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Meddevicetracker Weekly Roundup

February 12-16, 2018

February 12, 2018



AVITA Medical Announces FDA Approval for Expansion of RECELL Compassionate Use Program

AVITA Medical announced that the U.S. Food and Drug Administration (FDA) approved an increase in the number of patients who may be treated in the United States with the RECELL Autologous Cell Harvesting Device under a FDA Compassionate Use Investigational Device Exemption (IDE) program.

RECELL is a regenerative medical device designed to facilitate skin regeneration while reducing the amount of skin harvested at the time of surgery. Under the expanded protocol, up to 88 patients with life-threatening injuries, including severe burns, may be treated with RECELL. This is the fifth expansion to the Compassionate Use protocol for RECELL approved by the FDA, with the most recent expansion occurring in April 2017. This approval expands the number of patients who may be treated by 20. Eligible patients are those who have insufficient healthy skin available for standard skin grafting treatment of their injuries and whose treating physicians believe there to be no suitable alternative treatment.


To date, 64 Compassionate Use cases using RECELL have been conducted at leading institutions, including Arizona Burn Center at Maricopa Medical Center, Baton Rouge General Hospital, Massachusetts General Hospital, MedStar Washington Hospital Center, Regional Medical Center at the University of Tennessee, Wake Forest Baptist Medical Center, Walter Reed National Military Medical Center, Riley Hospital for Children (Indianapolis), St. Christopher’s Hospital for Children, Shriners Hospitals for Children – Boston, Sidney & Lois Eskenazi Hospital, U.S. Army Institute for Surgical Research (San Antonio), University of California San Diego Health System, and University of South Alabama.


Funding provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, to support the development of RECELL by AVITA has included support of the expanded Compassionate Use program. In September 2017, AVITA submitted to the FDA a Pre-Market Approval (PMA) application for RECELL for the treatment of burn injuries, and the Company expects the PMA review to be completed during the second or third calendar quarter of 2018.


See more about RECELL on Meddevicetracker.


Cerecor Announces Acquisition of Avadel Pharmaceuticals’ Pediatric Assets


Cerecor announced it has entered into definitive agreements with Avadel U.S. Holdings, and certain of its subsidiaries, to purchase and acquire all rights to Avadel's marketed pediatric products. The acquired products consist of Karbinal ER, AcipHex Sprinkle, Cefaclor for Oral Suspension, and Flexichamber. Additionally, Avadel Ireland will develop and provide Cerecor with four stable product formulations of Cerecor's choosing utilizing its proprietary LiquiTime and Micropump technology. Three of these development projects are already underway.


Under the terms of the asset purchase agreement, Cerecor will purchase Avadel's interest in the Avadel pediatric assets for a nominal cash payment and will assume Avadel's financial obligations to Deerfield, which include a $15 million loan due in January 2021 and certain royalty obligations through February 2026. Trailing twelve-month net sales for the acquired products were approximately $8 million.


Under the terms of the licensing and development agreement, Avadel will develop and provide Cerecor with four stable product formulations utilizing its LiquiTime and Micropump platforms. Cerecor will reimburse Avadel for any costs associated with the development of these products in excess of $1.0 million in aggregate. Upon transfer of the product formulations, Cerecor will assume all remaining development and regulatory costs. Once approved and marketed, Cerecor will pay Avadel quarterly royalties on net sales of such products. Under the development agreement, Avadel expects to complete the initial bioequivalence studies within 18 months.


Avadel expects the transaction to close before February 28, 2018, subject to the satisfaction of certain closing conditions including the delivery of certain third-party guarantees and consents. 


See more about Flexichamber on Meddevicetracker.


For the full development history of the drugs to be acquired, please see the Karbinal ER, AcipHex, and Ceclor profiles on Biomedtracker.




February 13, 2018



Emerging Implant Technologies Announces CE Mark of the EIT PLIF Cage


Emerging Implant Technologies (EIT) announced that it has received CE Mark approval and performed the first surgeries in Germany with EIT PLIF cage, its 3D printed adjustable interbody fusion cage.


