A Medical Device Daily

TransMedics (Andover, Massachusetts), a company developing a system to circulate warm blood through hearts and other transplant organs while they are being transported, as opposed to the cold transport system currently in use, has filed plans for an initial public offering (IPO) potentially worth more than $86 million.

The company filed paperwork for the anticipated IPO late last week. Price range, shares to be offered and a specific IPO data haven’t been disclosed yet. But the company, in its filing, said it would seek as much as $86.3 million when it hits the public markets.

TransMedics, which employs more than 80 people, was founded in 1998 and does not generate significant revenue yet. The company is trying to develop and sell a system that would allow for “transplantation of beating hearts and other functioning organs,” according to its IPO filing.

The device currently dubbed the Organ Care System (OCS), makes it possible to actually deliver a beating heart to the surgeon.

The company said it intends to use the net proceeds from this offering to fund research and development relating to the OCS, including clinical trials, the recruitment and training of additional sales and clinical support personnel and marketing initiatives, and for general corporate purposes. It may also use a portion of the net proceeds to acquire, license or invest in complementary businesses, technologies or products.

The system has been marketed in the European Union since mid-2007. TransMedics is now conducting a clinical feasibility study in the U.S. to use the device for heart transplantation.

The study, according to the company’s IPO filing, would involve enrollment of 20 patients at up to five heart transplant centers. The company hopes to clear the federal hurdles by early 2009. It is also developing a system for lungs, livers, and kidneys.

The company said it had a limited operating history and has incurred substantial net losses since its inception. As of June 30, it had a deficit accumulated during the development stage of $79.3 million. Its net loss was $7.9 million for 2004, $17.4 million for 2005, $17.6 million for fiscal 2006 and $11.1 million for the six months ended June 30.

AdvanDx (Woburn, Massachusetts) reported that it closed a $15 million Series C financing round from new investor bioM rieux (Marcy L’Etoile, France) and existing investors LD Pensions and SLS Venture.

The company said that this latest financing will be used to accelerate the commercialization of its product pipeline through its global sales and marketing operations as well as to expand its research and development activities.

The funding follows the recent announcement of AdvanDx’s exclusive distribution partnership with bioM rieux for its PNA FISH rapid in vitro diagnostic products for positive blood cultures in the U.S. Together with the funding, the distribution partnership secures a significant cash flow stream for AdvanDx, the company said.

AdvanDx’s suite of molecular diagnostic products is designed to provide pathogen identification in hours vs. days. Studies demonstrate that implementation of these products can lead to a significant reduction in intensive care unit related mortality due to Staphylococcus aureus bloodstream infections.

In other financings news:

• Delcath Systems (New York) said it has entered into definitive subscription agreements with selected institutional investors to sell 3,833,108 shares of its common stock and warrants to purchase 1,916,554 shares of common stock with an exercise price of $4.53 per share through a registered direct offering.

Each unit, consisting of one share of common stock and one warrant to purchase 0.5 shares of common stock, was priced at $3.70 for gross proceeds of about $14.2 million, before deducting offering fees and expenses.

Canaccord Adams and ThinkEquity Partners acted as placement agents for the offering. Canaccord Adams acted as the lead placement agent.

The company said it intends to use the net proceeds from this offering to fund the continued advancement of its Phase II and Phase III clinical trials currently underway, to fund new research and development activities, and for other general corporate purposes.

The shares are being offered pursuant to the Company’s effective shelf registration statement Delcath is the developer of percutaneous perfusion technology for organ- or region-specific delivery of therapeutic and chemotherapeutic agents. The Delcath system is currently being tested with the drug Melphalan in a Phase III trial of patients with metastatic ocular and cutaneous melanoma in the liver, and a Phase II trial of patients with primary liver cancers and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas, as well as patients with melanoma who previously received isolated perfusion.

• Edwards Lifesciences’ (Irvine, California) board has authorized an additional share repurchase program to acquire up to $250 million of the company’s outstanding common shares.

The company said it expects to continue repurchasing shares under an existing 4 million share repurchase program that was initiated in May 2006. Since Jan. 1, 2007, the company has repurchased about 2.2 million shares for a total of $107.2 million. In 2006, the company repurchased 3.3 million shares for a total of $145.8 million. As of Aug. 31, 2007, the company had about 56.8 million shares outstanding.

Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies.