Zeta Surgical, transforming surgery with mixed reality and collaborative robotics, celebrates U.S. Food and Drug Administration clearance for its revolutionary Zeta Cranial Navigation System, confirmed in early-September, 2023.
A Brinc portfolio company from our Spring 2020 MedTech accelerator program, Zeta Surgical is a digital surgery company focused on advancing the accuracy, safety, and accessibility of image-guided procedures. Zeta, its navigation and robotics platform, leverages cutting-edge computer vision and artificial intelligence to enable real-time image guidance directly at the point of care. This innovation, expertly designed as a portable cart, simplifies and enhances minimally invasive surgeries, including the treatment of neurological emergencies, brain cancer, and neuromotor disorders.
Led by co-founders and Harvard graduates Jose Maria Amich (CEO) and Raahil Sha (CTO), Zeta Surgical has certainly had a momentous year so far. Prior to the news of its FDA approval, its list of significant accolades and achievements in 2023 include:
- First in-human clinical trial success: In mid-2023, Zeta Surgical announced the groundbreaking treatment of its first patient using the Zeta Cranial Navigation System at Singapore’s National Neuroscience Institute.
- Healthcare robotics program participation: In June, the company participated in the 2023 MassRobotics Healthcare Catalyst program, in cooperation with MITRE, to finalize the development of the Zeta Cranial Navigation system and submit its 510(k) FDA application.
- Talent recognition: The company’s two bright, young co-founders were named in the Forbes 30 Under 30 list in the Local Boston category.
- Design honors: In April, the Zeta computer vision-based navigation system, designed by Design+Industry in Australia, won two crowns: NY Product Design Awards and iF Design Award.
We asked the two busy co-founders eight quick questions to update us on their recent successes and future plans:
- Congratulations on your FDA regulatory clearance for the US market. What are Zeta’s immediate plans following this milestone achievement?
Jose Maria Amich & Raahil Sha: We will soon kick-off our initial commercial pilots at three centers of excellence across the US, in Massachusetts, Ohio, and North Carolina. We will also be pursuing regulatory filings in more countries. As we wrap up our ongoing clinical trial in Singapore, we expect to launch additional clinical trials to evaluate new indications, such as transcranial magnetic stimulation to treat depression.
- So, after the US, is Asia your next geographical target?
JMA & RS: Correct, we intend to file for regulatory clearance in Singapore, and are also evaluating filing for regulatory clearance in Japan in the near future.
- Looking back at Zeta’s early days in 2018, and when you were both still Harvard undergraduates, where do you think this spark of ingenuity came from?
JMA & RS: We were both passionate about the intersection of research, medicine and technology. Our company stemmed from work that we were conducting in computer vision, and our interest to transform it into a product that would reach patients.
- What was your biggest takeaway from joining Brinc’s 2020 MedTech accelerator program?
JMA & RS: We worked closely with the Brinc team on selecting our product designer and contract manufacturer. Brinc’s unique experience in hardware and deep tech makes it a tremendously valuable partner for healthcare companies such as ours.
- Speaking of product design, Zeta’s surgical navigation and robotic-tool system has won numerous design awards. Given that research and trials reflect your medical advancements, do your product designs represent your aesthetics or personalities?
JMA & RS: Both of us believe that ease-of-use and simplicity are incredibly important aspects of any product, and in medical devices specifically, usability plays an important role in maximizing the device’s performance and patient outcomes. We wanted to build a product that was also beautiful and fun to work with, which is why usability and design played an important role in our design process.
- What new products are coming up?
JMA & RS: We are building two new products: a surgical robotics system (Nexus) and a focused ultrasound system (ZetaFUS), to mediate non-invasive drug delivery to the brain. We plan to file Nexus’ FDA application next year and have already completed and published the device’s pre-clinical data. ZetaFUS has also undergone bench testing, and we expect to start our first animal studies with it in upcoming months.
- Can you share any latest insights or trends in the medtech industry?
JMA & RS: Minimally invasive/non-invasive surgical approaches are certainly a key theme in medical devices. Also, the use of AI via robotics, computer vision, machine learning, and others are playing an increasingly important role in the way surgeons and physicians treat patients.
- Lastly, what word of advice can you share with other medtech startup founders today?
JMA & RS: Spend as much time as possible validating that surgeons and physicians need the device that you’re building, in terms of improving clinical outcomes and speeding up procedures. Also, work with users from day one while developing a device, and test prototypes with users as much as possible.
Stay updated with Zeta Surgical here.
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