Having a Wellness Map and a Healing Perspective Can Lead to Well-being Moments

JULY 12, 2019       Dr. CBY DR. C 

A man walks into a store and asks for a map. The storekeeper responds, “We have lots of maps. Where are you going?” The man snaps, “Anywhere but here.” The shopkeeper says, “Sorry. We don’t have a map to ‘anywhere but here.’”

When I was first hit with a sudden loss of vision, I wanted to escape. Anywhere was better than here. I thought I had lost my way to well-being because all I saw was a distorted view of life through my obscured vision. It seemed as if I had no wellness map. It took me a while to realize that there is no wellness map to “anywhere but here.” Instead, a wellness map can help us move toward an increased probability for well-being moments. The first step in that direction is to gain a perspective that promotes healing.

A well-being moment can be described as bliss, flow, mystical, and healing. It is characterized by clear euphoria, awe, sense of time loss, a shift in perception, and wisdom. Well-being moments are holistic, touching mind, body, emotions, and soul. These characteristics distinguish them from artificial “feel-good” moments.

Parkinson’s is a long, gradual, progressive disease with many changes and losses. The CHRONDI Creed illustrates some of the changes I made along the way to my wellness map. I had moments when I realized the extent of my loss — in my physical stamina, my ability to work, my coordination, and my ability to easily engage in activities that I had previously enjoyed. Many of the changes incorporated a shift in perspective, which I described in a previous column.

Following my vision loss in combination with my Parkinson’s, the first tweak I made to my wellness map was to stop perseverating on the loss and to shift to seeking wisdom. This adjustment involves more than moving past grief and accepting the loss; it is a shift of focus away from loss, disease, and suffering, and on to what has been gained in this new Parkinson’s reality. The first tweak to the wellness map is shifting the perspective about the trauma to allow for more moments of well-being.

Some people are confused about well-being. Much suffering is linked to chasing after its feel-good aspect. Some think that the fleeting feel-good moment is all that there is as they reach out and grasp — or purposefully try to create — that moment of rapture. Grasping the butterfly destroys its wings; not grasping allows wellness to unfold. Tweaks to a wellness map are aimed at opening the possibility for well-being moments to occur and holding open that possibility with compassion, lightness, and patience. I have had times when I’ve lost a sense of well-being and had trouble using my map, but shifting to a healing perspective helped me to find my way back.

Do I have moments when Parkinson’s wears me down or makes me frustrated? Of course. Does my vision loss sometimes feel like “just one more thing” I’ve lost in my life? Absolutely. But each day is spent with the intent that I can continue to create my wellness map and walk toward a sense of well-being despite these challenges.

Having Parkinson’s and vision loss does not make me less of a person — to myself, my family, my friends, and my contributions to the world at large. These challenges merely represent a new way of seeing and interacting with the world to which I can adjust.

I believe that events are intertwined across time and space. My vision loss was connected to more of my life, including how I experienced Parkinson’s, than I was willing — or perhaps able — to understand at the time. The shift in perspective helped me to understand the meaning of my experiences, decrease the angst, and increase the frequency of well-being moments.

Well-being moments cannot be forced to happen. Alternatively, we create a life, an inner relational space, that is more conducive to the occurrence of well-being moments. Learning how to wisely access a shift in perspective is an essential part of living within that sacred relational space.

Well-being moments are characteristically difficult to describe. Perhaps we can come together and share our experiences of these moments in the face of Parkinson’s, and in doing so, expand our collective understanding.

Please share your well-being moment experiences in the comments below.

***

Note: Parkinson’s News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Parkinson’s News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinson’s disease.

https://parkinsonsnewstoday.com/2019/07/12/well-being-moments-healing-perspective-wellness-map/

Onstryv Now Available to Patients with Parkinson’s Disease in Canada

 JULY 12, 2019 BY ALICE MELÃO IN NEWS.

 https://parkinsonsnewstoday.com/2019/07/12/onstryv-is-now-available-to-patients-with-parkinsons-disease-in-canada/

Patients in Canada with diagnosed Parkinson’s disease can now receive Onstryv (safinamide) to help manage their symptoms and their “off” episodes.

