Great article from the WSJ on taxation of medical device companies- there has never been a truer statement than the headline- "The Innovation Tax" - or the last sentence. We think this is an unfortunate effect of the U.S. government needing to finance long-overdue healthcare reforms when they are already over-extended with insurance co. and investment bank bailouts, car company rescues, and the sinking U.S. dollar (shall we go on?). We also noted an insightful sentence toward the end of the article, "the device makers simply don't have the same political clout as the other big players, making them an easier mark." AdvaMed is apparently not as politically connected as PhRMA and the likes of Merck, Pfizer, and less diversified pharmaceutical manufacturers that don't derive as much of their revenue from devices and diagnostics. Too much of the U.S. system is rooted in money/profits and influence (i.e, political'connections'.)
Wednesday, 21 October 2009
Wall Street Journal's take on medical device industry tax
http://online.wsj.com/article/SB10001424052970204518504574418941379207328.html
More reaction to medical sector taxation reform
Yesterday morning saw representatives from several Minnesota medical technology companies, a VC company and even a couple of patients gather at Plymouth City Hall to protest against the $40 Billion tax on medical device firms, proposed as part of the Senate Finance Committee's health care reform bill.
Minnesota, as highlighted previously on this blog, is a key area for medical device companies, with somewhere in the region of 200 companies listed as being located there, and employing around 20000 people.
Rumours of a possible additional tax for medical device companies is causing considerable concern because of the potential impact on research and development, jobs and manufacturing as companies try to cut costs. Rumours around the tax have already begun to impact VC funding to small companies, impacting innovation. These companies are not just the lifeblood of the larger medical companies who frequently acquire clever start ups, but in the long term they are the lifeblood for patients laying their hopes on improved medical advance to cure diseases. Increasing taxes will increase costs or stifle development.
We hope that the mounting concerns are heard and acted upon. Extraordinary developments continue to be made by medical device companies all of the time, and without the small start ups, innovation in the sector will be strongly impacted. Taxing the innovation and creativity taking place in U.S. device and diagnostics companies is counter-productive from nearly every perspective. How would the tax apply to a larger healthcare company which receives a minority of its revenues from devices/diagnostics? Would it be exempt? Would the tax apply on a pro rata basis? Anyone know?
Tuesday, 20 October 2009
Company Focus: CeloNova Bio Sciences
Spoke yesterday with Teresa Wilson, Director of Strategic Analysis at CeloNova in Newman Georgia about the company's product, Embozene Colour Advanced Microspheres. CeloNova is involved in producing microspheres for embolization, an increasingly used technique in the field of Interventional oncology, both for the treatment of tumours or areas of unwanted bleeding, whereby Interventional Radiologists or specially trained physicians inject drugs or radiation into a blood vessel to target affected areas.
CeloNova is not alone- their key competitors in producing microspheres are BioCompatibles, Biosphere Medical and Boston Scientific, but where CeloNova differentiates itself is in being the first company to offer colour-coded microspheres to allow the doctor conducting the procedure to clearly see which calibration of tiny microsphere is being used, thus offering strong benefits in terms of patient safety, but also to help with the speed of the procedure, thus minimising possible radiation exposure time.
The use of microspheres to treat cancers has come about as doctors and researchers looked for targeted solutions that would allow the cancer itself to be destroyed whilst allowing the healthy tissue around the cancer to remain undamaged. Furthermore, because the threat to healthy tissue is reduced, higher doses of radiation or drugs can be applied to the tumour.
CeloNova has been in the press a couple of times in recent weeks, firstly when Dr Franco Orsi and his colleagues at the European Institute of Oncology concluded that the company's small, highly calibrated Embozene Microspheres were better than other products for the treatment of liver cancer and metastases. The EIO team has developed a technique to cut off the blood supply deep within the tumour bed of primary and metastatic liver tumours, leading to effective tumour control and reduced recurrence of tumours without thr use of chemotherapy drugs. The team highlighted that "The dimension and shape of embolic particles seem to be the most important characteristics for this aim".
This week the company also announced that it had received BSI approval for an expansion of the list of medical indications for which Embozene Microspheres can be used, as well as the addition of a tenth size of the product. In Europe, Embozene Microspheres are now approved for the treatment of liver cancer, uterine fibroids, tumour of the head, neck, torso and skeletal system, for bleeding and trauma, and for reducing pre operative bleeding throughout the body with the exception of the central nervous system.
