In this episode of the Neural Implant Podcast, I speak with Fabio Boi, Co-Founder and CSO of Corticale, an Italian neurotech company that is redefining the landscape of brain-computer interfaces. Corticale is pioneering a new generation of minimally invasive, CMOS-based neural implants that can record from thousands of neurons simultaneously—introducing their flagship technology, SiNAPS.

Fabio walks us through how SiNAPS achieves single-cell resolution recordings via its 1024-electrode array, enabling high-fidelity access to both action potentials and local field potentials deep within cortical tissue. We also explore the significance of modular probe design, ultra high-density sensors, and the potential clinical and research applications of such a breakthrough platform.

This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/

Top 3 Takeaways:

• Corticale’s SiNAPS probes miniaturize electronics directly beneath each electrode, enabling every channel to independently record signals. Unlike traditional systems that require pre-selection or external r eadout bottlenecks, this design supports simultaneous, high-resolution recording across the entire array.
• Moving from hundreds to thousands of recording channels exposes neural complexity that was previously missed. For brain-computer interfaces, this data richness significantly improves decoding accuracy and performance.
• Startups should prioritize building the right team even before finalizing the technology. As Fabio reflects, having a team with the right expertise early on can help avoid costly mistakes, save time, and steer the company in the right direction—something he wishes he had done from the beginning.

0:45 Do you want to introduce yourself better than I just did?

3:00 What are some of the features of your technology?

5:30 What kind of cutting edge fabrication are you using?

6:30 What application do you see this being useful for?

10:15 Sponsorship by blackswan-ip 

10:45 So who are you main customers now?

12:45 What are the upper limits of this technology?

16:00 So you guys are working only on the hardware side of things?

16:45 What kind of data processing do you need for this?

18:45 What do the next 5 years look like for you?

20:15 What kind of patient population would you be targeting?

21:00 What is it like to be based in Italy?

24:00 Is there anything that we didn't talk about that you wanted to mention?

In this episode of the Neural Implant Podcast, we sit down with Ben Woodington, co-founder of Coherence Bio, a groundbreaking medical technology company pioneering a new frontier in cancer treatment. By integrating neurotechnology, neurobiology, and machine learning, Coherence is building a platform that doesn't just fight cancer—it manages it in real time.

Ben shares how Coherence is moving beyond the traditional "cut, burn, poison" model of oncology, and instead focusing on precision neuromodulation to monitor and control cancer progression—offering hope for 24/7 adaptive treatment with fewer side effects and better quality of life. Their platform, SOMA, is the first in a suite of technologies aimed at achieving this ambitious goal.

We also explore the emerging field of cancer neuroscience, the role of BCIs and digital neural interfaces in oncology, and how Coherence's research is predicting brain metastasis, decoding neural signatures of gliomas, and applying electrotherapy to fight tumors.

This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/

Top 3 Takeaways:

• Coherence is targeting glioblastoma as its first application due to its urgent unmet clinical need—patients face a median survival of just 14 months, and the standard of care hasn’t evolved in over two decades. Despite the broader applicability of their technology across brain cancers, focusing on this aggressive, treatment-resistant form gives them a high-impact entry point to demonstrate the value of real-time, adaptive neuromodulation.
• Coherence is exploring two groundbreaking mechanisms for treating brain cancer: directly stimulating cancer cells to inhibit division, and disrupting the neural-cancer feedback loop that drives tumor growth. Inspired by work from Stanford’s Michelle Monje lab, they aim to block the synaptic connections between neurons and tumor cells—cutting off the electrical signals and neurotrophic support that fuel cancer proliferation.
• Implants will be placed during patients’ scheduled tumor resection surgeries, minimizing additional intervention. Rather than performing separate procedures, the team collaborates with surgeons during planned tumor debulking to implant devices, enabling safety and neural recording studies without altering standard care pathways.

0:45 Do you want to introduce yourself better than I just did?

2:00 Is that what OptoBio was doing as well?

3:15 What is the mechanism of action for curing cancer?

6:00 How are you treating the cancer?

8:15 Is this a localized treatment around the implanted area only?

17:15 Sponsorship by blackswan-ip 

11:15 How are you measuring the signal of the cancer?

12:00 What level of development are you guys at?

14:00 How are clinical trials approval different for terminal patients?

15:45 How do you deal with the sense of urgency to get this technology out?

18:30 What would you want to see in the Neural Implant Community?

