advanced medical technologies

According to a study published in 2006 in the Journal of the American Medical Association (JAMA), despite increasing efforts over the last several years by government organizations, physicians, public health administrators and the media to stem the tide, obesity isn’t going away. The researchers found that the prevalence of overweight and obesity among children and adolescents, and of obesity among men, increased significantly between 1999 and 2004. If one applies the prevalence of extreme obesity from the study to the total US adult population, there are about 9.9 million morbidly obese women and 3.9 morbidly obese men, totaling 13.8 million; these figures include only those with a BMI of 40 or above, and does not include those people with a BMI of 35 or higher and at least two co-morbidities caused by obesity. To include the latter group would make the number much higher. Reasons put forth for the growth of obesity over the last 100 years include a more sedentary lifestyle, increase in the amount of high fructose corn syrup (HFCS) sugars in foods, and convenience of fattening fast foods. However, while it’s easy to point to these reasons, researchers have found others that may be equally, or even more, responsible for the thickening waistlines.

Once thought to be caused by greedy overeating and laziness, overweight and obesity are now known to be created by a complex interwoven array of reasons: physical, hormonal, environmental and psychological. While researchers know much more about the causes than was known a decade ago, they also admit that there is much that is still not understood. The research may ultimately lead to drug targets, new surgical procedures and the development of devices and vaccines to prevent or reverse overweight and obesity. However, moving from finding a hormonal cause or a process pathway to putting a drug on the market can be the work of decades.

Once a drug has been developed, there are still the hurdles of regulatory approval to be overcome. Sanofi-aventis knows all about this; the company pulled its FDA application for rimonabant, known as Acomplia in the EU, when the FDA committee implied that it would unanimously recommend denial of market approval due to concerns about potential psychological side effects of the drug. To make matters worse, EU sales have not been meeting expectations. One result of the rimonabant problems was that the market forecast for pharmaceutical treatment of obesity immediately dropped, as the US would have been the largest market for this drug; that dampening of the market is reflected in this report. Another outcome was the immediate appearance of rumors to the effect that Sanofi-aventis might end up on the block; it had had very high hopes for rimonabant, hopes which have, for the time being, been dashed.

What is clear is that populations around the world are increasing in the percentage of overweight and obese individuals—of all ages, both sexes, and virtually all races. The WHO estimates that there are 1.6 billion overweight people globally, and 400 million are obese. In ten years, predicts WHO, the number of overweight will increase by 40%—to 2.2 billion.

Obesity puts a burden on so many aspects of life that the socioeconomic cost is almost inevitably enormous—as well as challenging to quantify. At the individual level, there is the lower quality of life, days missed from work, decreased wages, premature retirement, potentially unemployment, and the medical costs of related illnesses, which may include depression, cardiovascular disease, joint and arthritic problems, diabetes, stroke, etc. At the societal level, there is the mounting healthcare bill, as well as the increased costs falling upon employers due to missed work days. The healthcare bill would increase even if no one in the US was obese, because of the wave of aging baby boomers. But add to this wave the additional costs of treating the co-morbidities of obesity, and the magnitude of the wave increases significantly.

The ideal treatment for weight loss is lifestyle modification through diet and exercise. However, the compliance rate for this method of treatment is very low: according to some studies, less than 2% of obese people who lose excess weight through diet and exercise are successful in keeping it off for two or more years. Researchers have concluded that, given the current available treatments, the only effective, long-term treatment for morbid obesity is bariatric surgery. Any eventual drug treatment for overweight and mild obesity is likely to involve combination therapy, i.e. the prescription of two or more drugs, in addition to lifestyle changes, in order for the patient to successfully lose the excess weight and keep it off.

There continues to be a private sector market for these devices. Patients may resort to private payment for the surgery for one or more reasons, such as long waits, perhaps years, for the surgery; little or no insurance coverage for the device and surgery; or lack of regulatory approval for the device in the patient’s country. Some patients travel to other countries where the procedure may be available more quickly or at a lower price. However, the majority of the recorded surgical procedures are performed under insurance coverage; relatively few patients can afford to pay out of pocket for surgery that may cost $25,000-30,000 or more, including medical follow-up, travel, nursing care, special nutritional needs, etc.

