When Miracor Medical CEO Olivier Delporte joined the company in 2016, he had one stipulation: they needed to conduct randomized clinical trials to demonstrate the value of its flagship product, the PiCSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, a novel treatment for acute myocardial infarction, more commonly known as a heart attack.
PiCSO is intended for use during percutaneous coronary intervention (PCI), a first-in-line procedure to treat heart attacks as a way to reduce infarct size, which Olivier says should lower mortality rates and lead to fewer hospitalizations due to heart failure.
Under Olivier’s guidance, Miracor is focused on building a strong evidence base for PiCSO and is pursuing an expansive randomized clinical trial program to demonstrate value for doctors, patients, and payers — by showing that PiCSO can reduce heart failure that can often occur after a heart attack.
“The standard of care [for heart attacks] today is still stenting. Stenting has helped these patients, but at the cost of heart failure hospitalization,” Olivier says.
The company is conducting clinical studies in Europe and plans to initiate a randomized controlled trial for FDA clearance in 2023.
In this episode of Medsider, Olivier talks about the importance of gathering robust clinical evidence in randomized clinical trials, how the company uses remote video monitoring to guide procedures, and why startups should raise the bar on their financial goals.
Olivier has more than 20 years of sales, marketing, and general management experience, mostly in the medical device industry. In 2016, he became the CEO of Miracor Medical, a medical device company based in Belgium. Under Olivier’s guidance, the company is advancing its flagship PiCSO treatment for severe myocardial infarction.
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Key Lessons from Olivier’s Experiences
- Keep collecting data even after you get regulatory approval. Generating strong clinical evidence through randomized trials substantiates the value of your technology to patients, doctors, and payers, even after you’ve hit the market.
- Miracor Medical takes advantage of remote monitoring tools to make its clinical trials more efficient and cost-effective. Consider going virtual using high-end surgical monitoring platforms, like Avail and ExplORer Surgical. You can also use more common video conferencing platforms for less complicated procedures.
- Focus on long-term fundraising goals and aim to raise more money than you think you need. You want to be prepared should you encounter development delays or challenges.
Generate Strong Evidence in Randomized Trials
Randomized trials have always been the gold standard, and the need for strong clinical evidence has only increased over the years
Without this type of data, you won’t have adequate evidence for health care providers and you likely won’t get reimbursement, Olivier asserts.
“As a company, you want to know the true efficacy and the true value of your product. In the end, randomized trials … will help you understand,” Olivier says.
Miracor is conducting randomized trials with a focus on patients who experience ST-elevation myocardial infarction (STEMI), a more serious heart attack.
The company launched its first randomized study in Europe in July 2019, and the trial demonstrated positive results. The European Union has already granted marketing authorization to PiCSO, but Miracor isn’t resting on its laurels. The company continues to focus on generating strong clinical evidence in its other European clinical studies, too.
Miracor is currently enrolling patients in its second randomized trial in Europe. The company also is conducting an observational study to gather data from the real world and bolster its evidence base.
Miracor is also pursuing regulatory approval with FDA and plans to launch additional clinical trials in the United States and Canada to support its submission.
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Take Advantage of Remote Monitoring Technologies
Clinical trials are expensive and time-consuming, especially when, like Miracor, you’re collecting data across multiple sites.
To boost efficiency, Miracor is using remote proctoring — where clinical specialists use a laptop to virtually monitor and guide cardiologists through the PiCSO procedure.
Miracor’s clinical specialists have proctored procedures from their cars and even the airport, Olivier says.
Virtual surgical consultation platforms like Avail and ExplORer Surgical provide higher-quality video and communication options than platforms available to the general public. But Miracor also uses FaceTime- and WhatsApp-based video. PiCSO is a fairly simple technology, Olivier says, so the learning curve is smaller.
“I think this is only one of the areas where technology is revolutionizing healthcare and will continue to,” Olivier says.
Up the Ante on Your Fundraising Goals
Olivier says more traditional investors — what he calls the “old-money” shareholders — often will direct companies to be more conservative when raising money. But Olivier believes companies should raise more money than they think they will need.
Building a startup is going to require twice the money and twice more time than you think it will, he says. Companies need to make sure they have a financial cushion, especially in case of major disasters or other unforeseen events, like a global pandemic.
Startups should avoid “managing toward a wall” — that is, when leaders focus on raising money to reach a single milestone in the hopes that hitting it will open up opportunities to raise more money.
Think about the long-term goals when setting fundraising targets, Olivier says. Your plan should be to create value for your company and translate that into financial returns for investors.
“I've become very pragmatic. We need to create value for the company. And in the end, a company needs to be able to be independent in some way,” Olivier says.
Miracor is currently focused on raising money for its clinical trial program. Olivier believes PiCSO is a transformational therapy, and he wants to make sure Miracor demonstrates that to investors and payers through robust clinical evidence.
“The focus is really on clinical studies and getting access to the U.S. market with the right data and with the right reimbursements,” Olivier says.
In the medical device world, data is king. Strong clinical results can help medical device companies better understand the efficacy, safety, and true economic value of their products and ultimately boost their chances of success.
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