23:15 Is there anything we didn't talk about that you wanted to mention?

In this episode, we dive into the world of European intellectual property and medtech innovation with Dr. Christian Wende, a German and European Patent Attorney specializing in medical technology at DTS. With a background in mechanical engineering, a Ph.D. in liver dialysis research, and a Master of Laws in European IP law, Christian brings a rare and powerful combination of technical, legal, and clinical insight.

We explore how startups and investors should think about IP strategy in Europe, the impact of the new Unified Patent Court (UPC), the nuances between U.S. and EU patent landscapes, and how IP due diligence is handled during VC rounds and M&A activity. Whether you're a founder, investor, or innovator in medtech or neurotech, this episode is packed with actionable insights.

This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/

Top 3 Takeaways:

• When looking for a good IP lawyer, don’t try to search blindly—ask founders who’ve successfully done it before. You’ll often hear the same trusted names. And even if those lawyers are conflicted, they’ll usually refer you to a trusted colleague. The IP community is small and highly referral-driven.
• Becoming a qualified German and European patent attorney is a long and rigorous journey—often taking over 14 years. It includes a PhD, a three-year legal apprenticeship, two bar exams (German and European), and additional certification for the Unified Patent Court. Only about 25% of German candidates pass the European exam on their first try.
• Investors expect transparency and a plan—especially when IP litigation risk is involved. Hiding potential legal issues is a red flag that can derail multimillion-dollar investments, particularly in later-stage rounds. For high-stakes backers, surprise IP battles are deal-breakers, not details.

1:30 What is a patent and how is it different in Europe vs the US?

3:30 How far in advance should you be thinking about European patents?

8:15 How did you get into patent law?

10:00 What kind of education is necessary for this?

14:30 What was your role in the Sapiens DBS IP portfolio?

17:15 Sponsorship by blackswan-ip 

17:45 What are common issues especially in Merger and Acquisition deals?

27:15 What is one of the biggest mistakes you see neurotech companies do?

30:00 How do you recognize good legal counsel?

32:30 How do your Japanese roots fit into everything?

36:00 Are you knowledgable about the Asian side of medtech?

38:00 Is there anything that we didn't talk about that you wanted to mention? 

In this special episode recorded after the workshop in Barcelona, I talk with Nicolas Barabino and Antoni Ivorra, two of the key organizers behind the 2025 Active Implantable Medical Devices (AIMD) Workshop. We dive into the vision behind this growing event, which brings together top researchers, engineers, clinicians, and entrepreneurs to explore the cutting edge of implantable medical devices.

Nicolas and Antoni share insights on the evolution of AIMD technologies, the role of multidisciplinary collaboration, and how this annual workshop is shaping the next generation of innovators. We also touch on the challenges that startups face in the space—regulatory hurdles, IP strategy, and the importance of academic-industry partnerships.

Whether you're a student curious about the field or a seasoned expert navigating the complexities of medical implants, this conversation is packed with valuable takeaways from the heart of Europe’s neurotech and medtech community.

This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/

Top 3 Takeaways:

• This year’s AIMD workshop struck a successful balance between clinical research and industry—50/50 over two days. Feedback from both local and international attendees praised the diverse topics, especially the sessions on soft electrodes and innovative implantable technologies.
• The AIMD Workshop stood out for its diverse programming—not just cutting-edge technology talks like those on soft electrodes, but also valuable discussions on market strategy, startup resources, and IP, including insights from a patent lawyer on what investors really look for. This blend of technical and business perspectives resonated strongly with attendees. 
• At events like AIMD, aim for just one meaningful 10–15 minute conversation per day—enough to be memorable and lay the groundwork for a follow-up. Quality over quantity builds lasting connections.

1:00 Antoni, do you want to talk about why you were hosting the workshop and what you liked about it?

2:15 Nicolas, do you want to introduce yourself again?

4:30 It was aimed at students, what percentage were students?

5:15 What kind of talks were there?

8:15 Can we define Active Impalntable Medical Device and why was it focused on neurotech?

11:00 Sponsorship by blackswan-ip 

11:30 What will next year's meeting look like?

12:45 Which of the topics have some of the biggest future in the field?

17:45 What kind of advice do you have for students who can attend these kinds of conferences?

21:00 Anything that we didn't talk about that you wanted to mention?