All in all, there is a strong market for the clinical treatment of overweight and obesity. That market is forecast to reach about $6.4 billion globally by 2015, on a revenue compound annual growth rate (CAGR) of 23.2%, and a unit CAGR of approximately 19%. That figure includes prescription drugs for weight loss and maintenance, over-the-counter alli from GlaxoSmithKline; devices used in bariatric surgery; and the predicted sales of drugs and devices with anticipated market launches during the study period.

Description: The report is a detailed market and technology assessment and forecast of the products and technologies in the clinical management of obesity. The report describes the current and projected patient population in obesity, detailing their incidence in the U.S., Europe, and Rest of World, and the clinical practices in obesity management encompassing surgical approaches, medical supervised severely restricted diets, drug therapies, OTC treatments, biopharmaceuticals, non-pharmacologic approaches and weight maintenance approaches. The report describes clinical trends in the management of the obese. The report details the products on the market and the status of those in development for bariatric surgery, drug therapy, gastric stimulation devices, brain stimulation devices, combination therapies and genetic therapy, and provides current and forecast of the market for these products in the U.S., Europe and Rest of World. The report profiles key companies in the market, detailing the current products, products in development, market position and overall businesses in obesity management.

 

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Technologies for the treatment of spinal disc disease and trauma are being driven away from the relatively crude solution of fusing adjacent vertebrae to solutions that aspire to restore the dynamic structure and function of the spine.

Non-fusion products
Arguably one of the strongest underlying trends in the development of technologies for the treatment of degenerative disc disease is the trend toward dynamic stabilization, also referred to as motion-preservation. Both market leaders and small, innovative companies are focusing upon the challenges of stabilizing damaged or degenerated vertebrae without permanently freezing the joints via spinal fusion. Several non-fusion products are either on the market or in advanced clinical trials; as these devices come on to the market, non-fusion is expected to cannibalize the spinal fusion market, causing a slow-down in the fusion market as discussed above. However, both fusion and non-fusion markets will continue to be substantial markets, supported by the growing number of aging adults who wish to remain active in their later years. In addition, it will take several years for clinicians to convince themselves, through experience, that non-fusion is not only a viable option but one that gives satisfactory and long-term results to the patient. For example, surgeons are beginning to believe that dynamic stabilization needs to address the facet as well as the disc, in order to truly mimic the natural motion of the spine. Perhaps combination devices will achieve the desired physical mimicry in the future. Proof of safety and efficacy won’t emerge overnight, and in the meantime many clinicians are likely to continue to view, and utilize, spinal fusion as the gold standard for treatment of degenerative disc disease.

Disc arthroplasty (total disc replacement)
Cervical arthroplasty, or total disc replacement (TDR) is viewed as easier than lumbar arthroplasty (or TDR) because there is significantly more mechanical strain and a wider range of motion in the lumbar spine. Any device placed in the lumbar spine must meet a long list of requirements: it needs to be strong enough to support axial loading, preserve the proper intervertebral space, be very flexible so as to handle the rotation, flexion, extension and translation which occur in the lumbar spine, and should be relatively easy for the surgeon to customize to the individual patient. In addition, while cervical arthroplasty patients are usually in their 60s or older, lumbar arthroplasty patients tend to be on average about 35 years of age. Ideally, any lumbar artificial disc placed in a younger patient must be designed to last many more years than a cervical disc. Despite these technical challenges, both cervical and lumbar arthroplasty and artificial disc replacement markets will reap strong sales in the US as devices come out of clinical trials. As of this writing, there are three artificial cervical disc replacement devices approved in the United States: the Prestige® and the Bryan®. Both devices are by Medtronic Sofamor Danek (MSD), and both were approved for market by the FDA in July 2007. In December 2007, the FDA approved Synthes Inc.’s application to market its ProDisc-C total disc replacement product in the United States. The ProDisc-C is already approved and used in Europe and other areas outside the US. Therefore, for the time being, Medtronic Sofamor Danek holds 99.9% of the market in the US, while Synthes has just launched its product.

