A Medical Device Daily

Home Diagnostics (Fort Lauderdale, Florida) has filed for an initial public offering seeking to raise up to $100 million. It initially has priced the offering of 6.6 million shares, from $14 to $16.

Home Diagnostics makes blood glucose monitoring systems and disposable supplies for diabetics. The company sells its products through retail pharmacies, mass merchandisers, distributors, and mail service providers in Australia, China, the UK and the US. It markets its products through these distribution channels in two ways, under its own brand names — including SideKick, TrueTrack Smart System, TrackEase Smart System and Prestige IQ — and through co-branded partnerships in which the company's customers market its products under their brand names alongside Home Diagnostics' brands.

It banners its SideKick system as the world's smallest blood glucose testing system. SideKick is a vial of 50 test strips with a built-in meter. When the 50 test strips are used, the product is then thrown away. The ease of the system, the company says, encourages more frequent testing.

Home Diagnostics says it also works closely with hospitals and long-term care facilities to help them more affordably monitor and manage their patients with diabetes. Its partnerships include dialysis and respiratory care centers that have a high incidence of diabetes among patients receiving treatment.

The IPO is being managed by J.P. Morgan Securities. Its proposed Nasdaq symbol is HDIX.

In other financing news:

• LDR (Austin, Texas), a developer of non-fusion and fusion spinal implants, reported completing a $14 million Series B funding round, with $5 million of that amount coming from new outside investors. All original investors also participated in this round including Austin Ventures, Rothschild Private Equity, PTV Sciences and Path4 Ventures.

The company said that the financing will be used to support the investigational device exemption (IDE) studies of its second-generation artificial discs for cervical and lumbar applications and drive continued global revenue growth and expansion into the U.S. spinal sales market.

Christophe Lavigne, CEO of LDR, said, “This round of funding will be used for our continued sales growth in over 26 countries throughout the world along with providing critical support of the U.S. based, FDA-approved study for our Mobi-C second generation cervical disc.”

The Mobi-C is designed to provide six degrees of freedom via a mobile bearing technology, thereby better replicating the natural kinematics of the spine, the company said. The product also includes a “keel-less” feature that provides for minimal disruption to the cervical spine during implantation.

The Mobi-C cervical disc IDE study allows for one or two-level implantation, an anticipated indication for many patients throughout the world.

Reginald Davis, MD, a neurosurgeon with Greater Baltimore Neurological Associates, said that LDR's products are unique “and surgeons have enthusiastically supported LDR innovations such as Easyspine, Mobidisc and especially Mobi-C . . . [The] two-level option is an important, emerging market need.”

LDR was founded in 2000 by spine executives after their experience in the design and market introduction of the industry's first iteration of artificial discs. The Mobi-C was introduced in late 2004 and implanted in more than 900 patients outside the U.S.

• Singulex (Hayward, California) reported raising $10.5 million in series C and debt financing.

Singulex' existing investors, Fisk Venture and Prolog Ventures, were part of the latest financing round totaling $8 million, led by a new undisclosed investor.

The company also closed a $1 million round from GE Capital and a $1.5 million debt financing from Bridge Bank, bringing the total amount to $10.5 million.

The company is the developer of the Zeptx System, used to enable life science researchers to obtain quantitative information on normal and abnormal protein levels in any type of biological sample.”

Singulex' flagship digital single molecule detection system, the Zeptx System, incorporates a variety of well-established detection and immunoassay tagging technologies to create a quantitative system that can measure protein biomarkers in biological samples, including serum or plasma, at concentration levels that have been historically difficult to detect with a high degree of sensitivity, accuracy and precision in under an hour.

Philippe Goix, president/CEO of Singulex, said, “The financial backing from both new and existing investors will enable us to meet our target commercialization launch of the Zeptx System in the first half of 2007.”

The company has also opened a 6,000 square foot commercial operation facility in Hayward. R&D efforts will remain at the company's facility at the St. Louis Center for Emerging Technologies.

Singulex said it is conducting several pilot studies with academic and molecular diagnostic partners to validate the Zeptx System, which it projects to be commercially available in the first half of 2007.

• Avitar (Canton, Massachusetts) reported completing the sale of $520,000 of Secured Convertible Notes and 1.5 million seven-year warrant to accredited investors.

It said the proceeds will be used for the marketing and sale of its ORALscreen assay, an oral fluid test for drugs-of-abuse, and for general corporate development.

The notes will mature three years from the date of issuance and bear interest at 8%. They are convertible into shares of Avitar common stock, at the option of the investors, at 65% of the average of the three lowest intra-day trading prices of the common stock, as quoted on the OTC Bulletin Board for the 20 trading days proceeding the date that the investors elect to convert. The company has the right to prepay the notes at premiums ranging from 20%-35%.

Avitar manufactures products in the field of oral fluid diagnostics, the disease and clinical testing market, and customized polyurethane applications used in the wound dressing industry.

• Somanetics (Troy, Michigan) has entered into a contract development and exclusive licensing agreement with NeuroPhysics (Shirley, Massachusetts) to provide Somanetics with feasibility research, contract development and consulting services and certain ownership and licensing rights to intellectual property and technical knowledge associated with several near-infrared spectroscopy (NIRS) and imaging technologies under development at NeuroPhysics.

Somanetics will pay an initial license fee of $1 million, monthly license fees beginning April 1, 2008, for products continuing under development at NeuroPhysics, and a royalty on any future sales.