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Could One Hour a Day Make the Foot Pain Go Away?

Image of The Equinus Brace courtesy of IQ Med LLC
Image of The Equinus Brace courtesy of IQ Med LLC

More than three-quarters of Americans have suffered from foot pain, the American Podiatric Medical Association reported a few years ago.

Tendonitis and plantar fasciitis are common complaints, and treatments can include stretching and splints. Patients don’t always comply with stretching regimens, however. And night splints are not “super comfortable to sleep with,” explained podiatrist Dr. Patrick DeHeer, himself a patient with posterior tibial tendonitis. “Patients are always complaining about waking up with them. I consistently woke up in the middle of the night while sleeping on my side with my knee bent. I realized the night splint wasn't doing anything, because to effectively stretch your calf muscle, you have to have the knee fully extended.”

DeHeer decided to develop an alternative. He focused on addressing equinus, described by the American College of Foot and Ankle Surgeons as “a condition in which the upward bending motion of the ankle joint is limited.”

"The term equinus comes from equine. Its correlation is walking on the toes compared to a horse hoof, ” DeHeer told MD+DI

“Studies show patients with equinus have higher incidence of foot and ankle pain,” he continued. “It has accurately been termed ‘the root of all foot evils’ for a reason. Management of equinus either conservatively or surgically has been shown to reduce foot and ankle pain.”

To help patients stretch the two calf muscles associated with equinus—the gastrocnemius and soleus—DeHeer created The Equinus Brace along with John Moorin and Ricky Heath. Launched under the company name IQ Med LLC, The Equinus Brace is intended to address Achilles tendonitis, plantar fasciitis, and more than 30 other foot and ankle disorders.

The Equinus Brace only needs to be used for one hour a day, unlike night splints. According to the company, it is the only brace for equinus that extends above the knee, maintaining the knee in full extension while dorsiflexing the ankle. A patented toe wedge isolates the dorsiflexion force to the hindfoot as well as externally rotates the tibia to fully extend the knee. Adjustable ankle hinges promote gradual, safe stretching, the company stated in a brochure.

IQ Med reported in a news release that “Medicare covers The Equinus Brace, as do nearly all insurance companies.” In June a shorter brace launched for children and smaller adults, called "The Equinus Brace 2.0.”

IQ Med plans to launch a consumer version by the first quarter of next year.

Cardiovalve Makes Crucial Move in TMVR Market

Pixabay Cardiovalve Makes Crucial Move in TMVR Market

Another company is trying its hand at the emerging transcatheter mitral valve replacement space – which could someday outpace TAVR. OR Yehuda, Israel-based Cardiovalve said it has commenced the AHEAD US Multicenter Study, which will test the safety and feasibility of the firm’s device in reducing mitral regurgitation. Trial recruitment will start in early 4Q18.

The news came at the start of the Transcatheter Cardiovascular Therapeutics conference, being held in San Diego now and set to conclude Tuesday. Details of the first-in-human Cardiovalve procedure with the transfemoral mitral valve system will be presented by Prof. Francesco Maisano of the University Hospital Zurich, during TCT.

"The transfemoral approach to implantation was very straightforward, controlled and reassuring,” Maisano said in a release. “I believe that ultimately, Cardiovalve will change how mitral valve replacement is practiced in the clinical setting."

Cardiovalve was originally a part of Valtech Cardio, a company acquired by Edwards Lifesciences for $340 million and up to $350 million in milestone payments. Irvine, CA-based Edwards picked up the company to bolster its mitral and tricuspid valve offerings. The deal came about two years after a wave of acquisitions in the TMVR space by many of the larger medtech companies.

Recently, Abbott Laboratories, a key participant in the TMVR M&A spree of 2015, announced it had initiated SUMMIT, a pivotal trial of its mitral valve system.

Alydia Tackles Postpartum Hemorrhage with Device

Pixabay Alydia Tackles Postpartum Hemorrhage with Device

A small startup is developing a device aimed at treating and preventing maternal bleeding. Menlo Park, CA-based Alydia has raised $10 million in a series B round to help it get the technology past clinical trials and onto the market in the U.S.

