Source: NKUDIC, National Institutes of Health

Benign prostatic hyperplasia or hypertrophy (BPH) is a pathologic condition characterized by a cellular proliferation of stromal and epithelial components. BPH is not life-threatening, but it can be uncomfortable, embarrassing, and inconvenient for the patient. No single definition of BPH has gained universal acceptance, making it difficult for epidemiologists to accurately calculate its incidence and prevalence. Histology, prostate size, symptoms of prostatism, urodynamic measurements, and performance of a prostatectomy may all be used to define BPH. It is a condition in which the prostate is enlarged, but not cancerous. As the prostate grows later in life, it can restrict the urethra and partially block the flow of urine. The wall of the bladder becomes irritable and begins to contract or shrink, even when it contains only a small amount of urine. This can cause the feeling of needing to urinate, even though the bladder isn’t full.

The physician may use a number of methods to determine if the patient has BPH. These can include a urine flow study, cystoscopy, ultrasound, or rectal exam. Urinary symptoms due to an enlarged prostate often develop slowly, and may include increased need to urinate, especially at night; sudden need to urinate; needing to strain in order to start the flow of urine; a urine stream that has become weak, variable or dribbling; pain or burning during urination; and the feeling that the bladder isn’t completely empty after urinating.

Current and Emerging Treatment Trends

Due in part to the side effects and complications associated with traditional BPH therapies, many patients diagnosed with BPH are regularly monitored by their physicians but elect not to receive active intervention. This course of inaction is known as ‘watchful waiting.’ If symptoms persist or worsen, drug therapy or surgical intervention has traditionally been recommended.

Drug therapy is usually the first line of treatment. There are seven well-recognized prescription drugs available in the USA for treating the symptoms of BPH: Flomax (Boehringer Ingelheim International GmbH), Hytrin (Abbott Laboratories), Cardura (Pfizer Inc.), UroXatral (Sanofi-Synthelabo), Rapaflo (Watson Pharmaceuticals, Inc.), Proscar (Merck & Co., Inc.) and Avodart (GlaxoSmithKline), some of which are now also available in generic preparation. It is estimated that more than 20% of patients who initially pursue drug therapy discontinue treatment within 12 months for various reasons including cost, ineffectiveness, side effects and the burdens of compliance. Patients may also try multiple drugs or combinations of drugs to improve effectiveness. This leads to a more costly treatment and often more side effects.

Symptoms and failure of medical management constitute the primary reasons to recommend surgical intervention, but deciding which intervention to choose can be difficult. Transurethral Resection of the Prostate (TURP) has long been considered the gold standard for surgical intervention. TURP is an invasive surgery in which portions of the prostatic urethra and surrounding tissue are removed, thereby widening the urethra and improving urinary flow. While TURP results in a dramatic improvement in urine flow and reduction in symptoms, the procedure can require a lengthy recovery time and is reported to have a high rate of side effects and complications. The TURP procedure also requires a highly skilled surgeon with extensive experience in performing the TURP.

There are quite a few newer procedures for treating BPH, most of them ablative in their mechanism of action, including electrical, RF, thermal, ultrasound, Botox, laser and Intraurethral stents. Ablative technologies include:

• Transurethral Needal Ablation (TUNA)
• Transurethral Microwave Thermal Therapy (TURP)
• Transurethral Ablation Prostatectomy (TURAPY)
• Holmium Laser Ablation of the Prostate (HoLAP)
• Interstitial Laser Cagulation (ILC)
• Ultrasound/High Intensity Focused Ultrasound (HIFU)
• Water Intensity Hyperthermia (WIT)

For more information on clinical applications and markets for ablation technologies, see link.

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Temperature Controlled
One way to control the temperature at the tip of the RF electrode is to build in a feedback mechanism between the tip of the device and the RF generator. For example, in a device such as Covidien’s Cool-tip system, the RF generator was designed with a feedback algorithm. This algorithm senses tissue impedance and automatically delivers the best amount of radiofrequency energy for the situation. The Cool-tip’s electrode design serves further to eliminate tissue charring while allowing delivery of the maximum amount of energy, resulting in the ability to ablate a larger zone of tissue more quickly.

Fluid Cooled
In the highly-popular fluid-cooled devices, the electrode’s internal circulation of water cools the tissue adjacent to the exposed electrode, maintaining low impedance during the treatment cycle. Low impedance permits maximum energy deposition for a larger ablation volume. It also decreases the risk of charring, and allows the surgeon to work faster.

Catheter Manipulation Systems
Another recent development is the use of routine RF electrophysiology catheters in conjunction with a robotic catheter manipulation system, for both diagnostic and ablative EP applications. Examples of such systems include Catheter Robotics’ Remote Catheter Manipulation System, Hansen Medical’s Artisan Control Catheter/Sensei Robotic Catheter System, and Stereotaxis’ Magnetic Navigation System.

Benefits of such systems include use of a catheter which is already familiar to the EP; the ability to manipulate the catheter (once it has been inserted into the heart) via a system from outside of the zone of radiation, and thus eliminate the need to wear the lead aprons; and the EP can then guide the procedure while watching the EP monitors and x-ray images.

