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Cognoa Makes Push to Get FDA Nod for Digital Autism Diagnostic

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Cognoa is vying for FDA clearance of a digital device that has the potential to diagnose autism. Previously, the Palo Alto, CA-based company was granted breakthrough device designation by FDA in 2018.

The firm’s digital precision health platform applies machine learning and predictive analytics to parental inputs and diagnostic data and responses to therapeutics to create more personalized care.

Cognoa pushed forward with the clearance submission after its diagnostic surpassed targeted benchmarks in a pivotal study that ran from July 2019 through May 2020. The trial involved 425 participants – aged between 18 to 72 months – whose caregivers or pediatricians had expressed concern about their development but who were never formally evaluated or diagnosed with autism.

The pivotal study was a double-blinded, active comparator, cohort study conducted at 14 sites across the U.S. A number of the primary care appointments were completed via telemedicine, with the study finding that the investigational device performed equally well when administered remotely. The trial also showed that Cognoa’s diagnostic device is highly accurate across males and females as well as ethnic and racial backgrounds, thus addressing a longstanding issue of disparities in autism diagnoses.

“The data from our pivotal study was strong, and we are incredibly excited to submit a De Novo request for FDA clearance of Cognoa’s ASD Diagnostic,” David Happel, CEO of Cognoa, said in a release. “The accuracy of our autism diagnostic solution is unparalleled, exceeding all pre-specified endpoints, and we are looking forward to a priority review. Cognoa’s mission is to improve the lives of children and families living with autism and helping pediatricians diagnose autism within the primary care setting is a vital first step.”

Wearable to Be Developed for Ketamine Delivery

Image courtesy of Stevanato Group SG EZ-be Pod Stevanato Group

SG EZ-be Pod, a wearable device platform developed by Stevanato Group, will be customized to deliver Bexson Biomedical Inc.’s proprietary ketamine formulation, BB106, for which post-operative pain is the lead indication. Ketamine is currently delivered by doctors through in-office infusions, and healthcare providers have been limited in their ability to send patients home with ketamine, the companies reported in a news release. Bexson’s BB106 delivered subcutaneously through a wearable could provide a new solution. 

“In the midst of a pandemic health crisis and evidence of increasing opioid addiction and overdoses, there has never been a greater need for effective non-opioid pain management. Stevanato Group has the ideal technology to deliver Bexson’s BB106 subcutaneous ketamine formulation,” explained Gregg Peterson, Bexson’s Co-Founder and CEO, in the news release. “And beyond pain management, this partnership will create a true ketamine delivery platform that can be leveraged for a large number of future indications.”

Added Mauro Stocchi, chief business officer of Stevanato Group: “We look forward to working with Bexson to ensure that our award-winning SG EZ-be Pod device is ideally suited to the needs of their patients. Now, more than ever, we need to enable patients to take their medications inside the comfort of their homes or while outside performing their daily activities.”

Bexson and the Stevanato Group will collaborate to customize the wearable and programmable SG EZ-be Pod, which the group said is designed “to enable dynamic and convenient subcutaneous delivery for patients.” Stevanato Group offers experience in contract manufacturing and medical device innovation. “This design will support patient comfort with a discreet and intuitive device, and by utilizing our patented technologies, we address the importance of sustainability, while minimizing the overall cost per treatment,” explained Steven Kaufman, vice-president of drug delivery systems, Stevanato Group, in the release. “This agreement with Bexson is a step forward for our device portfolio strategy and ongoing efforts to work closely with biotech and pharmaceutical companies as an integrated solution provider.”

In 2019, Stevanato Group was honored at Pharmapack Europe with a ‘Best Innovation in Drug Delivery Device’ award for a cartridge-based wearable device.

Medtronic Wins Breakthrough Device Designation for TYRX

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Medtronic is keeping the product fires warm with a new breakthrough device designation aimed at enhancing ventricular assist devices (VAD). The Dublin-based company said on Tuesday FDA had granted it the destination for the TYRX Absorbable Antibacterial Driveline Wrap.

