The FDA-registered iWALKFree crutch provides unmatched mobility and freedom from the constraints of traditional crutches for those with non-weight-bearing lower leg injuries including sprained or broken feet or ankles, Achilles injuries, lower limb amputations, and other below the knee conditions. iWALK is the only crutch substitute offering a degree of mobility that allows users to carry out daily tasks, heal faster, and regain freedom.

This painless, affordable, and straightforward device is making waves in the medical community as more and more studies reveal its unique ability to expedite healing while mimicking the muscle actions of a normal unassisted gait.

“We’re constantly changing and evolving our design to make it work better,” says Hunter. “We have a staff of people dedicated specifically to improving the product.”

While version 3.0 is currently on the market, version 4.0 is already in prototyping. And before 4.0 goes into production, 5.0 will be in design.

New technology
Even though the company strives to make each version perfect, consumers continually provide feedback and suggestions for improvement.

“The problems we’re trying to solve on the newest generation of crutch are more refinements than actual issues,” Hunter says. “For any manufactured product, people have no concept of how difficult it is to make something that works every time and is defect-free.” He adds that when anything medical-related is at stake, it’s essential that everything works as it’s supposed to, which is why the company devotes so many resources to its total quality management system.

Consumers, although often proposing valuable suggestions for improvements, don’t always understand how challenging it is to make even minor changes to the product, for example, in the case of a request for a shock absorber. “Unfortunately, it would add a lot of complexity, cost, and weight for not enough benefit,” says Hunter. “When your heel strikes the ground, that’s when your leg and hips and body feel the most force. We wanted to dampen that, but a shock absorber wasn’t really feasible.”

Instead, the company found a clever way of incorporating shock absorption into the foot of the crutch, similar to that in the heel of a running shoe, that was both protective and cost-effective. It’s in prototyping and has been “extremely well received.”

To get to that point, the team built prototypes which had actual active suspension with pivots and dampeners to determine exactly what they needed to achieve and found a clever and economical way to do it.

Proven right
The company’s successful innovations are getting noticed, evident in the fact that numerous imitations are now coming on the market.

“There’s an old saying that knockoffs prove you’re doing something right. We’re not afraid of them, except that the hands-free crutch is a relatively new concept, and if people go for the cheap knockoffs, their functionality is terrible,” Hunter says. “That can ruin the reputation of the hands-free crutch concept in general. But they’re not a challenge for us at all. If anything, it’s authentication that we’re doing it right.”

Fortunately, the imitations aren’t a commercial threat as the companies involved aren’t putting effort and resources into the product as they don’t specialize in it.

Conversely, “We only do the hands-free crutch; it’s our total focus. We provide the resources, the R&D, the quality control, and we meet the regulatory requirements. We also have technical support and customer service for iWALK customers. We have replacement parts, warranty, everything,” Hunter explains.

There is also the challenge of marketing, however, as potential users looking for crutches may not know the iWALK exists. “But because we’re the best-selling crutch on Amazon, they discover us when searching for conventional crutches,” Hunter says. “Online sales are good for us, because, again, people aren’t typically looking for an iWALK, they’re looking for something else. We’re still unfortunately at that stage of awareness.”

However, more and more doctors are recommending the device as they become familiar with its benefits, due in part to the copious amount of clinical research that’s been published. “For doctors, nothing is real unless it has the white paper to back it up,” Hunter says. “We have independent, peer-reviewed clinical research that is published in medical journals. And that’s the currency that doctors need to feel comfortable and know that the iWALK is legit.”

Better healing
The studies have shown that the medical benefits of the iWALK are numerous. “When the research came out, it validated what we already thought, but then actually turned out to be even better than that,” Hunter shares.

One of the studies included an electro-myocardiogram (EMG), where sensors are placed on the body to reveal muscle activity at the location of the sensor. “They ‘sensored up’ somebody’s leg walking normally,” Hunter says, “and then put sensors on the same leg walking with an iWALK. And the researchers were blown away.”

The study showed that with an iWALK, the muscles from the hip to the knee were doing the same thing as in a normal human walking action, but not only were the muscles of the upper leg active, so were those in the lower leg. Why is that important? It means significant reduction of the muscle atrophy that typically accompanies immobilized limbs. So although the affected leg has become non-weight-bearing, it has retained more muscle mass and your recovery will be quicker. “But even more significant is blood flow,” says Hunter. “And this is what’s mind-blowing.”

