advanced medical technologies

Balloon kyphoplasty in spine surgery standing out in growth markets

P. Driscoll — Tue, 15 May 2012 16:33:44 +0000

Technologies in spine surgery are, for the most part, growing in sales worldwide, but some technologies are seeing rather variable growth worldwide, particularly as driven by greater adoption outside the U.S — and in particular in the Asia/Pacific region, where China is and will be contributing to increasingly larger shares of spine surgery device (and other) revenues.

To illustrate, below are the breakouts of a newer segment of the spine surgery products market — balloon kyphoplasty. Data is illustrated on the share of worldwide sales of balloon kyphoplasty by geographic region in 2011 and 2020. While the Americas are seeing only nominal growth (not decline) in this segment, the Asia/Pacific region is seeing dramatic growth. Hence, by 2020, the Americas will represent a substantially smaller share of the the global market than it does in 2011.

Source: “Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities 2010-2020″; Report #M520, MedMarket Diligence.

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Surgical sealants, glues, hemostats from fibrin, cyanoacrylates, bioglues drive $14 billion market

P. Driscoll — Mon, 14 May 2012 17:51:18 +0000

Competing against sutures and staples, advanced wound closure, sealing, hemostasis and anti-adhesion products are steadily gaining revenues. The 2012 report from MedMarket Diligence details this current $14 billion market and its forecast to 2017.

Traditional use of sutures and, more recently, staples and clips largely represents the target for advanced wound closure and securement products including fibrin (and other) sealants, hemostats, high strength glues and post-surgical adhesion prevention products. Manufacturers of advanced wound closure and securement have over the past decade learned many lessons about clinical applications, surgical practices and market need and have developed broad portfolios of products that succeed in meeting that need.

The pace of development of products for wound sealing, closure, hemostasis and anti-adhesion has not slowed despite the extent to which these products have deeply penetrated the clinical caseload in the management of traumatic and surgical wounds. Traditional wound closure methods, including sutures, clips and tapes, have been steadily either displaced or augmented by biologically and chemically-derived formulations that produce more rapid healing, less scarring, less blood loss, less infection and fewer complications. MedMarket Diligence details the associated products, technologies, companies and global market in its 2012 report, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017."

"The successes of advanced wound closure products in effecting reduced blood loss, faster healing time and better clinical outcomes have justified their continued expansion into caseload traditionally addressed by sutures, a growth that has been only partially mitigated by absorbable sutures" says Patrick Driscoll, President of MedMarket Diligence. According to Driscoll, the continued growth of these novel products in the closure and management of wounds will result in sutures and staples declining from 35% of the total in 2012 to about 31% in 2017, with fibrin (and other) sealants and high strength medical adhesives being the primary beneficiaries. Moreover, these shifts in the market balance are taking place concurrent with an aggregate 8% annual increase in the market.

The breadth of wound closure products of course encompasses traditional wound closure based on mechanical closure, non-resorbable sutures, resorbable sutures, staples, clips and other types, as well as surgical tapes. While this category of products is undergoing a siege from biologically and chemically based closure products, the traditional wound closure types are seeing continued product development focused on improving outcomes and otherwise competing more effectively against emerging wound closure technologies. Due to their well established use in clinical practice, and due to the value of adjunctive use of these products with emerging products, this category remains the largest share of the wound closure and securement market.

Hemostats are now formulated from thrombin, gelatin, collagen, fibrin, synthetic and other types by literally dozens of companies.

Surgical sealants are derived from fibrin, synthetics, biopolymers, device-based and other types. These products represent the fastest-growing segment of the wound closure and securement market.

High strength medical and surgical glues and adhesives are, in principle, designed to achieve wound closure with little or no dependence on sutures, staples or other mechanical closure. Predicated on cyanoacrylate-type formulations, these products often have the advantage of stronger closure offset by toxicity, which has been the subject of aggressive development efforts. As a result of the successes that have been achieved in development and clinical acceptance, these products are demonstrating market growth that is second only to fibrin sealants.

Anti-adhesion (i.e., the prevention of post-surgical adhesions), seemingly the antithesis to surgical sealants and glues, can in fact be addressed by different formulations of products otherwise used for wound sealing, in addition by hyaluronic acids, biopolymers and other products specifically formulated to prevent tissue adhesion. Given the overlapping development of technologies and participating companies, this segment is a natural complement to consideration of wound closure products and technologies.