The technology works with the normal contractions of the uterus to rapidly stop bleeding. The concept of the device was developed in 2010 at the Cal Poly Center for Innovation and Entrepreneurship.

“What is used now are drugs, which work too slowly or might not work,” Anne Morrissey, CEO of Alydia Health, told MD+DI. “They also complicate the clinical picture. Our expectation based on the feedback we’ve gotten from clinicians is that our device will be used in that treatment path after initial prophylactic uterotonics are given. Our long-term hope is that this device is a tool that will allow [physicians]to act as soon as they can.”

The financing was led by the Global Health Investment Fund. Astia Angels and other existing investors also participated in the round.

“The proceeds for our series B financing are for two main purposes,” Morrissey said. “One is to help us to complete [the PEARLE] clinical study. We have 107 patients in the study. In addition to that, the funding will be used for our 510(k) submission to FDA.”

Morrissey said it was the company’s hope that the device could be cleared come sometime in 2020. Plans also call for the company to seek approval for the device in developing countries where the mortality rate for postpartum is much higher.

“It is enormously important to develop and research new methods for management of obstetric hemorrhage, as it is a leading cause of maternal mortality and morbidity in the U.S.,” Mary D’Alton, M.D., Chair of the Department of Obstetrics and Gynecology at Columbia University Vagelos College of Physicians and Surgeons, Chair of the Foundation for the Society for Maternal and Fetal Medicine, and study-wide principal investigator for the PEARLE Study, said in a release. “I am therefore thrilled to evaluate Alydia's device through the PEARLE Study. If it is shown to be effective, it will add significantly to our options to address hemorrhage, which remains one of the most challenging complications to manage, here at home and globally.”

In a pilot study of 10 patients published in Obstetrics & Gynecology (the Green Journal), the device rapidly and effectively controlled postpartum bleeding, with hemorrhage controlled within minutes for each mother.

Medtronic and Mazor will Tie the Knot in a $1.6B Deal

Mazor Robotics Inc. Medtronic and Mazor will Tie the Knot in a $1.6B Deal
Building on a relationship that began in May 2016, Medtronic has agreed to acquire Mazor Robotics for about $1.64 billion.

Medtronic made a big move back in May 2016 by inking a major multi-phased strategic and equity investment agreement with Mazor Robotics. Today the pair made that relationship even more official by announcing that Medtronic will acquire Mazor.

The cash deal is valued at about $1.64 billion, or $1.34 billion net of Medtronic's existing stake in Mazor and cash acquired. Considering Mazor's revenue took a big hit in the second quarter due to lower pricing under its agreement with Medtronic, the acquisition is easily a win-win for both companies. It's also no coincidence that the deal was unveiled just days before the annual North American Spine Society (NASS) meeting in Los Angeles.

Medtronic and Mazor have been working to integrate Medtronic's spine implants, navigation, and intra-operative imaging technology with Mazor's robotic-assisted surgery systems. The result, a fully-integrated procedural solution for surgical planning, execution, and confirmation, will be showcased at NASS.

"We believe robotic-assisted procedures are the future of spine surgery, enhancing surgeons' abilities to perform complex procedures with greater precision, consistency, and control. Medtronic is committed to accelerating the adoption of robotic-assisted surgery and transforming spine care through procedural solutions that integrate implants, biologics, and enabling technologies," said Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. "The acquisition of Mazor adds robotic-assisted guidance systems to our expanding portfolio of enabling technologies, and we intend to further cultivate Mazor's legacy of innovation in surgical robotics with the site and team in Israel as a base for future growth."

In August 2017, Medtronic expanded its partnership with Mazor to become the exclusive worldwide distributor of the Mazor X system, leading to the installation of more than 80 Mazor X systems since launch. With this acquisition, Medtronic said it aims to accelerate the advancement and adoption of robotic-assisted surgery in the spine market.

Mike Matson, a medtech analyst at Needham & Co., said that the price of the deal is steep, but it clearly makes sense given Medtronic's prior partnership with Mazor. Specifically, he said the deal gives Medtronic improved margins on the Mazor product sales, more control over Mazor's R&D efforts, access to Mazor's lower-priced Renaissance System, and the ability to apply Mazor's technology in other areas of orthopedics, such as reconstructive surgery and extremities.

