1. Insulet touts glucose control study
Insulet Corp. announced the results from its first feasibility study of its Omnipod Horizon hybrid closed-loop system in a Feb. 17 news release. The positive results showed that the glucose control algorithm performed well and was safe to used day and night for adults who have type 1 diabetes. It also showed that it was effective at night with minimal hypoglycemia and fasting glucose. The Insulet study had 24 participants with type 1 diabetes and took place over a 36 hour period. The participants used a modified version of the Omnipod, a Dexcom continuous glucose sensor, and a model predictive control algorithm created by Insulet.
2. Pixium announces first Spanish implantation of Iris II ‘bionic eye’
The Institute of Ocular Microsurgery in Barcelona, Spain implanted the bionic vision system Iris II in the first Spanish patient, according to a Feb. 16 news release. The vision system has a bio-inspired camera and a 150-electrode epiretinal implant that can be removed if needed. Pixium Vision developed the bionic vision system to help patients who have lost their eyesight, and the Iris II is designed to help patients who lost their eyesight from retinitis pigmentosa. The surgery was performed by Dr. Borja Corcostegui, founder and medical director of the Institute of Ocular Microsurgery and a vitreoretinal surgeon.
3. Valeritas releases data for V-Go wearable insulin delivery device
Valeritas Holdings recently touted in a Feb. 16 news release that its V-Go Wearable Insulin Delivery device proved to have a greater reduction in A1c and insulin dose in patients who have type 2 diabetes. The study analyzed the electronic medical records from a multicenter diabetes system in the U.S. It evaluated the data of 107 patients to determine that patients had fewer insulin doses and needle sticks while using the V-Go, compared to using insulin pens.
4. Polyganics’ Stop Neuroma study shows reduction in pain
Polyganics announced in a Feb. 16 news release that its Stop Neuroma study has shown a sharp improvement in pain reduction in patients who participated in the program. The Stop Neuroma (surgical treatment of symptomatic neuroma) program was designed to determine how well the Polyganics Neurocap worked for reducing painful neuroma formation. The Neurocap is a nerve capping device that is the only approved dedicated device for managing symptomatic neuromas surgically. Patients saw an average pain reduction of 84% after a 3 month use, and patients who used it for 12 months felt they had improvement in daily functioning and quality of life.
5. BioTime closes public offering
BioTime has closed its underwritten public offering, according to a Feb. 15 news release. It sold 7,453,704 shares of its common stock at an offering of $2.70 per share. The company raked in approximately $20.1 million before the deduction of underwriting discounts, commissions and other expenses. BioTime will use the proceeds from the offering to fund clinical trials, research and development activities, general working capital and general corporate purposes.
6. Tandem Diabetes Care: Data shows its sensor-augmented pump has advantages over Medtronic
Tandem Diabetes Care recently did a study that compared data from its sensor-augmented pumps (SAPs) to Medtronic’s Minimed. According to a Feb. 15 news release, the Tandem SAP had significant clinical advantages like a reduction in hypoglycemia, increased time in range and an improved glycemic control. The data showed that about half of Medtronic SAP users were actively using a feature that suspended insulin delivery when blood glucose levels fell below a certain threshold. Both sets of data from Tandem and Medtronic used patients with type 1 and type 2 diabetes who used a SAP for at least 6 months and used a continuous glucose monitor for more than 15 days during the first 6 months.
7. FDA green-lights FlowAid Medical’s FA100 SCCD circulation aid
FlowAid Medical received FDA clearance this week for its FA100 SCCD (sequential continuous contraction device), according to a Feb. 15 news release. The FA100 SCCD is a handheld 4-channel electrical muscle stimulator that is small, lightweight and portable and provides low-frequency stimulation in sequential patterns. it requires no external pressure to the legs and allows the patient to move freely without interfering with daily activities. It is used on patients who have an increase of local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and for the prevention or stopping of disuse atrophy and edema reduction. The FA100 SCCS also received CE Mark approval in July 2016 and Health Canada approval in August 2016.