Companies developing total disc replacement include the following:

Advanced Prosthetic Technologies, Amedica, AxioMed Spine, B. Braun/Aesculap, Biomet Spine/EBI, Cervitech, DePuy Spine, Disc Motion Technologies, Globus Medical, Globus Medical, LDR Spine, Medtronic Sofamor Danek, Nexgen Spine, NuVasive, Orthofix International/ Blackstone Medical, Ranier Technology, Scient’x , SpinalMotion, Stryker Spine, Synthes Spine, Theken Disc, TranS1, U.S. Spine, Vertebron, Zimmer 

Nuclear arthroplasty
Nuclear arthroplasty (also known as nucleus replacement), although not yet available in the US, is expected to expand the number of patients who will be treated, since the treatment falls in between conservative options and discectomy. Patients who previously would not have received any treatment, will increasingly be offered treatment with nucleus replacement. Spinal disc nucleus replacement is said to have several benefits, including the preservation of disc height, and maintenance of spinal mobility and flexibility. For some patients, TDR may be overkill; disc nucleus replacement may be sufficient. The fact that nucleus replacement acts and will act as an intermediate treatment step will increase the market size for nucleus arthroplasty. In addition, many patients will receive more than one nuclear arthroplasty, thus further increasing the size of the patient population. Late 2008 may see the first devices launched in the US for nucleus replacement.

Companies developing prosthetic disc nuclei include the following:

Arthro Kinetics, Biomet Spine/EBI, Corin, CryoLife, DePuy Spine, Disc Dynamics, Dynamic Spine, Gentis, NP Solutions, NuVasive, Pioneer Surgical Technology, Raymedica, Replication Medical, SeaSpine, Spine Wave, SpineMedica, Stryker Spine, Synthes Spine, TranS1, Vertebral Technologies, Zimmer Spine

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The “advanced medical technologies” blog draws from the research, publications and other content of MedMarket Diligence as well as from my own readings, insights and perspectives.  While I am not wont to be stingy, I am not always inclined to give up valuable sources, but in the interest of quid pro quo, perhaps, I’d like to offer a few salient tips, sources and resources that I find useful.  I’ll get the self-promotion out of the way — a good source is a good source — and follow it with those I find invaluable (most, but not all, are rss/xml links):

• new medical technologies
• markets and recent developments in medical technologies
• medtech reports
• “medical technology” podcast
• Medical Device Guru
• Medical Devices News from Medical News Today
• medical device Google News
• PRWeb Medical Products
• PRWeb Medical Surgery
• Technorati “medtech”
• Biotech news
• Healthcare Sales & Marketing Network:  “Medical Device” and Biotech
• Medical Equipment News
• …there are many more, but this is a nice core to have

In addition to these resources, one of the most useful tools available in this era of information overload is software called WebSite-Watcher, which I have found to have more varied uses than I ever anticipated.  (Think “staying aware”.)  Another highly valuable resource is Google Alerts, which has been in beta seemingly forever, but has long since proven its worth.

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The formation of new companies in any industry can be a true litmus of the overall health of the industry and an indicator of the direction the industry is taking through the relative balance of companies with different areas of focus. We present in a bar graph the number of medtech startup companies categorized by the clinical/technology focus of each company (multiple categories possible; e.g., a company can be “surgical” and have a “minimally invasive” focus).

Data is drawn from the MedMarket Diligence “Medtech Startups Database”. Companies are identified as startups based on company registration and categorized by the clinical and/or technology focus of the company. (As a word of explanation, the principal criteria for inclusion of a company in this dataset is the company’s involvement in a market that has medical device involvement, complementary or competitively, and that the company’s founding date can be reliably determined.)

With a central consideration of companies identified and included in the data shown being that companies are either medical device companies or their products (some purely pharmaceutical, for example) are either competiting head-on with device technologies or are complementary to device technologies (e.g., drug-eluting stent hybrids, drug delivery devices, etc.), the most significant areas of company formation are in surgery, cardiovascular therapeutics and orthopedics/musculoskeletal areas of focus. These are, of course, among the most device intensive areas of medicine. See graph below on the number of cardiovascular therapeutics, ortho/musculoskeletal and surgery companies from 2000-2007.

The overall trend is positive for medtech company formations, albeit an apparent peak was reach in 2005/2006, after which formation has slowed somewhat. See graph of total number of medtech company formations from 2000 to 2008.