"Today is a historic day for spine surgery and a defining event in the market's evolution, and I want to acknowledge and thank all of those whose contribution and faith have been so critical and impactful to our success," said Ori Hadomi, CEO of Mazor Robotics. "The Mazor team and product portfolio's full integration into Medtronic will maximize our impact globally through Medtronic's channels, advance our systems' leadership position in the marketplace, and drive the realization of our vision to heal through innovation."

The acquisition is expected to close during Medtronic's third fiscal quarter ending Jan. 25, 2019. The transaction is expected to be modestly dilutive to Medtronic's fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic's business, the company expects to absorb the dilution. The company also projects that the acquisition will generate a double-digit return on invested capital by year four, with an increasing contribution thereafter.

Intuitive Surgical Could Help Usher in a New Era for Medtech

Pixabay Intuitive Surgical Could Help Usher in a New Era for Medtech
InTouch is following Amazon's lead to build a service offering that allows medical device companies to tap into data from their devices after they've been placed within a hospital or healthcare facility's secure network.

More than a decade ago Amazon recognized that it needed mass-cloud computing power, but didn't believe there was a third party service available to meet their needs, so they built their own cloud computing infrastructure. The online retailer also realized early on that this problem that it had solved for itself was the same problem that people and organizations all over the world were also facing, so they created the Amazon Web Services (AWS) subsidiary.

Santa Barbara, CA-based InTouch Health is following Amazon's example in an effort to offer medical device companies an ability to connect to their products after they've been installed within a highly secure healthcare network. The company has built a telehealth platform that allows it to tap into any of the 2,300 hospitals that its software is currently inside of in order to solve the challenge of interconnectivity between unaffiliated healthcare facilities. But rather than just keep this ability to itself, InTouch has started partnering with other medical device companies seeking a way to access data from their own devices and software systems that sit inside a healthcare environment.

This week the company announced it is working with Intuitive Surgical to build an Internet of Medical Things (IoMT) that will enable the surgical robotics company to access their surgical systems within hospitals or surgery centers.

"Intuitive came to us and said, 'Hey InTouch, we have 4,000 surgical robots all over the world and we would like to be able to pull data off of those devices and push software into them in a very secure, reliable network'," Joseph DeVivo, CEO of InTouch Health, told MD+DI.  "And because our network was built in a HITRUST certified, HIPAA-compliant manner for high-risk healthcare, it meets their requirements."

Although the financial terms of the partnership were not disclosed, DeVivo characterized it as "not an insignificant deal," that will enable InTouch to expand its capabilities. "And, like Amazon, we believe we will be building a separate business within InTouch, helping all medical companies who wish to have access to their devices in these secure environments to do so through our cloud," he said.

For Intuitive, the agreement will expand its use of real-time data to support surgeons in the operating room and help them achieve better patient outcomes, said Brian Miller, PhD , Intuitive's senior vice president of systems and vision.

 InTouch has data centers around the world, and its network is proactively monitored and serviced on around the clock, much like an alarm company. The InTouch Health Network provides redundancy, low latency, and the ability to reach thousands of highly secure global medical locations with one click, the company said.

"Hospital firewalls and security requirements are purpose-built to keep outsiders outside, which makes in-facility telehealth between two unaffiliated institutions with separate security protocols and VPNs a major challenge," DeVivo said. "Over the past 15 years, we solved this issue by creating the only telehealth network that reliably connects across secure provider networks. It's because of our network that our customers experience a first-time connection success rate of over 95%. Today, healthcare companies, like Intuitive, which want to push and pull data to and from their devices are asking InTouch to help them build an equally secure, reliable, and scalable network for IoMT. As we look for new ways to maximize the impact technology has on healthcare and enable the increasing demand for data, I believe InTouch's IoMT network will be as big of a market opportunity as our core telehealth business."

