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Medtronic Statement Regarding New York Times Article on March 29, 2020

Medtronic plc (NYSE:MDT) issued the following statement regarding a New York Times article mentioning Medtronic on March 29, 2020:

Medtronic seeks to provide additional facts regarding the New York Times article entitled The U.S. Tried to Build a New Fleet of Ventilators. The Mission Failed.”, dated March 29, 2020. The article lacks important information regarding Newport Medical’s contract with the U.S. Government.

Medtronic, who had no relationship with Newport Medical and who did not purchase Covidien until 2015 – nearly three years after the contract dissolved – had no prior knowledge of or involvement in this contract in any manner.

Since the outset of COVID-19 in early 2020 in China, Medtronic has ramped up production of its high-performance ventilators by more than 40 percent. The company’s employees are working 24/7 across multiple shifts to produce as many high-performance ventilators as possible – from a production level of approximately 100 PB980 ventilators pre-pandemic to more than 225 vents per week to date with plans to double that again to more than 500 vents per week. In addition, the company is working with third parties to explore other non-traditional mechanisms to increase production of ventilators, including providing its intellectual property and ventilator designs to the public for third-party ventilator production.

Medtronic’s review and understanding of the facts regarding Newport Medical are as follows:

  • In September 2010, Newport Medical, an independent, approximately 100-person company based in California, entered into a contract with the Government to develop a new fully featured, mid-level ventilator at a cost of $3,000.00. The contract required that the ventilator be capable of use in neonatal through adult populations. The three-year contract was initiated on September 24, 2010 with an expected completion date of September 23, 2013.
  • In May 2012, Newport Medical was then acquired by Covidien in order to provide Covidien with access to Newport’s existing mid-level acuity ventilators, thus expanding Covidien’s portfolio of ventilators into the mid-level acuity category.
  • Through the due diligence process, Covidien became aware of Newport Medical’s contract with the Government. Covidien learned that Newport’s work on the ventilator design for the Government had significant gaps between what it had promised the Government and what it could deliver – both in terms of being able to achieve the cost of production specified in the contract and product features and performance. Covidien management questioned whether Newport’s ability to complete the project as agreed to in the contract was realistic.
  • Covidien management attempted through 2013 to address and fill the gaps in Newport’s capabilities, however, they were unable to do so. They were not able to deliver a product close to the target cost of manufacture required by the contract specifications. In addition, the company was unable to secure FDA approval for use in neonatal populations – a contract requirement.
  • In November 2013, Newport/Covidien and the Government mutually agreed to end the contract. The Government retained ownership of all equipment, tooling, and intellectual property rights in the event the Government were to pursue the project with another manufacturer. To our knowledge, no one has provided such a ventilator to the Government to date.
  • Bob White, Medtronic’s EVP and President of its Minimally Invasive Therapies Group, was made available to the New York Times to discuss ventilators and the current efforts by Medtronic to supply the marketplace in light of COVID-19. In the process of the interview, he was asked about this contract. Mr. White did not immediately recall the specific details of the contract – events that occurred nearly eight years ago.

Medtronic Launches New Solutions to Help Monitor Patients for COVID-19

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced its Medtronic Care Management Services (MCMS) business is launching two new solutions designed to help assess, monitor, and triage support for patients who may be concerned about COVID-19 and their respiratory symptoms.

It has already launched its new Respiratory Infectious Disease Health Check to existing MCMS customers, and it is now launching a new COVID-19 Virtual Care Evaluation and Monitoring solution available to U.S. health systems, health plans and employers.

“With the rapid spread of COVID-19, we know that alternative approaches to screening, disease monitoring, and patient education are urgently needed to reduce additional population exposure to the virus and ease the burden on health care providers and facilities. It’s easy to understand why staying in self-quarantine and monitoring your own symptoms is challenging. Unless you consult a medical professional, it’s hard to know when your symptoms warrant seeking medical care,” said Sheri Dodd, vice president and general manager of MCMS. “Using technology for self-reported symptom monitoring may play an important role in slowing the spread of the disease and helping escalate patient needs to their provider when appropriate.”

The Respiratory Infectious Disease Health Check for existing MCMS customers is an included add-on to all current care management programs. The Respiratory Infectious Disease Health Check helps patients with chronic, co-morbid health conditions who are at the highest risk for complications or mortality associated with COVID-19 track their respiratory infectious disease symptoms and body temperature through daily health checks. The program reacts dynamically during the health check to present symptom questions based on the patient’s previous responses, and provides patient education to encourage and support self-care. Data is aggregated for clinician review and action if additional intervention is needed.

