Key Developments: Bioheart Inc (BHRT.PK)

BHRT.PK on OTC Markets Group

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Latest Key Developments (Source: Significant Developments)

Bioheart Inc announces clinical trials in India
Monday, 7 Jul 2014 08:00am EDT 

Bioheart Inc:Begun two clinical trials in India including the first ever combination stem cell trial in the world.Says first cardiac patient has successfully been enrolled and treated in India using AdipoCell or adipose derived stem cells.Says second trial will involve the combination of AdipoCell and MyoCell or muscle derived stem cells for congestive heart failure patients.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.  Full Article

Bioheart Inc announces joint venture in South Africa
Tuesday, 24 Jun 2014 08:00am EDT 

Bioheart Inc:Enters into joint venture with Walter Bell of South Africa.Walter Bell has been providing Bioheart therapies to patients in South Africa suffering from degenerative diseases since the end of 2013.Under this new agreement, the facilities in South Africa will be expanded to provide cell culture expansion and cryopreservation to local patients.Bioheart can multiply and preserve an individual's cells in sub-zero temperatures for future treatments as required.  Full Article

Bioheart Inc announces update on phase I Adipose Stem Cell Trial
Monday, 5 May 2014 08:00am EDT 

Bioheart Inc:Announces an update on the phase I safety trial using adipose derived cells.Says in April, 2010, Bioheart initiated a study using adipose derived stem cells (AdipoCell) in congestive heart failure patients.In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, five congestive heart failure patients were successfully treated in the initial pilot trial at Hospital Angeles Tijuana.Patients underwent a mini-lipoaspiration procedure where 60ccs of fat were removed.This fat was processed to obtain the stromal vascular fraction (SVF) which contains mesenchymal stem cells, progenitor/endothelial cells, pericytes, hematopoetic stem cells and more.Patients were recently contacted to assess quality of life.Patients have reported that they are in good spirits and doing well.Most compelling data from this trial is the strong safety profile.All adverse events were adjudicated by an independent data safety monitoring board and deemed not related to the therapy.  Full Article

Bioheart Inc announces joint venture with Magnum Cell Therapies
Monday, 17 Mar 2014 08:15am EDT 

Bioheart Inc:Has entered into a joint venture with Magnum Cell Therapies.Magnum Cell Therapies' mission is to provide the latest regenerative medicine therapies to patients suffering from degenerative diseases.  Full Article

Bioheart Inc announces positive six month data from Angel Phase I Trial
Tuesday, 4 Mar 2014 08:00am EST 

Bioheart Inc:Released 6 month data from its phase I ANGEL Trial. Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI).At the 6 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of about 68 meters as compared to an average improvement of 47 meters at 3 months.Eighty percent of the patients showed an improvement in their exercise capacity from 3 months to 6 months post stem cell injection.Another end point in the study is ejection fraction (EF) by echocardiogram. At the 3 month time point, 100 pct of the patients demonstrated either improvement or stayed the same.After 3 months, patients showed an average absolute improvement of 3 percentage points in ejection fraction.The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p = 0.01).  Full Article

Bioheart Inc Announces Contract With African-Middle East Medical (AFRIMID) To Begin Distributing Stem Cell Products in Uganda
Wednesday, 16 Oct 2013 08:00am EDT 

Bioheart Inc announced it has signed a contract with African-Middle East Medical (AFRIMID) to implement Bioheart therapies for the more than 36 million patients in Uganda. Bioheart will begin distributing MyoCell (muscle derived stem cells) and AdipoCell (adipose derived stem cells) for a variety of indications in Uganda. MyoCell is currently under investigation in an FDA Phase II/III US trial for congestive heart failure. AdipoCell is currently utilized at Bioheart Centers of Excellence throughout the world for indications including arthritis, limb ischemia, diabetes, heart disease, and more.  Full Article

Bioheart Inc Announces Positive Preliminary Data From Phase I ANGEL Trial
Thursday, 26 Sep 2013 01:21pm EDT 

Bioheart Inc announced preliminary data from its phase I ANGEL Trial. Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI). This phase I study will provide necessary safety and preliminary efficacy of adipose derived stem cells (AdipoCell) in patients with congestive heart failure. Endpoints include safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months. At the 3 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of 47 meters. In addition, 60% or a majority of the patients are walking greater than 65 meters further 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.  Full Article

Bioheart Inc Extends Licenses Of Electrical Stimulation Patents With Airspeed
Wednesday, 17 Oct 2012 07:12am EDT 

Bioheart Inc announced that they have agreed to extend the license agreement with Airspeed for four separate Bioheart patents. The patents include methods of electrical stimulation and biological pacing, which are marketed under the MyoStim product line. Airspeed holds exclusive rights to these patents and all products associated with the patents and pays Bioheart milestone payments and royalties based on future sales of products.  Full Article

Bioheart Inc Launches $20 Million Private Placement Round With Proceeds To Fund Bioheart Trials
Monday, 15 Oct 2012 08:00am EDT 

Bioheart Inc announced that it has launched a series a private placement financing round and intends to raise a maximum capital of $20 million in exchange for 30% of the Company. Bioheart had previously announced the formation of NorthStar Biotech in August of 2012, a consortium formed by major shareholders and insiders to purchase and protect Bioheart's senior debt that was collateralized with its intellectual property and technology. The primary use of the proceeds raised by the private placement is to fund Bioheart efforts including the Phase II/III MARVEL trial with muscle stem cells, the Phase I REGEN trial with gene modified muscle stem cells and the ANGEL trial with adipose derived stem cells.  Full Article

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