A Medical Device Daily

Viasys Healthcare (Conshohocken, Pennsylvania) and InnoMed Technologies (Boca Raton, Florida) reported that they have amicably settled their differences in the patent litigation between them, that they have entered into a settlement agreement, the terms of which are confidential, and that under the agreement, Viasys is free to sell its Lyra nasal cannula interface device in its present form.

Last year InnoMed filed suits against Worldwide Medical Technologies (Woodbury, Connecticut) and Viasys, its former distributor, for its alleged infringement of U.S. patent No. 6,595,215. The patent covers, among other things, a ventilation interface for sleep apnea therapy. The interface includes a pair of nasal inserts adapted to form a seal against a patient's nostril.

Viasys is a medical technology company focused on respiratory, neurocare and medical and surgical products.

Maxxon (Tulsa, Oklahoma) reported the current status of the Maxxon Safety Syringe and the results to date of the Securities and Exchange Commission (SEC) civil action against the company.

The company said that design changes to its safety syringe have been approved and transmitted to patent attorneys to incorporate in the existing patent as an amendment or a “continuation in part.“ All of the claims in the patent have been approved, and Maxxon has received official notification from the U.S. Patent and Trademark Office that the patent on its latest design, “The Genie“ was issued on Jan. 25.

In a meeting on Jan. 20 between Maxxon's medical advisor, Thomas Coughlin, MD, and engineers from Globe Medical and Design Pro, the final parameters delineating the vacuum retraction force, and the needle seat engagement and seal in the molded parts, were addressed. Steps also were taken to incorporate several components of the 3 cc syringe into the upcoming 5 cc design. It is estimated that the completed, functional prototype should be available for final testing within two weeks, according to the company.

On Dec. 30, 2002, the SEC filed a civil action against Maxxon, its president, Gifford Mabie, and Coughlin. On Nov. 18, 2004, the jury found that Coughlin did not violate any securities laws. The jury found one violation of Section 10(b) of the Securities and Exchange Act of 1934 and Rule 10b-5 against Maxxon and Mabie and a violation of Section 17(a)(2) and 17(a)(3) against Maxxon and Mabie.

Maxxon and Mabie have filed post-trial motions asking the court to grant judgment as a matter of law, or, in the alternative, for a new trial. Post-trial motions are set for oral argument on Feb. 17.

The company said that the SEC has “drastically re-duced“ the amount of monetary damages it is seeking from Mabie and is no longer seeking monetary damages from Maxxon. The SEC continues to seek injunctive relief, which in-cludes barring Mabie from being an officer or director of a public company and enjoining Maxxon and Mabie from violating the securities laws.

Maxxon said it does not believe that the SEC action will materially delay the development of its safety syringe.

Maxxon is a development-stage company committed to reducing the risk of accidental needlestick injuries and deaths to healthcare workers.

In other legal news:

The law firm of Wolf Haldenstein Adler Freeman & Herz (New York) reported the filing of a class-action lawsuit in U.S. District Court for the District of Massachusetts, on be-half of all persons who purchased the securities of Epix Pharmaceuticals (Cambridge, Massachusetts) between March 18, 2002, and Jan. 14, 2005, against defendants Epx and certain officers and directors of the company.

Epix is a developer of targeted contrast agents designed to improve the quality of images produced by MRI.

The complaint alleges that defendants violated the federal securities laws by issuing materially false and misleading statements throughout the class period that had the effect of artificially inflating the market price of the company's securities.

The complaint alleges that, among other things, the defendants failed to adopt and implement clinical quality management practices to deal with test and control scan problems which were ultimately responsible for difficulties in the statistical analysis and determination of efficacy of MS-325, the company's lead product under development.

The complaint also alleges that the Epix Phase III protocol for MS-325 permitted clinical investigators to substitute their own standards for MRI imaging and that those investigators were substituting their own standards for such imaging, resulting in the use of non-standard and non-uniform imaging methods to acquire the non-contrast MRA comparator control scans.

Additionally, the complaint noted that problems with uninterpretable images, multiple standards for acquisition of control scans, deficient clinical quality practices, and difficulties in the statistical analysis and determination of efficacy of MS-325 were known to defendants prior to the submission of the clinical data and results to the FDA.

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