A Medical Device Daily

AtriCure (West Chester, Ohio) has filed a statement with the Securities and Exchange Commission (SEC) proposing an initial public off-ering (IPO) of its common stock to raise a maximum of $57.5 million. It did not report the number of shares to be offered or the pricing.

AtriCure has developed what it terms a “bipolar ablation” system designed to create precise lesions in soft tissues. Though the company has not yet won FDA approval for use of the system to treat atrial fibrillation (AF), it says in its SEC filing that physicians have used it for this application, off-label, in an estimated 15,000 procedures. It reports its use in “22 of the 25 highest-volume heart centers” in the U.S.

The company is currently pursuing FDA clearance “for the ablation . . . of cardiac tissue and approval for the treatment of AF.” But it notes that without such approval it cannot market this application or train physicians in this use.

AtriCure said it would use up to $6 million of IPO proceeds to purchase the manufacturer of disposable handpieces, which it terms “an essential part of our bipolar ablation system.” It added: “We may also use a portion of the proceeds to acquire or invest in complementary busines-ses, products or technologies.”

It reports that its clinical studies indicate about 90% of study participants free of AF at six months following use of the technology during open heart surgery “or as a sole-therapy minimally invasive approach.”

It is currently conducting a clinical trial, named RESTORE-SR, to support premarketed approval for treating AF.

AtriCure says that cardiothoracic surgeons prefer the AtriCure bipolar system “because it is automated and simple to operate. Our ablation and sensing unit, or ASU, does not require any settings or adjustments and signals the surgeon when the tissue no longer conducts energy . . . In seconds our system can safely, rapidly and reliably create the transmural lesions required to block the abnormal electrical impulses that cause AF.”

Director Alan Kaganov owns about a third of the company, which was formed in 2000.

The company reports an accumulated deficit, as of Dec. 31, 2004, of $29 million.

UBS Investment Bank and Piper Jaffray & Co. are joint book-running managers of the offering, and Thomas Weisel Partners and A.G. Edwards are co-managers.

Preparing to start Phase III trials in the detection of acute cardiac ischemia, Molecular Insight Pharmaceuticals (Cambridge, Massachusetts) reported raising more than $28 million in a Series C financing round to advance a pipeline of imaging agents and radiotherapeutics.

That figure “exceeded the initial target by about 50%,” said David Barlow, CEO and chairman, due to oversubscription by investors.

To date, Molecular Insight has raised more than $51 million. The company also has been awarded 26 grants totaling about $4 million from the National Institutes of Health (Bethesda, Maryland) over the past five years, Barlow calling that “a very strong endorsement of our underlying technology platforms.”

The recent financing is expected to take the company through Phase III development of its lead compound, BMIPP, a molecular imaging pharmaceutical for detecting cardiac ischemia, based on changes in cardiac cell metabolism. Studies are expected to begin around the end of the year, with a new drug application filing toward the end of 2006 and marketing approval possible in 2007.

Existing diagnostic procedures are based on blood flow imaging agents, meaning that their efficacy is limited to only a few hours after chest pain symptoms have gone away. But, since a healthy heart muscle relies on fat and fatty acids as its primary source of energy, Molecular Insights decided to develop a method of detecting the heart’s use of fatty acids to determine risks for ischemia.

By injecting BMIPP, a fatty acid compound, “doctors can get an image of the heart and see how the heart is using fatty acid,” said John Babich, president and chief scientific officer of Molecular Insights. A reduction in the use of fatty acids indicates cardiac ischemia that will have to be medically or surgically treated.

The big difference between BMIPP and existing diagnostics is the time. BMIPP has a “window of about 30 hours after symptoms have gone away,” Babich added.

Of an estimated 6 million patients every year who enter the emergency room with chest pains, about 3.5 million of those will have to undergo a prolonged period of assessment to determine if they are suffering from a cardiac disease or a less-serious, unrelated problem with a similar symptom, such as indigestion. That assessment can take up to four days and include hospital admission.

BMIPP, if approved, would be marketed by Molecular Insights, Barlow said, since it is a market “we feel we can access with our own sales force.”

In addition to BMIPP, Molecular Insights also has second- and third-generation compounds in preclinical development. BMIPP is sold in Japan as Cardiodine by Nihon-Medi-Physics.

While its lead program makes its way through Phase III development, the company also intends to use funds from this financing to advance its first radiotherapeutic, MIP-120T, for the treatment of neuroendocrine tumors in children and adults. Phase I studies are expected to begin next year.

The company’s targeted radiotherapeutic program is based on the same technology used to create its molecular imaging pharmaceuticals, and there is “a lot of synergy and overlap,” Barlow said. “We saw a significant opportunity to apply this platform technology.”

Like the imaging pharmaceuticals, the targeted radiotherapeutics have a built-in radioactive isotope that selectively binds to a protein on specific disease tissues. But, instead of giving off radioactivity to be visualized in an imaging procedure, the isotope is designed to give off radiation to attack the tumor, thereby delivering “a therapeutic payload to that cancer,” Babich said.

New investors Siemens Venture Capital GmbH, a venture organization for Siemens AG (Erlangen, Germany), along with MedCap Management & Research (San Francisco) and Emigrant Capital (New York), joined existing institutional and individual investors in the recent round. SG Cowen & Co. (New York) served as placement agent.

In connection with the financing, Andrew Jay of Siemens Venture Capital joins Molecular Insight’s board.