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TriGUARD 3™ Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures

Doctor Nicolas Dumonteil, Interventional Cardiologist, Clinique Pasteur in Toulouse, France notes, “Even with increased operator experience and availability of next-generation TAVI devices, cerebrovascular complications remain at a stable level, but continue to be the most feared and devastating complications during TAVI. ” He added, “Interventional cardiologists are seeking options to avoid cerebral complications for their patients.”

TriGUARD 3™ Cerebral Embolic Protection Device is the only CE Marked product designed to cover and protect all three major cerebral aortic arch vessels. The state-of-the-art Nitinol frame and dome-shaped mesh deflector are delivered transfemorally and designed to “self-position” in the aortic arch.  This design allows the TriGUARD 3™ CEP device to conform to a variety of patient anatomies.

“Taking into consideration the devastating impact of stroke, we are pleased to bring this important technology to patients undergoing any transcatheter heart procedure.  The introduction of the TriGUARD 3™ CEP Device in Europe provides physicians the only commercially available device that is designed to protect all three cerebral vessels.” Stated Chris Richardson, Keystone Heart, President and CEO.

Keystone Heart recently completed the REFLECT Trial (a pivotal randomized trial of the TriGUARD 3™ CEP device).  Keystone Heart is currently finalizing data analysis ahead of the planned marketing application to the US Food and Drug Administration.

Zeto Raises Series A Funding

Zeto, Inc. today announced that it has raised $7.3 million in Series A financing led by Seraph Group and joined by Aphelion Capital, SV Tech Ventures and Shangbay Capital.

Zeto raised $4 million previously in dilutive and non-dilutive funding. The new capital will be used to accelerate the commercialization of its lead product, the zEEG headset and software platform, and develop new products to expand its portfolio. zEEG is the first true dry electrode EEG headset to be approved by the U.S. Food and Drug Administration (FDA) for clinical use.

“Since our commercial launch a few months ago, we added several customers who love the product and are utilizing it at high rates. We are glad to validate the strong product-market fit for zEEG. Inspired by the demand, we are excited to expand our commercial team and production capacity to serve our growing customer base,” said Aswin Gunasekar, MS, MBA, Chief Executive Officer and Founder of Zeto. “Our goal is to provide the most seamless and intelligent EEG experience for any clinical need. Current products are far behind what users need and Zeto is building a suite of convenient and intuitive products to eliminate the most time consuming and labor-intensive activities involved in traditional EEG. As a subsequent step, we plan to utilize artificial intelligence to not only supplement the reading physician with analytics and insight but also expand the diagnostic utility of EEG worldwide in areas of medicine where it has been underutilized.”

Zeto’s customer, Wave Neuroscience, Inc., said, “Our extensive intellectual property portfolio and business operations are built on award-winning science and medical innovation. For us to achieve a high level of results we are committed to, we rely on partners that never rest in their quest to achieve the highest standards. Accessing an FDA compliant EEG device that performs at an uncompromising standard, allows for increased throughput and provides a user experience that rivals the latest technology assets, was very attractive to us. Zeto transformed the way we think about EEG capture by advancing technology further in the past two years than the industry had in the prior three or four decades. Zeto provides us the confidence, convenience and data quality that we rely on, day in and day out.”

“We believe a new era is around the corner when researchers can accelerate our understanding of the brain with this breakthrough device and software platform. It not only makes commercial sense but also can serve as the infrastructure and library for neurological knowledge that leads to better diagnosis and treatment of brain disorders,” said Tuff Yen, CEO of Seraph Group, the lead investor.

“We are passionate about brainwaves, consider it a privilege to serve our customers and are committed to bringing great advancements for neurological care,” adds Aswin Gunasekar.

Changes in ZEISS Medical Technology Leadership

Effective 1 May 2020, Jim Mazzo will retire from his position as President Ophthalmic Devices and Head of the Ophthalmic Devices Strategic Business Unit for ZEISS Medical Technology. He will continue to support ZEISS as an advisor.

With over forty years in the ophthalmic industry, Jim has successfully transformed ZEISS Global Ophthalmic Devices as the number two industry leader in Ophthalmology by creating a strong customer focused organization within his three plus years with ZEISS Medical Technology.

“I am very proud of what we have accomplished for customers and employees and pleased to hand over responsibility to Euan and the team. With this team, we have achieved record breaking growth. I look forward to continuing my support for ZEISS as an advisor and my involvement in the ophthalmic community,” says Jim Mazzo.

