Cellnovo (EPA:CLNV) and Diabeloop said this week they are launching a CE Mark cross-over registration study for an artificial pancreas device Diabeloop is developing which uses Cellnovo’s insulin pump. The registration study aims to generate appropriate security & safety data as the company seeks CE Mark approval for the Diabeloop artificial pancreas combined with Cellnovo’s CGM some […]
Clinical Trials
Study: Gamida Cell’s NiCord cell graft yields fewer infections, shorter hospital stays
Gamida Cell said today that its NiCord cell graft produces fewer infections, shorter hospital stays and shorter time to engraftment compared to standard umbilical cord blood transplantation. The company’s work was published in Biology of Blood and Marrow Transplantation. “Our results indicate that rapid hematopoietic recovery from Gamida Cell’s NiCord transplantation approach is associated with clinical benefit. […]
PMD’s at-home spirometry could improve medication adherence in cystic fibrosis patients
PMD Healthcare touted data today from a pediatric cystic fibrosis study which the company said demonstrates the feasibility of at-home spirometry using its Spiro PD device. Cystic fibrosis patients take a variety of medications daily, PMD pointed out, and adherence to complicated regimens can be a challenge. The Allentown, Penn.-based company’s study examined forced expiratory volume, […]
Stable blood sugar linked to heart stent outcomes
Patients with type 2 diabetes and a coronary stent are at lower risk for heart attack and stroke if they maintain good blood sugar control, according to a recent study. “Although intensive glucose control had no benefit on the rate of major cardiovascular events in previous studies, our data suggest that strict glucose control after […]
Eyevensys wins approval to start clinical development of EyeCET platform
Private biotech Eyevensys said today that it won approval from the UK Medicines and Healthcare Products Regulatory Agency to advance its EyeCET platform into clinical development. The company’s EyeCET platform uses an electro-transfection injection system to deliver non-viral plasmids that encode for disease-specific therapeutic proteins in the ciliary muscle of the eye. Eyevensys’ lead product […]
Clearside closes patient enrollment in trial for diabetic macular edema therapy
Clearside Biomedical (NSDQ:CLSD) said today that it finished enrollment for the Phase 1/2 study of CLS-TA in patients with diabetic macular edema. The Hulk trial is designed to evaluate the safety and efficacy of a suprachoroidal injection of its suspension formulation of a corticosteroid, triamcinolone acetonide, with and without an intravitreal injection of Eylea in […]
Sentien launches trial for drug-device combo for treating acute kidney injury
Sentien Biotechnologies said this week it received an Investigational New Drug approval for its SBI-101 drug-device combination product meant for treating individuals with acute kidney injury. The multi-center, Phase 1/2 trial will be the the 1st for the company, and will examine its platform which uses a blood filtering device containing mesenchymal stromal cells for […]
Verily launches biosensor-equipped Study Watch for clinical study patient monitoring
Verily Life Sciences, the medical arm of Google parent Alphabet (NSDQ:GOOGL), today unveiled its Study Watch, a wearable device designed to passively capture health data. The watch, intended to create a method of unobtrusive biosensing, is equipped with multiple sensors, including an electrocardiogram, and can monitor heart rate, electrodermal activity and inertial movements, with a battery life of up […]
Novocure gains on additional Optune data
Shares in Novocure (NSDQ:NVCR) are on the rise again after the company today cited additional data from a pivotal trial evaluating its Optune device with temozolomide chemotherapy as a treatment for newly-diagnosed glioblastoma. Novocure’s Optune mobile device delivers low-intensity, intermediate frequency, alternating electric fields, called “tumor treating fields” or TTFields, to inhibit cancer cell replication. The […]
Medtech stories we missed this week: April 14, 2017
From FDA approvals to business expansion plans, here are medtech stories we missed this week but thought were still worth mentioning. 1. BioTelemetry launches offer to acquire LifeWatch BioTelemetry and LifeWatch announced in an April 9 press release that the 2 companies have entered a transaction agreement that states BioTelemetry will launch a tender offer to acquire all […]