December 4, 2017
Dance Biopharm and Phillips-Medisize Enter Into Joint Development Agreement for Advanced Inhaled Insulin
Dance Biopharm announced that the company has entered a joint development agreement (JDA) with Phillips-Medisize to develop a version of the Dance 501 device that has data connectivity for better management of diabetes treatment.
Phillips-Medisize brings world class software and hardware capabilities to implement Dance’s designs. Phillips-Medisize is currently involved in the design and manufacture of clinical devices for Dance and, based on this JDA, Dance has awarded Phillips-Medisize the development work associated with future enhancements to Dance’s devices as well as the commercial manufacturing of Dance’s inhaled insulin device when it comes to market.
See more about the Dance-501 Insulin Inhaler Device on Meddevicetracker.
Biocartis and Amgen Sign Companion Diagnostic Agreement for Idylla RAS Biomarker Tests
Biocartis announced the signing of a companion diagnostic (CDx) development agreement with Amgen for the Idylla RAS biomarker tests. The aim of the agreement is to register the Idylla RAS biomarker tests with the US Food and Drug Administration (FDA) as a companion diagnostic test for Amgen’s drug Vectibix (panitumumab). Vectibix is the first and only fully human monoclonal anti-epidermal growth factor receptor (EGFR) antibody indicated for certain metastatic colorectal cancer (mCRC) patients with wild-type RAS.
RAS testing is an essential predictive biomarker to determine the treatment plan for patients with mCRC. Currently, RAS testing in the US is not performed systematically for all patients, and if done, results can be delayed, which can affect patients’ outcomes.
The CDx agreement further builds on Biocartis’ and Amgen’s collaborations in Europe that are focused on accelerating results of RAS biomarker testing from up to one month to, in principle, same-day results for mCRC patients, using Biocartis’ Idylla platform and Idylla RAS biomarker tests. US FDA approval of the Idylla RAS biomarker tests could allow for a more widespread RAS clinical testing, regardless of the clinical practice size, available lab infrastructure or experience level, and could enable same-day turnaround times.
Under the agreement, Biocartis will pursue a premarket approval (PMA) for the Idylla KRAS Mutation Test and the Idylla NRAS-BRAF Mutation Test with the US FDA. Amgen will provide financial and operational support to Biocartis for the PMA process.
The two Idylla RAS biomarker tests together allow for a simultaneous detection of 44 clinically relevant mutations for colorectal cancer, operating directly from formalin-fixed paraffin embedded (FFPE) tumor slices.
See more about the Idylla CDx on Meddevicetracker.
December 5, 2017
Lilly Initiates Clinical Trial to Evaluate the Functionality and Safety of its Automated Insulin Delivery System
Eli Lilly announced the dosing of the first patient with type I diabetes in a feasibility study to evaluate the functionality and safety of an automated insulin delivery (AID) system currently in development. The first dosing occurred on December 4, 2017.
The AID system is part of the Connected Diabetes Ecosystem, which is being designed to make diabetes management easier by enabling people to use insulin more effectively. The AID system is a hybrid closed-loop platform that uses connected devices - an insulin pump with a dedicated controller, dosing algorithm, and continuous glucose monitor - to automate insulin dosing. These components are designed to work together to automatically adjust insulin infusion rates to maintain blood sugar levels within a specified target range.
The AID system is one of two platforms in development for the Ecosystem. The other is an integrated insulin management system, which combines a connected insulin pen with glucose-sensing technologies and software applications to deliver personalized insulin dose recommendations. Both platforms within the Ecosystem are currently in development, and more clinical trials will be initiated in the coming months in both people with type I and type II diabetes who use insulin. In conjunction with a variety of partners, Lilly is working to make these platforms available to patients within two to three years, pending FDA approval.
See more about the Automated Insulin Delivery System on Meddevicetracker.
Chesapeake Regional Healthcare Will Implement Glytec’s Software to Bolster High-Reliability Care
Glytec announced a partnership with Chesapeake Regional Healthcare for the implementation of Glytec’s eGlycemic Management System to support the optimization of intravenous and subcutaneous insulin therapy during hospitalization, and provide evidence-based guidance on transitions in insulin therapy from hospital to home.