This follows the approval of Onstryv by Health Canada in January 2019 as an add-on treatment to improve motor function in Parkinson’s patients who experience “off periods” while taking other therapies such as levodopa.

The oral therapy will be available under prescription in 50 mg and 100 mg tablets, and be marketed in Canada by Valeo Pharma — under a license agreement with Zambon. Valeo has launched a physician awareness and information campaign to facilitate and expedite patients’ access to Onstryv.

“The number of Canadians afflicted with Parkinson’s Disease is expected to grow by more than 50% over the next decade as the Canadian population ages,” Steve Saviuk, CEO of Valeo, said in a press release. “Onstryv is the first new oral treatment for Parkinson’s Disease to be approved in Canada in well over a decade.”

“Valeo is committed to building and supporting relationships with healthcare professionals, patients and other stakeholders to build awareness and ensure access to this new treatment for Parkinson’s Disease,” he added.

Known as Onstryv in Canada and Xadago in the rest of the world, the compound is an oral, once-a-day add-on therapy that works by selectively and reversibly inhibiting the MAO-B enzyme that can degrade several neural signaling molecules such as dopamine, which is deficient in Parkinson’s disease. The therapy was approved in the United States in March 2017 by the U.S. Food and Drug Administration.

Onstryv was developed by Newron Pharmaceuticals and has demonstrated effectiveness in helping to control the motor symptoms and complications of Parkinson’s disease for over two years in patients. Zambon acquired rights from Newron Pharmaceuticals to develop and commercialize Onstryv globally.

Clinical trial data has shown that Onstryv can significantly reduce motor fluctuations (on/off time) when used in combination with levodopa and/or Lodosyn (carbidopa) without increasing the risk of dyskinesia (involuntary movements).

“Now, with the Canadian launch, safinamide is available across the North American region,” Stefan Weber, Newron CEO, said in a press release.

“This marks another key milestone for Newron and its commercial partners in providing availability of safinamide in Canada for the treatment of patients suffering from Parkinson’s disease,” he added.

https://parkinsonsnewstoday.com/2019/07/12/onstryv-is-now-available-to-patients-with-parkinsons-disease-in-canada/

NSCF Will Launch First 3D Cellular Model of Parkinson’s to International Space Station

JULY 12, 2019             BY MARISA WEXLER 

The National Stem Cell Foundation (NSCF) announced it will launch the first 3D cellular models of Parkinson’s disease, and primary progressive multiple sclerosis (PPMS), to the International Space Station (ISS) to study the cells in low-gravity conditions.

“This innovative approach to study has the potential to provide new insights into the mechanism of these diseases that may accelerate new drug and cell therapy options for patients,” according to the NSCF.

The models, called organoids, use cells taken from people with these two neurodegenerative diseases. Because they are 3D and incorporate multiple kinds of cells — including microglia, the inflammatory cells of the brain — these models are considered relatively good representations of the way cells act and interact in the body. Researchers are particularly interested in observing, in microgravity, biological events such as cell signaling, migration, changes in gene expression — how information in a gene is synthesized to create a protein — and pathways of neuroinflammation.

This knowledge can help scientists gain insight into the molecular mechanism underlying these diseases, in this way accelerating therapy discovery.

Studying these models in the lower gravity of the ISS will provide “an opportunity to view the biological processes and biomarkers involved in a way that is not possible on Earth,” according to a NSCF press release. This has the potential to “enable progress in the field.”

The first organoids to be launched will go up on SpaceX18, which is scheduled for liftoff on July 21 from the Kennedy Space Center in Cape Canaveral, Fla.

This will be a preliminary flight aimed at testing the facilities and technology required to transport, house, and maintain cell cultures of this sort on the ISS. Studies specific to Parkinson’s and PPMS are planned for autumn of this year. Researchers will send patient-derived human 3-D models of the diseases to the space station for 30 days.

The project is being funded by the NSCF. It is a collaboration between the New York Stem Cell Foundation Research Institute, Summit for Stem Cell Foundation, and researchers at Aspen Neuroscience.

“The National Stem Cell Foundation is delighted to be funding innovative science at the frontier of new drug and cell therapy discovery,” said Paula Grisanti, DMD, MBA, the NSCF’s CEO. Grisanti said the research “may fundamentally alter our understanding of how and why neurodegeneration occurs.”

