A Medical Device Daily
CoAxia (Maple Grove, Minnesota) reported that its SENTIS (Safety and Efficacy of NeuroFlo Treatment for Ischemic Stroke) multicenter pivotal trial for treating ischemic stroke has enrolled its 30th patient and that it has signed a term sheet for an $11 million Series C financing.
The company said that 30 major medical centers are now participating in SENTIS, and enrollment is expected to accelerate through 2007 as additional North American sites join the trial in the coming months.
CoAxia reported that it has reached terms with Canaan Venture Partners, Prism Venture Partners, Affinity Capital Management and Baird Venture Partners for the $11 million round which it will use to fund progress toward the approval of its NeuroFlo cerebral perfusion augmentation therapy for ischemic stroke.
The lead investors, it said, were participants in its $17.6 million Series B financing of September 2004.With this latest round, the company said it has raised more than $33.35 million since 2000.
The Series C round of financing provides CoAxia with the capital necessary to continue to execute the SENTIS pivotal trial as well as initiate the SafeFlo24 study, it said.
Ashfaq Shuaib, MD, director of stroke services at the University of Edmonton (Alberta, Canada) and a principal investigator in the trial, said, “This important trial of a fundamentally new treatment for ischemic stroke is now on its way. Participation by nationally accredited stroke centers, as well as initial enrollment and safety results, confirm both the scientific validity and value of the SENTIS trial. The CoAxia NeuroFlo technology and its cerebral perfusion augmentation have the potential to become a new and simple-to-implement therapy, and we hope that it will prove to provide benefit to many thousands of stroke patients who present beyond the time windows of alternative treatments.”
SENTIS is a randomized evaluation of NeuroFlo treatment as compared to standard guidelines from the American Heart Association (Dallas) regarding the management of stroke. Patients are treated with NeuroFlo up to 10 hours after stroke onset and are evaluated neurologically at 90 days. The treatment is accomplished with CoAxia’s dual-balloon catheter that works by increasing blood flow to the brain via restricting flow in the descending aorta.
Coaxia says that the system for cerebral perfusion augmentation uses the brain’s collateral circulation to treat the stroke periphery (penumbra) and may limit the size and damage of the stroke. If successful, NeuroFlo may become an important treatment option for hundreds of thousands of patients that arrive at hospitals beyond the time limit for delivery of present treatments.
CoAxia reported that it also has submitted a new study to the FDA, SafeFlo24, an initial safety study for treating ischemic stroke patients up to 24 hours after the onset of their symptoms.
CoAxia is a development-stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions.
In addition to the SENTIS trial for ischemic stroke, CoAxia’s NeuroFlo system has been approved by the FDA via a Humanitarian Device Exemption for the treatment of medically refractory ischemic vasospasm following repair of a subarachnoid hemorrhage and has secured the CE Mark for cerebral perfusion augmentation.
In other financing activity:
• CardioDynamics (San Diego), a developer of impedance cardiography (ICG) technology, reported that an individual, high net worth shareholder, Dr. Herbert Wertheim, raised his personal investment in the company to 9%.
In an amended filing, Wertheim disclosed ownership of 4.4 million shares, increased from the prior 3.7 million, or 7.6% stake, disclosed in a past filing.
Wertheim is founder and chairman of Brain Power (BPI; Miami), a manufacturer of ophthalmic instruments and chemicals for eye care professionals and optical laboratories, with research and manufacturing facilities in the U.S. and Europe.
CardioDynamics develops noninvasive diagnostic and monitoring technologies and electrodes.
• Thermo Electron (Waltham, Massachusetts) and Fisher Scientific International (Hampton, New Hampshire) said they have provided conversion-right notices to the holders of Fisher’s 2.50% convertible senior notes, due 2023, Fisher’s floating rate convertible senior debentures, due 2033 and Fisher’s 3.25% convertible senior subordinated notes, due 2024, and together with the 2.50% securities and floating rate securities. Their right to convert such securities is a result of the planned $10.6 billion merger between Thermo and Fisher first disclosed in May (Medical Device Daily, May 9, 2006).
The companies said they expect the merger to be completed in the fourth quarter following regulatory approval.
On Aug. 30, stockholders of both companies voted to approve the merger. The current conversion price of the 2.50% securities is $47.46 per share of Fisher common stock, the current conversion price of the floating rate securities is $59.09 per share of Fisher common stock, and the current conversion price of the 3.25% securities is $80.40 per share of Fisher common stock.
The notice gives holders the option to surrender the securities for conversion beginning Oct. 2 until 15 calendar days after the effective date of the merger. Conversions are effective as of the close of business on the date that the securities are properly surrendered for conversion.
Holders surrendering their securities before the effective date of the merger will be entitled to receive cash representing the principal portion of the securities and cash and/or shares of Fisher common stock representing the in-the-money portion of the securities, if applicable.
Holders surrendering their securities after the effective date of the merger will be entitled to receive cash representing the principal portion of the securities and cash and/or the corresponding number of shares of Thermo common stock representing the in-the-money portion of the securities, if applicable, based on the exchange ratio in the merger of 2 shares of Thermo common stock for each share of Fisher common stock.
Thermo Electron is a developer of analytical instruments. The company’s Life and Laboratory Sciences segment provides analytical instruments, scientific equipment, services and software solutions for life science, drug discovery, clinical, environmental and industrial laboratories. Its Measurement and Control segment is a provider of analytical instruments used in a variety of manufacturing processes and in-the-field applications, including safety and homeland security.
Fisher is a provider of products and services to the scientific community.