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Spinally, founded by reputed doctors and entrepreneurs, disrupts chronic pain treatment. The intrathecal FuturaLead, designed for neural recording and stimulation of spinal cord, eliminates the need for opioids and transforms the lives of over 80 M individuals. Our stimulation lead precisely positioned on the spinal cord’s surface, enhancing treatment efficacy. This innovative approach recognized by top tier KOLs and industry market leaders marks a paradigm shift in pain relief therapy.

Completed 12 one day ago
119 investors
Investment achieved
635.604€
Target
575.000€
Invested
110.5%
110.5% INVESTED
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This campaign was live:
From: 02 April 2024
Until: 07 August 2024
Maturity

Prototype/preclinical

Premoney valuation

2.500.000

Estimated exit

2028

Sector

Medical devices

Equity offered

20%

Minimum investment

1.000

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Overview: Spinally

Valuation 2.500.000
Estimated return x15
% Offered 20%
Estimated exit 2028
The company

Spinally is a pioneering neuro-technology company founded by seasoned medical, engineering, and executive professionals. Our primary objective is to revolutionize chronic pain treatment through the development of the world’s first intrathecal Spinal Cord Stimulation (SCS) lead, that can be easily and safely implanted into patient’s body.

The pain industry stands out as market of the future and the most promising investment niche. With people living longer and desiring a high quality of life, demand for effective chronic pain management solution with no addiction and side effects is ever-growing. Furthermore, imperative to eliminate opioids from therapy adds urgency to our cause.

Technologies like ours, demonstrating efficacy in pain reduction, have the potential to bring relief to countless individuals while also yielding substantial returns for those involved. Historical acquisitions in our industry underscore the immense value placed on comparable projects, further solidifying the promise of significant returns on investment. Investing in our technology means not only contributing to the betterment of countless lives but also securing lucrative opportunities in a burgeoning market with proven success.

Extensive testing, simulations, and scientific publications indicate that our innovation addresses the limitations of conventional, epidurally implanted products. FuturaLead enhances electrical performance and extends its reach to a broader spectrum of neurons, allowing us to address more severe and widespread pain sensations throughout the body.

Our technology delivers unparalleled quality in neural signal recording, opening the door to personalized SCS therapy. The patented invention not only promises sustainable and effective chronic pain treatment but also presents opportunities in neurorehabilitation, neurorestoration, spasticity, Parkinson’s, Refractory Angina Pectoris, and various other neurological disorders.

Our PCT patent has passed the international search report with favorable results, published in multiple countries, and is expected to be granted in the EU countries, the UK, and other regions in the coming months.

Our goal is to provide key market players (Medtronic, Boston Scientific, Abbott, Saluda, Nevro) with technology that enhances the effectiveness of their therapy while remaining compatible with their stimulation generators, making SCS as widely available and used as it is for pacemakers.

Market projections indicate substantial growth in the Chronic Pain Treatment Market, expected to reach around $145 billion by 2030, with a CAGR of about 7.1% (2020-2030). The Global Neurostimulation Devices Market is projected to reach $20 billion by 2030, with a CAGR of 11.7%, making acquisitions in this field highly valued (to mention just a few: Axonics by Boston Scientific for $3.7 Bn, Relievant by Boston Scientific for $850 M + royalties, Spinal Modulation by St. Jude for $215 M).

In addition to the team’s expertise and knowledge, Spinally has established collaborations with research institutes and service providers for regulatory, certification, fast prototyping, and manufacturing across Europe, the USA, and Australia (see section ‘Partners’).

One of our most significant sources of pride is the recognition and appreciation of our idea by professionals in the field. Our invention has won prizes and grants, including progressing to the final stage of the US NIH $2 million grant, as well as INS and ESRA smaller grants (results soon). Renowned KOLs such as Dr. Eric Grigsby and Dr. David Abejon have joined us as scientific advisors.

With successful tests, patent applications, and ethics committee approval obtained in December 2023, we are poised to fabricate the final prototype and conduct feasibility trials on the sheep model. These trials will confirm implantability, high-quality recording, precise and deep stimulation, and include a head-to-head comparison between conventional (epidural) leads and our intrathecal solution to demonstrate unmatched effectiveness. The next stage of development will encompass company certification, biocompatibility tests, regulatory GLP studies, and our first in-human trial.

How confident we are? First off, our understanding of the human nervous system and how it ties into treating pain with SCS is solid. Plus, independent publications back up our calculations and tests. Moreover, we genuinely tackle the shortcomings of market leaders. Our solution is a game-changer, revolutionizing the use of neuromodulation and recording at the spine level, a frontier that hasn’t been explored much yet.