The engineering needed to transport and house the organoids is being led by Space Tango, which is developing automated systems to support this research. By removing the “human element,” these systems hold the promise of being more consistent and capable of analyzing many samples at once. In addition to improving research in space, this technology may help improve lab work done on the planet’s surface, researchers say.

“We are very pleased to support this important research on the ISS and look forward to continuing to work together with the National Stem Cell Foundation and other partners they may bring on for future flight,” said Jana Stoudemire, commercial innovation officer at Space Tango.

https://parkinsonsnewstoday.com/2019/07/12/nscf-announces-launch-first-3d-cellular-model-parkinsons-international-space-station/

Grant awarded to Andrews University will help therapy program for Parkinson's patients

 by Caroline Torie, WSBT 22 Reporter       July 12th 2019

Andrews University just got a grant that could help you or your loved one.

It’s going toward expanding a therapy program for Parkinson’s patients at its School of Communication Sciences and Disorders.

Therapy will help patients improve speaking and swallowing functions. Those elements are especially important to monitor for those with Parkinson’s, because 9 out of 10 diagnosed will see those problems.

The therapy soon expanding to Andrews University will help patients retrain their brain, shifting what used to be automatic to intentional and habitual.

The University has had an on-site speech clinic for a while, but there was a cost to patients. Now, this grant from Parkinson Voice Project is allowing patients to take advantage of this therapy for free.

Speech Language Pathologists and graduate students at Andrews will lead individual therapy called "SPEAK OUT!" It runs for 12 sessions, three times a week.

After that's complete, patients have the opportunity to do group therapy called "LOUD crowd" once a week.

In individual and group therapy, patients will work through a series of vocal warm-ups and exercises. They’ll also try reading, conversational and cognitive activities.

Therapy is expected to help patients speak in their best voice possible. It could also help prevent Aspiration Pneumonia, potentially happening after food or liquid goes down the wrong pipe. That’s significant, as it causes 70-percent of fatalities in Parkinson’s patients.

“They can do something. They have control of something. They have a choice every day where they can choose to do these exercises. That will help preserve their voice and their swallowing, or they can choose not to. But it something within Parkinson’s that they have control over,” said Jenica Joseph, Andrews University Speech Language Pathologist.

If you’ve noticed someone you know with Parkinson’s has to repeat frequently, their vocal quality has deteriorated, their volume is lower and their voice is more hoarse, or they are having problems swallowing, Joseph encourages you to give her department a call. If you are interested in the program you can contact her directly by email jenicaj@andrews.edu or call the department at 269-471-3468.

The first individual therapy sessions will get started in September.

Joseph hopes a Parkinson’s choir called "SING OUT!" can be started at some point in the near future.

https://wsbt.com/news/local/grant-awarded-to-andrews-university-will-help-therapy-program-for-parkinsons-patients

Boston researchers look to cycling as possible treatment option for Parkinson's disease

July11, 2019          Emily Riemer

https://youtu.be/gYTnC49bHfk

Approximately 60,000 Americans are diagnosed with Parkinson's disease every year. Researchers really don't know what causes it but they do know medication can help. What they're also learning is certain kinds of exercise can make a significant difference in a patient's quality of life.

Rich Borelli noticed the first uncontrollable twitch in 2010. It took years, though, for an official diagnosis of Parkinson's disease.

"You go through this sense of my body is betraying me," Borelli said.

Parkinson's is a disorder caused by a loss of neurons in the brain that produce dopamine. The symptoms include shaking, stiffness and instability.

Borelli had always been an athlete and though he was also dealing with other health issues, physical therapy and exercise helped. That exercise included cycling on a stationary bike, something he did with Pedaling for Parkinson's, a class created by researchers at the Cleveland Clinic and implemented in local gyms. 

"Patients will say that they feel better after just one session," said Dr. Kathleen McKee, a Partners neurology fellow in movement disorders and fellow in health policy and hospital management at Massachusetts General Hospital. McKee is one of the investigators studying the effectiveness of the Pedaling for Parkinson's programs in the greater Boston area. The study was funded by the MGH McCance Center for Brain Health. 

