Medical Device Daily Executive Editor

Insulin infusion pump maker Insulet (Bedford, Massachusetts) has filed a statement with the Securities and Exchange Commission for an initial public offering of 6.7 million shares of its common stock at $14-$16 a share, with the top-end price thus potentially producing more than $107 million.

All shares will be sold by Insulet, and the company will grant the underwriters an option to purchase somewhat more than 1 million shares to cover over-allotments.

After the offering, Insulet expects to have 24.6 million shares outstanding. The company has registered to be listed on the NASDAQ under the symbol PODD.

Insulet said it will use the proceeds for general corporate purposes, such as improving manufacturing capacity, expanding sales and marketing, and funding of R&D.

J.P. Morgan Securities and Merrill Lynch, Pierce, Fenner & Smith will serve as joint book-running managers, and Thomas Weisel Partners and Leerink Swann & Co. will serve as co-managers for the proposed offering.

Founded in 2000, Insulet manufactures the OmniPod Insulin Management System, which it calls a "discreet" insulin infusion system for those with insulin-dependent diabetes. The FDA approved the OmniPod System in January 2005 (Medical Device Daily, Feb. 3, 2005).

The system consists of a handheld, wireless Personal Diabetes Manager (PDM), which programs the OmniPod with insulin delivery instructions and monitors its operation; and the compact OmniPod itself, worn beneath clothing and delivering insulin through a cannula that the device inserts automatically under the skin. The PDM contains an integrated FreeStyle blood glucose meter similar in appearance to a personal digital assistant. Insulet manufactures the system from its plant in Bedford.

The company last year reported a net loss of $36 million.

In February the company signed an agreement with Aetna U.S. Healthcare (Hartford, Connecticut) to add the OmniPod to its network of covered products for diabetes management (MDD, Feb. 16, 2007).

In February 2006 the company reported raising $50 million from an investor group led by OrbiMed Advisors (New York), saying that the funding, to that point, brought its total

Among the risks listed by the company, it noted a number of large, established companies that it must compete with including Medtronic MiniMed, a division of Medtronic, the market leader in the conventional insulin pump market in the U.S.; Animas (West Chester, Pennsylvania), a division of Johnson & Johnson (New Brunswick, New Jersey), and Deltec, a division of Smiths Medical MD (St. Paul, Minnesota). And it noted that following the lifting of an FDA ban on the import of Disetronic insulin pumps, Roche Disetronic (Fishers, Indiana), a division of Roche Diagnostics (Indianapolis), reentered the U.S. conventional insulin pump market.

The company also referred in its filing to the potential for intellectual property claims against it. It said that in March it received a letter from Medtronic, "inviting" it "to discuss our 'taking a license to certain Medtronic patents,'" relating to some of its key technology. It said: "While we believe that the OmniPod System does not infringe these patents, we would consider resolving the matter on reasonable terms. If we are unable to reach agreement with Medtronic, Inc. on this matter, they may sue us for infringement."

Insulet said that it has "meritorious defenses" to any suit but noted the expense and management "diversion" resulting from protracted litigation.

ReVision Optics (lake Forest, California), a manufacturer of implantable vision products, reported raising $25 million in a Series D financing

The financing was led by Domain Associates, with additional investments from existing investors Canaan Partners and InterWest Partners. Brian Dovey, partner at Domain, will join the company's board.

ReVision targets the refractive surgery market with an emphasis on the surgical correction of presbyopia. The company's Presbylens reshapes the cornea to correct a patient's near vision. This lens is made from a biocompatible material that mimics the properties of the cornea and is removable. In clinical trials, the Presbylens, "appears to provide positive patient outcomes," the company said.

"We believe that ReVision's Presbylens technology is an important development in the fast-growing ophthalmology space and one of the few focused on treating the loss of near vision in a minimally invasive fashion," said Dovey.

ReVision said it is conducting clinical trials off-shore for the Presbylens, and that it will be introducing an investigational device exemption in 3Q07.

"With this financing, we have achieved another important milestone in establishing the leadership and innovation of ReVision Optics," said J. Randy Alexander, president/CEO of ReVision.

"The Presbylens from ReVision Optics has the potential to be the correction of choice for the near vision problems encountered by everyone over age 45," said Gil Kliman, MD, general partner, InterWest Partners and Chairman of the ReVision Optics board of directors. "The high quality customized optics enable immediate clear vision at distance and near for patients of all ages, with major advantages over bifocals, contact lenses, and experimental surgical approaches. With the addition of Domain Associates to our investor group we now have the resources in place to bring this innovative product to market."

In other financing activity: Sequenom (San Diego) reported closingthe sale of $20 million in common stock to new and existing unaffiliated institutional investors. Sequenom sold 6.67 million shares at $3 a share, with net proceeds to be about $18.4 million.

Lehman Brothers Inc. served as lead placement agent, and Rodman & Renshaw served as co-placement agent.

Sequenom is a provider of products for genetic analysis, used to translate genomic science into solutions for biomedical research, livestock and agricultural applications, molecular medicine, and non-invasive prenatal testing. Sequenom's MassARRAY system is a nucleic acid analysis platform that measures the amount of genetic target material and variations. The system is able to deliver data from complex biological samples and from genetic target material that is only available in trace amounts.

Sequenom has exclusively licensed intellectual property rights for the development and commercialization of non-invasive prenatal genetic tests for use with its MassARRAY system and other platforms.