Theresa also mentioned that the product has been piloted for use in cardiovascular procedures involving overactive heart muscles.
I asked Theresa about the challenges of interventional oncology gaining more mainstream acceptance, and she highlighted the continuing issue of "medical turf wars", that there are huge levels of competition between medical specialities and that the referral is always tricky to work out. This may be a specifically US problems- CMR has had discussions with a number of interventional radiologists in the UK, and the patients seem to be referred quite equally by phyisicans- as one told me "there are more than enough to go around".
Again, the U.S. system allows for, if not encourages, specialist physicians to 'market' themselves and their practices with the goal of maximizing their personal gain from their expertise; the 'entrepreneurial model'.For other innovators in the microsphere area, see Dr. Naomi Halas, Rice University, Houston, TX at http://www.ece.rice.edu/~halas/.
CeloNova is not alone- their key competitors in producing microspheres are BioCompatibles, Biosphere Medical and Boston Scientific, but where CeloNova differentiates itself is in being the first company to offer colour-coded microspheres to allow the doctor conducting the procedure to clearly see which calibration of tiny microsphere is being used, thus offering strong benefits in terms of patient safety, but also to help with the speed of the procedure, thus minimising possible radiation exposure time.
The use of microspheres to treat cancers has come about as doctors and researchers looked for targeted solutions that would allow the cancer itself to be destroyed whilst allowing the healthy tissue around the cancer to remain undamaged. Furthermore, because the threat to healthy tissue is reduced, higher doses of radiation or drugs can be applied to the tumour.
CeloNova has been in the press a couple of times in recent weeks, firstly when Dr Franco Orsi and his colleagues at the European Institute of Oncology concluded that the company's small, highly calibrated Embozene Microspheres were better than other products for the treatment of liver cancer and metastases. The EIO team has developed a technique to cut off the blood supply deep within the tumour bed of primary and metastatic liver tumours, leading to effective tumour control and reduced recurrence of tumours without thr use of chemotherapy drugs. The team highlighted that "The dimension and shape of embolic particles seem to be the most important characteristics for this aim".
This week the company also announced that it had received BSI approval for an expansion of the list of medical indications for which Embozene Microspheres can be used, as well as the addition of a tenth size of the product. In Europe, Embozene Microspheres are now approved for the treatment of liver cancer, uterine fibroids, tumour of the head, neck, torso and skeletal system, for bleeding and trauma, and for reducing pre operative bleeding throughout the body with the exception of the central nervous system.
Theresa also mentioned that the product has been piloted for use in cardiovascular procedures involving overactive heart muscles.
I asked Theresa about the challenges of interventional oncology gaining more mainstream acceptance, and she highlighted the continuing issue of "medical turf wars", that there are huge levels of competition between medical specialities and that the referral is always tricky to work out. This may be a specifically US problems- CMR has had discussions with a number of interventional radiologists in the UK, and the patients seem to be referred quite equally by phyisicans- as one told me "there are more than enough to go around".
Again, the U.S. system allows for, if not encourages, specialist physicians to 'market' themselves and their practices with the goal of maximizing their personal gain from their expertise; the 'entrepreneurial model'.For other innovators in the microsphere area, see Dr. Naomi Halas, Rice University, Houston, TX at http://www.ece.rice.edu/~halas/.
Monday, 19 October 2009
Is Minimally invasive prostate surgery riskier?
Interesting article in Medical News Today about possible complications surrounding robotically assisted prostate surgery and whether despite the fact that it offers patients improved short term recovery, it can actually create long term genitourinary complications. It would bhe interesting to hear further reaction from medical professional about this-Intuitive Surgical the key player in robotically assisted surgery has already come back to say that in 800 previous studies on robot-assisted prostate surgery, the overwhelming majority have shown superior results, while other medics have advised that the Medicare billing codes used to extrapolate data for the study don't necessarily reflect between robotically-assisted and other forms of MIRP.
Thoughts and views on this would be welcome- highlights and link to the full article below:
While it is accepted that minimally invasive surgery cuts post operative recovery time and shortens hospital stays, research from the US has highlighted the possiblity of complications for patients following minimally invasive procedures to treat prostate surgery. These possible complications include erectile disfunction and incontinence.
The research was the work of Dr Jim C Hu, from the division of Urolic surgery and the Center for Surgery and Public Health at Bringham and women's hospital Boston.
