Sanford Health vascular surgeon Patrick Kelly, M.D., has invented a unique device to transform treatment of blood clots in the lungs that kill as many as 100,000 Americans each year.
Dr. Kelly licensed his pulmonary embolism (PE) catheter to startup company Liquet Medical Inc. Its leaders are raising capital and plan to commercialize the device and obtain clearance from the U.S. Food and Drug Administration by late 2022 or early 2023.
“This catheter simplifies the approach we already use by using one incision in the groin rather than two and helps open the door for more doctors to use this device,” Dr. Kelly said. “We’ve invented what we think is a better catheter to dissolve the clot.”
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Dr. Kelly’s relationship with John Schindler, Liquet’s chief executive officer, and Derek Hall, chief operating officer, goes back a decade when the two business partners were working with another medical device that Dr. Kelly was using.
“The genesis of this company was a device that John sold, that I did engineering work on and that Dr. Kelly used to save patients’ lives,” Hall said. “So we’ve got this kind of Venn diagram where all three of us overlap with a product that’s been obsolete for 10 years.”
When Schindler formed Liquet in 2020, Dr. Kelly showed him several devices he had invented, including the PE catheter.
“Frankly, the pulmonary embolism catheter struck a chord with me personally because of my mom,” Schindler said.
Juanita Schindler holds her sons John (right), about age 2, and Mark, 4. She died about a year later from a blood clot in the lung, shortly after giving birth to her daughter, Nicole.
Photo courtesy of John Schindler
His mother, Juanita, died of a blood clot just hours after giving birth by caesarian section to his younger sister in 1971.
She was recovering in the intensive care unit and there just wasn’t the same awareness about how to prevent and treat blood clots at the time, he said.
“I’ve got 28-plus years in the vascular disease setting. And I just find it very ironic that 50 years after that event, I have an opportunity to help commercialize a product that can help patients with that problem,” Schindler said. “Had this technology been available in 1971, they could have potentially saved my mother by treating her right in the ICU. These patients can get into trouble quickly and by the time they are transported to an area where they can be treated, it’s too late.”
How it treats blood clots
When a blood clot, or pulmonary embolism, travels to and lodges in the lungs, it restricts blood flow, which decreases oxygen levels in the blood and can impact other organs, especially the heart, Dr. Kelly said. He likens it to a plugged sewer drain that backs up.
“That heart’s going to get tired or strained. That’s what actually really hurts the patient. Yes, it blocks the blood flow to the lungs and their oxygen levels drop. But what’s even more important is that the right side of their heart gives out. It gets tired and fails,” Dr. Kelly said.
Clots vary from the size of a pinky to thumb or in rare cases as big as a hand, which is fatal.
“You die almost instantly because it blocks all blood flow out of the heart,” Dr. Kelly said.
Anyone can suffer from blood clots. But they are most common after surgery, trauma or periods of prolonged immobility, in cancer patients, women who are pregnant, older people and travelers who must sit in airplanes or vehicles for long stretches.
“It’s a chronically occurring disease process. We see this a lot. We just now have figured out the best way to take care of it,” Dr. Kelly said.
The standard treatment has been to treat the person with blood thinners. But that doesn’t always dissolve the clots, so physicians typically insert two catheters through the person’s groin, one into each leg, and into the pulmonary arteries in each lung. Then they dissolve the clots with a drug.
Dr. Kelly’s investigational PE catheter is a two-in-one device that allows the surgeon to insert a single tube and then extend separate catheters into the left and right lungs to deliver the drug. That reduces the risk of bleeding complications associated with a second incision.
“As we get up there and dissolve that clot and open these up, now blood can flow easily. Now the heart can contract and relax between each heartbeat and recover,” he said.
Once the pressure drops to an acceptable level and the heart’s not working so hard, the surgeon removes the catheter, which typically takes four to six hours. Many patients, who are awake during the procedure, go home the same day.
PE catheter advantages
Besides being less invasive, the PE catheter should make it easier for physicians from more specialties to use it because it’s similar to the Swan-Ganz catheter that’s been used for years.
“We think that this type of technology where there’s one single poke hole in the groin, a relatively small hole, will allow us to treat more patients quicker and by more doctors,” Dr. Kelly said. “We think that not just vascular surgeons or cardiologists or interventional radiologists will use this. We also see that this will be used by pulmonologists and intensive care doctors and possibly even emergency room doctors because it’s the type of catheter that they’re already using for certain disease processes, so they’re more comfortable with these kinds of tools.”
Another big advantage is the physician monitors the pulmonary artery pressure in real time, and it will help determine when the clot is dissolved enough so the catheter can be removed.
“We’re getting biofeedback. We’re getting physiologic information on how effective our treatment is. And if our treatment’s not very effective, we can move on to other options,” Dr. Kelly said.
It should also help lower health care costs because it utilizes one device instead of two and should help optimize the amount of drug delivered.
Liquet Medical’s role
Liquet, based in Charlottesville, Virginia, has a regulatory specialist with extensive experience getting catheters to market. The company has contracted with a manufacturer that has 25 years of experience making devices like the PE catheter.
“That brings a lot of confidence and credibility to this whole process,” Schindler said.
And the device is unique.
“It’s got to be a clear differentiating, disrupting technology that nobody else has before they’re even going to take a stab at it,” Schindler said.
A final risk mitigator is their backgrounds, Schindler and Hall said. Combined, they have more than 40 years of experience in successful medical device product launches, training of sales reps, management and business development.
“We understand very keenly the path to get the product into the hospital,” Schindler said.
“As first-time entrepreneurs,” Hall added, “we know sales and marketing in medical devices, and more specifically vascular drug delivery. We know this business very well. Our careers have been building us to this point. What we try to stress most, other than risk mitigation, is that we are the right team to bring this product to market.”
Schindler and Hall hope the partnership with Sanford Health on the PE catheter leads to other ventures.
“We would like this company to be more than just this one product. We see a real partnership with Sanford Health and an opportunity to advance future technologies to the market that would allow us to grow as a company,” Schindler said.
Sanford Health values the ideas and problem-solving ability of its physicians, researchers, clinical workers and support staff. Any employee with an idea for a device, therapy, software, tool or other method that helps patients is encouraged to contact the innovations team.