When the data and safety monitoring board for Biocardia Inc.’s phase III pivotal trial of its Cardiamp Cell Therapy for Heart Failure (Cardiamp HF) advised pausing the study in July to analyze the interim results, the company expressed surprise as the blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint. The trial has now been unblinded.

Industry nominally supportive of TCET, but urges US Medicare agency to expand scope 

The proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but the med-tech industry has serious misgivings about the proposal. One of the primary issues for them is the scope of the proposal, which industry argues should include in-vitro diagnostics as well as devices that do not qualify for FDA breakthrough status, changes that might drastically expand the workload at the Centers for Medicare & Medicaid Services. 

Amber Therapeutics acquires provider of UI bioelectrical stimulation device

Amber Therapeutics Ltd. acquired Bioinduction Ltd. as well as its neuromodulation therapy platform, Picostim Dyneumo. Amber is currently using the platform, an implantable system to deliver its closed-loop therapy for mixed urinary incontinence, Amber-UI, in a first-in-human study. With early indications confirming the safety and feasibility of the surgical procedure and adaptive therapy, it made sense to acquire the hardware which allows for the therapy to work, CEO Aidan Crawley, CEO and co-founder of Amber told BioWorld.

US FDA sees lack of alternatives for Datascope balloon pumps despite recalls 

The U.S. FDA recently posted another round of recalls for the Cardiosave line of intra-aortic balloon pumps (IABPs) by Datascope Inc., advising users to make sure they have a backup unit at the ready in the case of device failure. However, the agency noted that “alternative treatments are limited,” a clear sign that this market lacks competition, most likely due to a lack of incentives for the private sector to invest in this class of devices. 

Georgia Tech develops wax microneedle drug delivery patches

Researchers at the Georgia Institute of Technology in Atlanta have developed melting microneedle patches comprising a drug dissolved or dispersed in a wax. The small size of the microneedles enables them to cause little to no pain and target the intracutaneous space. The intracutaneous space is highly vascularized in the dermis and rich in immune cells in the dermis and epidermis, making it an attractive path to administer both vaccines and therapeutics. The microneedles may melt once in the intracutaneous space to release the substance of interest into the interstitial fluid and skin. 

Also in the news:

Agilent, Breathe Biomedical, Cordis, Graticule, Illumina, Acupath Laboratories, Bellaseno, Biocardia, Guardant Health, IBT, Atlatl, Mainz Biomed, Medalliance, Nyokassist, Synchron, Viveon Healthcare, Nanjing Changcheng Medical Equipment, Guardant Health, Gendius, Icecure Medical, Medimaps Group, Rapid Medical, Techsomed