Our ultimate goal is to secure the acquisition of our FuturaLead exclusively for pain treatment by a key market player. Simultaneously, Spinally aim to continue implementing our groundbreaking neuro-technology for other indications. To achieve this, we have already initiated discussions with clinicians and researchers working on various diseases.

Why is Capital Cell investing in this company?

Chronic pain, a major cause of disability worldwide, affects 18-34.5% of adults and incurs significant economic costs. There is an urgent need for innovation in this market, particularly in alternative technologies to opioids, one of the biggest current epidemics.

The spinal cord stimulation (SCS) device market is rapidly growing within the neuromodulation sector, projected to reach $20 billion by 2030. However, current technology faces limitations, especially in the implantation of electrodes in the epidural space, resulting in reduced electrical efficiency and compromised therapeutic precision. A major associated problem is the daily need to recharge these devices, similar to charging a mobile phone.

Spinally has developed a smaller and more efficient SCS device, named Futura Lead, which is 120 times more energy-efficient and is implanted without surgery. This advancement, which reduces the need for daily recharging to every three months, is crucial for both users and physicians.

The Spinally team combines technical and scientific knowledge, integrating experts from biotechnology companies with experience in leading companies from their inception to valuations of around $100 million and in raising more than $100 million in investments.

Minimum investment: 1.000
Type of exit expected: Exclusive acquisition of the Chronic Pain relief technology.
Drag-along rights
Tag-along rights
Capital Cell syndicated
Tax deductions
Main risks

The team's scientific expertise in this field is exceptional, and the technology has great scientific potential, but it is still in the preclinical phase, with a development path ahead before reaching the market.

The long road to market entails some inherent commercial risks, such as the development of other solutions. However, their exit strategy through acquisition by a leading company is feasible and significantly reduces the risk.

More information

The intrathecal electrode provides unmet so far sustained therapeutic effects in chronic pain, eliminating the need for opioids and establishing SCS as the premier choice for therapy.

An implant >50% thinner than the current one is easier to implant and wear. No need for a surgical opening, as it's implanted via needle.

The only electrode capable of directly measuring spinal cord activity essential for personalized therapy.

One-fits-all. Adaptable to any pulse generator on the market to facilitate accessibility to the general public.

Thanks to its intrathecal positioning, it is able to reach layers of neurons that were previously unreachable to provide treatment.

Our technology prevents therapy from being affected by the patient's movements.

120x more energy efficient, allowing for a time between recharges of months instead of days. This facilitates treatment adherence.

Addresses all unmet needs of key market players and the health system (low invasiveness, cheaper implantation procedure, miniaturization, higher efficacy, sustainable therapy).

Our experts say

Considering the innovative nature of Spinally 's SCS solution and its alignment with existing medical practices, the chances of the project successfully reaching patients and markets are very favorable.

Estefania Cerro

Head of R&D at ARTHEx Biotech

Good scientific basis, well-protected intellectual property and well-defined development plan.

Adam Martak

Founder of Ambiom

The company has an excellent founder and management team, covering all medical, technical, financial and business aspects. In addition, it has an advisory board with world-class strategy and thought leadership credentials.

Dr. Ali Ghanem

Analyst and Life Sciences R&D Consulting at Tata Consultancy Services.

The final rating

APPROVED: This company has successfully passed a rigorous legal and financial analysis.

Approved by
The BioExpert Network is an independent and exclusive network of experts in the life science industry and investment. Only proposals that receive positive evaluations in innovation, science, finance... make it successfully through to the funding campaign stage of Capital Cell.
Team
83%
Science
75%
Innovation
75%
Business
74%
Approved by
Alira Health is an international consultancy that provides a suite of integrated services designed to help companies in the healthcare and life sciences sectors.
Market access
70%
Regulatory
73%
Approved by
Elion is an intellectual property (IP) agency, which helps biotech and medtech start-ups with their protection strategies, patent drafting and prosecution, as well as freedom-to-operate studies.
Intellectual Property
72%

The project

Introducing FuturaLead: The miniaturized spinal cord implant for a pain-free life.

The gate-control theory of pain, proposed by Melzack and Wall in 1965, spurred the development of conventional spinal cord stimulation (SCS), which Dr. Shealy used for the first time to treat pain. For over 50 years, this technology has mostly stayed the same. Companies have miniaturized the device, redesigned the electrodes, improved battery life, and modified the stimulation parameters and protocol. But still, this method faces critical technological limitations and thus is not as effective as it could be. Consequently, this hampers the annual number of implantations, which could surpass the current figure of 60,000.

We won’t delve into the mechanisms underlying pain relief with the SCS method here as this is extensively described in the literature and well-known in the field. However, we are available to explain it during the meeting with investors and to provide our extensive technical review (under NDA).