The research suggests that there has been a rapid rise in minimally invasive radical prostectomy (MIRP), particularly robot assisted procedures, from 1% of all radical prostectomies in 2001 to 40% in 2006, and this despite the lack of data on outcomes when compared with open retropublic radical prostectomy (RRP), the more conventional prostate treatment.
For the study, Dr Hu and his team assessed the surgical outcomes of MIRP versus RRP in nearly 9000 men with prostate cancer, nearly 2000 of the men had MIRP, the others had RRP. The data they used came from US Surveillance, epidemiology, and end results medicare-linked data.
Results showed that over the study period, MIRP use went up by nearly five fold, from 9.2 % in 2003 to 43.2 % iin 2006-7. The study found that short term, MIRP offered good patient benefits such as shorter hospital stays, lower risk of postoperative respiratory complications, lower risk of miscellaneous surgical complications and lower likelihood of needing blood transfusions, while long term, men undergoing MIRP vs RRP experienced more genitourinary complications 4.7 % vs 2.1% and were more often diagnosed as having incontinence and erectile disfunction.
For full details of this story see http://medicalnewstoday.com/printerfriendlynews.php?newsid=167322
CMR wonders if there is a danger of confusing the robotic-assisted prostatectomies, other procedures included under 'minimally invasive radical prostatectomy', and surgical techniques, such as 'nerve-sparing' surgery designed to minimize erectile problems and other-post surgical complications?The preponderance of scientific evidence to this point suggests that robotic-assisted surgery does have financial advantages to the hospital/clinic/physicians' practice using it, i.e. less blood loss, shorter recuperations, fewer post-surgical clinical complications, all designed to facilitate faster patient movement through the operating suite to maximize revenue. While these advantages suggest a benefit to the patient as well, it seems that more study is indicated on the incidence of two specific complications and their psycho-social, as well as economic, implications for the patient's ultimate satisfaction with the procedure.
Thoughts and views on this would be welcome- highlights and link to the full article below:
While it is accepted that minimally invasive surgery cuts post operative recovery time and shortens hospital stays, research from the US has highlighted the possiblity of complications for patients following minimally invasive procedures to treat prostate surgery. These possible complications include erectile disfunction and incontinence.
The research was the work of Dr Jim C Hu, from the division of Urolic surgery and the Center for Surgery and Public Health at Bringham and women's hospital Boston.
The research suggests that there has been a rapid rise in minimally invasive radical prostectomy (MIRP), particularly robot assisted procedures, from 1% of all radical prostectomies in 2001 to 40% in 2006, and this despite the lack of data on outcomes when compared with open retropublic radical prostectomy (RRP), the more conventional prostate treatment.
For the study, Dr Hu and his team assessed the surgical outcomes of MIRP versus RRP in nearly 9000 men with prostate cancer, nearly 2000 of the men had MIRP, the others had RRP. The data they used came from US Surveillance, epidemiology, and end results medicare-linked data.
Results showed that over the study period, MIRP use went up by nearly five fold, from 9.2 % in 2003 to 43.2 % iin 2006-7. The study found that short term, MIRP offered good patient benefits such as shorter hospital stays, lower risk of postoperative respiratory complications, lower risk of miscellaneous surgical complications and lower likelihood of needing blood transfusions, while long term, men undergoing MIRP vs RRP experienced more genitourinary complications 4.7 % vs 2.1% and were more often diagnosed as having incontinence and erectile disfunction.
For full details of this story see http://medicalnewstoday.com/printerfriendlynews.php?newsid=167322
CMR wonders if there is a danger of confusing the robotic-assisted prostatectomies, other procedures included under 'minimally invasive radical prostatectomy', and surgical techniques, such as 'nerve-sparing' surgery designed to minimize erectile problems and other-post surgical complications?The preponderance of scientific evidence to this point suggests that robotic-assisted surgery does have financial advantages to the hospital/clinic/physicians' practice using it, i.e. less blood loss, shorter recuperations, fewer post-surgical clinical complications, all designed to facilitate faster patient movement through the operating suite to maximize revenue. While these advantages suggest a benefit to the patient as well, it seems that more study is indicated on the incidence of two specific complications and their psycho-social, as well as economic, implications for the patient's ultimate satisfaction with the procedure.
Tuesday, 13 October 2009
ATS Medical receives CE Mark for Cryoablation Probe
A good bit of news today about ATM medical receiving a CE mark for its Cryomaze 10-S Surgical Cryoablation probe aimed at treatment of cardiac arrhythmias. This is a nice example of a company directly responding to the preferences of surgeons in creating a product that makes awkward procedures easier.