“Jim has been an integral part of growing our global ophthalmology business and has strengthened a customer-oriented mindset and service into the ZEISS culture,” says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG. “His leadership, insights and guidance have been instrumental in building a strong team, while creating a global approach through regional alignment and increasing visibility of professional education for customers. We thank him for his knowledge, leadership and many contributions in helping advance eye care. We are looking forward to continuing this path under Euan Thomson’s leadership.”

Dr. Euan Thomson will succeed Jim Mazzo as President of Ophthalmic Devices and Head of the Ophthalmic Devices Strategic Business Unit for ZEISS. Euan Thomson currently holds the position of Head of the Digital Business Unit for ZEISS and he will continue to guide digital activities. Euan Thomson holds a PhD in physics from the University of London and has more than thirty years of experience in Medical Technology. Before joining ZEISS in September 2019, he was President and CEO of Photoelectron Corporation, President and CEO of Accuray Inc., worked in Venture Capital and was Head of Digital Health at Samsung Strategy and Innovation Center. Most recently Euan Thomson led digital technology development for Johnson and Johnson Medical Devices.

“I believe in the great work ZEISS Medical Technology is doing for patients around the world,” says Euan Thomson. “I look forward to continuing the mission to better serve ophthalmic customers and their patients and to supporting and shaping the company’s strategic goals.”

Andrew Chang, Head of Sales for Ophthalmic Devices, will be appointed as President of Carl Zeiss Meditec, Inc. He will continue to lead the global ophthalmic sales organizations including U.S. Sales and Service, based in Dublin, California.

CEL-SCI Initiates Development of Immunotherapy to Treat COVID-19 Coronavirus Infection Using its Patented LEAPS Peptide Technology

CEL-SC reports predictions of success using the LEAPS peptides against COVID-19 coronavirus are based on previous studies conducted in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID) with another respiratory virus, pandemic influenza (H1N1).

In those studies, LEAPS peptides elicited protection of mice from morbidity and mortality after the introduction of infection by activating appropriate T cell responses rather than an inflammatory response.

In addition CEL-SC notes although individuals of all ages are susceptible to COVID-19 coronavirus infection, the elderly and individuals with compromised lung function or immunosuppression are at the highest risk for severe morbidity and mortality. It is believed that, in most cases, the onset of symptoms takes between 2 and 14 days post-infection, a period of time that may allow intervention for those at highest risk and with a known exposure.

Daniel Zimmerman, Ph.D. Senior VP of Research, Cellular Immunology at CEL-SCI Corporation, said, ”We believe that a LEAPS COVID 19 coronavirus peptide will reduce or arrest the progression of the virus infection and prevent tissue damage from inflammation resulting from lung infection by the virus. In short, we believe that we can stimulate the correct immune responses to the virus without producing unwanted inflammatory responses associated with lung tissue damage. That should be particularly important in the older population who is at the highest risk of dying from this virus.”

CEL-SCI CEO Geert Kersten added, “CEL-SCI is currently in discussion with multiple health care partners to expeditiously move this critically important work forward. We look forward to combining the LEAPS technology, experience and expertise of CEL-SCI with the expertise of various partners to promote the rapid development of a LEAPS/COVID-19 product to help particularly those patients who are at very high risk from COVID-19 infection.”

COVID-19 is a member of the coronavirus family which “jumped” to humans from an animal reservoir. Unlike human coronaviruses, which include the second most common cause of the common cold, COVID-19, like its cousins SARS and MERS coronaviruses, can replicate at the higher temperatures within the human lungs and, as a result, can cause highly morbid/mortal disease. It is thought that the morbidity and mortality in the at-risk population is due to lung damage resulting from inflammatory immune responses to the virus.

CEL-SCI’s studies will utilize the LEAPS peptide approach which is unique in its proven ability in animals to elicit both a cell-mediated antiviral response and an anti-inflammatory immunomodulating response by activating CD8 T lymphocytes. Previous studies showed that LEAPS immunogens can prevent lethal infection by herpes simplex virus (HSV) and influenza A, and stop the inflammatory disease progression of rheumatoid arthritis in animal models. LEAPS peptides against HSV demonstrated that the T cell response was sufficient to prevent viral disease, and if there was residual virus production, anti-viral antibody was generated to further control the spread of the virus.

The proposed LEAPS peptides are directed towards antigens within the NP protein of COVID-19 that elicit cytolytic T cell responses. Unlike glycoprotein spike antigens which are important for antibody-based vaccines, these antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines. Cytolytic T cell responses attack the virus-infected cellular “factories” within the infected host in order to eliminate the source of the virus and help subdue the infection.