SCS systems contain an implanted pulse generator (IPG), electrodes (leads), battery charger, and programmer (remote control). Despite the community’s awareness of the substantial limitations associated with conventional electrode implantation in the epidural space, the chosen implantation site has remained unchanged over the years. Various tissues and barriers, including the dura mater, fat, blood vessels, ligaments, nerve roots, scars, and fibrosis, pose obstacles between the electrode and the spinal cord. Additionally, the distance between the electrode and the spinal cord is not insignificant. 

These limitations disable the high effectivity of the stimulation, quality signal recording for personalized closed-loop therapy, and new treatment discoveries.

Along the pathway between the electrode and the spinal cord, approximately 90% of the energy is lost or dissipated, given that these tissues act as electrical insulators (Howard et al., 2011). Consequently, existing SCS devices consume substantial energy and have a severely limited energy delivery capacity. As a consequence, the stimulation only reaches the superficial layer of the posterior columns, failing to impact the deeper axons (Huang et al., 2014).

Another challenge arises from the low spatial resolution of the current stimulation, a limitation markedly improved by intrathecal stimulation (Howell et al., 2014). Additionally, issues pertaining to the recording modality, among others, the evoked compound action potential (ECAP), which stands as the sole viable stance to enhance treatment efficiency through a closed-loop approach (Anaya et al., 2020; Chakravarthy et al., 2020). This methodology enables the customization and precise adjustment of stimulation parameters for patient therapy and rehabilitation. Achieving this level of precision demands electrode placement directly adjacent to the spinal cord, ensuring the best signal quality, a feat unattainable with conventional – epidural implantation. Furthermore, this strategic electrode positioning not only enhances treatment efficacy but also presents an opportunity to establish a new form of therapy as well as create biomarkers for diagnosing a range of neurological diseases.

Because of the limitations of conventional – epidural SCS, our team has explored intrathecal stimulation as a means to achieve selective and highly effective neuromodulation of fiber tracts deep within the spinal cord. Besides the implantation method and site, we have developed significant technical advances and implemented all of this in our FuturaLead. Our solution is 120 times more energy-efficient than current methods, enhancing treatment efficacy. FuturaLead design is noteworthy for its reduced diameter (0.5mm), making it safer for patients to wear and easier for doctors to implant. The Sentinel Pole System, an octopolar electrode with impedance measurement and current emission points, aids in precise placement and real-time adjustments for optimal therapeutic activity. This system addresses potential issues like unwanted oscillations and ensures stable and efficient electric field generation.

In summary, FuturaLead offers a more efficient and targeted approach to neuromodulation, addressing the limitations of conventional – epidural methods, eliminating the side effects of epidural SCS, and providing a safer and more effective solution for patients.

Our commitment extends beyond pain technology, envisioning FuturaLead’s application across various medical domains. Beyond chronic pain, examples of possible therapies considered by scientists with the use of a conventional system are as follows: neuropathic pain (Reddy et al., 2018), visceral pain (Nagel et al., 2018), and spasticity (Nagel et al., 2017). As the latest research studies indicate, Spinal Cord Stimulation (SCS) shows promise in post-stroke rehabilitation (Powel et al., 2023), Parkinson’s (Milekovic et al., 2023). All of these therapies can be significantly more effective with our product. 

Our team

In building the team, Dr García-Vitoria invited highly experienced individuals with a proven track record in commercialisation of the NeuroTech and BioTech products, dealing with EU, Canada and US regulations, and working with the largest MedTech companies. The team has built the market value of its former companies from zero to around $100M and has raised $100M+ funds to date.

Management team

Pawel Soluch , Chief Executive Officer
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MsC Neuropsychology, post-graduate: 1). Science and Technology Commercialization, 2). Leadership.

Former CEO and founder of neuro-tech R&D company (35 employees, collaboration with key med-tech industry players, as well as start-ups and leaders in the neuro-field). Led the development of Five products commercialized (scientific/medical), Two medical devices ready for commercialization. A company worth $20M at Pawel's exit stage.

Former Principal at NeuroTechX Services - consulting arm of the world largest neurotech organisation. Responsible for providing guidance for NTXS clients in company and product development, regulatory affairs, and commercialization.

