Biomedical Engineering News

Approximately 60 to 80 percent of amputees suffer from phantom limb syndrome, a sensation where a missing limb feels as if it is still attached to the body. Often to the detriment of the amputee, the phantom limb is perceived as clenched or in a painful position. Aside from drugs and electrical stimulation, patients can find relief via mirror therapy, which involves the use of a mirror to trick the brain into thinking that the actions of a remaining limb are being performed by the phantom limb.

While using virtual reality (rather than a mirror) as a therapeutic method for phantom limb research is not entirely new, one student named Benjamin Blundell, in collaboration with the Advanced Interfaces Group from the University of Manchester, has hacked the popular Microsoft Kinect gaming platform to build a more immersive virtual reality world for phantom limb sufferers. The Kinect has offered many hackers the technology and opportunity to re-purpose the motion sensors and game controls for different applications relatively cheaply and efficiently.

For his specific project, Blundell used the Kinect and wireless sensors to detect the rotation and positioning of the amputee’s existing limb so that the amputee’s missing limb could be virtually ”filled in”. The patient was instructed to wear virtual reality goggles, to make this experience more realistic, and Blundell expects specific games to be developed for users in the future.

While the Kinect hack is still not quite as cheap as a mirror box, preliminary results from the informal patient trial show promise and Blundell and his fellow researchers hope to take the technology forward and explore the possibilities. A paper on the project has been accepted for publication:

S. Pettifer, T.L.J. Howard, B. Blundell, and D. Edwards. An immersive virtual environment for phantom limb pain rehabilitation. In Proceedings of the International Conference of Computer Graphics Theory and Applications (GRAPP), February 2012.

For a quick overview of the project, check out the video below.

Shiga toxin is a dangerous by-product of certain infectious bacteria, such as strains of Shigella and E. coli, which causes symptoms ranging from intestinal pain to kidney failure and even death. Over 150 million people are afflicted with Shiga toxicosis every year, mostly in developing countries where waterborne diseases are prevalent. It is estimated that Shiga toxins kill more than one million people annually, and is particularly lethal to children. Even in developed countries, Shiga toxicosis remains a threat via foodborne outbreaks.

While exploring the inner workings of the cell, scientists at Carnegie Mellon discovered that Shiga toxin exploits the GPP130 protein found in the Golgi apparatus. As described in their article for the January 20th issue of Science, when a harmful substance enters the cell, it is normally packaged by the Golgi apparatus and sent to the lysosome for degradation. GPP130, however, is an unusual protein that cycles from the Golgi apparatus to endosomes and back without crossing paths with the lysosome. This feature of the GPP130 is utilized by the Shiga toxin which binds to the protein to avoid detection allowing it to remain in the cell where it can cause harm.

However, when high levels of manganese infiltrate the cell, GPP130 alters its pathway to go directly to the lysosome. Beyond a certain point, manganese is also toxic to humans, but the concentrations and methods of administration are already well-documented.

“Manganese is inexpensive. While Shiga toxin affects people in the developed world, it affects far more people in the developing world. An inexpensive, accessible treatment– not a designer drug — is the ideal solution,”  says Adam Linstedt, professor of biological sciences at Carnegie Mellon. “While further testing is needed to determine if manganese is a suitable treatment for humans, I’m optimistic that trials should move forward quickly.

Current treatment methods utilize antibiotics to kill the Shiga-excreting bacteria, which actually causes them to lyse (or break apart) and release the toxin in higher concentrations to the detriment of the host. The researchers propose using manganese in conjunction with the antibiotics to neutralize the toxin as well as the bacteria simultaneously. If the scientists are successful in balancing the manganese dosage and the proper supply chain avenues are set up, millions of lives could be saved.

Qualcomm Life, a subdivision of the major telecom product company that aspires to be a market leader in the developing wireless health network, recently unveiled their new 2net™ Platform and Hub.  Qualcomm Life was formed last week as a wholly owned subsidiary to operate the formerly known Qualcomm Wireless Health. 2net™ includes a wireless hub hardware that integrates signals from many health monitoring devices around the home, collects and encrypts the data,  then sends it to the cloud for physicians or other permitted parties to view.

Roughly 133 million Americans suffer from chronic diseases and their homes are littered with health monitoring devices such as blood pressure monitors or glucose meters. These devices collect data that would greatly benefit health providers in making more efficient treatment decisions if only they had access to that data.