Her work was inspired, in part, by a patient in the Netherlands featured in 2010 in the New England Journal of Medicine.

That patient was a man with advanced Parkinson's disease, hardly able to walk without assistance yet he was able to ride his bike for miles every day. When he rode, many of his symptoms were temporarily gone.

Research done in a lab has shown cycling at a fast pace, 80 to 90 revolutions per minute, can improve symptoms for other patients, as well.

"We think it has something to do with the fact that by forcing themselves to go quickly, it may feed back to the brain and allow them to then keep going quickly and to move more smoothly even after they've stopped riding the bicycle for the hourlong session that they've been on it," McKee said.

The question for McKee and the other investigators was if a similar outcome could be replicated outside the lab environment. That's where Pedaling for Parkinson's comes in.

Implemented by local YMCAs, patients cycled three times per week for eight weeks, at that fast pace. It was a pace Borelli had to get used to.

"You have a real sense of accomplishment when you go 40 minutes on a bike, and do whatever your routine looks like," Borelli said.

Perhaps just as important, the class gave him a sense of community.

"When we're biking some will say, 'Well, I woke up feeling terrible this morning. You know, my legs were stiff, my back was stiff.' It's the understanding of I'm not so different from everybody else," Borelli said.

The studies wrapped up this spring and the data is being analyzed right now.

https://www.wcvb.com/article/boston-researchers-look-to-cycling-as-possible-treatment-option-for-parkinsons-disease/28338152

They are the ‘Loud Crowd’ and they are quite proud of it

By David N. Young - July 11, 2019

Pictured (left to right), are Thomas Wright, David Sloane, Mark Curley, Samuel Sebabi, Lynn M.L. Gallandt, M.S. CCC-SLP, June Helton, Lou Belanger and Kenny Sams in the Loud Crowd class at Los Alamitos Medical Center. Photo by David N. Young

Parkinson’s victims learn to reclaim their voices

Although most of this class is retired, they practice speaking as though their lives depended on it. In many ways, what they learn here does matter and will make a difference in the everyday quality of their lives.

They are the “Loud Crowd” and each of them are a victim of Parkinson’s Disease. Though the disease has slowly taken from them the ability to be understood, this pioneering program being administered at Los Alamitos Medical Center is giving them a chance to fight back.

“This (Loud Crowd) is a program to give victims of Parkinson’s a chance to reclaim their voices,” according to Speech Language Therapist Lynn Gallandt (M.S. CCC-SLP), who teaches the small class twice weekly.

“I’m proud of you for not let Parkinsons’ take your voice,” Gallandt tells her class as she coaches them through weekly speaking drills. While Parkinson’s Disease affects the brain’s neurochemical pathways in a patient’s brain, Gallandt says the underlying muscle system in patients is very much intact.

As the disease progresses, she says, patients begin to find their voices weaken, eventually softening to the point of not being understood. They begin to speak softly and for some, not at all.

Twice weekly, this group of about 10 victims of Parkinson’s Disease sit around a conference room table as Gallandt puts them through paces that teaches them to use and train the facial muscle which they can still control.

“Let’s say it again,” she tells the group, “this time act like you’re at a football game these phrases,” she said. “Let’s make it a little stronger.” By exercising specific muscle patterns, their voices become stronger, louder and better understood.

“For me, the program has been a tremendous help,” said patient Samuel Samuel Sebabi. “My wife would urge me to go out. I found every excuse in the book not to go. I found myself getting stuck on words. Then I started losing my voice. After just four sessions here,” he said, “I knew I was in the right place.”

Actually, the Loud Crowd is a registered regimen developed by the nonprofit Parkinson’s Voice Project in Richardson, Texas. Patients can only enter the program once they’ve completed the “Speak Out” portion of the treatment, says Gallandt.

“They lose the ability to do things that once happened automatically,” said Gallandt, like blinking, swallowing, speaking and sometimes walking.

Lou Belanger, 91, a longtime factory manager and yes, an aspiring singer, said “I was having trouble understanding what I was saying. I thought I was the one needing hearing aids,” he said before realizing his voice was slowly, softly disappearing.

