2021 Focused Ultrasound Foundation - Midyear Report
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Focused Ultrasound Foundation 2021 Midyear Report
Growth and Progress
Despite Confusing Times
We were hoping by this time Covid’s grip on the way
we live and work would have relented. Unfortunately, this
has not occurred and there remains often confusing rules
and regulations impacting where and how we work, travel,
and learn.
But the good news is that the Foundation staff and focused
ultrasound community at large have adjusted to operating
in this state of uncertainty. The field continues to grow—to
thrive, actually—with increasing momentum, as documented
here and in our recent 2021 State of the Field report.
This year has already seen first-in-human clinical trials,
important brain and body studies, workshops, strategic
partnerships, reimbursement wins, developments in
Asia—and even a record number of interns and fellows at
the Foundation.
This widespread progress is a testimony to the commitment
of all the stakeholders in the focused ultrasound community
to improve the lives of millions of people around the world
with a wide variety of serious medical disorders.
We thank you for your continued interest, support, and effort.
Be well.
Neal F. Kassell, MD
Focused Ultrasound Foundation | 2021 Midyear Report 1
creating knowledge research milestones
Global research institutions have pioneered focused ultrasound
in the areas of veterinary cancer, MR imaging, transcranial histotripsy, and liver tumors.
preclinical Improving MRI for
Focused ultrasound
studies
A collaborative team of researchers at
the University of Virginia and Virginia
Polytechnic Institute and State
University developed a transcranial
focused ultrasound treatment bath that
is invisible during MRI scans. Because
Clinical trial degassed water degrades the quality of
the MR-guided images, this important
Veterinary cancer and innovative advance could be used
to replace degassed water as an acoustic
Researchers at Oklahoma State
coupling bath. The newly designed
University studied whether two types
coupling bath material contains specially
of focused ultrasound—mechanical and
designed iron oxide nanoparticles. n
thermal ablation—would be effective
in treating various types of low-grade
tumors in dogs. The group treated
a total of 11 dogs with six different
types of tumors and then compared
the therapeutic and immunological
effectiveness of the treatments.
Several of the dogs had
complete tumor remission. n
2 Focused Ultrasound Foundation | 2021 Midyear Report
creating knowledge research milestones
Cholangiocarcinoma
Liver tumors
What is Preclinical researchers at Virginia Transcranial
Polytechnic Institute and State
Histotripsy? University completed a study to
Histotripsy
determine the optimal histotripsy
Histotripsy is a mode of focused Researchers at the University of
parameters to ablate cholangiocarcinoma,
ultrasound involving very short, high- Michigan completed in-vivo brain
a rare liver cancer with a low 5-year
intensity ultrasound pulses (powerful histotripsy experiments in a preclinical
survival rate of 10%. The study was
pressure waves) to mechanically model to demonstrate the safety
conducted in collaboration with Hospital
break up tissue to destroy it. of the technique. This project, which
Universitari Mutua de Terrassa in is currently in review for academic
Histotripsy is a fundamentally Barcelona, Spain, that provided publication, helped move the
different mechanism of action than human liver tissue specimens for use technology closer to clinical work with
thermal ablation and could allow for in histotripsy experiments. n histotripsy for brain tumor treatment. n
much faster treatment times, as it
enables single-session treatment of
much larger targets than possible
histotripsy
with thermal ablation. n
time
pressure
Focused Ultrasound Foundation | 2021 Midyear Report 3
creating knowledge research milestones
The brain is considered the vanguard target for focused
ultrasound. Important human studies are assessing treatment for glioblastoma and
liquid biopsy to improve brain tumor marker detection.
clinical trials Enhanced blood testing
Brain tumors
Researchers from Sunnybrook and the
University of Toronto completed the
first clinical study to test the ability
of focused ultrasound to enhance brain
Glioblastoma Glioblastoma tumor biomarker detection from
a routine blood sample. Nine patients
BBB opening + Sonodynamic with GBM underwent the technique—
chemotherapy therapy called liquid biopsy—before and after
focused ultrasound treatment that
A new clinical trial is underway at The first three high-grade glioma
disrupted the blood-brain barrier to
Northwestern University in Chicago, patients have been enrolled in a new
enhance chemotherapy delivery. The
Illinois, for patients with recurrent sonodynamic therapy and focused
results suggest that liquid biopsy could
glioblastoma (GBM). ultrasound clinical trial at the Ivy Brain
reduce the need for invasive brain tumor
Tumor Center at Barrow Neurological
Phase I of the trial is determining the biopsies and allow for better monitoring
Institute in Phoenix, Arizona. This trial
safe dose of the chemotherapy drug of GBM treatment responses.
