Nia Therapeutics update: June 2021

Nia Therapeutics is developing precision brain stimulation therapies for the treatment of memory loss. Our first product, the Smart Neurostimulation System (SNS), is intended for the treatment of memory loss after traumatic brain injury. TBI-related memory loss currently affects over 1 million Americans and there are exactly zero FDA-cleared treatments available for these patients. Our team is very excited and grateful for the opportunity to develop therapies for this patient population.

The Smart Neurostimulation System (SNS)

The SNS is a cutting-edge neurostimulation platform that provides 64 channels of sensing, advanced AI for therapy personalization, and best-in-class stimulation artifact removal capabilities. We believe that the SNS will unlock rapid therapy development in memory loss and beyond. The system components include: (a) four 16-channel depth electrodes with 64 contacts; (b) a cranial implant for sensing and stimulation; (c) a wearable earpiece providing power and therapy control; (d) a laptop for programming the therapy; and (e) the Nia Cloud, an AI platform that personalizes the therapy for each patient.

The Latest News

We’ve been busy over the past several months demonstrating the effectiveness of our therapy, developing the SNS product, and building the business. Of note, we have:

• Demonstrated proof of concept efficacy in patients with a history of traumatic brain injury
• Completed development of our bench-top prototype and confirmed its cybersecurity architecture with FDA
• Received a $1M subcontract from US Army and expanded our engineering team
• Graduated from the Creative Destruction Lab accelerator and won the INVEST Precision Medicine pitch competition

More detail on each of these items can be found below.

We demonstrated memory enhancement in patients with a history of traumatic brain injury. Our team at U. Penn has published extensive clinical data demonstrating our ability to improve memory in neurosurgical patients. Nia co-founder Mike Kahana has now extended these results to neurosurgical patients with a history of traumatic brain injury. In eight patients with a history of TBI, he used a research prototype to demonstrate that closed-loop neurostimulation of temporal cortex improves verbal memory by 19% (equivalent to an effect size of 0.44). These data replicate and extend our previous findings and provide proof of concept that our therapy is effective in our intended clinical target: patients with TBI. Read the full manuscript here: https://t.co/S0p3OfKT8q

We completed development of our bench-top prototype and confirmed our cybersecurity architecture with the FDA. We have now completed development of the bench-top prototype of our neurostimulation device for the treatment of memory loss. The prototype demonstrates the core system functionality of “closed-loop” neurostimulation, allowing the device to adjust stimulation according to changes in the patient’s ongoing brain activity, as well as the wireless link between the implantable and wearable components. In addition, we recently met with the FDA to review our cybersecurity architecture, which protects the Nia device from hacking — an important aspect of modern medical device development. The meeting resulted in agreement on our proposed architecture, significantly reducing our regulatory risk. This is the third pre-submission meeting that we have held with the Agency. Previous meetings reviewed our clinical trial design and the therapy’s risk-benefit justification.

We received a $1M subcontract from the US Army and expanded our team. This non-dilutive subcontract is supporting the completion of a device prototype in the final implantable form factor (https://t.co/THdMv4sGcZ). The subcontract is part of a larger $3.5M contract to the University of Pennsylvania that is investigating the basic mechanisms behind Nia’s therapy. Nia Therapeutics has now raised $4.4M in private investor capital and $1.2M in non-dilutive funding from the Department of Defense.

As a result of this new funding, Andrew Smiles has joined our team as an Implantable Systems Engineer (https://bit.ly/3zVKk73). Andrew is a systems design engineer with experience creating biological to digital interfaces. He previously developed bidirectional neural interfaces for amputees at the University of Waterloo and at the Centre for Bionics and Pain Research. Nia now has four full time employees, as well as four additional engineers working with our contract engineering partner.

We graduated from the Creative Destruction Lab accelerator and won the INVEST Precision Medicine pitch competition. Late last year Nia was accepted into Creative Destruction Lab (CDL), a startup accelerator based at the University of Toronto. We have now graduated from the program, which was incredibly useful in helping to flesh out our business plan. We were also one of the few startups selected to participate in the CDL Super Session highlighting the best CDL startups around the world. After graduating from the CDL program, Nia was selected as the winner of the MedCity precision medicine pitch competition: https://t.co/YCujYX1xbT

That’s all for now. If you’d like to notified about future updates, send an email to: updates@niatherapeutics.com

Dan Rizzuto, PhD
Chief Executive Officer
Nia Therapeutics