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June 2005 - Volume 1 - Issue 11
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Bioheart Leads Development of Cell-based Treatment for Cardiovascular Diseases

Bioheart, Inc. is on the fast track to introducing breakthrough treatment for cardiovascular diseases in the United States and elsewhere around the world.

"We’re very confident that we will remain on schedule," Howard Leonhardt, chairman of the board and chief executive officer of the Sunrise-based biotechnology firm he founded in June of 1999, said. "We’re looking for the release of our product in Europe next year and in the United States in 2007."

That focus "product" is MyoCell™, which, Leonhardt explained, harvests specially selected cells from a patient’s own thigh muscle and utilizes that raw material to produce uniquely composed implants that are placed into the heart either percutaneously (via cardiac catheter) or by surgery. MyoCell™ therapy is designed to regenerate infarcted, scarred or non-functioning myocardial tissue into functioning muscle that contributes to increased global cardiac output and throttles the progression of CHF.

"What we’re offering is a more natural treatment of cardiovascular diseases; that is, living cells as opposed to chemicals (drugs) and artificial replacements such as metals and plastic," Leonhardt said. "It is an extension, if you will, of the way the heart repairs or rebuilds itself in a natural way. We feel it will have the blessing of patients and physicians alike, as well as the FDA (Food and Drug Administration)."

Bioheart also believes MyoCell™ and its other products hold the potential to "revolutionize" the treatment of cardiovascular diseases and become a new standard of care by offering treatments that enhance cardiac function, are more cost-effective, and are lower-risk than current alternatives such as heart transplantation, biventricular pacing, ventricular assist devices, and some drug therapies.

To emphasize that point, Leonhardt, who has 20 years of experience in biotechnology and related fields, points out that Bioheart’s scientific and research team has over 20 patents and patents pending related to the cellular treatment of a failing heart.

Leonhardt said MyoCell™, an autologous cell-based product, is currently in clinical trials in the United States and Europe. Other lead product candidates are:

  • MyoCath/SR 200, a percutaneous needle injection catheter for delivering cell therapy or other compounds to the myocardial tissue, currently in clinical trials in Europe.
  • MyoCell VT, a cell-based product for the treatment of ventricular tachycardia, currently in pre-clinical development.
  • BioPace, a cell-based product used for the treatment of sinoatrial nodal dysfunction disease, currently in pre-clinical development.
In March Bioheart moved part of its operations into 6,015-square-foot building at Sawgrass International Corporate Park in Sunrise. The facility formed housed World Medical Manufacturing Corp., a subsidiary of Medtronic, Inc. and a company of which Leonhardt served as president before starting Bioheart.

"We were very familiar with that building," Leonhardt said. "It was ideal for what we wanted to do in terms of separating our executive offices and our cell processing and cell research operations. When I was there before (with World Medical), we completely rebuilt the infrastructure and installed air filtration equipment that is ideal for our cell processing work we’re now doing at Bioheart."

That initial work cost $800,000, and Bioheart is investing another $900,000 to uprade the air filtration system. The firm also has raised $43-million in paid in capital into the state, $33-million of which was cash and $10-million in services provided in exchange for shares in the company, which Leonhardt says, "is the same as cash." In addition, Bioheart has term sheets on the table to bring in another $12-million in capital by June.

"Almost half of the $43-million in capital has been spent on developing our MyoCell composition and cell processing methods," Leonhardt said.

Local noted shareholders include Dr. William P. Murphy, founder of Cordis Corporation; Elliott Hahn, former CEO of AnDrx Pharmaceuticals; Pro Football Hall of Fame quarterback Dan Marino, and Jorge Descepedes and Carlos Descepdedes, founders of Pharmed Group.

Bioheart also is partnering with universities and colleges throughout Florida to ensure that more people will be trained and educated to meet the ever-growing needs of biotechnology firms in the state. In addition, his company also is involved with four renowned cardiology centers that are currently conducting the company’s clinical trials – the Thorax Centre in The Netherlands, ClinicaColumbus in Italy, Universitat Rostock in Germany, and Mount Sinai Medical Center in New York.


Taking part in traditional ribbon-cutting ceremonies at the grand opening of Bioheart’s new facilities in Sunrise are (left to right) William P. Murphy, M.D., Director; Joseph Scuotto, Vice Deputy, City of Sunrise; Howard Leonardt, Bioheart Chairman and CEO: Ben Graber, Vice Mayor, Broward County, and Sara Misselhorn, representative from the office of Gov. Jeb Bush. (photos by Dave Dacoteau / Downtown Photo)

In addition, Bioheart apparently has the ear and support of Florida Gov. Jeb Bush in its efforts to become "the cell" company by providing effective, non-elective therapies to interventional cardiologists to treat patients that have suffered from MI or CHF.

"This (biotechnology) is a very competitive business, especially between Florida and California," Leonhardt said. "We feel Florida has much more to offer, a friendlier environment to draw people who want to work in the business. Our tax structure is better for employers. The governor has been a great advocate of what we’re doing. We feel we’re far ahead of what they’re doing there (California), and we are committed to keeping it that way."

Leonhardt also is the founder of World Biotech, a private investment fund specializing in Biotechnology companies. He has received an honorary Doctorate of Biomedical Engineering degree from the University of Northern California. He currently serves as consulting professor and board advisor at Florida International University’s Biomedical Engineering Institute.

Leonhardt and his wife Brenda sponsor the Business Plan Competitions and Venture Academies, both at Florida International University and the University of Florida (see www.ufventure.com) and the Morays Young Entrepreneurs Forum in conjunction with the Miami Morays arena football team, of which Leonhardt is a co-owner.

Bioheart has hired graduates from the University of Miami, University of South Florida, University of Florida, Broward Community College and Florida International University. Most recently, the firm hired two biologists and a Quality Assurance specialist, bringing its work force to 20 full time employees and six part-time employees. The company also employs some 20 consultants and also has hired a number of its former employees on a contract basis at Bolton Medical in Sunrise to build Bioheart’s catheters.

Bioheart, a privately held company which has generated $33-million in cash investments – mostly from medical device makers and venture capitalists – may not have come into being had Leonhardt, 43, followed through on his initial plans after selling World Medical Manufacturing Corp.

"I was giving serious thought to retiring," he said. "But I really couldn’t see myself just going to the golf course or sitting by the ocean every day. I felt I was obligated to continue doing something that would benefit others with my God-given abilities and the education and experience I had. I was fortunate to have the (financial) resources to start Bioheart and even luckier to find people who share the same goals and ideals I have to come to work for us.

"We are blessed with compassionate people who have a passion for what our company is doing," Leonhardt said. "We want to make a difference. That’s what drives us every day."

For more information on Bioheart, Howard Leonhardt can be reached at (954) 835-1500 or visit www.bioheartinc.com.
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