Saphena Medical has raised $2.1 million in a new round of equity financing, according to an SEC filing posted this week. A total of 17 unnamed investors joined the round, with the date of the first sale recorded as June 12, 2018, according to the filing. The company offered Series D preferred stock in the […]
Argus downgrades Zimmer Biomet
Declining sales and the supply & manufacturing issues that have bedeviled Zimmer Biomet (NYSE:ZBH) recently prompted an Argus analyst to downgrade the orthopedic giant’s stock today. Argus analyst David Toung moved ZBH shares from a “buy” to a “hold” rating based on the company’s estimate that it would be the second quarter before it returned to full […]
Tandem wins FDA nod for insulin pump with predictive low glucose suspend feature
The FDA this week approved Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump with a predictive low glucose suspend feature designed to cut the frequency and duration of hypoglycemia. The San Diego, Calif.-based company said that upon launch, its new product will also feature Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitoring system. Tandem expects that the latest iteration of […]
GPB Capital puts $21m into CardioFocus for HeartLight catheter launch
CardioFocus landed a $21 million debt investment from GPB Capital and plans to use the proceeds to back the commercial launch of its HeartLight catheter for treating atrial fibrillation. The funding consists of a $21 million senior secured convertible note due to mature in April 2021. CardioFocus, which won FDA approval for its HeartLight Excalibur balloon last month, […]
FDA approves Senseonics’ implantable continuous glucose monitor
The FDA this week approved Senseonics‘ (NYSE:SENS) Eversense continuous glucose monitor for use in people ages 18 and older with diabetes. The device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. Get the full story at our sister site, Drug Delivery Business News.
Medtronic’s MiniMed system wins FDA nod for pediatric indication
The FDA this week expanded its approval for Medtronic‘s (NYSE:MDT) MiniMed 670G hybrid closed-loop diabetes management device to include people ages 7 to 13 with Type I diabetes. The system, which automatically monitors blood sugar levels and doses basal insulin accordingly, was initially approved in the U.S. for people ages 14 and older. Get the full […]
Breast implant maker Establishment Labs registers for $58m IPO
Breast implant maker Establishment Labs yesterday registered for an initial public offering worth nearly $58 million, saying it plans to use the proceeds to fund a pre-market approval study of its Motiva implants. The FDA granted an investigational device exemption in March for the PMA study and enrolled the first patient the next month, the […]
Wright Medical raises $675m in private placement
Wright Medical (NSDQ:WMGI) said today it inked a deal for $675 million in debt to be offered by a wholly-owned subsidiary. The Amsterdam-based company is offering 1.625% convertible senior notes due 2023 in the offering, which was arranged between Wright, a subsidiary and both investors and institutional buyers, according to an SEC filing. Wright Medical said […]
Analogic shareholders approve $1B go-private deal with Altaris
The $1 billion go-private deal between Analogic (NSDQ:ALOG) and private equity shop Altaris Capital Partners is slated to close tomorrow now that Analogic’s shareholders have approved the deal. Peabody, Mass.-based Analogic said that the $84-per-share deal, announced in April, is worth roughly $1.1 billion. The acquisition passed its first hurdle in the sale late in April, when the […]
Anika shares plummet after Phase III trial misses endpoint
Shares in Anika Therapeutics (NSDQ:ANIK) fell more than -30% this week after the company reported that its osteoarthritis drug, Cingal, failed in a Phase III trial. The therapy, designed to treat osteoarthritis of the knee, is a combination of cross-linked hyaluronic acid and triamcinolone hexacetonide. The trial’s primary endpoint compared the pain reduction experienced by patients […]
ivWatch to integrate IV infiltration sensor into Philips’ patient monitors
For decades, nurses have sent drugs surging through a patient’s body using the power of the circulatory system. Catheters deliver medications destined to travel through a person’s veins – but it doesn’t always turn out that way. Sometimes, leaky veins cause drugs to seep into surrounding tissue or to back out of the insertion site, […]
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