A Medical Device Daily

Emphasys Medical (Redwood City, California) reported that it has filed with the Securities and Exchange Commission to raise up to $86.3 million in an initial public offering.

The number of shares to be offered and the price range for the offering have not yet been determined. All of the shares in the proposed offering will be sold by the company, and the company has registered to sell its stock on the NASDAQ Global Market under the symbol EMPH.

Emphasys is focused on developing devices for the treatment of patients with emphysema and other breathing disorders.

The company recently completed a pivotal clinical trial to demonstrate the efficacy and safety of its first product, the Emphasys Bronchial Valve (EBV) in patients with emphysema. Emphasys submitted its application for pre-market approval to the FDA earlier this month. The company said it expects FDA approval for the EBV in late 2008.

The company said that it expects to use about $25 million of the IPO proceeds for sales, marketing and general administrative activities; $20 million for research and product development activities; $15 million for capital equipment and commercial scale-up of our manufacturing facility; and the balance for working capital and other general corporate purposes.

In its SEC filing, the company said it has incurred “substantial net losses” since its inception in 2000. As of June 30, it had accumulated a deficit during development stage of $64.4 million. In the six months ended June 30 the company said it has narrowed its loss to $4.6 million compared to $7.6 million in the same period last year. The company’s revenue jumped in that same period to $570,000 from $61,000.

The underwriters of the offering are Morgan Stanley & Co. as sole book runner, and Thomas Weisel Partners, Leerink Swann, and Canaccord Adams as co-managers.

JenaValve Technology (Munich, Germany), a company developing minimally-invasive heart valve replacement systems, reported securing 110 million ($14.07 million) in its Series A-2 financing, led by Edmond de Rothschild Investment Partners (EdRIP). Existing investor Atlas Venture was also a significant participant in this round, which was complemented by an additional new investor, NeoMed.

The company said it has now secured sufficient funds to complete the clinical phase of its first product, scheduled for mid-2009.

The company is currently developing aortic valve replacement systems for the transfemoral and the transapical approach.

“With our second round of financing, we have raised a total of 113.5 million to support product finalization, patent and marketing activities, pre-clinical and clinical trials and serial production. We expect CE certification by end 2008 or early 2009,” said JenaValve CEO Helmut Straubinger.

As part of the financings, Dr. Olivier Litzka, a partner at EdRIP, will sit on JenaValve’s board. Dr. Carl Christian Gilhuus-Moe, a partner at NeoMed, will join the company’s board as observer.

In other financing news:

• Cepheid (Sunnyvale, California) reported an agreement to license the Human Papillomavirus (HPV) patent portfolio held by Quantovir (Uppsala, Sweden) for the measurement of high-risk HPV types using DNA-based detection.

Quantovir said it believes it is the first to demonstrate that a molecular diagnostic test measuring the quantity, or viral load, of HPV DNA present in cervical specimens can be used to predict a woman’s risk of developing cervical cancer. Cepheid said it plans to use Quantovir’s technology to develop a new type of HPV test for the GeneXpert System.

Deal terms were not disclosed.

“The GeneXpert System is ideal for the rapid diagnosis of infectious organisms like Methicillin-resistant Staphylococcus aureus [MRSA], but it can also be used to generate actionable, treatment-determining results in other medical areas including oncology and pharmaocogenetics,” said John Bishop, CEO of Cepheid. “With the GeneXpert System, molecular diagnostics is no longer reserved solely for the highly complex laboratory setting; it is also enabling the benefits of this technology to be realized in moderately complex settings.”

Given the correlation of the presence of HPV with cervical cancer, HPV DNA testing has become a diagnostic determinant of cancer risk. However, current tests approved by the U.S. FDA do not measure sample adequacy, and thus cannot accurately quantitate HPV viral load, according to Cepheid. Cepheid said that its potential HPV test for the GeneXpert System will be designed to measure HPV viral load to identify high-risk patients, “making it unique among current HPV DNA testing products. “

Professor Ulf Gyllensten of the Rudbeck Laboratory (Uppsala), said, “Early detection delivers greater opportunities for improving patient outcomes.”

Quantovir is based on the R&D work of Gyllensten at the department of Genetics and Pathology at the Rudbeck Laboratory, and is owned by Innovationsbron I Uppsala, Uppsala Universitets Holdingbolag, together with a research group led by Gyllensten.

Cepheid manufactures systems for genetic analysis for the clinical, industrial and biothreat markets.

• Kensey Nash (Exton, Pennsylvania) reported that its board has approved a stock repurchase program in order, it said, to provide it with more flexibility to buy its own shares, which it believes are undervalued.

The program replaces an existing buyback program and allows it to repurchase up to a total of $25 million of its issued and outstanding shares of common stock and has no scheduled expiration.

The company said it intends to finance the repurchases using available cash, along with proceeds from a previously disclosed $27 million mortgage debt financing, to be drawn by the end of November.

As of Aug. 31, the company had about 11,946,000 shares of common stock outstanding.

The company provides a range of products, primarily in the endovascular, sports medicine and spine markets. The company also is the developer of the Angio-Seal vascular closure device, which is licensed to St. Jude Medical (St. Paul, Minnesota).

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