Insulet (Bedford, Massachusetts), developer of the OmniPod Insulin Management System, reported raising $50 million in financing from an investor group led by OrbiMed Advisors (New York).

The new financing brings to about $120 million that the company has raised to date. Its largest previous funding came with an infusion of $35.5 million in early 2004 (Medical Device Daily, March 3, 2004).

The OmniPod system is a continuous, subcutaneous insulin delivery system comprising two components, the OmniPod Insulin Management System and the Personal Diabetes Manager (PDM) that work together to deliver insulin with the assistance of a glucose meter built into the PDM. The system was FDA 510(k)-cleared in early 2005.

Duane DeSisto, president and CEO of Insulet, noted that first product sales were launched only last October. While not providing numbers, he said sales since then “dramatically exceeded all of our expectations“ and that sales “per salesman“ have been significantly higher than at comparable pump companies.

“We would have needed [additional financing] eventually,“ he told Medical Device Daily, but the pace of sales required another financing round at this time and there was a “window of opportunity.“

Compared to other pumps requiring “40 inches of tubing and a set inserted into the body,“ use of the Omnipod, DeSisto said, requires carrying only “one thing around and you never see a sharp.“

Small and lightweight, the OmniPod is worn on the skin and delivers insulin according to programmed, personalized instructions, transmitted wirelessly from the PDM. The PDM is a wireless, hand-held device that programs and monitors the OmniPod and stores and displays insulin delivery, carbohydrate, and blood glucose history. The PDM also features an integrated blood glucose meter enabling the user to control both insulin delivery and check blood glucose with a single device.

Insulet defines its mission as improving the lives of people with diabetes “and to break down the barriers to continuous subcutaneous intensive insulin therapy – through technology and through communications with healthcare professionals and those personally afflicted.“

The investor group for the new financing included the Federated Kaufman Fund, along with existing investors Alta Partners, Pequot Ventures, Prism Venture Partners, Schroeder Ventures Life Sciences and Versant Ventures.

Spine Wave (Shelton, Connecticut), a developer of ad-vanced materials, techniques and implant systems for spine surgery, reported completing a Series C round of $36.5 million in equity financing.

Mark LoGuidice, Spine Wave's CEO and chairman, said that with the financing the company “is now well-positioned to further pursue our global clinical programs and to invest in building the commercial presence to support the launch of our first product, the StaXx XD Expandable Device. We are confident that 2006 will be a very exciting and productive year for Spine Wave.“

The round was led by existing investor New Enterprise Associates (NEA), with new investor Foundation Medical Partners. Also participating in the financing were existing investors Canaan Partners, Morgenthaler Venture Partners, Sprout Capital, Thomas Cressey Equity Partners, CHL Medical Partners and California Technology Partners.

Ryan Drant, who represents NEA on the Spine Wave board, said, “Mark and the experienced team at Spine Wave have made excellent clinical development progress with products for three different large-market clinical indications: lumbar fusion, vertebral compression fracture repair and disc repair.“

Spine Wave is focused on the development and marketing of clinical solutions for three fast-growing spinal market segments: nuclear replacement and augmentation, vertebral compression fracture repair and spinal fusion. Its portfolio includes the NuCore Injectable Nucleus, the StaXx FX Fracture Repair System, the StaXx XD Expandable Device, and several products in development.

In other financing activity:

• AcuNetx (Superior, Colorado) reported securing a commitment for up to $12 million in growth capital from Cornell Capital Partners (Jersey City, New Jersey).

The funds, in the form of a Standby Equity Distribution Agreement, will permit AcuNetx to draw down up to $2 million per month in weekly tranches of $500,000 over a period of 24 months to fund ongoing operations and back development and launch of new products. It said that the funds also would allow it to acquire additional assets to enhance its core business.

Terry Knapp, MD, AcuNetx CEO, said that the funding is beneficial “because the board encourages management to constantly hit growth milestones in order to obtain board permission for subsequent drawdowns. Our board and management are committed to use this money in a pay-as-you-go, milestone-driven manner . . .“

AcuNetx combines diagnostic, analytical and therapeutic devices with software enabling health providers to diagnose and treat balance disorders; law enforcement officers to evaluate roadside sobriety; and employers in high-risk industries to determine, in real-time, the mental fitness of their employees to perform mission-critical tasks. AcuNetx has subsidiary operations in Torrance, California.

• HealthSouth (Birmingham, Alabama) reported that it has received the necessary consents of the holders of a series notes to the proposed amendments to the applicable indenture governing each series of the notes. HealthSouth said it promptly executed supplemental indentures implementing the proposed amendments, but such supplemental indentures will not become operative until and unless it accepts for purchase all of the notes tendered in the related tender offers.

The tender offers are scheduled to expire at midnight, EST, March 2, unless extended or earlier terminated.

HealthSouth is a provider of outpatient surgery, diagnostic imaging and rehabilitative healthcare services.

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