Kordata Launches To Power Next-Gen Clinical Trials

Kordata Dynamics has emerged from stealth to pursue a $26 billion opportunity to advance the clinical trials backlog across central nervous system (CNS) therapeutics with a combination of patient-facing neurotechnology and an enterprise B2B playbook.

BIOS Health supplied the core IP and business foundation, and retains majority ownership of the spinout. The two firms also share the same founder, Emil Hewage, who will lead Kordata as CEO alongside president Dawn McCullough, a former Biogen and Novartis executive behind 15,000 clinical trials.

I spoke with Hewage to learn about Kordata’s approach to bringing neural data into life sciences.

• Business Model: Kordata is partnering with large health systems and academic medical centers to enable new trial sites for pharmaceutical or life sciences companies. In addition to volume-based licensing revenue on deploying tools to these hospital and research networks, they will earn fees on new clinical trial sponsorships at partner sites.
• Target Market: With their partners, they will target life sciences firms, Hewage told me, “specifically those that have very precise products, with tight dosing ranges or unique inclusion criteria, who are designing novel trials.” Beyond the initial focus on drug discovery and device optimization in Alzheimer’s, Parkinson’s, and Epilepsy, he spoke to the unmet needs in drug resistant chronic diseases in cardiology, immunology, and beyond.
• Tech Stack as a Service: Hewage describes their health system partners as having “capacity, but not capability to run big trials.” Despite large patient volumes and clinical workforces, standard healthcare systems lack modern neuroimaging, recording, and transmitting capabilities to get novel data to trial sites securely through their electronic medical records, in compliance with institutional review board (IRB) and clinical research organization (CRO) requirements.
• Decoding Neural Data: Kordata is powered by BIOS’ proprietary platform, NeuroTune, which provides real-time dosing based on individuals’ treatment response. “The nervous system is the fastest thing to react in your body to pretty much most medical interventions,” Hewage said. “You’re really at the millisecond level, looking at organ responses and brain responses.” NeuroTune enables plug and play access to novel data sources from implanted systems or wearable tools, so partner sites can characterize patients reactions to medicines.

At a private launch event a few weeks back, Hewage said the room included leaders from the Royal College of Surgeons, NVIDIA, numerous startups and municipal leaders, as well as investors like Kern Venture Group and MAVRK Celestia Fund, who have both backed the new startup.

Being based in Bakersfield, CA positions Kordata in an established network of public payers and clinical sites whose patients work across a swath of industries and socioeconomic tracts, making for an ideal recruitment ground for life sciences partners.

Neurotech’s opportunity to improve drug discovery is well-documented, but historically tempered by the challenge of inertia from legacy systems, tools, and thinking. Kordata’s emergence comes at the dawn of a new era where AI is forcing new approaches into the market.

The signals are growing louder that biotech is neurotech’s biggest market frontier. From the FDA’s new real-time clinical trials initiative, to the emergence of neurotech market leaders in CNS, a growing push to commercialize psychedelics, growing biobucks for brain implants, and full-stack neurotech-healthcare collaboratories, new models of clinical research are open for business.