Battelle and Halyard Health (NYSE:HYH) snagged a $14.4 million contract from the U.S. Navy to develop a combination drug/device medical wrap that can help protect and save severely injured limbs, both at home and in the battlefield. The Office of Naval Research awarded the 4-year contract as part of its Acute Care Cover for Severely Injured […]
India updates patent policies for medical devices and drugs
India took a step toward modernizing its approach toward intellectual property, encouraging news for both the medical device and drug development industries. India had announced a new intellectual property policy meant to speed up online registration of trademarks and patents. As part of the change, India’s Dept. of Industrial Promotion & Policy will regulate the country’s intellectual […]
BioVentrix touts 1st-in-human procedure for Revivent device
BioVentrix said it successfully implanted its micro-anchor Revivent device into a 64-year-old female patient suffering from heart failure symptoms following a heart attack. The first-in-human test follows a similar successful procedure in a pre-clinical model last December. Researchers used Revivent in what it refers to as LIVE (less-invasive ventricular enhancement) a transcatheter-based procedure designed to […]
Otsuka gets in on ReCor Medical’s Paradise renal denervation device
ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension. Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea […]
Humacyte launches pivotal trial for lab-grown blood vessel
Humacyte is launching a Phase III study of its lab-grown blood vessel Humacyl in 350 patients with end-stage renal disease who are on hemodialysis and don’t qualify for a standard surgical treatment, and Boston’s Brigham & Women’s Hospital plans to take part. Plans to move ahead to Phase III follow a promising Phase II clinical study […]
Biotelemetry closes $16m VirtualScopics buy
BioTelemetry (NSDQ:BEAT) said yesterday that it closed its $15.5 million acquisition of clinical trial imaging provider VirtualScopics (NSDQ:VSCP), approximately 6 weeks after the deal was 1st announced. The all-cash buyout of Rochester, N.Y.-based VirtualScopics included a $4.05-per-share tender for roughly 3 million VirtualScopics shares. BioTelemetry also offered $336.50 per share for the company’s Series A and […]
Teleflex prices $400m debt offering
Teleflex (NYSE:TFX) yesterday priced $400 million worth of debt that the maker of surgical tools and equipment plans to use for debt refinancing. The offering, of 4.875% senior notes due in 2026, is expected to close May 16. Teleflex said it plans call to use the money to refinance $393 million in debt under its revolving credit facility. J.P. Morgan and BofA Merrill […]
Median Technologies expands U.S. footprint
France’s Median Technologies (EPA:ALMDT) is consolidating and expanding in Massachusetts, with a new Woburn facility set to open next week. The medical imaging software maker and developer said the site will consolidate its existing operations in the Boston area, but also be big enough to handle an “ambitious U.S. recruitment plan.” A company spokesperson told MassDevice.com that the facility’s “exact […]
For AirXpanders, a switch from 510(k) to de novo was no big deal
Scott Dodson didn’t worry when the FDA requested a call. Dodson is CEO of AirXpanders, a Palo Alto, Calif.-based company that had made a 510(k) submission for its AeroForm tissue expander, a device designed for post-mastectomy breast reconstructions that uses a gradual patient-controlled release of compressed gas to expand and stretch the skin/underlying muscle before […]
CE Mark in hand, Moximed hatches U.S. approval strategy for knee stabilization implant
The knee replacement market has reached stratospheric levels in the U.S., with competitors ranging from Zimmer Biomet (NYSE:ZBH) to Smith & Nephew (NYSE:SNN) and Johnson & Johnson (NYSE:JNJ). California device developer Moximed is betting its future, however, on patients not quite ready for the drastic surgery. The knee replacement market is worth an estimated $4 billion […]
Procyrion’s Aortix device could heighten heart pump competition
Pay attention to Procyrion over the next several months. CEO Benjamin Hertzog tells MassDevice.com that the company plans on heading to the clinic with a device that could heighten competition among makers of cardiac assist devices. The Houston-based startup plans to begin 1st-in-human trials of its Aortix catheter-based heart pump in the 1st half of 2016. […]