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I recently attended a symposium on Neuroprosthetics at Worcester Polytech Institute (WPI). Prosthetic technology has advanced tremendously in the last 10 years due to the demand for better prosthetics. I will cover the three main drivers for better prosthetics and the technology that resulted from this demand.

Read on to learn more about this topic and other current news. On the right are quick links to the topics covered in this month's newsletter. The next newsletter will be published on April 15th.   

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Please email me, Regina Au, if you have any questions, comments, or suggestions.

Sincerely,

Regina Au

Principal, Strategic Marketing Consultant

BioMarketing Insight 

There are three (3) main drivers for the advancement of prosthetic technology: 1) increased number of civilian amputees, 2) increased number of military amputees and 3) demand for better technology in transitioning amputees back into the work place and society.

In the US there are three major causes for the loss of a limb or limbs: 1) vascular diseases (i.e. diabetes and peripheral artery disease (PAD), 2) trauma (i.e. car and lawn mower accidents), and 3) war.

Civilian Amputees:

According to the Amputee Coalition, a national nonprofit organization, 507 people a day lose a limb, largely due to vascular-related diseases, and 60 percent are preventable.  Their mission is to increase awareness about limb loss prevention and those living with limb loss.

"Limb loss is not uncommon and, sadly, becoming less uncommon every day," said Kendra Calhoun, Amputee Coalition president and CEO. "More than 2 million Americans live with limb loss and that number grows by 185,000 each year."

Here are some statistics from the Amputee Coalition on vascular disease and trauma:

1. The main causes of limb loss are vascular disease (54 percent), trauma (45 percent), and cancer (less than 2 percent).
2. 60 percent of limb loss is preventable.
3. Diabetes and vascular disease are the leading causes of limb loss.
4. In 2008, hospital charges associated with having a limb amputated totaled more than $7.2 billion in healthcare costs.
5. Nearly 60 percent of the amputation procedures performed in 2008 was paid for by Medicaid and Medicare, totaling more than $5.2 billion in healthcare costs.
6. 600 children lose a limb due to lawnmower accidents each year. Lawn mower-related injuries account for more than 51% of traumatic amputations among children.
7. African Americans are four times more likely to lose a limb than non-Hispanic white persons.
8. 75 percent of pediatric amputations are due to trauma.

Military Amputees:

In 2009, a United States Military Casualty Statistics report, published by the Congressional Research Service, stated that the amputee population in the US Military forces due to Operation Iraq Freedom (OIF) consists of 1,091 service members. This number represents 85% of the total service member amputations which occurred between 2001 and 2009. More than 50% of the amputations were caused by improvised explosive devices (IEDs).

According to a Pentagon report on the Afghanistan war:  

1. The number of troops who have had amputations rose from 86 in 2009 to 187 in 2010. As of September 2011, the count was 147.
2. The number of troops who lost two or three limbs rose from 23 in 2009 to 72 in 2010; the figure was already 77 as of September of 2011.

From 2001 to September 10, 2010, the total number of amputees that included Operation Iraq Freedom (OIF), Operation Enduring Freedom (OED), and unaffiliated conflicts, was 1,621.   The Department of Veterans Affairs reported that 1,286 service members, who are now amputees, are the result of the Iraq and Afghanistan wars.  

It is difficult to calculate the actual number of amputees in the military because of the various methodologies used and the sources of information. The final result is that due to the Iraq and Afghanistan war, there are a significant number of amputees, twice that of past wars according to some reports.

Transitioning Back into the Work Place and Society:

Due to the increase in the number of amputees particularly from the military sector where soldiers may have single, double and triple loss of limb, there is a push for advanced technology to transition soldiers back into society successfully.

In 2004, the Department of Veterans Affairs awarded Brown University in Providence and MIT a five year joint research grant of $7.2 million to design more functional prosthetic limbs. The research focused on building better titanium prosthetic limbs, extend bone stumps for tighter attachment of prosthetics, and use computer technology to develop prosthetic devices that can be controlled by brain sensors implanted in patients.

According to Dr. Roy Aaron from Brown Medical School, at that time, the current VA medical system "literally cannot handle the load" of amputees.  Dr. Aaron headed up the Brown-MIT effort which included the Providence VA Medical Center. "Amputee research has never been a high priority because it's not . . . fashionable," said Aaron. "Iraq has changed that."

Stephan Fihn, acting VA chief research and development officer, said that military officials were concerned about the expected flood of amputees but that the system would "absolutely, without a doubt" be able to handle them. "Returning veterans from Iraq and Afghanistan are our highest priority now," he said.

