Nestle (VTX:NESN) lured the CEO of Fresenius (NYSE:FMS), Ulf Mark Schneider, to the corner office this week. Fresenius promoted CFO Stephan Sturm to replace Schneider.
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The German medical device company said the Edora pacemakers and cardiac resynchronization therapy pacemakers use a sensor called MRI AutoDetect that’s designed to ensure that the device goes into safe mode only during magnetic resonance scans, ensuring that the device continues to deliver therapy for as long as 14 days after the sensor is activated. Once the scan is over, the Edora device automatically resumes therapy without needing to be reset by a physician, Biotronik said.
“The MRI AutoDetect feature recently won the Cardiostim Innovation Award for ‘Best Practice Improvement,’ in recognition of our contribution to patient safety and easing physician workflows. With Edora’s approval, we are the first to offer MRI AutoDetect to all device patients, whether they are pacemaker, ICD, or CRT patients,” senior vice president Manuel Ortega said in prepared remarks. “With home monitoring and the closed-loop stimulation algorithm also on board, we’re proud to be able to give all patients, whatever device they need, the very best care possible.”
“MRI compatibility for cardiac devices has been a critical development in helping our patients to have longer, better lives. But there are still logistical challenges to managing workflow between cardiologists and radiologists. MRI AutoDetect will certainly help to simplify those,” added Dr. Paul Foley of the Great Western Hospital in Swindon, England. “Meanwhile, reducing the amount of time the device is in MRI mode helps to minimize both the risk to the patient and the impact on their quality of life. This is because the pacemaker functions with all its available features for as long as possible before the scan begins.”
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Shanghai Fosun Pharmaceutical (SHA:600196) led the round, joined by prior investors NGK Spark Plug, South Valley Angels, Iconical, Ohio Innovation Foundation and Carmen Innovation, Spirometrix said.
The Fenom Pro device is designed to measure the fraction of exhaled nitric oxide (FeNO) in exhaled breath, a biomarker for asthma. The Pleasanton, Calif.-based company, founded in 2011, said the device is based on sensor technology developed at the Ohio State University by Prabir Dutta. Spirometrix said its system also tracks data from other devices and monitors local pollen counts, pollution indices and air quality, looking to recognize and manage patterns.
Spirometrix said it’s raised a total of $29 million since its inception.
“We are extremely pleased not only to have Shanghai Fosun Pharmaceutical as a major financial and strategic partner in China, but also that our Series A and B lead investors have participated in this third round of financing,” CEO Dean Zikria said in prepared remarks. “This Series C funding underwrites a launch-pad for Spirometrix to commercialize its initial product, the Fenom Pro point-of-care breathalyzer, a 1st-of-its-kind offering in asthma that comprises several sensors as well as a digital ecosystem designed to prompt evidence that may lead to enhanced clinical decision support.”
“Lately, air pollution in China has triggered public consciousness to proactively manage health, especially in regard of respiratory health and wellness. By investing in Spirometrix, we hope to empower the public with a tool that not only better diagnoses asthma, but also actively monitors and manages this chronic disease,” added Fosun Pharma chairman Chen Qiyu.
The Chinese company is no stranger to the U.S. diagnostics arena, having put $20 million into Astute Medical and its NephroCheck kidney-injury test.
Zikria said the funds will go toward finalizing the development of a hand-held breathalyzer for home use and for product launches in the U.S. and the European Union within a year.
“FeNO monitoring in the management of asthma patients at the point of care has the potential to optimize asthma therapy, improve compliance of medication use and decrease the need for emergency visits and hospitalization,” Spirometrix scientific advisor Dr. James Wolfe of Stanford University said in a press release. “It should be noted that both American Thoracic Society and European Respiratory Society have issued guidelines recommending FeNO testing for the assessment, management, and long-term monitoring of asthma.”
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The data includes payments for items and services such as food and beverage, travel, education, honoraria as well as research, and is based on information related to 618,000 doctors, more than 1,110 teaching hospitals and 1,456 companies.
The Open Payments program, which was created by the Physicians Payment Sunshine Act as part of Obamacare with the aim of improving transparency, requires drug and device manufacturers to report payments to healthcare providers for items like speaking engagements about their products and research grants.
The report allows individuals to track payments to their physicians by drug companies. The need for greater transparency was spawned by concerns that physician prescribing habits and choices could be driven by payments from pharmaceutical and medical device companies.
The program reported $2.6 billion in general payments, $3.89 billion in research payments and $1.02 billion of ownership or investment interests.
This is the 3rd annual report in the program, which has a searchable website. In 2014, payments totaled $7.49 billion.
The agency said it had determined that 2.26% of all financial transactions between pharmaceutical companies and physicians were related to opioid medications.
Among companies with the highest payments is the largest U.S. drugmaker Pfizer (NYSE:PFE), which made $44.7 million in total general payments and $391.7 million in research payments.
Merck (NYSE:MRK) made $34.4 million in general payments and $128 million in research payments, according to the searchable database. Amgen (NSDQ:AMGN), another big drugmaker, made $31.4 million in general payments and $222.2 million in total research payments.