In simple terms, the heart pushes the blood out to the rest of the body with the furthest point being the lower leg. But the blood pressure from the heart pumping is not what brings blood back to the heart—what’s needed for that is muscle activity. The heart pushes blood out through the arteries and when the muscles contract, they push the blood back upstream through the veins to recirculate through the heart.

“If that muscle is dormant and has no activity, such as if using conventional crutches or knee scooters, then the venous pump—what this mechanism is called—is not activated. Essentially there’s a dam and the blood is blocked from flowing back upstream,” Hunter explains.

The most common place for this to happen is the lower leg. With no muscle activity, blood in the lower leg can pool, and nutrient- and oxygen-rich healing blood isn’t getting to the trauma site, meaning slower recovery.

“This can also lead to a blood clot called a DVT—deep vein thrombosis—and that’s nothing to fool with,” Hunter notes. It’s a serious, potentially deadly condition which is much more prevalent in people with non-weight-bearing lower-limb injuries due to lack of muscle activity. Ultimately, if you’re using crutches or a scooter, you run a higher risk of having a DVT than if you’re using an iWALK,” he says.

“It’s a lot to wrap your head around,” Hunter says, “but physicians understand it and fortunately, the research proves it. If there’s muscle activity, there’s venous pump activity. We all understand that muscle activity infers better blood flow, but because blood flow itself was not directly researched in the EMG studies, we didn’t actually prove the blood flow claim initially,” Hunter says. “So additional studies were conducted which specifically tested blood flow and researchers found that blood flow using an iWALK is substantially similar to normal unassisted human walking when you’re using not using a mobility device. And that’s huge.”

These studies also included surveys finding that fully 90 percent of people who use the iWALK, when given the choice between iWALK, conventional crutches, or a knee scooter, choose the iWALK. “Our primary problem is awareness and understanding. Awareness that this device exists and understanding of what it is, what it isn’t, and what it will do for you.”

Challenging the crutch paradigm
The company says that the biggest challenge it faces is changing a paradigm of thought.

“People have been using crutches for thousands of years and scooters now for 20 or 30 years. It’s just difficult to go against the mainstream, and it takes a lot of time.” But more and more people are saying their physician referred the iWALK to them, and more and more doctors are requesting brochures to hand out to their patients.

“So we’re winning, but we haven’t won yet,” Hunter says. “The biggest challenge, once again, is building a mainstream awareness of the device.”

Getting to the point of recognition and acceptance—as with knee scooters—is vital, he adds. “Because the device is so much better, the demand and the medical benefits are there. Our biggest challenge is educating everybody, including the physicians. We focus on the general consumer but also physicians because most people with a non-weight-bearing injury will go to a physician at some point. As a smaller company, we have a huge marketing challenge in building universal awareness of a new technology.”

Another challenge on a smaller scale is misconceptions. Because this is a new device and people have preconceived notions regarding blood flow and stability, ultimately, it’s the physicians who will have to provide sound medical advice.

“We identified a researcher who was the foremost expert in the field of angular momentum, which is the accepted way of measuring stability, and—surprise, surprise—the iWALK turns out to be way more stable than crutches, so it’s actually safer.” This debunks a common preconception that the iWALK might not be as stable as other mobility devices.

Quality systems
As iWALK has gained traction in the medical community and the company has grown, Hunter noticed the need for robust quality systems, both proactive and reactive, to be in place.

“I think we’ve done a particularly good job in that area, and this relates to the knockoffs of the iWALK. There’s no way they have the kind of quality control systems, with the documentation, that we have in place. You wouldn’t think this simple little device would have so much backing, but it does.”

The company also attends and exhibits at medical conferences, but right now its best salesperson is the customer who does a follow-up visit to their doctor and tells them how much they love the product.

“That’s still our most common referral source,” Hunter says. Social media is another excellent source of promotion where unbiased users in real-life situations share their experiences, photos, and videos.

“There’s so much user-generated content about the iWALK out there that’s building awareness organically,” he says. “And every endorsement and testimonial we’ve ever had was free, including 11 world champion athletes, gold medalists, and a list of celebrities including Harrison Ford. They may not know the medical benefits, but it’s all genuine.”