The class continues as Gallandt urges the Loud Crowd to “say it with intention. “You deserve for people to hear you. You deserve people to understand you.”

As they speak, she focuses them on using the muscles in their faces that have not been affected by Parkinson’s that allow them to speak at near normal capabilities.

She teaches them to “say it with purpose” and teaches them breathing exercises to replace the automatic neurochemical responses that Parkinson’s has taken from them.

For many attending the class, a large majority of whom had virtually given up socializing, they are now enjoying life again. Gallandt says she enjoys watching the transformation and hopes the program will expand to help others. She will soon be traveling for additional training, but Gallandt said results thus far are very promising.

“It’s given them a voice again,” she said, and that is “a wonderful gift.” And said Belanger in his thick, northeastern accent, “I’ve always got something to say.”

https://www.sunnews.org/they-are-the-loud-crowd-and-they-are-quite-proud-of-it/

How Parkinson's sufferers are being helped by a university in Wales

JULY 11, 2019    ByChris Peregrine  University of Wales Trinity St David

Driving innovation, creativity and entrepreneurship is the aim and it is getting valuable results

Special shoes developed by University of Wales Trinity Saint David's Centre for Advanced Batch Manufacture to help Parkinson's sufferers

A state-of-the-art centre in Swansea's SA1 development is helping to ease the pain of Parkinson's sufferers.

The Centre for Advanced Batch Manufacture (CBM), established by University of Wales Trinity Saint David (UWTSD), is playing its part in the medical fight.

Walk With Path, a London based company, approached CBM to help develop a device to aid the mobility of people suffering with freezing of gait (FOG), a common symptom of people suffering from Parkinson’s disease (PD).

FOG occurs in up to 53% of PD patients and is a major reason for falls by causing an inability to initiate or continue walking. When a patient attempts to lift a foot to step forward, the foot is felt to be ‘stuck’ to the ground, sometimes with trembling of the legs.

Research has shown that visual cues on a walking surface can make a considerable difference in overcoming FOG and the team at Walk With Path had the idea to develop a wearable device that would provide this vital visual cue. Walk With Path asked CBM to work with its industrial designer to develop this product, otherwise known as Path Finder.

https://youtu.be/dWdbSX6LXjE 

Path Finder is a laser light cueing device which attaches to a shoe, and projects a horizontal line on the ground in front of the user, at a set distance from the feet. This gives the wearer a visual cue to step across, and acts as an external stimulus to trigger walking.

A simple prototype had already been made which proved the principle and CBM was asked to help develop this into a commercial product.

CBM’s experience of manufacture and taking products through to market proved invaluable whilst defining the product design specification. Working closely with the Walk With Path team and potential users, it defined and refined the device operation to ensure the final design was fit for purpose.

CBM detailed each component in 3D computer aided design software before manufacturing three sets of working prototypes which were used for extensive user testing.

Feedback from the user trials allowed the design to be refined before a full set of 2D control drawings were produced for manufacture.

Less than 12 months after the first meeting, Walk With Path has launched the Path Finder, an innovative, affordable product to help Parkinson’s disease sufferers overcome walking difficulties.

Company founder Lise Pape said: “CBM helped us to prototype multiple iterations of our product, carrying out user testing at each stage by using their rapid prototyping services to make devices our users could interact with. Once we moved to mass manufacture the support did not end, and we were able to count on CBM to offer advice and opinion during the DFM stage of tool design.”

The development of a learning and innovation village in Swansea’s SA1 area supports UWTSD's aim to inspire individuals and develop reflective graduates and practitioners who can make a difference to society.

Centre has unique offering

University of Wales Trinity Saint David's Centre for Advanced Batch Manufacture is involved in making special shoes for Parkinson's sufferers

CBM is a core component of the university’s new SA1 Swansea Waterfront development, driving innovation, creativity and entrepreneurship among companies engaged in new product development and low-volume manufacture.

It is an industry focused advanced research, new product development, and batch manufacturing facility. Its unique offering is delivered via an experienced development team, utilising state-of-the-art technology platform’s which includes 3D printing, scanning and low volume manufacturing.