  • Clinical experience focused on innovative tools for diagnostics and therapy (fields of neurosurgery, neurology, psychiatry, and cochlear implants).
  • Won 6 awards for innovations and impact.
  • Extensive experience in medical devices development, team building, collaboration with key market players, healthcare systems worldwide, and regulatory (E.U., US, Canada).
  • Advised med-tech start-ups and mentored managers.
  • A solid scientific background (Ph.D. study, 30+ publications, conference presentations, two book chapters, former lecturer) and experience with grants ($ 6M budget in total).
  • Co-Founder and Co-host of the Neurotech Masterminds, FL USA - meetings dedicated to the selfdevelopment of C-level employees in the neuro-tech field and solving everyday challenges in their businesses.
  • Holder of 7 medical patents.
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Carles García-Vitoria , Chief Scientific Officer
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MD, Consultant Anesthesiologist and Interventional Pain Practitioner, Professor at Master's Degree of Universitat de València for Pain Therapy, PhD student in meningeal lesions

  • Founder of 3 biotech & software companies
  • MIT (Boston) Innovator Under 35 Europe Award
  • Forbes 30 Under 30 Spain list
  • Member of Spanish Pain Society, European Society of Regional Anesthesia and World Institute of Pain
  • European Award for Regional Anesthesia (ESRA Research Grant)
  • Researcher at the Carlos III Health Institute
  • Executive MBA from EDEM
  • Ironman triathlete
  • Top 10 Spanish Talent Award (Opinno)
  • Nova 111 list Spain
  • Author and director of an international scientific book with over 500 published chapters
  • PhD at the University of Valencia, researching human/ovine meninges
  • Master's in Pain Treatment, University of Salamanca
  • Extraordinary Award for Academic Performance in Valencian Community
  • Performing over 1000 nerve blocks per year and employing more than 200 techniques for chronic pain
  • Member of the Spanish Pain Society, Master's program professor at SED
  • Holder of 2 medical patents
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Andrés Izquierdo Riveras , Financial Specialist
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  • Deloitte, financial analysis and M&A department.
  • Founder experience (3 companies).
  • Graduate in economics in the high academic performance group, University of Valencia.
  • Lecturer in Master in Start-up Administration (UPV).
  • International Accelerator Fellow at UC Berkeley (SkyDeck).
  • Specialist in financial analysis and control under the Chartered Financial Analyst program.
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Beatriz Llamusí , Business Strategy and Regulatory
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  • Founder and CSO at Arthex Biotech. Led fundraising of over $50M.
  • Skilled executive with a solid scientific background, yet she has a good track record of
  • fundraising and building an international team of talent.
  • During her scientific career, Beatriz focused on studying the molecular basis of pathogenesis and potential treatments by generating animal models of human neuro diseases.
  • PhD studies focused on spinal cord regeneration therapies.
  • Principal investigator +10 years in the University of Valencia.
  • Author of more than 30 scientific articles.
  • Inventor of 7 patents.
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Key team members

Guillermo Varela-Carbajal
R&D Engineer

Advisors

Richard Nash
Go-to-market Strategy
Eric Grigsby
Scientific Advisor
David Abejon
Scientific Advisor
Prof. Nacho Redondo García
Veterinary Anesthesia Tenured Professor, Animal Trial Expert

The problem

Chronic pain ranks among the primary contributors to disability and the overall burden of disease worldwide. The prevalence rate, between 18%-34.5%, is rising due to the increasing number of chronic diseases and the aging population. The consequences of chronic pain extend beyond physical discomfort, impacting every aspect of life. This issue has resulted in significant economic losses, $635 billion, est in 2010, in the US alone. The treatment ladder involves highly addictive and lethal opioids or SCS, which faces technical limitations due to implantation in epidural space, which, in fact, is a barrier to stimulation.

The solution

We’ve developed an ultra-thin and technologically advanced spinal cord stimulation lead designed for intrathecal implantation, which means positioned precisely on the surface of the spinal cord. This eliminates the tissue barrier between the electrode and the spinal cord, leverages the conductivity of the cerebrospinal fluid, and reduces fibrosis risk compared to current SCS. Our product is more effective, easier, and safer to implant. We’ve addressed the drawbacks of current SCS, enhancing efficacy and patient comfort, meeting healthcare system requirements, and aligning with industry needs.

Our differentiation

We achieve 100% energy delivery to the spinal cord, while conventional – epidural systems lose approximately 90% of the energy along the way between the lead and the spinal cord.

Our personalized closed-loop approach precisely records neural activity, eliminating disruptions from body movement. In contrast, conventional – epidural implantation does not allow for high-quality recording, and its efficacy is sensitive to body movement.

Research indicates that our high-precision stimulation is significantly more efficient than conventional methods characterized by dispersed stimulation.

Our technology unlocks new therapeutic possibilities and broadens the scope of treatable patients and indications by accessing deep neuronal tracts, which conventional epidural stimulation cannot achieve.

Importantly, our system requires battery recharging only once every few months, a significant improvement over the daily recharging required for conventional SCS. This enhanced convenience is designed to provide a more comfortable experience for patients.

All of this allows for much more effective and sustainable therapy and miniaturization of existing generators.