For health systems, health plans and other employers new to MCMS programs, the company is launching a stand-alone assessment and monitoring service. The COVID-19 Virtual Care Evaluation and Monitoring solution uses a virtual assistant to evaluate patients through a Centers for Disease Control and Prevention (CDC) guideline-based survey for COVID-19 symptoms. If the user’s symptoms warrant it, the solution connects them to the MCMS nurse command center, where registered nurses review the patient’s data and either identify recommendations or the need for additional care assessment, based on the CDC guidelines. This could include a recommendation to continue monitoring symptoms at home, or to contact a healthcare provider directly.

“True to the Medtronic Mission, the health and safety of our customers, their patients, and our employees remains our highest priority as we address this unprecedented outbreak,” says John Liddicoat, M.D., executive vice president and president, Medtronic Americas Region. “Around the world, we are in ongoing communication with customers, suppliers, and governments to prioritize needs to the best of our ability. These solutions aim to help manage unnecessary exposures, minimize burden on the health care system, and escalate the most seriously ill patients for immediate care.”

New Non-Contact Forehead Infrared Thermometer to Aid in Coronavirus Prevention

DeltaTrak reports the new Model 15004 Non-Contact Forehead Infrared Thermometer serves as a valuable solution in the fight against the Coronavirus. One of the first steps in preventing cross-contamination is to measure and screen personnel that may have a fever, which is one of the main symptoms of COVID-19.

The need to screen individuals that work together in large workforce environments is imperative to reduce the risk of spreading the infection. The new FDA and CE approved Forehead Infrared Thermometer provides instant readings without necessary contact making it an ideal COVID-19 risk prevention solution.

With so much concern about health and safety at this time, it was important that we provided a solution that can be used to quickly and safely measure body temperature in large group settings,” said Frederick Wu, President and CEO of DeltaTrak. “Our focus is presenting meaningful solutions to current pandemic conditions for businesses we serve around the world. We believe that this new non-contact forehead infrared thermometer will be significantly beneficial in performing the daily preventive protection measures that we must do to minimize cross-contamination and maximize safety for all of us in every community during this trying time.”

 

GEN2 Pure-Vu System Receives CE Mark Approval

Motus GI is assessing potential strategic partnership opportunities for the Pure-Vu System with established medical device companies and distributors with commercial operations across the EU.

The CE Mark signifies that the Pure-Vu System meets the essential requirements of all relevant European Medical Device Directives. The directives outline the safety and performance requirements for medical devices in the European Union (EU). Receiving this regulatory clearance allows Motus GI to commercialize the Pure-Vu System and disposable sleeves across the EU and other CE Mark geographies.

“This is an important step in our commercialization strategy for the Pure-Vu system in Europe. We estimate that there are approximately 1.2 million inpatient colonoscopies conducted annually in the EU, making it one of the largest potential markets for our system,” stated Tim Moran, Chief Executive Officer of Motus GI.

“The next step in our plan to enter the European market with the Pure-Vu System is to assess potential distribution agreements with companies that offer proven sales capabilities in the GI space and working knowledge of each country’s regulations. We believe a partnership could be the most efficient and effective method to bring the clinical and economic benefits of our Pure-Vu® System to physicians and patients across Europe.”

The Pure-Vu System, a U.S. FDA cleared medical device indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure. The device integrates with standard and slim colonoscopes to improve visualization during a colonoscopy while preserving established procedural workflow by irrigating the colon and evacuating debris to provide a better quality exam. Challenges with bowel preparation for inpatient colonoscopy represent a significant area of unmet need that directly affects clinical outcomes and increases the cost of care.

Motus GI believes the Pure-Vu System may improve outcomes and lower costs for hospitals by reducing the time to successful colonoscopy, minimizing delayed and incomplete procedures, and enhancing the quality of an exam. In clinical studies to date, the Pure-Vu System significantly increased the number of patients with an adequate cleansing level, according to the Boston Bowel Preparation Scale Score, a validated assessment instrument.

Motus GI estimates that approximately 1.5 million inpatient procedures take place in the U.S. annually and approximately 4 million procedures take place worldwide each year.

National Ventilator Registry Launched by Phunware

“As the United States braces for an onslaught of coronavirus cases, hospitals and governments are confronting a grim reality – there are not nearly enough lifesaving ventilator machines to go around and there is no way to solve the problem before the disease reaches full throttle,” according to a recent NY Times article.

The Johns Hopkins Center for Health Security (JHCHS) estimates that there are about 160,000 ventilators available for patient care, but the American Hospital Association (AHA) estimates 960,000 people may need them over the course of the COVID-19 pandemic. While manufacturers race to ramp production, hospitals and patients need access to real-time utilization data of the existing ventilators in operation.