In this episode, we sit down with Chad Andresen, Chief Business Officer of Lunosa, to explore a groundbreaking approach to treating obstructive sleep apnea. Lunosa is developing a self-expanding, injectable neurostimulator that aims to replace invasive facial surgeries with a minimally invasive, high-impact solution — tapping into a $10 billion market. Chad also reflects on his time at Stimwave, a pioneering neuromodulation company that saw both innovation and controversy. He shares insights from testifying against Stimwave’s former CEO, lessons learned from the company’s collapse, and how those experiences shape Lunosa’s vision and execution today.

This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/

Top 3 Takeaways:

• User feedback can vary drastically by region — while patients in Mexico and Europe reported positive results, U.S. participants were far more critical and vocal, revealing major usability issues that had been previously overlooked.
• A major red flag in a startup is when experienced, well-tempered professionals leave quickly and repeatedly — it often signals deeper cultural or leadership issues that young founders may overlook until it's too late.
• Lunosa developed a novel “nerve net” implant that works like a fishing net—capturing multiple nerve branches responsible for tongue movement in sleep apnea—offering selective stimulation to activate helpful muscles while avoiding unwanted ones.

1:30 Do you want to introduce yourself better than I just did?

3:00 How did your career start?

5:15 How did the founding of StimWave look like?

7:15 How did that ramp up look like?

12:15 How did things go wrong?

17:15 What exactly was the issue that caused all the problems?

20:15 Sponsorship by blackswan-ip 

20:45 How did you find out that things had gone wrong?

26:15 What are some lessons learned from this process?

31:30 Do you want to talk about the misalignment of incentives often coming from VC funding?

35:30 Let's talk about LunOsa

44:00 What are some other exciting things coming from LunOsa?

47:00 Anything else that you wanted to mention?

In this special on-location episode recorded in Leuven, Belgium, we sit down with the co-founders and technical leaders of ReVision Implant—Frederik Ceyssens (CEO), Maarten Schelles (CTO), and Laurens Goyvaerts (CSO). The team shares their journey developing a high-density, intracortical visual prosthesis aimed at restoring vision for the blind. From developing reliable insertion technology to achieving long-term biocompatibility in nonhuman primate models, ReVision Implant is at the forefront of neurotech innovation. Tune in to hear about their challenges, breakthroughs, and what’s next in the race to cure blindness through brain stimulation.

This episode is sponsored by Black Swan IP – patent strategy and legal support for neurotech innovators. Learn more at www.blackswan-ip.com/

Top 3 Takeaways:

• Future users of ReVision's visual prosthesis express diverse goals—from navigating unfamiliar cities independently to recognizing familiar faces—highlighting the need for customizable solutions with both wide fields of view and high resolution.
• The team is exploring adaptive algorithms that could allow users to toggle between broad, low-resolution views and focused, high-resolution modes—such as reading letters or recognizing faces—offering personalized visual strategies even if only a few thousand stimulation points are achievable.
• Restoring vision is one of the most challenging neurotech applications—far beyond simply upgrading existing DBS systems—but taking that bold leap sets ReVision Implant apart in a space where few dare to innovate at this scale.

1:00 Do you want to introduce yourselves and your company?

6:30 What is the device and how is it different than other companies?

11:15 How many pixels or phosphenes are you expecting to get?

16:00 How much processing will be required to handle that many channels?

17:00 What is the form factor of the device?

18:15 How long is the battery expected to last?

23:30 What kind of acceleration would you expect from investment?

26:00 How does your fabrication process look?

31:30 Sponsorship by blackswan-ip 

32:15 Are you also looking at vision augmentation?

35:00 There's a large graveyard in this visual neuroprosthetics space, why do you think you will survive where others have died?

40:30 Did some of the other companies have technical issues that caused them to die?

45:30 Is there anything that we didn't talk about that you wanted to mention?

In this episode, we speak with Julio Martinez-Clark, CEO and co-founder of Bioaccess, a contract research organization helping Medtech and Biopharma startups slash months off their clinical timelines. With a focus on Latin America, Bioaccess enables early feasibility and first-in-human trials to be conducted faster, more affordably, and with high-quality data suitable for FDA and EU submissions. Julio shares how their global site network—built over 20 years—helps startups navigate regulatory hurdles, reduce costs, and de-risk innovation, all while improving patient lives in emerging markets.