MADE (Manufacture for Advanced Design Engineering) project is a suite of European-funded projects, being delivered by CBM, designed to collaborate with small and medium-sized enterprises within industry to future-proof their operations by upskilling and adopting advanced manufacturing technologies.

The project is being offered to qualifying organisations as an integrated portfolio, to help Welsh manufacturers understand the challenges they face and how they can respond to them, by tapping into disruptive technologies and training, appropriate for their businesses.

UWTSD deputy vice-chancellor Professor Robert Brown said: “These are challenging times for manufacturing in Wales, with a number of uncertainties ahead. The on-going Brexit process will usher in economic shifts. We are seeing rapid changes, relevant to manufacturing, unfolding in the world of technology, and there are underlying evolutions in play as far as working patterns and staffing is concerned.

“The MADE initiative offers a smart suite of collaborative projects, providing vital tools for manufacturers who are determined to be well-equipped for the future. We are already liaising with manufacturers of all kinds, to talk with them about how the MADE project can help them. We would encourage manufacturers to get in touch with the MADE team to find out how we can work together to benefit their operations.”

UWTSD vice-chancellor Professor Medwin Hughes (pictured above) said: “UWTSD has a long tradition of working in partnership with industry, delivering programmes and working in collaboration to meet their needs. The programmes offered through the MADE project will enable us to work with the manufacturing sector to respond to the technological challenges of the fourth industrial revolution and to support the sector to maximise the opportunities offered through such innovation.

“The university shares the Welsh Government’s ambition, in securing the funding though ERDF (European Regional Development Fund) of assisting companies to boost their competitiveness and productivity in order to secure growth and jobs, particularly in west Wales and the Valleys where such investment is much needed.”

Time of significant change

Eddyfi Technologies principal scientist/product manager Professor Neil Pearson said: "Eddyfi Technologies, with the UK Headquarters in Swansea, design and manufacture remote robotic inspection crawling solutions for the oil and gas industry. This is where we recently approached UWTSD in partnership with CBM to help us investigate alternative materials such as polymers, new additive manufacture techniques among others that would improve the manufacture of the housing and introduce new techniques to the company that we could apply to other products.”

Industry Wales chairman James Davies said: "Industry Wales is fully supportive of these EU programmes. At time of significant change and challenge for the Welsh Manufacturing sector, this operation is both timely and critical. With an established track record in providing industry focused solutions, UWTSD are ideally placed to deliver such an operation.”

CBM Research specialises in applied interdisciplinary research. Research projects typically employ advanced engineering technologies to drive innovation across a range of industrial sectors.

CBM has entered into a number of strategic partnerships in the UK, Europe and Asia. Academic partnerships across Europe support current PhD research projects, and further collaborations are under development in Asia to facilitate commercial opportunities.

Visit www.uwtsd.ac.uk

https://www.walesonline.co.uk/special-features/how-parkinsons-sufferers-being-helped-16560168

Insightec wants to usher in a new era of incisionless surgery

JULY 11, 2019    By KEVIN TRUONG

The Israeli company's technology uses the power of focused ultrasound guided by MR imaging to target conditions like essential tremor, Parkinson's disease and neuropathic pain.

Even the most basic movements like tying a pair of shoe laces, drinking a cup of coffee or snapping a selfie can be a daunting task for someone suffering from essential tremor. 

In the United States, the condition affects millions of people. Medications exist to treat the issue, but are largely ineffective for more severe cases. In those instances, the standard of care is deep brain stimulation (DBS), which involves an intensive surgery to apply electrodes near the center of the brain and connect them to an electrical pulse generator implanted in the body.The pacemaker-like device stimulates a part of the brain called the thalamus, thereby blocking the signals that cause tremors.     

Imagine – as an alternative –  an outpatient procedure that harnesses the power of sound and gives tremor patients back their free movement in a few hours without a single incision. Tirat Carmel, Israel-based company Insightec is making that scenario a reality with its ExAblate Neuro focused ultrasound device, which uses concentrated sound waves to thermally ablate the thalamus, leading to a significant reduction in hand tremors.

Focused ultrasound works by concentrating multiple high intensity sound waves using an acoustic lens and targeting that energy source with medical imaging technology. Think of how a magnifying glass can intensify diffuse light waves into a powerful beam that can burn a hole in a sheet of paper. 

