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December 12, 2016

 

Novocure Presents Phase 2 Pilot INNOVATE Trial Results

 

Novocure held a Research & Development presentation where it announced presented data from its Phase II INNOVATE clinical trial. The Phase II pilot trial was a prospective open label, single-arm, non-randomized, multicenter study testing the feasibility, safety, toxicity and preliminary efficacy of TTFields (Optune device) at 200 kHz together with weekly paclitaxel in patients with recurrent ovarian cancer versus historical controls.
The data suggested that Tumor Treating Fields (TTFields) in combination with weekly paclitaxel is tolerable and safe in patients with recurrent ovarian cancer. The data also suggested more than doubling of the progression free survival and an improvement in overall survival among patients who received TTFields therapy with paclitaxel compared to a recent Phase III trial of patients who received paclitaxel alone.

 

See more on Optune on Meddevicetracker.

 

NCCN Guidelines Recommend SIR-Spheres Y-90 Resin microspheres for the Treatment of Metastatic Colorectal Cancer

 

Sirtex Medical announced that SIR-Spheres Y-90 resin microspheres have been included as a Category 2A recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer. This designation denotes that there is uniform consensus among the NCCN panel that Selective Internal Radiation Therapy (SIRT) with yttrium-90 microspheres is an appropriate option in patients with liver dominant, chemotherapy resistant colorectal disease (mCRC). This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens.

 

The 2A designation represents a milestone for SIR-Spheres resin microspheres and provides further validation for the role of the Company's medical device as a treatment option for unresectable, liver dominant metastatic colorectal cancer. The Company also has positive signals in the first-line setting through the results to date of the pivotal SIRFLOX study and anticipate the overall survival results in more than 1,100 patients from the SIRFLOX, FOXFIRE and FOXFIRE Global studies which we expect to be available in the first half of 2017.

 

See more on SIR-Spheres on Meddevicetracker.

 

December 13, 2016

 

Boston Scientific Closes Acquisition of Advanced Biological Tissue Capabilities and Acquires Common Shares of Neovasc, Inc.

 

Boston Scientific Corporation announced the close of its acquisition of certain manufacturing assets and capabilities of the Neovasc advanced biological tissue business. With the completion of the acquisition, Boston Scientific will integrate certain manufacturing assets and biologic tissue capabilities into its structural heart business for use in the manufacturing of the Lotus Valve System and future heart valve technologies.

 

The two organizations announced a definitive agreement on December 2, 2016 for Boston Scientific to acquire the advanced biologic tissue capabilities and make a 15% equity investment in Neovasc, for a total of $75 million in cash. With the equity investment, Boston Scientific now beneficially owns, controls and directs 11,817,000 common shares representing in aggregate 15% of the issued and outstanding common shares which were acquired at a price of US$0.60 per common share for total consideration paid of US$7,090,200.

 

The common shares were acquired for investment purposes. Prior to these transactions, Boston Scientific did not beneficially own, control or direct any common shares of Neovasc.

 

See more on Boston Scientific and Neovasc on Meddevicetracker.

 

GI Dynamics, Inc. Announces Completion of A$1.5million Private Placement

 

GI Dynamics announced that it has received commitments for a private placement of 69,865,000 fully paid CHESS Depositary Interests (CDIs) of the Company (representing 1,397,300 shares of common stock) at an issue price of A$0.022 per CDI to investors in Australia and certain other jurisdictions to raise approximately A$1.5 million (Placement). The Company also announced it will shortly be offering an opportunity to participate in a Security Purchase Plan (SPP) to Eligible Shareholders with a registered address in Australia or New Zealand to raise up to an additional A$987,910.

 

GI Dynamics is focused on commercialization in Europe, moving forward as rapidly as possible with a US Investigational Device Exemption (IDE) study with the Food and Drug Administration (FDA), while continuing to operate the Company in a fiscally conservative manner.

 

Use of proceeds should allow GI Dynamics to continue operating, based on current operating levels, through the 2017 calendar year and allow it time to further solidify its ongoing European commercial and United States development options.

 

 

See more on GI Dynamics on Meddevicetracker.

 

 

December 14, 2016

 

Bioventus Enters Into New Agreement for DUROLANE

 

Bioventus announced it has a new agreement with Galderma for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis. Financial terms of the transaction were not disclosed.

 

Bioventus plans to file a premarket approval application with the FDA in early 2017 to bring DUROLANE to the US market in the near future. It owns the international rights to the product and has commercialized it outside of the United States for nearly 15 years. Bioventus currently markets and sells it in more than 25 countries including Canada, Mexico, Australia and much of Europe. Galderma manufactures DUROLANE and other HA products.

 

Bioventus and Galderma first entered into an agreement in February 2014. The agreement stated that Galderma would serve as the manufacturer of DUROLANE; however, Bioventus would control all future plans and distribution for the product outside of the United States.

