Asthmatx (Mountain View, California), a company developing a catheter-based procedure for the treatment of asthma, said it has received a $50 million equity investment from Olympus Medical Systems (Center Valley, Pennsylvania). Olympus invested $50 million in Series D preferred stock in exchange for a 15% stake in Asthmatx.

The company said this capital infusion is expected to fund Asthmatx through FDA approval and market launch of the Alair Bronchial Thermoplasty System, a non-drug treatment for asthma.

Olympus will join other Asthmatx financial investors from its prior financing rounds, including: Boston Scientific, Polaris Venture Partners, Menlo Ventures, MedVenture Associates, HBM BioCapital, Montreux Equity Partners, and Vanguard Ventures.

Olympus Medical Systems calls itself a "global leader" in endoscopic visualization, and the diagnosis and treatment of disease.

Glen French, CEO of Asthmatx, told Medical Device Daily that because Olympus has "tremendous expertise" in developing bronchoscopes — which is how the Alair System is delivered — the $50 million investment from Olympus is a "solid validation" of Asthmatx' technology.

Asthmatx has developed the Alair System to perform an investigational outpatient procedure called bronchial thermoplasty.

During bronchial thermoplasty, a small, flexible, tube is advanced into the airway through a standard, flexible, bronchoscope placed through the patient's mouth or nose — no incision is required. The Alair device has an expandable, wire basket at the tip and when it is expanded the four arms of the basket come in contact with and fit snugly against the airway wall. The expanded basket will then deliver controlled radiofrequency energy for about 10 seconds to heat the airway smooth muscle.

French said that about one-third of the targeted lung areas are treated during a single session and a total of three procedures are currently needed. Once the treatment session is complete the device and the bronchial tube are removed. The controlled heat delivered during bronchial thermoplasty is designed to reduce the amount of airway smooth muscle in hopes of reducing the airways ability to constrict. Less constriction may result in reducing the severity and frequency of asthma symptoms.

French told MDD that the procedure takes 20 minutes to 30 minutes while the patient is under conscious sedation.

"Our targeted patients are those patients who are taking the highest doses of medications and are still having asthmatic symptoms," French said.

The company has just finished enrolling patients in its fourth clinical study and French said that more than 700 procedures have been done with the device in clinical studies in hundreds of patients.

Now that the company has completed enrollment in its pivotal study, French said Asthmatx expects to submit a pre-market approval (PMA) application to the FDA by the 4Q07 or 1Q08.

French said results from the company's second study were published in the March 29 issue of the New England Journal of Medicine, which he says is "as good as it gets."

"So to be recognized with our feasibility study in the NEJM was very gratifying to us," French said.

Results reported in the NEJM included significant improvements, such as 50% reduction in asthma attacks and 45% reduction in rescue medication use for patients who've received the minimally invasive bronchoscopic procedure, French said. For example, he said patients in the study who did not receive the procedure had 20 inhaler puffs a week compared to those patients who did receive the procedure and only had 11 puffs a week.

French said the study also tracked patients' symptom-free days and those patients who were not treated with the device reported three months of symptom-free days in a year while patients who were treated with the device reported eight months of symptom-free days in a year.

Asthmatx said its Alair System was recently awarded "Best of 2006" by Popular Science Magazine, and Bronchial Thermoplasty ranked No. 5 on the "Top Ten Medical Innovations for 2007" by the Cleveland Clinic Foundation (Cleveland) (Medical Device Daily, Nov. 10, 2006).

The company has received the CE mark for the Alair System.

In other financing news:

• Genomic Health (Redwood City, California) said it plans to sell, subject to market and other conditions, 3 million shares of its common stock in an underwritten public offering. The company intends to grant the underwriters an option, for a period of 30 days, to buy up to 450,000 additional shares of common stock to cover any overallotments.

J.P. Morgan Securities is the sole book-running manager of the offering; Lehman Brothers is acting as co-lead manager. Piper Jaffray & Co. and JMP Securities are acting as co-managers.

Genomic Health, a company focused on the development of genomic-based clinical diagnostic tests for cancer, said it plans to use the net proceeds of this offering for general corporate purposes.

• Apnex Medical (Minneapolis) said it has completed a $16.1 million private equity financing to complete development and initiate clinical studies of its active implantable technology designed to treat obstructive sleep apnea.

Participants in the financing include Domain Associates, New Enterprise Associates (NEA), Polaris Venture Partners and Michael Berman.

• HepaLife Technologies (Boston), developing what it calls a first-of-its-kind artificial liver device, reported the completion of a private placement of $2.5 million of the company's convertible note to a single institutional investor. The company said it also issued to the investor 670,000-share purchase warrants exercisable at $1.50 for a period of five years.

The net proceeds of $2,125,000 from this private placement will be used for working capital and development of the company's bioreactor system, the main mechanical component of its bioartificial liver device.

• Tyco International (Pembroke, Bermuda) reported that, in connection with the tender offers of Tyco International Group S.A. for its outstanding non-convertible, dollar-denominated public debt, it is extending the deadline for holders to tender the notes to be eligible to receive the total consideration to 5 p.m., EST, Thursday.