The adjustable PLIF allows for restoration of lordosis angles up to 18° and supports minimally invasive insertion techniques. The goal is to reduce intraoperative trauma, optimize size adaptation and improve restoration of sagittal balance to improve fusion rates, reduce subsidence and adjacent segment disease (ASD) related to insufficient sagittal balance restoration. The bone contact areas consist of EIT Cellular Titanium porous structure to enhance primary stability and bony integration.


Dr. Marcus Eif, head of neurosurgery at the Klinikum Görlitz in Germany, performed the first case with the system and experienced that the EIT adjustable PLIF implant allowed for a minimally invasive approach, while still being able to restore the required lordosis.


See more about the EIT PLIF Cage on Meddevicetracker.


Orthofix Announces Initiation of Enrollment in Rotator Cuff Repair Study


Orthofix International announced that enrollment has begun in a study that will evaluate the use of pulsed electromagnetic field (PEMF) technology for rotator cuff repair. This study will assess the efficacy and safety of the RCStim device as an adjunctive treatment to surgical repair of full thickness rotator cuff tears.


The study will evaluate if PEMF technology that is currently used to promote bone growth can reduce the rate of repaired tendons being subsequently torn again and improve overall patient outcomes. The study will also gather data to see if there is a correlation between patients treated with PEMF and improvements in muscle strength and range of motion, and a decrease in pain scores.


The PEMF study for rotator cuff repair is a prospective, randomized, double-blind, placebo-controlled trial that will enroll approximately 538 patients who are between 21 and 80 years of age at up to 30 sites in the U.S. Study participants will be randomized in a two-to-one ratio to either an active or placebo control (inactive) device and followed for 24 months after initiation of treatment.


The Orthofix RCStim device is an investigational device and use in the study is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).


See more about the RCStim device on Meddevicetracker.



February 14, 2018



AMAG Pharmaceuticals Announces FDA Approval of the Makena Subcutaneous Autoinjector


AMAG Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved the Makena subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The prefilled Makena auto-injector offers a new administration option for patients and providers and contains a shorter, thinner non-visible needle compared to the intramuscular (IM) Makena injection.


Makena was approved by the FDA in February 2011. AMAG expects the subcutaneous auto-injector to be available in the second half of March, and the company will continue to offer the IM formulation of Makena in both single-dose and multi-dose vials.


AMAG developed the Makena auto-injector with its device partner Antares Pharma, which holds issued patents on the auto-injector device and drug-device combination, the last of which expires in 2034. AMAG also holds a U.S. patent directed to subcutaneous administration and dosing of the Makena auto-injector product which expires in 2036. AMAG will request Orange Book listing of the eligible AMAG and Antares patents. The Companies entered into the license, development and supply agreement in September 2014.


In addition, the company expects to file a new drug application (NDA) in the first quarter of 2018 for a new chemical entity (bremelanotide) to treat hypoactive sexual desire disorder (HSDD).


See more about the Makena QuickShot Autoinjector on Meddevicetracker.


As this device is classified as drug delivery technology, the full development history of Makena can be seen on Biomedtracker.




LivaNova Announces Agreement to Acquire TandemLife


LivaNova announced it has entered into an agreement to acquire TandemLife, which offers four product systems, all built around a common pump and controller. These systems, which include ExtraCorporeal Life Support (ECLS) and Percutaneous Mechanical Circulatory Support (pMCS), are complementary to LivaNova’s offerings in cardiac surgery.


With TandemLife, hospitals can deploy a versatile platform consisting of a single pump and controller upon which all of the company’s products operate. This platform creates ease of use for clinicians and offers mobility for patients. Each TandemLife system may include a pump, an oxygenator and cannulae for comprehensive, acute cardiac, pulmonary or cardiopulmonary care. The TandemLife system provides cardiopulmonary support through veno-arterial ECLS. For patients experiencing respiratory dysfunction, TandemLung provides pulmonary support through veno-venous ECLS. ProtekDuo and TandemHeart provide advanced pMCS for Right Heart Support and Left Heart Support, respectively.


LivaNova has agreed to pay up to $250 million for TandemLife. Upfront costs total $200 million, with up to $50 million in contingent considerations based on regulatory milestones. The deal is projected to be modestly accretive in 2018 and is expected to close in the first half of 2018 (subject to approvals and other customary closing conditions).


