Medical Carbon Research Institute (Austin, Texas) reported that it has become On-X Life Technologies after Paul Capital Healthcare (New York) and several other existing investors provided $32 million through a combination of debt, revenue interest and royalty conversion, as well as a new equity capital infusion into the company.
The company, which develops the On-X heart valve, is now at a capitalization of $70 million.
“The benefit is that we can branch out with new projects,” Clyde Baker, president/CEO of On-X life Technologies told Medical Device Daily. “In the past the company was so burdened with debt we couldn’t [expand into other markets]. But now we’re looking forward.”
The company said announcements of these other markets for expansion could come within the next three months.
Currently the company is engrossed in an FDA-approved study that takes a close look at a group of low-risk aortic valve replacement patients and two low-does warfarin groups of higher-risk aortic and mitral valve replacement patients.
The study, named Prospective Randomized On-X Clinical Trial (PROACT), was launched in June of 2006 and is expected to be completed by 2011. It is being conducted in 40 clinical sites comprised primarily of university-based medical institutions in the nation.
Results of the study, intended to support lower dosages of drugs required following implantation of mechanical valves, won’t come any time soon.
“We’re following these patients for five years,” Baker told MDD. “But we should receive some interim report in about 18 months. We’ll ultimately have 1,200 [patients enrolled.]”
The patient groups in the study include a non-warfarin group of low-risk aortic valve replacement patients and two low-dose warfarin groups of higher risk aortic and mitral valve replacement patients.
“Our expectation is that in these lower-risk aprtic valve replacement patients you have the same or better morbid event rates than the other groups,” Baker told MDD.
The lower-risk groups will be those without heavier medication to regulate the blood flow into the valve and stop clotting.
Following the first implantations in 1996, recent clinical evidence suggests that patients implanted with the On-X heart valve may be able to forego or reduce the dosages of anticoagulation therapy traditionally required by mechanical heart valve recipients.
The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. On-X LTI also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices.
Paul Capital Partners manages nearly $5 billion in equity capital commitments for its three investment platforms that include healthcare direct investments (including royalty and revenue interests in healthcare products), Private Equity Secondary’s and Top Tier Fund-of-Funds. The firm has offices in New York, San Francisco, Paris, London and Toronto.
Paul Capital Healthcare has $1.4 billion in equity capital commitments and debt facilities under management. It reports having made investments in the pharma, biotech and medical device sectors valued at more than $850 million.
In other financing news:
• CryoCor (San Diego) reported payoff in full of its existing $7 million debt facility and the completion of a new credit facility with a syndicate of lenders comprised of Oxford Finance, ATEL Ventures and Silicon Valley Bank.
CryoCor will receive $6 million and will have access to an additional $8 million if it receives FDA approval for its Cardiac Cryoablation System for the treatment of atrial flutter, and if it also raises an additional $20 million in equity financing.
CryoCor said it expects its cash resources to be sufficient to fund it until the fourth quarter of 2008.
• Elbit Vision Systems (Kadima, Israel)reported that it has consummated a private placement investment of $2 million from leading financial institutions in Israel. The investors received 6,290,941 ordinary shares of the company and warrants to purchase another 3,145,472 ordinary shares for a period of four years at 45 cents a share.
The company also entered into investment agreements with certain existing shareholders, including Mivtach Shamir Holdings, for about $3.7 million.
The agreements include an amendment to an outstanding $3 million promissory note, according to which Shamir will undertake to convert $1.5 million actually loaned by it to the company under the promissory note and invest the remaining $1.5 million, at a price of $0.315 a share.
The transactions will be completed immediately following their approval by the shareholders of the company. The company’s audit committee and board of directors have approved the transactions, which are subject to the approval of the company’s shareholders.
Elbit Vision Systems develops automatic vision inspection and quality monitoring systems.