The MedMarket Diligence report #S190, detailed at http://www.mediligence.com/rpt/rpt-s190.htm details the complete range of wound securement technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

The report is a market and technology assessment and forecast of surgical sealants, glues, hemostasis, other wound closure and anti-adhesion. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products, medical adhesives and products to prevent surgical adhesions. With full year actual data from 2011, the report provides a worldwide forecast to 2017 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade. The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan, Korea and Rest of World.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a five-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 in detail at link and may be purchased for immediate download via online store or may be purchased by order form. (Note that there is a discount expiring May 15, 2012.)
# # #
MedMarket Diligence provides data and insight to the medical products, investment and other industries on advanced medical technologies through focused medical technology market and assessment Reports and the Medtech Startups Database.

Obesity 2019: More Slices of Pie

P. Driscoll — Thu, 10 May 2012 21:42:38 +0000

The future market for treatments in obesity is certain to be more fragmented than it is now. There will be more different types of treatments offered by drug companies, device companies, surgical procedures, and other options.

Recent market developments in the field of obesity have principally centered around the mixed signals put out by the FDA on obesity drugs. Safety issues were responsible for major drugs by Arena Pharmaceuticals (Lorcaserin), Vivus (QNEXA) and Orexigen (Contrave) hitting roadblocks by the FDA indicating that the drugs in their current form would not be approved. The FDA and the companies have moved rapidly since then toward developments encouraging investors that the companies' drugs may indeed reach the market in the not-too-distant future.

Whether it is these drugs, or others, it is clear that the market for obesity treatments will be represened by a significant number of drugs as well as devices over the next few years, yielding the following expected picture of the market in 2019:

Worldwide Obesity Drug & Device Treatment Market by Major Type

Source: MedMarket Diligence, LLC; Report #S835.

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Spine surgery segments distinguished by size and growth

P. Driscoll — Wed, 09 May 2012 18:55:18 +0000

The laconic comedian Stephen Wright recalled that when he turned 2 years old, he was upset, because in one year his age had doubled and he worried that by the time he was 6, he would be 32.

The point to be had is that growth rates gain their relevance from the base on which the rate is applied. Growth from 1 to 2 is 100%, but growth from 100 to 101 (in both cases only an increment of 1) is 1%.

For this reason, it is worth considering the relevance of spine surgery segment growth rates, as illustrated below, by considering not only the growth rate, but the relative size of segments. Below is the global spine surgery product market by segment, presenting both the percentage of the total market each represents and the compound growth of each segment from 2011 to 2020.

Source: MedMarket Diligence, LLC; Report #M520.

It is obviously important to look at relative size and growth in order to put each in perspective. For example, Axial lumbar interbody fusion ("AxiaLIF") is projected to have dramatic growth, but the absolute significance of this is diminished since it proceeds from an almost insubstantial base. By contrast is posterior pedicle screw fusion systems, with a CAGR under 10% but representing well over 20% of the total market.

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Diabetes products and technologies development

P. Driscoll — Tue, 08 May 2012 21:12:37 +0000

Research in the field of diabetes management has taken two main directions: (1) improving the effectiveness and reducing the invasiveness or other burden of existing treatments and (2) pursuing the “complete solution” to the diabetes problem. Improvements in current therapy include making glucose monitoring and insulin delivery less invasive and more patient-friendly, and many significant advances have been made in this context in the past two decades. Among these have been the development of insulin pumps and of non- or minimally-invasive techniques for sampling blood. New, fast-acting forms of insulin have been introduced. There has been considerable research in non-injection dosage forms for insulin, and the first inhaled insulin product has recently been approved. This could herald a new era in insulin therapy.

Still within the boundaries of improving existing treatments, manufacturers hope to succeed in development of an “artificial pancreas.” This is the term used to describe a system in which continuous glucose monitoring is linked electronically to continuously variable insulin delivery, effectively making diabetes control automatic and freeing the patient to get on with his/her life. The technology behind an artificial pancreas lies simply in linking essentially existing glucose monitoring technologies with infusion delivery in an autonomous, feedback loop that would normalize blood glucose control without frequent patient or clinician intervenion. The premise is that a healthy pancreas is able to regulate blood glucose levels via combined glucose monitoring and insulin infusion and such roles are now currently provided in separate systems monitored frequently (multiple times daily) by the patient or clinician.