Glytec’s software-as-a-medical-device provides clinical care teams with evidence-based decision support to ensure that insulin therapy is managed safely and effectively, according to best practices established by the American Diabetes Association and American Association of Clinical Endocrinologists.
Glytec’s clinical services team will work hand in hand with clinicians and staff of Chesapeake Regional Healthcare to overcome impediments that have challenged the sustained utilization of basal bolus insulin methodologies. Glytec’s team will also help facilitate a comprehensive plan for continuous improvement in glycemic management, including surveillance, protocols, order sets, workflows and education programs as well as ongoing governance, measurement, analytics, response mechanisms and more.
See more about the Glucommander on Meddevicetracker.
Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection for the Treatment of Adults with Type 2 Diabetes
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes. Ozempic is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.
The approval of Ozempic is based on the results from a Phase III-a clinical trial program. In people with type II diabetes, Ozempic showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release. As a secondary endpoint in the trials, treatment with Ozempic resulted in reductions in body weight. The most common adverse reactions reported in ≥5% of patients treated with Ozempic are: nausea, vomiting, diarrhea, abdominal pain and constipation.
Ozempic is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen. The Company expects to launch Ozempic in the U.S. in the first quarter of 2018, with a goal of ensuring broad insurance coverage and patient access to the product. Ozempic will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce co-pays for eligible commercially-insured patients. Additionally, as part of the access strategy, Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions.
Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
See more about the Ozempic Pre-Filled Pen on Meddevicetracker.
ChoiceSpine Announces First Clinical Use of HAWKEYE Ti Device
ChoiceSpine announced the first clinical use of HAWKEYE Ti, a 3D-printed, titanium Vertebral Body Replacement (VBR) device. The first surgery was performed at Sentara Norfolk General in Norfolk, Virginia.
The HAWKEYE Ti device was designed to stabilize and fuse the vertebral column with simple implants in a variety of shapes and sizes. Its 3D printed architecture combines unique geometry with multiple coarse nano surfaces to encourage bony growth all around the implant and allowing for seamless integration with the vertebral endplates. The HAWKEYE Ti product portfolio provides a favorable environment for spinal fusion with its small and large footprints that range in size from 10 to 60 mm in height in either 0° or 8° lordosis.
ChoiceSpine received U.S. Food and Drug Administration (FDA) clearance for the HAWKEYE Ti device in September 2017.
See more about the HAWKEYE Vertebral Body Replacement System on Meddevicetracker.
December 6, 2017
Smith & Nephew Completes Acquisition of Tissue Regeneration Developer Rotation Medical Inc.
Smith & Nephew announced it has completed the acquisition of Rotation Medical. The acquisition cost is $125 million and up to a further $85 million over the next five years, contingent on financial performance.
The Rotation Medical Rotator Cuff System incorporates a technology and technique that balances biomechanics and biology to enhance the body's natural healing response. The bioinductive implant helps tendons heal by inducing growth of new tendon-like tissue, offering the potential to prevent tear progression and reduce the incidence of re-tears.
The system is complementary to Smith & Nephew's existing portfolio of shoulder repair technologies to supplement repairs of more complex tears. It will be sold through Smith & Nephew's larger sports medicine sales force and the integrated Rotation Medical sales team.
See more about Smith & Nephew on Meddevicetracker.
IMPLANET Announces the Signature of a MOU on a Worldwide Partnership with Korean Company L&K BIOMED
IMPLANET announced that it has signed a Memorandum of Understanding to set up a strategic partnership with L&K BIOMED. L&K BIOMED is a company listed on the Kosdaq stock exchange in Seoul, Korea, with its subsidiary, Aegis Spine, based in the United States. It designs, develops and markets an extensive range of high-end implants for spine surgery in Asia and the United States. This strategic partnership, which should be finalized by no later than January 31, 2018, provides IMPLANET with an opportunity to accelerate its expansion in the United States and Asia.
In the United States:
IMPLANET America will work with Aegis Spine to accelerate the marketing of its Jazz platform, notably through the deployment of existing and complementary solutions incorporating both companies’ technologies. Aegis Spine intends to make the most of IMPLANET's American sales network on the East Coast of the United States, where the company has little presence.
In Asia and in Oceania:
L&K BIOMED will distribute the Jazz platform in addition to its existing product range. The main objective for both companies will be to jointly penetrate the Japanese market. The two companies also intend to subsequently penetrate the Chinese market.
