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January 22, 2018


Novartis Completes Tender Offer for Advanced Accelerator Applications and Announces Commencement of Subsequent Offering Period


Novartis announced the successful completion of the tender offer by its subsidiary, Novartis Groupe France of Advanced Accelerator Applications (AAA).



The completion of the acquisition bolsters Novartis’ oncology profile with the addition of 68Ga-PSMA-SR6 Companion Diagnostic. 68Ga-PSMA-SR6 is currently in development for prostate cancer through novel molecular nuclear medicine techniques, utilizing 177Lu-PSMA-SR6 to detect Prostate-Specific Membrane Antigen (PSMA) expressed on prostate cancer tumor cells.



The planned acquisition of AAA was announced in October 2017.



See more about Novartis and the 68Ga-PSMA-SR6 Companion Diagnostic on Meddevicetracker.



As this product is a companion diagnostic, the full development history of the associated drug can be seen on Biomedtracker.



SFC Fluidics Announces Partnership with JDRF to Develop Pod Device for Automated Insulin Delivery


SFC Fluidics (SFC) announced an Industry Development and Discovery Partnership supported by the Juvenile Diabetes Research Foundation (JDRF). JDRF will provide funding to SFC for the development of a single pod Automated Insulin Delivery (AID) device and expand future therapy options for people with Type I Diabetes. JDRF launched its Artificial Pancreas Project in 2006 to accelerate the development of commercially available closed-loop systems.



The two-year funding commitment from JDRF allows SFC to pursue the development of a next-generation AID system that reduces the on-body burden by integrating all components into one disposable, miniaturized device that delivers insulin. The foundation of SFC’s insulin delivery technology, covered by several issued and applied-for patents, is small in size and has the potential to deliver highly accurate doses of insulin. SFC will integrate a continuous glucose monitor (CGM) and an algorithm into a single pod that can be disposed of every three days.



See more about the Automated Insulin Delivery Device on Meddevicetracker.





January 23, 2018

LivaNova Announces the Acquisition of ImThera Medical

Spencer Trask & Co., a privately held development firm, announced the sale of ImThera Medical. The company was purchased by LivaNova as part of a transaction valued at approximately $225 million. Spencer Trask & Co. co-founded ImThera with Marcello Lima. 



ImThera designed and developed a non-drug therapy for obstructive sleep apnea (OSA) that cyclically and continuously stimulates six muscles of the tongue via an implantable device. ImThera developed a programmable chip which stimulates the hypoglossal nerve that supplies the muscles of the tongue with signals from the brain. By so doing, the ImThera implant keeps the air passageway open throughout the night.



See more about LivaNova on Meddevicetracker.





January 24, 2018

Boston Scientific Announces Investment and Acquisition Option Agreement with Millipede


Boston Scientific announced it has closed an investment and entered an acquisition option agreement with Millipede, a privately-held company that has developed the IRIS Transcatheter Annuloplasty Ring System for the treatment of severe mitral regurgitation (MR).



Under the terms of the agreements, Boston Scientific has purchased a portion of the outstanding shares of Millipede along with newly issued shares of the company for a total consideration of $90M. Boston Scientific has the option to acquire the remaining shares of the company at any time prior to the completion of a first in human clinical study that meets certain parameters. Upon the completion of the clinical study, Millipede has the option to compel Boston Scientific to acquire the remaining shares of the company. Each company's option period expires by the end of 2019. Completion of this acquisition would result in an additional $325M payment by Boston Scientific at closing with a further $125M becoming payable upon achievement of a commercial milestone.



See more about Boston Scientific and Millipede on Meddevicetracker.



AngioDynamics Receives FDA Expedited Access Pathway Designation for the NanoKnife System for the Treatment of Stage III Pancreatic Cancer


AngioDynamics announced that the United States Food and Drug Administration (FDA) has granted the Expedited Access Pathway (EAP) designation to the Company's NanoKnife System and proposed indication for use for the treatment of Stage III pancreatic cancer.



