Appendix 4E and 2026 Annual Report
Released
Released
Announcement PDF
APPENDIX 4E
Preliminary Final Report to the Australian Stock Exchange
Name of Entity Paradigm Biopharmaceuticals Limited
ABN (ABN 94 169 346 963)
Year Ended 30 June 2026
Previous Corresponding Reporting
Period
01 July 2024 to 30 June 2025
1. Results for Announcement to the Market
$ $ and %
increase/(decrease)
over previous
corresponding period
Revenue from continuing activities 8,127,811 1,022,411 14.39%
(Loss) from continuing activities after tax attributable
to members
(56,331,246) 37,560,501 200.10%
Net (loss) for the period attributable to members (56,331,246) 37,560,501 200.10%
Dividends (distributions) Amount per security Franked amount per security
Final Dividend N/A N/A
Interim Dividend N/A N/A
Record date for determining entitlements to the
dividends (if any)
N/A
Brief explanation of any of the figures reported above necessary to enable the figures to be
understood: N/A
2. Key ratios
Current Period Previous corresponding
period (Restated)
Basic earnings per ordinary security (cents
per share)
(17.91) cents (5.97) cents
Diluted earnings per ordinary security (cents
per share)
(17.91) cents (5.97) cents
Net tangible asset backing per ordinary
security (cents per share)
0.44 cents 5.33 cents
3. Control Gained Over Entities Having Material Effect
Name of entity (or group of entities) N/A
Date control gained N/A
Profit / (loss) from ordinary activities after tax of the
controlled entity since the date in the current period on
which control was acquired.
N/A
Profit / (loss) from ordinary activities after tax of the
controlled entity (or group of entities) for the whole of
the previous corresponding period.
N/A
4. Audit/Review Status
This report is based on accounts to which one of the following applies:
(Tick one)
The accounts have been audited The accounts are in the process of being
audited
If the accounts are subject to audit dispute or qualification, a description of the dispute or
qualification: N/A
5. Attachments Forming Part of Appendix 4E
The Annual Report of Paradigm Biopharmaceuticals Limited for the year endedSyntax Warning: Invalid Font Weight
30 June 2026 is
attached.
6. Signed
Signed in accordance with a resolution of the Directors.
Signed ______________________________
Date: 28 August 2026
Paul Rennie
Managing Director
Building the future of
osteoarthritis therapeutics
Annual Report 2026
Highlights 01
Chairman and Managing Director’s Report 02
Chief Medical Officer’s Report 06
Developing Zilosul® in Modern Osteoarthritis Care 10
Directors’ Report 14
Remuneration Report 22
Auditor’s Independence Declaration 28
Consolidated Statement of Profit or Loss and Other Comprehensive Income 29
Consolidated Statement Financial Position 30
Consolidated Statement of Cash Flows 31
Consolidated Statement of Changes in Equity 32
Notes to the Consolidated Financial Statements 33
Consolidated Entity Disclosure Statement 60
Directors’ Declaration 61
Independent Auditor’s Report 62
Shareholder Information 66
Corporate Governance Statement 68
General Information 68
Corporate Directory 69
Paradigm Biopharmaceuticals Ltd.
is a late-stage clinical development
company. We are driven by a purpose
to improve patients’ health and quality
of life by developing and delivering
pharmaceutical therapies.
Paradigm has a vision to be recognised as a global leader
in the development and commercialisation of innovative
pharmaceutical therapies. Paradigm’s values of innovation,
transparency, adaptability, collaboration, respect, and
accountability comprise the central pillars of the organisation
and influence all activities and decisions.
CONTENTS
Paradigm Biopharmaceuticals Limited ABN 94 169 346 963
PARA_OA_012 PHASE 3 STUDY LOCATIONS
HIGHLIGHTS
Safety Profile
Supported
Independent DSMB reviews
identified no material safety
concerns; study continues
as planned.
100% Recruitment
Complete
Phase 3 enrolment target
exceeded, transitioning
PARA_OA_012 to clinical
evidence generation.
Value Inflection
Ahead
Interim Analysis and subsequent
primary endpoint top-line
readout represent the next
major clinical catalysts.
Hong Kong
1 sites
Moldova
3 sites
United States
of America
41Syntax Warning: Invalid Font Weight
sites
Australia
12 sites
A$21.7m
Capital raised during FY2026
57
Global clinical sites
538
Phase 3 participants enrolled
Annual Report 2026
Paradigm Biopharmaceuticals Limited 1
$21.74M
AUD
Capital Raised
Placement and Share
Purchase Plan.