TYRX is intended to securely hold a percutaneous driveline in patients. A vital component of VAD systems, the driveline connects the implanted heart pump to an external controller that is powered by an AC or DC adapter, or external batteries. Because the driveline extends outside the body, it is susceptible to infection. 

To help reduce driveline complications, the TYRX can be used It is fully absorbed by the body approximately nine weeks after implantation,  and stabilizes a cardiac implantable electronic device such as a pacemaker or implantable defibrillator, or an implanted neurostimulator.

Medtronic’s most famous device in the VAD market is its HVAD system. The company inherited the technology when it acquired HeartWare in 2016 for $1.1 billion. A little more than two years ago, Medtronic gained a nod for a less invasive implantable approach of the HVAD system.

EuroBio Launches Rapid COVID-19 Diagnostic

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Eurobio Scientific has launched a rapid diagnostic for the detection of the SARS CoV-2 virus antigen. The Les Ulis - France -based company said the Sofia SARS Anitgen test was developed by its partner, Quidel.

Eurobio Scientific said as part of the current campaign to detect the presence of the SARS CoV-2 virus in patients, the number of tests performed in France has become of such magnitude (more than 1 million tests per week) that the delays in submitting results have lengthened considerably.

The company said even if virus detection performance is lower than that of PCR tests, rapid antigenic tests make it possible to carry out a rapid initial screening of asymptomatic patients. Such a process would unclog testing laboratories while maintaining the scale of the viral activity monitoring campaign.

“It was particularly important for our group to complete its range of screening tests in order to meet the demands of our customers,” Jean-Michel Carle, Chairman and CEO of Eurobio Scientific said in prepared remarks. “The overcrowding of analytical laboratories required an evolution in the testing technologies that we immediately make available to them. Our offer now includes a first test already CE marked and intended for our customers equipped with the Sofia reader, mainly hospital departments requiring rapid unit tests. "

The test comes as there is a surge of COVID-19 cases in the U.K. Medical experts in Britain said the number of new infections – which stood at 4,300 on Monday – could reach as high as 50,000 day in October if immediate action isn’t taken, according to a report from the Associated Press.

Could AI Help Predict How Ill a COVID-19 Patient Could Become?

Image by Gerd Altmann from Pixabay Inherent Biosciences

Inherent Biosciences Inc. has been awarded $255,959 from the National Science Foundation (NSF) to study epigenetic biomarkers that could predict patient response to SARS-CoV2 (COVID-19) infection, the company reported in a news release. The goal is to develop an on-site, clinical test that would use artificial intelligence to compare patient blood samples with a dataset of those biomarkers associated with COVID-19 infection.

Andy Olson, CEO of Inherent Biosciences, told MD+DI that the epigenetic biomarkers “are differential methylation patterns on the patient's DNA (in this case from white blood cells). Biomarkers like this have been used previously for evaluating patients to help with disease diagnosis, prognosis, and treatment response. Previous studies of numerous diseases including respiratory impairment, multiple cancers, blood disorders, and type 1 diabetes have demonstrated the prediction capability of DNA methylation patterns in disease subtyping and stratification of prognosis and reaction to treatment.”

Blood samples would be “collected and analyzed for DNA methylation patterns correlated with COVID-19 disease severity and treatment response,” Olson explained. “The goal of the DNA methylation test is to supplement the current standard for risk profiling in order to optimize healthcare resources (equipment, beds, and staff) and ultimately save lives.”  

The Small Business Innovation Research Phase I standard grant will help Inherent generate the dataset of white blood cell DNA methylation patterns, health history, and clinical data for patients infected with COVID-19, the company reported in the release. AI and machine learning would then be tapped to identify DNA methylation biomarkers predictive of disease severity and treatment.

When asked about a potential submission to FDA for approval or an EUA, Olson said that “assuming a positive outcome from the next steps and successful development, we anticipate an initial launch with our clinical lab partner as a Lab Developed Test (LDT) followed by a subsequent FDA submission.”