is investigating the use of focused
Abraxane®; phase II will evaluate the
ultrasound to treat patients with The world-first results were published in
effectiveness of combining the drug
recurrent GBM and other high-grade the Journal of Neuro-Oncology. n
with opening the blood-brain barrier
gliomas. Researchers are exploring
using CarThera’s SonoCloud device after
sonodynamic therapy—or using focused
surgical removal of the recurrent GBM. n
ultrasound to activate a drug to
cause cell death only in the tumor—
in these patients. n
“ To detect cancer biomarkers
through a blood test could provide
a diagnosis for patients and either
avoid an operation or allow the
surgery to be planned in advance.”
— James Perry, MD
Sunnybrook
4 Focused Ultrasound Foundation | 2021 Midyear Report
creating knowledge research milestones
patient spotlight
Barbara’s story
Glioblastoma
Barbara Frisbie wholeheartedly “loves poor track record of conventional GBM “Rick and I have been involved with
life.” And she has much to love about her treatments and decided to pursue a the Focused Ultrasound Foundation for
life in Kilmarnock, Virginia, with her different course: noninvasive focused many years,” says Barbara. “We believe
husband of 58 years, Rick, their two sons ultrasound. She recently became the in the technology and the promise that
and four grandchildren, and many friends. first patient treated in a GBM focused it holds for humanity. I feel fortunate to
ultrasound clinical trial at the University be able to take part in a clinical trial.”
On March 5, 2021, Barbara suddenly
of Virginia (UVA). The trial—led by
suffered a seizure and was flown to “The use of focused ultrasound to open
Jason Sheehan, MD, PhD, Professor of
VCU Medical Center in Richmond, the blood-brain barrier should permit
Neurological Surgery at UVA and the
Virginia, where she was diagnosed appreciably more chemotherapy to be
Foundation’s Senior Advisor for Brain
with a glioblastoma (GBM). GBMs are delivered to brain tumors and, hopefully,
Tumor Research—aims to open the
an aggressive type of malignant brain lead to therapeutic benefits,” adds Dr.
blood-brain barrier to allow higher
tumor with a generally poor prognosis. Sheehan. “This approach could be a
concentrations of chemotherapy to enter
game changer.” n
After completing the initial surgery the brain to destroy any residual tumor
and radiation, Barbara considered the tissue and hinder regrowth.
Read Barbara’s full story on the
Foundation’s website.
Focused Ultrasound Foundation | 2021 Midyear Report 5
creating knowledge research milestones
Additional major brain research beginning in 2021 is focusing on
debilitating pain, Parkinson’s disease, and pediatric DIPG.
clinical trials Pediatric DIPG
A team at Columbia University has
launched their first-in-human clinical
trial using focused ultrasound to treat
diffuse intrinsic pontine gliomas (DIPGs),
a malignant brain tumor that typically
affects young children. The phase I
Trigeminal neuralgia Parkinson’s disease trial is assessing the use of focused
A team at the University of Maryland A novel pivotal trial validating the use ultrasound to disrupt the blood-brain
has launched a clinical trial investigating of focused ultrasound to treat the barrier to allow increased amounts of
the use of focused ultrasound to address cardinal features of Parkinson’s disease chemotherapy to more effectively reach
trigeminal neuralgia, a chronic and (PD) was published in the New England the brain tumor. n
disabling pain condition. Researchers are Journal of Medicine.
using focused ultrasound to ablate
Professor José Obeso and his team at
a small nucleus in the thalamus located
HM CINAC in Madrid, Spain, collaborated
deep within the brain—called the
with W. Jeffrey Elias, MD, at the School
central lateral nucleus—which is known
of Medicine at the University of
to play a role in pain perception and
Virginia. Both groups used focused
transmission. n
ultrasound to successfully ablate a
portion of the brain called the subthalamic
nucleus, a proven neurosurgical target
for treating features of PD. n
october meeting The Foundation is sponsoring
a virtual workshop on focused
ultrasound for DIPG in October.
6 Focused Ultrasound Foundation | 2021 Midyear Report
creating knowledge research milestones
A first-in-human heart valve disease trial and positive results using
focused ultrasound to relieve significant hand movement issues are highlights of clinical trials
around the globe.