The EAP program is designed to help patients gain more timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, for which no approved or cleared alternatives exist. This is achieved by expediting the device's assessment and review processes through more interactive and timely communication with the FDA, pre- and post-market balance of data collection requirements, efficient and flexible clinical study design, FDA review team support and Agency senior management engagement, and priority review.



See more about the NanoKnife System on Meddevicetracker.



Migraine Abortion Trial Shows Positive Results for Cefaly Acute Medical Device


Cefaly Technology announced positive results from its Migraine Abortion Trial using the Cefaly Acute device. Previous pilot and pivotal trials (ACME) demonstrated the efficacy and safety of the Cefaly Acute for the acute treatment of migraine attacks and led to the FDA approval in September 2017.



This new trial on migraine abortion was identical to the design used to test abortive migraine medication, including medications already on the market (triptans) and the new drugs still under medical investigation: Lasmiditan, Ubrogepant and Rimegepant.



The outcome at 2-hours of using Cefaly Acute showed that 70.8% of patients had pain relief, 35.4% were pain-free, and 60.4% were free from the most bothersome symptom (MBS). In comparison, available data on Lasmiditan shows 59% of patients had pain relief at 2-hours, 32.2% were pain free and 40.9% were MBS-free; for Ubrogepant pain relief at 2-hours was 58.8%, while 25.5% of patients were pain free; and for Rimegepant at 2-hours pain relief was at 61.2%, with 32.9% of patients pain free. At the 24-hour mark, sustained pain freedom with Cefaly Acute was 25% of patients. In contrast, Ubrogepant showed 21.6%, while Rimegepant demonstrated 28.2%.



Based on these positive results CEFALY Technology is now moving forward with a Phase III clinical trial in the US that is scheduled to be completed by the end of 2018.



See more about the Cefaly Device on Meddevicetracker.





January 25, 2018 

REVA Announces First Implant of the Fantom Bioresorbable Scaffold in Italy


Reva Medical announced the first implant of the Fantom bioresorbable scaffold (BRS) in Italy. The procedure was conducted at the Fatebenefratelli Hospital in Milan. 



The Fantom BRS is made from Tyrocore, REVA's proprietary tyrosine-derived polymer designed for vascular scaffold applications. Tyrocore is visible under x-ray, making the Fantom BRS visible during x-ray angiography procedures. Fantom offers a thinner profile while retaining radial strength; thinner profiles have been shown to improve deliverability and support vessel healing. 



Previously reported results from the FANTOM II clinical study have shown low Major Adverse Cardiac Event (MACE) rates of 4.2% at 12 months in 240 patients and 5.6% at 24 months in an interim, 125 patient data set. 



See more about the Fantom Bioresorbable Scaffold on Meddevicetracker.  



M3DICINE Introduces Stethee, an AI-Enabled Stethoscope System


M3DICINE Inc announced the launch of Stethee. The Stethee family of products allows users to listen to heart and lungs sounds with amplification and filtering technology and to instantly capture and analyze heart and lung sounds and data via Bluetooth to the Stethee iOS or Android App.



The Stethee system includes three core products: The FDA cleared Stethee Pro for medical and healthcare professionals, Stethee Vet for veterinarians and animal professionals, and Stethee Edu developed specifically as an education and research tool.



The technology platform behind the Stethee AI engine, named “Aida,” can analyze heart and lung sounds to build a unique personal biometric signature. Stethee captures clinical information in only 20 seconds. The sound and data from the device streams to any Bluetooth enabled device or wired headphones. Aida analyzes the signal to identify heart sounds and respiratory activity, as well as any patterns that might indicate a disease condition. The data is represented in real time in the Stethee App for easy understanding of vital signs, and can be easily shared with peers, caregivers or specialists anywhere in the world.