Tipping point
What the company is looking for is the proverbial tipping point of awareness, he adds. Scooters, for instance, weren’t advertised much, but the more people saw them “in the wild,” the more they started asking for them. “Ultimately, we want everyone to understand that this exists. Once that’s done, everything else will take care of itself.”

Hunter is convinced that as awareness and understanding of the benefits of the iWALK become more universal, the iWALK will become the first choice of mobility device, both by physicians and end users. “Once the medical community understands how significant the medical benefits are that this $150 device provides, one could argue that not having the iWALK as their primary recommendation subjects the qualified patient to preventable risk.”

The post Painless, Affordable, Straightforward – This Crutch is Made for Walking<p class="company">iWALKFree </p> appeared first on Manufacturing In Focus.

INSTI® HIV tests are innovative, user-friendly diagnostic kits for HIV infection diagnosis and are the fastest HIV rapid diagnostic assays available, taking only 60 seconds to read. The INSTI® HIV-1/ 2 Antibody Test is a quick and qualitative in vitro test that can be used to find antibodies against Type 1 or Type 2 HIV in human plasma, fingerstick blood, or whole blood.

“The U.S. is our largest customer, and even the Department of Health is using our tests and loves them,” says Rob Mackie, CEO. “And there are so many more applications to use them.”

Utilizing a self-test means not only the freedom to test when and where you want (without supervision, as the test comes with full instructions!) but also receiving your results instantly, allowing for faster access to medical intervention.

“We’ve come a long, long way. In the beginning, self-testing had a tough time gaining traction, because with every reactive result, it was felt that we needed to ensure an officially monitored link to care,” Mackie says. “But that didn’t work because no one would get tested, and they were losing the fight to HIV.”

Most people generally don’t randomly get tested for HIV (unless they’re in a high-risk population) because HIV still carries the stigma of promiscuity, he adds, which is why having a self-test for different diseases is so vital.

“When it comes to Hepatitis C, once you find out you have it via symptoms, it’s often too late. But if you find out through a test, there’s a 12-week treatment that used to be over $70,000 but now some treatments are under $5,000, and for 95 percent of people, the treatment works, and you’re rid of it forever.”

There are also many ways to contract Hepatitis C, which is why it’s so important that people have access to a test that can save their lives.

“One thing the pandemic taught us is to take our healthcare into our own hands,” Mackie says. “No one’s going to come and save you… you’ve got to take that responsibility now.”

The pandemic also meant three years of significantly reduced testing for HIV, pushing advancement in testing rates back many years, he says, with numbers similar to those seen 10 years ago. “Almost all resources for testing were put toward one thing, and that was COVID-19. Additionally, everyone was locked at home, personal encounters went up, and awareness of rapid testing, STIs, and knowing your status went down.”

Mackie explains that it is estimated that 60 percent or more of the disease’s spread comes from people who don’t know they have it. Upon learning you have HIV, you immediately go on antiretrovirals to suppress your CD 4 count, not only to avoid infecting someone new but to freeze your virus at a state where you don’t have flu-like symptoms, you’re not feeling lethargic all day, and symptoms won’t turn into AIDS, the actual disease.

“If every single person knew their status, and the people that were positive were on treatment, HIV would go away, but we just can’t seem to get a handle on that,” Mackie says. “The reason we’re now doing this chlamydia/gonorrhea duplex test is because, according to WHO, Africa spends close to $30 billion a year on healthcare, and people can’t get an appointment to see the doctor because STIs are taking up all the appointments with chlamydia and gonorrhea.”

There are one million new sexually transmitted infections every day—over 374 million new infections last year—so with everyone knowing their status regarding chlamydia, gonorrhea, or any STI, they’re far less likely to have an encounter and put themselves in a position to spread it, he adds.

“We know chlamydia and gonorrhea aren’t killers, but they’re so painful and uncomfortable that you will wait in a lineup at the doctor’s office to get your antibiotics or whatever’s going to get you pain-free, and it’s clogging their whole system,” Mackie says.

While there are new products and tests available now which weren’t before, nobody knew about them until bioLytical got test approval in Canada, and even now, unless the company spends a significant amount of time increasing awareness, many people still won’t know unless they’re in a high-risk community, actively doing something that puts them at risk.

