Faculty Feature: Dr. Bobak Mosadegh

For this newsletter’s Faculty Feature, Francis He and Nick Bartelo had the opportunity to sit down with Dr. Bobak Mosadegh. Dr. Mosadegh received his PhD in 2010 from the University of Michigan in Biomedical Engineering. He completed a postdoc at Harvard where he worked on soft robotics and 3D paper-based cell culture systems in the lab of George Whitesides. Dr. Mosadegh joined Weill Cornell as an Assistant Professor in 2014, where his lab’s focus is on the development of next-generation medical devices for surgical and minimally invasive procedures. He now holds the title of Director of the Dalio Institute of Cardiovascular Imaging, which leverages enabling platform technologies such as AI, XR, and robotics to enhance cardiac diagnosis and treatment. Since joining Weill Cornell, he has co-founded three companies: smartHer, Conform Medical, and Ohms. The interview below focuses on smartHer, a company focused on helping women better understand their treatment options and receive the best outcomes for uterine fibroids through the development of AI-enabled end-to-end software.

SVG: SmartHER is attempting to enhance the current standard of care for imaging uterine fibroids, which uses ultrasound, by instead using MRI. Can you please describe your experiences that allowed you to realize the problem with standard care that led to the founding of SmartHER and your journey as an entrepreneur thus far?

Dr. Mosadegh: A lot of this started because of co-founder Tamatha Fenster, the co-director of the fibroid center here at Weill Cornell Medicine. She was looking for ways to better visualize and identify fibroids based on available imaging and other modality. I serve as the Director of the Dalio Institute of Cardiovascular Imaging, where we already have workflows to process preoperative CTs and MRIs using AI and XR technologies in order to provide better visualization. We also wanted to see if we can utilize our technology in gynecology.

The current problem is the radiologist that look at those MRI images will generate a text-based report that gets sent to a gynecologist who will review the report and describe to the patient using figures that might not fully recapitulate the actual tumor. We are trying to make an end-to-end software that we can upload these MRI images and generate 3D renderings that are much more intuitive. Surgeons can also use this software to better guide their procedure, as tumor resections during laparoscopic surgeries or robotic surgeries do not give the same haptic feedback to the surgeons.

SVG: Can you tell us when the moment was that you realized the project could be a startup and discuss your experience of working with the tech transfer office?

Dr. Mosadegh: I would give a lot of credit to the Bioventure eLab and the tech transfer office as they really encouraged us to spin this out. The Bioventure eLab is a hub for technologies and faculty, and they directly connected Dr. Fenster and me. We were lucky to get a prize in the Bioventure eLab 100K Business Plan pitch competition and that provided us the capital to spinout a company. Currently we are working towards getting external funding either through VCs and/or STTR funding. We’ve had a lot of internal support from the departments who helped us to complete a pilot study in which we demonstrated the value of enhaced image visualization by creating 3D renderings for use during the surgery. What the study found was that we had significantly less repeat procedures occur compared to surgeries without the smartHER enhanced renderings. A big benefit of our approach, is that we are not changing anything about the standard of care, as these surgeries can be done exactly how they are done and the provided rendering is optional for clinicians to look at. This makes the whole process of IRB approval and eventually regulatory approval to be much simpler and really allows for easier adoption by clinicians and hospital systems.

SVG: SmartHER won second place at the Bioventure eLab 100K Business pitch challenge in 2021 and also the 1st prize at the M2D2 $200k pitch competition. How have these competitions helped to develop SmartHER with the prize money and also the recognition received from winning?

Dr. Mosadegh: Money was quite critical for us to really get to our minimum viable product which allowed us to conduct the clinical study. Unlike ordinary academic funding, that money could be used to outsource software development that is typically very difficult or expensive to do within an academic institution.

More importantly was the connections we made with potential partners. Coming from well known academic institution, academic spinouts have a lot of credibility, but winning these awards gave us significant visibility that accelerated these partnerships and gave valuable feedback on commercialization strategies. In addition, we received customer discovery feedback on how we should best utilize our technology and the minimum viable product to be considered for an acquisition

SVG: If you center your company’s software around AI will that complicate the FDA approval process as well as future clinical trials?

Dr. Mosadegh: Our first pilot clinical trial was IRB approved but didn’t need FDA approval since it doesn’t post any significant risk. This study was to validate our hypothesis that the tool we are developing has value and to determine what that value is exactly. Our primary indicators for the outcomes were that we were going to make the procedure shorter and we would have less blood loss, which actually was not the case. We found the real benefit of this was that we were able to reduce the repeat surgeries. It is a necessity to conduct these pilot studies to explore and understand where your technology can be used.

Our product is likely to be a 510(K) medical device, given the current predicates available, and since we are not changing anything about the standard of care we hope to not be a de novo or need a premarket approval (PMA) device. If we’re a 510(k), FDA clearance won’t require another clinical trial. However, we likely will continue to do studies to prove the efficacy because we performed only one pilot study with 20 patients. The next step would be a much larger scale clinical trial at different sites to show that our product is efficacious.

SVG: The SmartHER website states that the SmartHER MRI uses mixed reality and deep learning to perform tasks. How has the use of AI in your company evolved since the conception of SmartHER? Has the sentiment about AI from investors changed throughout the company’s history?

Dr. Mosadegh: The sentiment behind AI has not changed because AI is still hot and people really want to know how you will best utilize it. For our case, AI is essential. Previously, we conducted our clinical trial without AI by manually using other software. This was necessary to get preliminary evidence that our product is necessary to fill an unmet need.

Now we want to get external funding to use AI to automate these processes because it currently takes too long to process the patient images manually. This will be our commercial software. AI also allows us to parallelize different products within the same technology. Other comorbidities and diseases may be identified with the same software, but now the AI is trained only to identify fibroids so we are not at all replacing radiologists. However, the more data collected, the more helpful our tool can be to highlight issues for the gynecologists and radiologist and provide better outcomes.

SVG: What would be your advice for graduate students and post-docs who want to start a company?

Dr. Mosadegh: Make sure that you’re prepared for the sacrifices necessary but also that you will enjoy the process of creating a company. It is always going to be very challenging, so you have to be passionate about the problem you’re setting out to solve. Often believing in your product/solution is not sufficient, since that idea will likely fail or no longer be relevant, so you will eventually need to pivot and evolve your solutions. If you’re committed to solving the problem and your passion won’t let go that a solution must exists in the world, then you will make it a success one way or another. I think being academics, we train ourselves to go through failure after failure in experimentation until we figure out a successful result. So having that grit and endurance will serve very well in a entrepreneurial path.