Bioject (OTC:BJCT) said it’s unsure of its ability to stay afloat after the FDA instituted new rules last year governing jet injection of vaccines, which accounts for about 70% of Bioject’s business, according to a regulatory filing.
Carticept Medical closed a $10 million financing led by existing investors Domain Associates, New Enterprise Associates and SonoSite Inc.
The Alpharetta, Ga.-based company said it will use the proceeds to fund the commercial launch of its Navigator computer-controlled drug delivery system. The device uses ultrasound guidance to deliver medications for joint pain.
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Companies combining valuable devices with known drugs may be able to land a high-value exit before ever hitting the market, MIT researcher Michael Cima told a group of medical device industry leaders today.
Speaking at the Cooley Medical Device Growth conference in Boston, Cima urged med-tech companies and investors to consider drug-device combinations, acknowledging a higher up-front risk with the potential for an earlier and larger reward.
Delcath Systems Inc.’s (NSDQ:DCTH) ChemoSat organ-targeting chemotherapy system will get a pre-new drug application meeting with the FDA mid-January 2012, the company announced this week.
The ChemoSat device uses a system of tubes to localize the delivery of toxic chemotherapy agents by isolating the targeted organ — in this case, the liver — from the rest of the body’s bloodstream.
MASSDEVICE ON CALL — The top ten med-tech innovations of 2012, selected by Cleveland Clinic and announced this week spanned the range of health care from detection to treatment to data management.
In the top spot was a system of renal denervation for treatment of high blood pressure. The procedure uses a catheter probe threaded into the renal artery near the kidneys to delivery low-power radio-frequency energy and disrupt nerves, lowering blood pressure.
Delcath Systems Inc.’s (NSDQ:DCTH) Chemosat organ-targeting chemotherapy system extended the lives of terminal eye cancer patients by several months without disease progression, researchers said.
Melanoma of the eye often spreads to the liver, generally killing a patient in 1 to 2 months, according to a press release. Patients who received targeted treatment to saturate the liver lived an average of 8.1 months, compared to 1.6 months for patients receiving the best alternative care.