Delcath Systems (NSDQ:DCTH) proposed offering up to $5 million in units and $5 million in pre-funded units this week to fund the company’s clinical and commercial operations. The New York-based company plans to offer 500,000,000 units made up of Series C units with one share of common stock and Series E warrants to buy one share […]
How CHF Solutions is using health economics to expand product adoption
Two years after CHF Solutions (NSDQ:CHFS) acquired Baxter‘s (NYSE:BAX) Aquadex fluid filtration device for $5 million, the company’s executives are working to weave together the evidence they need to land reimbursement in the U.S. and expand patient access for its technology. The Aquadex system is designed to filter water and salt from patients experiencing fluid overload due […]
Illumina, Loxo Oncology partner for next-gen pan-cancer companion diagnostics
Illumina (NSDQ:ILMN) and Loxo Oncology (NSDQ:LOXO) are teaming up to develop a multi-gene panel for broad tumor profiling. The two companies ultimately hope to sell a next-gen sequencing-based companion diagnostic that will boast a pan-cancer indication. Illumina and Loxo plan to seek approval for a version of Illumina’s TruSight Tumor 170 test as a companion […]
Delcath approves massive reverse split
Delcath Systems (NSDQ:DCTH) said today that shareholders approved a bid to increase the company’s authorized shares of common stock from 500,000,000 to 1,000,000,000. The New York-based oncology group also voted to effect a reverse stock split of Delcath’s common stock at a range of 1-for-100 to 1-for-500. The board of directors have until April 6, 2019 […]
Companies push back against allegations of FCA violations over excess at-home blood testing
A 70-year-old former Marine is taking a group of companies to court over their at-home blood testing services, arguing that the industry players broke the law by requiring patients to conduct weekly tests. The companies then submit these bills to Medicare for reimbursement, even asking to be repaid for services that weren’t rendered, according to […]
Tandem inks distro deal in Italy for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) has signed a distribution deal with Movi SpA to commercialize Tandem’s t:slim X2 insulin pump in Italy. The San Diego, Calif.-based company said today that Movi is slated to run sales, marketing and customer training for Tandem’s products in Italy, according to the terms of the agreement. “Partnering with experienced insulin pump […]
Manufacturing fault prompts BD to recall blood collection tubes
Becton Dickinson‘s (NYSE: BDX) life sciences division issued a recall last month for some of its blood collection tubes, citing a manufacturing flaw that resulted in devices without sufficient additive. The company explained that an internal investigation found that Vacutainer Citrate Plus tubes with too little additive led to falsely-shortened clotting time and could impact patient […]
AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers
Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]
Embolx wins $2m NIH grant for pressure-directed embolization therapy
Embolx said today that it landed a $2 million grant from the National Cancer Institute to fund development of its next-generation Sniper balloon occlusion microcatheter. The Sunnyvale, Calif.-based medical device company has developed a drug-delivery system that administers therapies into targeted areas of the body by controlling pressure. Embolx’s Sniper balloon is designed to treat cancerous […]
Study: PET imaging agent could help predict depression drug’s efficacy
Researchers have identified a positron emission tomography imaging agent that could identify the patients that are more likely to benefit from a drug designed to treat major depressive disorder, according to a study published this month in The Journal of Nuclear Medicine. The C-DASB tracer targets a protein, 5-HTT, found in the part of a person’s […]
