CEO: Daniel Hawkins
Based: Fremont, CA
The scoop: Shockwave Medical is designing a transfemorally delivered balloon catheter that precracks calcium in rigid lesions to make subsequent treatments more effective. Its technology utilizes lithotripsy, or extremely strong but infrequent energy waves traditionally used to break up kidney stones. The company's Lithoplasty balloon catheter is CE-marked to treat peripheral artery disease by delivering lithotripsy and then angioplasty (hence the name). Commercialization is slated for next year.
CEO Daniel Hawkins said in an interview that he's aiming to develop the technology for use in the coronary artery and aortic valve as well. Calcification affects half of all PAD patients, 30% of coronary artery disease patients, and 100% of those with aortic stenosis.
Hawkins said the addressable market opportunity is $3 billion per year, split fairly evenly between the peripheral, coronary artery and aortic valve arenas.
What makes Shockwave Fierce: Shockwave has ambitions to reduce the use of leg stents in PAD patients, improve stent and TAVR implantation and treat the roughly 3% of patients with biscupid valves who account for about 20% of all heart failure cases.
|A rendering of the Lithoplasty balloon catheter, screenshot--Courtesy of Shockwave Medical|
A $40 million VC round in May suggests the technology is promising and means the company has the money to achieve its goals. It was co-led by returning investor Sofinnova Partners and new investor Venrock. Other investment companies and two large strategic investors participated as well.
"When there's calcium in there, no existing device works particularly well in terms of enabling vessel expansion while minimizing vascular injury," Hawkins said, referring to the rigid vascular and valvular lesions that he's seeking to treat.
Peripheral stents are usually necessary following angioplasty because high-pressure balloons cause injuries to the inner lining of the vessel wall known as flow limiting dissections, or a "flap of vessel wall tissue that breaks away and sits in the flow of blood."
In a previous interview, he explained that delivering lithotripsy is akin to rolling a boiled egg on a table to make it softer and more compliant. Precracking the calcium with the energy waves enables the device's angioplasty balloon to more evenly push on the vessel wall because the firmness of the target is more uniform. As a result, the Lithoplasty does not produce flow-limiting dissections, Hawkins said.
The main effect of adoption of the Lithoplasty to treat PAD would be a reduction in the use of peripheral stents in the leg. "Unlike with coronary vessels, clinically one would ideally prefer not to have a stent in the legs. The peripheral vessels are a comparatively hostile environment for stents due to the tendency of vessels to elongate, contract and twist. Those motions tend to place severe mechanical stresses on stents that can lead to fracture and associated tissue damage," Hawkins said, adding that cutting use of leg stents would save the healthcare system money. They cost about $1,400.
Moreover, the CEO stressed that in certain lesions the Lithoplasty may be useful when used in conjunction with the new round of drug-coated angioplasty balloons for PAD, such as those launched by Medtronic ($MDT) and C.R. Bard ($BCR), saying clinicians using the devices will want to precrack the calcium so that the drug is absorbed appropriately. He compared the calcium to an impenetrable sidewalk lining the vessel that prevents drugs from reaching deep into the vessel walls, saying drug-coated balloons have limited effectiveness in calcified vessels.
In a 35-patient study for European CE-mark approval, the trial easily met its goal of less than 50% average residual stenosis. The average residual stenosis was 23%, meaning that on average, the vessel was more than three-fourths open after surgery, Hawkins said during a prior interview. And 87% of the patients achieved the goal using the Lithoplasty alone, while the rest required an additional angioplasty procedure using a different balloon. No major adverse events were reported.
The CEO said he has begun discussions with the FDA on securing its blessings for the commercialization of the Lithoplasty in the U.S. and is confident it will be reviewed via the 510(k) clearance pathway for low-to-intermediate risk devices, as opposed to the arduous PMA pathway for high-risk devices.
What to watch for: The company's aims to develop the Lithoplasty technology for coronary artery disease and aortic valve stenosis are farther afield, but worth watching, for they are in the more lucrative cardiology arena.
Hawkins said that using the Lithoplasty device prior to stenting will improve outcomes because calcification can prevent full stent expansion, which occurs when the device is not fully circular. "This in turn has negative implications for clinical outcomes since suboptimally expanded stents have the highest restenosis rates among patients treated for coronary vascular disease," Hawkins said.
He believes that the Lithoplasty can reduce the need for repeat stenting procedures to fix complications from suboptimally expanded stents, thereby cutting usage of the devices by 25%.
To that end, Shockwave plans to report the results of its first-in-human trial of its Lithoplasty device for the coronary artery at the upcoming Transcatheter Therapies Conference (TCT) in October, and hopes to start a trial for CE-mark approval next year.
In addition, Hawkins sees an opportunity to deploy the device in the aortic valve, saying "We believe that using Lithoplasty balloons designed for the valve we can restore leaflet function without surgery and without an implant in mild to moderate aortic stenosis patients."
The company will be especially focused on the 3% of patients who are "dealt a tough card" in the form of a bicuspid (as opposed to tricuspid) valve. Such patients account for 20% of heart failure cases, cannot be treated with TAVR devices, and typically require reintervention about every 10 years. In addition they typically become symptomatic around age 50--earlier in life than those with normal tricuspid valves.
"We also believe we have the opportunity to restore leaflet function using Lithoplasty balloons designed for the valves of bicuspid aortic stenosis patients. By doing so we have the opportunity to delay surgical intervention substantially in this patient population," Hawkins said.
Shockwave is testing a version of Lithoplasty designed for the aortic valve in human cadaver studies and will give the public a progress report at TCT.
-- Varun Saxena (email | Twitter)
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