A Medical Device Daily
Instant Technologies (IT; Norfolk, Virginia) reported that it has acquired Accu-Stat Diagnostics (Lake Forest, California) for an undisclosed sum.
Accu-Stat recently obtained FDA 510(k) clearances to sell its Accu-Stat line of home testing products for drugs of abuse, breath alcohol, cholesterol, and fecal occult blood tests over-the-counter.
"The acquisition of Accu-Stat is strategic to the advancement of [our] goal to expand our product portfolio and enter the consumer products market," said Jeff Konecke, IT's director of business development. "The OTC market for drugs of abuse is poised for growth and is in need of a strong market leader, which we intend to become."
Instant Technologies is a developer of rapid test devices that include drug and alcohol testing, women's health and clinical diagnostics.
Cambrex Bio Science Walkersville, a subsidiary of Cambrex (East Rutherford, New Jersey), reported that it has entered into a purchase agreement for all of the stock of Cutanogen (Cincinnati), a privately-held biotechnology company focused on products used to treat patients with severe burns.
The purchase price consists of $1.5 million to be fully paid at closing, with additional purchase price payments of up to $4.8 million subject to the achievement of certain regulatory and commercial milestones.
The company said it expects to expense all purchase price payments prior to regulatory approval of the product as in-process R&D. The transaction is also projected to be dilutive by about 15 cents a share in 2006 primarily due to the purchase price payments and accretive in 2007 and thereafter.
Cambrex believes that Cutanogen's lead product, PermaDerm cultured skin, is the first multi-layered product that combines autologous epidermal and dermal layers of the skin in a product for severe burns that is pliable and grows with the patient, which it said is a "particular advantage when a burn patient is a child."
PermaDerm has been given a Humanitarian Use Designation (HUD) by the FDA for the treatment of third degree burns covering 50% or greater of the patient's body.
The company said it anticipates applying for a Humanitarian Device Exemption (HDE) with the FDA by mid-2006.
Under the HDE, Cambrex could begin providing the product to critically injured patients and be reimbursed for the cost of manufacturing and distribution.
The company said it intends to begin a pivotal trial for PermaDerm cultured skin by the end of 2006. The trial is estimated to take about 15 months.
Upon completion of the analysis of the pivotal trial data, the company expects to submit the results to the FDA in its premarket approval application.
The purchase is expected to close within 30 days, subject to the completion of customary closing conditions.
Cambrex said that PermaDerm cultured skin will complement OrCel, a wound healing product from Ortec International (New York), which the company expects to market upon its anticipated regulatory approval this year.
In other dealmaking news:
• Community Health Systems (CHS; Brentwood, Tennessee) reported the execution of a definitive agreement to acquire the healthcare assets of Vista Health, which includes Victory Memorial Hospital with 336 licensed beds and St. Therese Medical Center, currently utilizing 71 non-acute care beds (both Waukegan, Illinois); as well as Vista Imaging Center (Gurnee, Illinois); Vista Surgery and Treatment Center (Lindenhurst, Illinois); and Vista M.R. Institute (Lindenhurst/Gurnee). The seller is a non-profit corporation.
CHS is an operator of general acute-care hospitals in non-urban communities throughout the country. Through its subsidiaries, it currently owns, leases or operates 71 hospitals in 21 states.
• LifePoint Hospitals (Brentwood, Tennessee) had signed a definitive agreement for the acquisition of 63-bed Smith County Memorial Hospital (Carthage, Tennessee), by Sumner Regional Health Systems (Gallatin, Tennessee).
The transaction, the terms of which were not disclosed, is expected to close in 1Q06.
LifePoint is a hospital company focused on providing healthcare services in non-urban communities. Of the company's 52 hospitals, 49 are in communities where LifePoint Hospitals is the sole community hospital provider.
• BioForce Nanosciences (Ames, Iowa) shareholders recently approved a merger with Silver River Ventures. The merger received formal approval with the substantial majority of shareholders voting in support. Formal closing of the transaction is expected to take place within the next few weeks.
In anticipation of the closing, Silver River has changed its name to BioForce Nanosciences Holdings.
BioForce Nanosciences has patented and patent-pending technology and products for ultramicroscale and nanoscale placement and patterning of active biomolecules and other materials. This technology is embodied in the NanoArrayer System, an instrumentation/software platform. The company is focused on providing practical molecular printing tools to the biomedical and life sciences markets.