Medical Device Daily Associate

A company developing a new approach to the treatment of lesions in bifurcated vessels yesterday reported that it is a step closer to making the product a reality with its reception of an undisclosed seed round of funding.

Stentys (Clichy, France) said that the financing, provided by Sofinnova Partners (Paris), will be used for the development of the company's second-generation dedicated stent for the treatment of blocked coronary artery bifurcations, thus providing patients the opportunity to avoid open-chest surgery.

"Our mission is to make treatment of blocked coronary artery bifurcations as simple and effective as a conventional stenting procedure," Stentys' CEO and co-founder, Gonzague Issenmann told Medical Device Daily in a telephone interview.

The company's device is designed to offer improvements over first generation devices that Issenmann said generally have a side port of the bifurcated stent that must be aligned precisely with the side branch.

The innovative feature of Stentys' bifurcated stent is that the stent-opening for the side branch can be created anywhere in the stent after it is implanted in the vessel. In short, the procedure's success is independent from initial precise stent positioning.

Issenmann said the Stentys procedure is performed "exactly like any cath lab procedure." First the stent is threaded into the body via a catheter through the groin. It is then implanted in the main vessel with an approximate positioning, like a standard stent, and is imaged with standard fluoroscopy X-ray.

The surgeon then simply places the stent in the Y-shaped bifurcation area by inserting a standard balloon through the stent mesh and the balloon inflation disconnects the mesh and creates the opening for the side branch. Thus, Stentys' self-expanding property allows the in situ modeling of the stent to fit the patient's unique arterial anatomy.

"We create a major opening to allow access to the other [vessel] branch. By doing that, not only do we create this access which is very important for other treatments of the side branch but also allows us to create the shape of the bifurcation and it scaffolds the whole area allowing good blood flow for the side branch."

Another advantage of the Stentys device, Issenmann said, is that a surgeon has the option not to implant another stent at the bifurcation if it is not needed, this allows the surgeon to perform a provisional approach, with the option of implanting a standard workhorse stent at the bifurcation if needed at a later date.

Issenmann characterized the market for the device as a $1 billion opportunity. He said that narrowings at a bifurcation site are quite common. Indeed, 18% of percutaneous coronary interventions involve a bifurcation stenosis. Of those, restenosis occurs in 20%-25% of bifurcations treated with drug-eluting stents.

The device was developed along with another colleague by the company's other co-founder, surgeon and inventor, Jaques Séguin, MD. Séguin has already founded another company, Devax (Irvine, California), that is developing first-generation bifurcated stenting technology via a device called the Axxess. He is also a founder of CoreValve (Paris), which is developing a delivery system for percutaneous heart valve replacement called the ReValving system.

Issenmann largely attributes Séguin's involvement in the company to its ability to raise the seed financing. "Definitely his track record helped us tremendously to close the first round," he said.

Stentys is still involved in its animal studies and is shooting for a first-in-man 5- to 10-patient trial by the middle of 2007 in Europe.

"The money from this funding will serve us to complete a first-in-man study." Once that is complete, he said the company will seek to raise additional funds to initiate a major clinical trial for a CE mark, which the company hopes to have by mid-2008. Ultimately, it will follow the basic and more lucrative path of taking the device to the FDA to win U.S. commercialization.

In other financing news:

  • Misonix (Farmingdale, New York), a developer of ultrasonic technology for the treatment of cancer and other chronic conditions, reported that it has entered into a credit security agreement with Wells Fargo Bank, National Association, acting through its Wells Fargo Business Credit operating division, for a revolving note facility up to $8 million.

The revolving note with Wells Fargo Bank will replace the company's existing $2 million revolving credit facility with Bank of America.

Misonix's ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications.

  • Grant Life Sciences (Los Angles) said it has received a cash infusion of $400,000. The company said it intends to use this cash to fill outstanding orders for its products and continue validating its in-licensed diagnostic opportunities.

"Taking in a relatively small amount of money—$400,000—at this time provides us with a short-term connection to what management hopes will be a much larger opportunity," said Hun-Chi Lin, PhD, Grant's president and chief scientist.

Grant Life Sciences is developing diagnostic kits for the screening, monitoring, and diagnosis of diseases with emphasis on women's health, infectious diseases, and cancers.

As required by American Stock Exchange rules, Celsion (Columbia, Maryland) reported the grant of a stock options to Michael Tardugno, who began this week as Celsion's president/CEO. As previously disclosed, the board of Celsion approved the option grant to Tardugno effective Jan. 3 to purchase 430,000 shares of common stock at a per-share price equal to the closing price of the common stock on The American Stock Exchange on Jan. 3. The closing price on such date was $2.42.

The stock option granted to Tardugno vests in four equal annual installments commencing on the first anniversary of the grant date and subject to forfeiture in the event of resignation or termination for cause prior to vesting.

The grant was made outside of any company equity incentive plan or shares reserved for issuance under any such equity incentive plan and in connection with Tardugno's previously disclosed appointment as, and as an inducement for him to serve as president/CEO and board member.

Celsion's Prolieve Thermodilatation system, a minimally invasive transurethral microwave system, combines a transurethral microwave thermotherapy device with pressure applied by a balloon catheter. Prolieve is marketed in the U.S. through an agreement with Boston Scientific (Natick, Massachusetts).