Allergan (NYSE: AGN) made $35.6 million in general payments and $27.5 million in research payments and Actavis Inc – which now goes by the name Allergan after a merger – made $13.4 million in general payments and $36.6 million in research payments, according to the database.
Amgen said it supports initiatives that bring greater transparency to interactions between industry and healthcare providers. Such collaboration “contributes to bringing innovative medicines and therapies to patients,” the company said in an emailed statement.
Merck declined to comment, while representatives for the other companies were not immediately available for comment.
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Durham, N.C.-based Bioventus was formed in 2012 when Smith & Nephew (NYSE:SNN) spun out its biologics and clinical therapies division in a joint venture with venture capital firm Essex Woodlands. In October 2014 Bioventus acquired the OsteoAMP product line from Advanced Biologics for an undisclosed amount; late last year the company added BioStructures, a developer of absorbable bone grafts, also for an undisclosed amount. In January Bioventus named former Medtronic (NYSE:MDT) CEO Bill Hawkins as chairman. The company tapped the CEO of Abiomed (NSDQ:ABMD), Mike Minogue, for a seat on the board last week.
The company’s IPO registration put a placeholder amount of $150 million, but that number is likely to change when Bioventus prices the flotation.
The business has grown since the spinout from Smith & Nephew, which in 2010 reported $44 million in profits on $223 million in sales. Yesterday Bioventus said sales grew 4.4% to $253.7 million last year, but said losses widened by 7.4% to -$4.0 million.
Second-quarter losses also widened, rising 9.3% to -$1.0 million on sales growth of 22.6% to $65.4 million, according to the IPO registration.
Bioventus plans to list its shares on the NASDAQ exchange under the “BIOV” symbol.
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The FDA is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions.
The first part of the campaign will be launched on June 19, 2016, World Sickle Cell Day, observed annually to help increase public knowledge and raise awareness of Sickle Cell Disease, which primarily affects people of African and Hispanic descent. We want to encourage diverse communities to learn more about how they can become a part of the research process to bring new therapies to the market.
Clinical trials are a critical step in making new medical products available. Medical products—from vaccines to drugs for blood pressure or diabetes management — are tested in clinical trials.
Although FDA generally does not conduct clinical trials, we do the critical work in reviewing the data to assess the safety and efficacy of medical products before they can be used in medical practice. None of this is possible without clinical trials and the patients who go the extra mile by being research participants.
In order to help ensure that medical products are safe for everyone, we need a diverse pool of research participants—racial and ethnic minorities, women, even the elderly.
We know that certain diseases impact some populations differently. For example, diabetes occurs more frequently in blacks and Hispanics, high blood pressure and heart failure occurs more frequently and severely in blacks; and, Asian American communities experience more hepatitis B.
Clinical trials participants need to more closely mirror the patients who will ultimately use the medicine. This is especially important when considering health disparities — diseases that occur more frequently or appear differently in non-white populations. But most clinical trials participants are white and male. That means we may miss vital data that could be used to be make better evidence-based, regulatory decisions. If we do not develop a more diverse pool of research participants, health disparities may persist because we will not know if a medical product is safe and effective in the actual population that will ultimately use it.
And that’s why we’re launching our campaign, which includes a series of educational aids such as videos, a blog, and an infographic. In these videos Shirley Miller, who lives with sickle cell disease, talks about her experience participating in clinical trials and encourages her peers to learn more about research studies.
In another video Dr. Luciana Borio, FDA’s Acting Chief Scientist, discusses why clinical trial diversity matters from FDA’s perspective.
This campaign is taking us one step closer to a world where health equity is a reality for all. It supports FDA’s initiative: “The Year of Clinical Trial Diversity.”
It is a part of our larger effort to improve clinical trials diversity — we also work with stakeholder groups, support research, develop multi-lingual resources, and use social media to promote a community of “Clinical Trials Champions.”
Everyone has a stake in the game —health care providers, researchers, and patients. Share these videos and other materials. Start a conversation today.More information about this campaign and FDA’s OMH can be found here: http://ift.tt/1SS0VjG
Follow us on Twitter @FDAOMH
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
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The companies expect to reach a final agreement within 15 days, putting to rest a battle that began when Medtronic subsidiary Warsaw Orthopedic sued NuVasive in 2008. San Diego-based NuVasive counter-sued; in September 2011 a jury split the verdict, awarding $101.2 million in damages to Medtronic and $660,000 to NuVasive.
Last year the U.S. Court of Appeals for the Federal Circuit upheld its decision to award a win to NuVasive and ordered a new trial to determine damages (that trial has not taken place).
“We are very pleased to have negotiated a mutually agreeable settlement that removes the ongoing burden of this litigation and provides for a framework for resolution of potential patent disputes in the future,” NuVasive CEO Gregory Lucier said in prepared remarks.
“We look forward to continue focusing our efforts on accelerating innovations that transform spine surgery and improve outcomes for more patients,” Medtronic spokesman Eric Epperson told Reuters.
Material from Reuters was used in this report.
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