A Medical Device Daily

Tengion (East Norriton, Pennsylvania) said it has closed a $33 million Series C financing, including participation from new investor Deerfield Partners.

Proceeds from this financing will be used to advance the late-stage clinical development of the Tengion Neo-Bladder Augment, being evaluated in two Phase II trials, and to accelerate expansion of its regenerative medicine platform into the development of other autologous organs and tissues in the genitourinary and cardiovascular systems.

“This funding provides the company with flexibility to accelerate our investment in pipeline programs including Tengion Neo-Vessels and Tengion Neo-Kidneys, while we continue to advance the Phase II Neo-Bladder Augment clinical programs in pediatric patients with neurogenic bladder due to spina bifida and in adult patients with spinal cord injury,” said Steven Nichtberger, MD, president/CEO of Tengion.

The company’s most advanced regenerative medicine program is the Neo-Bladder Augment, consisting of a biodegradable scaffold seeded with cells cultured from the patient’s own cells. A surgeon implants the Neo-Bladder Augment in the patient’s body, where it is designed to harness the body’s regenerative capabilities resulting in a regenerated bladder with improved functionality.

In addition to Deerfield Partners, participants in this round included Tengion’s full roster of current institutional investors: Bain Capital, Johnson & Johnson Development, HealthCap, Quaker BioVentures, Oak Investment Partners and L Capital Partners, as well as equity investments from the company’s current lenders, Horizon Technology Finance and Oxford Finance.

In other financing news:

• Ivivi Technologies (Northvale, New Jersey), a developer of non-invasive, electrotherapeutic technologies, said it has entered into a definitive purchase agreement with an institutional investor, The Pinnacle Fund, to raise $5 million of gross proceeds in a private placement of its common stock.

Ivivi will issue an aggregate of 1 million shares of common stock at $5 a share. Net proceeds from the private placement, after the payment of expenses of about $125,000, are expected to be roughly $4,875,000. Proceeds from the transaction will be used to provide additional working capital and for general corporate purposes. The closing price of Ivivi’s common stock on the American Stock Exchange on the date of execution of the agreement was $4.80 a share.

Ivivi said it plans to close the private placement promptly, subject to customary closing conditions, including approval of the listing of the additional shares of Ivivi’s common stock by AMEX.

• StatSure Diagnostic Systems (Framingham, Massachusetts) said it received a $500,000 strategic investment from Inverness Medical Innovations.

StatSure and Inverness also signed two additional agreements. First, the two companies signed an agreement for Inverness to acquire an option to the exclusive, worldwide marketing and distribution rights to certain infectious disease diagnostic tests developed by StatSure that may use specified Inverness and/or StatSure intellectual property.

The option provides for StatSure and Inverness to equally share development expenses and profits. StatSure and Inverness also entered into a license agreement granting StatSure a license to certain Inverness lateral flow patents for use in a rapid test to detect HIV antibodies in point-of-care markets subject to payment of royalties to Inverness. This license pertains to HIV tests using formats other than StatSure’s “barrel format,” which already is being sold by Inverness and awaiting a CLIA waiver from the FDA, the companies said.

The investment consists of a purchase of 1,428,572 common shares at 35 cents a share. Additionally, Inverness received five-year warrants to buy up to an additional 1.1 million shares of the company’s stock at 75 cents a share. The proceeds will be used for general corporate purposes and to fund development of other infectious disease applications for the company’s test format.

• MediKeeper (San Diego), a provider of technology solutions for the health and wellness industry, has closed its Series A investment round led by Hawaii-based venture capital firm PacifiCap. The amount of the round was not disclosed.

MediKeeper was founded in 2003 by a team of entrepreneurs and medical professionals with the purpose of making medical records secure, mobile and accessible online. Beginning with its flagship personal health record, the company provides customized patient-centered management tools.

As part of the investment, MediKeeper is establishing an R&D lab in Hawaii.

• Aspect Medical Systems (Norwood, Massachusetts) reported that on Oct. 5 the Securities and Exchange Commission declared effective the shelf registration statement filed with the SEC on Aug. 29 in connection with the registration for re-sale of an aggregate principal amount of $125 million of 2.5% convertible senior notes due 2014, which Aspect issued in a private placement in June and shares of Aspect common stock, $0.01 per value, which are issuable upon conversion of the notes.

Holders of the notes and the common stock may sell these securities in one or more separate offerings with the size, price and terms to be determined at the time of sale.

Aspect makes brain monitoring technology.