A Medical Device Daily

MedicalCV (Inver Grove Heights, Minnesota) said that it has filed a registration statement with the SEC for a public offering of common stock of about $30 million.

The company said it has filed an application with Nasdaq for the listing of its common stock on the Nasdaq Capital Market. The application is pending. The company said it is seeking to have the listing approved concurrent with its proposed public offering.

Additionally, the company said it approved a one-for-ten reverse split of its common stock, applicable to shareholders of record on May 31. Upon market open on June 1, MedicalCV's common stock will begin trading on a split-adjusted basis.

As a result of the reverse stock split, every ten shares of MedicalCV's common stock that are issued and outstanding on the record date will automatically be combined into one issued and outstanding share without any change in the par value of such shares.

No fractional shares will be issued in connection with the reverse stock split. Shareholders who would be entitled to fractional shares will receive cash in lieu of receiving fractional shares.

The company also reaffirmed that it intends to file an application with the FDA by the end of the first half of 2006 for 510(k) clearance for its Atrilaze, a stand-alone, minimally invasive system designed to ablate cardiac tissue in a closed-chest beating heart setting.

Among the risk factors that the company discussed was the fact that the company will face stiff competition in the market to develop cardiac ablation systems including such companies as AtriCure (West Chester, Ohio), Boston Scientific (Natick, Massachusetts), CryoCath Technologies (Montreal), Edwards Lifesciences (Irvine, California), Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota),Johnson & Johnson (New Brunswick, New Jersey) and Cardima (Fremont, California).

The company also noted that it received a letter from Edwards Lifesciences concerning its Atrilaze system. While it said that Edwards did not claim that the company's products infringe any of its patents, Edwards' letter called attention to six of its patents and requested that MedicalCV comment on how its products differ from the claimed methods and apparatus of the six specified Edwards patents. The company said it does not believe that its Atrilaze system infringes any of the Edwards patents.

MedicalCV has focused all of its attention onto the cardiac ablation market after its exit from the heart valve market last year (Medical Device Daily, April 14, 2005).

C.E. Unterberg, Towbin is acting as the lead book running manager of the share offering, together with Craig-Hallum Capital Group and Roth Capital Partners as co-managers.

Inviro Medical (Duluth, Georgia) reported securing an additional $12 million round of funding. The company said the funding would help as it prepares for a North American product launch in June of its InviroSNAP! safety syringe line.

The InviroSNAP! looks and functions like a traditional syringe. With hand and fingers safely positioned behind the needle, the clinician administers the dose, pulls the plunger back – causing the needle to retract inside the barrel – and snaps off the plunger, permanently disabling the device, the company said.

In other financing news:

• Hanger Orthopedic Group (Bethesda, Maryland) reported that it has commenced tender offers to purchase for cash any and all of its outstanding $200 million aggregate principal amount of 10-3/8% senior notes due 2009 (and its outstanding $15.56 million aggregate principal amount of 11-1/4% senior subordinated notes due 2009) for certain proposed amendments to the indentures pursuant to which the notes were issued.

The offers are conditioned upon the consummation of a new $75 million revolving credit facility and $230 million bank term loan, the issuance of $190 million aggregate principal amount of new senior notes and the issuance of $50 million of Series A convertible preferred stock or other similar financing, on terms and conditions satisfactory to the company.

Hanger said it intends to use the net proceeds from such financing to fund the purchase of the notes in connection with the offers.

Lehman Brothers and Citigroup Corporate and Investment Banking are the co-dealer managers for the offers and agents for the solicitations.

Hanger provides orthotic and prosthetic patient care services.

• Clinical Data (Newton, Massachusetts) reported that Third Security Staff 2001, an affiliate of Randal Kirk, chairman of the company's board of directors, purchased 100,000 shares of the company's stock from Israel Stein, MD, the company's executive vice chairman and interim CFO, for $20 per share in a private transaction.

Clinical Data provides molecular and pharmacogenomics services as well as genetic tests to improve patient care.