October 5, 2006

For Immediate Release

Technologies on the Leading Clinical Edge -- Insights into Emerging Market Opportunities

FOOTHILL RANCH, CA — The most significant developments affecting current and future medical technology markets are revealed at a point MedMarket Diligence (MMD) refers to as the "Leading Clinical Edge".  Here, the most important clinical trial results emerge, specific new technologies are evaluated, clinicians explore new techniques and other developments occur that have the potential to dramatically expand, overturn or create medical technology markets.  "Leading Clinical Edge" is a regular feature of MedMarkets, from MMD.

"As we track and measure the impact of developments in medical technology markets, the real crux of how future markets are formed, or even dissolved, becomes apparent by examining the leading edge of clinical development," says Patrick Driscoll, president of MMD. "This is where new medical devices, other medical products and even new medical/surgical techniques are demonstrated for their potential to redefine medical markets."  According to Driscoll, the most obvious source of information is clinical trial results, but that reveals only a small view of the potential future.  Peer-reviewed journals, technology transfer sources, patent applications, and a host of other published information can reveal important market opportunities for medical product manufacturers.

In each month's issue of MedMarkets, the "Leading Clinical Edge" column highlights the developments revealed by MMD researchers and analysts to have the potential to alter medical product markets.  Subscribers can get important glimpses of future medical technology markets.

Below is an excerpt from Leading Clinical Edge in the September 2006 issue of MedMarkets.


Mice Stem Cells Reprogrammed

Adult stem cells from mice can be reprogrammed to closely resemble embryonic stem cells (ESCs), according to Japanese researchers. With the introduction of four factors (genes), the researchers were able to convert the mouse cells into cells that behave like ESCs. The cells, called induced pluripotent stem cells, exhibit the physical, growth and genetic characteristics typical of ESCs. This study suggests it may be possible to obtain cells offering the advantages of ESCs from nonembryonic sources. Still, the researchers cautioned that results from the study are preliminary and additional research needs to be conducted to determine the full application of the pluripotent stem cells. Kazutoshi Takahashi, et al., Cell, 126(4): 663–676 (August 25, 2006).
Web Site: http://www.cell.com

Cardiology & Cardiovascular Surgery

Gene’s Role in Heart Disease Studied

Variations in the gene, GATA2, which acts as a switch to activate other genes, may predispose individuals to heart disease, according to a team of international researchers. The study focused on specific gene variants, called single nucleotide polymorphisms (SNPs), which occur when a single nucleotide building block in the strand of DNA is altered. The scientists analyzed DNA from 3,000 people with a familial history of coronary artery disease. Using these samples, they scanned the GATA2 gene for SNPs that differed in sequence between individuals with and without coronary heart disease. Five SNPs were closely associated with early onset coronary artery disease, leading the researchers to validate the suspected link between GATA2 and coronary artery disease. Jessica Connelly, et al., Public Library of Science Genetics, 2(8): 139–145 (August 2006).
Web Site: http://genetics.plosjournals.org

Cardiac CT Can Date Heart Attacks

Cardiac computed tomography (CT) can determine whether an MI is recent or long-standing by measuring attenuation values and ventricular dimensions, report researchers from Massachusetts General Hospital. The researchers evaluated contrast-enhanced coronary CT scans of patients with a recent MI (less than seven days), a long-standing MI (greater than 12 months) and no MI. In studying the results, the researchers created a number of thin slices parallel to the myocardial wall. The slices were assessed for myocardial attenuation, the ventricular wall was measured for thickness and the myocardial cavity was measured. The patients with long-standing MI had significantly lower CT attenuation values than the other groups. Koen Nieman, et al., The American Journal of Cardiology, 98(3): 303–308 (August 1, 2006).
Web Site: http://www.ajconline.org

Replacing Electronic Pacemakers with Cells

A custom designed protein and gene delivery system has been used successfully to restore normal heart rhythms in pigs with electronic pacemakers, according to a UC Davis study, which was co-authored by an international team. In the study, the scientists delivered a gene, which encoded a bioengineered cell-surface protein to heart muscle cells of pigs. The protein mimics the combined action of several proteins called HCN ion channels, which help maintain a normal, evenly paced heartbeat. By getting heart muscle cells to produce bioengineered HCN channels, the researchers were able to reconstruct the sinoatrial node of the heart in pigs with implanted electronic pacemakers. In just a few days following the gene transfer, the pigs’ hearts had generated bioartificial nodes at the injection sites. Two weeks after the injections, the new nodes were able to take over pacemaking function from the electronic devices. Hung-Fat Tse, et al., Circulation, 114(10): 1000–1011 (September 5, 2006).
Web Site: http://circ.ahajournals.org