Focal hand dystonia
Inaugural
A team of researchers in Japan led by Andrew J. Lockhart
Takaomi Taira, MD, PhD, investigated
whether focused ultrasound
Postdoctoral Fellow
thalamotomy could be used to treat Caitlin Tydings, MD, was awarded
focal hand dystonia (FHD), which the inaugural Andrew J. Lockhart
causes excessive and involuntary muscle
contractions in the fingers, hand,
Aortic stenosis Postdoctoral Fellowship in Focused
Ultrasound and Immuno-Oncology.
and forearm. Researchers concluded A team of clinicians and researchers At Children’s National Hospital,
that focused ultrasound thalamotomy from France and The Netherlands Dr. Tydings is developing focused
significantly improved FHD. n shared results from a clinical trial using ultrasound as an immune modulator
focused ultrasound to treat calcific in pediatric cancers. The one-year
aortic stenosis, the most common fellowship—established through the
disease for heart valves. The study generosity of the Lockhart family
uses Cardiawave’s Valvosoft , an
®
in honor of their son, Andrew J.
investigational device being developed Lockhart—is designed for early-career
to mechanically soften hardened researchers as a way for the Foundation
valves, improve valve function, and to cultivate the next generation
reduce symptoms. of investigators who could advance
the development and clinical
The first-in-human results were published
adoption of focused ultrasound in
in Circulation. n
immuno-oncology. n
Focused Ultrasound Foundation | 2021 Midyear Report 7
convening the community
Providing critical space for conversations continues to be a major
focus of the Foundation’s work and resources.
GBM Workshop 23-28 October 2022
please join us
In May, the Foundation partnered with
the Society for Neuro-oncology and
the AANS/CNS Tumor Section to host
a virtual workshop discussing focused
ultrasound for GBM. More than 260
attendees from nearly 60 institutions
8th Symposium
worldwide convened to share on Focused Ultrasound
knowledge, identify gaps in evidence,
This meeting is being planned as clinicians, and other stakeholders
and create a roadmap for the technical
a hybrid virtual and in-person event in virtually—more than 1,800 participants
developments, laboratory studies, and
Bethesda, Maryland. from 58 countries—to showcase the
clinical trials necessary for focused
ultrasound to progress in the treatment tremendous progress in the field of
The final proceedings from the 7th
of GBM. n focused ultrasound. n
International Symposium on Focused
Ultrasound are now available. The
2020 fall symposium united scientists,
A video archive of the presentations is
available on our website.
+250
A white paper summarizing the workshop’s
proceedings is also available online.
Scientific presentations
19
Expert panels
8 Focused Ultrasound Foundation | 2021 Midyear Reportfostering collaboration
Facilitating patient access and commercialization of the
technology through strategic professional and trade partnerships remains a priority for
the Foundation.
new partnerships
125
Advocacy
Connecting with
Professional organizations
As part of the Foundation’s advocacy
efforts, we partnered with the Medical
Device Manufacturers Association
(MDMA), a national trade association
“ We believe it’s important
to have all the various trade
associations—including MDMA,
based in Washington, DC, that provides MITA, and AdvaMed—engaged
The Foundation has partnered with educational and advocacy assistance to with focused ultrasound companies
the American Brain Coalition (ABC), innovative and entrepreneurial medical
and the Foundation so they can
joining a group of more than 125 of technology companies. Through
the United States’ leading professional better understand the issues
this partnership, the Foundation and
neurological, psychological, and 10 focused ultrasound companies have we face and effectively advocate on
psychiatric organizations. The ABC is become members of MDMA. n our behalf.”
a nonprofit umbrella organization
that serves as a powerful voice for — Jessica Foley, PhD
Chief Scientific Officer
people with brain disorders by uniting
Head of Advocacy and Government
various organizations to try to reduce Relations
the burden of these conditions to Focused Ultrasound Foundation
individuals, families, and society.
Through this relationship, the
Foundation hopes to bolster its current
advocacy efforts to demonstrate
focused ultrasound’s potential to treat
brain disorders. n
Focused Ultrasound Foundation | 2021 Midyear Report 9cultivating the next generation
A record number of students and graduates collaborated with
the Foundation’s medical, scientific, and communications teams.
