NEW YORK, Feb. 4, 2020 /PRNewswire/ -- While the healthcare industry has made great strides in the last several years, many complex issues within the industry remain unsolved. From all the segments under the healthcare umbrella, it is the medical device market that is uniquely positioned to solve some of healthcare's most persistent problems. In the modern technologically-driven healthcare landscape, the business model of medical device companies has evolved from device makers to problem solvers. And among the many examples, medical device manufacturers are leveraging the cloud to improve clinical workflow, help physicians remotely monitor patients with real-time data and analytics solutions, as well as using innovative solutions to cut costs and improve outcomes. Furthermore, focusing on the technological 'problem solving' aspect of medical devices has also helped the industry put the patient at the center of their business model. In a report published by PwC, Andrew Thompson, co-founder and CEO at Proteus explained that, "The reason why the technology industry in the last two decades has created trillions of dollars of value is because tech companies have started to collaborate and put consumers at the center of their business models, and build solutions. They don't work to optimize their own piece of the solution, and then tell the consumer to go figure it out. That approach, in healthcare, represents a massive opportunity for new value." As a result, the medical device market is expected to reach an estimated USD 432.6 Billion by 2025 while expanding at a CAGR of 4.1% from 2020 to 2025, according to data by Lucintel. Endonovo Therapeutics, Inc. ENDV, Globus Medical, Inc. GMED, Hologic, Inc. HOLX, Dentsply Sirona Inc. XRAY, Tandem Diabetes Care, Inc. TNDM.
The Food and Drug Administration (FDA) also recognizes the innovative progress the medical device market has started to go through. Back in 2018, medical device manufacturers saw a higher number of novel medical device approvals than ever before in FDA history. During that year, the federal agency approved 106 novel devices, surpassing the 40-year record we set in 2017 of 99 novel device approvals. In addition, the FDA also granted 112 Breakthrough Device Designation requests since the start of the program in April 2015, and, during 2018, approved or cleared nine breakthrough devices. PwC indicates that while 2018's record is good news for the industry, which saw fewer than half the current level of approvals and clearances as recently as 2013, the record is probably the result of expanded use of particular review pathways and other operational improvements. As an example, consider the recent legislation that made the De Novo pathway considerably easier to use; As a result, the number of submissions almost doubled in 2017, from 54 to 101, and the FDA has accelerated review periods from an average of 866 days per filing in 2009 to 280 days as of 2016. Clearly, the FDA has been making significant changes to its medical device regulatory programs, simultaneously trying to improve the safety of certain products and to expedite their review, clearance or approval.
Endonovo Therapeutics, Inc. ENDV announced today the, "reduction of current liabilities and restructuring the balance sheet as the result of the modification of the terms of the Preferred C shares through filing of an Amended and Restated Certificate of Designation of the Series C Secured Redeemable Preferred Stock. The amended designation of the Preferred C Shares was approved by the holders of a majority of those shares and removes the Company's obligation to redeem those shares for approximately $1.8 million which was included as a debt on our balance sheet.
Endonovo Therapeutics CEO Alan Collier stated, 'Strengthening our balance sheet is a priority that we feel is instrumental in our continued and long-term success. This reduction of debt provides us the flexibility to expand our sales and marketing initiatives and to further develop our nationwide reach to hospitals, as well as the other medical facilities we have identified as prospective partners without having financial restraints. Additionally, reducing the debt increases our shareholder equity which is another step in our goal of attaining Nasdaq listing requirements as we look to uplist.'
Details regarding the arrangement are included in Endonovo's 8K report filed with the Securities and Exchange Commission on February 3, 2020.
About Endonovo Therapeutics Inc.: Endonovo Therapeutics is a commercial-stage developer of noninvasive wearable Electroceuticals® therapeutic devices. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals® therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and central nervous system (CNS) disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's noninvasive Electroceutical® therapeutic device, SofPulse®, which uses pulsed short-wave radiofrequency at 27.12 MHz, has been FDA-cleared and CE marked for the palliative treatment of soft tissue injuries and post-operative pain and edema and has CMS national coverage for the treatment of chronic wounds. The Company's current portfolio of preclinical-stage Electroceuticals® therapeutic devices addresses chronic kidney disease, liver disease non-alcoholic steatohepatitis (NASH), cardiovascular and peripheral artery disease (PAD), and ischemic stroke. The Company's noninvasive, wearable Electroceuticals® therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur. www.endonovo.com."
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Globus Medical, Inc. GMED musculoskeletal solutions company, announced earlier last September the launch of the AUTOBAHN® Nailing System. This comprehensive platform provides advanced clinical solutions for fractures of the tibia and femur. The AUTOBAHN® portfolio includes the Intramedullary Trochanteric Nail, Antegrade/Retrograde Femoral Nail, and Tibial Nail. These new nail offerings are part of Globus Medical's expansion into the Trauma market over the past 24 months. "Globus' ability to understand our customers' needs and to innovate in this space allows us to provide instruments and solutions not previously available to today's surgeons," says Barclay Davis, VP of Trauma. The AUTOBAHN® Nailing System complements the available ANTHEM® Plating and ARBOR® External Fixation Systems, and expands the Globus Medical Trauma Portfolio.
Hologic, Inc. HOLX announced earlier last year the Launch of Unifi™ Workspace, Comprehensive Reading Solution for Breast Health Diagnostics. Unifi Workspace integrates reading of MRI, ultrasound and mammography into one dedicated platform, and is designed to allow for more efficient review of breast images. The new solution features multimodality pre-fetching capabilities and MRI tools, such as MR CAD with subtraction, colorization and wash-in wash-out curve; MR motion correction; and multimodality-enabled hanging protocols. "Over the years, we've listened closely to radiologist feedback on how we could improve the reading experience," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "Unifi Workspace represents a prime example of how we've innovated with the end user in mind. By integrating multiple imaging modalities into one system, this new solution can not only improve workflow efficiencies and patient outcomes, but also significantly reduce costs over time as it eliminates the need for additional workstations. We believe this product is a real game changer for our customers and we're confident they will agree."
Dentsply Sirona Inc. XRAY introduced last year the CEREC Primemill, a brand-new grinding and milling unit. CEREC Primemill features a powerful 7-inch touch interface, an integrated camera for scanning blocks with compatible data matrix code and an RFID scanner for reading tool information. It also works with a wide range of materials. The new design offers significantly smoother operation. "CEREC Primemill is a real game changer in the whole workflow," said Dr. Gertrud Fabel, dental practitioner in Munich (Germany) and key opinion leader for Dentsply Sirona. "Everything works significantly faster than before, the quality of the restorations is convincing due to the very fine margins and smooth surfaces, and handling is more than simple: the team can provide perfect support and thus accelerate the entire workflow to make it even more pleasant for the patient."
Tandem Diabetes Care, Inc. TNDM announced back in January its commercial launch of the t:slim X2™ insulin pump with Control-IQ™ technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL). It is the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar. The system integrates with Dexcom G6 continuous glucose monitoring (CGM), which requires no fingersticks for calibration or diabetes treatment decisions. The Company will soon begin sending emails with update instructions to all in-warranty t:slim X2 users in the United States, who have the option to add the new feature free of charge via remote software update. t:slim X2 pumps pre-loaded with Control-IQ technology are now shipping to new customers.
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