More radical approaches to diabetes mellitus, also the subject of vigorous research, include ways of replacing the whole cumbersome business of glucose testing and insulin administration with normally functioning pancreatic cells. Transplantation of healthy pancreatic islets into diabetic patients has been explored, but the problems of rejection are a significant hurdle. More promising is the modification of adult or embryonic stem cells so that they develop into pancreatic beta-cells capable of being implanted in the patient and serving as a replacement for the insulin-secreting cells that have been destroyed.

Further in the future are developments based on genetic manipulation. Several gene anomalies have been identified as related to the development of type 1 diabetes in particular, and these may present targets for intervention to prevent the disease from developing.

Across this spectrum of possible developments — improving existing monitoring, improving existing insulin infusion, developing an integrated pump/monitor and cell-based or genetics-based “cures” to diabetes — there are a startling number of products, technologies and active companies.

See link for a complete analysis from MedMarket Diligence, LLC.

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Obesity Drugs and Devices Both Driven by Rapid Growth

P. Driscoll — Sun, 06 May 2012 18:48:47 +0000

With the rise of prevalence in obesity, much attention is being given to emerging treatment options — whether drugs or devices. Considerable commercial potential lies in treatment options that are less invasive device treatments than bypass surgery and obesity drug options represent sort of a "least invasive possible" option, although many obesity drugs have been stuck in the "awaiting approval" stage for some time due to concerns about safety.

Nonetheless, in even the short run, obesity drugs are driving more revenue than devices, with the expected lion's share of obesity drug revenues coming from combination drugs.

By 2019, drug's share of the total obesity treatment market will will have increased only moderately, the aggregate market will have increased by over fourfold. See the segmentation of obesity drugs and devices, below:

Source: MedMarket Diligence, LLC; Report #S835.

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Trickle down technologies in medtech

P. Driscoll — Sat, 05 May 2012 18:16:36 +0000

The length of time a technology has been in use in healthcare correlates pretty strongly with a geographic continuum from well developed, Western-style economies to less well developed economies to, at the extreme, Third World economies. This is not an extraordinary revelation, since new technologies tend to be, obviously, more expensive and well developed economies are in a better position to afford them. As time passes, the increased competition for providing advanced technologies creates downward pressure on prices, making each technology more affordable. Concurrently, as manufacturers face greater competition in existing markets, the natural next step is to then expand presence to other markets, where margins may be lower, but will nonetheless result in additional cash flows.

There are a couple ways to show this. In one case, we show below the distribution of wound securement technologies that include the more advanced "post surgical adhesion prevention" products as well as the less well advanced "tapes" for wound closure in Japan versus the rest of Asia/Pacific in 2011.

Source: MedMarket Diligence, LLC; Report #S190, "Worldwide Market for Sealants, Glues, Wound Closure and Anti-Adhesion, 2010-2017."

In another example, we look at a relatively new technology, in this case kyphoplasty used in spine surgery, and illustrate the USA's share of the worldwide market over time.

Source: MedMarket Diligence, LLC; Report #M520, "Worldwide Spine Surgery Markets, 2010-2020."

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Development of high strength medical and surgical adhesives

P. Driscoll — Fri, 04 May 2012 02:12:26 +0000

Although some form of suturing wounds has been used for several thousand years, sutures can be troublesome. There are procedures in which sutures are too large or clumsy, and locations in which it is difficult for the surgeon to suture. They can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot getting stuck and obstructing blood flow. In addition, sutures may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. These are some of the reasons why surgical adhesives are becoming increasingly popular.

As a logical derivative, surgeons want a product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. Challenges to product development include that products not be derived from human or animal products (to avoid immunogenicity or viral transmission), not produce toxic byproducts and be readily delivered, applied and/or activated in use.

High strength adhesive alternatives developed by manufacturers for specific clinical uses include those made with forms of cyanoacrylate, urethane, and other new adhesive products based on existing biomaterial adhesives (e.g., fibrin and albumin compounds), and new polymer adhesives based on entirely new chemistries (e.g., polyurethanes, proteins from living organisms).

Source: MedMarket Diligence, LLC; Report #S190.

For complete coverage of high strength adhesives and other sealants/glues used in medical/surgical applications, see "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017", Report #S190.

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Making or Buying Growth in the Medical Device Arena

P. Driscoll — Thu, 03 May 2012 20:04:41 +0000

A revealing analysis by CFO Publishing examined the impact on value (measured by share price) of making acquisitions versus funding research and development in the medical device arena. The study looked at “…the 30 largest U.S. medical device companies in terms of their current market capitalization that were publicly traded from 2002 through 2011, and examined this relationship during two separate periods, 2002 through 2006 and 2007 through 2011.”

