8-K: Tivic Health Partners with Feinstein Institutes to Advance Non-Invasive Vagus Nerve Stimulation Research

Tivic Health has entered into a collaboration with the Feinstein Institutes for Medical Research to advance its non-invasive cervical vagus nerve stimulation (ncVNS) technology.

Summary

• Tivic Health Systems, Inc. has partnered with The Feinstein Institutes for Medical Research to further develop its non-invasive cervical vagus nerve stimulation (ncVNS) technology.
• The collaboration involves a research program to test the effects of ncVNS on the autonomic nervous system (ANS) in healthy individuals.
• The study will use the NDS Labs multi-modal index to quantify ANS activation during clinically relevant tests.
• The project is expected to last one year, with payments to the Institute tied to specific milestones.
• Tivic Health will be responsible for participant reimbursement and the costs associated with the study, including IRB approval, recruitment, data analysis, and algorithm development.
• The agreement outlines a payment schedule with four milestones totaling $244,856, with payments made upon completion of each milestone.
• The agreement continues until the study is completed or for five years, unless terminated earlier.

Sentiment

Score: 8

Explanation: The document outlines a positive collaboration with a reputable research institute, and the study has the potential to advance the company's technology. The tone is optimistic and forward-looking.

Positives

• The collaboration with the Feinstein Institutes provides access to expertise and resources for advancing Tivic Health's technology.
• The research program aims to optimize ncVNS for specific clinical indications.
• The study will use a multi-modal index to quantify ANS activation, potentially leading to more precise and effective treatments.
• The agreement includes a clear payment schedule tied to specific milestones, ensuring accountability.
• The study builds upon successful Phase 1 results, indicating a strong foundation for further research.

Negatives

• The agreement includes a clause that allows either party to terminate with ten days notice if a protocol cannot be agreed upon.
• The agreement includes a clause that allows either party to terminate with ten days notice if the IRB rejects the protocol.
• The agreement includes a clause that allows either party to terminate with thirty days notice without cause.
• The study is limited to healthy individuals, and further research will be needed to validate the technology in patient populations.

Risks

• The study may not receive IRB approval, which would require the parties to pursue other options or terminate the agreement.
• The study may not yield the desired results, which could impact the development of Tivic Health's ncVNS technology.
• The agreement could be terminated by either party with 30 days notice, potentially disrupting the research program.
• The company is reliant on the successful completion of the study to advance its product development.

Future Outlook

Tivic Health plans to use the results of this study to optimize its ncVNS device therapy for use in specific clinical indications and accelerate product development.

Management Comments

• Blake Gurfein, Ph.D., Chief Scientific Officer of Tivic Health, stated that the next phase of research will build upon previous results to tailor the therapy to specific clinical indications and accelerate product development.
• Management believes the novel ncVNS approach could have clinical utility in several patient populations, including those with epilepsy, post-traumatic stress disorder, and ischemic stroke.

Industry Context

The collaboration aligns with the growing interest in vagus nerve stimulation as a treatment for various conditions, and the company is positioning itself to lead the way in non-invasive VNS devices.

Comparison to Industry Standards

• The document references the neurostimulation market which is projected to grow at a CAGR of 12.2% from 2023 through 2032, according to Global Market Insights.
• The document mentions that VNS is currently indicated for treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation, and it is being studied for other neurological, cardiac, and immune conditions.
• The document notes that many current VNS applications rely on surgical implants, highlighting the potential for Tivic Health's non-invasive approach.
• The document compares the 60% responder rate in their study to similar results seen in implantable devices, suggesting a competitive efficacy for their non-invasive approach.
• The document notes that non-invasive devices have variable results, highlighting the need for optimization, which is the goal of this study.

Stakeholder Impact

• Shareholders may view the collaboration positively, as it represents progress in the development of the company's technology.
• Employees may be motivated by the opportunity to work on a cutting-edge research project.
• Customers may benefit from the development of new and improved treatment options.
• The collaboration may enhance the company's reputation and attract new partners and investors.

Next Steps

• The parties will collaborate on the development and drafting of a research protocol.
• The protocol will be submitted for institutional and IRB approval.
• If approved, the study will be implemented, and data will be collected and analyzed.
• Tivic Health will use the study results to optimize its ncVNS device therapy for specific clinical indications.

Key Dates

Keywords

vagus nerve stimulation, bioelectronic medicine, neuromodulation, autonomic nervous system, clinical research, non-invasive, Tivic Health, Feinstein Institutes