Neuraura: Solving PCOS with Bioelectronic Medicine

In the healthcare landscape where technology is unlocking solutions to change lives of millions, Neuraura made itself a name in the bioelectric medicine industry. Founded by Claire Dixon and Pierre Wijdenes, the company's mission is to transform the standard of care for underserved health conditions through bioelectronic medicine. Neuraura's latest innovation to be introduced is LoOoP, a solution set to be the first effective and widely accessible remedy for PCOS (polycystic ovarian syndrome).

In addition to partnering with another Tech4Eva start-up RU Medical, Neuraura has reached an important milestone with its preliminary human testing to treat chronic insulin resistance causing Polycystic ovary syndrome (PCOS). Affecting nearly 1 in 5 women, this prevalent hormonal condition can lead to distressing symptoms, debilitating chronic health complications and even infertility. Despite its impact, there is still a lack of effective and widely accessible solutions available on the market.

The root of the company

Neuraura has an interesting story, having been established as a brain-machine interface company originating from the Hotchkiss Brain Institute, a leading institution in the brain-chip interface field. The outcome of the team efforts was a neural electrode designed for intra-cranial recording, which is set for FDA submission later this year. Remarkably, this product has been proven to outperform the clinical gold standard in large animal studies.

When the company made the decision to license the neural electrode technology instead of pursuing direct commercialization, their attention shifted towards addressing PCOS – a prevalent, yet often overlooked and underserved health condition impacting women. Now, Neuraura is fully dedicated to utilizing their platform technology to enhance the quality of life and increase the number of healthy years lived for those affected by this condition and other similarly profound health challenges. The team developed LoOop, a product that uses the combination of micro electrodes with a wearable Transcutaneous Electrical Nerve Stimulation (TENS) device to modulates insulin uptake, thus ease PCOS symptoms.

How does LoOoP work?

The bioelectronic device LoOoP offers low-frequency electrical stimulation at multiple levels within the nervous system. When applied locally, LoOoP increases blood flow through micro-vessels in the targeted muscle, mimicking the effects of exercise. In addition, this stimulation influences nerve growth factor activity in other skeletal muscles, resulting in similar benefits. The remarkable outcome includes both short-term improvements in glucose uptake and long-term shifts in baseline metabolism. At the central nervous system level, LoOoP takes it a step further by modulating the pulse frequency of GNRH (gonadotropin-releasing hormone), thereby rebalancing the LH / FSH (luteinizing hormone / follicle-stimulating hormone) ratio. This adjustment directly impacts the production of female and male sex hormones (androgens) by the ovaries, effectively targeting the core underlying mechanism of PCOS. With LoOoP, women have a concrete solution to address their overlooked health condition.

Neuraura’s competitive advantage

Neuraura possesses a unique advantage thanks to its patented micro-electrode technology. In the case of LoOoP, the electrodes gently penetrate the outer layers of the skin for percutaneous stimulation, effectively overcoming the natural barrier and delivering a more potent therapeutic effect. Additionally, these electrodes offer exceptional signal and spatial resolution for recording in other applications.

Neuraura has a strong tradition of developing solutions that are backed by scientific evidence. With over 5 years of experience working together as a cohesive team, Claire and Pierre have successfully combined scientific expertise with a robust commercial approach, allowing them to bring solutions to market in a streamlined and cost-effective manner.

The roadmap

Since re-focusing Neuraura on addressing a significant unmet clinical need in Q4 2022, the company has made significant progress. They have successfully developed several iterations of device prototypes and conducted preliminary human studies to prove the efficacy of stimulation through their electrodes. Additionally, key distribution and channel partner relationships have been established.

Through the FDA pre-submission process, Neuraura has confirmed a Class II 501(k) regulatory pathway in the US, using pain management devices as predicates. With approval anticipated in the US in early 2024, the company has plans to target distribution in Canada, Australia, the EU, UK, and India. They aim to expand claims for PCOS through progressive clinical studies.

The growing interest and focus on women's health are expected to result in increased funding for research and the translation of research into healthcare solutions. Neuraura hopes to witness the positive impact of these developments on women's lives within the next five years. However, the company acknowledges that some legacy investors may struggle to fully grasp the potential of the vast commercial opportunities in women's health, primarily due to the lack of a personal connection to these issues.

In the field of bioelectronic medicine, Neuraura envisions LoOoP, along with partner solutions and competitive products, effectively addressing a wide range of health conditions, especially those related to chronic health and longevity. The company is optimistic about the booming opportunities in "active" or bioelectronic wearables, building on the impressive 30% year-on-year growth rates in wearables for health monitoring. Neuraura’s has achieved significant commercial and technical traction since refocusing on the PCOS application a few short months ago. They recently secured a letter of support for up to C$1M in pre-sales from a leading online pharmacy in Canada and secured preliminary evidence from their first human study for LoOoP. In addition, the team is making the conscious decision to pursue an over-the-counter channel strategy to avoid the significant gaps and delays in PCOS diagnosis.

Over the next few months, the team plans to raise seed financing as well as securing further pre-sales commitments from both channel partners and end-users.  In parallel, they will finalize the pre-production version of the LoOoP device in preparation for FDA submission as well as continuing to build out their distribution and channel partnerships.  

About joining Tech4Eva

Claire says: Tech4Eva brings together some of the most promising start-ups in women’s health to provide peer support, industry-specific insights and world-class connections to potential customers, partners, and investors. There are several structural challenges in women’s health because of historical data gaps, under-funding and societal attitudes and taboos.  PCOS is a prime example of a highly complex, multi-systemic, chronic condition that has been significantly under-funded and is therefore relatively poorly understood.

In a few short months, I have built an ecosystem of committed, knowledgeable and accomplished experts in women’s health spanning the globe.  I feel completely blessed to have this powerful group of supporters to call upon and ask for support, expertise, and connections.  Given the headwinds that still exist in this field, this network is invaluable, and I would encourage anyone entering this industry to invest in that network early to test your ideas and learn from other’s successes and missteps.

About Claire Dixon

Claire has 25+ years’ international leadership, strategy, and operational experience, including 15 years as a strategic consultant to capital and technology-intensive businesses, 5 years in senior operational roles and 6 years as a deeptech founder and Entrepreneur in Residence for one of Canada’s leading accelerator programs.

She holds an MBA from Harvard Business School and an MEng/MA (Cantab.) in Mechanical Engineering from Cambridge University, Claire's diverse expertise laid the foundation for Neuraura's transformative work.

About Pierre Wijdenes

Dr. Pierre Wijdenes graduated from the Ecole Nationale Superieure de Cognitique in Bordeaux, France, with an engineering degree specialized in Human Factors and Product Engineering. He then worked at Essilor International before completing a PhD in Biomedical Engineering at the University of Calgary. He co-founded Neuraura with Claire Dixon and Colin Dalton while going through the Creative Destruction Lab accelerator program, and their team subsequently raised $4M+ in funding (dilutive and non-dilutive) to further the development and testing of the company’s core technology. He is now the President and Chief Product Officer leading the product and regulatory strategy along partnership and business development activities.

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More info:

Website: https://www.neuraura.com/looop

Linkedin : https://www.linkedin.com/company/neuraura