Dr. Jason Spector, chief of the Division of Plastic and Reconstructive Surgery at Weill Cornell Medicine, is a prolific inventor and serial entrepreneur with multiple patents and a global patent portfolio. In this conversation, Dr. Spector shared with Enterprise Innovation and fellow Weill Cornell Medicine clinicians his journey of becoming a serial entrepreneur.
Dr. Spector, you have quite an impressive record as an entrepreneurial clinician. To name a few: you founded Fesarius Therapeutics, a startup focused on developing innovative tissue-engineered products for the regeneration of skin and soft tissue. You were involved with a company Tepha, which was later acquired by BD (Becton, Dickinson and Company). You also started another company with Dr. David Putnam, the associate dean for Innovation and Entrepreneurship at Cornell University. Can we start by talking about Tepha, which has an interesting product?
Tepha is a company that I had worked with in my role as a principal investigator of a translational technology and tissue engineering lab. We have a project in my lab where we were looking to engineer nipples to help women who have lost theirs, primarily from cancer.
Women who have mastectomies these days end up getting a mastectomy that involves the nipple about 70 to 75 percent of the time. In those patients who undergo a reconstruction of the breast, they also need reconstruction of the nipple. It's a relatively straight-forward surgical fix to reconstruct the nipple using the local skin; however, the reconstructed nipple will start to flatten with time because skin, as it heals, naturally contracts. The contracture can range from about 30 percent of the initial projection all the way down to flattening out completely.
We developed this approach in my lab where we 3D printed scaffolds, which are similar to many women’s nipples in terms of shape and dimension, with an inexpensive, readily available, biocompatible material called polylactic acid (PLA) and designed them in a way that would induce tissue to grow into them. The concept worked. The problem was PLA takes years to disappear. Our premise was that we wanted to use a scaffold that would disappear once there was enough tissue in there that could withstand the contracture of the skin. PLA wasn’t the right material.
I knew people at Tepha from previous research projects and presented them with this idea. They liked it because they saw the potential for commercialization. Tepha has the exclusive rights to a biocompatible medical polymer called P4HB or Poly-4-Hydroxybutyrate, which has been widely used in mesh and suture materials. So, we entered into a research agreement with Tepha to build these scaffolds out of P4HB, and we made several different designs to see which would optimize the rate of tissue ingrowth and have the best residual projection.
We have done two consecutive year-long studies with Tepha. Both showed excellent results in terms of maintaining the projection [of the nipple] even as the material degraded and lost strength.
Tepha was acquired by BD about a year and a half ago. Technically, we’re doing sponsored research with BD now. They’re in discussion internally what to do with the technology next and whether to move it forward into the commercial realm. We also have some new ongoing sponsored research projects with them utilizing other new exciting technologies that I hope to be able to share soon. That’s the story with Tepha.
How about your companies Provis and Fesarius Therapeutics? How were they founded?
I also have longstanding collaborations with David Putnam, a brilliant and innovative material scientist at Cornell’s Ithaca campus.
I had what I thought was a good idea for a device but had no idea how to make the material for it. As surgeons, we use instruments called retractors when we operate. We use these devices to push the organs out of the way and prevent them from harm from the needles and sutures when we close the abdominal cavity. Retractors are made of either plastic or metal. Obviously, you have to take those devices out before closure (it is a major incident when they are unintentionally left inside the patient) but what’s problematic is once you take the device out, you still have a few centimeters or inches left to close, and the organs are in your way again. Keep in mind there are almost 4 million abdominal surgeries performed in the US every year, so we are talking about a potentially huge market.
I would always ask David, ‘Can't we make a retractor that is strong enough to resist a puncture by a needle but then you can leave it in and it disappears in a few hours?’ David came up with a formulation for a material in 2016 or 2017, and we did some preclinical experiments with it. Although it worked out great and met all the criteria that I was looking for, it was made from materials that were not FDA authorized and didn't seem to have a commercially viable pathway.
The idea was put on the back burner until his lab was shut down by the COVID-19 pandemic, so he started to experiment in his garage. He called me up and said, ‘I have the formulation.’ David figured out the basis for the same exact device - a strong, flexible, transparent shield, which you can use to protect the organs inside a patient, and it dissolves in four to six hours. Since elective surgery was still shut down because of COVID, I had time to query my surgeon friends and we even sent out a survey. About three quarters of them said they would be interested in the product.
David and I talked to the CEO of a startup mesh company, whom I knew through a friend. He loved the idea, so he joined. That's how the company Provis was spun out of Cornell. We have done lots of preclinical studies. And we have a contract development manufacturing company that is doing the development and manufacturing work. We have submitted a supplemental package to the FDA, which will help determine what regulatory pathway we are on and look to obtain our FDA authorization in late 2024. Beyond being a helpful device for surgeons operating in the abdominal cavity, we believe that this device may even provide some long-term benefit in terms of preventing intra-abdominal adhesions, which are a huge clinical problem after any operation in the abdominal cavity. If this turns out to be the case, then our dissolvable retractor may become a blockbuster device!