The findings revealed that companies gained more value from investment in R&D than from acquisition and, moreover, that the period from 2007 to 2011, when capital markets were squeezed, resulted in a bigger gap between lost value from acquisitions and gained value from R&D investment.

Shareholder value evidenced by share price is a fussy variable that does not always lend itself to logical analysis (see “irrational exuberance”), but in general this pessimistic response on the part of the market to acquisition versus R&D investment seems to reflect the market’s view that buying bricks and mortar does not equate with the value gained in creating intellectual capital. And, in a recessionary market, when funds are more dear, the need for careful spending on growth is viewed even more critically.

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New technologies at medtech startups

P. Driscoll — Wed, 02 May 2012 20:27:36 +0000

Below are new medical technologies at companies added in April 2012 to the Medtech Startups Darabase:

Less invasive interventional products to treat patients with hemorrhagic stroke
Proximal femur fracture fixation
Minimally invasive, low-cost surgery such as for prostatectomy
Fiber-optic catheter for removal of tumors and delivery of drugs, including for lung cancer

See the Medtech Startups Database described at link.

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The undeniable hemostasis opportunity

P. Driscoll — Wed, 02 May 2012 02:32:26 +0000

Among many functions that wound management products might offer — wound closure, wound sealing, anti-infection, anti-adhesion, etc. — hemostasis represents a function that offers entry to the market by manufacturers of products derived from thrombin, gelatin, platelets, collagen, fibrin, fibrinogen, synthetics, etc.

Ideally, products offer multiple functions that will result in effectively closed and healed wounds with few complications. Nonetheless, the urgency with which bleeding must be stopped in acute wounds has driven the development of products that demonstrate important clinical utility simply by focusing on hemostasis rather than comprehensive wound management.

As a result, a good number of companies have emerged and become successful in the hemostasis niche.

Below is illustrated the distribution of companies active in marketing and/or developing products in hemostasis.

Source: MedMarket Diligence, LLC; Report #S190.

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Drug and Device Options for Obesity Increasingly Splitting the Global Caseload

P. Driscoll — Tue, 01 May 2012 21:37:56 +0000

The obesity market is on the verge of new product introductions (especially drugs) and will soon become more fragmented by treatment options and competitors. The FDA has relented in the drug front, making it likely in the next 1-2 years (as we predicted) that the market will be split among appetite suppression, malabsorption, satiey and combination drugs. The trend is equally strong in the device arena, where the market dominance of restrictive devices (e.g., Lap-Band) will cede to artificial fullness, malabsorption, gastric emptying, and appetite suppression devices.

Below is illustrated the balance of the drug and device markets by type of obesity product.

Balance of Obesity Drugs and Device Markets by Type 2009-2019

Source: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", Report #S835, MedMarket Diligence, LLC.

Of course, another way to view the obesity market that is supported by the general trend of clinical treatment options competing against each other irrespective of technology type is that the aggregate obesity market is comprised of a shifting balance among device and drug options. In any case, below is illustrated the relative balance of all drug and device markets for the treatment of obesity.

Balance of All Obesity Drugs and Device Markets by Type 2009-2019

Source: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", Report #S835, MedMarket Diligence, LLC.

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Medical technology investment dips in April 2012

P. Driscoll — Sun, 29 Apr 2012 22:24:12 +0000

Total medtech financings for medtech reached only $197 million in April 2012, compared to an average of $379 million per month for the first three months in 2012.

The top medtech financings for the month are below:

$32.7 million – Myoscience, Inc. – Cryotherapy
$25.0 million – EnteroMedics, Inc. – Neuroblocking devices for the treatment of obesity
$21.2 million – Silk Road Medical, Inc. – Medical devices for neurovascular conditions
$17.9 million – Derma Sciences, Inc. – Devices and pharmaceuticals in advanced wound care
$16.5 million – AlloCure, Inc. – Isolation and expansion of mesenchymal stem cells for treatment of kidney injury
$16.5 million – Wavetec Vision Systems – Wavefront measurement systems for use in ophthalmology

The complete list of medtech companies receiving financing and/or investment in April 2012 is shown at link.

Sutures, staples and mechanical wound closure

P. Driscoll — Wed, 25 Apr 2012 21:53:15 +0000

From Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Worldwide Market, 2010-2017.

