A Medical Device Daily

Hercules Technology Growth Capital (Palo Alto, California), company providing venture debt or equity to venture capital and equity-backed technology and life science companies, reported providing $10 million in debt financing to support the sales launch of the therapeutic device company, EKOS (Bothell, Washington).

The company said the funds will be used to launch its Lysus Peripheral Infusion System and Micro-Infusion Catheter, using ultrasonic radio waves to assist therapeutic drugs in penetrating clots associated with peripheral arterial occlusions and deep vein thrombosis.

Peter Rule, CEO and chairman of EKOS, said the funds will be used to accelerate the marketing of our FDA-approved products and bring access to faster, more effective treatments ... .”

EKOS is backed by several venture capital and industry investors, including Ascension Health Ventures, EGS Private Healthcare, MedVentures Associates, Mitsui & Co. Venture, Morgan Stanley Venture Partners, NGN Capital, Oakwood Medical Investors and Protostar Equity Partners.

“Hercules is continuously looking for medical device companies which significantly improve clinical outcomes for patients and provide clear economic advantages for hospitals and physicians,” said Kathy Conte, managing director of life sciences at Hercules. “EKOS Corporation has developed a product which does both.”

Hercules’ investments are originated through its principal office in Silicon Valley, as well as offices in Boston, Boulder, Colorado, Costa Mesa, California and Chicago.

Training of physicians seen key to marketplace success

Training of interventional cardiologists in the new valve replacement procedures is seen by the companies involved as a key to their success

With a transapical intervention such as that being pursued by CoreValve (Irvine, California), the catheter enters between two ribs to directly access the heart compared to the now-conventional transfemoral technique. Significantly, a surgeon is required to assist with the intervention, a fact that has powerfully shaped the strategic approach to the market by all three competitors.

For example, upon winning the CE mark in May CoreValve trod carefully in its announcement, saying it “will not immediately market the ReValving System. Rather, the company will proceed with an expanded clinical evaluation at a small number of international centers to help ensure that interventional cardiologists are well trained.”

More simply put, none of the companies wants to repeat the experience of angioplasty’s introduction in the 1980s that drove a wedge between surgeons and cardiologists.

“The procedure is brand-new and training is extremely important,” Larry Wood, corporate vice president responsible for the valve replacement programs at Edwards Lifesciences (Irvine, California), told Medical Device Daily during last month’s EuroPCR meeting in Barcelona, Spain, “The ideal specialty for this procedure does not exist. We have surgeons who are very excited about this approach. Bringing the two specialties together is the best approach for patients.

“We believe surgeons will drive this,” he said. “The population will be huge as specialists begin to consider patients who should be treated earlier than they are today.”

Shown Michiels’ roughly drawn pie chart for the market in 2015, Wood agreed with the three segments carved out by CoreValve, but drew a larger circle, saying, “There will be a much bigger pie in eight years.”

He added, “The data tells us that for each heart valve candidate who receives one, there is one who does not, either because he is too sick or else not sick enough. Because surgery is so invasive these patients are simply not referred and the cardiologist tends to hold a patient until he becomes so sick surgery is required.”

According to Wood, the market for open-heart surgery grew greater, and not smaller, after the introduction of transcatheter angioplasty and stent placement.

“The introduction of percutaneous intervention tools, such as imaging, started improving diagnostics and this led to growth for surgeons and cardiologists,” he said.

“The good question is to ask what is going to make this a viable option?” said Wood. “A lot of focus now is on procedural issues. We are fast moving out of that stage with proofs the procedure is viable. The question now is the device we leave behind. Edwards is applying 30 years of leaving surgical valves in place with 20-year durability.”

— John Brosky, Contributing Writer

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