US Stem Cell Inc (USRM)

[InvestorStemCell]

MIKE TOMAS- CEO of BIOHEART BLOG


Bioheart, A Year In Review 0 By iCELL News on November 23, 2014 · Sector


Dear Bioheart Shareholders and Friends, Bioheart has achieved major milestones in 2014 and I feel strongly we have turned the corner in many key areas. Our achievements have opened the doors for critical partnerships necessary for future clinical trials. BIOHEART’S IP Our intellectual property received a strong boost in Q3 when we released the 12-Month Preliminary Data from our Phase I ANGEL Trial. I am very enthusiastic about the favorable safety and efficacy data that has been reported as of the 12-month end point. The trial showed incredible improvements in multiple endpoints for patients—and these improvements included exercise capacity, quality of life and ejection fraction. The 12-month data reaffirms and further builds upon previous animal studies that show how congestive heart failure patients can benefit from stem cell therapy. We continue to be inspired by the potential to provide patients safe treatment that does not require complex and invasive surgery. We have ongoing IRB studies enrolling patients in order to gather data to substantiate the safety and efficacy of this treatment for multiple conditions. Bioheart is currently drafting an outline for an upcoming US FDA trial and I anticipate the Company will initiate the Phase I/II ANGEL trial with the US FDA in 2015. It must be emphasized that although this study is very promising, a larger multi-site study will still be needed.

FINANCIAL MILESTONES

On dollars and cents, Bioheart has achieved a number of significant financial milestones in 2014.
Most importantly, we have increased revenue through international Myocath sales, proprietary stem cell culturing, laboratory kits, as well as physician training throughout the world. Below is a brief summary of financial spotlights: · – our YTD Revenue increased from $56,000 to $1.6m, 2013 vs. 2014. · – 3Q Revenue up from $32,000 to $580,000, 2013 vs. 2014. · – Current liabilities were reduced 23% from $13.4m to $10.3m YTD. This was accomplished by debt to equity conversion at $0.04 as well as debt limitations under Florida law. · – Working capital deficit improved by 24% from $13.4m to $10m YTD · – YTD net actual loss down 48% from $2.4m to $1.2m year-over-year. · – Launched joint ventures in South Africa, Australia, Honduras, Azerbaijan and Columbia. · – Cash used in operating activities down 52%: $747,000 in YTD 2014 as compared to $1.6m in YTD 2013. · – $3 million Equity Enhancement Program (“EEP”) with a Magna affiliate fund, Magna Equities II, LLC.

Please view the most recent 10Q here. http://www.bioheartinc.com/Investors/SECFilings

ACCOMPLISHMENTS

Bioheart has succeeded in realizing a number of strategic accomplishments in Q3 of 2014 that have positioned the Company for continued success in the New Year. Through joint ventures and strategic alliances, we continue to bring Bioheart’s cell therapies to other countries, offering patients suffering from degenerative diseases more options and gathering valuable data to further advance the field. Joint Ventures & Revolutionary Treatments Our joint venture with Magnum Cell Therapies, a state-of-the-art facility in Honduras, offers our cutting edge therapies to the Honduran community. During the grand opening of Magnum Cell Therapies, we completed the world’s first combination stem cell treatment on a cardiac patient with congestive heart failure. The patient was treated with a combination of AdipoCell™ (adipose derived stem cells) and MyoCell® (muscle derived stem cells). AdipoCell™ may help to promote angiogenesis or new blood vessel formation in ischemic tissue while MyoCell® may help to promote myogenesis or new muscle formation. The cells were delivered directly into the damaged areas of the heart using the MyoCath® Catheter. Our scientists believe that this new cell combination method is the optimal treatment option available to patients suffering from heart failure. Since its inception, Bioheart has strived to break new ground in regenerative medicine and this momentous achievement is a testament to that goal. This accomplishment marks another milestone for Bioheart as we continue to develop the most advanced cell therapies that will provide patients the best possible chance for clinical improvement. Clear around the world in South Africa, the Company launched its joint venture with Dr. Walter Bell and has begun to offer Bioheart’s cell therapies, as well as cell culture expansion and cryopreservation services to local South African patients. The new facility, named South African Cell Institute, treated a total of 12 patients during its grand opening with Bioheart’s autologous cell therapies. This joint venture will aid in establishing a principal connection with the South African Government and institutionalizing Bioheart’s protocols as the standard of care for patients in South Africa. As a result of Bioheart’s partnership with Anosis Biomedical Limited, the first successful intracoronary implantation of autologous adipose-derived stem cell (ADSC) in Azerbaijan was performed. Emrah Anar MD (Chief of Cardiology and Cardiovascular Surgery) in Baku (Azerbaijan) Cardiac Center of Central Military Hospital successfully performed the treatment on a 70 year-old male patient suffering from ischemic cardiomyopathy. Clinical Trials Bioheart has launched two clinical trials in India including the first ever combination stem cell trial in the world. The first trial will utilize AdipoCell™ or adipose derived stem cells and the second trial will involve the combination of AdipoCell™ and MyoCell® or muscle derived stem cells for congestive heart failure patients. This study will complement the data completed in the ANGEL trial on patients with congestive heart failure (CHF). Thus far, the first cardiac patient has been treated in India with AdipoCell™ at the Yatharth Hospital in Noida. The trials are fully funded by Bioheart and Revita Lifesciences and will provide insights for future treatments. Through these trials we will gather important safety and efficacy data to ensure we fully understand the expected outcomes with these therapies. Bioheart’s study on the use of adipose derived stem cells or AdipoCell™ in patients with degenerative disc disease (DDD) has expanded to a second clinical trial site to enroll up to 100 patients and incorporate a randomized control arm into this study. This study will determine the safety and efficacy of AdipoCell™ in patients with DDD and has been reviewed and approved by the Institutional Review Board (IRB) of the International Cellular Medicine Society (ICMS). Other News Miami Dade College’s new Idea Center, which serves as a hub for their entrepreneurship students, has honored me with the opportunity to be a part of the board of advisors who are dedicated to developing the entrepreneurial program. I look forward to helping grow the new venture incubator called CREATE, which helps nurture and accelerate the entrepreneurial ideas and ventures of the students. Miami is currently undergoing a huge transformation with a keen focus on biotech, tech, and entrepreneurship. As the CEO of Bioheart, I am excited that our company is right in the middle of it all. This November Bioheart’s Chief Scientific Officer, Kristin Comella, attended three conferences, two of which she presented about the clinical applications of adipose derived stem cells (ADSCs): the 17th Annual Pain Symposium in Coral Springs, FL, the American Academy of Physical Medicine and Rehabilitation 2014 annual assembly in San Diego, California, and the 17th Clinical Applications for Age Management Medicine (AAMG) in Las Vegas, Nevada.

Thank you to our shareholders and friends for your continued support in Bioheart as we expand processes and business opportunities. We remain steadfast in bringing our human and animal stem cell products to market and strongly believe in the value of establishing synergistic partnerships to help us achieve this mission.


Thank you again for your continued support and as always please reach out to me via email with your comments or questions. Warm Regards, Mike Tomás and the Bioheart Team - See more at: http://investorstemcell.com/sector/10249/#sthash.IVgLjAqs.dpuf