Irvine-based Edwards Lifesciences Corp.’s chief executive said he thinks new product introductions will bring “some significant uptick” in the market for less-invasive heart valves.”
Michael Mussallem shared his thoughts on the subject during an April 24 conference call with analysts and investors on Edwards’ first-quarter financial results. He was responding to a question from Goldman Sachs Group Inc.’s David Roman regarding Edwards’ market potential with current entries like Edwards Sapien.
The question also touched on rival Medtronic Inc., which makes the Medtronic CoreValve. Edwards had recently won a preliminary injunction against Medtronic in a long-running patent battle―but the injunction’s enforcement had just been delayed, and Edwards has told doctors it’s not interested in having CoreValve removed from the market.
“… We think that there is a significant uptick (that) will come from having valves that will treat patients with larger annulus,” Mussallem said, referring to rings surrounding openings in the heart in which the valve is inserted.
He mentioned that Edwards had market growth in Europe, Sapien’s first market, when it introduced a 29-millimeter valve.
Mussallem also said he believes Sapien growth would accelerate once the company introduces smaller valves such as Edwards Sapien XT in the U.S. The chief executive earlier in the call said Edwards expects that the Food and Drug Administration will approve the device this quarter.
“Receiving [this] approval is important, and it will provide greater options for patients who can benefit from the substantial enhancements of this proven platform,” he said.
Mussallem also talked about the European introduction of Sapien 3 that started about two months ago and about how it’s being received by clinicians and hospitals.
“It might take all year for it to happen, but we largely think that when people have an option to go to Sapien 3, they will go there,” he said.
Transcatheter heart valves accounted for $189.2 million in Edwards’ sales in the first quarter, up 11.5% from a year earlier.
Boston Medical Aims to Grow
Costa Mesa-based Boston Medical Group Inc. is looking to major cities with populations of educated, affluent men for growth.
The company treats erectile dysfunction, premature ejaculation, low testosterone and other male sexual health issues. The clinic has 250 offices worldwide, including 22 in the United States.
It’s using a strategy of opening offices for growth rather than adding doctors to existing offices, according to Chris Morrow, Boston Medical’s business development director.
Morrow said Boston Medical has been doing so in markets such as Chicago, Houston and New York, as well as in Southern California. He said it wants its doctors to see eight to 12 patients on average in a workday rather than the 10 to 20 seen in most other practices.
Boston Medical emphasizes privacy in its clinic settings.
“We can bring the office closer to the patient, as well as offer a higher level of service with privacy,” Morrow said. “When you walk into our office, we don’t have a crowded waiting room. Right when you walk in, you’re immediately put into a private waiting area. You’re usually seen [by] the doctor within five minutes.”
Boston Medical estimates that some 20 million men in the U.S. “have no recourse” for erectile dysfunction because Viagra and other prescription pills don’t work for them.
“Generally, our patients that come to us have already tried things like Viagra, Cialis and Levitra,” Morrow said, adding that medications are effective in roughly half of men with erectile dysfunction.
The practice touts nonsurgical approaches to treating erectile dysfunction, as compared to penile implants, which are generally done by urologists.
“Urologists by nature are surgeons; they want to do surgery,” Morrow said.
Dr. Daniel Ha, Boston Medical’s founder and medical director, said one of the more popular treatment options for patients is intracavernous pharmacotherapy, in which vasodilation medications are injected into the penis’ spongy tissue, expanding penile arteries and tissues and resulting in increased blood flow and an erection in minutes.
“It is done quickly, painlessly, with a little device,” Ha said. “It is a painless application of medicine applied directly to the penis.”
Privately held Boston Medical doesn’t disclose revenue figures.
Men’s sexual health generally falls into the “cash-pay” sector of medicine, although insurance sometimes covers diagnoses and treatment.
“Most erectile dysfunction medications aren’t covered. And that’s simply because you don’t have to have an erection to live,” Morrow said.
Bits & Pieces
Children’s Hospital of Orange County said it purchased an automated pharmacy compounding system from Winnipeg, Manitoba-based Intelligent Hospital Systems. The system, known as Riva, prepares medications for syringes and IV bags in an aseptic environment. … Garden Grove-based Saint-Gobain Seals Group said its Rulon 1439 sealing material has achieved full United States Pharmacopeia certification for medical device and pharmaceutical uses.
