A Medical Device Daily

Privately held CHF Solutions (Brooklyn Park, Minnesota) has completed a $22.9 million offering of its convertible preferred stock.

The company said it would use the proceeds to complete a clinical trial, called UltrafiltratioN vs. IV Diuretics for Patients HospitaLized for Acute Decompensated Congestive Heart Failure (UNLOAD), and expand the marketing for its Aquadex System.

The largest investors are MPM Capital and SV Life Sciences. Other investors are Investor Growth Capital, Kaiser Permanente Ventures, Brightstone Capital and Mason Wells Biomedical, along with several other existing investors.

SV Life Sciences led the financing round and both SV Life Sciences and Kaiser Permanente Ventures are new investors in CHF Solutions.

Aquapheresis is a form of ultrafiltration that can remove up to four liters (about one gallon) of excess fluid from the body in eight hours. Unlike some drug-based therapies, Aquapheresis removes this fluid with no clinically significant impact on electrolytes, heart rate or blood chemistry.

The company said the procedure, using the company's Aquadex system, is highly automated, easy to use, transportable and can be performed in virtually any clinical setting. Standard catheters inserted into peripheral or central veins connect the patient to the Aquadex System. Recent technological advancements will now allow the therapy to be delivered via standard peripheral IVs, further improving the safety, ease, and convenience of Aquadex therapy.

Aquapheresis with the Aquadex system technology received 510(k) clearance in mid-2002 and is currently being used in 52 hospitals across the nation.

“We are very pleased to have the support of such strong investment firms,“ said John Erb, CHF Solutions CEO. “Their interest in CHF Solutions is a testament to the prospects of the Aquadex System in addressing the profound need for an expedient and cost-effective therapy for fluid-overloaded patients. The UNLOAD clinical trial is a major undertaking, and the data will contribute significantly to our knowledge of the sustained benefits of Aquapheresis therapy. Additional marketing resources will help us bring the Aquadex System to more hospitals and patients who can benefit from this therapy.“

The UNLOAD trial, launched in mid-2004, is comparing the safety and efficacy of treatment with the Aquadex system to conventional pharmaceutical therapy (i.e., intravenous diuretics) in heart failure patients with fluid overload. This study will enroll 200 patients at as many as 30 U.S. clinical sites. Researchers will document outcomes during the patient's hospitalization and three months following discharge to demonstrate acute and sustained clinical benefit.

Tm Bioscience (Toronto), a developer of genetic testing products, has entered into an agreement with a syndicate of underwriters led by Orion Securities and including Dlouhy Merchant Group, under which the underwriters have agreed to buy on a private placement basis 3.5 million common shares from Tm Bioscience and sell to qualified investors at a price of C$2.15 per common share, representing an amount of C$7,525,000.

The net proceeds from the offering will be used for the advancement of the company's pipeline of genetic tests and for general working capital. Closing of the placement is set for Feb. 3, subject to regulatory and stock exchange approvals, completion of standard documentation and other conditions.

Tm Bioscience's pipeline includes tests for genetic disorders, drug metabolism and infectious diseases.

In other financing activity:

Bioenvision (New York) said that it plans to publicly offer 7 million shares of its common stock that were previously registered on the company's shelf registration statement that filed with the Securities and Exchange Commission declared effective on Jan. 5. Bioenvision will grant the underwriters an option to purchase up to an additional 1,050,000 shares of its common stock from the company to cover over-allotments, if any.

Bioenvision proposes to sell the shares through an underwriting syndicate led by JP Morgan Securities and UBS Investment Bank acting as joint book-running managers and co-managed by CIBC World Markets and Friedman, Billings, Ramsey & Co.

Bioenvision develops compounds and technologies for treating cancer.

Invacare (Elyria, Ohio) reported entering into a new $450 million revolving credit facility for a five-year term, replacing its previous $325 million facility and refinancing the bridge loan in place to fund the purchase of WP Domus GmbH in September 2004.

Invacare makes home and long-term care medical products that promote recovery and active lifestyles.

Osteotech terminates Red Cross agreement

Osteotech (Eatontown, New Jersey) said that on Jan. 14 it entered into an agreement with American Red Cross (ARC; Washington) terminating the processing agreement between Osteotech and ARC. Termination of the processing agreement with ARC was necessitated by the previously announced transaction between ARC and the Musculoskeletal Transplant Foundation (MTF) in which MTF will acquire the assets related to ARC's allograft tissue banking operations.

The termination agreement with ARC will become effective with the closing of the transaction between ARC and MTF, expected to occur later in January. Should the ARC/ MTF asset acquisition agreement not close, the processing agreement between ARC and Osteotech would remain in effect.

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