Israel’s Bonus Biogroup (TLV:BONS) said today that it successfully injected its lab-grown, semi-liquid bone graft into the jaws of 11 people in an early stage clinical trial evaluating bone loss repair. The company is presenting its results at the International Conference on Oral & Maxillofacial Surgery in Spain today. The material is grown in a lab from […]
Clinical Trials
Siemens Healthineers inks deal with N.Y. provider Northwell Health
Siemens Healthineers (NYSE:SI) said today it inked a 4-year research deal with N.Y. state healthcare provider Northwell Health. The 2 parties aim to develop research projects evaluating clinical effectiveness and outcomes using data analytics-based population health evidence. As part of the 4-year partnership deal, Siemens Healthineers will also provide full-time employees who will work jointly with […]
FDA approves Cardiac Dimensions trial for Carillon mitral repair device
Cardiac Dimensions said today that the FDA granted an investigational device exemption for a pivotal trial of its Carillon mitral valve repair device. Kirkland, Wash.-based Cardiac Dimensions said the 400-patient study will compare the device with guideline-directed treatment of symptomatic functional mitral regurgitation associated with heart failure after a year. The percutaneous Carillon annuloplasty device is designed […]
Nordisk touts Tresiba insulin injection data
Novo Nordisk (NYSE:NVO) said today that data from the Devote clinical trial indicated that its injected insulin, Tresiba, reduced the risk of severe hypoglycemia when compared to insulin glargine. The trial enrolled more than 7,500 type 2 diabetes patients at high risk of adverse cardiovascular events and treated them for 2 years with either Tresiba or insulin glargine […]
OCUL registers for $40m stock sale
Ocular Therapeutix (NSDQ:OCUL) is looking to raise $40 million through a public stock offering, according to a prospectus filed with the federal Securities & Exchange Commission this week. The Bedford, Mass.-based company said it inked a controlled equity offering sales agreement with Cantor Fitzgerald & Co., and agreed to pay Cantor Fitzgerald commissions of up to 3% […]
Moximed launches IDE trial of Atlas unicompartmental knee
California orthopedic device developer Moximed said today it enrolled the 1st patient in an FDA approved investigational device exemption trial of its next-gen Atlas unicompartmental unloading knee implant. The Atlas is designed to treat osteoarthritis knee joint pain in patients ages 35 to 65 whose condition has not degenerated enough to require arthroplasty. The device is a joint unloader […]
Oramed touts phase Ib data for type 2 diabetes capsule
Oramed Pharmaceuticals (NSDQ:ORMP) said today that it finished a phase Ib study of its oral GLP-1 analog capsule for type 2 diabetes. Glucagon-like peptide-1 (GLP-1) is a hormone that stimulates the pancreas to secrete insulin. Exenatide, a GLP-1 analog, is available on the market as an injection for patients with type 2 diabetes. The analog […]
Windtree touts inhaled therapy for infants with respiratory distress syndrome
Windtree Therapeutics (NSDQ:WINT) today released data from a phase IIa trial evaluating its inhaled Aerosurf lucinactant designed for premature infants with respiratory distress syndrome. Results from the trial were presented at the 6th International Congress of European Neonatal and Perinatal Societies in Valencia, Spain. Premature babies often lack adequate surfactant – a naturally occurring substance that reduces the surface […]
Micell begins MiStent clinical trial in Japan
Micell Technologies said today that it began its Dessolve J randomized, double-blind study comparing its MiStent SES sirolimus eluting absorbable polymer coronary stent to the Xience V everolimus eluting coronary stent in patients with coronary artery disease. The Durham, N.C.-based company touts its device as a bare-metal stent coated in crystalline drug, sirolimus, and an absorbable polymer, […]
Tests to begin for HIV therapy injections, long-acting implants
Drugs from companies such as GlaxoSmithKline (NYSE:GSK), Gilead Sciences (NSDQ:GILD) and Merck (NYSE:MRK) are reportedly being considered for large-scale trials evaluating injectable HIV prevention therapies. Eventually, researchers hope to produce matchstick-sized implants that could provide year-long protection to vulnerable populations. Foster City, Calif.-based Gilead has a once-daily pill, Truvada, which prevents HIV infection during sex. Pre-exposure prophylaxis, also known […]
Galera adds $15m for Series B
Galera Therapeutics said today that it landed $15 million for its severe oral mucositis treatment, bringing its Series B financing total to $57 million. Sofinnova Ventures led the round, joining existing investors New Enterprise Associates, Novartis Venture Fund, Novo Ventures, Correlation Ventures, Enso Ventures and Galera Angels. The Malvern, Penn.-based company said the proceeds will be […]