Clearside Biomedical (Nasdaq:CLSD) today announced that the ODYSSEY study of its drug-device combination achieved its primary and secondary outcomes. Alpharetta, Georgia-based Clearside develops the SCS Microinjector suprachoroidal injection device. It enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to […]
Clinical Trials
Trinity Biotech completes pre-pivotal study of next-gen CGM
Trinity Biotech today announced that it completed the first pre-pivotal clinical trial in Europe for its next-generation CGM technology. The study assessed the analytical performance of continuous glucose monitoring (CGM) technology enhancements implemented by Trinity. Dublin, Ireland-based Trinity added the improvements to the CGM technology it acquired from Waveform Technologies in January. Trinity implemented an […]
Medinol has first human implant of drug-eluting peripheral stent in Australia
Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent. Dr. Gerard S. Goh and Dr. Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, completed the stent implant. The company says it introduces a “revolutionary advancement” in the mechanics, durability and drug delivery of peripheral drug-eluting stents. Tel Aviv, Israel-based Medinol […]
MannKind has more positive inhaled insulin data
MannKind announced top-level 30-week results from its Phase 4 INHALE-3 study comparing inhaled insulin to traditional delivery methods. The Danbury, Connecticut-based company designed Afrezza, a rapid-acting inhaled human insulin, to improve glycemic control in adults with type 1 diabetes mellitus. The INHALE-3 study looks at Afrezza against usual care. Mannkind defines usual care as multiple […]
Qnovia wins FDA nod for nicotine inhaler as smoking cessation therapy
Qnovia announced that the FDA cleared its investigational new drug (IND) application for the RespiRx smoking cessation inhaler (QN-01). RespiRx, a drug-device combination product, offers inhalable nicotine replacement therapy (NRT) to assist in the quitting of smoking. IND clearance allows Qnovia to initiate a Phase 1 trial in the U.S. to determine the pharmacokinetics, safety, […]
Vivani can begin first-in-human GLP-1 implant trial in Australia following regulatory approval
Vivani Medical (Nasdaq:VANI) today announced that Australian authorities approved a first-in-human clinical trial for its subdermal GLP-1 implant. The LIBERATE-1 trial will evaluate the miniature GLP-1 (exenatide) implant in obese and overweight subjects. This follows FDA approval for an investigational new drug (IND) application for the company’s implant in June. The FDA lifted the clinical hold […]
CereVasc data shows that eShunt could help deliver gene therapies to the central nervous system
CereVasc shared data from a study demonstrating that its eShunt system may help deliver gene therapies to the central nervous system (CNS). eShunt, a minimally invasive system, includes an endovascularly implantable cerebral spinal fluid shunt and delivery components. CereVasc designed the system to enable transvenous-transdural access to the CNS to treat communicating hydrocephalus (CH) without […]
Ypsomed reports positive outcomes with automated insulin delivery for maternal health
Ypsomed reports positive outcomes from a large, randomized trial of its closed-loop insulin delivery technology during type 1 diabetes pregnancy. The Switzerland-based company’s AiDAPT study demonstrated that hybrid closed-loop therapy significantly improves maternal glycemic control. Pregnant women with type 1 diabetes used the automated insulin delivery system based on the CamDiab CamAPS FX algorithm in […]
Vaxxas begins avian flu vaccine trial using high-density microarray delivery patch
Vaxxas announced that it began a multi-center Phase I clinical trial of a vaccine against avian flu using its high-density microarray patch. The company develops a vaccine patch based on its proprietary HD-MAP delivery technology. Vaxxas designed its HD-MAP technology to use an ultra-high-density array of micro projections, invisible to the human eye. Applied to […]
CorFlow Therapeutics raises $48.5M for diagnostic, drug delivery platform
CorFlow Therapeutics announced today that it raised €44 million ($48.5 million) to support its novel diagnostic and drug delivery platform. Broadview Ventures and Panakes Partners led the financing round. 415 Capital, Merieux Equity Partners, Merieux Equity Partners, Laerdal Million Lives Fund, Wellington Partners, M&L Investments, Unorthodox Ventures, KOFA Healthcare and Monte Carlo Capital also participated. […]