Medtronic Acquires Stimgenics, Pioneer of DTM™, a Novel Spinal Cord Stimulation Therapy
January 08 2020 - 5:19PM
Medtronic plc (NYSE:MDT) announced it has acquired Stimgenics,
LLC, a privately-held company based in Bloomington, Illinois,
that has pioneered a novel spinal cord stimulation (SCS) waveform
known as Differential Target Multiplexed (DTM™) Spinal Cord
Stimulation. The therapy, which is delivered via the Medtronic
Intellis™ platform, is a new and unique programming option to treat
patients with chronic pain. Three month results from
a randomized control trial (RCT) evaluating DTM versus
conventional SCS will be presented at the upcoming North
American Neuromodulation Society (NANS) 23rd Annual Meeting on
January 23-26 in Las Vegas. The RCT will continue to evaluate
outcomes through 12 months follow-up.
The DTM waveform may engage a novel mechanism that
modulates both neurons and glial cells, expanding the understanding
of SCS mechanisms of action. The DTM waveform has been studied
in animal models, showing statistically significant reversal of
pain behaviors compared to either low frequency or high frequency
alone.1,2 In addition, preclinical studies investigating the
genome of nerve-injured animals suggests that the DTM waveform
has a greater impact in the neural-glial interaction than other
frequencies alone. Decades of basic science research have expanded
the understanding of the role of glial cells in the nervous system,
which outnumber neurons 12:1 in the spinal cord.3-6 Glial
cells are no longer thought to be only “glue” in the brain and
spinal cord, but active contributors to neural processing and
various disease states including chronic pain.7
“Stimgenics’ research is deeply rooted in clinical
science that began with animal work more than a decade ago. Our
preclinical data demonstrated that the modulation of both neurons
and glial cells may return glial cells to their normal state and
modify how they interact with neurons, which could normalize
biological processes and break the pain cascade,” said Dr. Ricardo
Vallejo, co-founder and director of research at Millennium Pain
Center in Bloomington, Illinois, and founder and lead investigator
of Stimgenics, LLC. “I’m thrilled that Medtronic has acquired a
therapy that has the potential to significantly improve outcomes
for chronic pain patients.”
Stimgenics’ preclinical research on the
neuronal-glial mechanism of action has been recognized at various
medical society meetings. Over the course of the past two years,
the team has received six “best of” awards for their research,
three of which were specific to research investigating the DTM
mechanism of action. NANS awarded the “Best Basic Science Research
Award” to Stimgenics at their annual meeting in both 2018 and
2019.
“Medtronic is committed to providing
clinically-proven therapeutic options for millions of patients
suffering from chronic pain around the world,” said Marshall
Stanton, M.D., president of the Pain Therapies business, which is
part of the Restorative Therapies Group at Medtronic. “We believe
that DTM therapy will advance the treatment of chronic pain,
supported by clinical evidence and preclinical research on a
neuronal-glial mechanism of action. It’s an exciting, new
proprietary SCS waveform that will be available on the Intellis
platform, and we are looking forward to seeing the results of the
randomized control trial data later this month at NANS.”
This transaction is expected to be neutral to
fiscal year 2020 earnings per share and meet Medtronic’s long-term
financial metrics for acquisitions. Additional terms of the
transaction were not disclosed.
About Stimgenics, LLCStimgenics,
LLC is a private company based in Bloomington, Illinois, that
pioneered a novel spinal cord stimulation waveform known as
Differential Target Multiplexed (DTM) Spinal Cord Stimulation.
About Medtronic Pain TherapiesMedtronic has
more than a 40-year history of developing innovative medical
devices that have been shown to alleviate pain in different disease
states and has a broad portfolio of device-delivered therapies that
are alternatives or adjuncts to oral opioids.8 Medtronic
strives to be at the forefront of medical device innovation and to
develop high-quality pain therapies that reduce pain and
improve quality of life. While Medtronic pain therapies do not
treat opioid addiction, the company is committed to leveraging its
capabilities and product portfolio in partnership with stakeholders
— patients, providers, payers, regulators, elected officials,
patient advocacy groups and employers — to address the unmet needs
of pain patients and to support efforts to prevent opioid misuse
due to chronic intractable pain.
About the IntellisTM PlatformThe
Intellis platform offers the world’s smallest implantable
neurostimulator. It is powered by proprietary
OverdriveTM battery technology and was designed to overcome
limitations with other SCS systems, optimized for a wide range of
energy demands and provides effective long-term pain relief for
patients. The neurostimulator also features SureScanTM MRI,
allowing access to MRI anywhere in the body under certain
conditions, and AdaptiveStimTM technology, which automatically
adjusts stimulation based on the patient’s needs and preferences in
different body positions to ensure the patient receives the right
dose of stimulation at the right location.
About MedtronicMedtronic plc
(www.medtronic.com), headquartered in Dublin, Ireland, is among the
world's largest medical technology, services, and solutions
companies – alleviating pain, restoring health, and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals, and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to
risks and uncertainties such as those described in Medtronic's
periodic reports on file with the Securities and Exchange
Commission. Actual results may differ materially from anticipated
results.
-end-
References
- Cedeno D.L., Cass C.L., Kelley C.A., et al. Pre-clinical
comparison of differential-target multiplexed scstm with low and
high rate SCS. Neuromodulation 2019 22:3 (E185-)
- Cedeno D.L., Kelley C.A., Cass C.L., et al. Pre-clinical
Comparison of Differential-Target Multiplexed SCS with Low and High
Rate SCS. Presentation at ASRA 2018. San Antonio, Texas.
- Milligan ED, Watkins LR. Pathological and protective roles of
glia in chronic pain. Nat Rev Neurosci. 2009 Jan;10(1):23-36.
- Vallejo R, Tilley DM, Vogel L, Benyamin R. The role of glia and
the immune system in the development and maintenance of neuropathic
pain. Pain Pract. 2010 May-Jun;10(3):167-84.
- De Leo JA, Tawfik VL, LaCroix-Fralish ML. The tetrapartite
synapse: Path to CNS centralization and chronic pain. Pain. 2006;
122:17-21.
- Ruiz-Sauri A., Orduña-Valls J.M., Blasco-Serra A. et al. Glia
to neuron ratio in the posterior aspect of the human spinal cord at
thoracic segments relevant to spinal cord stimulation. Journal
of Anatomy, vol. 235, no. 5, 2019, pp. 997-1006.
- Allen NJ, Barres BA. Neuroscience: Glia - more than just brain
glue. Nature. 2009 Feb 5;457(7230):675-7.
- Deer T. Atlas of implantable therapies for pain
management. New York, NY: Springer Science and Business Media,
LLC; 2011.
Michelle ClaypoolPublic Relations+1-763-526-9452
Ryan WeispfenningInvestor Relations+1-763-505-4626
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