Advanced Cell Technology Inc. (OTC:ACTC) successfully dosed the first patients in clinical trials of stem cell implantation for blinding eye diseases, making it only the second company in the U.S. to win FDA permission to study a therapy derived from embryonic stem cells.
ACTC’s two trials involve implantation of retinal pigment epithelial cells derived from embryonic stem cells into patients with Stargardt’s macular dystrophy and dry age-related macular degeneration.
The first patient in each trial successfully underwent an outpatient surgery and both are recovering uneventfully, according to the press release.
"This first treatment milestone is welcomed by scientists, stem cell advocates and patients hoping for cures," Gary Rabin, interim chairman & CEO of ACTC, said in prepared remarks. "The two trials could not have started any smoother, and we are very pleased to announce that the procedures went well."
Dry AMD, the most common form of macular degeneration, Stargardt’s and other forms of atrophy-related macular degeneration are usually untreatable, company officials reported, but the trials mark a step forward for embryonic stem cell research as well.
"It’s vindication," ACTC chief scientific officer Robert Lanza told Xconomy. "In the early days, we were called murderers. We almost went under a few times. This was not easy."
ACTC won CE Mark approval in the European Union for its stem cell treatment in March.
Carticept Medical Inc. won 510(k) clearance for its Navigator Delivery System, a computer-controlled drug delivery system joint pain. The Alpharetta, Ga.-based company’s device prepares the injection, delivers the dose to the patient under precise computer control and maintains a medical record by transferring treatment data to an electronic health system or print-out.
Luminex Corp. (NSDQ:LMNX) landed FDA clearance for its xTAG respiratory viral panel, which promises to deliver 96 actionable patient results in a few hours by testing for multiple virus strains and subtypes that lead to infection.
BG Medicine (NSDQ:BGMD) received ISO 13485 certification from the International Organization for Standardization for meeting internationally recognized quality standards for the design, development, production and sale of medical devices.
Alphatec Spine Inc., a subsidiary of Alphatec Holdings Inc. (NSDQ:ATEC), announced that it won Japanese regulatory Shonin approval for the Illico posterior fixation screw system for minimally invasive surgery.
Biosense Webster Inc., a Johnson & Johnson (NYSE:JNJ) company, and a global company in the diagnosis and treatment of cardiac arrhythmias, announced the enrollment of the first patient in a U.S. trial of the Diamond Bar, Calif.-based company’s Thermocool SmartTouch contact force sensing catheter system.