NSF supports research and education in science and engineering through grants, contracts, and cooperative agreements, according to its Web site. Said Andrea Belz, Division Director of the Division of Industrial Innovation and Partnerships at NSF, in the release: “NSF is proud to support the technology of the future by thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering. With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs.”

What If the Affordable Care Act Is Overturned?

Image by zimmytws - Adobe Stock Affordable Care Act

The death of Supreme Court Justice Ruth Bader Ginsburg threatens the Affordable Care Act (ACA), according to Mike Matson, a medtech analyst at Needham & Co. In a report issued Monday, Matson shared his views of what this means for the industry.

Matson noted that the Supreme Court is scheduled to hear oral arguments for the California v. Texas case challenging the constitutionality of the Affordable Care Act on Nov. 20. Given the change in the Supreme Court's make-up with the death of Ginsburg, legal scholars have reported an increased chance that the law is overturned. A decision is expected next year and could come as late as June 2021, Matson noted. If the Affordable Care Act is in fact overturned, it is estimated that around 20 million Americans could lose their health insurance.

"If this does occur, we see two potential ways that med tech companies could be affected," Matson wrote. "First, there could be a decline in elective procedure volumes. We're not sure how significant this would be, however, since it's not apparent in our view that there was a surge in elective procedures following the ACA when millions of patients gained coverage. Second, there could be a hit to hospital capital spending."

The analyst did caution, however, that the implemenation of the law could have had a more gradual impact on procedure volumes over time, whereas a repeal could have a more sudden impact on procedure volumes.

However, we caution that it is possible that the implementation of the law had a more gradual impact on procedure volumes over time, whereas a repeal could have a more sudden impact on procedure volumes.

Matson went on to say that he believes hospitals would be the most directly hurt by the elimination of the Affordable Care Act because bad debt expense would increase significantly, hurting hospitals' financial results, which in turn would result in smaller capital expenditure budgets, such as new surgical robotics systems. This could exacerbate the financial challenges hospitals are already facing because of the COVID-19 pandemic, Matson pointed out.

The analyst also noted that the Affordable Care Act has survived two prior Supreme Court challenges, first in 2012 and again in 2015, and experts had previously thought that this case, which centers on the viability of the law since the insurance mandate was removed in 2017, was unlikely to be successful. But again, that was before Ginsburg died.

"If the Supreme Court rules on California v. Texas with the current eight justices, legal scholars predict that the court could end up in a 4-4 tie based on prior decisions, which would preserve the lower court's ruling overturning the ACA," Matson said. "And if a new conservative justice is appointed in time ... scholars predict that there could be a 5-4 ruling against the ACA."

Boston Scientific Gains Exclusive Option to Acquire Farapulse

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Boston Scientific has signed an investment agreement and an exclusive option to acquire Farapulse, the developer of the pulsed-field ablation (PFA) system. The move has the potential to strengthen the Marlborough, MA-based company’s position in the treatment of atrial fibrillation.  

The Menlo Park, CA-based company is received breakthrough designation for the PFA system in May of 2019. The device – comprising a sheath, generator, and catheters – is intended to ablate heart tissue via the creation of a therapeutic electric field instead of using thermal energy sources such as radiofrequency ablation or cryoablation.

Farapulse said it intends to initiate a pivotal IDE trial and is pursuing CE Mark approval in Europe.  

"The tissue-selective Farapulse PFA technology is a promising energy source for cardiac ablation – including pulmonary vein isolation – with recent study results demonstrating the effectiveness of the ultra-rapid approach," said Allan Zingeler, president and CEO, Farapulse, Inc, said in a release. "This next chapter in our collaborative relationship with Boston Scientific will further accelerate our progress towards regulatory approval so we can bring this pioneering system to market."

The agreement has shades of Boston Scientific’s deal with Millipede Inc., developer of the transcatheter annuloplasty ring system for the treatment of severe mitral regurgitation. Recall in 2018, Boston Sci, while in the middle of an M&A spree, picked up the remaining shares of the Santa Rosa, CA-based company for $325 million. Boston Scientific had taken a $90 million stake in Millipede earlier that year.