Convertible Note Facility
Funding certainty through
key Phase 3 milestones.
$27M
USD
CHAIRMAN AND MANAGING DIRECTOR’S REPORT
Paul Rennie
Chairman and
Managing Director
Dear Shareholders,
FY2026 was a defining year in
Paradigm’s evolution. Throughout
the year, the Company successfully
delivered the major operational
objectives established at the beginning
of the financial year, culminating in the
completion of patient recruitment into
our global Phase 3 PARA_OA_012
study for Zilosul® in osteoarthritis.
While this achievement represents
an important milestone in our clinical
development, it also reflects the
disciplined execution of a broader
corporate strategy. Over the past
twelve months, Paradigm has
strengthened its financial position,
expanded its development platform,
advanced strategic collaborations
and continued to engage with potential
commercial partners, positioning the
Company for its next phase of growth.
With patient recruitment now complete,
our focus transitions from operational
execution to clinical evidence generation.
The forthcoming Interim Analysis and
subsequent primary endpoint top-line
readout represent significant milestones
not only for the Phase 3 development
but also for Paradigm as we continue
preparing for regulatory submissions
and future commercialisation.
Delivering Operational
Excellence
Successfully executing a global
Phase 3 clinical trial requires
considerably more than enrolling
patients. It requires robust operational
systems, experienced clinical leadership,
disciplined project management and
strong execution across multiple
countries and clinical sites.
During FY2026, Paradigm completed
recruitment of 538 participants across
approximately 60 clinical sites spanning
the United States, Australia, Hong Kong
and Moldova, exceeding the original
enrolment target of 466 participants.
This achievement reflects the
commitment of our clinical operations
team, investigators, study coordinators
and, most importantly, the patients
participating in the trial.
Completion of recruitment marks an
important transition for the Company.
With the operationally intensive
recruitment phase complete, the focus
now moves to participant follow-up,
database management, Interim Analysis
preparation and generation of the
clinical evidence package that will
underpin future regulatory, commercial
and partnering discussions.
FY2026 was a defining year for Paradigm.
The Company successfully delivered the major
operational objectives established at the
beginning of the financial year, including
completion of recruitment into the global Phase 3
PARA_OA_012 study, strengthening our
financial position, expanding our development
pipeline and advancing strategic collaborations.
These achievements position Paradigm to
transition from operational execution
to clinical evidence generation and
future commercialisation.
2
Annual Report 2026 Paradigm Biopharmaceuticals Limited
Equally encouraging has been the
continued oversight provided by the
independent Data Safety Monitoring
Board. Safety reviews completed,
have identified no material safety
concerns, allowing the study to continue
as planned while reinforcing confidence
in the quality and integrity of the Phase 3
clinical trial.
Financial Discipline and
Capital Management
Throughout FY2026, the Board
remained focused on ensuring
Paradigm had sufficient capital to
execute the Phase 3 PARA_OA_012
trial through its key value inflection points
while maintaining the flexibility to pursue
strategic opportunities as they arose.
We recognise that the capital raising
undertaken during the year occurred
during a period of sustained weakness
in the Company’s share price. While this
was disappointing for shareholders and
the Board alike, securing the funding
required to successfully execute our
pivotal Phase 3 trial remained the
Company’s highest priority. Our focus
was to remove funding uncertainty,
maintain Phase 3 momentum and
preserve the integrity of the study
through completion of recruitment
and the upcoming clinical milestones.
During the year, Paradigm completed
an A$14.0 million institutional Placement,
followed by a strongly supported Share
Purchase Plan raising A$7.74 million,
generating total gross proceeds of
approximately A$21.74 million. We were
particularly encouraged by the strong
participation from existing shareholders
in the Share Purchase Plan, reflecting
continued support for the Company’s
long-term strategy despite the
challenging market environment.
These initiatives complemented the
Company’s staged US$27.0 million
Convertible Note Facility with Obsidian
Global Partners. The facility was
deliberately structured to provide funding
certainty while allowing capital to be
drawn progressively as operational
milestones were achieved, avoiding
the need to raise all capital upfront.