Insightec was founded back in 1999, the brainchild of Kobi Vortman, a healthcare entrepreneur and expert in medical imaging. Seeded with funding from Elbit Medical Imaging and GE Healthcare, Insightec started the long road of developing and commercializing their device.

The company received FDA approval in 2004 for the use of its technology in treating uterine fibroids, followed by another approval in 2012 as a pain treatment for bone cancers and investors poured in hundreds of millions to support its growth. But, the approval and investments notwithstanding, reimbursement and a viable U.S. market for the technology failed to materialize.

To jumpstart a turnaround, the board appointed veteran healthcare executive Maurice Ferré as the company’s chief executive back in 2014, who refocused on Insightec’s efforts in neurology – specifically in essential tremor and Pakinson’s disease.

Prior to his position at Insightec, Ferré was the CEO of surgical robotics company MAKO Corp., and shepherded the business through its IPO and eventual $1.65 billion sale to Stryker Corp. 

Insightec’s prospects improved with a raft of new financing including a $150 million Series E round led by Koch Disruptive Technologies in 2017 at a post-money valuation of $610 million.  The company has raised more than $400 million.

Insightec CEO and Chairman Maurice Ferré

In a phone interview, Ferré said the treatment has enabled patients to enjoy their hobbies or extend their professional careers. One is a mother who was able to finally tie her children’s shoes, another was an artist that was able to put a paintbrush to canvas again.

“Tremor is a disease that causes a lot of problems at the social level and there hasn’t been any alternative treatment for the five million patients who are refractory to medication,” Ferre said. 

Dr. Vibhor Krishna, a neurosurgeon at The Ohio State University has used Insightec’s product for more than a dozen tremor patients and said patient enthusiasm is high for an alternative to deep brain stimulation to treat their condition.

“A lot of patients have physical dependence and mental agony of living through essential tremor,” Krishna said.“The excitement has allowed these patients to at least seek out treatment and understand for themselves what would they want to do for their condition.” 

There are advantages and disadvantages of focused ultrasound treatment versus deep brain stimulation. For one, deep brain stimulation can be dialed up if tremors worsen with age and dialed down in the case of side effects related to the electrical stimulation.

Focused ultrasound, on the other hand, has little risk of infection or bleeding and a much faster recovery time of hours or days, rather than weeks. 

But it’s not all positive. Krishna said there is a risk in focused ultrasound of ablation spilling over into other brain structures though improvements in imaging technology is helping to lower that danger. 

While clinical adoption has started to pick up, regulatory tailwinds are also pushing the company forward. So far, Neuro ExAblate has treated around 2,000 tremor patients and is currently offered at 16 sites around the U.S., including top academic medical centers like UCLA, Stanford University and the Cleveland Clinic. The cost of the Neuro ExAblate equipment is around $2 million and the outpatient procedure takes between two and four hours.

Insightec received FDA approval for its Neuro ExAblate device to treat essential tremor in 2016.  That was followed up with an expanded indication from regulators in 2018 for the treatment of with tremor-dominant Parkinson’s disease. Insightec’s pivotal study for essential tremor found that the treatment resulted in a 50 percent improvement in patient tremors and motor function scores.

Alongside the company’s regulatory wins, Insightec has finally made strides in its reimbursement strategy and is currently approved as a Medicare covered benefit in 38 states. Insightec has also won coverage from 18 Blue plans around the country, equivalent to around 50 million covered lives.More recently, the company received Japanese national reimbursement approval for Neuro ExAblate. 

Ferre said the reimbursement approval has helped the company usher in a growth phase with the hope to install 300 or more systems in the U.S. over the next decade.

One of the leading figures trying to establish the use of focused ultrasound in mainstream clinical practice has been Neal Kassell, the founder and chairman of the nonprofit Focused Ultrasound Foundation. A neurosurgeon by training, Kassell started the organization back in 2006. 

Kassell —  who was involved in commercialization efforts for the Gamma Knife focused radiation technology —  was stuck by the sheer number of ways that focused ultrasound energy can be medically useful. Researchers have used focused radiation technology in use cases ranging from helping to augment immunotherapy drugs to increasing the permeability of the blood-brain barrier.