M3DICINE has signed exclusive agreements with Korea Telecom for the distribution of Stethee Pro for telemedicine projects into a number of developing countries and an exclusive distribution agreement with Cargill Korea for Stethee Vet to veterinarians in South Korea.



See more about the Stethee Pro 1 Digital Stethoscope on Meddevicetracker.



Stryker’s DAWN Trial Results Contribute to Updated Acute Ischemic Stroke Guidelines from the American Heart Association and American Stroke Association


The American Heart Association and American Stroke Association announced updated the ischemic stroke guidelines. The new recommendation expanded the treatment window from 6 to 16 hours based on overwhelming clinical evidence from the Stryker-sponsored DAWN trial and confirmed by DEFUSE 3. The guidelines state that it may be reasonable to treat patients up to 24 hours after a stroke, based on the DAWN Trial criteria. The new guidelines mean that more patients will be treated based on clinical presentation rather than a strict time cutoff alone.



Currently, less than 1 in 10 patients suffering from an ischemic stroke receives thrombectomy, a procedure to remove a blood clot that causes stroke. The updated guidelines represent a major step in recognizing that more patients should be eligible for treatment and has the potential to save lives and reduce patient disability.



The guidelines also reconfirmed that stent retrievers are the only devices proven to effectively treat ischemic stroke with level 1A evidence and remain the first choice for neurointerventional treatment.



See more about the Trevo Pro Retriever on Meddevicetracker.  





January 26, 2018 

Flow Neuroscience Raises 1.1M USD in Seed Round Lead by Khosla Ventures to Develop a Device to Treat Depression


Flow Neuroscience, a Sweden-based medtech company, is developing a new treatment for depression combining brain stimulation with behavioral therapy. They have now secured a $1.1 million seed-round from Khosla Ventures, SOSV and a Swedish angel investor.The funding will enable Flow to complete the regulatory process, get its first product approved in the EU, and grow its team.



Flow's wearable device is linked to a behavioral training program mobile application based on peer-reviewed scientific literature. The technology is called tDCS (transcranial direct current stimulation), which uses weak currents to stimulate the brain. It has been shown to change neuronal activity, and influence depressive symptoms similar to antidepressant medication, with less severe side effects. The app teaches the patient how to eat, sleep, and exercise to further reduce depression. 



See more about the Flow Brain Stimulation System on Meddevicetracker.



Medtronic Medtronic Launches IDE Study to Evaluate the Abre Venous Self-Expanding Stent System


Medtronic announced the initiation of its investigational device exemption (IDE) study for the Abre venous self-expanding stent system. The ABRE IDE Study will evaluate the safety and effectiveness of the Abre stent in subjects with iliofemoral venous outflow obstruction. The first procedure was performed in December 2017, by Dr. Erin Murphy, at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, North Carolina, and national principal investigator for the ABRE IDE Study in the U.S. 



Data from the study will be used to support the Abre stent’s U.S. pre-market approval (PMA) application for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.



The Abre stent is an investigational device in the U.S. intended for permanent implant in the iliofemoral vein. It is pre-mounted on a 9 French delivery system and features a nitinol stent with a tri-axial shaft design. The stent utilizes an open-cell design with three connection points between the cells that are intended to enable flexibility and conformability. Upon deployment, the Abre stent uses an optimized balance of strength and flexibility to exert an outward force and open the vein. 



Abre received CE (Conformité Européene) Mark approval in April 2017 and is intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction. 



The multi-center, single arm study intends to enroll 200 subjects with deep venous disease from up to 35 sites throughout the U.S. and Europe. The primary efficacy endpoint will evaluate patency at 12 months, which is defined by freedom from occlusion and freedom from clinically-driven target lesion revascularization (CD-TLR). The primary safety endpoint will evaluate the incidence of composite Major Adverse Events (MAE) at 30 days following stenting of an obstruction in the iliofemoral venous segment. 



See more about the Abre Venous Self-Expanding Stent System on Meddevicetracker.


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