Hansen Medical’s system has been used in the ablation of AF. The Stereotaxis Magnetic Navigation System utilizes two magnets, external to the patient, to create a magnetic field. This generates sufficient force to steer magnetically tipped, FDA-approved catheters and guidewires. The system has been used in various EP procedures, including mapping, pacing, and ablation.

RF ablation represents, on a share basis, a relatively minor segment of the aggregate ablation technologies market, but demonstrates an above average growth rate annually.

Ablation Market Worldwide, by Segment 2010

Source: Report #A145, "Ablation Technologies Worldwide"; MedMarket Diligence, LLC

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• The global economy is down from two years ago, but is measurably if not significantly up from one year ago.  I gauge this based on the overall level of business we directly receive and the feedback my authors receive from researching medtech companies. This should be no surprise to anyone who reads other business news on a regular basis.
   
• U.S. markets, for a number of reasons, seem to be lagging markets in the global economy in this period of economic recovery. If I simply use the measure of the number of medtech company inquiries to us originating from U.S. versus OUS companies, I have seen a clear trend that started with a global decline in 2008 followed by a flat 2009 followed by a steady growth in inquiries from OUS companies in 2010 and relative smattering of U.S. company inquiries.  Why this is so may be the subject of countless speculation, but one reason, I believe [insert personal insight here] is that OUS companies (whose pockets weren't so deep as those in the US) felt the hit of the global recession  before the US companies and they sooner ran out of patience waiting for markets to rebound, electing instead to move forward on product development, market development and other initiatives.    
   
• The trend of OUS emerging from the global recession before the US is one that runs counter to the other truth I see, which is that the U.S. is almost universally a market leader (with the exception of areas like cell therapy, in which academia and business OUS has been more than happy to push forward in research while the U.S. vacillates between right- and left-wing politics).  Almost without fail, I continue to see the most advanced technologies emerging principally from US rather than OUS companies.
   
• There has been more activity emerging from China and (rogue island) Taiwan in medtech over the past two years than I have ever seen.  This activity — purchase of market research, formation of companies or commercialization in general — has a concentration in academic organizations or institutes apparently seeking to commercialize research discoveries originating from "pure" research.
   
• Hope springs eternal in the U.S.  Despite two full years of economic woes in the U.S., a surprisingly steady stream of new medtech companies continue to be founded, as entrepreneurs commit to the commercialization of technologies they see warranting the rigorous development, clinical testing, FDA and other hurdles en route to the market.  But to temper the idea that in the US there is a greater abundance of adventurous entrepreneurs, I must note that a remarkable number of new companies in the US recently have been started by serial entrepreneurs, who have so often previously run the gauntlet demanded of startups  that they are fully prepped to make new runs with new technologies. 
   
• Minimally invasive is minimally invasive (is better).  Lower long term cost is better. With few real "untapped" clinical targets being the subject of new medtech development, the vast majority of activity is clearly centered around improvements in care that lend to the argument of better clinical outcomes and/or reduced cost of patient care.  The thrust of R&D is on yielding advantages that reduce invasiveness, speed the treatment process and/or time to healing or simply provide competitive clinical costs at or lower than alternatives.
   
• Notwithstanding the prevalence of developments noted above, in reducing cost/invasiveness, there are distinct areas of new technology development that center on providing outcomes where few, if any, effective therapies existed previously.   A good point (perhaps the most salient example) is in cell therapies, deriving from autologous, embryonic or adult stem cell technologies.  Despite ongoing ethical/policy/legal battles regarding embryonic stem cells, cell therapy has moved rapidly to the foreground as one of the most significant drivers of new technologies soon to spawn therapies for previously untreated diseases.  While this field may certainly characterized as simply being en vogue, and is therefore only momentarily benefiting financially from recent attention, there are very real advances in the science and technology of cell therapies that are moving these to clinical and market fruition.

These are some of the insights I have picked up and can reveal from our market research.  It would certainly be intriguing to me to hear what readers have themselves witness that either corroborates, or refutes, what I see.

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There are six main categories of closure and securement devices as discussed below:

• Sutures, Staples, and Other Mechanical Closure Devices
• Tapes
• Hemostats
• Fibrin and Other Sealants
• High-Strength Medical Adhesives
• Post-Surgical Adhesion Prevention

This market may be subdivided into the following product categories: sutures, staples and other mechanical closure devices; tapes; hemostats; fibrin and other sealants; high-strength medical adhesives; and post-surgical adhesion prevention. The total securement market is growing at an aggregate of almost 10% annually. 

