will also be providing systems and supplemental kits to be used in the trial.
Furthermore, Bioheart has announced the launch of a clinical trial for the treatment of Chronic Obstructive Pulmonary Disease (COPD) using adipose-derived stem cell technology. The clinical trials will be held at the Global Stem Cells treatment center in Cozumel, Mexico, as well as in several U.S. states. A Global Stem Cells Group affiliate, Regenestem, in collaboration with CMC Hospital of Cozumel, offers cutting-edge cellular medicine treatments to patients from around the world. The study titled “An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered intravenously in Patients with Chronic Obstructive Pulmonary Disease” is led by principal investigator Armando Pineda-Velez MD, Global Stem Cells Group Medical Director. The Cozumel clinical trials will be led by Rafael Moguel, MD, an advocate and pioneer in the use of stem cell therapies that treat a wide variety of degenerative conditions. COPD is one of more than 150 chronic conditions that adult stem cells can treat by reducing or eliminating the potential risk of surgery, transplants, and toxic drugs.
Our upcoming 10K (which will be filed on-time prior to March 31st) will outline the results of our recent commercial programs, for example:
\- Our physician training programs in the field of cellular medicine continues at a fast pace.
- Partnering with Anosis Biomedical Limited to distribute Bioheart therapies to patients in the Middle East and surrounding areas. Bioheart announced that its first successful adipose derived stem cell (ADSC) implantation was performed in Azerbaijan at Baku Central Military Hospital. Azerbaijan is the largest country in the region located at the crossroads of Western Asia and Eastern Europe. - Bioheart announced exclusive license in veterinary medicine for patents for cancer-related immunotherapy products from inventor Allan Wu, M.D. - Bioheart has extended licenses of electrical stimulation patents with Airspeed for MyoStim product line. Bioheart has successfully been treating patients for a range of conditions for almost 15 years with our autologous cellular products. On other community news, I recently made my first public appearance since surgery as the moderator of Florida International University’s Entrepreneurs in Tech Panel. The Pino Global Entrepreneurship Center’s mission is to foster entrepreneurship throughout South Florida. The Center provides FIU and local communities with the knowledge and networks that enable them to reach their entrepreneurial objectives of designing, launching, and nurturing successful new ventures and assisting established innovative enterprises in moving to the next level. Our intention is to form and lead an alliance of related regenerative medicine companies in the area and work in tandem to more expeditiously bring these therapies to market.
We strongly believe that Bioheart’s efforts will prove to be invaluable towards accomplishing our mission to find a treatment for the unmet medical needs that afflict millions of individuals. As we bring our technology to market we realize 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 email with your comments or questions.
AI