Ultrasound Helps Drugs Enter Cells

Ultrasound energy can briefly enter the protective outer membranes of living cells to let drugs and other therapeutic molecules inside, report scientists from Georgia Institute of Technology. This development could advance the use of ultrasound for delivering gene therapies, as well as for administering chemotherapy and large-molecule drugs that cannot readily move through cell membranes. The researchers showed that the violent collapse of bubbles, caused by ultrasound, creates enough force to open holes in the membranes of cells. The holes, which close in a matter of minutes, allow the entry of molecules as large as 50 nanometers in diameter. Daniel Hallow, et al., Ultrasound in Medicine & Biology, 32(7): 1111–1122 (July 2006).
Web Site: http://www.umbjournal.org

A Portable, Inexpensive MRI?

Researchers at the U.S. Department of Energy’s Lawrence Berkeley National Laboratory are testing a laser-based MRI technique that could result in a new compact, portable and less expensive tool for administering magnetic resonance imaging (MRI). This new laser-based technique separates the two basic steps of MRI: signal encoding and detection. Physically separating these two steps allows each to be optimized for sensitivity. The researchers used optical atomic magnetometry, which possesses a high sensitivity independent of the strength of the static magnetic field. This extends the applicability of MRI to low magnetic fields and could eliminate imaging artifacts associated with high fields. Shoujun Xu, et al., Proceedings of the National Academy of Sciences, 103(34): 12668–12671 (August 22, 2006).
Web Site: http://www.pnas.org


Nanowires, Neurons Used to Study Brain Activity

Slender silicon nanowires have been used by Harvard researchers to detect, stimulate and inhibit nerve signals along the axons and dendrites of live mammalian neurons. The tiny nanowire transistors developed by the researchers gently touch a neuronal projection to form a hybrid synapse, making them noninvasive. In addition, these nanowires are thousands of times smaller than the electronics currently used to measure brain activity. The researchers are now working toward monitoring signaling among larger networks of nerve cells. They previously had shown that nanowires can detect, with great accuracy, molecular markers indicating the presence of cancer in the body, as well as single viruses. Gengfeng Zheng, et al., Science, 313(5790): 1100–1104 (August 25, 2006).
Web Site: http://www.sciencemag.org


Immune Cells Used as Tumor Fighters

Researchers at the National Cancer Institute have genetically engineered normal immune cells to become specialized tumor fighters, demonstrating for the first time that these cells can be used to shrink large tumors in humans. Two of 17 patients with advanced melanoma who received the experimental treatment saw their tumors shrink and were declared cancer-free more than a 18 months after the therapy began. The therapy focuses on using T cells, a special type of immune cell that can recognize and attack foreign cells such as those found in tumors. Although the study up to now has only involved a small group of melanoma patients, the researchers are exploring applications for breast, lung and liver cancer. Richard Morgan, et al., Science, published online on August 31, 2006.
Web Site: http://www.sciencemag.org

New Procedure for Benign Liver Tumors

Ultrasound-guided radiofrequency ablation (RFA) is efficient and safe in treating hepatic primary cysts, according to Chinese researchers. Compared to other methods, ultrasound-guided RFA can be performed using local anesthesia and does not require a laporotomy, minimizing injury and pain. The study also demonstrated that after one year following the procedure, the majority of patients did not experience significant recurrence. The study involved 12 male patients and 17 female patients, and the mean age was 47.2 years. For more information, contact Dr. Du Xi-Lin at dxlin@fmmu.edu.cn or dxlin0705@163.com.


Researchers Await Knee Repair Study Results

Researchers and orthopedic surgeons eagerly await initial results in October of the first clinical trial using stem cells to repair the meniscus. A total of 55 patients were treated in the Phase I/II double blinded, placebo-controlled trial designed to evaluate the safety and effectiveness of stem cell therapy that could potentially regenerate meniscus. The therapy involves injections of Chondrogen, which are adult mesenchymal stem cells (MSCs). In the United States, approximately 800,000 people each year have surgery to remove damaged or torn meniscus. While the surgery often relieves the pain, patients who have this surgery are at a much greater risk for developing arthritis. For more information, contact Dr. C. Thomas Vangsness, lead researcher, at http://www.vangsnessmd.com.


About MedMarket Diligence
MedMarket Diligence provides tactical decision-making solutions on medical technology to the medical products and investment industries. The company publishes the MedMarkets newsletter, a monthly analysis of the market implications of new medical technologies, and dedicated reports on technology markets.  For additional details, contact Patrick Driscoll at email or call 949-859-3401 or toll-free (in the U.S.). 1-866-820-1357.