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December 26, 2017

Endonovo Acquires Assets of Rio Grande Neurosciences



Endonovo Therapeutics announced it has acquired the Pulsed Electromagnetic Field (PEMF) assets of Rio Grande Neurosciences (RGN) for $4.5 million and settled its lawsuit concerning RGN’s termination of the binding letter agreement to acquire RGN dated July 8, 2016. Under the terms of the settlement agreement, RGN paid $150,000 to Endonovo Therapeutics and granted an exclusive option to Endonovo to acquire the PEMF assets of RGN for $4.5 million, which the Company exercised per the settlement agreement.


The PEMF assets includes a portfolio of intellectual property, including 27 issued patents with foreign patent protection covering the therapeutic use of PEMF for the treatment of various central nervous system disorders. Endonovo Therapeutics will initiate and fund both currently planned and all future clinical trials to evaluate the use of PEMF in the treatment of central nervous system disorders, including traumatic brain injury, post-concussion syndrome, stroke and multiple sclerosis.


The PEMF assets additionally include a portable, disposable PEMF device with a CE Mark and an FDA 510(k) clearance for the treatment of soft tissue injuries and post-surgical pain and edema in addition to medical reimbursement for the treatment of chronic wounds. Endonovo Therapeutics will begin the commercialization of the PEMF assets through licensing and joint venture agreements and the creation of various sales channels and distribution agreements.



See more about SofPulse Targeted Microcurrent Therapy Device on Meddevicetracker.



December 27, 2017

Anika Announces FDA 510(k) Clearance for Its Injectable HA-Based Bone Repair Treatment



Anika Therapeutics announced that its HA-based bone void filler received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury. The bone void filler, which is composed of a synthetic, biocompatible bone graft substitute material, is injected into a void, hardens at body temperature, and is then resorbed and replaced by the growth of new bone during the healing process.



See more about the HA Injectable Bone Repair Treatment on Meddevicetracker.



DarioHealth Granted Another U.S. Patent 



DarioHealth announced the U.S. Patent and Trademark Office has issued the Company patent #9832301 titled "Systems and Methods for Adjusting Power Levels on a Monitoring Device."


DarioHealth uses this patented technology to enhance the way its smart meter communicates with users' smartphone devices. In the U.S. market, the Dario Blood Glucose Monitoring System connects to a smartphone via a coin-sized dongle that does not require a battery for operation; rather, it relies on the smartphone's battery as its power source. In the effort to reduce battery-dependence and ensure 100% real-time data capture, the application is able to monitor and adjust power levels on smartphones accordingly to enable sufficient output with minimal reliance.



See more about Dario Diabetes Management Solution App  and Dario Smart Meter on Meddevicetracker.



Mithra and Adamed Sign Commercialization Agreement for MyRing in the Czech Republic




Mithra announced a non-exclusive, 10-year license and supply agreement with Adamed Group (Adamed), for the commercialization of Myring, Mithra’s combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA), in the Czech Republic. Adamed is a Polish pharmaceutical and biotechnology company with a focus on gynaecology. Financial details of the agreement were not disclosed. Under the terms of the agreement, Adamed will have the rights to sell Myring in the Czech Republic. Mithra will exclusively manufacture and supply the product to Adamed from its Contract Development & Manufacturing Organization (CDMO) research and manufacturing center. In addition to an upfront fee and a milestone payment, Mithra anticipates annual revenues following commercial launch of MyRing, which is expected in the second half of 2018. 


Earlier this year, Mithra announced an exclusive long-term license and supply agreement with Mayne Pharma for the commercialization of Myring in the Unites States, as well as an agreement with Gynial for the Austrian market. 



See more about MyRing on Meddevicetracker.




December 28, 2017

iVascular Receives CE Mark for 200 cm Length Oceanus 35 PTA Balloon Catheter




iVascular announced that its Oceanus 35 PTA balloon dilatation catheter has received CE mark approval for its new usable catheter length of 200cm. With this approval, iVascular offers a complete portfolio including the lengths 80cm, 140cm and now 200 cm. 


Oceanus 35 is designed for dilation of stenosis located in the renal, iliac, femoral, popliteal and infrapopliteal arteries, and for the treatment of obstructive arteriovenous dialysis fistulae, native or synthetic. 



See more about Oceanus 35 PTA Balloon Catheter on Meddevicetracker.



December 29, 2017

BD Completes Bard Acquisition, Creating New Global Health Care Leader



Becton, Dickinson and Company (BD) announced it has completed the acquisition of C. R. Bard, Inc.



Under the terms of the transaction, upon completion of the acquisition, Bard became a wholly owned subsidiary of BD, and each outstanding share of Bard common stock was converted to the right to receive (1) $222.93 in cash without interest and (2) 0.5077 of a share of BD common stock. As a result of the completion of the acquisition, Bard shares will cease trading and will be delisted from the New York Stock Exchange.



See more about Becton, Dickinson and Company on Meddevicetracker.





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