Definition of Surgical Closure and Securement Products

Product	Description
Suture	Sutures are medical devices made out of woven or single filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.
Staple	Staples are rigid or semi-rigid suture-like materials delivered through a closure device and consisting of single- or multi-filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.
Tape	Tapes are fabric and polymer-based medical devices that are used to secure cuts, lacerations, and incisions in the surface of the skin as an adjunct to wound closure.
Hemostat	A hemostat reacts in the presence of blood to establish the normal cascade of factors that arrest bleeding. These products can be added to a bleeding field during surgery to prevent further bleeding, and are mostly dependent on a full complement of normal factors in the patient’s blood.
Sealant	A sealant will prevent leakage of fluid and/or gas from a surgical incision (such as pulmonary gases or spinal fluids). These products will often hold back pressurized fluids from normal vascular activity. Although their efficiency does not normally require the full complement of active clotting factors in blood to be within normal levels, these products (e.g., fibrin sealants) normally also have some hemostatic activity.
Glue/adhesive	Glues and adhesives (e.g., cyanoacrylate glues) are used to attach organs, structures, or tissues to each other or to effect repair. These materials can be enhanced by incorporating additional hemostatic or sealant properties, such as Angiotech’s Vitagel (a combination of collagen and thrombin) and Nycomed’s Tachocomb (a combination of thrombin, collagen and fibrin).
Adhesion	Abnormal joining of two organs or tissues occurring after inflammation, especially post-surgery. Adhesion-prevention products are medical devices or substances made from synthetic polymer or natural biomaterials that are manufactured into gels, fabrics, films, and dried solids that are used to avoid the formation of post-surgical adhesions (PSA).

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

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Pressure ulcers, or bedsores, are areas of local necrosis resulting from vascular insufficiency due to the prolonged application of pressure to the tissues. There is an important relationship between the magnitude of pressure applied to the capillary bed and the duration that pressure is applied. Pressure ulcers are more likely to occur under relatively low pressures over long periods of time rather than under short episodes of high pressure. A healthy adult can develop a pressure ulcer if pressure sufficient to close capillaries (25-32 mm Hg) is applied for sufficient time, such as when undergoing a lengthy surgical procedure. In the compromised or elderly patient, significantly lower pressures may lead to pressure ulcer formation.

Pressure ulcer formation is enhanced through the additional application of shearing forces, friction, and moisture. Shearing occurs when the skin is anchored to a surface, such as a bed or chair, and restrained from sliding over the surface while the underlying tissues are forced to move. The shearing force contributes to the destruction of deep tissue through the angulation and obstruction of blood vessels and excessive stretching of tissue. Shear occurs when a patient left sitting in a bed is pulled down into a slouch by gravity. The skin will adhere to the bed linen, while the coccyx will gradually drag the underlying tissue downward. Shearing forces may result in a disruption of the dermal-epidermal junction and produce blisters. Proper and frequent repositioning of a patient can reduce both pressure and shearing forces.

Friction occurs when the adhesion to the surface is not quite sufficient to prevent sliding, but sufficient to impart resistance to motion, that results in heat and wearing away of the outer layers of the skin. A patient who has slid down toward the bottom of the bed and is dragged back to the top will experience friction on the heels and other bony prominences. For this reason patients should be lifted back into position, and sliding over the bed surface should be avoided. Dressings that protect against friction and mattress covers with a low friction coefficient are helpful.

Moisture that is in prolonged contact with the skin produces maceration and reduction in the skin’s ability to tolerate additional stress. Macerated skin has a higher friction coefficient, increasing the likelihood of damage from friction and shear. Several sources of moisture are common in hospital and nursing home situations, including perspiration and urinary and fecal incontinence. Moisture may lead to fungal infections, and fecal incontinence can generate infections by E. coli. Thus, moisture may contribute to wound formation and present complications to wound healing.

Staging of Pressure Ulcers

• Stage I ulcers are indicated by damaged friable surface skin with considerable hidden cell death caused by continuous pressure damage usually from immobilization in a single position. Identification of signs of pain and early indications of visible damage is a significant event in that it alerts caregivers of the need for interventions to prevent more serious damage. 
   
• Stage II ulcers present as partial thickness wounds, which may heal with early intervention by regeneration under advanced wound care techniques. 
   
• Stage III ulcers are usually full-thickness pressure sores. These are often difficult to classify due to the presence of eschar that obscures visualization of the wound bed. The presence of eschar does indicate a full thickness wound but the eschar must be removed (debrided) before classification can be established. 

  Early Stage III or Stage IV pressure ulcers may superficially resemble Stage I ulcers. A wound initially classified as Stage I may, therefore subsequently appear to progress to higher stages as the already damaged deeper tissues slough off or as auto-debridement occurs with moist wound healing therapy. 
   

• Stage IV pressure ulcers are characterized by full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining of healthy surrounding skin and sinus tracts may also be associated with Stage IV pressure ulcers.

The success of the four-stage system of pressure ulcer classification has led to attempts to utilize it for other wound types, with varying degrees of success. The four-stage system was developed for the initial assessment of the wound by determining the depth of injury and tissues involved. As full thickness wounds heal by granulation and scar formation it is inappropriate to use the system to describe the process of healing. Stage IV wounds do not become Stage III wounds during the course of healing. Tissues destroyed during the wounding process are not regenerated in full thickness wounds.

