ClearPoint Neuro Congratulates Partner Aspen Neuroscience on Use of the ClearPoint® Navigation System for All Enrolled Patients in ASPIRO Clinical Trial
June 20 2024 - 8:45AM
ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global
device, cell, and gene therapy-enabling company offering precise
navigation to the brain and spine, today congratulates its partner
Aspen Neuroscience, Inc. on use of the ClearPoint Neuro Navigation
System to transplant dopaminergic neuron precursor cells (DANPCs)
for all enrolled patients with Parkinson’s Disease (PD) in its
recently launched ASPIRO Phase 1/2a clinical trial. ASPIRO is an
open label trial to assess safety and tolerability of ANPD001, an
autologous, dopaminergic neuron cell replacement therapy for
participants with moderate to severe PD.
The DANPCs are transplanted to the putamen, a small structure
located in the mid-brain, in a single transplantation procedure
using ClearPoint MRI guidance, the SmartFlow® Cannula, and the
Aspen Metered Delivery Syringe (AMDS). This surgical approach was
developed by the trial’s lead neurosurgeon and renowned MRI-guided
stereotactic neurosurgery pioneer Paul Larson, MD, FAANS, professor
of neurosurgery at the University of Arizona College of Medicine -
Tucson and neurosurgeon at Banner University Medical Center,
Tucson.
“We are thrilled to partner with Aspen to support the first
multi-center trial for an autologous neuron replacement therapy for
Parkinson’s disease,” commented Jeremy Stigall, Chief Business
Officer at ClearPoint Neuro. “We also applaud Aspen’s decision to
standardize the surgical approach across all enrolled patients with
ClearPoint, as we believe this reduces surgical variability and
de-risks study results.”
The ClearPoint Neuro Navigation System utilizes intraprocedural
MR images to provide navigational instruction for the neurosurgeon,
and confirmation that the desired anatomical target has been
reached with submillimetric accuracy. Combined with the SmartFlow®
Cannula, which is less than 2 millimeters in diameter, this allows
for minimally invasive delivery of therapeutic agents in a
patient’s brain.
About the ASPIRO Trial
The Autologous-derived Study of a Parkinson’s Investigational
Regenerative therapy in an Open-label trial (ASPIRO) is a Phase
1/2a clinical trial to assess the safety, tolerability, and
potential efficacy of ANPD001 in patients with moderate to severe
Parkinson’s disease. The dose escalation study includes patients
aged 50–70 years of age and excludes patients with cognitive
impairment and other comorbidities that could preclude treatment.
All enrolled patients are under the care of a movement disorder
specialist.
The primary study endpoint is safety and tolerability of
ANPD001. Secondary endpoints include improvement in “on” time, when
patients experience periods of symptom control, and improvements in
motor symptoms and quality of life based on standard Parkinson’s
disease rating scales.
About ANPD001
ANPD001 is an investigational autologous neuronal replacement
therapy being studied as a regenerative therapy for PD. Aspen’s
personalized approach means that patients do not require
immunosuppressive drugs to counteract the body’s immune response
against foreign cells.
Aspen’s manufacturing process starts from a small sample of the
patient’s own skin cells, followed by reprogramming to induced
pluripotent stem cells (iPSCs) and then differentiation of the
iPSCs into dopaminergic neuron precursor cells (DANPCs). These
DANPCs are transplanted into the putamen, replacing cells that were
lost or damaged due to disease. The quality of each person’s cells
is assessed at every manufacturing stage using Aspen’s proprietary
machine learning-based genomics tests.
About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a
clinical development-stage, private company focused on autologous
regenerative medicine. The company’s patient-derived iPSC platform
is used to create personalized therapies to address diseases with
high unmet medical needs, beginning with autologous neuron
replacement for Parkinson’s disease.
Aspen combines cell biology with the latest machine learning and
genomic approaches to investigate patient-specific, restorative
cell treatments. The company has developed a best-in-class platform
to create and optimize pluripotent-derived cell therapies, which
includes in-house bioinformatics, manufacturing and quality
control. For more information and important updates, please
visit https://www.aspenneuroscience.com.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling
company offering precise navigation to the brain and spine. The
Company uniquely provides both established clinical products as
well as pre-clinical development services for controlled drug and
device delivery. The Company’s flagship product, the ClearPoint
Neuro Navigation System, has FDA clearance and is CE-marked.
ClearPoint Neuro is engaged with healthcare and research centers in
North America, Europe, Asia, and South America. The Company is also
partnered with the most innovative pharmaceutical/biotech
companies, academic centers, and contract research organizations,
providing solutions for direct CNS delivery of therapeutics in
pre-clinical studies and clinical trials worldwide. To date,
thousands of procedures have been performed and supported by the
Company’s field-based clinical specialist team, which offers
support and services to our customers and partners worldwide. For
more information, please visit www.clearpointneuro.com.
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statements within the context of the federal securities laws, which
may include the Company’s expectations for the future performance,
market, and revenue of its products and services. These
forward-looking statements are based on management’s current
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which may cause the Company's actual results to differ materially
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Company’s ability to market, commercialize and achieve broader
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Company; the ability of our biologics and drug delivery partners to
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results are described in the “Risk Factors” section of the
Company’s Annual Report on Form 10-K for the year ended December
31, 2023, and the Company’s Quarterly Report on Form 10-Q for the
three months ended March 31, 2024, both of which have been filed
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Contact:
Media Contact:
Jacqueline Keller, Vice President of Marketing
(888) 287-9109 ext. 4
info@clearpointneuro.com
Investor Relations:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
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