The product provides a more controlled stiffness than the current Cryomaze probe, and increased support through the length addresses the desire of some surgeons for more probe leverage to access hard to reach areas.
The device was first used by Professor Mohr a globally renowned thought leader within the cardiac surgery community, who highlighted the benefots of using the device in minimally invasive procedures.
The company highlighted the product as its response to request from cardiac arrhythmia surgeons for a more substantial cryoablation instrument
It is good to see companies listening and being so reactive to medical communities' needs.
The product provides a more controlled stiffness than the current Cryomaze probe, and increased support through the length addresses the desire of some surgeons for more probe leverage to access hard to reach areas.
The device was first used by Professor Mohr a globally renowned thought leader within the cardiac surgery community, who highlighted the benefots of using the device in minimally invasive procedures.
The company highlighted the product as its response to request from cardiac arrhythmia surgeons for a more substantial cryoablation instrument
It is good to see companies listening and being so reactive to medical communities' needs.
Medical device startups are taking a recessionary hit
While the big boys in the medical device sector are weathering the recessionary storm, the innovative medical device start-ups have struggled with adverse finanical conditions according to a report released today by Ernst and Young. US and European medical technology companies saw total industry financing drop by 38% in 2008. The US has been particularly badly hit.
The big players are performing well, but their new life blood, the types of tiny companies producing compelling device innovations that they acquire in order to keep growing, are struggling. Mergers and acquisitions, usually the only way these companies can make a return for their investors, showed a strong decline in 2008, down 41 % from the previous year.
A sobering thought for an industry which in the US particularly is facing new goverment reform and taxation threats.
However, there is reason to be positive; medical advance will always be needed, and the Ernst and Young report does highlight some key regions for medical device technology that are still thriving; California, Massachusetts and Minnessota are major hubs for medical device innovation, with strong support from a population of skilled scientists, access to capital, and a robust network of support institutions such as hospitals and universities.
The big players are performing well, but their new life blood, the types of tiny companies producing compelling device innovations that they acquire in order to keep growing, are struggling. Mergers and acquisitions, usually the only way these companies can make a return for their investors, showed a strong decline in 2008, down 41 % from the previous year.
A sobering thought for an industry which in the US particularly is facing new goverment reform and taxation threats.
However, there is reason to be positive; medical advance will always be needed, and the Ernst and Young report does highlight some key regions for medical device technology that are still thriving; California, Massachusetts and Minnessota are major hubs for medical device innovation, with strong support from a population of skilled scientists, access to capital, and a robust network of support institutions such as hospitals and universities.
Monday, 12 October 2009
Is embolisation actually a better treatment for uterine fibroids?
Uterine fibroids are a very common disease amongst women. Approximately 30 % are affected, and symptoms may include heavy menstrual bleeding, bowel obstruction, pain, and pressure on the bladder.
Usually, fibroid removal requires hysterectomy or a myomectomy, (In the UK, it is estimated that gynaecologists perform some 12,000 hysterectomies due to fibroid disease every year), but both are invasive treatments and hysterectomy is clearly not suitable for anyone still planning a family. Uterine Artery Embolisation (UAE) can offer treatment for fibroid disease, but is currently only widely practiced in the USA, UK and France, and many women in Europe still do not have widespread access to this procedure. A quick scan of the web reveals why- there has been little conclusive proof about its effectiveness, notably long term.
However, the results of two randomized studies comparing the results of hysterectomy and embolisation in treating uterine fibroids were presented at the last CIRSE meeting in Rome in September. Both the Dutch EMMY trial and the Scottish REST study were performed independently, and both show a similar quality of life for patients following both the surgical and the embolisation procedures. The EMMY study also showed that this was maintained after a two year follow up period.
This is the first time results indicating the success of UAE have been proved in randomized studies, and there is now scientific proof that embolisation is an effective alternative to hysterectomy. Both studies even went further, revealing that embolisation procedures are almost 40 % cheaper than the surgical option.
These trials represent another siginificant step in cementing interventional radiology treatment as a viable and mainstream alternative in procedures where surgery may not be an option, and can offer a less invasive and even more cost effective alternative.
Uterine fibroids can also be an obstacle to successful conception and child-bearing and, as such, along with endometriosis, are of interest to gynecologists and reproductive endocrinologists, as well as interventional radiologists.
