The new cardiovascular company scheduled to be spun off from Baxter International (Deerfield, Illinois) in the first half of this year will be named Edwards Lifesciences Corp. Baxter said in a statement that the name "draws upon a heritage of innovation ... that can be traced to one of the cardiovascular company's founders, Miles (Lowell) Edwards, known to clinicians the world over for his pioneering therapies and products."

Edwards, who was credited with co-inventing the world's first commercially available artificial heart valve, as well as a number of other medical advancements, founded a medical device company in the 1950s that would later become American Edwards Laboratories. In addition to the first implantable heart valve, that company produced the first hemodynamic monitoring balloon catheter, the first catheter to remove clots from peripheral blood vessels, and the first disposable oxygenator for heart-lung bypass. The Baxter statement said Edwards and various former employees are credited with "helping spawn the biomedical industry in Orange County, California."

Baxter acquired American Edwards Laboratories in 1985.

"For those familiar with the medical devices industry and, in particular, cardiovascular care, the name Edwards Lifesciences will evoke both a rich heritage of innovation and a strong track record of success," said Michael Mussallem, Baxter group vice president, who will become the new firm's CEO and board chairman.

The cardiovascular businesses that will operate under the Edwards Lifesciences name have existing annual sales of nearly $1 billion. Its headquarters will be in Irvine, California, where the Baxter CardioVascular Group is based. The Irvine facility employs more than 1,400; the new company will have about 5,000 employees worldwide and will do business in more than 80 countries. More than 40% of its sales are generated outside the U.S.

Esperion, Neuron Therapeutics raise funds

Esperion Therapeutics and Neuron Therapeutics, privately held companies developing cardiovascular and stroke therapies, have completed financings that will allow further development of those products.

Esperion (Ann Arbor, Michigan) completed a $22 million financing from both existing and new investors. Existing investors include TL Ventures, Oak Investment Partners, and HealthCap KB. New investors include Canaan Partners and Avalon Investments. The financing was co-led by TL Ventures and Canaan Partners. "This financing shows the high level of interest the financial community has in the therapies we are developing," said Roger Newton, Esperion president and CEO. "This financing will help us move four products into the clinic in the next 12 months, and we plan to aggressively seek other candidates to build our pipeline."

The funds will be used to advance Esperion's product development programs, which hope to show atherosclerosis can be reversed safely in humans. Esperion is developing four product candidates, including apoA-IMilano (AIM), a natural, biologically active human recombinant protein that has been shown in animals to open arteries clogged by atherosclerotic plaque; and ESP 24228, a novel lipid formulation that will be examined as a treatment for acute coronary syndromes. The company also has a series of three small new peptides which are believed to interact with phospholipids to form new HDL-like particles, and which may prove effective in removing excess cellular cholesterol. The lead peptide, ESP 24218, has been shown to dramatically increase the HDL-cholesterol level in animals. The final product candidate is pro-Apo A-I, a natural, biologically active human recombinant protein that has already been shown to promote reverse lipid transport in humans. All products are scheduled to enter the clinic this year.

Neuron Therapeutics (Malvern, Pennsylvania) raised $12.2 million in a private equity financing to take its novel stroke therapy – a sort of cerebral spinal fluid (CSF) substitute – into clinical testing. The financing, the second for privately held Neuron Therapeutics, included seven venture capital firms and was led by the sole new investor, Chase Capital Partners (New York). The funds will be used to take its novel stroke drug into Phase I/II clinical testing and develop the next generation of devices for delivering the drug.

"This financing will allow us to move forward on multiple fronts," said Bruce Shook, president and CEO. "We're going to initiate our first clinical trials, develop the next generation of medical devices, expand our management team and pursue new intellectual property." Neuron Therapeutics got its start in September 1998 and currently has 11 employees. The company was formed to develop treatments for ischemic conditions of the central nervous system using its proprietary fluorochemical technology that was developed in the Neurosurgery Laboratories at Thomas Jefferson University (Philadelphia, Pennsylvania).

Neuron Therapeutics' fluorocarbon emulsion helps protect brain tissue at risk of death following an ischemic event by providing oxygen, glucose, amino acids and electrolytes to the brain, inducing hypothermia to slow brain activity and preserve brain tissue, and flushing dangerous metabolites from the brain. "The idea is to support the brain tissue at risk of dying during an ischemic event whether caused by stroke or head trauma," Shook said.

The company has designed a system that employs two shunts – one into the lateral ventricular space and the other in the lumbar spinal column – to deliver and remove the fluorocarbon emulsion. Prior to being administered to the patient, the fluorocarbon emulsion is conditioned: it is oxygenated, has its pH adjusted, nutrients added and finally it is cooled.

Shook said the company intends to begin its first clinical trial of the therapy sometime this year. The first study will be in patients with severe ischemic stroke, caused by occlusion of the blood supply to the brain rather than bleeding in the brain.

CardioDynamics launches web strategy

CardioDynamics International (San Diego, California), manufacturer of BioZ noninvasive digital cardiac output monitoring systems, has launched the first phase of its Internet medical product development strategy, including the infrastructure for an Internet-based electronic data center, BioZ.net, and the company's electronic commerce program, the BioZ.buy site at www.cardiodynamics.com. Michael Perry, CardioDynamics' CEO, said BioZ.net "will provide e-commerce ordering capabilities, as well as a foundation for our telemedicine business."

This first phase provides access to the approximately $83 billion spent annually by hospitals and other health care organizations on medical supplies and equipment. The company said it spent more than two years evaluating and planning the Internet-based data center and medical supply chain business, and intends to offer its products through its strategic alliance partnerships, including GE Marquette Medical Systems' (Milwaukee, Wisconsin) e-commerce initiatives.

Perry added, "The business of exchanging data among patients and physicians on a real-time basis is finding more applications and acceptance, as evidenced by research published in the January issue of Chest, which found very high patient acceptance of an Internet-based home telemonitoring system. This is the exact niche we are expanding into."

The company's BioZ System, BioZ Portable, and BioZ.com use impedance cardiography to noninvasively obtain data on a wide range of hemodynamic parameters. The company estimates the worldwide market potential for BioZ products at $5 billion, together with an additional $800 million in recurring annual revenue for disposables.

Companies ... in brief

Cambridge Heart (Bedford, Massachusetts) raised $2.1 million through a private placement at a 10% discount to its recent closing price, completing an overall $7.4 million round of financing initiated last fall. The company said the proceeds will be used primarily to promote its T-wave Alternans Test and to pursue a third-party payer reimbursement strategy, as well as fund general operational needs ... CardioFocus (West Yarmouth, Massachusetts) completed a $9.6 million private placement in its second financing round, which will be used to continue development of its light-based Lightstics technology currently being tested in two cardiovascular applications. The company is selling the Lightstics materials to Pharmacyclics (Sunnyvale, California), which is using them in tests of a photodynamic device/drug system to treat blocked arteries as an alternative to traditional angioplasty. CardioFocus is pursuing its own preclinical trials to treat atrial fibrillation via lesions created with controlled light. The company said that in both applications, the extreme thinness of the Lightstics materials allows access to very small spaces in the heart unreachable with other materials ... Vascular Solutions (Minneapolis, Minnesota), maker of the Duett device for sealing arterial puncture sites following catheterization procedures, in late December raised $5 million from the exercise of an outstanding option and warrant. The company issued almost 900,000 shares of common stock as part of the transaction.