CDU

The first steps toward commercializing a product require: one, discovering and developing the product and, two, identifying the best application for that product. And this second often turns out to be the more difficult.

Consider, as a case in point, Cardiogenesis (Foothill Ranch, California).

The company can claim leadership in the use of laser technology to treat angina – via its system for creating channels in the heart to give it more oxygen, called transmyocardial revascularization (TMR).

But this technology has been crawlingly slow to develop, and the company has hit major roadblocks in winning FDA approval for the percutaneous version of the system, called percutaneous myocardial channeling (PMC).

Now Cardiogenesis may have hit on a major new offering for its lasers, with last month’s news of the first clinical procedure with its Phoenix Revascularization Delivery System that combines its laser system with the delivery of biologic materials (the name Phoenix being rather suggestive of its revitalizing possibilities).

That first procedure was carried out, the company reported, on Jan. 25 by Wan Feng, MD, chairman of the department of cardiac surgery at The People’s Hospital of Beijing University.

The Phoenix system was used to provide delivery of stem cells, percutaneously, to the heart of a woman in combination with the company’s Holmium: YAG TMR laser.

The early result, as expressed by Michael Quinn, president and CEO of Cardiogenesis with hyperbole that indicates his enthusiasm for the result: the 77-year-old patient is “tap-dancing in her room,” he told Cardiovascular Device Update.

The company has been developing the Phoenix system over the past two years, Quinn said, acknowledging some stealth in not issuing earlier reports. And he enthuses about its main benefit – the ability to improve on the impact of stem cells, or other biologics, with the use of a laser effect he describes as “thermoacoustic” – the combination of heat and acoustic vibration.

That effect, he says, multiples the production of angiogenesis “geometrically,” meaning more than arithmetically, to produce “a much larger and much faster effect on the tissue.”

The company promotes TMR as increasing the flow of oxygen to the heart via angiogenesis, and Phoenix basically improves on this, he explains.

“The key is, if the procedure is done with the angina treatment, we’re hoping to broaden our label in the U.S.,” he says. “It’s the most exciting thing we are doing.”

The discovery was a kind of “Eureka!” for the company and came “more by luck than design.”

Quinn described what the Cardiogenesis researchers found via metaphor. The channeling effect of the laser is “like a farmer plowing,” he said, with the thermoacoustic energy stimulating the heart tissues both inside and outside the channels to promote activation of the biologics being delivered.

“It creates waves that cause the tissue in the heart to resonate, opening up fissures so that the biological can sneak in. We were amazed when we saw the first application and distribution of the biological throughout the entire myocardium.” The amazement, Quinn said, was a definite “eureka!” for the company.

Key to the system, he added, was the development of a new combination handpiece enabling, in a procedure taking only about 15 minutes, the two operations: one providing the laser channeling, the other a needle with multiple holes on its sides, not just at the tip, to deliver the biological material “substantially around the channel.”

Quinn described the company’s work with the Phoenix Delivery System as top priority for the company, with ongoing international trials to support CE-marking. He predicted Phoenix commercialization outside the U.S. “fairly soon,” perhaps as early as six months out.

The next natural target is FDA approval, but Quinn declined to provide an estimated timeline for that goal.

“We are focused on verifying the surgical safety and feasibility with Dr. Wan and other targeted centers around the world as we understand more about the application stem cells and other biologics to increase and optimize the physiologic benefits of our therapy,” he said. He added that “feedback” from Feng “confirms that we are on the right track . . .”

The Phoenix system was used in combination with off-pump coronary artery bypass grafting, with implantation of autologous stem cells. The patient suffered from chest pain related to an acute infarction, with angiography confirming severe three-vessel disease. For the procedure, 5 ml of stem cells were derived from her bone marrow. Following the off-pump heart bypass through a median sternotomy, the TMR channeling and implantation of stem cells in and around the channels was performed in all ischemic regions and the infarct zone.

As it pushes forward with clinical trials of the Phoenix, Cardiogenesis continues its efforts to win approval for its PMC system, in January receiving FDA approval for a clinical trial under the investigational device exemption protocol. The trial will be double-blinded and randomized and involve up to 500 patients.

Prior to that approval, the company entered into a binding letter of agreement with the FDA to ensure that key scientific and clinical issues regarding the PMC technology and trial are clearly understood and agreed to. Quinn said that approach “was essential to first clarifying, and then agreeing with the agency on all of the key points needing to be addressed in the trial.”

He added: “This completes the migration of our technology along the continuum-of-care spectrum from surgical, to the minimally invasive and robotic platforms that are currently under FDA review, and finally to the percutaneous procedure. We are approaching 30,000 TMR procedures worldwide.”

Meanwhile, Quinn said that the Phoenix system offers for the company essentially a complementary platform to provide treatments to other areas of the body besides the heart, such as to the peripheral vasculature.

“We’re very excited about this,” he said of the Phoenix project. “We’re going to do it right. We’re going to have the data.”

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