For those women for whom surgery is not an option, a non-invasive alternative is available in the form of injections of a Gn-RH agonist, such as Lupron Depot, which down-regulates production of estrogen and shrinks fibroids. Although effective, critics point out that loss of estrogen produces some undesirable side-effects, such as 'hot flashes', mood swings, and vaginal dryness, but these effects can be successfully managed in many patients by low doses of progesterone.These study results, together with a large body of clinical evidence from the U.S. show that UAE is a viable option for treatment of uterine fibroids in women for whom radical surgery and medications are not options.
Usually, fibroid removal requires hysterectomy or a myomectomy, (In the UK, it is estimated that gynaecologists perform some 12,000 hysterectomies due to fibroid disease every year), but both are invasive treatments and hysterectomy is clearly not suitable for anyone still planning a family. Uterine Artery Embolisation (UAE) can offer treatment for fibroid disease, but is currently only widely practiced in the USA, UK and France, and many women in Europe still do not have widespread access to this procedure. A quick scan of the web reveals why- there has been little conclusive proof about its effectiveness, notably long term.
However, the results of two randomized studies comparing the results of hysterectomy and embolisation in treating uterine fibroids were presented at the last CIRSE meeting in Rome in September. Both the Dutch EMMY trial and the Scottish REST study were performed independently, and both show a similar quality of life for patients following both the surgical and the embolisation procedures. The EMMY study also showed that this was maintained after a two year follow up period.
This is the first time results indicating the success of UAE have been proved in randomized studies, and there is now scientific proof that embolisation is an effective alternative to hysterectomy. Both studies even went further, revealing that embolisation procedures are almost 40 % cheaper than the surgical option.
These trials represent another siginificant step in cementing interventional radiology treatment as a viable and mainstream alternative in procedures where surgery may not be an option, and can offer a less invasive and even more cost effective alternative.
Uterine fibroids can also be an obstacle to successful conception and child-bearing and, as such, along with endometriosis, are of interest to gynecologists and reproductive endocrinologists, as well as interventional radiologists.
For those women for whom surgery is not an option, a non-invasive alternative is available in the form of injections of a Gn-RH agonist, such as Lupron Depot, which down-regulates production of estrogen and shrinks fibroids. Although effective, critics point out that loss of estrogen produces some undesirable side-effects, such as 'hot flashes', mood swings, and vaginal dryness, but these effects can be successfully managed in many patients by low doses of progesterone.These study results, together with a large body of clinical evidence from the U.S. show that UAE is a viable option for treatment of uterine fibroids in women for whom radical surgery and medications are not options.
Interventional radiology gains some solid recognition
Is interventional radiology just a useful thing to be able to do as part of a "bigger job"?
According to CIRSE, ESR and SIR, the many practising interventional radiologists worldwide, cardiologists and oncologists using IR techniques, the patients whose lives have been extended, made easier or saved because they might not have been able to undergo regular surgery, interventional radiology is categorically an important medical division in its own right...and now UEMS, the European Union of Medical Specialists has chosen to agree. On 25th April the UEMS council vote overwhelmingly went in favour of establishing a division of Interventional Radiology.
Interest in interventional radiology continues to grow. Many non-radiologists may think of IR as a collection of peripheral vascular interventional procedures, but actually its breadth is considerable, covering non-vascular interventions (biliary, gastrointestinal and urinary) and increasingly gaining interest for its use in oncology with procedures such as embolization and tumour ablation.
Interventional radiology in our mind is the use of imaging simply to conduct pinhole surgery, both in treatment and diagnostics. IR allows patients to recover faster, and in many cases to undergo considerably less traumatic surgery. IR can offer a last piece of hope for some patients where other treatments have failed.
With a positive vote on the establishment of an IR division within the UEMS Radiology section, IR has finally been recognised as a medical speciality in Europe, and interventional radiologists as distinct medical specialists. The next step will be the national implementation of this decision.
The decision is important not just in terms of a long deserved status, but in achieving significant goals, such as the establishment of a European training curriculum for IR, a European IR skill certification and quality standardisation. A good solid foundation for a highly valuable discipline.
According to CIRSE, ESR and SIR, the many practising interventional radiologists worldwide, cardiologists and oncologists using IR techniques, the patients whose lives have been extended, made easier or saved because they might not have been able to undergo regular surgery, interventional radiology is categorically an important medical division in its own right...and now UEMS, the European Union of Medical Specialists has chosen to agree. On 25th April the UEMS council vote overwhelmingly went in favour of establishing a division of Interventional Radiology.