Pressure ulcers occur most frequently over bony prominences where the padding effect provided by adipose tissue and muscle is least present. Pressure ulcers may also occur under casts, orthopedic devices and under compression bandages and stockings. The majority of pressure sores occur in the following regions:- lower spine (40%), feet (21%), trochanters 20%), scapula (5%), with upper spine, elbows, ribs, head, knees, and lower limbs making up most of the remainder.

(See further coverage of pressure ulcers and the associated products in wound management on the market and under development in MedMarket Diligence report #S247.)

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August 2010 financing came in at a modest $267 million, following the year-high month of July which had financings of $518 million.

If the remainder of 2010 follows a typical course, total medtech financings will hit just shy of $4 billion, compared to a total $3.2 billion in 2009.  However, variability (and uncertainty) in the market (healthcare and the general economy) is considerable, so predictions are a somewhat academic exercise.

2010 Medtech Financings by Month

Compiled by MedMarket Diligence, LLC

Source: MedMarket Diligence, LLC

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Below is illustrated the global diabetes market segmented by geography, with further detail shown for the U.S. markets product segments.

The U.S. represents the single largest share of the global diabetes market, with insulin, glucose meter test strips (not including meters) and anti-diabetic drugs contributing the largest segments to the U.S. total.

Source: MedMarket Diligence, LLC; Report #D510.

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In the early days of insulin treatment, animal insulin was used—bovine and porcine, of which porcine became the favorite as the molecule differed from human insulin by only a single amino acid. Bovine insulin was phased out as the purification and supply of porcine insulin was scaled up. This helps to explain why the Danish company Novo Nordisk became the leading insulin manufacturer in Europe, given the strength of the Danish pig industry.

Ultimately, it became possible to make "humanized" insulin from pig insulin by replacing the pig-specific amino acid with the human-specific amino acid. Human insulin is now manufactured from cloned human insulin genes. Genentech and Eli Lilly devised a means of achieving this for the U.S. market and Novo Nordisk followed suit in Europe. The bulk of the market is now converted to human insulin.

The second major innovation in insulin has been the development of ultra fast-acting insulin derivatives. The introduction of recombinant production methods of human insulins made it possible to alter the insulin molecule in order to tailor the pharmacokinetics. Thus, insulin analogues such as insulin lispro (Humalog, Eli Lilly) and insulin aspart (NovoRapid, Novo Nordisk) are absorbed very rapidly and the variability of their effect is minimized.

There is a great variety of insulin formulations on the market; as summarized in the following tables.

Rapid acting (onset less than 15 minutes)

Type	Company	Source
Humalog, Insulin lispro	Eli Lilly	Analogue
Humalog Cartridges	Eli Lilly and Company	Analogue
NovoLog, Insulin aspart	Novo Nordisk	Analogue
ApidraTM, insulin glulisine	Aventis Pharmaceuticals	Analogue

Short acting (onset 1⁄2-2 hours)

Type	Company	Source
Humulin R (Regular)	Eli Lilly and Company	Human
Iletin II RegularTM	Eli Lilly and Company	Porcine
Humulin R Cartridges (1.5 ml)	Eli Lilly and Company	Human
Novolin R (Regular)	Novo Nordisk	Human
Velosulin Human (Regular) (Buffered)	Novo Nordisk	Human

Intermediate acting (onset 2-4 hours)

Type	Company	Source
Humulin L (Lente)	Eli Lilly and Company	Human
Humulin N (NPH)	Eli Lilly and Company	Human
Iletin II Lente	Eli Lilly and Company	Porcine
Iletin II NPHTM	Eli Lilly and Company	Porcine
Humulin N Cartridges (1.5 ml)	Eli Lilly and Company	Human
Novolin N (NPH)	Novo Nordisk	Human

Long acting (onset 4-6 hours)

Type	Company	Source
Humulin U (Ultralente)	Eli Lilly and Company	Human

Very long acting (24+ hours)

Mixtures

Type	Company	Source
Humalog, Insulin lispro	Eli Lilly	Analogue
Humalog Cartridges	Eli Lilly and Company	Analogue
NovoLog, Insulin aspart	Novo Nordisk	Analogue
ApidraTM, insulin glulisine	Aventis Pharmaceuticals	Analogue

Source: MedMarket DIligence, LLC; Report #D510, "Diabetes Management Worldwide, 2009-2018".

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Below is the spreadsheet listing of medtech financings for August 2010.  This blog post will reflect in the spreadsheet below the current listing of financings as we identify them.

Source: MedMarket Diligence, LLC

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Below is illustrated the distribution of the ablation market by modality across the major markets in Western Europe.

Source: MedMarket DIligence, LLC; Report #A145, "Ablation Technologies Worldwide Market, 2009-2018."

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An overview (map) of the spectrum of clinical applications in tissue engineering and cell therapy is shown below:

Source: Report #S520

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Source: MedMarket Diligence, LLC; Report #D510, "Worldwide Diabetes Management Market, 2009-2010."  Available for download at link.

