A Medical Device Daily

LinkMed (Stockholm, Sweden) said it is investing SEK 4 million in Likvor, which is developing an instrument to measure cerebrospinal fluid pressure.

Likvor becomes the 12th company in LinkMed’s portfolio. The company is currently carrying out a multi-center study at five university hospitals in Sweden and Denmark that will form the basis for the commercial design of the product.

LinkMed’s investment is being made in conjunction with a new share issue from Likvor for a total of SEK 5.5 million to finance the development work. It will have an ownership stake of 49% in the company. The investment is pending certain conditions.

Patients with changes in the pressure of cerebrospinal fluid often show different symptoms, such as changes in personality, dementia, disturbances in balance, irritation, headaches and vomiting. The pressure can be evened out by operating a shunt into the brain.

Linkmed said there currently are no commercially available methods for measuring cerebrospinal fluid in a safe and successful way. As a rule, patients with problems related to high pressure are identified in healthcare checkups, but patients with normal or low pressure sometimes experience symptoms such as disturbance in balance or dementia-like symptoms and are harder to identify.

The venture firm said that V sterbotten county council and the institute of clinical neuroscience at Umeå University have carried out “extensive research” on the measurement of pressure in the brain and cerebrospinal fluid. That research has resulted in an instrument that can safely and effectively measure cerebrospinal fluid pressure and has been used on more than 1,000 patients at Umeå University Hospital.

Likvor, established earlier this year by Uminova Invest, has acquired the instrument and related patents in order to develop a commercial product. It is estimated that clinical work will be completed by year-end, after which the results will be compiled and analyzed.

LinkMed develops new life-science companies in collaboration with innovators. It said it has contributed entrepreneurship and capital to create a portfolio of 11 companies, six in drug development and biotechnology and five in medical technology.

CE mark for PleuraSeal system

Covidien (North Haven, Connecticut) has introduced the PleuraSeal Lung Sealant System to the European market. The system, CE-marked, is intended for use as a surgical sealant during elective pulmonary resection as an adjunct for standard closure techniques of visceral pleural air leaks.

The PleuraSeal sealant system offers surgeons an advanced hydrogel technology that Covidien said provides “an immediate airtight seal that is effective intra-operatively and throughout the critical lung healing period.”

The company said it may improve patient outcomes by enabling earlier chest tube removal once drainage is complete and by reducing the incidence of prolonged air leaks.

“Our investment and efforts to develop and commercialize new biosynthetic technologies aim to address unmet clinical needs and to improve patient outcomes,” said Scott Flora, president, surgical devices, at Covidien. “We believe that this highly innovative synthetic sealant will be adopted quickly by any surgeon unsatisfied with the options available today.”

Air leaks are a common complication during thoracic procedures, requiring chest tube management until they resolve, thus impacting patient length of stay. Covidien said \air leak duration is difficult to predict and, in some cases, may lead to prolonged air leaks and additional complications, including infection.

Paul De Leyn, MD, professor of thoracic surgery at the University Hospitals Leuven Gasthuisberg (Leuven, Belgium) and coordinating investigator of the PleuraSeal Multi-Center Randomized Post-Market Study, said, “An easy-to-use and effective thoracic lung sealant to address complications in thoracic procedures will be very welcomed by the surgical community. We have been impressed by the performance characteristics of PleuraSeal [thus far].”

The PleuraSeal system is available throughout Europe and in select Middle East markets. It has not yet been approved in the U.S.

Calypte sets up new branch in Geneva

HIV test maker Calypte Biomedical (Lake Oswego, Oregon) reported that it has established a branch office in Geneva, Switzerland, to expand its relationships with international organizations, as well as market its diagnostic tests to Europe, Central Asia and French-speaking Africa.

The company named Khatuna Janjalia president and Kartlos Edilashvili VP of the Geneva branch office.

“We believe that a regional presence on the ground is a key component in reaching these new markets, which represent attractive opportunities for our Aware test,” said Roger Gale, company CEO and Chairman. “The Geneva branch office also will provide policy and technical advisory services for the company, liaising with external counterparts in international NGO, humanitarian organizations and multilaterals based out of Geneva.”

Janjalia joins Calypte from Audit Control and Expertise Group (ACE), where she was head of the credit enhancement organization’s department for East Europe, South Caucasus and Central Asia. While there, she established and strengthened affairs with partner companies in the countries within Eastern Europe, South Caucasus and Central Asia. She also originated structured trade and commodity finance.

Previously, she was a senior representative for international and media relations of the World Agency of Planetary Monitoring and Earthquake Risk Reduction (WAPMEER) and also held position as consul of the Embassy of Georgia to Switzerland, counselor of the Permanent Mission of Georgia to the United Nations Office and other international organizations in Geneva.

“I am excited to join Calypte, where I expect to use my relationships to help market Aware to governments and international organizations,” Janjalia said. “Geneva represents the ideal location, as many of the organizations involved in global healthcare — such as the Global Fund, UNAIDS and the World Health Organization — are based here. I look forward to helping Calypte play an important role in the prevention and treatment of HIV.”

Calypte’s Aware HIV-1/2 OMT test is used at the point of care and in the home.