Coronavirus Impact on Imports Expected to be Larger and Last Longer Than Previously Expected

“There are still a lot of unknowns to fully determine the impact of the coronavirus on the supply chain,” NRF Vice President for Supply Chain and Customs Policy Jonathan Gold said. “As factories in China continue to come back online, products are now flowing again. But there are still issues affecting cargo movement, including the availability of truck drivers to move cargo to Chinese ports. Retailers are working with both their suppliers and transportation providers to find paths forward to minimize disruption.”

“Now that we are in the coronavirus environment, uncertainty has expanded exponentially,” Hackett Associates Founder Ben Hackett said. “Our projections are based on the optimistic view that by the end of March or early April some sort of normalcy will have returned to trade.”

This month’s report comes as a separate NRF survey of members found 40 percent of respondents said they are seeing disruptions to their supply chains from the virus and that another 26 percent expect to see disruptions as the situation continues.

U.S. ports covered by Global Port Tracker handled 1.82 million Twenty-Foot Equivalent Units in January, the latest month for which after-the-fact numbers are available. That was up 5.7 percent from December but down 3.8 percent from unusually high numbers a year ago related to U.S. tariffs on goods from China. A TEU is one 20-foot-long cargo container or its equivalent.

February was estimated at 1.42 million TEU, slightly above the 1.41 million TEU expected a month ago but down 12.6 percent from last year and significantly lower than the 1.54 million TEU forecast before the coronavirus began to have an effect on imports. March is forecast at 1.32 million TEU, down 18.3 percent from last year and less than the 1.46 million TEU expected last month or the 1.7 million TEU forecast before the virus.

April, which had not previously been expected to be affected, is now forecast at 1.68 million TEU, down 3.5 percent from last year and lower than the 1.82 million TEU forecast last month.

While the coronavirus makes forecasting difficult, the report calls for imports to jump to 2.02 million TEU in May, a 9.3 percent increase year-over-year, on the assumption that Chinese factories will have resumed most production by then and will be trying to make up for lower volume earlier. June is forecast at 1.97 million TEU, up 9.6 percent year-over-year, and July is forecast at 2.03 million TEU, up 3.3 percent year-over-year.

Imports during 2019 totaled 21.6 million TEU, a 0.8 percent decrease from 2018 amid the ongoing trade war but still the second-highest year on record. The first half of 2020 is forecast to total 10.23 million TEU, down 2.8 percent from the same period last year and below the 10.47 million TEU forecast a month ago.

Global Port Tracker, which is produced for NRF by the consulting firm Hackett Associates, provides historical data and forecasts for the U.S. ports of Los Angeles/Long Beach, Oakland, Seattle and Tacoma on the West Coast; New York/New Jersey, Port of Virginia, Charleston, Savannah, Port Everglades, Miami and Jacksonville on the East Coast, and Houston on the Gulf Coast. The report is free to NRF retail members, and subscription information is available at NRF.com/PortTracker or by calling (202) 783-7971. Subscription information for non-members can be found at www.globalporttracker.com.

Clinical Trial for Detection of Mild Traumatic Brain Injury in Children Commences

“A diagnostic kit for rapid detection of mild TBI in children is truly important. It will satisfy the urgent need to improve the detection of brain injury in children who suffered a head injury” said Dr. Mårten Kvist, Medical Director of Medicortex Finland Oy. The rapid diagnostic kit ProbTBITM, currently being developed by Medicortex, helps to diagnose brain injury especially in patients who don’t show visible symptoms of brain damage – which is frequently the case with a concussion and mild injury.

The clinical trial will be conducted at Satasairaala hospital in Pori – the main hospital in Satakunta region with the first level pediatric emergency department and expertise in the TBI management. Body fluid samples will be collected from young patients (0 – 17 years) with suspected mild TBI, and the samples will be studied with respect to a specific biomarker signature following a head injury. The Principal Investigator, Dr. Sari Malmi, Head of the Department of Pediatric Surgery, says that a new test for improving the diagnosis of traumatic brain injury is highly needed. It will improve the examination of young patients with a traumatic brain injury and thus improve the quality of their treatment.

“ProbTBITM will be a highly innovative diagnostic kit for rapid detection of concussion. Children, in particular, will benefit from it since they can be refrained from radiation or sedation which are needed for the CT scan of the head, as well as from exposure to other sick patients in the hospital” said Dr. Adrian Harel, CEO of Medicortex. “Participation of the young patients shortly after a head injury will be a challenge, but we have a committed and skilled clinical team working for us in the hospital” Dr. Harel adds.