The vast majority of sutures, staples and endostaples are used to close procedures involving acute surgical wounds. Typically, chronic wounds do not involve use of suture and staple products unless some degree of surgical intervention is employed to remove necrotic tissue or to create a new acute wound bed to aid healing.

Sutures are classified as absorbable or non-absorbable; monofilament, multifilament or braided; and natural or synthetic. Absorbable or non-absorbable describes the suture’s effective life within tissue. Absorbable sutures lose the majority of their tensile strength within 60 days after use. Non-absorbable sutures are resistant to living tissue and do not break down. Monofilament, multifilament and braided describe the structure or configuration of the suture and is based on the number of strands used to manufacture the product. Natural or synthetic refers to the origin of the suture. Natural suture materials include surgical gut, chromic gut, catgut and silk. Catgut is made from the natural collagen fibers found in the intestine of sheep, goats, cattle, hogs and horses. (It was never made from the gut of cats.) It is debatable whether catgut should continue to be used for suturing wounds, since cotton is cheaper and cotton or synthetic threads are less likely to result in an infection. Synthetic suture materials include nylon, polyester, stainless steel, polypropylene, polyglycolic acid (PGA), polyglycolide-co-caprolactone (PGCL), and polydioxanone.

Sutures are made of two component parts, the needle and the suture. These can be found in a wide range of sizes and types, made of a range of materials, and the method of attachment of the suture to the needle can involve a variety of methods. Sutures are divided into braided and monofilament categories. Braided sutures are typically more pliable than monofilament and exhibit better knot security. Monofilament sutures are wirier and may require a more secure knot. Their major advantage is that they cause less tissue drag, a characteristic that is especially important in cardiovascular, ophthalmic and neurological surgery. Over the last few years, some companies have developed devices (such as Abbott Vascular’s Perclose, ProGlide and Prostar suture-mediated devices) that can complete the suturing process and tie the finishing knot quickly.

Stapler devices are an evolution of suture technology. The goal of stapler products is to avoid infection, make it easier to skillfully suture a wound closed, and make the total procedure go faster and more easily. Staples are made of stainless steel and biomaterials and are used to join internal tissues, reconstruct or seal off organs, remove diseased tissue, occlude blood vessels, and close skin incisions. They are primarily used during surgery as internal and/or external closure devices.
Staples are available in an assortment of sizes and features; procedure-specific stapler devices have been developed for use in one specific procedure or for multiple uses.

Internal staplers are used to approximate (or close) internal tissues and organs. The devices may be reusable or disposable. Some disposable staplers may be reloaded several times during the course of a single patient surgical procedure, before being discarded.

The most recent internal staplers are used to perform minimally invasive surgical procedures. These allow the surgeon to endoscopically secure internal wounds instead of having to operate through an open procedure. Staples can be made to dissolve, which obviates the need for removal. Such staples are ideally suited to laparoscopic surgery and are delivered via procedure-specific laparoscopic instruments. However, most staples are still made of stainless steel and when used for internal stapling procedures, whether open or laparoscopic, are not removed after healing. Skin staples are removed after the incision is healed. Probably the major benefit of staples is that they can be applied more rapidly than sutures and can be placed precisely without requiring the skill necessary for sutures. This also means increased safety for the patient, and patients can often be discharged more rapidly if procedures are stapled rather than sutured.

While cosmetically acceptable results are usually obtained, staplers normally are not used in highly visible areas such as the face. Here surgeons will still close by hand to minimize any scarring. In many procedures, sutures have begun to be replaced by cyanoacrylate glues, but the ideal alternative to suturing has not yet been developed; for example, cyanoacrylate glues used for external skin closure are only one-fifth as strong as sutures.

Traditional types of physical wound closure (sutures, staples, clips) continue to represent the lion's share of the wound closure and related products market. However, as shown in the graph, the share of the total market is declining due to the relatively higher growth of advanced wound products like sealants, glues, hemostats and anti-adhesion products.

Worldwide Market for Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2010-2017

P. Driscoll — Mon, 23 Apr 2012 00:08:30 +0000

A Worldwide Business Report from MedMarket Diligence:

· 420 pages · 155 Exhibits · 122 Company Profiles · Report #S190 · Published February 2012

Price: $3,950 (print or PDF; add $200 for both).
Site/Global License also available.

Order online (for report download)
or fax us your order form.

MedMarket Diligence has completed its comprehensive 2012 report entitled, "Worldwide Market for Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2010-2017". The report examines the global market, and geographic breakdowns, to reveal the size, outlook and opportunities for current and hopeful competitors in advanced wound closure, sealants, medical/surgical glues, hemostasis and anti-adhesion products.

