VentureBeat

Featured companies: Aryx Therapeutics, FlowCardia, Graftcath

FlowCardia raises $30M for artery roto-rooters — Sunnyvale, Calif.-based FlowCardia, a medical-device maker building catheter systems that bore holes in blood clots, raised $30 million in a third funding round. Investors included Gilde Healthcare Partners, Life Sciences Partners, Hambrecht & Quist Capital Management, New Science Ventures, Frazier Healthcare Ventures, JP Morgan Partners, Pappas Ventures, Rockport Venture Partners and Gold Hill Capital. The funding is intended to speed commercialization of the company’s “recanalization” device, which essentially busts through clots that totally block arteries.

Aryx aims to raise $86M in IPO for rejiggered drugs — Aryx Therapeutics, a Fremont, Calif., biotech company that derives ostensibly safer versions of existing drugs, filed to raise up to $85.3 million in an initial offering. The company uses a technology that reengineers these current drugs so they aren’t broken down by the same metabolic pathway in the liver, which is subject to “traffic jams” that can boost drug levels in the blood and lead to side effects.

Aryx’s first candidate is a reengineered form of cisapride, an acid-reflux (read: heartburn) drug better known by the brand name Propulsid, which was withdrawn from the U.S. market after it was linked to heartbeat irregularities. Aryx is also at work on a redone version of warfarin, a blood thinner usually administered to people at risk of blood clots. (See our recent coverage of FDA’s decision to include pharmacogenomic information on the warfarin label that might alleviate side effects here.)

GraftCath aims for $10M to develop better dialysis catheter — Eden Prairie, Minn.-based GraftCath, a medical-device company working on alternative to central venous catheters for kidney-dialysis patients, aims to raise $10 million in a fourth financing round by October, VentureWire reports (subscription required). The news service didn’t name any investors in the round.

From VentureWire:

To initiate dialysis, doctors must create an entranceway into the bloodstream. This can be done by joining an artery to a vein to create a fistula, or by using a graft to connect the artery and vein. Both methods provide adequate blood flow for dialysis, but fistulas are preferred because they use a patient’s own vessels and are less susceptible to infection and to becoming narrowed or occluded.

[When] patients aren’t eligible for fistulas or grafts… [they typically receive a] central venous catheter over the long term for their access point. These catheters put patients at a higher risk for blood-borne infection than either fistulas or grafts. These blood-borne infections, or bacteremias, are dangerous to patients and costly to hospitals. According to a study published in May in the journal Infection Control and Hospital Epidemiology, the mean cost of catheter-related bacteremia is estimated to be $23,451 per hospitalization.

GraftCath claims its device reduces the risk of bacteremia, although VentureWire’s explanation isn’t terribly clear. Supposedly the device is safer because it’s implanted under the skin, although it clearly has to exit somewhere, since otherwise there’s no way to hook up the patient to a dialysis machine, which clears the blood of toxins in people whose kidneys are failing. The company doesn’t have a Web site that might explicate things, either.

(UPDATED: See below.)

Personalized medicine — the idea that doctors will one day tailor your medical care based on your genetic profile — has been a long time coming, as I’ve previously written. As it turns out, that’s no fault of the Food and Drug Administration, which has emerged as one of the biggest fans of the concept. Yet the FDA is now pushing ahead with efforts to pair drugs with genetic tests in a way that has alarmed critics, who claim the agency is forging well ahead of the medical evidence, as the WSJ’s Anna Wilde Mathews reports today.

The current controversy involves warfarin, a one-time rat poison now commonly used as an anticoagulant designed to prevent dangerous blood clots from forming. The generic drug was prescribed more than 30 million times last year, but because it can sometimes cause patients to bleed excessively, it also frequently sends people to the emergency room — 43,000 times a year, by one estimate, making warfarin the second-most dangerous drug after insulin.

Roughly a decade ago, evidence began to emerge that genetic differences between patients might explain why some people were more likely to experience bleeding on the drug. In particular, researchers identified two genes that seemed to play a major role in modulating warfarin’s effects. Some variants of the gene CYP2C9, for instance, appeared responsible for breaking down the drug more slowly, meaning that it tended to linger in the blood, effectively mimicking the effects of a higher dose. Variations in another gene, VKORC1, affect how the body processes vitamin K — a crucial finding because warfarin’s activity depends in part on its ability to interfere with vitamin K.

The FDA concluded that patients with some of these genetic variations should probably receive lower initial doses of warfarin — which is exactly the sort of thing personalized medicine is supposed to do. Today, the WSJ reports, the FDA is scheduled to announce changes to the warfarin label that urges lower doses for patients based on their genetics, albeit with a variety of caveats.

Many doctors, however, think the FDA has moved too fast. The genetic tests, which cost between $300 and $500, are covered by Medicare but not many private insurers, and doctors fear that patients who don’t get them and end up with bleeding problems may sue. It also takes time to get results from genetic testing, meaning that doctors aren’t necessarily any better informed when starting patients on warfarin, often following a heart attack, a stroke, or another blood-clot-related problem.

Adding fuel to the fire is the fact that the link between the genetic variations and better patient outcomes hasn’t been fully established by the field’s gold standard of evidence, a prospective randomized, controlled clinical trial. So one of the fascinating aspects of this story is that it pits two of medicine’s emerging trends — personalized medicine and evidence-based medicine (see our coverage here) — directly against each other.

Has the FDA acted precipitously, or is it pushing forward where other parts of the medical establishment fear to tread? Feel free to give us your take in comments.

UPDATE: The FDA statement is now available here (hat tip: Pharmalot).