 

See more on DUROLANE on Meddevicetracker.



Nanobiotix Reports Positive Phase I/II Preliminary Data on NBTXR3

 

Nanobiotix announced a readout of initial data on the safety and feasibility from the first patients treated in its Phase I/II trial evaluating NBTXR3 in liver cancers, including primary (Hepatocellular, HCC) and metastatic tumors.

 

Nanobiotix’s Phase I/II trial evaluates the safety and preliminary efficacy of NBTXR3 nanoparticles administrated by intra-tumoral (IT) or intra-arterial (IA) injection and activated by high precision radiation therapy, delivered as high dose fractions (Stereotactic Body Radiation Therapy (SBRT)) for the treatment of liver cancers. The trial is now recruiting next dose levels to evaluate safety and feasibility at higher doses along with exploratory efficacy endpoints (complete Response Rate, Progression Free Survival and Overall Survival).

 

Two sub-groups of patients have been treated at 10% dose of NBTXR3, with Intra Tumoral injections (IT), using either 24 Gy or 45 Gy total radiation dose, based on patients dosimetric constrains. Intra-arterial injection has not been explored so far because the Intra Tumoral (IT) injection has been shown to be feasible and successful. The data validate the feasibility of the injection with a volume level equivalent to 10% of the baseline tumor volume in both patient populations: primary cancer (HCC) and liver metastasis. The product appears to stay within the tumors with no leakage in the surrounding healthy tissues from the day of injection until end of radiotherapy treatment. It confirms and supports the findings reported from the clinical trials in Soft Tissue Sarcoma or Head and Neck cancers patients.

 

See more on NBTXR3 on Meddevicetracker.



FDA Clears Integration Between LifeScan’s OneTouch Verio Flex Blood Glucose Monitoring System and WellDoc’s BlueStar Diabetes Management Platform

 

 

LifeScan, part of Johnson & Johnson Diabetes Care Companies, announced that the FDA has cleared the wireless integration of the OneTouch Verio Flex blood glucose monitoring system with WellDoc’s clinically validated diabetes management platform, BlueStar, creating a digital health solution for people with Type II diabetes.

 

Using blood glucose data wirelessly and automatically transmitted from the OneTouch Verio Flex blood glucose monitoring system with built-in Bluetooth Smart Technology, WellDoc's technology will provide patients with individualized real-time feedback and virtual coaching based on the patient’s specific treatment plan, and also help health care teams make timely diabetes management decisions. Along with the OneTouch Reveal web and mobile app, the offering seeks to create a comprehensive, data-driven and payer-reimbursed program for the management of Type II diabetes.

 

OneTouch Verio Flex meter with BlueTooth Smart Technology features ColorSure technology, and is a simple blood sugar test for people with diabetes. The OneTouch Verio Flex meter also has optional wireless connectivity with the OneTouch Reveal mobile app to help patients manage their diabetes. WellDoc’s BlueStar is a digital therapeutic platform cleared by the U.S. Food and Drug Administration for adults with Type II diabetes. LifeScan and WellDoc are working with health plans to help provide patient access for this integrated system.

 

See more on OneTouch Verio Flex and BlueStar on Meddevicetracker.

 

December 15, 2016

 

St. Jude Medical Announces FDA Clearance of EnSite Precision Cardiac Mapping System

 

St. Jude Medical announced FDA clearance and launch of its EnSite Precision cardiac mapping system and Advisor FL Circular Mapping Catheter, Sensor Enabled.
The EnSite Precision cardiac mapping system is designed to provide automation, flexibility and precision in cardiac mapping during the treatment of patients with abnormal heart rhythms (cardiac arrhythmias).

 

The new EnSite Precision cardiac mapping system offers a new dual-technology platform that provides highly detailed anatomical models and maps to enable more efficient treatment of a wide range of arrhythmias — including complex arrhythmias, such as atrial fibrillation or ventricular tachycardia.
St. Jude Medical submitted the 510(k) application in Q1 of 2016.

 

See more on EnSite on Meddevicetracker.



Biocartis Receives CE Mark for NRAS-BRAF Mutation Test

 

Biocartis announced the CE-marking of its solid biopsy Idylla NRAS-BRAF Mutation Test. Together with the Idylla KRAS Mutation Test, Biocartis offers its patients a complete testing for metastatic colorectal cancers (mCRC) for clinical use on its Idylla molecular diagnostics platform, as recommended by the most recent clinical guidelines.

 

 

Operating directly from formalin-fixed paraffin embedded (FFPE) tumour slices, the fully automated Idylla NRAS-BRAF Mutation Test combines, in a single-tissue biopsy test, the detection of 18 NRAS and 5 BRAF mutations at high sensitivity.

 

 

See more on the Idylla NRAS-BRAF Mutation Test on Meddevicetracker.











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