Illumina Set to Acquire Grail for $8B

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The rumors are indeed true – Illumina is attempting to acquire early cancer detection specialist Grail for about $8 billion. Both companies issued a statement earlier this morning discussing the proposed deal.

Last week, it was revealed that Illumina had an interest in acquiring Grail, in a report from Bloomberg citing people familiar with the deal. The proposed acquisition comes hot on the heels of Grail announcing it was seeking to go public.

Both companies have a shared history of sorts, as San Diego, CA-based Illumina spun out Grail in 2016. Grail went on to raise nearly $2 billion in funding. Illumina has a 14.6% stake in Grail with about 98.3 million shares.

“Over the last four years, Grail’s talented team has made exceptional progress in developing the technology and clinical data required to launch the Galleri multi-cancer screening test,” said Francis deSouza, Illumina’s president and CEO, in prepared remarks. “Galleri is among the most promising new tools in the fight against cancer, and we are thrilled to welcome GRAIL back to Illumina to help transform cancer care using genomics and our NGS platform. Together, we have an important opportunity to introduce routine and broadly available blood-based screening that enables early cancer detection when treatment can be more effective and less costly.  Multi-cancer early detection is better for patients, their physicians, and payors.  As we accelerate our path to clinical leadership and the path to multi-cancer early detection, we will continue to drive significant value creation for our stockholders.”

Under the terms of the agreement, at closing, Grail stockholders (including Illumina) will receive total consideration of $8 billion, consisting of $3.5 billion in cash and $4.5 billion in shares of Illumina common stock, subject to a collar.  The deal is expected to close in the second half of 2021.

Next-generation sequencing is poised to revolutionize oncology care, and this acquisition allows Illumina to participate more fully in the high-value clinical solutions that are enabled by its NGS sequencing technology.  With Grail, Illumina will continue as a sequencing innovator and partner, while also becoming a proprietary test provider. Illumina said the NGS Oncology Testing Total Addressable Market Anticipated to Grow to $75 Billion by 2035.

Wearable Medical Devices

10 FDA Cleared or Approved Wearable Devices that Redefined Healthcare

There’s no doubt that wearable medical devices are becoming a permeant fixture in everyday life. The market for wearable medical devices proves this to be true as it was valued at 27.91 billion in 2019 and is set to reach $74.03 billion by 2025, according to a report by Mordor Intelligence.

But there are some wearable medical devices that have caused a paradigm shift in healthcare. These devices have generated tremendous amounts of data, causing the user to have more ownership of his or her healthcare.

And the companies that have developed these wearable medical devices are diverse too. Big tech giants and small startups all have a seat at the wearable medical device market’s table.   

MD+DI has compiled a list of 10 cleared or approved wearable medical devices by FDA that have redefined healthcare.

Medtech in a Minute: Big Deal Rumor, Apple's Blood Oxygen Tracker, and More

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The Apple Watch Rumors Were True

As speculated, blood oxygen (SpO2) tracking will be enabled on the Apple Watch Series 6. The sensor uses infrared lights to measure your blood oxygen in seconds, and can take measurements while you sleep. The company is working with various research teams to examine how longitudinal measurements of blood oxygen and other physiological signals can help manage and control asthma; how blood oxygen measurements and other Apple Watch metrics can help with management of heart failure; and how Apple Watch apps such as heart rate and blood oxygen could serve as early signs of respiratory conditions like influenza and COVID-19.

Speaking of Apple ...

Fitbit Moves in on Apple's ECG Turf

Fitbit’s ECG app is slated to be available in October. The product winning a nod in both the United States and Europe comes about two years after Apple's FDA nod for an ECG app. It also comes at a time when Fitbit is in the middle of being acquired by Google.

Illumina May Want Another Chance with Grail

Illumina could be interested in (re-)acquiring liquid biopsy startup Grail, according to a recent report from Bloomberg. The gene sequencing company could pay more than $8 billion for Grail which now has a valuation of $6 billion, Bloomberg reported citing people familiar with the matter. The rumored deal comes about a week after Grail's IPO news (see below), and about four years after Illumina spun Grail off into a separate company.