“When I saw highly-focused ultrasound I realized that this was a technology that had applications far beyond what the Gamma Knife was able to do,” said Kassell, who previously served as an Insightec board member. “It was game changing.”

A major barrier for adoption has been getting reimbursement approval for the technology from payers. Kassell said companies are often faced with the disconnect between the research needed to receive regulatory approval and evidence necessary to get the technology actually paid for in the healthcare system.

One of the reasons for the failure of Insightec’s uterine fibroids product was the status quo: the lucrative business many providers had in performing hysterectomies.

“Physicians as a group are very slow to change and resistant. And since it’s a disruptive technology, there’s fairly vicious turf battles between the different medical specialists that have to be overcome,” Kassell said. 

However, there are signs of progress. According to data collected by the Focused Ultrasound Foundation, more than 100 clinical indications exist for which focused ultrasound is in various stages of research, development, and commercialization, many of which have received regulatory approval outside of the U.S. Additionally, the number of manufacturers working in the space have ballooned to nearly 50 companies.  

Kassell compared the progress of focused ultrasound to that of MRI, which has seen exponential growth in clinical use over the past 20 odd years.

“Awareness is growing, but it’s still been called medicine’s best kept secret. However, that’s changing pretty rapidly,” Kassell said. “There’s regulatory approvals, insurance reimbursement is starting to kick in and by nearly every measure the field is actually starting to explode.”

Insightec’s technology uses focused ultrasound to target structures deep in the brain.

Ferre said the company has identified seven neurological conditions to prioritize that affect a cumulative 200 million people worldwide. In the near future, Insightec is likely to tackle neuropathic pain, an indication for which it has already received approval in Europe, Russia and Korea. The company is also in Phase III clinical trials for advanced Parkinson’s disease.

Longer term though, the company hopes to expand its platform technology into areas such as targeted drug delivery, Alzheimer’s disease and epilepsy. Ferre said the company is currently running around 70 different trials around the globe at different levels of development. 

It was that overarching potential that led Koch Disruptive Technologies (KDT) – the venture investment arm of the industrial conglomerate – to lead Insightec’s $150 million Series E round. It happened to be KDT’s first investment in a healthcare company.

KDT Managing Director Brett Chugg said the firm was drawn to Insightec by the pedigree of its leadership and the potential of the technology to be a safer and more cost efficient treatment option across a selection of different neurological conditions. 

“We’re looking for high potential opportunities. Not individual products, but platforms,” Chugg said. “We see Insightec having that potential with a number of different indications with its ability to do everything from lesioning and ablation to helping with targeted drug delivery.”

That wide range of options provides ample open ground for development, which as Chugg puts “is not too bad of a problem to have.” 

The partnership between KDT and Insightec isn’t simply a pure financial transaction. Chugg said his firm has helped broker meetings and relationships in the marketplace and and shared its expertise in areas like manufacturing. 

One of the most promising applications for use of the technology is in temporarily breaking down the blood-brain barrier, which provides an obstacle for the vast majority of neurological treatments. Virtually all large-molecule neurotherapeutics and 98 percent of all small-molecule drugs are blocked by the boundary. 

Dr. Krishna at Ohio State is currently running a clinical trial using the technology to explore its efficacy of using high-intensity ultrasound to open up the blood-brain barrier to potentially help treat Alzheimer’s disease by decreasing amyloid plaque load. With the use of Insightec’s technology, high intensity ultrasound waves are directed at infused micro bubbles in the bloodstream which vibrate and can make the layer permeable for around 12 to 24 hours. 

Still, the application represents just one of the more than 15 different mechanisms of action for focused ultrasound that have been identified. 

In sketching out his overall vision for Insightec, Ferré positions the company as part of the larger transformation of the concept of surgery from “mechanical to molecular.”

“Over the next ten years we see this MR-guided ultrasound technology as the next paradigm of surgery as we’ve gone from open to minimally invasive to robotics and now to incisionless,” Ferré said.

https://medcitynews.com/2019/07/insightec-wants-to-usher-in-a-new-era-of-incisionless-surgery/?rf=1