Organogenesis said today that it launched its PuraPly Antimicrobial clinical research program, which will evaluate patients treated with PuraPly AM for up to 12 weeks. The 1st studies have started enrolling patients, according to Organogenesis. The Canton, Mass.-based company’s PuraPly AM is a 510(k)-cleared device indicated for the management of acute and chronic wounds. The […]
Clinical Trials
Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety
Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]
Medtech stories we missed this week: March 24, 2017
From companies receiving CE marking to other companies adjusting their distribution deals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. […]
European advisory committee backs label update for Nordisk’s Tresiba
Shares in Novo Nordisk (NYSE:NVO) were up 2% this morning after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed the company’s application for a label update to its Tresiba insulin injection. The company submitted an application in November to add data from 2 studies to the medication’s label. The final ruling is expected […]
BioClin Therapeutics raises $30m to advance antibody-drug combo therapy
BioClin Therapeutics said yesterday that it closed a $30 million Series B round led by new investors Sofinnova Ventures and Ysios Capital. Existing investors HealthCap, Life Sciences Partners and Tekla Capital Management also invested. The company plans to use the newly-acquired funds to advance its lead candidate, B-701, as a treatment for metastatic bladder cancer in […]
Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]
Origin treats first patients in study of nitric oxide for diabetic foot ulcers
Origin said today that it treated the 1st patients in its dose-ranging Genesis Phase IIb-equivalent trial. The study is evaluating therapeutic quantities of plasma-generated nitric oxide as a treatment for chronic diabetic foot ulcers. The 27-week trial is slated to enroll up to 100 patients. Patients will be randomized into 1 of 4 dosing regimens, […]
Progenitor cell therapy improves motor function in patients with spinal cord injury
Shares in Asterias Biotherapeutics (NYSE:AST) jumped 11% today to $3.53 apiece after the company reported positive data for its AST-OPC1 progenitor cell therapy in patients with spinal cord injuries. The Phase 1/2A clinical trial includes 6 patients in the AIS-A 10 million cell cohort. The company’s AST-OPC1 progenitor cell therapy is derived from human embryonic […]
Biotronik touts Orsiro data at Japanese conference
Biotronik touted data today from the BioFlow-IV study of its Orsiro hybrid drug-eluting stent at this year’s Japan Circulation Society congress. The company’s study enrolled 579 patients with de novo coronary lesions and randomized them to receive either the Orsiro stent or Xience stent. After 12 months, the researchers confirmed non-inferiority of its stent, based […]
ACC Roundup: Boston Scientific touts 3-year outcomes for Synergy bioabsorbable drug-eluting stent
The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as news comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19. Boston Scientific touts 3-year outcomes for Synergy bioabsorbable drug-eluting stent Data presented at ACC 2017 showed that Boston Scientific‘s (NYSE:BSX) Synergy bioabsorbable polymer drug-eluting […]