News Feature | December 10, 2015

Edwards Invests In, Gains Option To Buy Mitral Valve Repair Startup

By Jof Enriquez
Follow me on Twitter @jofenriq

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Edwards Lifesciences announced a deal to invest in — and gained the exclusive option to acquire — Baltimore-based mitral valve repair device startup Harpoon Medical for an undisclosed amount.

Harpoon Medical, a spinoff from the University of Maryland School of Medicine, "is pioneering a beating-heart, transcatheter therapy for minimally invasive surgical repair of a degenerative mitral valve," according to a press release from Edwards related to the company's annual investor conference.

The amount of upfront investment by Edwards in Harpoon was not disclosed by either company. Harpoon previously raised $1.4 million in convertible debt in September, part of a $2 million bridge round, and raised $3.2 million in Series A funding last year, reports the Baltimore Business Journal. The early financing rounds were allocated for Harpoon's early feasibility study in Europe of patients with severe mitral valve disease.

The company presented at the 2015 Transcatheter Therapeutics Conference in San Francisco positive results of the ten-patient study, which demonstrated 100 percent procedural success rate, reduction of mitral regurgitation to mild or less in all patients, with 100 percent survival, no stroke, renal failure, conversion to open heart surgery, and no blood transfusion.

After pioneering transcatheter aortic valve replacement (TAVR) therapy with the industry-leading Sapien heart valves, Edwards is trying to replicate that first-mover advantage in the mitral valve arena by buying early-stage developers of mitral valve replacement and mitral valve repair devices, aside from internal R&D.

On the replacement side, Edwards acquired CardiAQ Valve Technologies for $350 million in July. CardiAQ has a transcatheter mitral valve implantation (TMVI) system that uses a transfemoral-transseptal approach. With the option to acquire Harpoon, Edwards now gains a complementary product on the mitral valve repair therapy side.

In the release outlining its growth strategy, Edwards expects to strengthen its foothold in the transcatheter heart valve segment, backed by the market-leading SAPIEN 3 valve. The company anticipates a late 2016 intermediate risk U.S. approval and initiation of a low-risk trial during the year.

The company says Transcatheter Heart Valve Therapy (THVT) sales are projected to increase 10 to 18 percent to $1.2 billion to $1.4 billion in 2016, despite stiffer competition from other device makers eager to cash in on the global TAVR market that is estimated to be worth $5 billion by 2021.

"We expect another year of strong performance for Edwards Lifesciences in 2016 led by growth in SAPIEN 3 valve sales and continued leadership in our core businesses," said Michael A. Mussallem, chairman and CEO, in the statement.  "Despite foreign exchange headwinds, we are projecting solid financial results next year while we continue to invest aggressively to provide breakthrough therapies for patients in need."  

Edwards projects 2016 global sales amounting to between $2.5 billion and $2.75 billion, representing underlying growth of seven to 11 percent. The device maker reiterated its full year 2015 financial guidance.