MeMed Looks to Distinguish Between Bacterial and Viral Infections

Courtesy of MeMed Diagnostics MeMed Looks to Distinguish Between Bacterial and Viral Infections

Bacterial or viral infection, that is the question. Haifa-Israel based MeMed Diagnostics is developing a point-of-care platform and immune-based test that will one day be able to provide answers. Such a test could help with the overuse and underuse in antibiotics used to treat patients.

“Often what the clinician is trying to figure out, is if this is a bacterial or viral infection,” Eran Eden, co-founder and CEO of MeMed, told MD+DI. “If it’s a bacterial infection – then [the patient gets] antibiotics. If it’s antibiotics then usually [the patient would get] chicken soup.”

To help with its mission MeMed has raised more than $70 million in an oversubscribed financing round. MeMed said participation in the round came from new and existing investors including Ping An Global Voyager Fund, Foxconn, Caesarea Medical Holdings, Clal Insurance, Phoenix Insurance, OurCrowd, Social Capital, WTI, and Horizons Ventures.

MeMed has developed and validated an immune-based protein signature called MeMed BV. The company is also developing MeMed Key, a platform that opens the way to measuring multiple proteins and signatures, conventional and innovative, with central lab precision at the point-of-care. MeMed Key will measure MeMed BV within minutes.

The company said it will use proceeds from the funding round for the market adoption of MeMed; complete development and upscale manufacturing and clearance of the MeMed Key, and to expand its pipeline of tests that integrate machine learning and immune-based measurements to tackle big clinical challenges.

MeMed was founded in 2009 and has raised about $100 million in equity plus about $25 million to $30 million in prizes, grants, and contracts. Eden said the firm’s journey wasn’t without hardship and setbacks, but ultimately it has made sufficient progress.

“I think to get to the point where we are today, we failed on multiple fronts -both on the signature and developing the platform,” Eden said. “We had to reinvent ourselves several times. These are very big and difficult problems to solve. There are no magic bullets, no aha moments – just hard work that takes years.”

Supplier Stories for the Week of September 16

This is a compilation of the latest news from suppliers in the medical device industry.If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Could a New Biosensor Be Able to Smell Cancer?

Image of the EssenceChip courtesy of Aromyx Corp.
Image of the EssenceChip courtesy of Aromyx Corp.

Researchers from Aromyx Corp. announced this month that the company’s flagship technology, the EssenceChip, will be made available to select partners by the end of this year. The new biosensor technology was designed to work with a digital platform that can measure the human sense of smell and taste by placing olfactory receptors from the nose onto a disposable biochip that can then produce a digital readout.

Aromyx Corp. founder and CEO Chris Hanson says that the new biosensor technology was developed using the human sense of smell and taste as a blueprint to create a digital capture of the human senses.

“Our technology is based on the human sense of smell and taste,” Hanson said. “Aromyx has built a solution for the digital capture of smell and taste by placing olfactory and taste receptors from the nose and tongue onto a disposable chip, with a digital readout. We then apply artificial intelligence to the resulting data to give customers insights that are unobtainable with other technologies.”

Hanson said that although previous academic institutions and companies have worked with a limited number of receptors in the past, they have relied upon using live cell lines that have to be kept in well equipped laboratories. The key difference with the EssenceChip is that it utilizes a simple product with no live cells, so that it can be used anywhere in the world. Whether it’s used to detect ingredients in coffee or tea, or as a diagnostic tool to detect disease, the EssenceChip has the potential to impact both the medical and consumer product industries.

“Imagine if you could deliver higher yield drugs at a cheaper cost or detect cancer with a simple breath," Hanson said. These are a few of the applications that the EssenceChip technology can enable, he said. "We are entering the market with a focus on quality control and manufacturing yield improvement in both pharmaceuticals and consumer goods,” he said.

The genesis of the technology actually dates back to the 1990s when the Defense Advanced Research Projects Agency (DARPA) attempted to create a “digital dog-nose” technology that could be used to sniff out improvised explosive devices, known as IEDs, and their component explosives. The project also hoped to produce a technology that could detect mustard gas, Sarin, and various nerve agents, but the breakthrough for Aromyx actually came when they switched to human receptors.

