From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. Viveve Medical closes public offering
Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. The public offering price was $4 per share, and the company estimates that the net proceeds from the offering will be nearly $31.7 million after deducting underwriting discounts and commissions.
2. Masimo receives CE Mark for Rad-97 Pulse CO-Oximeter
Masimo announced that it received CE Marking for its noninvasive blood pressure measurements from its Rad-97 Pulse CO-Oxumeter and connectivity hub, according to a March 20 news release. Rad-97 allows clinicians to measure arterial blood pressure in adults, pediatric and neonatal patients. It measures using 3 measurement modes: spot-check, automatic interval and stat interval. The built-in port lets clinicians connect a blood pressure cuff inflation hose right on the Rad-97. It also enables easy and automatic charting of blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin and other noninvasive parameters. The device has WiFi and Bluetooth connectivity that allows the device to connect to other devices that are nearby. With its user-friendly multi-touch navigation, clinicians can customize the high-resolution, 1080p HD color display to what they need.
3. Glaukos announces reimbursement win
The opthalmic medical technology company Glaukos Corp. has announced that the Current Procedural Terminology (CPT) Editorial Panel of the American Medical Association has given it a 5-year extension to 3 Category III CPT codes that describe insertion of aqueous drainage devices into the anterior chamber of the eye during micro-invasive glaucoma surgery, according to a March 16 news release. Physicians and other healthcare providers use CPT codes to report and receive Medicare reimbursement for services. The 3 CPT codes that received an extension are 0191T, 0253T and 0376T, all of which deal with the iStent device.
4. DiamiR wins $2.75 million grant for Alzheimer’s biomarker diagnostic device
DiamiR announced in a March 15 news release that it was awarded a $2.75 million Small Business Innovation Research (SBIR) Phase IIB grant from the National Institute on Aging and the National Institutes of Health. The grant is going toward supporting the development of DiamiR’s targeted diagnostic technology that analyzes brain-enriched microENA biomarkers in plasma to detect Alzheimer’s disease. The grant will stretch over a 3 year period and builds on to the company’s earlier studies that received SBIR Phase I and SBIR Phase II grants.
5. Flowonix and Cerebral Therapeutics launch clinical trial
Flowonix and Cerebral Therapeutics announced that the first patients of its clinical trial have had the Prometra implanted, according to a March 14 news release. The clinical trial, called ADDRESS, is the first multi-center dose ranging clinical study that evaluates intracerebroventricular (ICV) delivery of the drug valproate in patients who have focal seizures and have a temporal lob onset with to without secondary generalization. The study includes 9 patients who will undergo this treatment and will receive the valproate from the Flowonix Prometra II Programmable Pump.
6. Bonesupport extends U.S. bone Cerament distribution deal
Bonesupport has extended the terms of its U.S. distribution agreement with Zimmer Biomet, according to a March 14 news release. Zimmer Biomet will continue to have exclusive rights to Sonesupport’s Cerament Bone Void Filler designed for orthopedics, trauma and foot and ankle indications in the U.S.
7. Ortho Clinical Diagnostics and Astute Medical extend partnership
Ortho Clinical Diagnostics has expanded its agreement with Astute Medical for its NephroCheck Test distribution, according to a March 13 news release. The NephroCheck Test is a biomarker-based test that asses the risk for acute kidney injury. This new agreement gives Ortho Clinical Diagnostics the distribution rights in more European countries. Astute Medical gave Ortho a license to develop and market the NephroCheck Test in the U.S. and certain countries in Europe in 2014.