Importantly, the facility fulfilled
the strategic objective for which it
was established. Together with the
Placement and Share Purchase Plan,
it enabled Paradigm to complete 100%
patient recruitment into the global
PARA_OA_012 study, continue patient
treatment and follow-up, prepare for the
Interim Analysis and advance regulatory,
manufacturing and commercial
readiness activities.
The Placement and Share Purchase Plan
also included approximately 117 million
listed attaching options (ASX: PAROB),
exercisable at A$0.2375 per option.
If fully exercised, these options have
the potential to provide approximately
A$28 million in additional capital. Each
attaching option exercised before expiry
also entitles the holder to receive a
piggyback option exercisable at A$0.38,
providing the Company with a further
potential source of future funding while
rewarding shareholder participation.
Subsequent to year end, Paradigm
completed the US$3.0 million Tranche 4
drawdown under the Obsidian facility
and expects to receive an R&D Tax
Incentive refund of approximately
A$5.5 million during the September
2026 quarter. Following the Tranche 4
drawdown, approximately US$7.0 million
remains available under the facility
should the Company elect to access it.
Collectively, these funding initiatives
have achieved their intended purpose,
providing the financial certainty required
to execute one of the largest and most
important clinical trials in Paradigm’s
history. With recruitment complete,
the Company’s attention now turns
to generating the clinical evidence that
we believe has the potential to create
meaningful long-term shareholder value.
Paradigm Biopharmaceuticals Limited 3 Annual Report 2026
CHAIRMAN AND MANAGING DIRECTOR’S REPORT
continued
Building Long-Term Value
Beyond Phase 3
While successful execution of the Phase
3 program remained our highest priority
throughout FY2026, we also continued
to invest in opportunities that expand
the long-term value of Paradigm’s
pentosan polysulfate platform.
Development activities progressed
for Pentacoxib®, our proprietary
combination of pentosan polysulfate
sodium and a selective COX-2 inhibitor.
Initially focused on veterinary
applications, Pentacoxib® provides an
opportunity to broaden the Company’s
development portfolio while potentially
establishing a future pathway into
human therapeutics.
Alongside pipeline expansion,
Paradigm continued to invest in
scientific research designed to further
characterise the biological activity of
pentosan polysulfate. During the year,
the Company established a research
collaboration with City St George’s,
University of London, utilising an
integrated translational research platform
that combines advanced quantitative
MRI with gene and protein profiling
of human tissue collected during total
knee replacement surgery.
The collaboration is designed to
provide deeper insights into the
biological behaviour of bone marrow
lesions and the potential effects of PPS
across bone, cartilage and synovial
tissue. By integrating advanced imaging
with molecular profiling, the study
has the potential to generate a more
comprehensive understanding of
how PPS interacts across the
osteoarthritic joint.
Subject to study outcomes, these
findings may further strengthen the
scientific differentiation of Zilosul® and
contribute to future clinical development,
regulatory engagement, reimbursement
discussions and commercial partnering.
This work complements Paradigm’s
broader strategy of building a robust
scientific evidence base around the PPS
platform while identifying opportunities
to maximise its long-term commercial
value beyond the current Phase 3 clinical
development program.
Business Development and
Commercial Engagement
As the PARA_OA_012 clinical trial
advanced, Paradigm continued to
expand its business development
activities in preparation for future
commercialisation.
During FY2026, members of the senior
management team attended the BIO
International Convention in San Diego,
engaging with pharmaceutical and
biotechnology companies regarding
potential regional and global licensing
opportunities for Zilosul®. Discussions
centred on completion of patient
enrolment, the upcoming Interim
Analysis, Phase 3 timelines and the
commercial potential of a differentiated
non-opioid therapy for osteoarthritis.
Completion of recruitment represents
an important milestone in these
discussions. As the trial transitions
from operational execution to clinical
evidence generation, Paradigm
continues to engage with potential
commercial partners while maintaining
its focus on delivering the upcoming
clinical milestones.
Looking Ahead
Paradigm enters FY2027 having
successfully delivered the major
operational objectives established
for the previous year.
Completion of patient recruitment,
continued progression of our Phase 3
development, expansion of our
development platform and ongoing
commercial engagement have
positioned the Company for the next
phase of its evolution.
We also recognise that, despite the
significant operational progress achieved
during FY2026, shareholder returns
have not reflected the value we believe
has been created within the business.