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Neutrality doesn't just come in handy, either.  It is instrumental in enabling us to characterize markets in a defensible manner. For example, if Company A is interested in knowing the detailed status of development of products by Company B, then Company A must either (1) rely on publicly disclosed (e.g., annual report or SEC 10(k) or similar) information (IF, that is, the company is public), (2) devise a research methodology that reveals Company B's info without revealing Company A's identity (also known as corporate espionage) or (3) pursue the information through a neutral, third party source capable of gleaning information from clients and filtering out the inherent marketing hype or other bias in the information.  (I find it more than a little entertaining — it is in fact very telling — when, as has happened on more than one occasion, I have received a call from an "MBA student working on a project" seeking free information from one of our reports, while their Caller ID clearly identifies which company they are working for.  I can only guess how often these "students" try a similar approach of contacting competing medtech companies.)

In this business, where my clients are also the subject of the analysis provided through our reports, I am sometimes constrained from revealing all I know, sometimes at all, but more often only until it can be part of an objective, third party analysis.  Like in journalism, where sources' identities are protected from being revealed, it would not be in my interest to blog about the latest gossip or juicy industry scuttlebutt (a la TMZ).  Until a development is corroborated (both to verify its accuracy and minimize its linkage to one confidential client) or appropriately integrated through methodology into a meaningful analysis, it is merely a tidbit of insight that I do not exploit.

Maintaining neutrality is also very important, especially when there can be enormous pressure to bend to a client's request for coverage of their product, or with their language.  Doing so will sometimes most assuredly result in a sale of the report to those whose interests are more aligned with that company's fortunes (e.g., their management and investors).  However, just as assuredly, if that coverage even appears to the broader audience that we have used a different ruler to measure one client's products, we lose much more in the balance.

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(PressMethod) – Surgical procedures focus on a wide range of clinical endpoints — the creation of a lesion to block aberrant cardiac rhythms, the destruction of cancerous tissue, the ligation of tissues with associated hemostasis, and many others — which has driven the development of an array of ablation technology types that are now competing aggressively with each other for a growing caseload of procedures. The ablation technologies with some of the most rapidly growing use rates are cryotherapy and radiofrequency ablation, followed by ultrasound, laser and, due to innovations in its implementation, radiotherapy. These are among the findings in a new medical technology report from MedMarket Diligence.

Although the applications of ablation devices include a number of aesthetic treatments, the majority of applications remain chronic disorders in areas which include cancer, cardiovascular, urology, gynecology and orthopedics. Many of these disorders are age-related, and the related device segments are driven by the aging of the global populations. Other market drivers include the Chinese government's push to modernize its healthcare facilities by building 400 hospitals per year, and developed country populations which are demanding anti-aging treatments, to which physicians are responding by purchasing equipment.

"Like the most successful medical technologies, ablation technologies have as their underlying driver for success the ability of physicians to capture greater caseload due to their ability to promote the clinical efficacy of ablation, faster healing times, fewer complications and many other benefits," says Patrick Driscoll, President of MedMarket Diligence. According to Driscoll, the top ablation technologies are growing at nearly 20% annually in manufacturer revenues. These include control systems, instrumentation and probes and other disposables used during the procedures.

The MedMarket Diligence report, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities", describes alternative energy-based technologies and the nature of their effect on soft tissue, the underlying basis of the technology, the requisite systems for their use (including capital equipment, devices and disposables), and their strengths and weaknesses for specific clinical applications. The report details current and anticipated target applications and assesses the current and forecast caseload for each energy-based therapeutic considering competition from any and all alternative energy-based or other therapeutics, with current and worldwide market forecasts (2009-2019) segmented by technology type and specific clinical segment. The report provides segmentation of the worldwide ablation market by both ablation technology and region/country: Americas (USA, Canada, Mexico, Brazil), Europe (Germany, United Kingdom, France, Italy, Spain, BeNeLux), Asia/Pacific (Japan, China, India, Australia) and Rest of World. The report details the current and emerging products, technologies and markets for each energy-based therapy. The report profiles 76 key companies in this industry detailing their current products, current market position and products under development.

The report is described in detail, including table of contents and list of exhibits, at link. The report may purchased for immediate download at link.

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As well established as the practices are for the management of types 1 and 2 diabetes, a raft of new technologies, from modest to radical, are steadily entering clinical practice and the industry, according to a new report from MedMarket Diligence.

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Aug 16, 2010 – The diagnosis, monitoring and management of both insulin-dependent diabetes mellitus (also known as Type 1) and non-insulin dependent diabetes mellitus (aka Type 2) is a well established practice of regulating blood glucose levels. Nonetheless, manufacturers have steadily developed new technologies that continue to improve the management of the disease by reducing burden on patients, reducing the incidence of diabetes-related complications and reducing the overall cost of the disease on healthcare systems.