“Our focus on the STI market with the RI (registered intermediary) status product is going to be just huge for our company because there’s such a need for it,” Mackie says.

As with many products, educating the general public is key to gaining trust and sharing knowledge. Today’s political climate, unfortunately, has fostered suspicion of information from scientific sources that is challenging to combat.

“We have to educate people, but it’s hard to educate people now because they don’t know what to believe,” Mackie says. “It’s not about them being ignorant, because I think they have valid reasons to be suspicious due to the world we live in, and that’s disappointing. But it’s hard for companies like us.”

bioLytical has high-quality products, he adds, and being Canadian-based means working under stringent regulations and audits from Health Canada.

“We have no choice but to put out a high-quality product, and that’s why everyone’s coming to us,” says Mackie. “We don’t have any of this controversy following us or any data giving false results.”

As much damage as the ongoing pandemic has caused, it has also forced companies—and governments—to learn. bioLytical, for instance, spent a million dollars trying to make its original platform work for COVID. When the company couldn’t get it to work for less than $25 a test, it developed a new platform out of necessity, and that platform will now be utilized against STIs.

While bioLytical already has approval for its Hepatitis C test in Europe, there are upcoming additional approvals, such as inclusion into the Australian Registry of Therapeutic Goods (ARTG) and the WHO’s pre-qualification, which opens up all tenders in the developing world, including Africa and India, where NGOs working in those areas often can’t afford to buy their own product.

And receiving the upcoming self-test HIV approval in the United States will be a huge triumph for the company.

“HIV is more prevalent now than it was 10 years ago, with a significant increase over the last three years, largely attributed to the decrease in testing due to the pandemic,” says Mackie. “We’re still getting about 1.5 million infections a year globally, and we’re sitting at about 39 million people living with HIV. The U.S. has about 1.2 million infections total, a significant amount for a rich country.”

Catching up on years of missed testing and escalating cases seems daunting, but bioLytical has the skills and experience to handle the challenges.

“We’re a medium-sized company, and we’re growing into a good-sized company,” says Mackie. “And we’re nimble because we’re private; we’re not a public company controlled by a board. We obviously answer to a board, but I’m in the office every day, and I chair the board, so we don’t have to go outside for decisions.”

Keeping everything in-house is also important, he adds. “We don’t get to a point in product development where we have to negotiate something with someone that makes it not even economically feasible. If you have one component you have to buy from someone else, and they see you have this huge market and just need their one component, you can only imagine how hard it is to negotiate. We control our own destiny by having everything made in-house and decisions all made in-house.”

This also means controlling quality. “We’re only as good as the last test we made, and we have such a good reputation for quality that we wouldn’t put out our COVID test early until it was solid,” he says.

The company knew it was missing the market but refused to compromise its 20 years of quality by trying to take advantage of “low-hanging fruit,” instead staying the course and putting out a high-quality product. “For the sake of our integrity and quality, it’s very risky for us to outsource,” Mackie says.

This all results in high company morale as well, he adds, with staff feeling deep satisfaction from accomplishing everything on their own. “When you’re doing everything—from the science to the clinical trials to all the production to the solution manufacturing—no one else gets any of the credit when you do something good.”

Doing good also includes philanthropic work, such as working with the REACH program in Canada on syphilis and HIV; providing hurricane-relief funding; and continually spreading knowledge and awareness of the importance of self-testing across the world.

“There’s nothing pretty about Hep C,” says Mackie. “When it rears its head, you’re going to have a painful death on dialysis and cost the taxpayer a quarter of a million dollars. Or you can find out early—with no symptoms—that you have Hep C, and you just need this treatment, and it can save you, as opposed to not knowing and fully developing Hep C. What a waste! No one survives that.”

Again, he says, education is key to understanding that it can be caught early and treated completely.

“We have this great dream, and it’s not even a ‘suppression’ of the disease like HIV. If you’re rid of Hep C, it’s out of your blood. It’s quite amazing. There should be lineups to get heavily tested, but I don’t think there are lineups or even much awareness of the disease.”

Unfortunately, people will look for any reason to not get tested, he adds, even though bioLytical’s rapid tests are highly reliable, involve a mere finger prick, and give almost immediate results.

