LONDON – Oviva AG has raised US$21 million in a series B funding to further advance commercialization of its digital diabetes treatment program across Europe.
SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod Horizon. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. In combination, the devices will operate as a closed loop system to automatically adjust insulin dosage over time in response to blood glucose levels.
SAN FRANCISCO – This was the final presentation for Omar Ishrak at the J.P. Morgan (JPM) Healthcare Conference. He has held the CEO position at Medtronic plc since June 2011. During that period, the Dublin-based company managed to roughly quadruple its valuation to $160 billion from $40 billion – making Ishrak’s tenure clearly a successful one.
SAN FRANCISCO – Dexcom Inc. is working hard to take its business to the next level. Wall Street has been rewarding it heavily, doubling its market cap to about $21 billion since the end of 2018. But investors pulled back a tad on the company’s presentation at the J.P. Morgan (JPM) Healthcare Conference in San Francisco, sending shares down about 4% despite beating analyst expectations.
PARIS – Diabnext SAS, of Versailles, France, has launched Clipsulin 3XS, a sensor intended to monitor and manage diabetes that the company says is compatible with all insulin pens on the market. “This is the first sensor that automatically reports insulin doses injected by the pen, in both children and adults,” Laurent Nicolas, co-founder and CEO of Diabnext, told BioWorld MedTech.
One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.
Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults.
Medtronic plc, of Dublin, reported good news in terms of its quarterly results Tuesday, with key revenue segments coming in line with or beating expectations. Wells Fargo's Larry Biegelsen noted that coronary and structural heart sales of $955 million exceeded the consensus of $949 million and his organization's $923 million estimate. The company pointed to its transcatheter aortic valves as helping in the boost, following the expansion into the low-risk patient population.
Fractyl Laboratories Inc. is pioneering a procedure known as duodenal mucosal resurfacing (DMR) to reverse chronic metabolic disorders. This month it has reported positive results from a couple of clinical trials that are shaping its planning for a pivotal trial that is slated to start next year in type 2 diabetes patients.
Senseonics Inc., of Germantown, Md., reported gloomy results for its 2019 third quarter, with revenue of $4.3 million, down 17% from the same period last year. The tally also fell far short of the consensus on Wall Street, which estimated third-quarter revenue of $6.07 million.