Wide range of
Internship projects
As part of the 10th year of our robust Baruch College Ultrasound Microbubble Tumor Analysis
Telemedicine and Telesurgery White Paper Caleb Hallinan
summer internship program, the
Isabella Berkeley Optimization and Application of
Foundation accepted a record 15
a FUSF low-cost Hydrophone Scanning System
students and recent graduates. Their Cornell University Colin Haws
Profiling Asia-Based Companies and Conducting
projects ranged from Research on Strategics in Relation to Regulatory Neuronavigation with VR and Kranion
Approved FUSF Indications Adam Kippenhan
a technical nature—such as analyzing
Dylan Shen Optimizing Internet-Based Electronic Outreach
ultrasound wave behavior in a
Regarding Focused Ultrasound: Facilitating
real-world application; constructing North Carolina Central University Broader Understanding, Reach, and Engagement
Advocacy to Expand Equitable Access to Focused Darrah Sheehan
computer-based models for treatment Ultrasound Treatment in Women’s Health
Samia Taliaferro Neuronavigation with Kranion
planning; and simulating focused
Kathleen Nguyen
ultrasound procedures to improve Penn State University and
University of Virginia
patient care—to research, advocacy, Harvard University
School of Medicine
Review paper on Theranostics in the Vasculature:
and communications. n Sonodynamic Therapy Landscape Analysis
Bioeffects of Ultrasound and Microbubbles
Leslie Hansen
to Induce Vascular Shut Down
Cancer Immunotherapy Landscape Analysis Western Albemarle High School
Summer Interns Jackie Brenner
Optimizing Internet-Based Electronic Outreach
15
Piedmont Virginia Regarding Focused Ultrasound: Facilitating
Community College Broader Understanding, Reach, and Engagement
Kimball Sheehan
students HIFU Knee Phantom
Jack Snell Xavier University and
Harvard University
9
University of Exeter, UK
Focused Ultrasound for Gene Therapy Review FUSF Hydrophone Tank Lens Application
Juliette Strubel Expanding Simulation Research at FUSF Using
academic institutions
CIVA Software
University of Virginia Dawn Bordenave
Sonodynamic Therapy Landscape Analysis
The Foundation’s summer technical Isha Bhatia
internships are generously funded
by the Claude Moore Charitable
Foundation.
10 Focused Ultrasound Foundation | 2021 Midyear Reportcultivating the next generation
Webinar showcasing
Women in science
A banner year for Jackie Brenner—a Foundation intern
who reaches hundreds of thousands
Global Scholars of young adults using social media
The Foundation’s Global Scholars channels like TikTok and Discord to
Program has had a record year in 2021, teach the basics of science, technology,
supporting: engineering, and math—used her
Discord platform, STEMPotential,
24
to host a two-day webinar series
showcasing successful women in STEM.
students from
20 institutions across
7 countries
+600 people from
around the world tuned in to the
Jackie began interning at the
Foundation in 2019, when she
Canada
Cyprus weekend series, which included examined the effects of anesthesia
Italy webinars and panel discussions with
with focused ultrasound in
Russia graduate students, medical students,
South Korea glioblastoma. She has transitioned
and medical doctors. n
United Kingdom
that experience into her current
United States
internship, where she is researching
the bioeffects of microbubbles
Students in this program paired up
with an established researcher in the with ultrasound to induce vascular
field of focused ultrasound to conduct shutdown, sonodynamic therapy,
laboratory or clinical research for and other immunotherapy
a three-month summer internship. n
projects under the guidance
of Frédéric Padilla, PhD, the
Foundation’s Director of Applied
Physics Research.
Focused Ultrasound Foundation | 2021 Midyear Report 11overcoming barriers
Regulatory approvals and reimbursement “wins” for new
clinical applications of focused ultrasound continue around the world.
Essential tremor
+75
In May, Aetna became the first national
insurance payor in the US to cover
focused ultrasound for medication-
Reimbursement refractory essential tremor (ET). The
More than 75 treatment centers around
treatment earned FDA approval in
Highlights the world now offer focused ultrasound for ET.
2016 and already has nationwide US
4,000
Medicare coverage.
In 2020, manufacturers reported
a record 1,540 ET patient treatments
across the globe. Reimbursement is a key
Nearly 4,000 patients worldwide have
component in the adoption of focused
April | In the UK, national been treated to date.
ultrasound as a standard of care. n
government insurance coverage went
into effect for focused ultrasound
treatment of essential tremor.
January | A new Category I CPT®
code went into effect for focused
ultrasound ablation of malignant
prostate tissue with EDAP-TMS’ Focal
One® device, valid for both Medicare
and private payer reimbursement in
the US.
July | The American Medical
Association issued a new Category III
CPT® code for histotripsy of the liver.
Essential tremor
Medicare and Aetna now provide
reimbursement in all 50 states
and Washington, DC.