“I have four kids and when I retired, I could have done anything, but when the technology of bioLytical came across my table, I thought, ‘what a great legacy, to try to do well while doing good,’” shares Mackie. “I just thought that if we could be successful, it would sure be a cool thing to be successful at, and who knew it would go way beyond HIV. We’re getting close to 50 million in tests and probably have stopped 20 million new infections. That’s pretty awesome.”

The post Saving Lives with Science<p class="company">bioLytical Laboratories</p> appeared first on Manufacturing In Focus.

StressMarq is regarded internationally for its high quality bioreagents which include antibodies, aggregated proteins, and assay kits, and the company’s academic and biopharmaceutical customers are using these technologies to make meaningful strides in diagnostic and therapeutic advances. These discoveries are leading to breakthroughs in the field that have enabled scientists to proactively model neurodegenerative diseases while working to slow, stop, and eventually, reverse them in their tracks.

A matter of heart and mind
For President and CEO Ariel Louwrier, StressMarq Biosciences’ focus on neurodegenerative disease research is a matter close to his heart. Having lost his father to Alzheimer’s and his father-in-law to Lewy Body Dementia, there is both a personal and professional drive to better understand and eventually mitigate the impacts of neurodegenerative diseases that were historically under-researched.

Now, in what Louwrier refers to as the “Age of the Brain,” a better understanding of the physiological processes that lead to neurodegeneration is being elucidated.

Neurodegenerative diseases occur when there is a gradual loss or death of cells in the central nervous system. Plaques—which are the result of self-catalyzing proteins that deviate from their typical biological function—aggregate and ultimately kill healthy cells, leading to neurodegeneration.

StressMarq Biosciences has artificially replicated this process across disease states such as Alzheimer’s and Parkinson’s and accelerated it, enabling researchers to conduct research to better understand the behaviors of the aggregating proteins and how to slow, stop, or reverse this activity.

“We’re the ‘tools’ people, but overall, these tools really lift the sector, regardless of what else is happening. While the products we make are for research purposes only, they are transformational for diagnostic and therapeutic advancements in the field,” Louwrier explains.

Seeds of change
The biological tools that StressMarq Biosciences manufactures complement some of the pioneering work carried out by the Michael J. Fox Foundation and its Parkinson’s Progressive Market Initiative (PPMI), research that led to the development of what appears to be predictive technology (called the Synuclein Amplification Assay, or SAA). This technology is able to determine whether a patient has or could develop Parkinson’s with a significant degree of certainty.

“Part of the completed studies indicated for the first time that even if a person didn’t show Parkinson’s symptoms, there was a predictive element that suggested they were already on the path of developing the disease within a certain timeframe. That finding was completely new, because usually when symptoms appear, it’s generally too late to do a great deal in terms of returning the brain to normal health,” notes Louwrier.

When Parkinson’s progresses to the point of the presentation of symptoms, upwards of 50 to 60 percent of the brain’s dopaminergic neurons have been lost, which is a traumatic loss that will have significant impacts on a patient’s quality of life. Given the extraordinary ability of the brain to cope with this level of damage, if you could intervene at only 20 to 30 percent neuronal loss, the disease progression could be slowed, and a person’s quality of life could be greatly improved for a significant time period—possibly the rest of their life.

The method used to identify the disease requires the use of monomeric proteins associated with Parkinson’s disease—called alpha synuclein—which, when in their singular form, can aggregate. While this process is generally slow, it is greatly accelerated in the presence of existing natural aggregates, or “seeds” that are present in certain biological fluids such as cerebrospinal fluid from diseased patients. Using this method, the process can be accelerated to produce results in up to one to three days. Critically, these results would be assay-based, complementing or replacing existing cognitive evaluations alone.

As Louwrier explains, “The seeds, ironically, are exactly what those monomeric proteins become once they aggregate, so it’s kind of a circular accelerating event that doesn’t require any other form of intervention to occur, and the methods for detecting the aggregated proteins from their building blocks are simple and well established.”

There are, however, downsides to this technology. Because the proteins inherently self-aggregate, there is a tendency toward false positives, but StressMarq Biosciences has been working to create a monomeric preparation for this particular assay that removes the tendency to self-aggregate while still allowing for a strong positive response when seeded.