Phunware’s Knowledge Graph is uniquely suited to track critical data attributes in near real-time, while Phunware’s mobile digital front door provides clinicians with everything they need to monitor and track the utilization of key resources like ventilators. However, to do this across the country, Phunware is calling on the medical community to compile a National Ventilator Registry so that clinicians can have complete visibility on existing resources and patients can locate the lifesaving equipment that they need.

“We have built a data engine that is capable of managing over a billion active devices and four billion daily transactions while generating more than 5 terabytes of data each day,” said Randall Crowder, COO of Phunware. “We can leverage our technology to identify and track critical medical assets like ventilators, but we need to act now and we need everyone’s help getting the word out to medical professionals on the frontline so that we can collect the information that we desperately need.”

More about Phunware’s efforts to locate and track ventilators across the United States in order to optimize resource allocation and utilization visit here.

Barco Uniforms Launches COVID-19 Scrub Donation Program

Barco Uniforms pledges to donate 10,000 scrubs each month for the duration of the coronavirus pandemic to healthcare professionals on the front line treating patients who have been infected. Donations will be prioritized and distributed based on requests made by Healthcare teams who submit a scrub donation request on Barco’s website.

“We are launching our scrub donation program to show our sincere thanks and demonstrate our immense gratitude to Healthcare professionals all over the country, all of whom have been so heroic in the fight against this pandemic,” said Barco Uniforms president/CEO David Murphy. “We are here to support the Healthcare workers as they take care of all of us.”

Scrub donations include all seven of Barco’s brand collections, including Barco OneTM, Grey’s AnatomyTM and SkechersTM by Barco.

“We are launching our scrub donation program to show our sincere thanks and demonstrate our immense gratitude to Healthcare professionals all over the country, all of whom have been so heroic in the fight against this pandemic,” said Barco Uniforms president/CEO David Murphy. “We are here to support the Healthcare workers as they take care of all of us.”

Barco Uniforms has served Healthcare professionals for over 90 years and has been built on the belief that those in the Healthcare and services industries are multidimensional individuals with their own experiences of risk, vulnerability and struggle. The company’s Made to Matter philosophy, was created to give back and honor the spirit of healthcare professionals around the world. “Serving those who serve others has been a pillar of our legacy for over 90 years and at the forefront of everything we do, but these words have never had greater strength and deeper meaning than they do today during these unprecedented times,” added Murphy.

ShiraTronics, Inc. Completes $3 Million Additional Series A Financing

ShiraTronics notes the financing was provided by Breakout Ventures (BOV). BOV joins previous Series A lead investors USVP, Amzak Health, and Strategic HealthCare Investment Partners (S.H.I.P), with participation from Aperture Ventures, LivaNova PLC, and a leading Academic Institution.

“Breakout Ventures backs bold companies bringing the strongest scientific insights to bear on important problems. ShiraTronics’ approach builds on years of clinical evidence for the effectiveness of neuromodulation, when properly administered, in the treatment of chronic migraine. We believe the time is right to build a safe, convenient system dedicated to this purpose and that the team behind it has the experience needed to succeed,” said Lindy Fishburne, Breakout Ventures’ Managing Partner.  “We are honored to join an investor syndicate with deep expertise in commercializing medical devices to further accelerate ShiraTronics’ path to market, and ultimately to patients.”

“We are thrilled to be partnered with such an experienced investor group led by USVP, Amzak, and S.H.I.P. This important financing from Breakout Ventures provides us additional resources needed to develop and advance a novel therapy for migraine headache in the clinic,” said Lynn Elliott the President and Chief Executive Officer of ShiraTronics.

“Our therapy under development for migraine, a condition that disproportionately impacts women, has the potential to positively impact the lives of millions of patients worldwide. We warmly welcome the addition of Breakout Ventures to this world-class consortium of investors to further develop this valuable therapy,” said Mudit K. Jain, Ph.D., a co-founder and Chairman of the Board of ShiraTronics.

Orthofix Medical Completes Acquisition of FITBONE Limb Lengthening System

Orthofix Medical Inc. has announced it has completed the acquisition of assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones.

The transaction also includes other potential applications of the technology which are in development, including the FITSPINE® system for fusionless surgery to treat early-onset scoliosis. With the addition of the FITBONE assets, Orthofix becomes the only orthopedic company that offers a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction.

“The acquisition of the FITBONE® intramedullary lengthening system further demonstrates Orthofix’s commitment to investing in differentiated products that are a strong strategic fit within our core businesses,” said Orthofix President and Chief Executive Officer Jon Serbousek. “Adding this technology to our current limb reconstruction portfolio enables us to offer physicians solutions to meet the needs of their patients which may require internal or external fixation procedures. We look forward to developing other applications of this exciting platform.”

