From Glytec partnering to beat diabetes to Biolase, Gramercy Extremity Orthopedics and more getting FDA clearances, here are 7 recent medtech stories we missed this week, but were still worth mentioning.
1. BioTime proposes public offering of common stock
Clinical-stage biotechnology company BioTech is intending to offer common stock shares in an underwritten public offering. BioTime focuses on developing and commercializing products that address degenerative diseases. It expects to offer a 30-day option to purchase up to an additional 15% of the number of shares of the common stock to underwriters. The net proceeds from the offering will go toward funding clinical trials of products in development, financing research and development programs and general working capital. Raymond James and Associates will be the sole book-running manager of the offerings.
2. Glytec inks deal with N.C. hospital system for diabetes management
Winston-Salem, N.C.–based Novant Health has partnered with Glytec to offer clinicians a set of tools and technologies to fully adopt basal-bolus insulin therapy in medical centers across the U.S. Glytec’s eGlycemic Management System (eGMS) will be in all 14 of Novant Health’s medical centers throughout North Carolina and Virginia, delivering personalized care to patients. The health systems will use the GlucoSurvelliance module of the eGMS to speed up early identification and administer insulin therapy for hospitalized patients.
3. FDA clears Bioness L300 Go rehab device
The FDA recently cleared the L300 Go System by Bioness for ankle dorsiflexion in adults and pediatric patients with foot drop or assist knee flexion. The L300 Go System is an improvement to Bioness’ previous systems, the NESS L300 Foot Drop System and NESS L300 Plus System. It is the first functional electrical stimulation system that offers 3D motion detection of gait events and muscle activation. It uses data from a 3-axis gyroscope and accelerometer and measures movement in all 3 kinetic plans. Stimulation is administered whenever it is needed during the gait cycle. The L300 Go also offers multi-channel stimulation that allows clinicians to control the amount of dorsiflexion and inversion/eversion the system transmits.
4. Lombard touts first 15 IntelliFlex LP procedures for Aorfix stent graft
Lombard Medical has successfully treated 15 patients in Japan using its new IntelliFlex LP Delivery System for the Aorfix Endovascular Stent Graft. IntelliFlex is the only AAA stent graft with global regulatory approvals to treat aortic neck angulation up to 90 degrees. It is low profile and uses ergonomic features that were designed with physicians in mind.
5. Geneva Health Solutions pulls down $2M Series A
Geneva Health Solutions has raised $1.9M to expand its Cardiac Remote Monitoring Solutions business to cardiology providers. The money will help manage patients who have implanted cardiac devices. Critical cardiac data from patients who have implanted devices, like pacemakers and defibrillators, can send cardiac data from their devices to its provider through the cloud. This allows providers to monitor patients for alerts with device issues and clinical needs, like notifying indicators of heart failure or arrhythmias.
6. Gramercy Extremity Orthopedics wins FDA nod for bone screw
Gramercy Extremity Orthopedics received FDA 510(k) clearance for the GEO Bone Screw System that is used for osteotomies, arthrodesis, bone fractures, osteochondritis and tendon reattachments. The bone screw system has a variety of low-profile titanium screw lengths, diameters, thread lengths and fully-threaded options to choose from. The screws are also double sterile packaged, self-drilling, self-tapping and reverse-cutting. The GEO Bone Screw System is the first offering in the company’s product line.
7. Biolase receives FDA clearance for Waterlase Express All-Tissue Laser System
Biolase has announced that its fifth-generation all-tissue laser system has received FDA 510(k) clearance for commercial distribution. The Waterlase Express is for sale to dentists in the U.S. and select markets in Europe, the Middle East and Asia. The Waterlast Express is easy to learn, use and get support for. It is the smallest and most cost-effective laser system to come from Biolase so far.