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专题报告: 没有解剖刀的手术

Brendon Nafziger, DOTmed News Associate Editor | August 30, 2013
From the September 2013 issue of HealthCare Business News magazine

To treat it, HistoSonics envisions using its device to send high intensity ultrasound into the excess prostate tissue to, in effect, shave it away. To do this, the therapeutic ultrasound is placed at the perineum, between the rectum and scrotum, and the energy is focused through the skin at a target in the prostate. The cavitation then essentially liquefies the tissue, letting doctors perform noninvasive ‘surgeries’ using the ultrasound energy as a scalpel.

“It liberally homogenizes soft tissue to an a cellular slurry,” Tom Davison with HistoSonics explains. “Because it’s non-thermal, the margins are very precise — it heals rapidly, with much less inflammation compared to thermal modalities.”

The homogenized slurry would then be reabsorbed by the tissue or excreted by urination. In BPH, that means patients could basically urinate out the sludge that was their excess prostate tissue. Studies on dogs have shown the healing is rapid, Davison says, usually occurring within 30 days.

“We believe compared to what’s out there for the treatment of BPH, that this technology is game-changing,” he says. “The urologists are going to like a modality that does essentially the same operation you do with a TERP — which removes the tissue by literally resecting with electrosurgery or lasers.”

Transurethral resection of the prostate, or TERP, is a procedure in which an instrument is threaded through the urethra and then removes, often by laser, the part of the prostate that blocks urine. TERP has about an 18 percent complication rate, Davison says.

So far, the company has raised $11 million in Series A financing from several venture capital groups. Davison says this amount takes them through product development and validation and into the pilot studies — the company has just filed an investigational device exemption with the FDA to begin a clinical trial, which it hopes to launch in a month or two. HistoSonics also has approval from Health Canada to do some studies in our neighbor to the north.
“We are currently, actively engaged in putting together Series B financing,” Davison says. He says they currently have a “couple million” left and they’re hoping to raise $12 to $15 million to take them through clinical trials and into the marketplace.

Right now, HistoSonics only has nine full-time employees. “We’re pretty lean and mean,” Davison says.

“I’ve been a serial entrepreneur for 25 years, and I’ve started a lot of companies, and to be able to accomplish what we have with (nine) people and $11 million is pretty amazing.”

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