HEARTX Frequently Asked Questions
Q: Can our company apply to the program if we’ve yet to receive FDA clearance for our technology?
A: Yes, you can still apply. Each year our cohorts represent a good mix of companies that have already received FDA clearance or don’t need it, and also companies that are pre-FDA clearance. If your technology needs clearance and has yet to receive it, we would help you move through IRB approval with whatever IRB is used by our participating cardiology practice.
Q: In what stage of development do we need to be in order to qualify for the program?
A: The two general requirements are:
Your company needs to have data of some sort indicating your innovation works. Ideally, that would be in the form of a pilot project or clinical trial conducted at another clinical site. Short of that, the better data you can provide, the stronger your application will be.
Your company needs to have raised at least $500K of external capital.
These two requirements, of course, are intended to mitigate the program’s risk. Our cardiology practices will be investing a significant amount of time with our cohort companies, and we want that time to be invested in companies that are financially stable and have validated technologies.
In terms of stage of development, cohort companies are required to be able to onboard patients into their pilot projects or clinical studies within one year of entering the program. If you won’t be able to meet that timeframe, please wait until next year’s program to apply. Additionally, companies admitted to this year’s cohort will need to be able to attend the program kickoff, to be held as part of the MedAxiom CV Tranforum Conference October 16-19 in Denver, CO.
Q: How many pilot projects or clinical trials will we receive in the HeartX program, and where are the cardiology practices based?
A: Each cohort company invited to participate in the program is guaranteed at least two pilot projects or clinical trials, though companies often receive more than two. The two pilots or clinical studies can be separate, or simply two different sites in a multi-site study. In terms of site locations, the seven largest cardiology practices in Arkansas and additional MedAxiom member practices from around the country partner with us in this program. When an invitation is extended to your company to participate, you’ll be notified of your “sponsoring” cardiology practices so you can factor that into your decision on participation.
Q: Will we need to compensate the hospitals for their work with us?
A: The general essence of the HeartX program is there’s no economic exchange between the cohort company and its sponsoring sites. That is, our cardiology practices don’t have to pay to pilot solutions with companies that are otherwise conducting paid pilots. And conversely, cohort companies aren’t required to compensate our cardiology practices for clinical studies. A few exceptions to this:
Cohort companies are expected to provide any supplies or equipment used in pilot projects and clinical trials, and are also expected to cover any third-party IRB fees, when applicable.
Occasionally our practices will agree to compensate cohort companies to pilot solutions that are already in the market, especially if there’s corresponding reimbursement that can be achieved by the sites. If being compensated for the pilot is important to your participation, please indicate that in your application, as well as whether reimbursement by CMS currently exists for your solution.
Occasionally our practices will require reimbursement from cohort companies for clinical trials, especially if the study requires significant time from a cardiologist or other clinician that would otherwise take that person away from “billable time” in his or her practice.
When an invitation is extended to your company to participate, you’ll know the economic terms of your participation and can thus factor that into your decision on participation.
Q: How do the in-kind and cash investments work in the HeartX program?
A: Each cohort company will receive a $150K cash investment from the HeartX Fund on market rate terms. That means that if your company is in the middle of an open capital round when you enter the program, the HeartX Fund will simply “tag along” as part of that round on the same terms. If you’re between rounds, the $150K cash investment will be through a SAFE or convertible note in which only the cap and discount rate will need to be negotiated.
In addition to the $150K investment position you’ll offer in exchange for cash, you’ll issue a total of $100K of in-kind investment positions ($50K to MedAxiom and $50K to HealthTech Arkansas) in exchange for the value of going through the HeartX program. Thus, the total investment in your company will be $250K of equity (or an investment position through a SAFE or convertible note) in exchange for $150K of cash + the value of the program. In terms of what you’ll receive of value in exchange for the $100K of in-kind equity, it can be summarized as:
At least two pilot projects or clinical trials (referenced above) that are mostly “free” to you. HealthTech Arkansas’s clinical trials manager will work with you to help you develop the scope of your study, develop a protocol (when applicable), and engage you with your participating sites to help you facilitate and execute your clinical trials.
The suite of services MedAxiom will provide to each company: the ability to host a webinar for their membership (~ 9,600 cardiologists nationally and 3,000+ C-suite leaders), to exhibit with cohort companies at one of the MedAxiom conferences each year, to “push” content through the MedAxiom newsletter and other channels, access to MedAxiom operational data, and representation on the MedAxiom website.
Q: Can we propose different types of pilot projects or clinical trials in our application?
A: Yes! In your application, please outline whatever types of studies will be impactful for your company and which you anticipate being impactful for our participating cardiology practices. Giving our cardiology practices choices on the types of studies they can conduct is often a bonus. And often, our participating practices will work with cohort companies to creatively design studies incorporating the company’s technology to solve real problems and challenges in the sites’ clinical practices. All parties work together to design and execute mutually beneficial pilot projects and clinical trials.
Q: When can we expect to hear from the HeartX program about the status of our application?
A: The application deadline for this year’s program is April 30th, 2024. Before or shortly after that date, companies will be notified whether they’ve made it to the pre-screening round to be interviewed by program administrators, comprised of members of HTA and MedAxiom. From the pre-screening interviews, approximately 10-12 companies will be advanced to secondary interviews with the selection committee, comprised of representatives from our participating cardiology practices. After these secondary interviews, our participating cardiology practices will have two weeks to deliberate, identify a PI, and select companies they would like to conduct a final interview with. All of these interviews will be 30-60 minutes in length, conducted via Zoom, and will take place between April and August. At the end of this process, five companies will be chosen by our selection committee to receive invitations to participate in the program. The final selections will be made no later than September 3rd.
Q: How long will the application take me to complete, and what should be emphasized in the application?
A: The online application has just 17 questions, and we limit the number of characters in the responses. So overall, it shouldn’t take you more than 20 minutes or so to complete. All of the questions are important, but we’d ask you to especially focus on the question that asks you to outline the types of pilot projects or clinical trials you wish to conduct in the HeartX program. The more detail you can provide in this answer, the better position our participating cardiology practices will be in to assess whether they can provide a value-added experience in the program for your company. The application includes an option to upload any relevant attachments; please upload any files you think would be helpful in explaining your services further, such as a slide deck, videos, pictures, etc.
Q: Is the program virtual?
A: Nearly so. You’ll need to attend the program kickoff October 16-19 in Denver, CO at MedAxiom’s Transforum conference. Beyond that, you’ll visit your sites for whatever in-person work needed (clinician training, etc.) to conduct your pilot project or clinical trial, just as you would with any given pilot or clinical study.
Q: If we don’t receive an invitation to participate in this year’s program, can we apply again next year?
A: Definitely! Many of our cohort companies received invitations after applying multiple times to the program. As your company makes progress, your value prop to cardiology practices and thus your application often becomes stronger.
Q: HOW DOES HEALTHTECH ARKANSAS ASSIST US IN FACILITATING OUR PILOT PROJECTS AND CLINICAL TRIALS?
A: Our highly experienced clinical trials manager, Priya Bargoti, works individually with each cohort company to help structure and execute pilot projects and clinical studies with sponsoring hospitals, serving as a conduit between our participating sites and their their respective cohort companies. Please watch the video below to learn more about how we help guide your trials within the program.