Faculty Feature: Dr. JASON SPECTOR

For this newsletter’s Faculty Feature, Francis He and Nick Bartelo had the opportunity to sit down with Dr. Jason Spector. Dr. Spector received his medical degree (AOA) from New York University School of Medicine, trained in general surgery at NYU Medical Center, plastic surgery at NYU’s Institute of Reconstructive Plastic Surgery, and completed a post-doctoral research fellowship and a clinical fellowship in reconstructive microsurgery (IRPS). Dr. Spector joined Weill Cornell as an Assistant Professor of Surgery in 2006, and runs a lab focusing on the development of novel approaches for tissue engineering, wound healing, and precision medicine. Dr. Spector has published more than 170 peer reviewed articles and has 11 patents (or pending) related to his research. Since joining Weill Cornell, he has co-founded two companies: Fesarius Therapeutics and Provis Medical. The interview below focuses on Fesarius Therapeutics, a company focused on developing tissue engineered regenerative medicine products for use in reconstructive and aesthetic surgery. Dr. Spector is implementing a new standard of care for patients in need of reconstructive surgeries.

SVG: Fesarius Therapeutics develops innovative engineered tissue scaffold products for the skin and dermal layers to transform reconstructive and aesthetic surgery. What led you to begin your entrepreneurial journey and what sets your technology apart from the competitors in this space?

Dr. Spector: I was always interested in entrepreneurship and I found my opportunity to solve an important problem working with patients who sustained full thickness skin loss (FTSL) from either surgical excision, trauma, burn and/or infection. When a patient has full thickness skin loss, the standard way to replace it is with a split thickness skin graft, which is composed mostly of the thin outer skin layer called epidermis with a tiny bit of the thick, strong, elastic dermis. The problem is that without the dermal portion, which the body is unable to regenerate on its own, there is inevitably a lot of secondary contracture and hypertrophic scarring can occur.

More than 30 years ago, a product called Integra was developed which was a novel device called a dermal regeneration template that could reconstitute the dermal layer. The major disadvantages were the patient had to return 2-4 weeks later for a second surgery which added a thin epidermal skin graft to the wound and during that time it was very susceptible to microbial contamination and infection.

In my lab, we were researching how to improve the rates of vascularization since that is the key to wound healing. While experimenting with hydrogels, we found that cells could sense the differential densities formed between cracks in the hydrogels, the gel and the plate, and air bubbles formed, causing them to invade much more quickly than we saw with Integra. We hypothesized that if we took collagen microspheres of a certain density and embedded them in the same exact collagen of a different density we could maximize those interfaces of differential density. When we did those experiments we indeed saw much faster and robust invasion than we saw with Integra. At this point, I knew our technology would help patients suffering from FTSL.

SVG: Now that the company has a marketable product, how has the company transitioned from a startup to a biomedical/medical device company and how has your changed over the course of this journey?

Dr. Spector: I have been involved in the whole process in terms of overall strategic mission and the science of it. I am the Chief medical officer, which suits my expertise in the field, but I have understood from the outset that it is very hard to run a business. I understand that I am not an expert of the day to day operation of the company and I am not a CEO nor a COO and am fortunate that Fesarius’ SCO and CEO are quite good at their jobs!

You need people with experience and it can be logistically challenging to find these people. I was fortunate as I had my brother who had a lot of experience to really help getting things off the ground. Maybe I could have done it but I couldn’t have done it while being a full-time surgeon. Also, it is a mistake for most people to think they can be the CEO of a company without any experience, for example with fund raising, as this is a common issue for most startups. You must identify your skill set and use this to your advantage. I am very good at developing technology but I am not so good at running a business—at least not yet.

SVG: It is the 10 year anniversary of the founding of Fesarius Therapeutics. Can you please describe the initial investment process for your company?

Dr. Spector: The initial rounds of funding involve friends and family, and they are investing in you specifically. They do not know or understand the technology. You can make a slide deck and make it as simply explained as possible, but the reality is that they have known you for a while and you seem pretty smart and motivated so they choose to give you money. If you can use that to your advantage, you may be able to come back and get more money. It looks good to have consistent investors.

However, it’s one thing to ask people for a 50K check or a 100K check. When you start to need more money and you’re asking for millions, you may not have that in your friends and family network. You then need to go to other funding sources. For example, we went to institutional investors. We were seeking 6 million and that was to fund us through 18 months of operation to get us through the FDA and on the market. However, as the founder I have to think what’s good for the company and how much equity will be taken. In the end, we took about 9.5 million because we also had outside investors like family offices. Having more runway is good because the terms of raising more money are very disadvantageous for companies low on funds.

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

Dr. Spector: Overall, there is an ecosystem here where you can get some basic understanding of the landscape and have meetings both for just education about the process and about meeting people. Specifically, always get outside your comfort zone. Do things that make you feel a little bit uncomfortable since that is how you grow. Also, your network is everything. To meet with new people, especially those with expertise different from you, is the most important and potentially beneficial thing you can do, not only for this stuff, but generally for life. That is where the best collaborative ideas come from.

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.