12 Focused Ultrasound Foundation | 2021 Midyear Reportovercoming barriers
patient spotlight
Tom’s story
Essential tremor
Tom Donegan comes from a “proud clinical trial assessing bilateral (both sides)
Irish Catholic family” of 11 children— focused ultrasound treatment.
eight of whom have essential tremor
Today, Tom says, “I feel like I have my
(ET). While he first started noticing
life back. It’s tremendous. Neither of
symptoms in his late 20s, Tom was not
my hands shake anymore. And I don’t
officially diagnosed with ET until
have to take any medication—at all.
age 55, when he could no longer even
I’m hopeful that all my brothers
write his name.
and sisters can benefit from this too.” “It’s been a game-changer and a life-
In September 2019, Tom underwent saver. It’s the answer.”
Tom’s brother Phil was successfully
focused ultrasound treatment on his
treated with focused ultrasound on just Focused ultrasound for essential
left (dominant) side at the University
his dominant side in March 2020 at tremor is now covered by Medicare in
of Maryland Medical Center. A year
the West Virginia University Rockefeller all 50 US states. n
later, he was thrilled to have a second
Neuroscience Institute. He received
procedure to address the tremor in his
a second treatment in spring of 2021 on
non-dominant hand as part of a new ET
his nondominant side at the University
of Maryland. and he too Phil says,
Watch Tom and Phil’s story on the
Foundation’s website.
Focused Ultrasound Foundation | 2021 Midyear Report 13overcoming barriers
Geographic expansion of focused ultrasound is making the
treatment available to an ever increasing number of patients around the globe.
19
Reimbursement
Expanded Regulatory
Highlights
The Centers for Medicare and Medicaid Medicare patients in Kentucky, Ohio,
Services announced in March expanded and 10 states in the Northeast now have
coverage for patients undergoing access to focused ultrasound therapy
focused ultrasound treatment for for TDPD; a total of 19 states have
tremor-dominant Parkinson’s disease announced coverage for the treatment
(TDPD). The decision means that under Medicare. n
February | Insightec received
approval in China for treatment of
essential tremor and Parkinson’s
disease, tremor.
May | Profound Medical received
the CE Mark in 33 European countries
for treatment of desmoid tumors.
May | Insightec received approval
in Singapore for treatment of
essential tremor and Parkinson’s
disease, tremor.
Parkinson’s disease reimbursement
is now available in 19 states.
14 Focused Ultrasound Foundation | 2021 Midyear Reportaggregating & sharing knowledge
Webinars and publications communicate the latest news
on focused ultrasound for a broad range of audiences, from clinicians and industry to
patients and donors.
2021 State of the Field
Report available
The 2021 State of the Field Report
Webinars documents the progress that is only
Educate thousands possible through the hard work,
time, and resources of everyone in
Virtual meetings and webinars continued our community.
to serve as an optimal vehicle for
New this year: an in-depth analysis of
sharing information in the first half of
all research areas; the cumulative
2021. The Foundation’s webinar series
number of mechanisms of action by
covered a wide variety of topics from
indication and stage of research;
neuroethics to advancing women in
and a detailed look at industry trends,
the field. n
regulatory approvals, and investments
in the field. n
l “Picture a Scientist” Panel Discussion
with Women in Focused Ultrasound The 2021 State of the Field Report
available on the Foundation’s website.
l Focused Ultrasound for Pediatrics
Highlights
l Neuroethics for
Novel Neurotechnologies
l Focused Ultrasound for
Cancer Immunotherapy
Distinct indications 152 34
Indications with regulatory approvals
l Noninvasive HIFU Treatment
of Varicose Veins: New indications 11 Insured for bone metastases in US120m
European Experience and
US Market Perspective
6
New indications in clinical trials Eligible patients in the US 302.4m
Commercial treatment sites 799 54
Clinical device manufacturers
Clinical research sites 235 FUS industry investment $326m
6
Veterinary program sites 6
New FUS industry companies
52,200+ Combined webinar views
Centers of Excellence 10 15
Companies with regulatory approvals
Focused Ultrasound Foundation | 2021 Midyear Report 15raising awareness
Foundation Chairman reaches thousands
and shares the promise of focused ultrasound treatment across
multiple virtual platforms.