“Without a doubt, the 10-year study known as Diabetes Control and Complications Trial, or DCCT, played an enormous role in validating the technologies that now routinely serve to improve the quality of life for diabetics,” says Patrick Driscoll, President of the medical technology business research firm MedMarket Diligence. “But the steady growth in diabetes prevalence worldwide, driven by increased prevalence of obesity, demographic trends and other forces, combined with persistent demand for ever less intrusive monitoring technologies and better long-term blood glucose management, creates an enormous opportunity for new technology development by diabetes product manufacturers.”

According to Driscoll, and detailed in the MedMarket Diligence report (see link), products in diabetes management represent an enormous $36 billion global market annually, encompassing insulin, blood glucose meters, lancets, test strips, insulin pumps, syringes (and other delivery devices), continuous blood glucose meters and a broad range of anti-diabetic drugs (oral hypoglycemic agents). Each of these product areas has many competitors offering and developing new products (even the area of insulin has a dozen competing companies), with a steady stream of innovations being introduced to the market and clinical practice. Moreover, aggressive research has continued to push for more advanced solutions to diabetes, including novel insulin delivery methods, pancreas transplants, islet cell transplants, stem cell approaches, antibody treatment, vaccines, novel drugs, new continuous blood glucose monitoring systems and the “holy grail” of diabetes management, a closed-loop blood glucose monitoring and insulin pump system (sometimes referred to as an “artificial pancreas”), which may be approved for marketing in the very near future.

Growth in the market for diabetes management products ranges globally from a low of about 11% annually in Europe to nearly 24% annually in Asia. Overall, the U.S. and Europe, with their advanced healthcare markets and payment systems, still represent an aggregate 68% of the global market. By product area, the segments driving the largest annual revenues are insulins and anti-diabetic drugs, comprising almost two thirds of the global sales of diabetes management products.

The MedMarket Diligence report #D510, “Products, Technologies, Markets and Opportunities in Diabetes Management Worldwide, 2009-2018,” details the worldwide incidence and prevalence by country/region of Type 1 and Type 2 diabetes and details the current and projected market for diagnostic and therapeutic products in the management of diabetes, including anti-diabetic drugs, alternative insulin types, blood glucose monitoring (including continuous monitoring devices), insulin pumps, and other established and emerging products in diabetes management. The report provides an emphasis of detail on the status of development of novel products including noninvasive monitoring, oral/inhaled/other insulin delivery. The report details the clinical and technology developments underlying this huge and evolving worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. Separate size, growth and competitor share data are presented for the U.S., European, Asia/Pacific and Rest of World. The report profiles active companies including detailed profile information on major competitors, brief profiles of companies with less sizeable current or potential positions in the market, plus additional profiles of companies with novel or advanced research activities in the market.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

The report is described, with complete table of contents and list of exhibits at http://www.mediligence.com/rpt/rpt-d510.htm and may be accessed for immediate download via http://mediligence.com/store/page34.html.

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The primary competitors in the field of tissue engineering and cell-based therapies for cardiovascular applications are shown in the exhibit below illustrating the stages in which they have cardiology/cardiovascular applications in development.

Key Competitors in Tissue Engineering and Cell Therapies for Cardiovascular Applications

Note: See specific products in development detailed in report #S520.

Source: MedMarket Diligence, LLC; Report #S520, "Tissue Engineering, Cell Therapy and Transplantation 2010."

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Below is shown the global market for ablation technologies distributed by clinical segments.

Share of Energy-based Market by Clinical Market Segment, 2010

Source: "Ablation Technologies Worldwide Market, 2009-2019", report #A145, published by MedMarket Diligence, LLC.

Restraints in this market include the down side of the global recession, which makes it more difficult for physicians to obtain credit to purchase new equipment; and stricter hospital budgets which have dampened, in recent years, the Radiation market for large capital expenditures. Still, the market is expected to begin improving by 2011; this will be reflected in the increased revenues through the remaining years of the forecast period.

Electrical and electrocautery devices have long been a mainstay of the surgeon’s toolbox, and they will continue to be used for the foreseeable future. Some estimates say that as much as 80% of all surgical procedures make use of one of these devices. Key among the advantages offered by these products is the ability, depending upon the procedure, to assist the surgeon to conduct a procedure rapidly—often more quickly than with a cold scalpel. Electrical ablation is used in a wide array of surgical procedures, including colon resection, hysterectomy and gastric bypass, to name a few.

Radiation devices cause destruction of target tissues by disruption of cellular mechanisms, often with surgical precision, without ever cutting the skin. These systems have advanced to a high-tech level unforeseen even ten years ago. Radiation ablating equipment includes traditional radiotherapy machines, image-guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT). Over the last ten years or so, radiologists have been moving towards more advanced treatment techniques, such as those utilizing multiple or non-coplanar beams, 3-dimensional conformal radiotherapy (3DRT) and IMRT, to treat tumors. Physicians view the accuracy of computed tomography-based 3-dimensional target delineation, which provides more detailed targeting than does 2-dimensional design, as another very attractive treatment option.

