Longeviti Neuro Solutions, a neurotechnology company with a focus
on innovative solutions for complex brain surgeries, proudly
announces the issuance of a groundbreaking patent for its novel
prosthetic translucent, cranial implant. The ClearFit® implant
integrates brain-computer interface (BCI), brain mapping, and
neurosonography (brain ultrasound). This product sets a new
standard in neurosurgical procedures, marking the first time a
single implant has been patented to cover three critical areas.
ClearFit’s patented technology was recently on the cover of Science
Translational Medicine demonstrating promising research around this
implant and neurosonography.*
Longeviti received patent issue notification from the United
States Patent and Trademark Office (USPTO) for US Patent No.
12,004,954 B2 entitled “Method for performing single-stage
cranioplasty reconstruction with a clear custom craniofacial
implant.” It was approved in June 2024.
“This technology and exclusive IP surrounding the ClearFit
prosthetic implant family, represents a significant advancement in
the field of neurosurgery. It allows Longeviti to openly
collaborate with others in the field across the globe,” said Jesse
Christopher, CEO, Longeviti Neuro Solutions. “Together, Longeviti
and its partners will advance neurosonography and neurosurgical
patient care to significantly reduce the cost and time it takes to
monitor brains anywhere in the world, real-time.”
The implant's integration of BCI technology allows for direct
communication between the brain and external devices, offering
control and interaction for patients. Coupled with advanced brain
mapping capabilities, the implant provides surgeons with real-time,
detailed anatomical images, allowing for new real-time tools to
enhance precision during surgical procedures. In addition, the
incorporation of neurosonography within the cranial implant allows
for continuous, non-invasive monitoring of brain activity and
conditions, vastly improving postoperative care and monitoring.
“Longeviti not only enhances surgical accuracy but also
significantly improves the overall quality of patient care. This
specific cranial implant allocates unprecedented access into the
brain allowing physicians to see into the brain real-time, reduce
patient radiation exposure, allow point of access care so patients
do not need to be transported or moved, and is reimbursable,” said
David Langer MD, Chief Medical Officer, Longeviti Neuro Solutions.
“Our dedication to clinical excellence and improved patient
outcomes underscores the company's commitment to innovation.”
Clinical research has demonstrated the implant’s effectiveness
in improving surgical precision and patient recovery. Surgeons
using the implant have reported enhanced accuracy in targeting
brain regions, reduced surgical times, and better patient recovery
outcomes.
Most recently, Science Translational Medicine, the leading
weekly online journal publishing medical research, highlighted a
study conducted by researchers from University of Southern
California and Caltech with a cover story. The team implanted
Longeviti’s patented ClearFit prosthetic translucent implant in a
human patient’s skull to capture high-resolution brain imaging
using non-invasive functional ultrasound imaging (fUSI). They
successfully recorded and decoded brain activity in an adult who
suffered a traumatic brain injury, suggesting applications in
brain-computer interface (BCI) and clinical monitoring.
“In our recent study, we were able to measure functional brain
signals transcranially from an awake, behaving, adult human using
fUSI for the first time,” shared Dr. Charles Liu, Professor of
Clinical Neurological Surgery and Neurology, Keck Medicine of USC
and Director, USC Neurorestoration Center.** “This was made
possible through the transparent and sonolucent implant with a
specially designed acoustic ‘window to the brain.’ Importantly,
this first-in-human demonstration was achieved using a commercially
available implant.”
The release of ICD-10-PCS procedural codes by the Center for
Medicare and Medicaid Services (CMS) makes the cost of Longeviti’s
ClearFit® implants fully reimbursable for hospitals in 48 states.
The ICD-10-PCS code XNR80D9, which stands for "Replacement of Skull
with Ultrasound Penetrable Synthetic Substitute, Open Approach, New
Technology Group 9," is exclusively named and is only associated
with the Longeviti ClearFit® device. This device allows for
ultrasound penetration and is used in cranioplasty procedures to
replace part of the skull with a synthetic substitute. The specific
coding for this procedure reflects the incorporation of this new
technology in surgical practices.
“This new ICD-10 PCS code allows hospital systems and patients
to benefit from bringing imaging to the bedside, rather than
bringing beds to imaging, without absorbing new technology
expenses. Immediate, real-time bedside imaging could save valuable
time and significant costs if/when used where appropriate,”
said Aimee C. DeGaetano, PhD (ABD) MPH RD, Eastern Virginia
Medical School, Department of Health Science and Medicine.
For more information on the novel prosthetic cranial implant and
to access detailed clinical study results including Science
Translational Medicine, Neurosurgery, and Science Direct,
visit https://longeviti.com.
“We’re pleased to see the success of portfolio companies like
Longeviti,” said Troy LeMaile-Stovall, TEDCO CEO. “Over
the years, they’ve seen significant growth through many of our
funds and programs, and they’re a great example of the types of
companies we look for to help strengthen Maryland’s economy.”
About Longeviti Neuro Solutions
(https://longeviti.com)
Longeviti Neuro Solutions is a leading innovator in functional
neurotechnology, dedicated to developing advanced solutions that
improve the lives of patients with neurological conditions during
and after surgery, returning them to anatomical normalcy. The
Baltimore-based company has full manufacturing, packaging,
designing, and sterilizing capabilities in-house with multiple FDA
clearances, successful FDA audits, and ISO 13485 Certifications.
Longeviti has 17 patents to date.
Longeviti’s mission is to develop innovative solutions for
complex brain surgery. Its products are currently approved for use
in over 100 hospitals across the globe. To date Longeviti
neurosurgical implants have helped over 4,000 patients.
In July 2024, Longeviti announced a 10,000 square foot Class A
office lease at Rye Street Market within the Baltimore
Peninsula.
*Neurosonography - an exploding field of neuroscience utilizing
ultrasound and its dynamic functional capabilities, also which
historically could not penetrate the skull.
**Dr. Liu does not have any conflicts of interest disclosed. He
does not receive compensation for any of the work related to
Longeviti and its implants.
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