In the following years, several different studies began to explore the ability for dogs to detect a variety of different diseases. The studies found that olfactory receptors could actually detect unique biomarkers for certain diseases. Armed with this information, Aromyx set out to develop a technology that could digitally capture the sense of smell and taste to scan for these unique biomarkers. The result was an exciting new technology with unprecedented capability.

“We think the Aromyx technology could provide inexpensive, noninvasive, and real-time diagnosis of a wide range of diseases at early stages,” Hanson says. “We are working on this with Dr. Brett Sheridan, chief of surgery at California Pacific Medical Center in San Francisco, and with Dr. Danny Dhanasekaran, director of the Center for Basic Cancer Research at the University of Oklahoma Stephenson Cancer Center.”

Hanson said that the company believes the technology could be used in research applications by the middle of next year, which is when the company hopes to make the EssenceChip widely available. For now, the company is offering early partners eval units in an effort to begin working with the chip and platform. Eventually, the EssenceChip would need some level of FDA approval before being used as a widespread clinical diagnostic tool — something the company will continue to explore in the months ahead.

Is AI the Key to Diving Deeper into Images and Pathology?

NYU School of Medicine Is AI the Key to Diving Deeper into Images and Pathology?
Researchers at New York University School of Medicine trained a deep convolutional neural network (Google's Inception v3) on whole-slide images obtained from The Cancer Genome Atlas to accurately and automatically classify them into two prevalent subtypes of lung cancer, or normal lung tissue. Typically, pathologists use histopathology slides to assess the stage, type, and subtype of lung tumors. The work is published in Nature Medicine.

In a tale of two studies, it appears artificial intelligence is helping researchers analyze cells in ways that weren't possible before.

In one study, published this week in Nature Methods, scientists at the Allen Institute in Seattle, WA used machine learning to train computers to see parts of the cell that the human eye cannot easily distinguish. Using 3D images of fluorescently labeled cells, the team taught computers to find structures inside living cells without fluorescent labels, using only black and white images generated by an inexpensive technique known as brightfield microscopy.

Fluorescence microscopy, which uses glowing molecular labels to pinpoint specific parts of cells, is very precise but only allows scientists to see a few structures in the cell at a time, the researchers explained. Human cells have upwards of 20,000 different proteins that, if viewed together, could reveal important information about both healthy and diseased cells.

"This technology lets us view a larger set of those structures than was possible before," said Greg Johnson, PhD, a scientist at the Allen Institute for Cell Science, a division of the Allen Institute, and senior author on the study. "This means that we can explore the organization of the cell in ways that nobody has been able to do, especially in live cells."

According to Rick Horwitz, PhD, executive director of the Allen Institute for Cell Science, the prediction tool could also help scientists understand what goes wrong in cells during disease. Cancer researchers could potentially apply the technique to archived tumor biopsy samples to better understand how cellular structures change as cancers progress or respond to treatment, he said. The algorithm could also aid regeneration medicine by uncovering how cells change in real time as scientists attempt to grow organs or other new body structures in the lab.

"This technique has huge potential ramifications for these and related fields," Horwitz said. "You can watch processes live as they are taking place — it's almost like magic. This method allows us, in the most non-invasive way that we have so far, to obtain information about human cells that we were previously unable to get."

The combination of the freely available prediction toolset and brightfield microscopy could lower research costs if used in place of fluorescence microscopy, which requires expensive equipment and trained operators, the team noted. Fluorescent tags are also subject to fading, and the light itself can damage living cells, limiting the technique's utility to study live cells and their dynamics. The machine learning approach would allow scientists to track precise changes in cells over long periods of time, potentially shedding light on events such as early development or disease progression.

To the human eye, cells viewed in a brightfield microscope are sacs rendered in shades of gray. A trained scientist can find the edges of a cell and the nucleus, the cell's DNA-storage compartment, but not much else. The research team used an existing machine learning technique, known as a convolutional neural network, to train computers to recognize finer details in these images, such as the mitochondria, cells' powerhouses. They tested 12 different cellular structures and the model generated predicted images that matched the fluorescently labeled images for most of those structures, the researchers said.

It also turned out what the algorithm was able to capture surprised even the modeling scientists.