The capital raising undertaken during
the year was completed at a challenging
point in the Company’s share price
performance, and we understand the
disappointment this has caused many
shareholders, including the Board and
management, who remain significant
shareholders ourselves.
Despite these market challenges,
our focus has never wavered.
Throughout the year we continued to
deliver the milestones we committed
to, completing recruitment into our
pivotal Phase 3 clinical study,
strengthening the Company’s funding
position, advancing our pipeline,
expanding commercial engagement
and preparing for the next stage of
clinical development. We firmly believe
that consistent execution and disciplined
delivery remain the most effective way
to create sustainable long-term
shareholder value.
With recruitment now complete,
the Company’s focus shifts to clinical
evidence generation. The upcoming
Interim Analysis and subsequent
primary endpoint top-line readout
represent significant milestones that
have the potential to fundamentally
change the value proposition of
Paradigm. Together with our ongoing
regulatory, partnering and commercial
activities, these catalysts position
Paradigm for what we believe will
be one of the most important periods
in the Company’s history.
On behalf of the Board, I thank our
shareholders for their continued support
and patience, our employees for their
dedication and professionalism, and
our investigators, research partners
and patients whose commitment
has made this progress possible.
We remain committed to delivering
on our strategy and look forward to
updating shareholders as we continue
building value through disciplined
execution and the delivery of the
important clinical milestones that
lie ahead.
Paul Rennie
Chairman and Managing Director
Melbourne, Victoria
28 August 2026
4
Annual Report 2026 Paradigm Biopharmaceuticals Limited
Funding
Secured
Raised A$21.74 million through
the Placement and Share
Purchase Plan, complemented
by the staged US$27 million
Obsidian facility.
Phase 3
Execution
CompletedSyntax Warning: Invalid Font Weight
recruitment and
transitioned the PARA_OA_012
trial from operational execution
to clinical evidence generation.
Independent
Safety Oversight
Independent DSMB safety
reviews completed with no
material safety concerns,
supporting continuation
of the study as planned.
Pipeline
Expansion
Continued development of
Pentacoxib® and expanded
scientific collaborations beyond
osteoarthritis.
Commercial
Engagement
Advanced global partnering
discussions at BIO International
Convention with continued
interest from potential regional
and international partners.
Research
Collaboration
Established collaboration with
City St George’s, University of
London, investigating additional
therapeutic applications of
pentosan polysulfate.
Financial Year Highlights
100% Recruitment
Completed
Successfully enrolled 538
participants, exceeding the
planned enrolment target
of 466 across 57 global
clinical sites.
Annual Report 2026
5
Paradigm Biopharmaceuticals Limited
538
PARTICIPANTS
ENROLLED
Exceeded planned
recruitment target.
Across four countries.
57
GLOBAL CLINICAL
SITES
CHIEF MEDICAL OFFICER’S REPORT
Dr Donna Skerrett
Chief Medical Officer
New York City, New York
Dear Shareholders,
Delivering a global Phase 3 clinical
trial is among the most complex
undertakings for any biotechnology
company. It requires meticulous
planning, experienced investigators,
rigorous oversight and an unwavering
commitment to patient safety and
data quality.
Throughout FY2026 our clinical
focus remained clear, to execute the
PARA_OA_012 trial to the highest
possible standard while maintaining
the scientific integrity required to
support future regulatory submissions.
That objective has guided every decision
we have made.
Executing a High-Quality
Global Phase 3 Trial
During FY2026, Paradigm achieved one
of the most significant milestones in the
Company’s history with the successful
completion of patient recruitment into
the Phase 3 PARA_OA_012 trial.
A total of 538 participants were enrolled
across approximately 60 clinical sites
spanning the United States, Australia,
Hong Kong and Moldova, exceeding
the original recruitment target of 466
participants. While achieving recruitment
targets is an important operational
milestone, the quality of the participants
enrolled, and the consistency of trial
execution are equally critical to the
success of a pivotal Phase 3 study.
Considerable effort was invested
in identifying investigators and clinical
sites with extensive experience in
osteoarthritis research, proven
recruitment capability and a
demonstrated commitment to
protocol compliance and participant
engagement. This deliberate site
selection strategy, combined with
ongoing training and close operational
oversight, has helped establish a study
conducted to the highest scientific
and operational standards.
Completion of recruitment represents
the culmination of years of planning
and collaboration. It also marks the
beginning of the next important phase
of the study, as participants continue
through scheduled follow-up
assessments that will generate the
clinical evidence required to evaluate
the efficacy and safety of Zilosul®.