1
Podcast
In a interview on Health Professional
Radio in June, Foundation chairman
Neal F. Kassell, MD, talked with host
2
Blog
In a popular post published in the
Foundation’s newsletter in May,
“Driving Focused Ultrasound into the
3
Virtual presentation
Dr. Kassell also shared current news about
the Foundation and the potential of
focused ultrasound at a Member-Led
Neal Howard about the massive Mainstream,” Dr. Kassell shared the five Forum at the Economic Club of
potential of focused ultrasound and the elements needed to transform the Washington, DC (ECW), in April. According
current state of research and treatment Foundation’s vision into a reality and to ECW, these “topic-driven, member-
for the technology around the globe. establish focused ultrasound as a only, and off-the-record” virtual forums
mainstream standard of care accessible are designed to discuss “important issues
Listen on SoundCloud or YouTube
and utilized globally: of the day.” As a result of connections
to hear about the promise of focused
made during the presentation, the
ultrasound therapy for a wide range 1 evidence
Foundation was also proud to participate
of conditions. n
2 awareness in the ECW’s summer internship program,
which—in partnership with Urban
3 $ capital Alliance—allows scholars to gain real
life work experience, professional
4 partners
development, and financial support to
5 businesses offset college expenses. n
Focus Feature
Parkinson’s disease
The Foundation’s latest Focus Feature, of Parkinson’s (PD). Focused ultrasound
“Focused Ultrasound and Parkinson’s is currently approved in the US and
Disease,” was released in April Europe for treatment of tremor-
Read the full report on during Parkinson’s Awareness Month, dominated PD. This special report—and
the Foundation’s website documenting the important progress much more about focused ultrasound
that has been made in the field of for PD—can be found on our website. n
focused ultrasound for the treatment
16 Focused Ultrasound Foundation | 2021 Midyear Reportraising awareness
patient spotlight
Rich’s story
Parkinson’s disease
Rich Nagy was on a motorcycle with focused ultrasound in October 2020.
camping trip in 2017 when he first “After only the third sonication, I already
began experiencing the symptoms of had no involuntary motion in my hand
Parkinson’s disease (PD). Over time at all! I was just astonished that my
his symptoms worsened, and he was tremor had stopped.”
eventually diagnosed with PD by
He also noticed that the tension and
a neurologist in his hometown of
nervousness often associated with
Gilbertsville, Pennsylvania.
PD was immediately gone: “It was the balance—which he assumes is due to
Rich poured himself into researching the first time in several years that I actually disease progression, Rich says, “For me,
pros and cons of the various treatment felt normal.” focused ultrasound was a wonderful
options. He eventually connected with decision. I have absolutely no regrets,
Nearly a year since his treatment,
Dr. Jeff Elias at the University of Virginia and I encourage anyone who might be
Rich does not need any medications
in Charlottesville and was treated there considering the treatment to pursue it
to help with movement issues. And
whole-heartedly.” n
despite noting the return of some mild
symptoms over time—such as issues with
Read Rich‘s full story on the
Foundation’s website.
Focused Ultrasound Foundation | 2021 Midyear Report 17building momentum in Asia
Medical therapy revolutionization in Asia is occurring due to the rapidly
growing field of focused ultrasound, made possible through the ambition, time, and resources
of the global focused ultrasound community.
Asia by the
Numbers
Asia leads the world in Regulatory approvals and
commercial treatment sites reimbursement in the region
Focused Ultrasound
Hong Kong Foundation
The Foundation created a Hong Kong
subsidiary, Focused Ultrasound Hong
318
of the 799 total sites are located there.
29
indications have been approved for
treatment with focused ultrasound.
66 9
Kong Foundation (FUSHK), through
which funds are already being received
from Hong Kong and Asia-based
philanthropists to be distributed to
research institutions in Asia. FUSHK will
officially launch in 2022. n new FUS commercial treatment sites Countries in Asia provide reimbursement
have been identified in 2020. for a total of 7 indications:
Benign prostatic hyperplasia
Bone metastases
Essential tremor
Neuropathic pain
Parkinson’s disease, tremor dominant
Prostate cancer
Uterine fibroids
Major depressive disorder
Alzheimer’s disease
18 Focused Ultrasound Foundation | 2021 Midyear Reportbuilding momentum in Asia
The region leads global regulatory approvals with 28 of
32 occurring in Asia last year, most of which were in Hong Kong and Thailand.
28
New
Approvals
China | NMPA Kazakhstan | NCEM
Benign prostatic hyperplasia Essential tremor
Prostate cancer Neuropathic pain
Parkinson‘s disease, tremor
Japan | MHLW Taiwan | FDA
Parkinson‘s disease, dyskinesia
Prostate cancer
Parkinson‘s disease, tremor
Hong Kong | MDD Thailand | FDA
Arthritis, facetogenic Arthritis, facetogenic
Bone cancer Bone cancer
Bone metastases Bone metastases
Bone tumors, benign Bone tumors, benign
Essential tremor Essential tremor
Multiple myeloma Multiple myeloma
Neuropathic pain Neuropathic pain
Parkinson’s disease, tremor Parkinson’s disease, tremor
Uterine adenomyosis Prostate cancer
Uterine fibroids Uterine adenomyosis
Focused Ultrasound Foundation | 2021 Midyear Report 19building momentum in Asia
Clinicians, advisors, and manufacturers in Asia have become critical
partners to the Foundation.