Interest in interventional radiology continues to grow. Many non-radiologists may think of IR as a collection of peripheral vascular interventional procedures, but actually its breadth is considerable, covering non-vascular interventions (biliary, gastrointestinal and urinary) and increasingly gaining interest for its use in oncology with procedures such as embolization and tumour ablation.
Interventional radiology in our mind is the use of imaging simply to conduct pinhole surgery, both in treatment and diagnostics. IR allows patients to recover faster, and in many cases to undergo considerably less traumatic surgery. IR can offer a last piece of hope for some patients where other treatments have failed.
With a positive vote on the establishment of an IR division within the UEMS Radiology section, IR has finally been recognised as a medical speciality in Europe, and interventional radiologists as distinct medical specialists. The next step will be the national implementation of this decision.
The decision is important not just in terms of a long deserved status, but in achieving significant goals, such as the establishment of a European training curriculum for IR, a European IR skill certification and quality standardisation. A good solid foundation for a highly valuable discipline.
Interventional radiology used to treat blood clots
A trial for the catheter-based treatment of deep vein thrombosis will evaluate the use of clot-dissolving drugs in conjunction with clot removal devices to prevent post- thrombotic syndrome (PTS) in patients with DVT.
PTS causes permanent damage to the veins, resulting in debilitating chronic leg pain, swelling, fatigue and ulcers. About 25% of patients currently develop PTS when being treated with blood thinners alone, which did not dissolve the existing clot. Preliminary studies have indicated that interventional clot-busting treatments can remove clots and have strong potential to prevent PTS.
The $10 million trial, ATTRACT, will be funded by the NHLBI and may fundamentally alter the way that DVT is treated in the USA, moving interventional radiology to the core of DVT treatment. ATTRACT ( Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) is a multicenter randomized trial that will establish whether PTS can be definitively prevented with the use of interventional techniques.
If the trials prove to be successful, this is important news both in preventing PTS but also in the considerably greater use of interventional techniques in DVT.
PTS causes permanent damage to the veins, resulting in debilitating chronic leg pain, swelling, fatigue and ulcers. About 25% of patients currently develop PTS when being treated with blood thinners alone, which did not dissolve the existing clot. Preliminary studies have indicated that interventional clot-busting treatments can remove clots and have strong potential to prevent PTS.
The $10 million trial, ATTRACT, will be funded by the NHLBI and may fundamentally alter the way that DVT is treated in the USA, moving interventional radiology to the core of DVT treatment. ATTRACT ( Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) is a multicenter randomized trial that will establish whether PTS can be definitively prevented with the use of interventional techniques.
If the trials prove to be successful, this is important news both in preventing PTS but also in the considerably greater use of interventional techniques in DVT.
One step closer to simple and portable tuberculosis tests for the developing world
Googling tuberculosis reveals some shocking statistics- one third of the world's population has been affected with the illness, and new infections occur at a rate of one per second. The proportion of people in the general population who become sick with tuberculosis each year is stable or falling worldwide but, because of population growth, the absolute number of new cases is still increasing.
TB remains the seventh leading cause of death worldwide, killing more than 1.5 million people annually. 90% of people carrying TB have "latent" infections, and have no symptoms. The 10% of people who go on to develop full-blown TB infect, on average, another 10-15 people per year.
There is therefore a critical need to detect latent TB infection, particularly in the developing world.
A group of researchers at Colorado State University (CSU) have demonstrated a new way to use light to detect traces of TB bacteria in fluids. The researchers have developed a technique that can sensitively detect different molecular markets indicating a TB infection. The test would be cheap to use and no more difficult to administer than a pregnancy test, making it ideal for use in the developing world.
TB is curable after a lengthy course of antibiotics. The basic strategy of the WHO's efforts to curb the spread of TB worldwide is to simply find the people infected and give them the antibiotics to cure the disease. Currently however, finding the people infected is difficult, particularly those infected with latent symptoms. The CSU development could go a long way to helping detect these people, but it could be some time before it is widely available, as it will need to undergo significant clinical trial testing.
TB remains the seventh leading cause of death worldwide, killing more than 1.5 million people annually. 90% of people carrying TB have "latent" infections, and have no symptoms. The 10% of people who go on to develop full-blown TB infect, on average, another 10-15 people per year.
