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Tuesday, Jul 23, 2024

Medical-Device Firm Gains Clearance From FDA

CryoCor Inc., a small medical-device firm in San Diego, said on Oct. 25 that it won pre-marketing clearance from the Food and Drug Administration to market a surgical cooling device for treating irregular heartbeat to surgeons.

But CryoCor isn’t quite ready to launch the device, said Cheryl Monblatt Allen, a company spokeswoman.

“We don’t know if we are going to sell this (product) ourselves. Right now we are talking to other medical-device companies,” Monblatt Allen said. Creating a sales force is expensive.

CryoCor’s Breva Surgical Probe is intended to be used by cardiothoracic surgeons to treat arrhythmias, or irregular heartbeat.

The device works through cryoablation, the use of extreme cold to destroy electrically abnormal heart tissue.

Cooling techniques are being widely adopted by surgeons either in conjunction with open-heart surgery or as a stand-alone minimally invasive procedure, CryoCor said.

Partnering with a big cardiovascular medical-device company would enable CryoCor to piggyback its device on the shoulders of an existing sales fleet with the know-how to get new products in front of doctors.

Monblatt Allen couldn’t give names of companies CryoCor is talking to, but instead offered a list of potential partners: Medtronic of Minneapolis; Johnson & Johnson of New Brunswick, N.J.; Boston Scientific of Boston; Guidant of Indianapolis; St. Jude Medical of St. Paul, Minn.; and CR Bard of Murray Hill, N.J.

CryoCor was spun off from CryoGen in the fall of 2000 with $7 million in raised financing from MPM Capital, a major venture capital group in Boston.

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German Technology Back In German Hands:

San Diego-based Laser Diagnostic Technologies, whose German-born founder Andreas Dreher led the development of a machine to detect glaucoma, was recently bought by Carl Zeiss Meditec AG, a large German ophthalmology company.

Carl Zeiss Meditec said in an Oct. 21 statement that LDT’s glaucoma detector has generated $20 million in worldwide sales.

Several phone calls requesting comment on the fate of the local LDT work force were not returned.

The deal is expected to close in 30 to 45 days, pending shareholder approval, Carl Zeiss Meditec wrote.

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Nanogen Launches Second-Generation Device:

San Diego-based nanochip-maker Nanogen Inc. recently introduced a second-generation workstation to help researchers find gene mutations that can lead to disease.

Nanogen showcased its NanoChip 400 instrument at the American Society of Human Genetics annual event in Toronto on Oct. 27.

Nanogen claims the machine is ideal for mid-to-high-volume laboratories where workflow is critical.

The machine is easy to use and cost-effective compared with research-grade thousand-gene chip testing, Nanogen said on Oct. 27.

The instrument, which is being made by Nanogen’s partner, Hitachi Instruments Group, under FDA good manufacturing practices guidelines, will be marketed in 2005.

Contact Marion Webb at mwebb@sdbj.com or call her at (858) 277-6359, Ext. 3108.


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