An antiretroviral drug released from an experimental vaginal ring to protect women against HIV is absorbed in low concentrations into breastmilk, according to researchers from the NIH-funded Microbicide Trials Network. The team touted data today from a Phase I trial of the device at the 9th IAS Conference on HIV Sciences in Paris. The dapivirine […]
Women's Health
Boston Scientific joins OAB device dev Amphora Medical’s $36m Series B
Amphora Medical said today it closed a $35.5 million Series B financing round, led by major medtech player Boston Scientific (NYSE:BSX), with funds slated to support a US pivotal trial of its Selective Bladder Denervation System for treating women with overactive bladder. Amphora’s Selective Bladder Denervation System is a minimally-invasive, cystopic device which uses targeted ablation […]
Inovio prices $75m public offering
Inovio Pharmaceuticals (NSDQ:INO) said today that it priced its underwritten public offering of 12.5 million shares of common stock at $6.00 apiece. The offering is expected to bring in nearly $75 million for the Plymouth Meeting, Penn.-based company. The offering, which is expected to close on July 25, includes a 30-day option for underwriters to buy up […]
Inovio looks to raise $75m in public offering
Inovio Pharmaceuticals (NSDQ:INO) said yesterday that it is launching an underwritten public offering to sell $75 million shares of common stock. The Plymouth Meeting, Penn.-based company said it plans to grant underwriters an option to buy up to $11.3 million additional shares of common stock. Get the full story at our sister site, Drug Delivery Business News.
Guided Therapeutics re-opens FDA discussions seeking LuViva PMA
Guided Therapeutics (OTC:GTHP) said today it re-entered discussions with the FDA about pursuing premarket approval for its LuViva advanced cervical scan device. The Norcross, Ga.-based company said the decision was prompted by “constructive” outcomes from previous meetings with the organization alongside a “perceived more favorable environment for device approvals under the new presidential administration” and a […]
Missouri judge slashes 86 plaintiffs from Essure suit against Bayer
A federal judge in Missouri cut 86 of the 94 plaintiffs from a group of consolidated lawsuits filed against Bayer (ETR:BAYN) over its Essure female sterilization device. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said in 2015 that it received 5,093 complaints in the 13 years since Essure’s approval, including […]
CDC chief propped up controversial anti-aging medicine in private practice
Before the newly-appointed CDC head Dr. Brenda Fitzgerald ran the public health department for the state of Georgia, she was a board-certified OB/GYN with a private practice. But according to a report from Forbes, she not only provided women’s healthcare in the 30 years she practiced medicine – she was also a fellow in “anti-aging medicine.” Get more […]
Medtronic touts 5-year data on InterStim neuromod device for OAB
Medtronic (NYSE:MDT) today touted 5-year results from the InSite study of its InterStim neuromodulation treatment for overactive bladder syndrome. InterStim is designed to stimulate the sacral nerve to treat OAB, meaning urinary urge incontinence and/or urgency-frequency. The InSite study enrolled 340 patients, of which 272 were implanted with an InterStim device, comparing treatment with the device […]
Report: J&J attempted to block French warning on transvaginal meshes
Johnson & Johnson (NYSE:JNJ) attempted to stop health authorities in France from publishing a report which warned against the use of untested pelvic mesh devices for fear that it would damage their business, according to a new Guardian report. The French report came 2 years after the devices began to see use in Australia, where the […]
MobileODT raises $7m for portable cervical cancer detection device
MobileODT said today that it raised $6.8 million in a Series B financing round. OrbiMed Advisors led the financing and was joined by a previous investor, Tristel. To date, the Israeli cancer diagnostic company has raised more than $13 million. MobileODT’s device, EVA, is a cheap, portable device that uses an imaging system to detect […]
Dune Medical raises $12m to expand MarginProbe footprint
Dune Medical Devices said today that it raised another $12 million it plans to use to expand the indications for the radiofrequency spectroscopy technology used in its MarginProbe cancer detection device. Alpharetta, Ga.- and Caesarea, Israel-based Dune said the $12.3 million round was led by Canepa Healthcare, ATON Partners and the Kraft Group. Dune said it plans […]