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March 7, 2012, 6:47 pm
Bioheart Agrees to Terms to License Electrical Stimulation Patents to Airspeed Equity
December 29, 2011, 1:56 pm
SUNRISE, Fla., July 29, 2011 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRT) announced today that they have agreed to terms to enter into a license agreement with Airspeed Equity regarding four separate Bioheart patents. The proposed license agreement will have great benefits to both companies: Airspeed will be granted exclusive rights to these patents and all products associated with the patents. Airspeed will pay Bioheart milestone payments and royalties based on sales of potential products. Mike Tomas, President and CEO, stated, "Bioheart is currently focused on our core technology of muscle stem cells for congestive heart failure patients and we are excited about the opportunity to work with Airspeed to bring other Bioheart technologies to market."
The patents include methods of electrical stimulation and biological pacing which are marketed under the MyoStim(TM) product line. Howard Leonhardt, Bioheart's Co-founder and Chief Technology Officer, stated, "The discovery that low voltage electrical stimulation of the heart can both regenerate damaged heart tissue and replace high voltage implantable defibrillators for arrhythmia fibrillation recovery may change the course of care for the more than 30 million patients suffering of heart failure worldwide."
"Bioheart's patents fit perfectly within our medical industry strategy. We are pleased Bioheart selected us to commercialize what we believe will be successful products that can improve people's lives," said Alan Remen, Managing Director, Airspeed Equity.
About Bioheart, Inc.
Bioheart is focused on completing the Phase II/III MARVEL study for chronic heart failure using MyoCell. The product candidate has been in clinical trials since May of 2001 with the goal of commercial approval with the current clinical program. There are approximately 130 more patients needed to complete the randomized, double blinded, placebo controlled MARVEL trial. In part one of the MARVEL trial, the performance of MyoCell was nearly 500% above its primary end point goal of 16 meters improvement in exercise capacity testing. MyoCell treated patients improved 91.7 meters while placebo patients declined 4 meters.
MyoCell is a muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the intended purpose of improving cardiac function and quality of life in chronic heart failure patients.
For more information on Bioheart, visit http://www.bioheartinc.com.
About Airspeed Equity, LLC
Airspeed Equity is a private investment, entrepreneurial capital, management firm and leading edge, multi-project business development enterprise that creates and supports new technology companies.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2010, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2011.
CONTACT: Bioheart, Inc.
954-835-1500 Bioheart Receives Notice of Allowance for Nine New U.S. Patent Claims for Utilizing Electrical Stimulation to Enhance Stem Cell Regeneration of Damaged Heart Muscle
December 17, 2011, 10:00 am
SUNRISE, Fla., Nov. 6, 2008 (GLOBE NEWSWIRE) -- Bioheart, Inc. (Nasdaq:BHRT) announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for nine new patent claims covering the use of electrical stimulation to enhance stem cell regeneration of damaged heart muscle.
The invention and its claims are deemed to be pioneering in that they harness the natural electro-chemical instructional program that teaches stem cells to become heart muscle and then apply this process to damaged heart muscle in patients suffering of heart failure. The stimulation not only attracts stem cells with a homing signal but also causes the release of beneficial proteins. The stimulation method may be applied with or without the injection of stem cells. The claims of the patent also cover pre-conditioning stem cells towards a cardiac phenotype by electrically stimulating them during culture before implantation into damaged heart muscle.
Bioheart built prototypes of devices that can run this electrical stimulation program and tested the proof of concept studies over the past several years leading up to this patent notice of allowance, working with Dr. Juan Chachques, Associate Professor Cardiac Surgery, Pompidou Hospital, Paris, France.
"This truly has the potential to be a landmark invention in the field of heart failure treatment," stated David Holmes, M.D., Chairman of Cardiology, Mayo Clinic, Rochester, Minnesota.
The inventors, Howard J. Leonhardt, Chairman, CEO and CTO of Bioheart, Inc. and Dr. Chachques, have previously partnered to receive other related patents for complementary devices and methods.
"We believe Bioheart's intellectual property estate is unmatched in the field of heart muscle repair," stated Howard Leonhardt.
"The best way to predict the future is to create it," stated Dr. Juan Chachques. "This invention could be regarded in the future as one of the most important developments ever in the fight to reduce the death rate from heart failure."
Bioheart, Inc. now holds the rights to more than 36 related patents with over 400 patent claims.
About Bioheart, Inc.:
Bioheart, Inc. (Nasdaq:BHRT) is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell(r), is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell(r) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit www.bioheartinc.com.
MyoCell and MyoCell SDF-1 are trademarks of Bioheart, Inc.
Forward-Looking Statements:
Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as "may", "will", "to", "plan", "expect", "believe", "anticipate", "intend", "could", "would", "estimate", or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to secure additional financing; (ii) the timely success and completion of our clinical trials; (iii) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (iv) regulatory approval of our product candidates; (v) our dependence on the success of our lead product candidate; (vi) our inability to predict the extent of our future losses or if or when we will become profitable; (vii) our ability to protect our intellectual property rights; and (viii) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2007, as amended by Amendment No. 1 on Form 10-K/A and its quarterly reports on Form 10-Q for the quarters ended March 31, 2008 and June 30, 2008.
CONTACT: Bioheart, Inc:
William Kline, Chief Financial Officer
(954) 835-1500
RedChip Companies, Inc.
Bioheart Investor Relations:
Len Hardison
(800) REDCHIP (733-2447), Ext. 118
info@redchip.com
Source: Bioheart, Inc.