In this clinical trial, Medicortex seeks to collect a sufficient number of pediatric samples in order to prove the applicability of the brain injury test in children, as a natural continuation for previously proven clinical performance in adults. The clinical trial is posted at the public database ClinicalTrials.gov with identifier NCT04288167.

Medicortex Finland Oy is engaged in the development of first-of-its-kind diagnostic kit for rapid detection of concussion and mild TBI from non-invasive body fluid samples. The Company has the technology to capture biomarkers from urine and saliva and to develop them into an affordable diagnostic tool. The patent portfolio held by Medicortex secures exclusivity to develop the product.

FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications

The FDA today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” to solicit public comment on its proposals for broad safety evaluations before drug approval that look beyond ischemic (reduced blood flow)  cardiovascular disease, as well as for the inclusion of a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects.

The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes, which was recommended in previous guidance and has typically been done through cardiovascular outcome trials.

“The FDA continues to review new clinical trial evidence and update its recommendations for drug development to reflect emerging scientific information,” said Lisa Yanoff, M.D., acting director of the Division for Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “By following previous FDA recommendations, sponsors have shown that new type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients. Now, with this proposed approach, we will have broader, valuable safety information for these medications.”

The 2020 draft guidance stems from the ongoing evaluation of cardiovascular outcomes trials and recommendations from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which noted safety data beyond ischemic cardiovascular safety data was desired to evaluate the safety profile of antidiabetic drugs before they were approved.

More than 30 million Americans have diabetes, and 90% to 95% of them have type 2 diabetes. People with type 2 diabetes can suffer from serious medical complications, such as nerve damage, kidney and eye damage, sleep apnea, and heart and blood vessel disease, as a result of high glucose (blood sugar) levels in the blood. These patients may also be more likely to die prematurely compared with people without type 2 diabetes.

While a healthy lifestyle may slow or even stop the disease, many patients also take medications to improve glycemic (blood sugar) control. It is important that companies robustly evaluate the medications’ safety in clinical trials to identify risks. This knowledge can help patients and their health care providers make the most informed treatment decisions.

The 2020 draft guidance will replace the FDA guidances for industry, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” published in December 2008, and “Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention,” published in February 2008.

Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.

These products are unapproved drugs that pose significant risks to patient health and violate federal law.  The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak. The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19).

“The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one,” said FDA Commissioner Stephen M. Hahn, M.D. “We understand consumers are concerned about the spread of COVID-19 and urge them to talk to their health care providers, as well as follow advice from other federal agencies about how to prevent the spread of this illness. We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”

“There already is a high level of anxiety over the potential spread of coronavirus,” said FTC Chairman Joe Simons. “What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”

The FDA is particularly concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm.

The FDA and FTC jointly issued warning letters to Vital Silver, Quinessence Aromatherapy Ltd., Xephyr, LLC doing business as N-Ergetics, GuruNanda, LLC, Vivify Holistic Clinic, Herbal Amy LLC, and The Jim Bakker Show.  The products cited in these warning letters are teas, essential oils, tinctures and colloidal silver. The FDA has previously warned that colloidal silver is not safe or effective for treating any disease or condition. The FDA and FTC requested companies respond in 48 hours describing the specific steps they have taken to correct the violations. Companies that sell products that fraudulently claim to prevent, treat or cure COVID-19 may be subject to legal action, including but not limited to seizure or injunction.

There are currently no vaccines or drugs approved to treat or prevent COVID-19. Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness.

In addition to following up with companies that fail to make adequate corrections, the FDA and FTC will continue to monitor social media, online marketplaces and incoming complaints to help ensure that the companies do not continue to sell fraudulent products under a different company name or on another website. An FDA cross-agency task force has been established and dedicated to closely monitor for fraudulent products related to COVID-19. The task force has already reached out to major retailers to ask for their help in monitoring their online marketplaces for fraudulent products claiming to combat coronavirus and other pathogens. The task force has already worked with major retailers and online marketplaces to remove more than three dozen listings of fraudulent COVID-19 products. Several have already agreed to monitor their marketplaces for COVID-19 claims.

The FDA reminds consumers to be cautious of websites and stores selling products that claim to prevent, mitigate, treat, diagnose or cure COVID-19. Fraudulent COVID-19 products may come in many varieties, including dietary supplements and other foods, as well as products purporting to be drugs, medical devices or vaccines. Products that claim to cure, mitigate, treat, diagnose or prevent disease, but are not proven safe and effective for those purposes, defraud consumers of money and can place consumers at risk for serious harm. Using these products may lead to delays in getting proper diagnosis and treatment of COVID-19 and other potentially serious diseases and conditions.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.