FY2026 represented a defining year for
Paradigm’s clinical development activities.
The successful completion of patient
recruitment into the Phase 3 PARA_OA_012
trial reflects years of planning, regulatory
preparation and operational execution.
I am immensely proud of what our clinical
team, investigators and partners have
achieved as we transition from trial execution
to clinical evidence generation.
6
Annual Report 2026 Paradigm Biopharmaceuticals Limited
Recruitment Complete
Transition to clinical
evidence generation.
100%
Collaboration and Clinical
Execution
Executing a study of this scale requires
seamless collaboration between
Paradigm and our external partners.
Our Clinical Research Organisation,
Advanced Clinical, has been fully
integrated with Paradigm’s internal
clinical operations team throughout
the study. Their expertise in clinical
trial management, combined with
outstanding communication between
investigators, study coordinators
and Paradigm personnel, has been
instrumental in achieving our
recruitment objectives.
I would also like to acknowledge Nordic
Bioscience Clinical Development A/S
(NBCD), whose world wide expertise
in arthritis clinical research fills an
important role in supporting the global
expansion of trial activities to Hong Kong
and Moldova while ensuring quality and
consistency of data being generated
throughout the trial.
The commitment demonstrated by
these organisations, together with
our investigators and site coordinators,
has enabled the study to be executed
with exceptional professionalism across
every participating region.
Paradigm Biopharmaceuticals Limited 7 Annual Report 2026
CHIEF MEDICAL OFFICER’S REPORT
continued
Independent Safety Oversight
Patient safety remains the highest
priority throughout every stage of
clinical development.
The PARA_OA_012 trial continues
to be independently monitored by an
experienced Data Safety Monitoring
Board (DSMB), which periodically
reviews unblinded safety data to assess
participant wellbeing and determine
whether the study should continue
as planned.
During FY2026, the DSMB completed
its scheduled safety reviews, including
the planned 20% safety review, with
no material safety concerns identified
and recommended that the study
continue. Subsequent to year end,
the independent DSMB completed
the planned 50% and 80% safety
reviews, with both reviews resulting
in a recommendation for the Phase 3
PARA_OA_012 study to continue
unchanged, with no modifications
to the clinical trial protocol.
These independent reviews provide an
important level of external governance,
reinforcing confidence in both participant
safety and the integrity of the trial as
it progresses towards its major clinical
milestones.
A Team Effort
Although clinical milestones are often
measured through recruitment numbers
and timelines, they ultimately represent
the dedication and commitment of an
extraordinary team of people.
I would like to acknowledge Paradigm’s
clinical operations team, whose tireless
work over many months has enabled
the successful delivery of one of the
largest and most complex clinical
studies ever undertaken by the
Company. Their commitment has
extended far beyond day-to-day study
management, encompassing site
selection, investigator engagement,
participant support, regulatory
coordination, operational oversight
and continuous collaboration across
multiple countries and time zones.
I also extend my sincere appreciation
to our investigators, study coordinators,
Advanced Clinical, Nordic Bioscience,
the independent DSMB and our
many specialist service providers.
Their professionalism and shared
commitment to scientific excellence
have been fundamental to the successful
execution of this study.
Most importantly, I would like to thank
every participant and their families.
Clinical research is only possible
because of their willingness to contribute
their time and place their trust in the
research process. Their participation
has brought us significantly closer to
potentially delivering a new treatment
option for the millions of people living
with osteoarthritis worldwide.
A Personal Reflection
As many shareholders will know,
I stepped away from the Board to
dedicate my full attention to leading
the clinical execution of our Phase 3 trial.
Seeing this study successfully recruit
538 participants has been one of the
proudest achievements of my career
and reflects the extraordinary
commitment of our clinical team,
investigators and partners.
As the trial now transitions from
operational execution to clinical evidence
generation and preparation for future
regulatory submissions, including a
potential New Drug Application (NDA),
my role within Paradigm will naturally
evolve. I remain fully committed to the
Company and look forward to continuing
to support activities that will be critical
as we progress towards these important
milestones.
In the coming months, we expect to
welcome a new Chief Medical Officer
who will lead the next stage of clinical
development, including the generation
of the Phase 3 clinical evidence package
for iPPS in osteoarthritis and the
continued exploration of opportunities
beyond OA. I look forward to ensuring
a seamless transition and to support
the continued success of the
programme.