Colonel Geoffrey Ling, MD, Program Manager, DARPA, one of the speakers at the Neuroprosthetics Symposium funded research for upper limb prosthetics. I'll be covering this research in the next section.

Image source: www.mirror.co.uk.

Extensive media coverage of extraordinary Paralympics athletes such as Oscar Pistorius (aka The Blade Runner) from South Africa, help to make disabilities a thing of the past. They also serve as role models for those with prosthetics. Oscar's motto: "You're not disabled by the disabilities you have, you are able by the abilities you have."  

Blade Runner Oscar Pistorius qualified for the World Championships and the London 2012 Olympics after clocking 45.07 seconds for the 400 meters in Italy.   

The South African double amputee runs with carbon fiber prosthetic running blades.  He was born without a fibula in both legs but achieved the 45.25 seconds 'A' standard qualifying time by winning a race in Lignano.

The 24-year-old four-time Paralympic gold medalist, finished well above his personal best time of 45.61 seconds.

For more information on Oscar Pistorius, click here.  

Contact me should you have any questions or  feedback on this topic. 

In 2010, the global orthotics and prosthetics market was valued at $3 billion according to Companies and Markets research. The company forecast that the compound annual growth rate (CAGR) from 2010-2017 will be 6% to more than $4.5 billion by 2017. 

1. The US is the largest orthotics and prosthetics market with 42% of total global revenue
2. The orthotics market accounted for 74% of the combined orthotics and prosthetics market 
3. DJO Incorporated is the global market leader in the orthotics market with 21% market share
4. Otto Bock is the market leader in the prosthetic market with 55% market share

Contact me should you have any questions or feedback in this area. 

Photo by Len Rubenstein.

Hugh Herr, PhD. is Associate Professor of Program in the Media Arts and Sciences and MIT-Harvard Division of Health Sciences and Technology. His goal is to "apply neuromechanical principles of human movement to the development of highly functional prostheses and orthoses." His research is on Biomechatronics, an interdisciplinary science of integrating mechanical elements, electronics, and parts of biological organisms in developing actuator technologies or artificial muscle that behaves like human muscle.

The existing low technology leg prostheses provide mobility to an amputee, but there are many problems due to the laws of mechanical properties:

1) Leg prosthetic - requires a lot of energy and one can't walk very far.  As one tries to accelerate their speed while walking, the prosthetic is slow to react to the subject's desires or intentions.

2) Mechanical Ankle - it's a simple spring and does not mimic the human ankle.

3) Mechanical Knee- such as the Rheo knee can adapt automatically to individual walking speeds.  However; 

a) It can't recognize and adapt to different terrains quickly such as going up or down the stairs or slope.

b) It doesn't have the ability to obtain vertical lift like a human knee in conserving energy and making it more efficient in walking.

Biomechatronics devices are based on how the human body works. In order for a foot to walk, four different steps must occur to be able to lift the foot.  First, impulses from the motor center of the brain are sent to the foot and leg muscles. Second, the nerve cells in the feet send information to the brain telling it to adjust the muscle groups or amount of force required to walk across the ground. Different amounts of force are applied depending on the type of surface being walked across. Third, the leg's muscle spindle nerve cells then sense and send the position of the floor back up to the brain. Finally, when the foot is raised to step, signals are sent to the muscles in the leg and foot to set it down.

A simplistic correlation to the human body would be that the biosensors acts as the motor center of the brain used to detect the person desires or intent. The mechanical sensors in the biomechatronic device act similar to nerve cells measuring information about the device and relays it the controller. The controller relays the intention of the person to the actuator or artificial muscle that produces movement.

Professor Herr has been successful in developing the following:

1)      Powered ankle foot - has several microprocessors to control a motor to replicate the spring-like action of the Achilles tendon to conserve energy thereby making it more efficient in walking.

2)      Swing leg control-position - able to obtain x, y, z axis or swing trajectory for pattern recognition in distinguishing the difference between walking up or down a hill and walking up or down steps.

3)      Force and varying stiffness of the ankle - able to alleviate strain on the knee and foot.

To see a video of Professor Herr's work, click here.  

Professor Herr predicts in the future there will be more neural control devices that have cognitive feedback. There are currently no prostheses that have cognitive feedback or a closed loop system where muscle nerves relay the movement back to the brain. A number of labs have been and are currently working on cognitive feedback for a number of years.  Future technology include:  

1)      Bi-directional peripheral neural interface that is implanted into the muscle to communicate with the nerve.

