The heart is a miraculous organ, perhaps even able – some recent research would suggest – to regenerate itself. Howard Leonhardt, CEO and chairman of Bioheart (Weston, Florida), isn't so sure about that, though. Grudgingly, he grants that some regeneration of some muscle cells is possible, but says he doesn't believe it is enough to bring a severely damaged heart back to full operation.

"We're not even sure there's limited regeneration of the heart," Leonhardt says. But granting the hypothetical that there may be some "multiplication" of new heart muscle cells, this is "never enough to repair a large damaged area" of the heart. "You need to supplement any natural regeneration," he told Cardiovascular Device Update.

"Supplement" is the key word here, highlighting Bioheart's Myocell product approach, a strategy for injecting autologous cells into a damaged heart to support its regeneration. The term might also serve to describe the infusion of investment capital made by Guidant (Indianapolis, Indiana), announced last month. The total of that new capital is not being disclosed by the parties, Leonhardt said, but it is Bioheart's largest fundraising to date, according to a company statement. Coming as it does from one of the largest players in the cardiovascular sector, the investment clearly heartens Leonhardt's belief in what the company is up to. Specifically, it signals, he says, "the recognition by traditional medical technology companies of the importance of biologics in the treatment of congestive heart failure and heart attack patients."

While the new investment comes with no specific obligation on Bioheart's part, Leonhardt says that the company has launched informal talks with Guidant, creating what he calls a sort of "task force" to explore a combination of Bioheart's MyoCell technology with Guidant's biventricular pacing technology and implantable cardioverter systems. The result could be a kind of hybrid device/biologics treatment.

That approach, Leonhardt said, "is of great interest to both parties. At the very least, we want to determine that it's not contraindicative to have their biventricular pacers in our patients."

Used alone, Bioheart's treatment strategy is to harvest muscle cells from the patient's own thigh, treat these cells with a proprietary process and then reinsert these myoblast cells, via catheter, into the patient's ventricle. The cells are delivered by means of a 7 Fr catheter through a femoral artery and into the ventricle, the catheter working, Leonhardt says, "like a finger – with controlled movements up and down into the damaged region of the heart."

This endoventricular approach is not just less invasive but "monumentally different than surgery," Leonhardt says, and allows the patient to return to normal activity in short order.

While dead heart muscles don't regenerate, Leonhardt says that they can serve the all-important function of providing a scaffold for the new cells to grow and return a heart to strong pumping activity. Proof of this concept has been demonstrated in the company's preclinical trials in a variety of animals, with MyoCells serving to rebuild hearts that are "barely pumping," he says. This in turn provides the foundation for the company's human trials recently launched in Europe and expected to be initiated in the U.S. soon, perhaps as early as next month.

If successful, the ability of MyoCell technology to rebuild heart tissue and muscle is "really a heart transplant, in a sense, without taking a heart from another human being," Leonhardt says, and therefore avoids the problems of rejection. Critical here, he adds, is selecting from the patient's thigh "the very right type of cell" and Bioheart's ability "to identify and separate out those cells at the right stage of development."

The treatment appears to offer broad applications, from simple angina to total heart failure, with Leonhardt estimating a population of about 12 million in the U.S. who might be helped by the procedure. And further out he sees the possibility of combining standard bypass procedures with MyoCell therapy, as well as the newly opened potential for using MyoCells in tandem with the implantable pacing devices from Guidant and others.

Bioheart was launched in 1999 by Leonhardt and partner Robert Lashinski, who helped form Arterial Vascular Engineering (now Medtronic AVE, Santa Rosa, California). In addition to the new Guidant funding, the company recently completed a $14 million investment and has sufficient capital "through the end of this year," Leonhardt says. "Beyond that it's difficult to predict" the company's needs, he adds, noting a "number of variables" that will impact those needs further out. One of those, he says, is reimbursement in Europe, where the company is currently negotiating coverage of its trials. A second variable is the potential for combining MyoCell therapy with open surgical procedures, a path Leonhardt says the company has not yet fully committed to.

While acknowledging these variables, Leonhardt also acknowledges his significant excitement. "We really, honestly feel that this is the most important development in the history of fighting heart disease to date, whether you're talking heart transplants, angioplasty, stents or radiation therapy. We think this is finally a punch in the gut to this monster that's really going to change the statistics."

The job ahead, he says "is convincing everyone else, especially the regulatory authorities. We're trying to take the right steps and move very carefully."

Thoratec sets restructuring plans

Thoratec (Pleasanton, California) said that it will consolidate all of its ventricular assist device (VAD) manufacturing at its manufacturing and headquarters facility in Pleasanton and that these moves, once completed, will save it an estimated $2 million annually. With the consolidation, the company said it will reduce its manufacturing and related work force at its Woburn and Chelmsford, Massachusetts, facilities over the next 18 months. Those facilities were acquired as a result of its merger with Thermo Cardiosystems in February.

Additionally, Thoratec said it will increase staffing at its California facility to support manufacture of the HeartMate family of products. The HeartMate devices currently are manufactured at the Massachusetts facilities, employing about 175 people. D. Keith Grossman, president and CEO of Thoratec, said that to reduce disruption of operations and to obtain FDA certification of the new facilities in Pleasanton, the consolidations process will not be completed "until the latter part of 2002 – consequently, we believe that most of the affected positions will remain at the Massachusetts facility until the end of the transition process." Grossman said that the company "remains committed to maintaining a long-term and significant non-manufacturing presence" at its Massachusetts facility, "including research and development, clinical and regulatory affairs, technical service, marketing, and others."

QMed expands CAD management

QMed (Laurence Harbor, New Jersey) said it plans to expand its cardiovascular disease management business by partnering with the Regence Group (Portland, Oregon). The company will implement its coronary artery disease (CAD) management services and its stroke program, initially covering 300,000 members of Regence BlueCross BlueShield of Utah and Regence BlueShield of Idaho.

Michael Cox, QMed president and CEO, said, "Their members will benefit not only from our information technology, which assists physicians in managing their patients' cardiovascular disease, but will benefit also from the support we offer in self-managing their care." Cox said QMed's program "improves the collection, organization and flow of actionable clinical information, yielding better health care and economic savings."

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