A Medical Device Daily

OrthoMimetics (OM; Cambridge, UK), the first technology spin-out from the Cambridge-MIT Institute (CMI), reported completing a Series A funding round totaling $9.6 million (5 million) net of costs.

Led by Andrew Lynn, founder and CEO, a team of surgeons, scientists and engineers from the University of Cambridge and the Massachusetts Institute of Technology (MIT; Cambridge, Massachusetts) OM to bring to market a medical device technology that it says has the potential to reduce the need for joint-replacement surgery.

“Closure of this funding round provides OrthoMimetics with a sound financial basis to move forward swiftly with its development program to bring the first of its products through clinical trials to CE-mark approval,” said Lynn.

The company said that completion of the funding round will enable it to advance the first two products derived from its orthobiologics scaffold platform towards market approval. ChondroMimetic, the company’s flagship product for cartilage repair, and LigaMimetic, OM’s pipeline product for ligament repair, address a combined yearly global market in excess of $1 billion the company said.

The financing round, managed by independent stock broking and wealth management group Eden Financial, was supported by a syndicate of investors including Schroders Investment Management, Oxford Capital Partners and Sloane Robinson Private Equity and a group of private investors of Eden Financial.

Abbott introduces DNA tests to Europe

The Abbott Molecular unit of Abbott Laboratories (Abbott Park, Illinois) said it has introduced six CE-marked DNA tests in Europe for use by diagnostic laboratories in identifying chromosomal abnormalities associated with certain forms of leukemia.

The tests are based on Abbott’s fluorescence in situ hybridization technology (FISH) and employ DNA probes used to detect genetic abnormalities, such as extra or rearranged chromosomes, common in patients with acute lymphocytic leukemia, chronic myeloid leukemia and chronic lymphocytic leukemia.

DNA probes are molecules stained with fluorescent dyes that recognize and bind to specific target molecules in patient samples. The fluorescent probes can be viewed under a special microscope, enabling the detection of chromosome gains, deletions or translocations.

According to the World Health Organization (Geneva, Switzerland), the global incidence of leukemia is about eight to nine per 100,000 people each year, with about 250,000 new cases occurring annually worldwide.

Abbott said the FISH tests are intended to supplement conventional cytogenetics (the analysis of chromosomes) and in some cases provide additional information not detected by other test methods. Conventional cytogenetics, for example, may indicate if large chromosome changes have occurred, whereas the FISH method targets specific, more cryptic chromosome defects known to be associated with cancers.

Both methods are needed to tell treating physicians whether a particular cancer is present or has recurred and to determine the patient’s prognosis.

“Combining traditional cytogenetics with FISH testing provides doctors with the accurate information they need to make better decisions regarding treatment options and quality of life,” said Professor Christine Harrison, director of the Leukemia Research Fund Cytogenetics Group at Southampton General Hospital in the UK.

Timothy Stenzel, MD, PhD, medical director at Abbott Molecular, said, “Certain genetic aberrations can be important indicators of whether a patient has a particularly aggressive form of leukemia or whether they will respond to certain therapies. Abbott’s FISH technology helps physicians diagnose different leukemias that may look similar but have different genetic abnormalities and therefore may require different treatment.”

The six probes that have received CE mark certification, allowing them to be commercially marketed in the European Union, include the Vysis LSI(R) p53/LSI ATM and LSI D13S319/LSI 13q34/CEP 12 Multi-Color Probe Sets; Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set (20 assays and 50 assays); Vysis LSI BCR/ABL ES Dual Color Translocation Probe Set; Vysis LSI BCR/ABL Dual Color, Single Fusion Translocation Probe Set; Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe; and Vysis LSI 21 SpectrumOrange Probe.

The six probes already are available in the U.S.

Vysis (Downers Grove, Illinois) is a unit of Abbott.

Abbot Molecular said these products represent the first in a series of CE-marked DNA probes that it expects to launch in Europe in the coming months. Future probes will be offered for a variety of applications in cancer and genetic testing.

Abbott Molecular develops FISH probes, offering a menu of tests for use in cancer diagnostics and genetic testing.

Statistics back use of Lucas system

The city of Lund has for the last three years (2003-2005) claimed the top position in the Swedish National Registry of Cardiac Arrest statistics for one-month survival rates of out-of-hospital cardiac arrest victims.

A presentation at last month’s Swedish CPR (CardioPulmonary Resuscitation) congress in Gothenburg strongly indicated that KAMBER, the organization of pre-hospital care in the region, has found an efficient way to save more lives.

Some 13.7% of the victims in Lund are alive one month after the event, close to double the Swedish national average of 7.3%.

A key factor in Lund is the implementation of the automatic Lucas Chest Compression System from Swedish firm Jolife (Lund, Sweden) in all ambulances. Lucas provides mechanical compressions, which helps to ensure critical circulation to the heart and brain in a situation where time is limited.

The Lucas Chest Compression System provides continuous compressions, which ensures blood flow to the brain and heart.

“[Our] focus has been to optimize the ability to give enduring CPR with good quality over time, with a minimum of exposure for EMS personnel to traffic hazards during transportation,” said Johan Silfverstolpe, MD, of KAMBER.

“KAMBER is a pioneer worldwide in implementing Lucas,” said Jolife CEO Erik von Schenck. “The Lucas device was deployed in service in 2002, and it’s very exciting to follow the progress in survival rates.”

He added that the experiences of the company’s Swedish and other European customers are “very encouraging,” particularly since Jolife is currently introducing Lucas widely in Europe and the U.S.”