Light-based laser devices use high-intensity light to shrink or destroy tumors. Various lasers have different effects on different tissues, depending on the laser’s wavelength. Lasers commonly used for medical and/or aesthetic purposes include Erbium:YAG, ruby, CO2, and neodymium:YAG-laser (Nd:YAG). Also in this category are femtosecond and excimer lasers. Femtosecond lasers allow extreme precision in surgery. The possibilities for its use now include but are not limited to femtosecond keratoplasty, astigmatic keratoplasty, and keratoconus. Excimer lasers typically produce ultraviolet light, and are used in LASIK eye surgery. 

Radiofrequency energy is characterized by a specific frequency measurable in Hz. Medical devices that emit RF energy produce a change in the electrical charges of the treated tissue, creating an electron movement. Electrosurgical cutting uses sharply focused, intense heat at the surgical site to cut the tissue. By holding the electrode a small distance away from the tissue, the surgeon can produce the most intense heat over a very short amount of time. This results in vaporization of the tissue and the desired cutting effect. Vessel sealing and ligating devices usually utilize electrical energy combined with pressure to seal vessels and to cut off small bits of tissue.

Ultrasound energy relies on the fact that as an acoustic wave propagates through tissue, part of it is absorbed and converted to heat. Focusing sound waves allows concentrated energy deposition to occur deep in tissue, allowing precisely localized heating and thermal coagulation while sparing intervening tissue. High intensity focused ultrasound, or HIFU, treats a precisely defined portion of the targeted tissue. Because this technology can achieve precise ablation of diseased tissue, it is often referred to as ‘HIFU surgery’, or ‘non-invasive HIFU surgery.’

Cryotherapy uses extreme cold to freeze and destroy the target tissue, such as a cancerous tumor. It is applied in a freeze-thaw process. The cryotherapy probes, needles or catheters are carefully positioned in place using ultrasound guidance, then the freezing agent, argon gas, is allowed to circulate through the cryotherapy probes, causing an ice ball to form in the tissue at the tip of the probes. The tissue is frozen rapidly, then thawed slowly and completely, and then is put through a second freeze-thaw cycle. It is the intensity of the freezing that determines the ultimate response of the targeted tissue, which may range from chilled to inflammation to cell death. Different cell types show different sensitivities to freezing, a fact which can be used for therapeutic purposes. For example, prostate cancer cells demonstrate different susceptibilities to freezing than do other tissues, a difference that has been linked to the presence of the androgen receptor.

Thermal ablation devices may be engineered to produce a variety of temperatures in tissues, depending upon the intended usage. These temperatures may range from 39 – 40 °C up to as high as 80 – 90 °C, under well-controlled conditions. When hyperthermia is used, there is evidence of a number of processes taking place, which can include enhancement of the anti-tumor effects of radiation and of various drugs; induction of immunological processes; induction of gene expression and protein synthesis; and general changes to the tumor’s environment which make the tumor more accessible to some therapies. Above 43°C, the heat itself has a cytotoxic effect on the cells.

Microwave hyperthermia is a non-ionizing form of radiation therapy. Low levels of microwave energy are used to vigorously vibrate water molecules in tissue to quickly and effectively heat the tissue to a physical penetration depth defined by the microwave frequency. Microwave has also been shown to improve the results of radiation therapy for the treatment of some recurrent and progressive tumors. The resulting hyperthermia destroys cancer cells by raising the tumor temperature to a ‘high fever’ range. Recent research appears to show that cancer cells may be particularly vulnerable to microwave-induced hyperthermia due to their high acidity. Microwave energy disrupts the stability of the cellular proteins and kills the cells.

Hydromechanical ablation is energy-based tissue destruction accomplished via mechanical means, such as extracorporeal shock wave lithotripsy devices, or jets of water or saline. In extracorporeal shock wave lithotripsy, the lithotriptor uses an external hydromechanical energy source to break up the stone with minimal collateral damage. The successive shock wave pressure pulses result in direct shearing forces which fragment the stones. Water jet surgery, a form of dissection which has been used successfully for several years, employs the kinetic energy of the water jet to separate different tissue types by their varying elasticity and firmness. In hepatic surgery, for example, the device can selectively differentiate between liver parenchyma, blood vessels and bile ducts. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.

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• Single incision laparoscopic surgery and natural orifice transluminal endoscopic surgery.
• Medical device development company.
• Surgical instrumentation and osteogenic biomaterials for spine surgery.
• Clinical diagnostics including a noninvasive prenatal diagnostics.
• Laparoscopic surgical instrumentation.
• Ultrasonic breast cancer detection device.
• Technologies for tendon, ligament and soft tissue repair.
• Cryogenic ablation system
• Emerging procedure for bone fracture fixation.
• Laser ablation technology
• Intramedullary repair system for vertebra fractures
• Undisclosed orthopedic device technology.
• Less invasive pericardial access for treatment of cardiac arrhythmia.
• Medical technology company
• Surgical instrumentation
• Laser technology applied to tissue closure, other applications.

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The exhibit below indicates the wide differences in prevalence among the regions as defined by the IDF, and the projected evolution to 2030.

Regional Estimates for Diabetes (Age 20-79 Years), 2010 and 2030

Source: IDF Diabetes Atlas, 4th Ed., International Diabetes Federation, 2009; and MedMarket Diligence, LLC.