“It’s a bit analogous to a tug of war—you’re pulling in both directions, trying to find a sweet spot and set of conditions to create the perfect assay,” says Louwrier. To make things more complex, aggregated proteins and their precursors can exist as different variants, or ‘flavours,’ as he refers to them, and using different ones can produce very different outcomes. “We were trying to create this SAA assay preparation and I think we figured it out, so we’ll be looking to launch that for research purposes later this year.”

Breaking ground
StressMarq Biosciences always has something potentially groundbreaking in the product pipeline. Recently, the company worked to advance a patented antibody that showed great promise for diagnostic impact. At this point, however, it is being sold as a Parkinson’s research tool and is producing some very interesting data.

“We’re beginning to see some very interesting results with this antibody. It appears to detect specific disease states within the brain, so this is the sort of tool that could be particularly useful to researchers, because the results are not ambiguous,” says Louwrier.

He continues, “What’s really important about antibodies is that they are generally excellent binding agents. However, a given antibody may bind other things that are very similar structurally.” This can present a significant problem in that an antibody could bind to its target too indiscriminately to be useful. Since aggregated proteins are made of multiple units of identical monomers, there’s an unusually high degree of commonality between the two, be it the monomeric or aggregated form, which could produce an overwhelming background signal if both entities are significantly detected.

“We can detect aggregates in the gut of mice that were injected with artificial recombinant seeds in the brain weeks prior. While that’s not really novel, this is an area that will continue to be of relevance in the sector—that is, examining the connection between what is happening in the brain and how that translates to what is happening in the gut. This is referred to as the gut-brain-axis, or GBA.”

StressMarq has also developed a labelled monomeric protein that was used in studies in the United Kingdom, published in Science Advances, whereby the construct was used in cells to measure the beginnings of the oligomerization process in significant detail.

“You go from a point where there’s no signal, to signals being generated, so these proteins can be shown to interact with each other, forming aggregates. These can be readily identified using novel technology, so that was a very interesting study. It’s quite niche of course, but it’s another positive element in understanding and unraveling the mysteries of these diseases,” Louwrier says of that work being led by Dr. Matthew Horrocks from the University of Edinburgh.

There are a whole range of protein constructs offered by StressMarq Biosciences that are achieving fascinating results in different research applications worldwide and being published in peer-reviewed scientific journals. One of the more interesting ones from a physiological standpoint is tau, which is a protein that undergoes aggregation in Alzheimer’s disease. StressMarq recently launched a unique preparation of tau, designed to structurally mimic the aggregates found in patient brains.

“That has never been done before, and now that we know what that defined structure looks like, we have made it commercially available to scientists,” Louwrier says of the enabling nature of these tools for research purposes. “For the first time we can actually put something directly into the scientific toolbox for researchers that is designed to be structurally identical to what is seen in a patient brain.”

Making an impact
Unlike genetic techniques which take anywhere from six to 18 months to model in an animal host, StressMarq Biosciences’ recombinant protein aggregates can model the diseases in as few as 30 days, which not only saves time but also money. This is relevant in a sector where funding is dependent on the markets, institutional investors, and governments, where currently budgets are being tightened.

“I think the biopharma folks have been extremely receptive to the information that we’re able to give them in terms of our data and experience with these proteins because, and I’ll use the words from one of our clients in pharma, ‘you just saved us two years of work,’” Louwrier shares. In some cases, however, the two concepts have been merged: “You can have a genetic approach that creates a disease background, or a disease-prone background, and you take the proteins—the ‘seeds’ that StressMarq creates—and it accelerates even more.”

Through collaboration and education, the advantages of StressMarq Biosciences’ tools, plus the ingenuity and dedication of researchers, are taking neurodegenerative disease drug discovery to new places.

“We have a range of international collaborations going on at any given time—different proteins, different disease states—where we provide materials to scientists and in return, receive relevant data that we can show the rest of the world,” which serves to educate and advance the efforts of StressMarq and its customers.

One of those collaborators is Gubra, a contract research organization (CRO) that is utilizing StressMarq Biosciences’ proteins in new and extraordinary ways and providing valuable data. Louwrier refers to Gubra’s work as “visually arresting,” particularly the ability to develop three-dimensional brain imaging techniques that offer targeted imaging down to the single cell level.