Additional Resources:

HTC VIVE Technology Used in Penumbra’s REAL Immersive System for Stroke Patient Recovery

REAL™ Immersive System (REAL System) is using a custom-designed VIVE Focus™ head-mounted display to help patients recover from stroke and other neurological injuries.

Penumbra reports evidence shows that rehabilitation can help survivors of neurological injury, such as those due to stroke or trauma, recover their abilities. Rehabilitation drives neuroplasticity, or the brain’s ability to reorganize itself by forming new connections. However, research has shown that only 30% of patients ever attend rehabilitation. And even if they do attend, the average amount of days spent rehabilitating using traditional methods is less than optimum. Created by Penumbra, and using Vive VR technology, the REAL System places patients into an animated world with therapeutic experiences designed to increase neuroplasticity through patient engagement and retention.

“When it comes to patients who have suffered neurological injury, there are very real barriers to overcome in the rehabilitation process,” said Dan O’Brien, HTC Global Head of Enterprise. “We’re excited the Vive Focus can help by providing the power and portability for clinicians to treat patients outside of traditional settings with the REAL System.”

The REAL System is a portable VR rehabilitation solution for upper-extremity rehabilitation that can be used at the patient’s bedside, in a therapy gym, or in a mobile health location. The three main components of the system include the Vive Focus headset, a set of six sensors, and a tablet with the TherapyView™ app that allows the clinician to administer and monitor the therapy session.

Upon powering on, the patient is immediately immersed in VR, engaging in visual and physical challenges guided by their therapist. Body sensors are attached with soft neoprene bands, and in less than two minutes of set-up time, the patient is working in a virtual world with their full-presence avatar. The therapist can see what the patient sees on an included tablet interface, which the therapist uses to select various activities, adjust activity parameters, and monitor the patient’s experience at the tap of a button. Data from the patient’s movement and accomplishments is securely saved so that documentation is easy to produce, and long-term trending can guide the patient’s recovery.

Vive Focus is HTC’s signature standalone headset for enterprises. The high-resolution dual 3K AMOLED screens and Qualcomm® Snapdragon™ 835 processor enables patients to enjoy real-time feedback and interaction with Penumbra’s content, while the wireless headset ensures patients can move freely. Penumbra worked closely with HTC to customize the headset specifically for rehabilitation patients, ensuring that it had the proper weight, fit and comfort.

Lumenis Introduces Stellar M22™

Lumenis, the inventor of IPL, is proud to introduce the next generation in Multi-Application platforms, The Stellar M22™. This system offers everything users need in one platform, while making both the physician and patient experience more seamless and successful than ever before.

Lumenis notes the launch continues Lumenis’ mission to improve the standard of care in the ever-growing, multi-billion-dollar energy-based skincare market.

“Lumenis is the pioneer in IPL, from the PhotoDerm to the M22, all of which were and are the gold standard,” said Dr. Mitchel Goldman from San Diego, California. “The Stellar M22’s efficiency is second-to-none with improved patient comfort, speed, versatility, reliability and results with better outcomes. At the end of the day, we offer patients treatments that work, which translates into increased patient satisfaction and increased profitability,” continued Dr. Goldman.

The Stellar M22 is built and based upon the gold standard of Lumenis’ original M22, and continues to carry out all treatment capabilities (i.e. treatment of vascular lesions, skin texture, tone, and hair removal) but with upgrades that make for a further amplified experience.

“The new Stellar M22™ IPL allows for easy and quick treatment with the great output and efficacy we already know from Lumenis,” said Dr. Tretti Clementoni, from Milan, Italy. He continued, “It is a huge time saver and the results are stellar!”

The latest leaps of the sixth generation IPL, Stellar M22™ include a dramatically improved user interface with a larger screen that enables a faster treatment time and more comfortable viewing from a distance. In addition, the Stellar M22™ provides a new ergonomic IPL hand piece design and longer SapphireCool™ Lightguides for better visibility of the treatment area.

“Lumenis is thrilled to introduce the new Stellar M22™, our next-generation in multi-application devices, enabling treatment of over 30 skin conditions and hair removal across skin type, gender and age,” said Tzipi Ozer-Armon, CEO of Lumenis. “Like the M22 before it, Stellar redefines the benchmark in the category and demonstrates our continued commitment to innovation and better technology for better patient care.”

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