Terms of the agreement executed with Wittenstein SE, a privately-held Germany-based company who developed the technology, include $18 million in cash closing consideration and a manufacturing supply contract with Wittenstein SE.

The FITBONE system will be a part of the Orthofix Extremities portfolio of solutions that include the TL-HEX computer-assisted ring fixation system for external limb lengthening and the eight-Plate Guided Growth System for correcting angular growth deformities in pediatric patients. To learn more about Orthofix’s dedication to helping surgeons and limb deformity correction patients, please visit JuniOrtho.club.

Consisting of an intramedullary lengthening nail that is surgically implanted in the bone through a minimally invasive procedure, the FITBONE system includes an external telemetry control set that manages the distraction process. The patient’s treatment is also supported through the FITBONE app that guides the patient throughout the limb-lengthening treatment. Over 3,500 cases in more than 15 countries have been performed with the FITBONE system.

The FITBONE intramedullary lengthening system is available in the U.S. under a U.S. Food and Drug Administration 510(k) clearance and in European Countries under a CE Mark approval.

Jonathan Chapman Appointed President and CEO of PTS Diagnostics

Jonathan Chapman brings 20 years of leadership experience in the medical device industry, most recently serving as President of ARKRAY USA, Inc.

Jonathan Chapman joins PTS Diagnostics with an accomplished track record regarding mergers and acquisitions, post-acquisition integration, global product launches, market identification, and strategic positioning.

I’m honored to join the PTS Diagnostics team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes and assessment of cardiovascular disease risk,” said Jonathan Chapman, President and CEO of PTS Diagnostics. “We will continue our legacy of bringing leading innovation to patients across the globe. PTS Diagnostics’ broad capabilities, world-class leadership team, and committed people give me great confidence about our future.”

Jonathan Chapman received a Bachelor of Arts from Sheffield University UK, LLM Commercial and Corporate Law from University of London (SOAS) and LLM Health Law from Hamline Law School, St. Paul, MN. PTS Diagnostics is confident that his international experience will be immensely valuable when leading the organization across global markets.

Mr. Chapman will be based out of the Whitestown, Ind. global headquarters.

As a comprehensive point-of-care diagnostics company, PTS Diagnostics manufactures solutions that close gaps in care for patients with chronic conditions such as diabetes, cardiovascular disease, and other related comorbidities.


Other executives in the news can be found here.

Change in Chief Executive Officer Announces Bioventus

Tony Bihl, CEO of Bioventus is electing to retire on April 30, 2020. As a result, the Bioventus Board of Managers has unanimously appointed Ken Reali, former President and CEO of Clinical Innovations, LLC, to assume the role of CEO of Bioventus. Reali will also become a member of the Company’s Board of Managers, effective April 20, 2020.

Reali served as President and CEO of Clinical Innovations, a medical device company focused on woman’s healthcare, from June 2015 until its successful sale on February 12, 2020. He started his career at Biomet and worked at Stryker, Smith & Nephew and Baxano Surgical where he held positions of increasing responsibility, including CEO over the past ten years. Reali also worked within the Clinical Therapies business of Smith & Nephew over a decade ago which was later spun out to become Bioventus. He currently serves on the boards of Ossio Integrative Orthopedics, AdvaMed and AdvaMed Accel and is Chairman of the Ethics and Compliance Committee for AdvaMed.

“I am honored to have the opportunity to lead Bioventus,” said Reali. “The Company’s broad product portfolio, global presence, and solid growth have it well-positioned to serve the needs of patients and physicians. Even more  successes lie ahead and I’m excited to work with the talented Bioventus team to drive strong value for all stakeholders.”

“Tony has been an outstanding CEO and Leader of Bioventus and we will miss him, though at the same time, the Board and I are pleased to welcome Ken Reali as the incoming CEO of Bioventus,” said William Hawkins, retired Chairman and CEO of Medtronic, Senior Advisor to EW Healthcare and Bioventus Board Chairman. “Ken’s experience in business development, driving top and bottom-line growth while building a compliant culture, global product commercialization and sales of medical devices, combined with a strong background in ethics and compliance, market analysis, experience as a CEO in both public and private companies is just the right fit to lead Bioventus.”

“Today I feel great satisfaction with the progress we have made toward achieving our mission and growing Bioventus. We have broadened our product offering, built a talented team, grown revenue and profit each year, and woven together a positive culture focused on the patients we serve,” said Bihl. “I want to thank the Board and my colleagues at this great company and I know Ken Reali will bring new ideas and energy for the next growth phase of Bioventus.”