A Medical Device Daily

CoreValve (Paris) reported that it has closed on a Series B round of financing of $24 million led by Apax Partners (Paris). HealthCap also participated in the round.

Previously, CoreValve raised $6 million from angel investors and one major venture capital investor, Sofinnova Partners (Paris).

The CoreValve procedure – using the CoreValve Percutaneous ReValving System – can be performed in a cardiac cath lab just like angioplasty and stenting, resulting in less trauma to the patient and substantial cost saving to the healthcare system.

Jacques Seguin, MD, PhD, founder, chairman and CEO of CoreValve, termed the funding from these investors “a dramatic endorsement of CoreValve’s ReValving approach to percutaneous aortic valve replacement – a procedure that no doubt represents the area of legitimate excitement for the future of interventional cardiology. Not only will ReValving offer immediate hope to patients who are currently left untreated because of their high surgical-risk profile, but ReValving also will eventually offer all patients the opportunity to avoid the trauma of open-heart surgery.”

“CoreValve’s ReValving approach has universal applicability, and it will allow both patients with aortic stenosis and aortic regurgitation to be treated less invasively,” said Laurent Ganem, MD, a partner at Apax. “We are impressed with the company’s progress to date, in particular in having achieved clinical proof-of-concept. CoreValve’s technology offers a new standard of care that will reduce the cost of each individual procedure and represents an attractive investment proposition – especially at a time when the shifting demographics of an aging population are increasing the demand for treatment of degenerative aortic disease.”

Laurent Ganem, MD, a partner with Apax, and Johan Christenson, MD, PhD, a partner with HealthCap, will join CoreValve’s board, which also includes Seguin as chairman; Antoine Papiernik, managing partner, Sofinnova; and Dolf Meewis, founder of Medilogic.

Founded in 2001, privately held CoreValve, with R&D and manufacturing facilities in Irvine, California), has developed a proprietary delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery.

HepaLife Technologies (Vancouver, British Columbia), an early-stage company focused on the development of technologies and products for detecting liver toxicity and the treatment of various forms of liver dysfunction, reported entering into an agreement to raise up to $15 million in equity financing from institutional investor Fusion Capital Fund II (Chicago).

Fusion agreed to purchase up to $15 million of newly issued HepaLife stock, in $500,000 monthly amounts, over a period of up to 30 months, based upon the market price of the common stock at time of purchase.

HepaLife said it has the right to control the timing and the amount of stock sold, if any, to Fusion. Further, and at the company’s option, Fusion can be required to purchase fewer or, subject to the satisfying certain conditions, greater amounts of common stock each month.

Harmel Rayat, a director of HepaLife, said, “With the added capital, our management team can focus on HepaLife’s core research activities, expanding and accelerating the scope of our science and working towards creating the first-of-its-kind artificial liver device and developing proprietary in-vitro toxicology and pre-clinical drug testing platforms.”

HepaLife is concentrating its efforts on creating a first-of-its-kind artificial liver device and developing proprietary in vitro toxicology and pre-clinical drug testing platforms.

Through a cooperative R&D agreement, HepaLife is working to improve the functionality of its patented PICM-19 cell line, which has demonstrated to have potential application in the production of an artificial liver device for use by patients with liver failure.

Hepatotoxicity, or liver damage caused by medications and other chemical compounds, is the single most common reason leading to drug withdrawal or refusal of drug approval by the FDA. In fact, about one-third of all drugs fail preclinical or clinical trials due to the toxic nature of the compounds being tested, costing pharmaceutical companies around $2 billion annually on such toxicity-related drug failures.

With the cost to develop an FDA-approved drug approaching $1 billion and taking 10 to 15 years, a 10% improvement in predicting failures before clinical trials could save $100 million per drug.

The PICM-19 cells grown in vitro synthesize liver specific proteins such as albumin and transferrin, and display enhanced liver-specific functions such as ureagenesis and cytochrome P450 activity.

In other financing activity, Endologix (Irvine, California), developer of the Powerlink System, reported completion of a previously disclosed private placement of 4.15 million shares of common stock to selected existing and new accredited investors at a price of $4 a share, resulting in net proceeds of about $15.5 million.

Adams Harkness and Montgomery & Co. acted as co-placement agents on this transaction.

The financing was unveiled last week (Medical Device Daily, July 8, 2005), with the company then saying that the new money would be used to support the “next phase” of its commercial launch of the Powerlink System.

The Powerlink System is an endoluminal stent graft for treating AAA, a weakening of the wall of the aorta, resulting in a balloon-like enlargement susceptible to rupture. AAA is estimated to be the 13th-leading cause of death in the U.S., Endologix said. The system received FDA approval last fall (MDD, Nov. 2, 2004).

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