HITLAB Team •
Octin Health, an emerging medical device startup, has partnered with HITLAB to accelerate the development and clinical validation of its flagship device, Elika. Designed to simplify aortic arch surgeries, Elika aims to make these complex procedures safer, more accessible, and cost-effective. Through this collaboration, Octin will leverage HITLAB’s expertise to validate Elika’s economic model, generate clinical evidence, and refine usability, ensuring the device is safe, affordable, and user-friendly.
Aortic Surgeries: Advances and Gaps
Each year in the U.S., approximately 1.7 per 100,000 people¹ are diagnosed with acute Type A aortic dissections, while thoracic aortic aneurysms occur at a rate of 5 to 10 per 100,000². Many of these patients require open-heart surgery involving deep hypothermic circulatory arrest (DHCA), a method that cools the body to about 18°C and stops blood flow for 20 to 90 minutes. While DHCA helps protect organs during surgery, it carries risks such as stroke, kidney failure, and longer recovery times.
High-volume medical centers⁴ have seen improved outcomes over the years due to experienced teams and advanced infrastructure. However, lower-volume hospitals continue to experience higher complication rates. Additionally, the geographic concentration of these high-volume centers⁴, combined with the high costs of care¹ limits access for rural and underserved populations. These disparities create a significant barrier, particularly for low-income patients who often delay or forgo elective surgeries, leading to worsened conditions and emergency interventions. Octin Health is committed to addressing these inequities by derisking aortic arch surgeries in lower-volume settings, thereby enabling more patients to receive timely, life-saving care.
Elika by Octin Health: Innovation for Safer Surgery
Founded in early 2024, Octin Health is on a mission to make aortic arch surgery safer for patients, easier for surgeons, and more affordable for healthcare systems. Its innovative device, Elika, is a specialized cardiopulmonary bypass cannula designed to maintain continuous blood flow to both the brain and lower body. This allows surgeons to isolate the aortic arch and create a bloodless surgical field, without relying on DHCA.
Elika offers several potential benefits:
- Shorter procedure times
- Reduced complications, including stroke and organ damage
- Faster patient recovery, with shorter ICU and hospital stays
- Lower costs through better resource use and fewer adverse events
The company was founded by Dr. Meghana Helder, a cardiovascular surgeon with over 19 years of clinical experience. Trained at the Mayo Clinic, Dr. Helder has a strong passion for research and innovation. She has authored more than 26 peer-reviewed publications and serves on the editorial board of The Journal of Thoracic and Cardiovascular Surgery and is a feature editor of Seminars in Thoracic and Cardiovascular Surgery.
“The goal is to make elective aortic arch operations safer and more feasible in hospitals with fewer resources. Wider adoption can reduce emergency cases and improve outcomes system-wide,” says Dr. Helder.
Partnering for Impact: Octin Health and HITLAB
Through this collaboration, HITLAB will support Octin Health in several key areas:
- Economic Modeling: Validation of Elika’s potential to reduce costs and increase revenue under existing reimbursement structures
- Evidence Generation: Development of a robust clinical study design to evaluate safety, efficacy, usability, and outcomes
- Product Development: Guidance on usability and design improvements based on clinician feedback
As part of the early validation process, HITLAB conducted qualitative interviews with experienced cardiac surgeons to gather feedback on Elika’s design and clinical potential. Surgeons highlighted Elika’s ability to maintain continuous lower-body perfusion, which could significantly reduce the risk of ischemic injury to organs like the kidneys, liver, and limbs. They also noted the device’s potential to shorten bypass time, reduce complications, and improve operational efficiency through reduced ICU stays and hospitalizations.
While the potential is clear, surgeons emphasized the need for strong clinical evidence to support widespread adoption.
Path Forward: From Prototype to Practice
With a working prototype in place and a global patent application submitted, Elika is now entering its next phase of development. Octin Health is preparing to launch clinical studies in collaboration with leading institutions including Northwestern University, Penn State University, Emory University, Stanford University, and the University of Minnesota, alongside pursuing FDA clearance.
Feedback from HITLAB’s surgeon interviews will be vital in refining the device and ensuring readiness for clinical use. By addressing the core risks of aortic arch surgery and streamlining complex workflows, Elika could help transform the standard of care, making life-saving operations safer, faster, and more accessible to patients everywhere.
About Octin Health
Octin Health, Inc. is a medical device company founded in 2024, focused on improving outcomes in high-risk cardiac surgery. Established by a practicing cardiovascular surgeon, the company is committed to advancing surgical care through innovation and clinical collaboration.
References
- Smedberg, C., Hultgren, R., Olsson, C., & Steuer, J. (2024). Incidence, presentation, and outcome of acute aortic dissection: results from a population-based study. Open Heart, 11(1), e002595.
- Mehrabi Nasab, E., & Athari, S. S. (2022). The prevalence of thoracic aorta aneurysm as an important cardiovascular disease in the general population. Journal of cardiothoracic surgery, 17(1), 51.
- Goldstone, A. B., Chiu, P., Baiocchi, M., Lingala, B., Lee, J., Rigdon, J., … & Woo, Y. J. (2019). Interfacility transfer of Medicare beneficiaries with acute type A aortic dissection and regionalization of care in the United States. Circulation, 140(15), 1239-1250.
- Andersen, N. D., Brennan, J. M., Zhao, Y., Williams, J. B., Williams, M. L., Smith, P. K., … & Hughes, G. C. (2014). Insurance status is associated with acuity of presentation and outcomes for thoracic aortic operations. Circulation: Cardiovascular Quality and Outcomes, 7(3), 398-406.
Share the article:
