The “Shark Tank” Innovation Competition: Potential Disruptors at TCT

The Skirball Center for Innovation (SCI) at the Cardiovascular Research Foundation (CRF) Interventional Innovation Corner is headed by section editor Juan F. Granada, MD, Executive Director and Chief Innovation Officer; Assistant Professor of Medicine, Columbia University College of Physicians and Surgeons, New York City, New York.

In this issue, Juan F. Granada, MD, discusses the cutting-edge Shark Tank Innovation competition, now in its third year at the Transcatheter Cardiovascular Therapeutics (TCT) conference. TCT takes place October 29-November 2, 2016, in Washington, D.C.

Schedule for the Shark Tank Innovation Competition @ TCT

Monday, October 31, 8:00 am - 12:00 pm
Location: Room 202, Level 2
Chairs: Louis A. Cannon, Juan F. Granada, Chaim S. Lotan
Judges: Tony Das, Peter J. Fitzgerald, Frank Litvack, Julio Palmaz, Martin T. Rothman, Tamir Wolf, Paul G. Yock

    Initial presentations from the 7 companies chosen to participate 
    in the competition.

Wednesday, Nov 2, 11:15 am - 11:30 am 
Location: Main Arena IV 
Moderators: Juan F. Granada, Greg L. Kaluza

11:15 am: The TCT 2016 Innovation Award Competition: 
                 Session Highlights and Winners Announcement
11:20 am: Shark Tank Innovation Award Competition Winner (Presentation)
11:25 am: Shark Tank Innovation Award Competition Winner (Presentation)

What is the purpose of TCT’s Shark Tank Innovation competition?

TCT is a premiere event when it comes to innovation. Interventional innovation is the engine for development of our field, and really, for every single field that is trying to implement catheter-based techniques. Several years ago, inspired by the fact that we receive so many applications to present innovation at TCT, we decided to separate innovation from mainstream education and hold dedicated sessions in order to display the best innovative concepts in interventional cardiology today. We present the best device concepts and technological developments in dedicated sessions, but we separated these further, into separate sessions that we call “The Shark Tank Innovation Competition”, with the whole idea being to select and highlight the most innovative companies in the present moment. While funding and money is an important thing for these companies, perhaps the most important thing they can get from a meeting like TCT is endorsement from their peers. It is an endorsement from the highly knowledgeable and experienced competition judges who say yes, we believe this is a concept with a lot of viability, from the idea itself, to the technological platform, all the way out to commercialization plans. The Skirball Center for Innovation at the Cardiovascular Research Foundation (CRF) started this competition with the idea of selecting the best innovative concepts and presenting them to interventional cardiology, because we are aware that these are technologies that will be fully clinically adopted in the future. 

Is the focus only on catheter-based intervention?

No, we opened the competition to anything that has to do with our field. For example, we accept diagnostic tools, screening methods, and implantable and non-implantable cardiovascular technologies. We accept monitoring solutions and we are open and eager to accept even more digital healthcare solutions. The number of submissions continues to increase every year. The competition is open to any cardiovascular technologies that promise to disrupt the endovascular therapy field. The competition is wide open.

Who will be presenting in this year’s competition?

Seven companies will be presenting. In no particular order: 

• SoundBite Medical Solutions is a chronic total occlusion (CTO) company. Their device uses ultrasound pulses to soften the cap and cross the CTO. 
• Pedra is developing non-invasive assessment of limb reperfusion for critical limb ischemia (CLI). Their device uses infrared technology to detect disease, guide the outcomes of a procedure during an intervention, and also has the potential to detect failures. It is a handheld technology that can be used in the office or the cath lab. 
• Fulgur Medical is seeking to treat atrial fibrillation with an implantable device. A stent is placed in a patient’s pulmonary veins, and an external source heats up the stent, producing the ablation via stent implantation. Fulgur brings the atrial fibrillation ablation procedure into the cath lab via the implantation of a stent in the pulmonary veins. That is quite exciting. 
• Transverse Medical has developed an embolic protection device for transcatheter aortic valve replacement (TAVR). There is a lot of enthusiasm for brain protection during TAVR, but many questions remain and randomized studies are still under development. Microinfarcts do occur during TAVR, but are these microinfarcts important? Does the cost justify the benefit? It is similar to protection for carotid stenting, where we know there is a role, but for TAVR, it is not so well defined that people will agree to a universal use of filters. I think it is still an extremely important field with potential for innovation. 
• ThermopeutiX, Inc. is a company offering TwinFlo, an endovascular brain cooling technology. Stroke intervention is a big target and the field is growing dramatically. It remains an underserved field in which the protocols and standardization of therapy are not very clear, and is a hot field in innovation. 
• BackBeat Medical has a novel pacemaker algorithm for the treatment of hypertension. The idea behind this technology is to treat hypertension with the use of a pacemaker algorithm. The algorithm of the pacemaker is modified to adjust heart performance and thus treat hypertension. It is interesting as a non-interventional approach to hypertension for people who already have pacemakers or who are undergoing pacemaker implantation. 
• MedShr is a company presenting a virtual physician connectivity platform. The entire healthcare field continues to have discussions about the importance of digital healthcare. I think it is important to bring digital technologies to TCT, because the more you learn and understand about the potential for virtual connectivity, the better we are going to be. 

I am looking forward to seeing what all seven companies have to say.

How does the competition work?

A highly qualified group of judges discusses the potential of each technology. We have a very select group of people who are not only physicians, but are physician innovators, physician investors, or physicians involved in building companies and developing innovative concepts. This is important, because physicians’ perception of value may be different than people who are very involved with the regulatory process, the investment process, and so on. The judges evaluate, in a very comprehensive fashion, the submissions that have been accepted into the competition. They must do their homework. They need to review the presentations, they have to understand the technologies, and they must have an idea about what a company is going to present and already have questions prepared according to what they feel is important. Each company is then given the opportunity to present, with no interruptions. This year, an expert will provide a 5-minute overview after the presentation, discussing the importance of the technology in its particular field. For example, if a chronic total occlusion (CTO) technology is being presented, a CTO expert will give a 5-minute overview as to how this company could potentially make an impact on that field. After that editorial perspective discussion is finished, the judges start asking questions of the company. Next, each judge scores the company in an electronic format, and we keep going until all the companies present. The top four companies are selected according to the scores. They return to present again, and have a rebuttal phase to answer more questions from the judges. Finally, we select two finalists to present in the main arena. It is a very comprehensive, hands-on process.

Who are the judges?

This year, we have Louie Cannon, Tony Das, Chaim Lotan, Peter Fitzgerald, Frank Litvack, Julio Palmaz, Martin Rothman, Tamir Wolf, and Paul Yock. We try to select the judges based on the technologies being presented and try also to mix in people with a wide range of expertise. We may change slightly from year to year, but we keep a core of people who are already familiar with the process. 

What are the judges considering as they score each technology?

We have five categories that are scored independently. First is the validity of the idea. Is the idea relevant compared to what is out there? The second category is the intellectual property (IP) landscape. Nobody is going to read 100 patents, but for example, there are fields we know have potential patent landmines, such as stents and percutaneous valves. The judges need to understand where the company is playing and the value of the IP. The third category is what we call biological principle. Each company must identify where they stand in terms of the validation of the technology preclinically or clinically. The fourth category is the regulatory plan and how the complexities of the regulatory process will be handled. The final, fifth category is the technology’s commercialization potential. Based on these five components, every judge scores the company and then each company gets an aggregate score from all five categories. We then winnow it down to two companies, but we don’t actually disclose the winner until both companies present in the main arena, which is quite an honor. We announce the winner after both presentations have taken place. 

The winner comes away with the knowledge that it has been selected as the best technological concept at TCT.

Exactly. We talked to many of our TCT partners about giving a monetary award, but most of the companies presenting at TCT have already been formed, already have a track record, with at least a few years of doing work, and most, if not all, already have funds from venture capital groups, private money, etc. In reality, they don’t really need a small monetary award. Certainly, it is nice, but for these companies, what is actually important is to have our group of judges, academicians, and people knowledgeable about business endorse them as a potential technology for the future. This is what makes the award most exciting and valuable, rather than a small token of appreciation, which, in the whole scheme of things, is not very much compared to the funds they will have to eventually raise in order to properly validate their technology. 

How are the presenting companies selected?

There is a formal submission process through the TCT submission site. The event is publicized through the regular TCT channels and submissions come through a dedicated site. This is our third year, and the number of submissions keeps growing. It is a very competitive environment, because of the number of applications that we get. I know it sounds cliché, but I do think is a big milestone simply to be in the competition, because we only have space for seven companies due to the time restrictions. We want to give enough time to the companies to present their ideas and have a discussion. The acceptance rate, which is between 10-15%, is getting tougher and tougher. 

Can you tell us about previous winners of the competition?

In 2014, the winner was Qool Therapeutics, a company that developed a nebulization system with frozen water in the form of iced microcrystals. Their first application was stroke treatment. High doses of frozen water, as microcrystals, are given to stroke patients through a nebulizer in order to cool down the body. It appears simple and safe, and produces controlled hypothermia. In 2015, we gave the award to two companies in the pulmonary space, who tied. One company is SoniVie, presented by Alexander M.K. Rothman, MD, and the co-winner was Inari Medical, presented by Brian Cox. 

Any final thoughts?

What is refreshing and exciting is that these technologies are not Stent A, Stent B, and Stent C. As a matter of fact, you will note that we don’t have any mainstream therapies in the competition, such as balloons or stents, i.e., things that have already been invented. The technologies in the competition are all potential disruptors that can dramatically change the way we treat patients. 

Schedule for the Shark Tank Innovation Competition @ TCT

Monday, October 31, 8:00 am - 12:00 pm
Location: Room 202, Level 2
Chairs: Louis A. Cannon, Juan F. Granada, Chaim S. Lotan
Judges: Tony Das, Peter J. Fitzgerald, Frank Litvack, Julio Palmaz, Martin T. Rothman, Tamir Wolf, Paul G. Yock

    Initial presentations from the 7 companies chosen to participate 
    in the competition.

Wednesday, Nov 2, 11:15 am - 11:30 am 
Location: Main Arena IV 
Moderators: Juan F. Granada, Greg L. Kaluza

11:15 am: The TCT 2016 Innovation Award Competition: 
                 Session Highlights and Winners Announcement
11:20 am: Shark Tank Innovation Award Competition Winner (Presentation)
11:25 am: Shark Tank Innovation Award Competition Winner (Presentation)