Safety Tests Look Positive for Maxim’s
Hepatitis C Drug
NuVasive, Inc. said it secured $29.3 million in venture capital funding, allowing the San Diego-based medical device maker to launch its first approved product, a unique tool used during spinal surgery.
William Blair Capital Partners VII, a private equity investment fund affiliated with Chicago investment bank William Blair & Co., LLC, led the financing. Other groups included Kleiner Perkins Caufield & Byers in San Francisco, Enterprise Partners in La Jolla, and Domain Associates, LLC, in Laguna Niguel.
Steven J. McGowan, CFO of NuVasive, said the money will be used for marketing in the United States and Europe and product improvements.
The technology, an electrode cannula, helps surgeons locate nerves more easily during minimally invasive spine surgery, McGowan said. That means safer and reproducible access for surgeons and less surgery and rehabilitation time for patients, according to Alex Lukianov, president and CEO of NuVasive.
“We believe the ability to treat all spine pathologies and even facilitate a fusion through a minimally invasive approach could become the standard of care,” Lukianov said.
McGowan said the firm hired 15 sales reps to bring the device to U.S.-based orthopedic and neurosurgeons. Distributors will soon be selling the device in Europe, where it was approved last month.
McGowan did not disclose a price. He also said it’s too early to project revenues.
The company was incorporated in 1997 by Dr. James Marino, an orthopedic surgeon specializing in sports medicine.
With $4.5 million in seed funding, Marino hired a technology-savvy staff to make the transition from an idea to a marketable product.
In December, the Food and Drug Administration gave the green light for marketing.
McGowan said it’s difficult to say what percentage of the total $2 billion worldwide spine surgery market NuVasive will be able to corner.
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Hepatitis C Study:
Maxim Pharmaceuticals Inc., a San Diego-based biopharmaceutical firm, announced positive results for its hepatitis C drug Ceplene, formerly called Maxamine.
The company said out of 18 patients enrolled in the study, 39 percent had a complete viral response after 48 weeks of triple-drug therapy, including Ceplene.
The study was designed to evaluate the safety of Ceplene, ribavirin and interferon-alpha in patients who did not respond to prior therapy.
In another study comparing Ceplene with interferon-alpha therapy to interferon-alpha, the complete response rate for patients taking Ceplene combination was more than double than for standard therapy alone after 72 weeks.
Five percent of patients treated with the Ceplene combination had to stop treatment as a result of severe side effects.
That compares to 14 percent of patients taking interferon-alpha alone, Maxim reported.
The next stage of the development program, said Kurt Gehlsen, Maxim’s senior vice president, development and chief technical officer, is to test Ceplene with pegylated interferon and ribavirin.
Pegylated interferon allows the drug to stay in the body longer with potentially smaller doses and fewer side effects, according to a biotechnology expert.
Last December, the Food and Drug Administration refused to approve Ceplene for skin cancer, saying the firm failed to follow FDA guidelines.
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