(See also "Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018", Report #D510, published July 2010.)

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See individual financings below.

• Replication Medical, Inc., has raised $1.1 million in funding according to a regulatory filing (implantable hydrogel devices used in spine surgery)
• Sensus Healthcare, LLC, has raised $1.5 million of a planned $7 million round of funding according to a regulatory filing (medical technology development)
• Figure 8 Surgical, Inc., has raised $1.36 million of a planned $1.5 million round of funding according to a regulatory filing
• Seguro Surgical, Inc., has raised $125K of a planned $1.25 milllion funding round (surgical instrumentation)
• Tissue Genesis, Inc., has raised $1.33 million of a planned $15.3 million round of funding according to a regulatory filing (tissue engineering and cell therapy)
• BIO2 Technologies has raised $1.1 million of a planned $2 million round of funding (tissue engineering scaffolds)
• Smart Pill Corp. has raised $7.95 million of a planned $9.5 million round of funding according to a regulatory filing (pill camera GI diagnostic)
• Cambus Medical has raised $1.89 million (€1.5 million) in a new round of funding (advanced catheter component solutions)
• Cappella Inc. has raised $3.69 million of a planned $9.9 million round of funding according to a regulatory filing (treatment of bifurcation in coronary artery disease)
• Uptake Medical, Inc., has raised $17.5 million in a Series B funding round (device for treatment of emphysema)
• Neoprobe Corp. has raised $14 million in funding (gamma detection technology in sentinal node biopsy)
• DFine, Inc., has raised $36.2 million in financing (minimally invasive treatments of vertebral compression fractures)
• EyeTechCare has raised $9.5 million (€7.5 million) in a new round of funding (high intensity focused ultrasound (HIFU) for treatment of glaucoma)
• Theranos, Inc., has raised $45 million of a planned $100 million round of funding (medical devices that monitor drug reactions)
• TriVascular, Inc., has raised $60 million in a new round of funding (technology for repair of abdominal aortic aneurysms)
• Ventus Medical Inc. has raised $40 million in a Series D round of funding (medical device technology for treatment of sleep disordered breathing)
• InVasc Therapeutics, Inc., has raised $3.2 million of a planned $12 million round of funding according to a regulatory filing (drugs for kidney disease and atherosclerosis)
• Innocoll Holdings, Inc., has raised $5 million in funding according to a regulatory filing (collagen-based drugs and devices)
• Vertiflex, Inc., has raised $2 million in funding according to a regulatory filing (non-fusion spine surgery technologies)
• Providien, Inc., has raised $10.5 million in seed funding (undisclosed medical device technology, principal investor Endeavor Capital)
• BBARRX Medical, Inc., has raised $15 million in a Series D round of funding (endoscopic treatments for GI diseases)
• Invuity, Inc., has raised $13.2 million of a planned $16 million round of funding (lighting and visualization in minimally invasive surgical instrumentation)
• EndoStim, Inc., has raised $6 million in a Series B financing (device treatment sphincter-related disorders such as GERD and urge uinary incontinence)
• Gentis, Inc., has raised $548K of a planned $2.25 million round of funding (orthobiologics products)
• AxioMed Spine Corp. has raised $14.5 million in a round of funding (spinal disc implants)
• Nfocus Neuromedical, Inc., has raised $3.31 million of a planned $7.15 million funding round (device treatment of brain aneurysms)
• Maya Medical, Inc., has raised $700K in an apparent seed financing (company founded by Motasim Sirhan, founder of Avantec Vascular)
• inCyte Innovations, LLC, has raised $3 million in funding according to a regulatory filing
• SuperDimension Ltd. has raised $9.8 million in a funding round (technology to detect and map lung cancer)
• USHIFU, Inc., has raised $1.02 of a planned $10 million funding round according to a regulatory filing (therapeutic use of high intensity focused ultrasound)
• Devicor Medical Products Group, LLC, has raised $151.5 million from seven investors to fund development of breast-care business (now named Mammotome) from J&J's Ethicon Endo-Surgery.
• IDEV Technologies, Inc., has raised $27.7 million of a planned $44.8 million round of financing according to a regulatory filing (biliary stent technologies)
• Sound Surgical Technologies, LLC, has raised $2.1 million of a planned $5 million funding round (ultrasound based liposuction for cosmetic surgery)
• Avedro, Inc., has raised $4.58 million in funding according to a regulatory filing (non-invasive procedure for treatment of keratoconus in vision correction)
• InfraReDx, Inc., has raised $1.53 million in a round of funding according to a regulatory filing (infrared imaging of blood vessels for catheterization)
• Aethlon Medical, Inc., has raised $890K in a round of funding according to a regulatory filing (blood purifier to treat infectious diseases)

Recent Reports from MedMarket Diligence:

New! Diabetes Management Worldwide 2009-2018

New! Ablation Technologies Worldwide Market, 2009-2018

Tissue Engineering, Cell Therapy and Transplantation, 2009-2018 

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