IMPLANET will distribute L&K BIOMED’s implants, which complement the Jazz platform.
See more about the JAZZ System on Meddevicetracker.
December 7, 2017
Stryker Announces Definitive Agreement to Acquire Entellus
Entellus Medical announced a definitive merger agreement by which Stryker Corporation will acquire Entellus in an all cash transaction for $24.00 per share, or an equity value of approximately $662 million. The Entellus Board of Directors unanimously approved entering the agreement.
The closing of this transaction is subject to approval by Entellus’ stockholders, expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is expected to be dilutive to Stryker’s 2018 adjusted net earnings per diluted share by approximately $0.04 and accretive thereafter.
CMS Issues Proposed National Coverage Determination of NGS IVDs Including Thermo Fisher Scientific’s Oncomine Dx Target Test
The Centers for Medicare & Medicaid Services (CMS) has proposed coverage for the Oncomine Dx Target Test as part of a national coverage determination (NCD) for next-generation sequencing (NGS) in vitro diagnostic (IVD) tests. Once implemented, the NCD would provide Medicare beneficiaries with reimbursable testing using Thermo Fisher Scientific's multi-biomarker non-small cell lung cancer (NSCLC) diagnostic.
Oncomine Dx Target Test is designed to identify patients who may be eligible for treatment with one of three U.S. Food and Drug Administration (FDA)-approved targeted therapies for NSCLC. The proposed coverage determination also extends to clinical trials that meet a specific set of criteria, including the NCI-MATCH trial, which uses a standardized NGS protocol developed with Thermo Fisher's Oncomine reagents and Ion Torrent sequencing systems.
The Oncomine Dx Target Test was the first companion diagnostic test approved by the FDA to simultaneously screen for multiple NSCLC therapies, enabling physicians to match patients to FDA-approved therapies in days instead of several weeks. Since gaining FDA approval in June 2017, the Oncomine Dx Target Test received its first positive coverage decision for regional coverage in Oregon, Idaho, Utah and select counties of Washington.
The draft NCD would cover Medicare beneficiaries with advanced cancer (i.e., recurrent, metastatic or advanced stage IV cancer), who have not been previously tested using the same NGS technology. The final policy is expected to be issued during the first quarter of 2018 following public comment of the preliminary NCD.
See more about the Oncomine Dx Target Test at Meddevicetracker.
Exactech Announces First Surgery With Vantage Total Ankle Mobile Bearing System
Exactech announced the successful first surgery using its new Vantage Total Ankle Mobile Bearing System, the newest addition to the Exactech extremities product line. Orthopaedic surgeon and Vantage Ankle design team member Professor Victor Valderrabano, MD, PhD, chairman of the Swiss Ortho Center Basel, recently performed the first case in the world with the mobile, three-component implant in Switzerland. In addition to performing the ankle replacement, Valderrabano had to correct an ankle deformity through fibular lengthening and calcaneal osteotomies.
The Vantage Ankle Mobile-Bearing System received CE approval in Europe, and full European market availability is slated for 2018. The Vantage Ankle Mobile Bearing System is not available for sale in the U.S.
December 8, 2017
Soleno Therapeutics Announces Joint Venture Agreement for Development and Commercialization of CoSense Monitoring Technology
Soleno Therapeutics announced that it, and its wholly-owned subsidiary, Capnia, have entered into a Joint Venture (JV) agreement with OptAsia Healthcare Limited (OAHL), a Hong Kong-based healthcare firm, for the development and commercialization of Capnia’s Sensalyze technology, which includes the CoSense End-Tidal Carbon Monoxide monitor that assists in the detection of excessive hemolysis in neonates, and other related products.
Under the terms of the JV agreement, OAHL will invest up to $2.2 million in tranches to purchase shares of the Capnia subsidiary and as a result of this investment, Capnia will no longer be a wholly-owned subsidiary of Soleno. Going forward, OAHL will be responsible for funding the operations of Capnia. In addition, OAHL has the option to buy the remaining shares of Capnia at a prespecified future time, and at a value based on revenue.
See more about Soleno Therapeutics at Meddevicetracker.
See more about the Vantage Total Ankle System at Meddevicetracker.