Companies
Spotlight
Our ambassadors
in Asia
The Focused Ultrasound Foundation Neurosona is a Korean focused NaviFUS has designed and
has valuable assets on the ground in ultrasound company that aims to manufactured neuronavigation and
Asia connecting with manufacturers, develop the technology for brain ultrasound-guided focused ultrasound
industry partners, researchers, and treatments, including neuromodulation. systems for the treatment of brain
scientists in order to further expand the Their low-intensity focused ultrasound diseases and disorders in Taiwan since
global reach of focused ultrasound. platform has already been used for 2015. Their three current devices are
several pilot clinical trials, including the being used in clinical trials for brain
treatment of major depressive disorder tumors, epilepsy, and soon, Alzheimer’s
and Alzheimer’s disease. n disease. Biomechanisms in development
include blood-brain barrier opening
Dong-Guk Paeng, PhD, serves as an and neuromodulation. n
ambassador of the Foundation in Asia,
cultivating relationships with laboratory
and clinical research sites, commercial Shanghai A&S Science
treatment sites, and manufacturers Technology Development
throughout the region. n has manufactured and marketed IMage Guided Therapy—
diagnostic and therapeutic ultrasound also known as IMGT Co., LTD—is a
devices in China and internationally for Korean company that is developing
more than 20 years. Its tumor ablation a nanotechnology-based gene and
device, HIFUNIT9000, is used to treat drug delivery system. The system uses
Jessica Che-yi Chao is Chief Advisor uterine fibroids and various cancers. n ultrasound-guided focused ultrasound
of Asia who builds and strengthens to provide enhanced immunotherapy
connections with Asia-based solutions. Their portable focused
philanthropists, investors, manufacturers, ultrasound device is designed to target
and partners. She is also a member desired treatment areas that contain
of the Foundation’s Council. n malignant tumors, such as breast
cancer, sarcoma, and thyroid cancer. n
20 Focused Ultrasound Foundation | 2021 Midyear Reportbuilding momentum in Asia
FUS + drug delivery
Pancreatic cancer
“
Clinicians at Seoul National University
I first heard of focused Hospital in Korea are using low
ultrasound when I attended power (mechanical) effects of focused
ultrasound to treat pancreatic
a speech by Neal Kassell, MD,
cancer lesions to try to enhance
at an event in Hong Kong.
the effectiveness of the anti-cancer
I was immediately struck by this FOLFIRINOX regimen. The hope is
innovative alternative to the that the treatment will help disrupt
trauma of more conventional the dense tumor stroma to allow
better penetration and effectiveness
treatments. I am happy to support
of the drugs. n
the Focused Ultrasound Hong
Kong Foundation’s efforts in
the hopes that this treatment
becomes widely accepted
treatment in Asia.”
— Alasdair Morrison
Focused Ultrasound Hong Kong
Foundation donor
Focused Ultrasound Foundation | 2021 Midyear Report 21mobilizing resources
Advancing focused ultrasound worldwide and increasing
awareness in the clinic is aided by the addition of new Senior Advisors.
Foundation announces
new Senior Advisors
“
Alan H. Matsumoto, MD, MA, joined
the Foundation as a Senior Advisor for Clinical trials and research
Medical Imaging and Image-Guided support by the Foundation and
Therapeutics. He provides input on
others should accelerate the
research projects and represent the
application of revolutionary
Foundation at scientific and medical
focused ultrasound-based
meetings. An expert in his specialty,
Dr. Matsumoto has been on faculty therapeutic options for brain tumor
at the University of Virginia (UVA) patients. I am delighted to help
since 1991, where he is currently in the neuro-oncology efforts of
Chair and Theodore E. Keats Professor the Foundation team.”
of Radiology in the Department of — Jason Sheehan
Radiology and Medical Imaging.