Note, please, that the 2008 figure understates the number of company formations since, in our experience, we see a minimum of 2-3 months of “stealth” in the medtech companies during which they are successful generally in keeping the company’s formation under wraps. For this reason, we anticipate over the next few months a surge in 2008 companies identified, including in those founded in the January to May time frame.

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For details on the Medtech Startups Database, go to link.

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From MedMarket Diligence report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011.”  See link.

• The use of products such as tapes and sutures for wound closure and securement leads to faster wound healing with less risk of contamination by debris and infectious agents, and with improved cosmetic outcomes. Failure to use these products can lead to significant complications, infections, significant delays to healing, and potentially loss of life through infection of the tissue leading to septicemia.

• Hemostats, sealants and glues have been shown to aid recovery and rehabilitation after invasive surgical procedures, to reduce morbidity associated with infection rates and post-surgical adhesions, and to reduce morbidity associated with specific procedures. For example these products may be used to reduce the risk of deep vein thromboses resulting from tourniquet application to reduce bleeding during total knee replacements.

• Hemostats and sealants have been demonstrated to have substantial cost-effective benefits during many surgical operations and the cost of these products are increasingly seen as minor in comparison with the time saved during the surgical procedure alone, even without taking into account rehabilitation. These products have been shown to be highly cost effective for topical wound closure and there are also many potential internal applications for these products.

• Use of cyanoacrylate glues for closure has established a considerable following in all regions of the world. Conservative accident and emergency costs for closure of a small bleeding trauma laceration with sutures, local anaesthetic, antibiotic cream and suture removal kit are approximately $75 (before labor and time are included). Cyanoacrylate products can be used without anaesthetic, without sutures, and since cyanoacrylate sloughs off the skin surface, without a removal kit. The FDA has approved cyanoacrylate products as having an anti-microbial outcome, which further reduces the cost of using them to approximately 30% of using sutures. Once labor and time are added this falls to 5%.

• Effective haemostasis also demonstrates attractive cost attributes; hemostats can be used for rapid and effective control of bleeding during surgery, thus avoiding an element of the hourly cost of an operating room ($2000 to $10000 per hour). For example, a $115 haemostat needs to shave 4 minutes off the operating time to ‘pay its way’. Often, these materials can save from five minutes to two hours depending on procedure.

• Sealants also have attractive health economic attributes. The most obvious cases come from specific procedures which have become the lead indications and focus for development programs in many companies. For example, air leaks during lung surgery lead to the need for extended hospitalization (up to 28 days) and more intensive care, as well as additional surgical procedures. Sealants are also commonly applied to avoid cerebrospinal fluid leakage during neurological and spine surgery; leakage of cerebrospinal fluid would otherwise result in infection (including meningitis), debilitating headaches and other problems. In addition, the surgeon uses significant direct time to achieve meticulously leak-proof closure of the dura. This can be avoided by expert and experienced application of appropriate sealant products.

• Significant cost-effectiveness arguments can be made for products that avoid blood transfusions or reduce the quantities of blood transfusion products required. Approximately 8 million patients worldwide would benefit directly from increased usage of hemostats, sealants and glue products to reduce bleeding during cardiovascular, orthopaedic, urologic, and other general surgical procedures. Units of blood cost approximately $180 each; however the benefit of reducing transfusion requirement goes beyond this simple saving. Often, the real benefit is that appropriate haemostasis reduces the risk of mortality. For example, reducing blood loss during cardiovascular procedures in particular not only prevents the use of large volumes of donated blood (e.g. 5-10 units for dissection of aortic aneurysms) but significantly reduces mortality rates (which can be as high as 30% for aortic aneurysm procedures).

• Adhesion-prevention products have been shown to significantly reduce post-surgical adhesions associated with gynaecological, spinal, cardiovascular and orthopedic procedures. Post-operative adhesions can severely complicate subsequent interventions by making re-entry hazardous, and impeding orientation and visibility, which can lead to damaging the surrounding tissues or vessels. There may also be increased blood loss, and significantly longer operating time required to cut through the adhesions.

The securement market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products.  The total securement market is forecast to grow from almost $7 billion in 2006 to reach $10 billion in 2011 at a CAGR of 7.5%.

The complete report on “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011″ is described with complete table of contents and list of exhibits here.

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