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Tuesday, 08/10/2004 4:28:43 PM

Tuesday, August 10, 2004 4:28:43 PM

Post# of 27534
BIPH:

Here's a study from John Hopkins (sponsored by Medtronic, St. Jude, and Guidant) that might be resposible for the lower PPS today. The big boys fight back with paid research, but notice they aren't changing their reccomendations to avoid MRI scanning with their products implanted based on this report:
http://scienceblog.com/community/article3477(dot)html

This article contains some comments from Biophan:
democratandchronicle.com/biznews/081022569I2_business.shtml

Biophan gets key patent

Process allows probe devices to be seen during MRI

By Michael Wentzel
Staff Writer

(August 10, 2004) — Biophan Technologies Inc. of Henrietta has added another patent-protected technology to its portfolio that could boost the company's efforts in the medical-device business.
Nanoset, a private company based in East Rochester and a Biophan research partner, has received a patent on a particle-coating technology. Devices, such as biopsy probes and guide wires, currently can not be detected clearly in the body by magnetic resonance imaging. This technology makes the devices visible in an MRI.

Biophan has exclusive worldwide rights to medical uses of the technology, Michael Weiner, Biophan's chief executive officer, said Monday.

The technology will help advance the development of surgery and other procedures guided by medical resonance imaging or MRI, he said.

Shares of Biophan closed Monday at 69 cents, up 4 cents. In the last year, the stock has reached a high of $1.65 and a low of 10 cents.

Weiner also disputed the impact of a new Johns Hopkins University School of Medicine study that found that devices such as pacemakers and defibrillators can be safe for use in magnetic resonance imaging or MRI.

For more than two million Americans who have an implanted device, such as a pacemaker, magnetic resonance imaging is considered unsafe and is rarely used, even though an MRI is the best tool for diagnosing many cancers and some heart conditions.

Biophan is developing technology to make the devices and surgical and diagnostic tools safe and compatible with MRI equipment by reducing heat and filtering distortion.

The Hopkins study, published last week in the journal Circulation, found that an MRI did not cause the metal components in selected devices to heat up enough to damage tissues. The researchers, who conducted tests in animals and in the lab, also said an MRI did not dislodge the device or damage it.

The Food and Drug Administration is well aware of the risks of an MRI for a patient with an implanted device, Weiner said.

“The Hopkins study is important but not exactly accurate,” Weiner said. “The FDA won't approve the use of MRIs until they are made safe and not the way they are made today.”

Dr. Emanuel Kanal, professor of radiology at the University of Pittsburgh Medical Center and chairman of the American College of Radiology's magnetic resonance safety committee, said there is no guaranteed way to make an MRI safe for a patient with an implant.

“A tremendous amount needs to be done before this can be considered safe,” Kanal said. “The Hopkins study is excellent research but it has been blown out of proportion.”

Kanal said Biophan's technology has “tremendous promise” but might not be the method chosen by the medical device industry.

Weiner said the Hopkins study erred in examining only newly-implanted devices. Tissue grows around some pacemaker components after implant. An MRI can heat up the components, causing tissue damage and scarring, according to Biophan studies.

With the addition of the Nanoset patented technology, Biophan can provide a way to see an implanted device or tool and prevent it from heating, Weiner said.


MWENTZEL@DemocratandChronicle.com


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