A Medical Device Daily

PLC Systems (Franklin, Massachusetts) said that Ktec Corp. (Tokyo), its exclusive distributor in Japan, has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market PLC Systems' first-generation CO₂ TMR Heart Laser System (HL1) in Japan.

CO₂ TMR offers a treatment option for angina patients who suffer from severe coronary artery disease. PLC developed the CO₂ Heart Laser, the world's first transmyocardial revascularization (TMR) angina relief device approved by both the Japanese MHLW and the FDA.

Mark Tauscher, president and CEO of PLC Systems, said, “We believe the Japan Ministry of Health approval reinforces the strength of the scientific data and clinical evidence that supports the use of CO₂ TMR by cardiac surgeons for very sick heart patients.”

He added, “TMR fits very well within the portfolio of tools and technologies that surgeons have to treat the expanding population of heart patients who have limited choices available for revascularization therapies.”

PLC said that to date, Ktec (formerly known as Imatron Japan), has made investments in purchasing its heart lasers, funding a clinical trial in Japan and supporting the regulatory approval process in that country.

Going forward, Ktec will manage the ongoing regulatory, clinical, marketing and sales activity for CO₂ TMR in Japan. For the remainder of 2006, Ktec will begin the process of establishing the TMR market through hosting educational seminars, attending scientific trade shows and conducting training events.

Currently, Ktec has 12 HL1s in Japan.

Inverness adds China facility

Diagnostics manufacturer Inverness Medical Innovations (Waltham, Massachusetts) said it has acquired a newly-constructed manufacturing facility in Hangzhou, China, as part of its acquisition of Acon Laboratories ' business of researching, developing, manufacturing, marketing and selling lateral flow immunoassay products in the U.S., Canada, Western Europe, Israel, Australia, Japan and New Zealand.

Inverness paid Acon about $20 million, including 417,446 shares of Inverness common stock to acquire the new facility. The aggregate purchase price for the acquired business, including the manufacturing facility, is expected to be approximately $175 million based upon a multiple of revenue and pre-tax profits of the acquired business.

The remaining payments under the agreement with Acon, which are expected to be about $80 million, are contingent upon completion of certain milestones related to achievement of functional manufacturing operations in certain territories and regulatory clearance in Spain and Portugal. Some $20 million of the remaining payments will be made through the issuance of Inverness common stock, with the balance payable in cash.

The sale of the new manufacturing facility was triggered when the parties agreed that the facility was fully functional with respect to the first substantial product and the facility is now producing several of the drugs-of-abuse testing products acquired by Inverness from Acon.

The remaining products acquired from Acon are expected to be transitioned to the new facility during the remainder of 2006.

Acon Laboratories retains its existing manufacturing facility, also in Hangzhou.

MedMira HIV test okayed in China

MedMira (Halifax, Nova Scotia), a maker of rapid diagnostic solutions, said it has received approval from the State Food and Drug Administration (SFDA) in China for its MiraWell Rapid HIV Test (MiraWell HIV) for use with whole-blood specimens.

MedMira's test is the first and only whole-blood rapid HIV test to fulfill the clinical requirements of the Chinese regulatory body. The test offers users instant results and has a shelf life of two years at room temperature storage.

“We are pleased to receive fast-tracked approval of our whole-blood rapid HIV test and view this as another major step taken by the government to stop the spread of HIV infection in China,” said Stephen Sham, chairman and CEO of MedMira.

The MiraWell HIV test for use with serum/plasma was initially approved by the SFDA in 2003 and since that time has faced many domestic competitors in the China market. The company said it pursued whole-blood approval to differentiate itself in the marketplace and meet the growing demand for rapid point-of-care testing.

With whole-blood approval now in place, MedMira said it intends to develop market opportunities in the over-the-counter sector for further penetration into China.

Sham said, “Our goal is to bring easy-to-use, quality rapid diagnostics closer to the patient. With whole-blood approval in China, we can now offer a lab-focused product as well as point-of-care tests. Soon, we will pursue the over-the-counter market, building on our experience gained in Hong Kong and Macao, where we have sold rapid HIV tests in pharmacies since early 2005.”

South Korean cancer diagnostic accord

Oncotech (Tustin, California), a provider of cellular and genomic information to oncologists to individualize chemotherapy, reported an agreement with Innocell , a cancer diagnostics and immunotherapy company in South Korea. Under the agreement, Innocell has been granted the rights to market Oncotech's cancer diagnostic services to South Korean physicians and cancer patients.

More than 5,000 physicians and some 1,000 hospitals in the U.S. already have utilized Oncotech's cancer testing services. In South Korea, the overall incidence for cancer is in excess of 100,000 patients per year.

Frank Kiesner, president and CEO of Oncotech, said, “Our relationship with Innocell will allow us to gain entry into the South Korean market with this initial launch into Asia and in the future our laboratory services will be offered to other Asian markets through additional agreements and affiliations.”

Dr. Hyun Jin Jung, president and CEO of Innocell, said, “Through this collaboration, we can contribute to prolonging the life and improving the quality of life for Korean cancer patients.”