Fesarius Therapeutics was founded in 2015. The technology behind the company was also a result of a collaboration with Cornell Engineering, in this case Abraham Stroock. In this instance, we were looking at ways to improve the rate and degree of new blood vessel invasion into collagen hydrogels. We weren’t getting the results we were ‘looking for’ and instead noticed cells tended to invade into imperfections and cracks in the gel and along the interface between the gel and the plastic. We hypothesized that the cells were responding to the interfaces of different densities/stiffnesses and along with Dr. Stroock came up with the design in which collagen microspheres of one density were embedded into the same collagen of a different density, in order to maximize the interfaces of differential stiffness/density within a given volume. We tested those constructs in my lab both in vitro and in vivo and the results were clear that this arrangement turbo charges cell and new blood vessel invasion. We then tested our formulation versus the market leading dermal template that I used frequently on patients—and our device won handily. Then I knew it was time to commercialize this technology. I was fortunate that my brother, who had a significant amount of entrepreneurial experience, co-founded the company and was able to help navigate many of the challenges getting us off the ground.
The company has made tremendous progress in terms of optimizing the formulation, and our first devices will be a truly disruptive technology in terms of reconstructing dermal loss. The current market leading dermal regenerative template requires a two to three-week interval between placement in the wound and a second surgery in which a split thickness skin graft (STSG) is applied for definitive closure. Our device, Dermisphere™, vascularizes so quickly that a STSG may be applied simultaneously, thereby obviating the second surgery and closing the wound a full two to three weeks earlier. Furthermore, this is a platform technology, that can be used in a flowable or even injectable form, which will allow us to capture not only the approximately $1.5 billion market in skin loss but ultimately move into the very lucrative $8-10 billion aesthetic injectable/filler markets. We are optimistic our first devices will receive FDA authorization in the second half of 2024 and are incredibly excited to see our tech used for the benefit of patients.
How did you become partners with Dr. Putnam? How do you build successful relationships with engineers and other experts to help you create products or spin out companies?
I met David through a retreat that happened between the Department of Surgery and Meinig School of Biomedical Engineering. I think it may have been in 2008 or 2009. He's easy to talk to, fun to hang out with, incredibly energetic and has a brilliant scientific and entrepreneurial mind.
This could be good advice for fellow clinicians here at Weill Cornell. As a surgeon who’s interested in device development but clinically busy, I know I need collaborations with smart scientists and engineers to be successful. There's a plethora of brilliant minds at Cornell with cutting-edge technologies. The optimal situation is to have people with completely non-overlapping expertise. You never know what you're going to learn [from the engineers] and how that might be relevant to what you do. I've gone to the biomedical engineering society national meetings. You don't see a lot of clinicians at that meeting, let alone plastic surgeons.
One of the programs that the Meinig School of Biomedical Engineering has is they send their first-year doctorate students to be immersed clinically in whatever specialty they might be interested in. I've been involved with that program from its inception, and it's highly valuable for them and for us because they come down [from Ithaca] with a certain knowledge. They can teach the people in my lab certain techniques that we would not otherwise have been able to obtain.
You need people who are equally committed. I have standing meetings, and I catch up with my collaborators on a regular basis because if you don't do that, your relationship will certainly wither. Then, some other project will come up and something else will get their attention, so it really requires commitment on both sides.
Aside from what you have already said, what does a clinician need to turn an idea into a real product or become an entrepreneur?
What I have learned in my parallel path as a device innovator and developer is they are separate learning processes. It's one thing to come up with an idea, but to go ahead and prototype it can be a challenge. I'm fortunate that I can prototype devices in my lab. A lot of people aren't aware of the next step you need, which is funding. Where do you get the funding? How do you set up a company?
I have been interacting with all the experts here at Weill Cornell and on the Ithaca campus. My brother, who co-founded Fesarius with me, is also a serial entrepreneur. You need the support. Know when to ask for help and be able to find the people who have the expertise you don't have – whether it's fundraising, marketing, or navigating the initial steps of not only filing the IP but starting a company.
What should aspiring clinician-entrepreneurs know before going down that path?
It will take up a lot of time. People always ask me, ‘What's your time commitment clinically versus research?’ I say, ‘I'm 80 percent clinical and about 70 percent research.’ I’m doing a lot of this work at night and on weekends. I still live a fun life. You need to find the time to do it and be committed to doing it. You should also have highly motivated people surrounding you in every aspect.
Networking is key. Reach out and speak to people who have done this before or even involve them. Figure out who could help get things off the ground. They can tell you how to do it and most importantly, how to avoid all the pitfalls that lay ahead. Bounce ideas off to see if your ideas would be interesting to people and if there is a potentially large market. Enterprise Innovation provides a good networking platform, helping connect you with partners and allowing you to do the marketing locally and regionally.
Entrepreneurialism or entrepreneurial spirit is innate, but that doesn't mean you know how to do it. There certainly is a value in understanding the basics: how does intellectual property work; what kind of company you should start, a C Corp or an S Corp; what are some basic structures. There is fundraising and regulatory execution risk, all of which you probably don’t have too much familiarity with, as a basic scientist or clinician, until you get into it. I think that knowledge can be obtained in some formal sense, either online or more locally at Weill Cornell Medicine. All the people I have interacted with have been incredibly supportive and helpful.
Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosures public to ensure transparency. For this information, see profile for Dr. Jason Spector.