See more about LivaNova and TandemLife on Meddevicetracker.




February 15, 2018



DreaMed Diabetes Receives CE Mark for Decision-Support Platform for the Management of Type I Diabetes


DreaMed Diabetes announced that it received CE Mark for the Advisor Pro decision-support platform for assisting healthcare professionals in the management of Type I diabetes. DreaMed Diabetes' cloud-based solution achieved similar glycemic control to that of medical experts in pilot studies, while simplifying patient experience, by offering a personalized insulin treatment plan based on the analysis of data from a variety of sources.


Advisor Pro uses proprietary algorithms combining event-driven, machine learning, and fuzzy logic technologies to process data from a range of connected devices, including insulin pumps, continuous glucose monitors or self-management blood glucometers, and food consumption information. The data is then analyzed to provide an informed and optimized insulin dosing treatment plan for maintaining balanced glucose levels. As a smart decision software, Advisor Pro learns individual patterns and supports highly personalized insulin therapy planning for people with Type I diabetes that use insulin pumps.


DreaMed Diabetes is currently conducting a multi-center clinical study for evaluating Advisor Pro. The controlled, randomized trial is being conducted in partnership with Glooko and is expected to enroll 112 patients in seven clinical centers in the US, Europe and Israel. The aim of the study is to assess the ability of Advisor Pro, as compared to diabetes experts, to adjust blood glucose levels within a predefined range and to prevent hypoglycemic events during a six-month intervention period. Results of the trial are expected by the end of 2018. In three clinical pilot studies performed to date at the Schneider Children's Medical Center of Israel, Advisor Pro achieved similar glycemic control to that achieved by medical expert-guided recommendations.


DreaMed Diabetes is on track with its multi-center clinical trial for Advisor Pro, and it is planning a soft launch in Europe in the summer of 2018.


See more about the MD Logic Pump Advisor on Meddevicetracker.




Edwards Lifesciences Receives CE Mark for the CENTERA Valve


Edwards Lifesciences announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards CENTERA valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. It is packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device preparation.


European certification of the CENTERA valve was based on the CENTERA-EU Trial, which enrolled 203 high-risk patients at 23 centers in Europe, Australia and New Zealand. Study results presented at EuroPCR 2017 in May 2017 demonstrated high survival rates (99 percent) and low rates of disabling stroke (2.5 percent) and new permanent pacemaker (4.9 percent) at 30 days. In addition, there was a low 0.6 percent rate of moderate paravalvular leak among patients, and zero incidents of severe paravalvular leak. All patients in the study were treated via the transfemoral access route with the majority under conscious sedation.


The CENTERA valve is not approved for commercial sale in the U.S.


See more about the CENTERA Transcatheter Heart Valve on Meddevicetracker.




February 16, 2018



BIOCORP and Chronicare Sign Strategic Partnership Agreement


BIOCORP and Chronicare, a US company developing connected monitoring solutions for chronic disease patients, announced that they have reached a development, supply and commercialization agreement.


The agreement, announced during the Advanced Technologies & Treatments for Diabetes (ATTD) International Conference in Vienna, Austria, enables Chronicare to integrate Easylog, the smart insulin pen cap device developed by BIOCORP, into Chronicare's integrated platform, Chronicare Connect, for improving medication adherence through remote monitoring, reminders and notifications, data analytics and coaching services. Terms of the agreement include technology licensing fees, development fees and minimum volume commitments for the commercial phase.


The BIOCORP and Chronicare partnership is a first step in improving medication adherence and outcomes for patients with both Type I and Type II diabetes. Easylog is a smart sensor that transforms all classic pen injectors, disposable and reusable, into smart, connected devices. Easylog captures key treatment information (dose, date, time) and transfers it to the Chronicare Connect Mobile App.


This integrated solution includes other Bluetooth devices such as a blood glucose meter and medication bottle cap; both of which connect to the Chronicare Connect platform to provide important patient treatment information. As Chronicare expands into chronic conditions beyond diabetes, more connected devices will be added to its technology portfolio.


See more about Easylog and Chronicare Connect on Meddevicetracker.

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