2)      Electromyogram (EMG) - using sensors that are implanted into the muscle and will be able to control one's gait.  If the calf muscle can't communicate with the device, there is no movement.

3)      Limitation of current intrinsic control is that is it unable to adapt or maintain balance in one's step due to the change in terrain.

Contact me should you have any questions or feedback on this topic. 

Colonel Geoffrey Ling, MD, Ph.D. is Program manager at the Defense Advanced Research Projects Agency (DARPA). Col. Ling focused on the upper extremities because lower-extremities have made significant advances due to the work of Hugh Herr mentioned above. But upper extremities are more difficult to develop largely due to the complexity of a five-fingered hand with an opposable thumb that allows 27 separate ranges of motion.

In a 2007 O&P Edge article with Col. Ling, he listed his requirements for upper extremities: a five-fingered hand; an elbow that can actually lift a decent amount of weight; a wrist that moves; and a shoulder.   "When you look at science right now - based upon myoelectric control that uses residual muscles - you simply don't have enough residual muscles to move all of the fingers and the thumb. Even if you were Bill Gates and you wanted to buy it, it just doesn't exist." Col. Ling says "You need the person's nervous system - their own thinking - to drive the arm."

A monkey feeding itself using a robotic arm   controlled by brain signals at the   University of Pittsburgh   (Andrew B. Schwartz, Ph.D./University of Pittsburgh)

Through an early program called Human Assist Neural Device (HAND), the works of Dr. Miguel Nicolelis, from Duke University, and Dr. Andy Schwartz from Univ. of Pittsburgh, trained monkeys to use their motor cortical activity to control an external mechanical arm to feed themselves. This inspired Colonel Ling, to develop the Revolutionizing Prosthesis Research Program in funding the development of two prosthetic arms.

Fast forward to today, the first is a noninvasive arm that is controlled by foot switches, body motion, and local control. It is strapped around the torso and the person is able to control the arm. However, the arm only meets the basic activities of daily living.

The second is a brain cortical controlled arm that promises to fully restore normal functionality including dexterous five finger control (see photo below). Tim Hemmes, a paralyzed adult with spinal injury, is controlling a robot arm with his thoughts. A series of electrodes were placed on the surface of his brain, so that he could control the external arm device. This project is being carried out by Andy Schwartz and other scientists at the University of Pittsburgh School of Medicine and UPMC Rehabilitation Institute.

Tim Hemmes gives his girlfriend a high-five (Photo: UPMC) Medical News Today, October 10, 2011

Engineers at Georgia Tech demonstrated at the IEEE International Solid-State Circuits Conference in San Francisco, a new wireless device that enables people with spinal cord injuries to operate a computer or maneuver a wheelchair by moving their tongue.

Image source: Futurity.org

The "Tongue Drive System" is worn like a retainer in the mouth of the user to track the location of a tiny magnet attached to the tongue.  "By moving the sensors inside the mouth, we have created a Tongue Drive System with increased mechanical stability and comfort that is nearly unnoticeable," says Maysam Ghovanloo, an associate professor in the School of Electrical and Computer Engineering at the Georgia Institute of Technology.

The signals from the sensors are wirelessly transmitted to an iPod or iPhone containing special software that interprets the user's tongue commands based on the magnet position relative to the sensors in real-time. This information can then move a cursor on the computer screen or the joystick on a powered wheelchair.

For the full story in Futurity.org, click here.   

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Thirty-one Medical Device and Thirteen Pharma/Biotech Funding Deals

To determine whether funding is picking up, I will be focusing on funds that are $1 million or greater in seed investments and series A or B (or the valley of death) that are pre-IPO. Even though VCs are investing, they continue to invest in their existing portfolio companies and less in new companies. Incubators, state funding, and business competitions are great for initial seed money but not enough to keep the company going long-term.

Partnerships and licensing deals with upfront payments and milestones will not be included.

Funding deals are in chronological order by date.

$0 = No financial terms disclosed. For more information, read more ....

Funding deals are in chronological order by date.

$0 = No financial terms disclosed. For more information, read more ...     

Acquisitions continue to be made for both medical device (12) and pharma/biotech (5). There were two private equity purchases:  Platinum Equity purchased DMS Health Technologies and Linden Capital Partners purchased SeraCare Life Sciences Inc.   

Acquisitions are in chronological order by date with Medical Device/Diagnostics followed by Pharma/Biotech.

$0 = No financial terms disclosed. For information on specific companies, read  more....

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