Having worked with pentosan polysulfate
for many years, I have never been more
excited, enthusiastic or confident about
its potential. The quality of the science,
the strength of the clinical execution
and the calibre of the team supporting
this trial give me enormous confidence
in what lies ahead.
Looking Ahead
Completion of recruitment marks an
important transition for the clinical team.
Our attention now turns to participant
follow-up, maintaining the highest
standards of data quality, database
preparation and delivery of the
planned Interim Analysis, followed
by the primary endpoint top-line readout.
These milestones represent the
culmination of many years of scientific
research, clinical development and
operational execution.
While there remains important
work ahead, I am immensely proud
of what our team has accomplishedSyntax Warning: Invalid Font Weight
and confident in the quality of the trial
we have conducted. Every decision
throughout the study has been guided
by scientific rigour, patient safety
and our commitment to generating
high-quality clinical evidence.
On behalf of the clinical team,
I thank everyone who has contributed
to this remarkable achievement.
We look forward to sharing further
progress as the trial advances through
its next important milestones.
Dr Donna Skerrett
Chief Medical Officer
New York City, New York
28 August 2026
8
Annual Report 2026 Paradigm Biopharmaceuticals Limited
Annual Report 2026
9
Paradigm Biopharmaceuticals Limited
DEVELOPING ZILOSUL®
IN MODERN OSTEOARTHRITIS CARE
Our understanding of OA has evolved
considerably over the past decade.
Once viewed primarily as a disease
of cartilage degeneration, it is now
recognised as a complex disorder
involving the entire joint, including
cartilage, subchondral bone, synovium
and inflammatory pathways. This shift
has influenced both scientific research
and clinical practice, with increasing
emphasis on preserving joint function,
maintaining mobility and improving
quality of life, rather than simply
managing pain.2
At the same time, patient expectations
have changed. Today’s patients expect
to remain active, independent and
productive for longer, creating demand
for therapies that deliver meaningful
improvements in pain and physical
function while supporting long-term
disease management. This evolving
treatment landscape has reinforced
the need for differentiated non-opioid
therapies capable of bridging the gap
between conservative management
and surgical intervention.
The Current Treatment
Paradigm
International treatment guidelines
recommend a stepwise approach
to OA management, beginning
with education, exercise and weight
management before progressing
to pharmacological therapies.3
While these interventions remain
the foundation of care, many patients
continue to experience persistent
pain and declining physical function
despite conservative treatment.
Current pharmacological options,
including oral NSAIDs, intra-articular
corticosteroids and hyaluronic acid
injections, can provide symptomatic
relief but each has recognised limitations
relating to safety, durability or variable
clinical response.3,4
Consequently,
many patients ultimately progress to
joint replacement surgery, which remains
highly effective for end-stage disease
but is invasive, resource intensive
and not appropriate for every patient.
This highlights one of the most
significant unmet needs in osteoarthritis
management: the need for therapies
capable of delivering durable
improvements in pain and physical
function before surgical intervention
becomes necessary.
It is within this treatment gap that
Paradigm believes Zilosul® has the
potential to play an important role. If the
Phase 3 PARA_OA_012 programme is
successful, Zilosul® has the potential to
provide physicians with a differentiated,
non-opioid treatment option positioned
between conservative care and joint
replacement surgery.
Positioning Zilosul® Within
Modern Clinical Practice
Zilosul® is being developed for patients
with symptomatic knee osteoarthritis
who continue to experience clinically
significant pain and functional limitation
despite conservative management.
Paradigm’s strategy is to position
Zilosul® as a differentiated, non-opioid
treatment option that, if supported
by successful Phase 3 outcomes,
complements existing treatment
pathways by addressing the gap
between conservative therapy
and joint replacement surgery.
While significant research continues
to focus on disease-modifying
osteoarthritis therapies, the immediate
priorities for both physicians and
patients remain consistent: reducing
pain, improving physical function
and maintaining independence.
These outcomes underpin regulatory
guidance, international treatment
recommendations and routine
clinical decision-making.3,4
Accordingly, Paradigm’s initial clinical
and commercial objective is clear—to
demonstrate clinically meaningful
improvements in pain and physical
function following a defined treatment
course. Structural imaging and
translational research are intended
to complement this evidence by
providing a
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