New York-based startup 3Dbio Therapeutics snagged a rare pediatric disease designation from the U.S. FDA for Aurinovo, its investigational combination product for reconstruction of the outer ear in patients with microtia. The product offers an alternative to established treatments, none of which enable patients to regain an auricle comprising living tissue other than rib grafts, which are associated with significant donor site morbidity.
Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.
Genomic testing firm Veracyte Inc., of South San Francisco, has inked a definitive agreement with Seattle-based Nanostring Technologies Inc. for the global rights to Nanostring’s Ncounter platform. The deal – for $50 million in cash and Veracyte stock, plus up to $10 million in potential milestone payments – will allow Veracyte to develop and commercialize diagnostic tests on Nanostring’s Ncounter Flex system.
The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in 2016, the test requires patients to sit in front of an all-in-one tablet-looking device and follow a series of moving targets. The goal is to identify ocular tremors, a persistent issue with Parkinson’s patients that prevents steady fixation on objects and images. The noninvasive test, which measures an individual’s ability to follow objects on a screen, could help doctors not only confirm the difficult-to-diagnose disease, but also detect it at earlier stages.
Stem cell biotech firm Novoheart Holdings Inc., of Vancouver, British Columbia, is partnering with Astrazeneca plc, of Cambridge, U.K., to co-develop a human-specific in vitro, functional model of heart failure with preserved ejection fraction.
Heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure, accounts for roughly half of all heart failure cases worldwide. The condition, which occurs when the ventricles do not relax as they fill with blood following heart muscle contractions, is especially common in elderly women, striking up to 10% of those over 80 years old. Now stem cell biotech firm Novoheart Holdings Inc., of Vancouver, British Columbia, is partnering with Astrazeneca plc, of Cambridge, U.K., to co-develop a human-specific in vitro, functional model of HFpEF. The goal is to give drug researchers critical clues of a drug candidate’s efficacy before it is tested in patients.
Menlo Park, Calif.-based startup Tusker Medical Inc. has received U.S. FDA approval to market its breakthrough-designated system for inserting tympanostomy tubes into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office. The Tula system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes and several devices for inserting the anesthetic and tubes into the ear drum. A low-level electrical charge delivers the anesthesia to the eardrum prior to tube placement, allowing for quick and needle-free numbing of the tympanic membrane.
Huntington’s disease is a fatal hereditary disease that results in the progressive breakdown of nerve cells in the brain. It erodes a person’s physical and mental abilities, usually beginning in their 30s and 40s, and to date has no cure. Now Austin-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to develop companion diagnostics (CDx) for Wave’s investigative allele-selective therapeutic programs targeting the genetic cause of the disease.