“You can literally view something and delve into the brain. It’s extraordinary because it’s three-dimensional. Gubra has used experimental mouse brains, for instance, that have been stained with a particular antibody that diffuses into the tissue and binds to a target. They have used our materials to generate disease states in these experimental systems,” he says. “We are then able to visualize, in three dimensions, the impact of the pathology being generated, as well as other things that are relevant, including the dopaminergic neurons dying as a result. Gubra’s technology is outstanding—their visually arresting 3D video output feels like you are seeing what is happening inside the brain.”

Louwrier also highlights the work of additional companies in the drug discovery space that have used StressMarq Biosciences’ products. reMYND is a Belgian company developing best-in-class treatments using a proprietary drug discovery platform to restore function for patients with diseases caused by cellular dysfunction. Swedish company Cellectricon is another player doing interesting work, utilizing StressMarq’s proteins to seed neuronal cells grown in microfluidic chip-based environments.

Results-driven growth
For Louwrier, operating a successful business that offers employment opportunities on Vancouver Island and scientific research products of the highest caliber is a priority, and it is paying off in the form of company growth. But for him, the real reward of these efforts is knowing the products play a role in the scientific breakthroughs that are taking place, and that the company’s customers and partners are seeing results.

He says, “When I talk to a customer or collaborator and they say, ‘we just conducted trials X, Y, and Z and we can’t give you the details yet because it’s proprietary, but we want you to know that it worked,’ I walk home and that’s a really good day for me because somebody did something useful with our materials.”

Knowing that the products are effective is one thing but seeing the collective efforts to improve drug discovery in the neurodegenerative disease space—and hopefully patient outcomes—is a real source of pride, and one that continues to motivate the work of StressMarq Biosciences and its partners.

The post Empowering Research in the ‘Age of the Brain’<p class="company">StressMarq Biosciences Inc.</p> appeared first on Manufacturing In Focus.

Early innovations in the field were driven by the need for precise positioning, allowing for more adherence to medical imagery, especially for the biopsy of brain tumors, but also for orthopaedic procedures and prosthetic hip replacements. And as communication technology ramped up in the 1990s, the notion of remote surgery started to push this innovation as well.

Today’s robotic surgery systems make use of advanced computing with custom software, dedicated signal filters and precision hand controllers to interpret a surgeon’s movements at a workstation and drive the robot in the operating theatre, all in real time. The surgeon directs the movement but isn’t physically performing the surgery with the surgical tools. While they’re still very much in control of the process, surgeons don’t have to go through the same demanding physical exertion, reducing physician fatigue and burnout and improving quality of care.

Early pioneers of the technology, like Dr. Fredrick Moll from the Stanford Research Institute, developed robotics for laparoscopy, which are procedures that require minimal incisions often performed around the abdominal cavity. The American College of Surgeons bulletin notes how Moll helped to expand the types of surgeries that robots could assist with. “Dr. Moll thought robotic surgery would offer more degrees of freedom to open, close or rotate the instrument than a straight shafted laparoscopic instrument would,” Dr. T. Sloane Guy told the College Bulletin in a May 2023 piece titled Robotic Surgery Is Here to Stay – and So Are Surgeons.

Guy is director of minimally invasive and robotic cardiac surgery at the Georgia Heart Institute where nearly 20,000 robotic surgeries have been carried out. As he put it, “There is a quiet tsunami of robotic surgery headed our way.”

But, like many new technologies, people were skeptical at first about robotic surgery and what could be done with it. Early on, some surgeons wanted more control over the operating field than what the robots could provide. The robotic prostatectomy, where part, or all, of the prostate is removed to treat prostate cancer or an enlarged prostate, was the first procedure to gain wide acceptance.

In 2018, the Journal of The Society of Laparoscopic & Robotic Surgeons published a piece, Origins of Robotic Surgery: From Skepticism to Standard of Care, where analysis showed that robotic assisted surgery decreased blood loss and reduced hospital stay times among prostatectomy patients.

Now, Intuitive Surgical, a leading global producer of surgical robotic products headquartered in California, estimates more than 12 million robotic surgery procedures have been performed with Intuitive systems. Further, an analysis published in JAMA Network Open in 2020, Trends in the Adoption of Robotic Surgery for Common Surgical Procedures, found that robotic surgical procedures entered into the Michigan Surgical Quality Collaborative registry increased from 1.8 to 15.1 percent from 2012 to 2018.

