What is the genesis of Rhaeos?
The idea behind the FlowSense device came about when Rhaeos Co-founder, Dr. John Rogers, and Northwestern Memorial Hospital neurosurgeon, Matthew Potts, connected to discuss the use of sensors as a better way to monitor treatment flow in Hydrocephalus patients. Dr. Rogers, a world-renowned wearables inventor, and Louis Simpson and Kimberly Querrey Professor of Materials Science and Engineering, Biomedical Engineering and Neurological Surgery at Northwestern, was intrigued by this potential application and looped me in. I worked in medical devices for 16 years, so when I heard about this opportunity, I hit the brakes on everything I was doing, knowing that this technology would become something exceptional. Then upon taking the helm, I recruited teammates from previous start-ups to which we participated. I wanted start-up veterans with battle scars. And it has paid off, as we continually hit our milestones primarily due to the team and its passion for our product.
Tell us about Rhaeos’ technology?
FlowSense is a wireless, non-invasive thermal flow sensor that affixes to a patient’s neck, overlying the shunt used to relieve cerebrospinal fluid (CSF) pressure, where it detects the presence and magnitude of CSF flow. Similar in size to a bandage, it is composed of hardware encased in soft silicone with no hard edges, and data is transmitted wirelessly to a custom-designed mobile app. With FlowSense, monitoring shunt function in outpatient clinics, inpatient settings, emergency departments, and patients’ home. Our company aims to significantly reduce unnecessary imaging, hospital length of stay, and readmission cost.
What has been the biggest hurdle to launching Rhaeos?
It has been getting prospective parties excited about improving Hydrocephalus treatments; it is not a mainstream condition people discuss. Most people do not know what it is. We have had to educate, and there is a lot of learning involved. Once people are aware of the condition and the magnitude of the clinical problems associated with it, then this does lead to interest.
Hydrocephalus is caused by excess cerebrospinal fluid in the brain that can lead to lethargy, seizures, and comas. There is neither a cure nor a way to prevent it from happening. Affecting roughly 1 million Americans, treating and managing the condition costs the healthcare system >$2B a year. As standard-of-care, neurosurgically implanted shunts often fail with life-threatening consequences. Patients with failed shunts show nonspecific symptoms, including headaches, dizziness and nausea. CTs and MRIs are often used for diagnosis but can prove inconclusive, expensive, and lead to unnecessary admissions.
What is Rhaeos’ value proposition?
We have many various value propositions concerning reduced cost and time in treating Hydrocephalus patients. For hospitals, FlowSense aims to reduce inpatient length-of-stay by one to two days, as well as lower readmission rates currently at 16%; when a patient returns shortly after discharge, the hospital is often on the hook for their follow-up treatments and care. Additionally, for many Hydrocephalus patients, side effects of a blocked shunt often mimic common episodes, e.g., a headache, nausea, dizziness, etc. Interpreted as severe, these non-specific events cause a patient to visit the ER 5-10 times a year for unnecessary X-ray imaging and needless radiation exposure. And for many, the X-rays are inconclusive, resulting in follow-on invasive testing where opening up the patient exposes them to additional complications. With FlowSense, the patient can be better monitored bedside or remotely, have peace of mind, and more easily triaged in the ER. For the neurosurgeon, it saves a lot of time, making it easier to provide better care and see more patients.
What are your plans for the use of the grand prize proceeds of US$350,000?
This prize will make a significant impact on our path to market. We do not need $5-10M to receive FDA approval and start selling into hospitals. With the FDA granting us breakthrough status, this money will support our clinical trials in recruiting sites and subjects sooner.
Tell us about your JLABS award.
We are also excited to have received the JLABS award. We need lab space, so this comes in handy and is a timely bonus. We are involved with Texas Medical Center, so maybe that will be an option to use space in JLABS in Houston.
Anna Lisa, what was your experience like with Medtech Innovator?
I have been a fan of Medtech Innovator since I heard about it in 2013. I have been working with start-ups for years. This program and its ecosystem are great. We applied because we wanted the opportunity to learn more about commercialization and be a part of the program. We participated in-person at the Medtech Innovator event hosted by Northwestern in Q1 (before COVID hit). I was born and raised in Chicago, so it was nice to pitch in my hometown and eventually bring home that win. Medtech Innovator provided a lot of access to resources for my company. Getting answers to questions on our commercialization strategy from the Medtech Innovator partners was no problem. We also found resources and help in developing concrete financial plans. It really didn’t matter that it was a virtual program this year. It really is a great ecosystem for learning; everyone wants to help each other out.
What is next up for Rhaeos?
As a start-up CEO, you are always fundraising. I am raising our seed round of $1.5M to get through 2021 and FDA approval. (Interested investors should reach out to Anna Lisa at [email protected]).
More About Medtech Innovator
Applications for MedTech Innovator 2021 are now open, and Ximedica highly recommends that interested parties apply early. In 2021, MedTech Innovator and its partners will give out over $500K in cash prizes and in-kind awards. MedTech Innovator provides unparalleled access to strategics and investors, does not require equity and there is no application fee. To learn more and apply, visit https://medtechinnovator.org/apply. The deadline to apply is January 15, 2021.
More about Anna Lisa Somera, Founder & CEO of Rhaeos, 2020 Grand Prize Winner of Medtech Innovator
Anna Lisa Somera, MS, MBA, MPH is the CEO of Rhaeos and brings over 16 years’ experience working with start-ups in different capacities including biomedical research, venture capital, technology transfer, operations, regulatory affairs, quality management systems, clinical research, grant consulting, and management. Her interest in leading start-ups has stems from OrthoAccel Technologies, a medical device company in the orthodontic space she co-founded in grad school that currently has products sold globally. From there, she worked in early-stage venture capital and served as senior management in several medical device companies.
She has led teams through several clinical trial launches, FDA 510(k) Clearances and CE Marks, ISO 13485 Certified Quality Management Systems, and also brought in over $40M in funding to companies. She has also served as a start-up consultant to Chain Reaction Innovations at Argonne National Labs, The Polsky Exchange at the University of Chicago, MATTER Chicago, INVO at Northwestern University, and the Illinois University Incubator Network. She has also served as senior personnel on several NIH, NSF, and DOD funded small business grants. She is also on the board of Women in Bio, Chicago.
Ms. Somera is currently the Chief Executive Officer of Rhaeos, Inc., a Northwestern University spin-out developing wearable flow monitoring devices. She holds 3 Masters’ Degrees in Cell Biology (Rush University), Business (University of Illinois at Chicago), and Public Health (University of Illinois at Chicago).