Svelte Medical Systems: Mark Pomeranz, Chief Executive Officer

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With many healthcare facilities cutting budgets and having to make harder choices about new technology, developing innovative products can be a challenge. One company has sought to introduce not only a new product, but also to re-engineer an entire procedure.

Svelte Medical Systems has created a low-profile expandable stent that eliminates about 50 percent of the steps involved in a normal stenting procedure.

“Our company is the first in 15 years to look at how to improve the angioplasty procedure and stent delivery to the patient,” said Chief Executive Officer Mark Pomeranz. “Our product provides benefits to the physician, patient, and payer. We have innovated not only around the product, but also around the entire procedure.”

Improving stent delivery

Svelte Medical Systems has developed an Integrated Stent Delivery System (IDS) that is the lowest-profile balloon-expandable stent in the market. The company’s bare-metal stent, the Svelte Acrobat, has been released in Europe and Brazil. Svelte plans to start clinical trials in the United States this year and is raising funds for a full OUS commercial launch and the U.S. clinical trial.

“We have done a limited launch to put the product in the hands of physicians,” Pomeranz said. “So far we have gotten positive feedback. We have also seen some surprises in the use of the product that reduce procedure time and potentially improve recovery time for patients.”

In a traditional angioplasty, patients have a catheter placed for a diagnostic check, then change out the diagnostic system and put in a new system to allow for the passage of the stent. Pomeranz said physicians using the Svelte Acrobat have put the product through the catheter used for diagnostic check, eliminating the need to change out the access system. And by making everything smaller, the access site for patients is smaller, lowering bleeding complications post-procedure. He also said fewer ancillary products are used along with the Acrobat.

“We have seen a low amount of contrast agent being used, which is a benefit to patients, many of whom have poor renal function,” Pomeranz said.

Svelte has three additional technologies in various stages of development and testing. The IDS technology navigates the arteries like a guidewire and offers time and cost savings to physicians. The Hybrid Acrobat Stent contains variable-width struts to create a flexible design that can be crimped to a low diameter on the IDS. Svelte is also developing a Sirolimus-eluting stent that has non-inflammatory properties, making it less irritating to the vessel lining. The coating is being developed to have the same drug-release kinetics as other products currently on the market and is fully absorbed once drug elution is complete.

“We have initiated a clinical study on the drug-eluting device,” Pomeranz said. “It has an amino-acid coating that will naturally bio-erode in the body in about nine months. Current enrollment is going well, and we anticipate having follow-up data available in the second half of this year.”

A family of entrepreneurs

Robert Fischell, Sc.D., and his sons, David Fischell, Ph.D., and Tim Fischell, M.D., founded Svelte Medical Systems in 2007 with a mission to “improve stent deliverability, reduce procedural time and costs, and improve patient outcomes.”

The family has more than 200 patents related to medical devices and has launched more than a dozen medical companies in the past 20 years. David Fischell is a physicist and stent designer, while Tim Fischell is an interventional cardiologist. Coupled with the family’s vast knowledge of the market, the management team at Svelte has more than 90 combined years of experience in bringing medical devices to market.

The idea for the Svelte technology came while a family member consulted with Johnson & Johnson. In the 1990s, Johnson & Johnson decided to pursue a different technology that mated well with the stent design of a smaller company Johnson & Johnson had acquired. In 2007, the Fischells licensed the IP from Johnson & Johnson and pursued the technology on their own.

Breaking into the market

Svelte has developed an innovative product that changes the angioplasty procedure, but introducing change into a struggling healthcare market creates its own challenges. Pomeranz said fundraising is a major focus of the company and is more arduous now than it has been historically.

“Once the hospital administration understands our story and realizes the product will save them time and money and provide potential safety benefits to their patients, they are open,” he said. “But there is resistance to bringing new products into hospitals because of the economic pressures in the healthcare environment.”

He said Europe is a more challenging market than the United States. Svelte has developed partners in countries throughout Europe. This has been essential to its initial success, because each country has its own filings and approval processes that are nearly impossible to navigate without partners in those countries.

Depending on the country, Pomeranz said Svelte will market either to a distribution partner or by direct sales. He said the initial target is the interventional cardiologist.

“We work with the physician, giving them access to the product,” he said. “Once we have physician backing, we move onto the sales process with the hospital administration.”

Pomeranz envisions Svelte Medical Systems becoming a key player in the angioplasty market with a full range of approved products available inside and outside the United States.

“We provide more innovation than just the incremental improvements here and there,” he said. “We are taking the next step in driving benefits to the physician, patient, and payer.”

-by Patricia Chaney

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