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By Omar Ford

Staff Writer

Biocardia Inc. said an independent data safety monitoring board has found there are no safety concerns for the first 10 patients treated in the phase 3 Cardiamp cell therapy trial. The San Carlos, Calif.-based company's ongoing multicenter, double-blinded, randomized, sham-controlled phase 3 trial is expected to enroll 260 patients at up to 40 centers across the U.S. and will continue as planned.

The trial is evaluating the Cardiamp cell therapy in adult patients with heart failure that develops following a heart attack. The primary efficacy endpoint is a significant improvement in six minute walk distance at 12 months' post-treatment.

Heart failure affects about 5.7 million people in U.S. over the age of 20, with an annual cost estimated to be $39 billion. It is projected to increase to $70 billion in 2030 Biocardia said. The market has provided a huge opportunity for device and pharma companies to provide innovations in the space.

"The big news is this pivotal trial is ongoing and moving forward quickly," Peter Altman, Biocardia's CEO, told BioWorld MedTech. "This is likely the first cardiac cell therapy that's going to have an actual pivotal trial held for approval."

Altman added, "This therapy is being regulated by the center for biologics evaluation and review at the FDA as a device. That's in part due to the fact that we have a companion diagnostic strategy, such that we are selecting patients with a prescreening of their bone marrow."

In addition to the diagnostic test, the three-pronged therapy includes a cell processing system consisting of a dose of 200 million of the patient's own bone marrow-derived cells taken from the hip bone and the Helix transendocardial delivery system.

"The entire procedure time takes about 60 minutes with 20 minutes for cell collection and 20 minutes for cell processing and while that's ongoing, the patient is repositioned for cardiac catherization, which takes about 20 minutes," Altman said. "It's a very straightforward procedure."

Earlier Cardiamp studies – including the phase II TAC-HFT-BMC trial – have shown a positive safety profile, with statistically significant improvements in patient quality of life and functional capacity.

The company anticipates filing an investigational device exemption supplement to add an interim efficacy readout in 4Q18 and expects topline data in 4Q19. Altman said if all goes well the data could put the therapy on track to be an approved product in 2020.

Biocardia merged with Tiger X Medical Inc. about a year ago. The Miami-based firm was formerly an orthopedics device company. Through the merger, Biocardia was able to transition from a private company to a public company.

Other developments in HF market

Late last month, Medtronic plc received FDA approval for the long awaited Heartware HVAD system as a destination therapy option for patients with advanced heart failure who are not candidates for heart transplants. (See BioWorld MedTech, Sept. 28, 2017. )

"The approval will allow Medtronic to enter the higher growth segment of the U.S. ventricular assist device market," said Joshua Jennings, an analyst with Cowen & Co.

Jennings noted the approval came roughly three months ahead of estimates.

"We view Medtronic's approval in destination therapy as a significant accomplishment given this history," Jennings said.

"And while some of HVAD's data raised regulatory questions, physician feedback for the device has always been solid.

Medtronic gained access to the HVAD system when it acquired Framingham, Mass.-based Heartware International Inc. for about $1.1 billion a little more than a year ago. (See Bioworld MedTech, June 28, 2016.)

Recently, Magenta Health Ltd. raised $15 million for its heart failure treatment solution. (See BioWorld MedTech, Oct. 2, 2017.) The company is developing a technology to alleviate congestion in heart failure patients. Among its investors is Abiomed Inc. Abiomed has developed the Impella, a device used for temporary ventricular support device in people with depressed heart function.



Published  October 3, 2017

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