There is therefore a critical need to detect latent TB infection, particularly in the developing world.
A group of researchers at Colorado State University (CSU) have demonstrated a new way to use light to detect traces of TB bacteria in fluids. The researchers have developed a technique that can sensitively detect different molecular markets indicating a TB infection. The test would be cheap to use and no more difficult to administer than a pregnancy test, making it ideal for use in the developing world.
TB is curable after a lengthy course of antibiotics. The basic strategy of the WHO's efforts to curb the spread of TB worldwide is to simply find the people infected and give them the antibiotics to cure the disease. Currently however, finding the people infected is difficult, particularly those infected with latent symptoms. The CSU development could go a long way to helping detect these people, but it could be some time before it is widely available, as it will need to undergo significant clinical trial testing.
Diabetes and Obesity Rates Soar
Shockingly, according to Diabetes UK, the number of people diagnosed with diabetes in the UK has risen by more than 145 000 in the last year. Latest data from GP surgeries shows that there are now more than 2.6 million people with diabetes in the UK, coupled with a staggering 5.2 million patients now regostered as obese. In basic terms, obesity now affects almost 9 percent of the UK population, and this is just the known cases.
The link between diabetes and obesity and the impact on the heart is well enough documented that most people should understand the risks, but the link between obesity, diabetes and very serious complications such as risk of lower limb amputation, severe eyesight problems and kidney damage may be less well known.
While ultimately patients need to help themselves by keepingtheir diabetes under control with sensible eating and exercise, how can device companies operating in diabetes help beyond improving tools such metering and pumps?
CMR believes there is room for further help with improving education to reinforce messages about these very grave risks, and to help patients to further manage their diabetes to bring it under control and reduce the chances of serious illness.
Diabetes UK also highlighted that almost 90% of people with diabetes in the UK have never received structured diabetes education, which is the key to improved self-management of the condition. In the USA, a recent medicare study also highlighted the importance of diabetes education in reducing health care costs.
Seems to us that there is an opportunity here for vendors to both aid patients and health care systems whilst building valuable brand perception.
The link between diabetes and obesity and the impact on the heart is well enough documented that most people should understand the risks, but the link between obesity, diabetes and very serious complications such as risk of lower limb amputation, severe eyesight problems and kidney damage may be less well known.
While ultimately patients need to help themselves by keepingtheir diabetes under control with sensible eating and exercise, how can device companies operating in diabetes help beyond improving tools such metering and pumps?
CMR believes there is room for further help with improving education to reinforce messages about these very grave risks, and to help patients to further manage their diabetes to bring it under control and reduce the chances of serious illness.
Diabetes UK also highlighted that almost 90% of people with diabetes in the UK have never received structured diabetes education, which is the key to improved self-management of the condition. In the USA, a recent medicare study also highlighted the importance of diabetes education in reducing health care costs.
Seems to us that there is an opportunity here for vendors to both aid patients and health care systems whilst building valuable brand perception.
Cleveland Clinic's top 10 medical innovations for 2010
A search of the web this morning yielded an interesting article whereby the top 10 medical innovations for next year have been unveiled by Cleveland Clinic at its 2009 Medical innovation summit. Devices highlighted range from treatments for sleep related breathing disorders to those aimed at helping patients with Parkinsons Disease to improve motor function.
10. Whole-Slide Imaging for Management of Digital Data In Pathology: A technology for creating digital pathology slides with excellent image quality that can be viewed, stored, streamed over the Internet, and analyzed on a computer
.9. Devices for Occluding Left Atrial Appendage to Reduce Stroke Risk: Device alternatives to long-term warfarin use that can prevent clots from developing in patients with atrial fibrillation
.8. Oral Thrombopoeitin (TPO) Receptor Agonist That Stimulates Platelet Production: A recently approved drug that stimulates production of cells in bone marrow that form platelet cells in the blood
.7. Outpatient Diagnosis of Sleep-Related Breathing Disorders: Self-contained, reliable, at-home sleep-monitoring devices for screening, diagnosing, and treatment assessment of sleep-related breathing disorders
.6. Forced Exercise To Improve Motor Function in Patients With Parkinson's: Pedaling at 90 RPMs on a tandem bike to dramatically improve motor functioning of patients with Parkinson's disease.