The types of surgeries have expanded considerably as well, with robots used for cancer, cardiac, and gynaecological surgery, and general ones like gastric bypass, hernia repairs, and gallbladder surgery.

The shift has also transformed medical curricula as residency programs make robotics part of their training, largely driven by demand of the residents themselves. Alisa Coker, the director of robotic surgery education at the Johns Hopkins University School of Medicine, told Wired magazine in an October 2023 story, Meet the Next Generation of Doctors – and Their Surgical Robots, “Some residency programs didn’t see the benefit of teaching their surgery residents robotics. But over the last six years, residents started demanding to be taught robotics… They were asking that we prepare a curriculum to teach them.”

Coker took that demand and turned it into a program that includes robotic simulators, which are used to teach the skills needed for robotic surgery. Most students now practice on simulators and assist on related cases.

While more surgeons are using robotics in surgery, the technology itself continues to advance. The three emerging trends in the future of robotic surgery are miniaturization, telepresence, and the impact of AI, according to the Vanderbilt University School of Engineering report of November 2023, The Future of Robotic Surgery: 3 Trends to Look For.

The top trend, miniaturization, involves micro-robots in surgery. Microbot Medical has recently expanded its surgical robot manufacturing capabilities and introduced the Liberty single-use endovascular robot system. Bearing an uncanny resemblance to Sherlock Holmes’ double-brimmed hat, the little robot can be hand-held and used remotely for neurovascular, cardiovascular, and peripheral vascular procedures. Basically, this mini robot can carry out intricate procedures targeting blood vessels. It also happens to be disposable and can cut back the requirement for larger pieces of equipment in the OR.

Telepresence—the option to remotely perform a surgery—broadens what can be done from further distances. And it doesn’t get much more remote than space. A robot aboard the International Space Station recently completed a surgery demo in space while the surgeons who remotely performed the demonstration were about 250 miles away in Lincoln, Nebraska. Not only does this have implications for space travel, but it can be used in remote places that may not have surgeons but could have robots.

The hurdle, however, with this kind of remote surgery is the delay between the actions of the surgeons and the movement of the robots, which increases with distance. Dr. Michael Jobst, a colorectal surgeon who was part of the space surgery demo, talked to CNN about these critical delays for the piece Surgery in space: Tiny remotely operated robot completes first simulated procedure at the space station. “In a live patient, if there is bleeding, it’s my job to stop that bleeding immediately. But to have an 800 to 850 millisecond lag between seeing the blood loss then doing something about it, I mean effectively that’s like… saying, ‘okay, one Mississippi, two,’ and then I get to go ahead and fix the problem,” said Jobst. “Five seconds would be an eternity in surgery, and a split second or half a second is going be significant. So, this was a big challenge.”

As CNN noted, the robot carrying out this surgery is called spaceMIRA, a two-pound compact robot that has two tools to grab and cut. It is specialized for weight and size to go into space where its Earth counterpart is three inches longer with a similar design.

The other major enhancement that will propel what robots can do in the future is AI and machine learning. Currently, AI is used to help recognize patterns and detect objects through inspecting digital images or videos. This goes a long way toward improving the diagnostic process. As the technology develops, the aim is to assist surgeons in real-time decisions as well as evaluate the risks and benefits of the surgery and postoperative complications. In the actual mechanics of an operation, AI could also perform simple tasks through the robot, like closing a port site when the device is removed or tying a suture.

Beyond this, AI could expand to artificial implant technology and programming that could allow someone who is profoundly deaf to hear.

With all this potential, some ethical questions are being asked, like who would be held responsible if an AI-led surgery results in a bad outcome? Is it the doctor for using the AI; is it the programmer who created the software behind the AI?

These questions are leading to the bigger ones for the medical profession where robotic surgery is involved. Is it ultimately human error that results in the negative consequences of surgery when the issue is a technical failure? Should humans be limited to the planning and decision making but physically stay out of the operating room?

We are still a long way from the scenario of a robot surgeon walking into an operating room to perform the surgery, but the decisions we are making now are shaping what that future will look like. It may come down to a question of trust. For something as intimate and life-altering as surgery, are we prepared to let the robots do the work or will we always want to have the human touch?

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