And in case you missed last week's Medtech in a Minute article ...

Grail Wants to Go Public

Liquid biopsy specialist Grail is set to go public four years after it was spun out from Illumina. The Menlo Park, CA-based company is developing early cancer detection tests and has set a placeholder amount of $100 million for its IPO. The company is known for its exorbitant financings and has thus far brought in about $1.9 billion in venture capital funding.

FTC to Send Out Refunds to Some Users of NeuroMetrix's Quell

Users of NeuroMetrix’s Quell wearable pain-relief device could be eligible for payments from the Federal Trade Commission (FTC) by check or through PayPal. FTC recently announced it was refunding almost $3.9 million to purchasers of the Waltham, MA-based company’s device that was designed to treat chronic pain throughout the body when placed below-the-knee. In a release, FTC said NeuroMetrix and its CEO, Shai Gozani, sold Quell to consumers, touting it as “clinically proven” and “FDA cleared” for widespread chronic pain relief. However, the agency said the defendants lack scientific evidence to support widespread chronic pain-relief claims, and their claims about clinical proof and the scope of FDA clearance for this use are false.

Chembio Gives COVID-19 Antibody Testing Another Go

Nobody can accuse Chembio Diagnostics of giving up too easily. FDA revoked the emergency use authorization (EUA) for Chembio Diagnostics' first antibody test. Now the company seeks an EUA for a new rapid COVID-19 antibody testing system. The company said new performance criteria from FDA regarding COVID-19 antibody testing provided clarity and direction for its development objectives.

Or if you missed Medtech in a Minute the week before ...

HHS Nixes Phillips' Ventilator Contract

The Department of Health and Human Services (HHS) recently canceled the remainder of a contract with Royal Philips for ventilators. Philips said the agreement was signed in April and called for the company to deliver 43,000 EV300 ventilators to HHS through December 2020. Philips supplied a total of 12,300 bundled ventilator configurations supplied to the Strategic National Stockpile by the end of August, in line with the contract. As directed by HHS, Philips will not supply the remaining 30,700 EV300 ventilators to the Strategic National Stockpile.

NHS Panel Says More Data Is Needed on Convalescent Plasma

According to a National Institutes of Health (NIH) panel, there is not enough data to determine if convalescent plasma is an effective treatment for COVID-19 patients. The COVID-19 Treatment Guidelines Panel said it reviewed the available evidence from published and unpublished data on convalescent plasma, including FDA’s analyses that supported emergency use authorization (EUA) for the therapy. The panel said convalescent plasma shouldn’t be considered standard of care for the treatment of patients with COVID-19 and that more trials are needed to determine whether the therapy is effective. The theory behind convalescent plasma is that people who have been afflicted with COVID-19 and have recovered will have antibodies in the blood that helped fight off the infection. The thought is that if people who are sick with the virus are given this plasma they could recover. FDA gave convalescent plasma an EUA for COVID-19 patients late last month based on clinical results from a Mayo Clinic study.

Abbott Makes Another Go at Resorbable Stents

Abbott is launching a new clinical trial to evaluate the Esprit below-the-knee drug-eluting resorbable scaffold. The company said this is the first U.S. trial to evaluate a fully resorbable device to treat blocked arteries below the knees, or critical limb ischemia, in people battling advanced stages of peripheral artery disease. Once fully enrolled the trial will see about 225 patients at centers around the world. The Espirit BTK System is designed to provide support to an artery immediately after a balloon angioplasty, preventing the vessel from reclosing. Once implanted, the scaffold delivers a drug over a few months that promotes healing and keeps the artery open. The scaffold is then naturally resorbed into the body over time, like dissolving sutures, and ultimately leaves only a healed artery behind. This isn’t Abbott’s first rodeo with resorbable stents - remember Absorb? In 2017, the company stopped selling its first generation of the Absorb stent, citing weak sales and mixed clinical data.