Repro-Med Systems last Friday updated on a warning letter it received in February over issues the FDA found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps. The company said it submitted a response to the warning letter last Friday to the FDA, 3 days before the required response date set by […]
Inovio Pharma picks up Bioject
Inovio Pharmaceuticals said today it paid $5.5 million for the assets of Bioject Medical Technologies including its needle-free jet injection tech, devices and intellectual property With the acquisition, Inovio said it will advance an integrated non-invasive delivery device combining the acquired jet injection tech with its own needle-free skin-surface electroporation tech. Inovio said it’s goal […]
Unilife & Amgen finalize $75m co-development deal
Unilife (NSDQ:UNIS) said today it finalized a $75 million collaborative deal with Amgen (NSDQ:AMGN) for injectable drug delivery systems, a deal the companies have been working out for the past month. The deal includes licensing, investment, development and supply agreements and is centered around Unilife’s prefilled customizable wearable injectors, according to an SEC filing from the York, […]
Precision Ocular raises $19m, inks deal with Consort Medical for drug-device combo
Consort Medical said today it inked a development and manufacturing deal with Precision Ocular, and joined in a round of financing to support Precision Ocular, who raised $19 million (UK £13.5 million) total. The collaborative deal will leverage Consort subsidiaries Bespak and Aesica, with Bespak providing device development and manufacturing capabilities and Aesica offering manufacturing […]
Bard touts data from Lutonix head-to-head study against MDT's In.Pact
C.R. Bard (NYSE:BCR) subsidiary Bard Peripheral Vascular touted results showing no significant difference in a study pitting its Lutonix DCB against Medtronic‘s (NYSE:MDT) In.Pact DCB in treating patients with complex femoropopliteal lesions. Clinical data from the investigator-sponsored retrospective, single-center study was presented during the Leibzig International Course in Leipzig, Germany last month. The study reported […]
Intersect ENT logs German reimbursement win
Intersect ENT (NSDQ:XENT) said today it clocked a German hospital reimbursement win from InEk, Germany’s Institute for Hospital Remuneration System, for its Propel sinus implant. The propel device is a small steroid releasing implant designed to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery. “We believe that the robust clinical evidence […]
Biotronik expands DCB line with CE Mark for Passeo-18 Lux
Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries. The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval […]
Mercator MedSystems launches dual-therapy BTK Bullfrog device trial
Mercator MedSystems said yesterday it enrolled the 1st patient in its Limbo-PTA clinical trial aiming to examine the use of the company’s Bullfrog micro-infusion device delivering anti-inflammatory steroids along with angioplasty to treat patients with below the knee critical limb ischemia. The Emeryville, Calif.-based company said that the purpose of adding an anti-inflammatory drug, delivered by […]
Glaukos touts 3-year iStent study data
Glaukos (NYSE:GKOS) said today data from a 3-year study of its iStent Trabecular micro-bypass stent indicated that it, along with cataract surgery, lowered mean intraocular pressure 36% and reduced mean glaucoma medications by 86% 3 years post-surgery. The study reported a mean IP of 14.99 mmHg in 39 patients monitored after treatment for 3 years, compared […]
Delcath launches Phase III trial for ocular melanoma treatment
Delcath (NSDQ:DCTH) said today it launched a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride designed for the treatment of hepatic dominant ocular melanoma. The newly initiated Focus trial will examine the safety, efficacy and pharmocokinetic profile of its Melphalan and HDS system when compared with the standard of care, the New […]