5. Fertility Preservation Through Oocyte Cryopreservation: A rapidly-improving technology that allows eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilized at a later date
.4. Non-Vitamin K Antagonist Oral Anticoagulants: Predictable and well-tolerated alternatives to the oral anticoagulant warfarin that provide a more convenient -- and safe -- way for patients to dose themselves and prevent blood-clot formation
.3. Continuous-Flow Ventricular Assist Devices: Tiny 3-ounce devices surgically attached alongside the heart that quietly and effectively take over the pumping ability of the heart
.2. Low-Volume, Low-Pressure Tracheal Tube Cuff To Reduce Ventilator-Associated Pneumonia: A device that dramatically reduces the risk of ventilator-associated pneumonia and death in the hospital ICU by providing continuous effective airway seals
.1. Bone Conduction of Sound For Single-Sided Deafness: A new non-surgical, removable hearing and communication device designed to imperceptibly transmit sound via the teeth to help people with single-sided deafness.
Four major criteria served as the basis for qualifying and selecting the Top 10 Medical Innovations. Nominated innovations were required to:
Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery).
Have a high probability of success.
Be on the market or close to being introduced.
Have sufficient data available to support its nomination.
10. Whole-Slide Imaging for Management of Digital Data In Pathology: A technology for creating digital pathology slides with excellent image quality that can be viewed, stored, streamed over the Internet, and analyzed on a computer
.9. Devices for Occluding Left Atrial Appendage to Reduce Stroke Risk: Device alternatives to long-term warfarin use that can prevent clots from developing in patients with atrial fibrillation
.8. Oral Thrombopoeitin (TPO) Receptor Agonist That Stimulates Platelet Production: A recently approved drug that stimulates production of cells in bone marrow that form platelet cells in the blood
.7. Outpatient Diagnosis of Sleep-Related Breathing Disorders: Self-contained, reliable, at-home sleep-monitoring devices for screening, diagnosing, and treatment assessment of sleep-related breathing disorders
.6. Forced Exercise To Improve Motor Function in Patients With Parkinson's: Pedaling at 90 RPMs on a tandem bike to dramatically improve motor functioning of patients with Parkinson's disease.
5. Fertility Preservation Through Oocyte Cryopreservation: A rapidly-improving technology that allows eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilized at a later date
.4. Non-Vitamin K Antagonist Oral Anticoagulants: Predictable and well-tolerated alternatives to the oral anticoagulant warfarin that provide a more convenient -- and safe -- way for patients to dose themselves and prevent blood-clot formation
.3. Continuous-Flow Ventricular Assist Devices: Tiny 3-ounce devices surgically attached alongside the heart that quietly and effectively take over the pumping ability of the heart
.2. Low-Volume, Low-Pressure Tracheal Tube Cuff To Reduce Ventilator-Associated Pneumonia: A device that dramatically reduces the risk of ventilator-associated pneumonia and death in the hospital ICU by providing continuous effective airway seals
.1. Bone Conduction of Sound For Single-Sided Deafness: A new non-surgical, removable hearing and communication device designed to imperceptibly transmit sound via the teeth to help people with single-sided deafness.
Four major criteria served as the basis for qualifying and selecting the Top 10 Medical Innovations. Nominated innovations were required to:
Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery).
Have a high probability of success.
Be on the market or close to being introduced.
Have sufficient data available to support its nomination.
Friday, 9 October 2009
This week the team has been discussing our plans for a multi client study on the area of interventional radiology. Why did we pick this area? Well, what is appealing about it is that IR techniques can often be applied where conventional surgery fails, so for those patients who may be unable to go through open surgery to correct a problem such as a vascular blockage, can be treated through pinhole surgery instead. The recovery time for the patient is considerably shorter than through traditional surgery.
The team were also interested to learn that techniques such as stenting that started out as an interventional radiology technique are now mainstream in areas such as cardiology.
But is there any growth in IR and why is it particularly interesting? Well at the moment, there seems to be a movement to "recognise" IR more, not necessarily pulling it out of the radiology department and into its own right, but certainly giving the speciality more of an identity of its own, and giving more doctors the impetus to train as IR specialists. Secondly, interventional oncology does seem to be a growth area, and a significant one too, as using techniques such as RF ablation to target tumours and burn the tumour away offer benefits both in terms of treating patients who may previously have been untreatable, but also in terms of reaching tumours that may previously have been unreachable due to location and shortening recovery times.
We're going to be talking to companies involved in producing products for this sector as well as interventional radiologists involved in treating tumours. More information on this fascinating area coming up soon.
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