While it is possible to use apps on smartphones to collect and transmit health data, not all signals from the array of health monitoring devices can communicate with smartphone technology. Qualcomm Life Vice President Rick Valencia purports that the new 2net™ Platform not only meets all medical standards, but is “technology agnostic, and can pair with virtually anything”. Qualcomm life is in the process of establishing partnerships with several device manufacturers and their case studies show positive results for the growing wireless healthcare user market.

“There are plenty of apps that will monitor your heart rate or glucose, but if it’s involved in any clinical decision making, that will need to be sent over secure channels and have backup capabilities,” says Andy Castonguay, principal analyst for handsets and devices at Informa.

2net™ is likely the first product on the market with its level of connectivity, security and ease-of-use. 2net™ Platform will probably include a service fee, but Qualcomm Life supports that the convenience and widely informative technology will be worth the price.

Biogen Idec Inc. has announced its third quarter 2010 results. Following are its highlights:

• Third quarter revenues were $1.2 billion, an increase of 5% over the third quarter of 2009, driven primarily by AVONEX(R) (interferon beta-1a) revenues, which increased 11% to $644 million and TYSABRI(R) (natalizumab) revenues, which increased 7% to $221 million. RITUXAN(R) (rituximab) revenues decreased 9% to $258 million.
• Global in-market net sales of TYSABRI in the third quarter of 2010 were $307 million, an increase of 9% over the third quarter of 2009, of which $151 million were in the U.S. and $156 million were in rest of world markets.
• Third quarter 2010 GAAP diluted EPS were $1.05, an increase of 11% over the third quarter of 2009. GAAP net income attributable to Biogen Idec for the quarter was $254 million, a decrease of 8% compared to the third quarter of 2009.
• Third quarter 2010 non-GAAP diluted EPS were $1.35, an increase of 21% over the third quarter of 2009. Non-GAAP net income attributable to Biogen Idec for the quarter was $328 million, an increase of 1% over the third quarter of 2009. A reconciliation of Biogen Idec’s GAAP to non-GAAP results is included on Table 3 within this press release.
• Year over year comparisons are impacted by an agreement with Knopp Neurosciences. The impact of this agreement on results for the third quarter of 2010 was $86 million and $26 million on a GAAP and non-GAAP basis respectively. Additional information on this agreement may be found in the slide presentation that accompanies our third quarter earnings conference call.

The U.S. Food and Drug Administration made a move this month that show a tougher regulatory agency—at least one that is erring on the side of patients, rather than pharmaceutical companies. The FDA revoked its approval for Menaflex Collagen Scaffold, a mesh that was intended to facilitate the regrowth of knee meniscus tissue after orthopedic surgery. The FDA had given ReGen Biologics 510(k) approval to manufacture and sell the surgical mesh for knee repair surgery in December 2008. However, the review process and approval were marred by controversy. Even Congress chimed in on in the Menaflex case as an example of how the the FDA’s 501(k) approval process may not be stringent enough to ensure patient safety. Many industry professionals view the FDA’s vote to pull ReGen’s approval as a sign of a different kind of FDA.

Those that predict stricter requirements for the FDA approval process cite the almost simultaneous decision pull sibutramine (Meridia) from the market. While Abbott Laboratories’ decision to pull the weight loss drug from shelves was considered voluntary, the pharmaceutical company’s letter to healthcare providers clearly states that it does not agree with the FDA’s decision that Meridia is unsafe for patients.

Some have suggested that the new climate at the FDA is based on the political atmosphere in Washington. The either years of the George W. Bush administration saw a relaxation in the positions of various regulatory agencies, including the FDA. Now that Democrats control the White House and both houses of Congress, there is a general move toward tighter regulation, including the process by which drugs and medical devices show safety and efficacy to the FDA in order to gain approval.

While it does appear that the 510(k) vehicle for approval is going to disappear, it is entirely conceivable that the requirements to demonstrate that a product is “substantially similar to predicate drugs/devices” will be more rigorously applied and enforced. At least until the pendulum swings the other way in Washington.

ViroPharma Incorporated has released their third quarter financial results. The main takeaways are as follow:

• Achieved a record $118 million in net product sales;
• Increased Cinryze net sales by 69 percent over prior year’s third quarter to $49 million;
• Attained Non-GAAP adjusted net income of $47 million, representing 70 percent growth over the prior year third quarter; GAAP net income reached $38 million;
• Delivered positive cash flows from operations of $45 million;
• Improved working capital to $512 million as of September 30, 2010, including cash, cash equivalents and short-term investments of $448 million; and
• Presented data from Phase 1 study of VP20621 (non-toxigenic C. difficile) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

You can read the entire news from ViroPhrama’s website.