1. Israel OKs E-Qure’s BST device for chronic wounds
E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the Israeli Ministry of Health, according to a Feb. 24 news release. BST is an electrotherapeutic method for treating chronic wounds. E-Qure will begin marketing its device in Israel by activating a signed distribution agreement with Chemipal. The BST device is the first electrical device on the Israeli advanced wound care market. E-Qure will also start commercial activity in the private healthcare market and has already filed for BST treatment to be included in Israel’s approved National Health Basket.
2. Nexstim touts final results from Phase III trial
Nexstim recently presented the results of a multi-center Phase III trial for the company’s Navigated Brain Therapy system (NBT) for stroke rehabilitation, according to a Feb. 23 news release. The results were presented at the International Stroke Conference in Houston, Texas by the lead investigator, Richard L. Harvey, M.D. The results showed that the NBT was safe and had no serious adverse events related to using the device. There was also significant clinical improvement of upper extremity motor function. Other results showed that there was some significant improvement in an Action Research Arm Test, Wolf-Motor Function Test, Stroke Impact Scale, National Institute of Health Stroke Scale, Chedoke McMaster Stroke Assessment for Hand and Arm and the quality of life instrument ED-5Q. The data from the trial will be combined with data from the study to supplement its FDA 510(k) submission.
3. Underwriter adds $350K to Skyline Medical’s $2M round
Skyline Medical recently announced that Dawson James Securities, the underwriter of its public offering, purchased an additional 175,000 shares of common stock at the public offering price, according to a Feb. 22 news release. Dawson James Securities also intends to purchase an additional 35,000 shares of common stock at a price of $0.01 under Series D Warrant to cover over-allotments. The proceeds of this purchase totaled approximately $358,312 after underwriting discount deductions and commissions. Skyline Medical also recently came into full compliance with the Nasdaq after it undertook a 1-for-25 reverse split of its stock last October.
4. Corin to distribute Humelock reversed shoulder from FX
Corin Group recently announced that it has launched the Humelock Reversed Shoulder System to treat patients with massive rotator cuff tears and severe shoulder arthritis, according to a Feb. 22 news release. The FX solutions developed Humelock Reversed Shoulder System received FDA clearance in January 2017 and is available in Europe and other international markets. Corin Group has a distribution agreement for the Humelock Reversed Shoulder System and the Humelock II Cementless and Cemented Anatomical and Reversible Fracture Shoulder Systems, giving them the right to distribute in the U.S., Germany and the United Kingdom.
5. Schein reaches distribution deal for Rijuven’s Cardiosleeve
Henry Schein Medical announced this week that it signed an exclusive distribution agreement with Rijuven to sell its CardioSleeve diagnostic device to medical practitioners, according to a Feb. 22 news release. The CardioSleeve is a stethoscope attachment that can record an electrocardiogram (ECG) and heart sound signals. It can transfer that data to a smartphone or Bluetooth-enabled device to give physicians a diagnostic interpretation of a patient’s heart from the office or any remote location. The CardioSleeve can also produce results that are built into a physician’s Electronic Health Record to track patients, review tests and enables them to consult patients remotely.
6. Clarius receives CE Mark for wireless portable ultrasound
Clarius Mobile Health received CE Mark approval this week for the commercial sale of its C3 and L7 Clarius Wireless Ultrasound Scanners that can be used by medical professionals, according to a Feb. 22 news release. The Clarius Scanners can be used with any iOS and Android smartphone or tablet. The Clarius Ultrasound Scanners are used for quick scans and to guide short procedures by clinicians. The C3 scanner can image the abdomen and lungs and can use a virtual phased array to quickly scan the heart. The L7 is used for guiding procedures and imaging superficial structures. The scanners use a rechargeable battery and are designed to withstand challenging environments. They can also be submerged in water for easy cleaning. Clarius won FDA 510(k) clearance in December for the C3 and L7 scanners.
7. Align Technology buys EMEA distributor
Align Technology acquired its distributor G.L. Dental Couture this week for an undisclosed amount, according to a Feb. 21 news release. This deal gives Align Technology access to customers and distribution in Russia, Commonwealth of Independent States, Baltics, Turkey, Monaco, Israel, Cyprus, the Middle East and Africa. It will also have all rights to territories in the Europe, Middle East and Africa (EMEA) regions. Align Technology manufactures and markets the Invisalign system that gives an array of treatment options for teens and adults.