"Going in, we had this idea that if our own eyes aren't able to see a certain structure, then the machine wouldn't be able to learn it," said Molly Maleckar, PhD, director of modeling at the Allen Institute for Cell Science and an author on the study. "Machines can see things we can't. They can learn things we can't. And they can do it much faster."

The technique can also predict precise structural information from images taken with an electron microscope. The computational approach here is the same, said Forrest Collman, PhD, an assistant investigator at the Allen Institute for Brain Science and an author on the study, but the applications are different. Collman is part of a team working to map connections between neurons in the mouse brain. They are using the method to line up images of the neurons taken with different types of microscopes, normally a challenging problem for a computer and a laborious task for a human.

"Our progress in tackling this problem was accelerated by having our colleagues from the Allen Institute for Cell Science working with us on the solution," Collman said.

Roger Brent, PhD, a member of the basic sciences division at Fred Hutchinson Cancer Research Center, is using the new approach as part of a research effort he is leading to improve the "seeing power" of microscopes for biologists studying yeast and mammalian cells.

"Replacing fluorescence microscopes with less light intensive microscopes would enable researchers to accelerate their work, make better measurements of cell and tissue function, and save some money in the process," Brent said. "By making these networks available, the Allen Institute is helping to democratize biological and medical research."

In a separate study, published this week in Nature Medicineresearchers at New York University School of Medicine explained how they trained a deep convolutional neural network (Google's Inception v3) on whole-slide images obtained from The Cancer Genome Atlas to accurately and automatically classify them into two prevalent subtypes of lung cancer, or normal lung tissue. Typically, pathologists use histopathology slides to assess the stage, type, and subtype of lung tumors. 

The NYU researchers said the performance of their method is comparable to that of pathologists, with an average area under the curve (AUC) of 0.97. The model was validated on independent datasets of frozen tissues, formalin-fixed paraffin-embedded tissues, and biopsies, they said. 

The researchers also trained the network to predict the 10 most commonly mutated genes in lung adenocarcinoma (LUAD) and found that six of them can be predicted from pathology images. They said the findings suggest that deep-learning models can assist pathologists in the detection of cancer subtype or gene mutations. The approach can be applied to any cancer type, they noted.

How a $2M Grant Could Change the Way Autism Is Diagnosed

Pixabay How a $2M Grant Could Change the Way Autism Is Diagnosed

Early treatment of autism spectrum disorder (ASD) can significantly improve the lives of affected children and their families, but diagnosing the disorder is often a challenge. A company in Syracuse, NY has developed an epigenetic test that could facilitate the early diagnosis of ASD, however, and in turn accelerate access to treatment.

The technology, developed by Quadrant Biosciences, managed to impress a panel of grant reviewers, landing the company a $2 million small business technology transfer (STTR) grant from the National Institutes of Health. The funds are expected to help the company refine the technology and bring it to market. 

STTR grants are meant to facilitate the translation of promising technologies to the private sector and ultimately provide beneficial healthcare innovations to consumers. The technology was developed in partnership with researchers at the State University of New York Upstate Medical University, Penn State Hershey Medical Center, and Quadrant Biosciences.

"This grant will allow us to validate epigenetic technology with the power to dramatically advance autism assessment," said Steven Hicks, MD, PhD, a researcher at Penn State Hershey Medical Center. “I am honored to play a part in this groundbreaking work.”

Quadrant and the company’s collaborators recently completed an NIH-funded study that included more than 500 children between the ages of 18 months and 6 years and utilized RNA features to differentiate children with ASD from peers with typical development or developmental delay. The diagnostic accuracy of the technology exceeded 85%, the company noted. The additional NIH funding is expected to further develop and confirm the efficacy of the test. The next phase of the study expands enrollment to five different academic medical center locations around the United States and involves recruitment of 750 additional children. As in the first study, the study includes not only ASD and typically developing children, but also children with developmental delays that are often difficult for clinicians to distinguish from ASD.

"While our results thus far have been very promising, further evaluation is always warranted," said Randall Carpenter, MD, executive director of clinical development at Quadrant Biosciences.