Shockwave Medical plans for growth with 2-3 product launches each year
10 Jan 2024
AcquisitionDrug Approval
The company, which develops intravascular lithotripsy (IVL) technology, first made waves last year with its acquisition of Neovasc. Neovasc develops the Reducer system for addressing refractory angina.
Shockwave remained in the middle of M&A talk, but on the other side of it as the year wore on. First, rumors swirled of Boston Scientific’s interest in acquiring the company. Weeks later, reports of interest from Johnson & Johnson and Medtronic came out as well.
While no deals came to fruition, the heightened interest in the company’s IVL technology remains. Shockwave carried on by raising $650 million in a private offering, then launching the Shockwave C2+ coronary IVL catheter following the receipt of FDA approval.
In a presentation at the J.P. Morgan Healthcare Conference today, Shockwave President and CEO Doug Godshall explained where the company’s priorities lie as it looks to continue its growth into 2024 and beyond.
“At Shockwave, we are on a mission to establish ourselves as the premier medtech growth company by transforming treatment of poorly served patient populations with paradigm-changing technologies,” Godshall said. “We have in front of us a $14 billion opportunity. We look to simplify procedures, optimize outcomes and validate our technologies through clinical evidence generation.
“We’re really enthusiastic about the future and love the opportunity in front of us.”
Driving growth through product launches and R&D
Godshall highlighted the company’s plans for growth, which include expanding the pool of treatable patients, improving customer economics and investing in clinical data.
Vitally, the company wants to increase penetration and accelerate growth through new products.
“We had a product launch in 2017, then another one in 2018, then a few years off before we got to see two in the U.S. Now, we’re going to be on a drumbeat of two to three product launches every year for the foreseeable future,” Godshall says. “That’s because we’ve been pouring so much money into our R&D program.”
Shockwave sees a “rich opportunity” in the coronary, peripheral and structural markets. It went from seven development programs and a $50 million R&D budget in 2021 to 27 programs and a $250 million budget last year.
Godshall pointed to excitement over early-stage programs with early-stage incubator activity. He expects it to lead to “very interesting new products.”
Next up, he says, is a catheter-based platform called Javelin.
“We had a balloon-based platform, and that’s what we’re selling today,” Godshall explained. In the not-too-distant future, we’ll have our first catheter-based platform, called Javelin, which sort of shifts the energy to the front of the catheter for really difficult-to-cross lesions, which is a subset of patients we just really can’t treat today.”
Additionally, Shockwave had a high-powered platform for treating the structural heart. It targets aortic first, then potentially mitral later.
Looking toward the end of 2026, the company’s CEO expects eight different purpose-built catheters to treat coronary and peripheral disease. After 2026, it expects to have another catheter for a carotid platform.
“We’re loving the throughput and efficiency of our R&D team and the considerable improvement in uniquely solving the challenges in each of these different disease states,” Godshall said.
Updates on Neovasc development
Shockwave completed its $147 million acquisition of Neovasc in April 2023. With this acquisition, the company brought in the Reducer, which alters blood flow within the myocardium of the heart. It also increases the perfusion of oxygenated blood to ischemic areas of heart muscle. Placement occurs through a minimally invasive, transvenous procedure.
The Reducer has FDA breakthrough device designation and CE Mark. Conducted under FDA investigational device exemption, the ongoing COSIRA-II trial could support future FDA approval.
“Neovasc developed the Reducer and has been plugging along for some time trying to generate enough data to get approval,” Godshall said. “We acquired it last year and are incredibly enthusiastic based on what we’re seeing, both anecdotally from our customers in Europe as well as in the clinical data that has been generated.”
Godshall said that, about 80% of the time, the Reducer meaningfully reduces angina. This enables patients to come off their medication and increase their exercise tolerance and experience an improvement in quality of life.
Shockwave currently has a rigorous, sham-controlled clinical trial ongoing in the U.S. as well. The company set a timeframe for approval around 2027.
Global expansion and reimbursement
Godshall joked that, when he first considered taking the job, people told him to avoid it. He said they claimed Shockwave’s technology would never earn reimbursement.
“I’m glad I ignored people who told me that,” he laughed.
The company received Medicare codes and now has a CPT code that just went into effect for physicians last week. Godshall anticipates full outpatient payment next year, too.
“We’re steadily building a strong economic base,” Godshall said. “We started with clinical validation first, reimbursement later. We didn’t build it on reimbursement, we built it because we solved a problem physicians didn’t have a better solution for.”
On top of reimbursement wins, Godshall noted the company’s global presence as a continuing growth driver. It has a commercial footprint in about 70 countries.
Based in Santa Clara, California, the company is putting the finishing touches on “a substantial new facility” in Costa Rica, too. In the future, Shockwave expects to have Santa Clara as an innovation hub for R&D, with pilots working out the kinks in California. From there, production will move to Costa Rica.
“We’ll continue to kick out new products that will enable us to maintain growth for the end of the decade,” Godshall said. “How are we going to keep growing? We’re going to increase penetration with new products expand the treatable pool of populations, continue to improve customer economics. We will invest in clinical data.”
“I’m thrilled with the quality of the team members we have on board and the caliber of the folks that we have been adding as as time has gone by.”
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