This episode is sponsored by Black Swan IP

Top 3 Takeaways:

•   “The sites and IRBs in Latin America follow international ICH-GCP guidelines—Good Clinical Practice standards set by the World Health Organization. If you're a professional in clinical research, these are the standards you adhere to. As a sponsor, it's your responsibility to ensure that the sites you select, after rounds of interviews and vetting, comply with ICH-GCP. There's also a new development in the region: the Global Clinical Site Certification, an organization based in London that accredits clinical research sites internationally. They're expanding across the Americas, and countries like Colombia and Panama have been especially receptive. For example, we’re currently working on certifying CVAC, a site network in Panama.”
• For FDA market clearance, sponsors typically need a large, U.S.-based pivotal study. But the FDA may accept up to 30% of that data from international sites—if it follows ICH-GCP standards. First-in-human trials in places like Colombia or Panama can help demonstrate safety and efficacy, supporting an FDA IDE application for a pivotal U.S. study.
• Many FDA-approved therapies never reach Latin America, simply because manufacturers focus on larger markets like the U.S., Europe, or Japan. Clinical trials provide patients in Latin America with early access to innovative treatments they might otherwise never receive.

0:45 Do you want to introduce yourself better than I just did?

1:30 Why is Latin America better for clinical trials

4:15 How does the speed and cost compare to the US?

6:30 What standard of cleanliness, ethics, and quality can we expect in a country like Panama?

8:45 What kind of capabilities are in these countries?

10:15 Axsoft and Paul LeFloch, previous Neural Implant Podcast guests, utilized your services, can you talk more about their study?

14:15 What was the timeline of that study selection all the way to the end of the study?

15:30 What kind of Institutional Review Boards look over the ethics? Are they internationally recognized?

16:15 Sponsorship by Black Swan IP

20:15 Could you also use this for FDA approval?

 22:45 Do you want to talk about the willingness of the patients in Latin America to take part in these trials?

29:45 When should medical device developers reach out to you?

33:30 Is there anything else that we didn't talk about that you wanted to mention?

In this episode of the Neural Implant Podcast, we’re joined by Nathan Piland, CEO of Nunex, a consulting firm that specializes in helping MedTech companies navigate the complex journey from concept to commercialization. With over two decades of experience across regulatory strategy, product development, and market access, Nathan shares invaluable insights into the critical steps for MedTech startups and established companies looking to succeed in today’s competitive landscape. Tune in as we discuss the unique challenges of the neurotech industry, strategic consulting for MedTech ventures, and how Nunex is helping companies grow and scale through a holistic, tailored approach.

Top 3 Takeaways:

• "Some people are saying that the brain is becoming the new heart, referring to the decades-long focus on cardiovascular research and devices, from mitral valve replacements to aortic repairs. However, advancements in heart treatments are becoming incremental, while the brain remains a vast unknown. In fact, we may know less about neuroscience than we do about the heart. This is exciting, though, as it means we have fewer biases about how to solve problems in the brain. There’s a lot of activity in areas like Alzheimer's and Parkinson's disease, with ongoing efforts to improve patients’ lives."
• "The reason we formed the company was to partner with founders and leaders in the MedTech industry. Like many listeners of this podcast, I’ve been on the other side, constantly receiving sales pitches. We believe we can add the most value by highlighting key insights and trends within the industry."
• "If I were the CEO of a startup, I would consider doing most of the work in another geography for a fraction of the cost, while still obtaining high-quality data. Then, I would come to the US for a follow-up study. Even if you needed to do a 50-patient study to confirm results with a US-based population to satisfy the FDA, it would be much cheaper, faster, and more cost-effective than conducting a large-scale trial here in the US with all the associated costs and challenges."

0:45 Do you want to introduce yourself better than I just did?

1:30 How did you get into medtech consulting?

5:15 Why did you decide to work with startups?

7:15 What are the 7 dimensions and what are the order of these?

12:45 What does a typical workflow look like with a company?

19:30 Is neurotech different or unique compared to other types of medtech?

23:45 Do you want to talk about your newsletter and conference also?

30:00 And you'll have another conference this year too?

32:00 Malaysia sounds great but are there any drawbacks to working there?

36:45 With the new administration what is your prognosis on funding and medtech development?

41:15 Anything that we didn't talk about that you wanted to mention?