He is also Medical Director of UVA’s
Focused Ultrasound Center, which was Jason Sheehan, MD, PhD, joined the
named the Foundation’s first Focused Foundation as a Senior Advisor for
Ultrasound Center of Excellence in 2009. Brain Tumor Research. In this role he
is helping to define the Foundation’s
“
overall strategy for brain tumor research,
I look forward to this as well as engaging in Foundation-
initiated laboratory and clinical research,
opportunity to help advance the
interfacing with medical societies, and
science and clinical application
assisting in organizing collaborative
of this cutting-edge technology
workshops. He is the Harrison
which is being used to deliver Distinguished Chair of Neurosurgery
novel and life-changing therapies and Professor of Neurological Surgery,
to patients.” Radiation Oncology, Biomedical
— Alan Matsumoto Engineering, and Neuroscience at UVA. n
Above, top to bottom
Alan H. Matsumoto, Jason Sheehan
22 Focused Ultrasound Foundation | 2021 Midyear Reportmobilizing resources
Four new members
Join Council
The Foundation’s Council—a group of
passionate, enthusiastic advocates who
connect the Foundation to the greater
community—added four new members
this year.
“ Focused ultrasound shows
great promise for improving
patients’ lives, and I am particularly
committed to technologies
that may transform treatment
for multiple cancers.”
“ “
— Bob Hugin
Former Chairman and CEO
Celgene Corporation Focused ultrasound I’m dazzled by the potential
“
shows tremendous promise of focused ultrasound to treat
to be a revolutionary therapeutic a massive number of human
I first learned about focused
technology for human and conditions, but I am even more
ultrasound several years ago,
veterinary medicine. I am delighted amazed at the speed of execution
and I continue to be amazed by its
to be a part of this remarkable in making these dreams reality.”
wide variety of mechanisms and
community that is committed to — Mary Lou Jepsen, PhD
potential applications.” CEO, Founder, and Chair of the Board
improving millions of lives.”
Openwater
— Carolyn Yeh
— Mark Onetto
Vice President
Retired Senior Vice President
Yale Club Hong Kong
Amazon.com, Inc.
Above middle, top to bottom
Bob Hugin, Mark Onetto
Above right, top to bottom
Mary Lou Jepsen, Carolyn Yeh
Focused Ultrasound Foundation | 2021 Midyear Report 23Board Council
Neal F. Kassell, MD Co-chairs
Chairman, Focused Ultrasound Foundation
Jane P. Batten
Former Co-chair of Neurosurgery,
University of Virginia Charles H. Seilheimer, Jr.
Scott Beardsley, PhD .....
Dean, University of Virginia Darden
School of Business John B. Adams, Jr.
Eugene V. Fife Dorothy N. Batten
Founding Principal, Vawter Capital, LLC
Ellen Block
Former Chairman,
Goldman Sachs International Amanda Brown
John R. Grisham Deborah Caldwell
Author
Jessica Che-yi Chao
William A. Hawkins III
Nancy J. &
Senior Advisor, EW Healthcare Partners
Retired Chairman & CEO, Medtronic Thomas N. Chewning
Daniel P. Jordan, PhD Marguerite & Norwood Davis
President Emeritus, Peter Gabriel
Thomas Jefferson Foundation
David Goode
Syaru Shirley Lin, PhD
Adjunct Professor, Rick Hamilton
Chinese University of Hong Kong Alice Handy
Director, Goldman Sachs Asia Bank
Diane Heller
Michael R. Lincoln
Global Business Department Chair, Robert J. Hugin
Cooley LLP Kat Imhoff
Michael Milken Mary Lou Jepsen, PhD
Chairman, Milken Institute
Dean L. Kamen
Edward D. Miller, MD
Former CEO, Johns Hopkins Medicine Ann Kingston
Frederic H. Moll, MD Harry Lester
Chief Development Officer, Johnson & Jonna Mendez
Johnson Medical Devices Companies
Co-founder, Auris Health, Inc. Jane Metcalfe
Charles “Wick” Moorman IV Paula F. Newcomb
Former Chairman & CEO, Norfolk Southern Marc Onetto
Former CEO, Amtrak
Mary Lou Seilheimer
Steve H. Rusckowski
Chairman, President, and CEO, Alice H. Siegel
Quest Diagnostics Inc. Allan C. Stam, PhD
Former CEO, Philips Healthcare
Fredi & Howard Stevenson
Gary Shapiro
President & CEO, Consumer Technology Bernice Szeto
Association (CTA)® Andrew C. von Eschenbach, MD
Carl P. Zeithaml, PhD Claude Wasserstein
Dean and F. S. Cornell Professor of
Free Enterprise, McIntire School Carolyn Yeh
of Commerce, University of Virginia
24 Focused Ultrasound Foundation | 2021 Midyear ReportFocused Ultrasound Foundation | 2021 Midyear Report 25
1230 Cedars Court, Suite 206 Charlottesville, VA 22903 434.220.4993 main line fusfoundation.org 26 Focused Ultrasound Foundation | 2021 Midyear Report
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