Date: November 06, 2008 08:20 ET Bioheart Awarded Patent for Method to Repair Heart Tissue by Combination of Cell-Based Therapy and Electrostimulation
December 17, 2011, 9:59 am
SUNRISE, Fla., March 17 /PRNewswire-FirstCall/ -- Bioheart, Inc.
(Nasdaq: BHRT) a biotechnology company that is focused on the development
of autologous (patient-derived) cell therapies and devices for the
treatment of chronic and acute heart damage, today announced that it has
been awarded U.S. Patent #: 7341062 (J. Chachques and H. Leonhardt) for a
method to repair damaged myocardium (heart tissue) by a combination of cell
transplantation and electrostimulation. The award of this patent brings to
more than 100 the number of related patents and patents pending to which
the company holds rights.
The patent covers methods for repairing damaged heart tissue by
providing electrostimulation to patient-derived myogenic cells either in
the laboratory while the cells are expanding or after the cells are
implanted into the damaged areas of the patient's heart. One potential
application for this technology that Bioheart is exploring is to adapt a
bi-ventricular pacemaker with a separate lead that could apply the
electrostimulation to the cell-transplanted regions. Electrostimulation
induces the cells to contract in an even more synchronized basis with the
surrounding tissue and increase their ability to release growth factors and
other beneficial proteins. This patent is complimentary to Bioheart's
previously granted patent for inducing angiogenesis by electrical
stimulation, based on research conducted by Dr. Shinichi Kanno and Dr.
Yasufumi Sato(1). Another application for this technology may be to combine
it with Bioheart's MyoCell(R) therapy for the recovery of heart muscle in
cardiac patients afflicted with damaged heart tissue.
"We are pleased with the awarding of this patent to Bioheart," said
William M. Pinon, president and chief executive officer of Bioheart. "We
believe that this procedure could one day be a cost-effective solution to
improve patient outcomes and enhance the quality of life for cardiac
patients worldwide."
About the Heart Failure Market
Heart failure is associated with significant morbidity, high incidence
of complications, frequent hospitalization and rising healthcare costs. In
the United States alone, an estimated 5 million individuals have a
diagnosis of "congestive heart failure," and an additional 500,000 new
cases are diagnosed annually.
About MyoCell(R)
Bioheart's lead product candidate, MyoCell, is an innovative clinical
cell therapy designed to populate regions of scar tissue within a patient's
heart with living muscle tissue for the purpose of improving cardiac
function in chronic heart failure patients. MyoCell uses adult stem cells
that are precursors to muscle cells, or myoblasts, which are derived from
the patient's own body. When injected into scar tissue within the heart
wall, myoblasts have shown to be capable of engrafting in the damaged
tissue and differentiating into mature muscle cells. The core technology
used in MyoCell has been the subject of human clinical trials conducted
over the last seven years and animal studies conducted over the last twenty
years. Our most recent clinical trials of MyoCell include the SEISMIC
Trial, a 40-patient Phase II clinical trial in various countries in Europe
and the MYOHEART Trial, a completed 20-patient Phase I dose escalation
trial in the United States. Final results of the MYOHEART Trial were
announced in January 2008. The FDA recently cleared us to proceed with a
multicenter Phase II/III trial for MyoCell in the United States, named the
MARVEL Trial, which will enroll up to 330 patients.
About Bioheart, Inc.
Bioheart, Inc. is a biotechnology company focused on the discovery,
development and, subject to regulatory approval, commercialization of
autologous cell therapies for the treatment of chronic and acute heart
damage. Its lead product candidate, MyoCell, is an innovative clinical cell
therapy designed to populate regions of scar tissue within a patient's
heart with autologous muscle cells, or cells from the patient's body, for
the purpose of improving cardiac function in chronic heart failure
patients. The company's pipeline includes multiple product candidates for
the treatment of heart damage, including Bioheart Acute Cell Therapy, an
autologous, adipose cell treatment for acute heart damage, and MyoCell II
with SDF-1(TM), a therapy utilizing autologous cells genetically modified
to express additional growth factors. The company holds rights to more than
100 related patents and patents pending.
(1) Circulation. 1999; 99:2682-2687
MyoCell and MyoCell II with SDF-1 are registered trademarks of
Bioheart, Inc.
Forward-Looking Statements:
Except for historical matters contained herein, statements made in this
press release are forward-looking and are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Without
limiting the generality of the foregoing, words such as "may," "will,"
"to," "plan," "expect," "believe," "anticipate," "intend," "could,"
"would," "estimate," or "continue" or the negative other variations thereof
or comparable terminology are intended to identify forward-looking
statements.
Investors and others are cautioned that a variety of factors, including
certain risks, may affect our business and cause actual results to differ
materially from those set forth in the forward-looking statements. These
risk factors include, without limitation, (i) our ability to secure
additional financing; (ii) the timely success and completion of our
clinical trials; (iii) the occurrence of any unacceptable side effects
during or after preclinical and clinical testing of our product candidates;
(iv) regulatory approval of our product candidates; (v) our dependence on
the success of our lead product candidate; (vi) our inability to predict
the extent of our future losses or if or when we will become profitable;
(vii) our ability to protect our intellectual property rights; (viii) our
inability to predict the extent of our future losses or if or when we will
become profitable; and (ix) intense competition . The company is also
subject to the risks and uncertainties described in its filings with the
Securities and Exchange Commission, including Post-Effective Amendment No.
5 to its Registration Statement on Form S-1 (Registration No. 333-140672)
filed on February 13, 2008.
Contact: William Kline Lytham Partners, LLC
Chief Financial Officer Joe Diaz
Nicholas Burke Joe Dorame
Vice President-Financial Operations Robert Blum
(954) 835-1500 (602) 889-9700
SOURCE Bioheart, Inc.