In this episode of the Neural Implant Podcast, we welcome Dr. Eugene Daneshvar, founder of Black Swan Intellectual Property (BSIP), a boutique law firm specializing in intellectual property for neurotech and medtech innovations. With a background in biomedical engineering and law, Eugene has a unique perspective on protecting the cutting-edge ideas that drive the future of healthcare technology. After years of working at a larger firm, Eugene founded BSIP to provide more accessible, fair, and transparent pricing for IP services, moving away from the traditional hourly billing model. In addition to his work in intellectual property, Eugene also offers strategic counsel for fundraising and business development, helping startups navigate the complexities of commercialization in the medtech and neurotech space.

Top 3 Takeaways:

• "It’s difficult to change large organizations. I had tried to build a neurotech-focused practice, but my previous firm wasn’t on board. The firm was primarily focused on pharma, with much deeper pockets than neurotech, and they controlled my hourly rate, which reached $1200 an hour. It was too steep for my clients in medical devices, so I decided to create a firm that would be more accessible and help those startups – I became an entrepreneur myself."
• "The most exciting part is that I switched to flat-fee billing, so no more billable hours. Everyone dislikes billable hours, and this approach creates a win-win situation for both myself and my clients. It provides predictability in costs, and it saves me time since I no longer have to track every minute of my work."
• "I offer deferrals based on what clients need—whether it's 30 or 90 days, or until they secure funding. Sometimes, I even take shares instead of cash, depending on the opportunity. As an angel investor with Life Science Angels, I help life science startups raise capital, typically between $200,000 and $1 million, by ensuring they are prepared for investment.

0:30 Do you want to introduce yourself better than I just did?

3:15 What are you specializing in?

4:15 Why do you think you're competent in this field?

9:30 What is a typical price for your services?

12:45 What are some other services that a neurotech company might need?

FogartyInnovation.org

16:30 How does being a small law firm affect reputation?

22:45 What is missing most? Or what is something that you wish people would know?

27:45 Is using AI an issue more for generating the patent claim or writing the claim?

31:00 So you feel confident that your job is safe from AI?

In this episode, we welcome Prof. Dr.-Ing. Maurits Ortmanns, a leading expert in ASIC design and professor at the University of Ulm, Germany. With a distinguished career in microelectronics, Dr. Ortmanns has contributed extensively to the development of integrated circuits for biomedical applications. He shares insights into the critical role of ASIC (Application-Specific Integrated Circuit) design in advancing neurotech implants, focusing on low-power, high-speed circuits that are essential for optimizing the performance and reliability of these devices. Dr. Ortmanns also discusses the challenges and future of circuit integration in neurotechnology.

Top 3 Takeaways:

• "Each ASIC is very low in cost because the development cost is spread across millions of units. The actual production cost is minimal; the primary expense lies in the development time until the first chips are produced and ready for manufacturing."
• "For an inexperienced engineer, it typically takes about six months to a year to design the blueprint for the chip. Then, depending on the manufacturer, it takes an additional four to six months for the actual fabrication of the ASIC. Finally, you would need another one to two months for testing, so the total turnaround time for a small chip is approximately one and a half years."
• "Let's take the example of a neuromodulator. You need recordings or data from neurons and stimulation data going to the neurons, so you essentially have these two components. Then, you encounter challenges like stimulation artifacts. One person might focus on eliminating the stimulation artifact in the recording channel. That requires additional algorithms or hardware, and the data needs to be digitized, which is another task. You may also have someone working on a compression algorithm and building digital circuitry to compress the raw input data. Then, there’s the data interface, power management, and wireless energy delivery. Each person works on their specific innovation, and if everything is well-planned and lucky, all these pieces can come together to create a complete system. However, sometimes you simply don’t have a breakthrough idea for power management or communication."

0:45 Do you want to introduce yourself better than I just did?

3:15 What is integrated circuit design?

7:30 What are ASIC's? How are they used in neurotech?

10:15 How does the million dollar fab cost get split into each chip?

11:30 What are typical functions of ASICs?

14:30 Why does the development time take so long?

18:15 So most of the libraries you use are your own and you don't use external ones?

19:45 To what extent is this modular?

22:15 What is the timeline of each of the sections of development?

27:45 How does it work managing IP from your company and your University?

30:45 Are there any Open Source initiatives in Europe for ASICs?

33:00 How many people in the world do this kind of work?

35:45 What is a good pathway for those looking to get into this kind of work?

38:45 How early should companies start talking about designs?

40:15 If you 10x the money could you make it go faster?

41:30 If people want to reach out how do they do so?

42:15 Anything else that you wanted to mention?