The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data for 2011 and forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies. The report establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

See link for complete table of contents and list of exhibits. The report may be ordered online (for report download) or purchased via order form.

Applications in surgical sealants, glues, wound closure, hemostasis, and anti-adhesion

P. Driscoll — Sun, 22 Apr 2012 18:53:39 +0000

Uses of products in Report #S190, "Worldwide Market for Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2010-2017."

Wound closure via sealant…

Sutures…

Surgical clips and staples…

Adjunctive use of sealants and sutures…

Hemostasis…

Prevention of surgical adhesions…

Obesity treatment moving toward fragmented clinical approaches

P. Driscoll — Fri, 20 Apr 2012 17:28:08 +0000

Below is illustrated the balance of the drug and device markets by type of obesity product.

Balance of Obesity Drugs and Device Markets by Type 2009-2019

Source: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", Report #S835, MedMarket Diligence, LLC.

Balance of All Obesity Drugs and Device Markets by Type 2009-2019

Source: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", Report #S835, MedMarket Diligence, LLC.

Medical technology investment, from broader and longer view, on the rise

P. Driscoll — Fri, 20 Apr 2012 15:48:29 +0000

According to a MoneyTree Report from PricewaterhouseCoopers LLP and the National Venture Capital Association (see coverage in TechCrunch), investment was strong across all sectors in fourth quarter 2011, then fell off in first quarter 2012.

This falls in line, generally, with our perspective, where we view medtech investment as money that finances the development of the spectrum of technologies competing for related clinical applications. This means we consider money from any source (debt, equity, IPOs, etc.) and a broader consideration of competition; for example, considering device investment in the same arena as certain biopharmaceutical (or other) investment if the biopharm competes with, or is even adjunctive to, device investment. With healthcare systems and third party payers increasingly fixated on cost, any and all technology that might be applied to treating or managing a given condition must be considered "competitive", even if it means pitting a pharmaceutical against a traditional medical device.

Below is the quarter-by-quarter investment in "medtech" from 2009 to 2012. While there is variability from quarter to quarter, the overall annual upward trend is apparent.

Source: MedMarket Diligence, LLC.

For a comprehensive look at medtech investment (from our point of view) over the past few years, see link.

Global Hemostasis Market Growing Near 10%

P. Driscoll — Thu, 19 Apr 2012 14:27:27 +0000

Rapid hemostasis is an urgent need in management of trauma and surgical wounds. While hemostasis is in a simple sense just one step in the process of wound healing, it represents an opportunity in medtech due to both the high clinical value of stopping bleeds and the number and type of ways hemostasis can be produced.

The wounding event—whether caused by trauma or by a surgical procedure—leads to damage of blood vessels, initiating a clotting cascade involving complement factors in the blood and resulting in the formation of fibrin clots. This clotting cascade also helps to block pathogens from accessing the blood or tissues at the injury site. Vasoconstriction occurs to aid the biochemical cascade and cause hypoxia, which attracts white blood cells into the tissue and causes a humoral and cellular inflammatory response. This occurs extremely quickly and leads to the release of vasoactive factors such as histamine and bradykinin; these maintain the flow of blood factors to deal with the damaged tissue and any pathogens at the wound site. Wound exudates are allowed to seep through to the damaged area carrying inflammatory immune factors for repair. Plasma factors, including lysozyme, white blood cells (WBC) and macrophages, then begin the process of removing dead cells and debris from the tissue. Macrophages and WBC play an important role in regulating the healing process through cytokines and growth factors.

Hemostasis is a general term given to the process which is initiated to stop the bleeding and thus prevent significant loss of blood, and to close the wound and block the entry of pathogens as quickly as possible. Central to hemostasis is the clotting process; denatured polymers such as collagen and other foreign bodies in the injured site activate substances known as complement factors in the blood; these act on a soluble, blood-borne thrombin precursor (prothrombin) to cause it to change to thrombin. Thrombin brings about the cleavage of the protein fibrinogen to form an insoluble fibrin clot; fibrin is then further cross-linked by an enzyme in blood called Factor XIII. The cascade of events also results in the release of vasoactive factors to accelerate blood clotting.

The extent of the clotting process, the biochemical makeup of the hemostasis cascade, and the density of the fibrin clot are dictated by a combination of genetic and environmental factors. It is thought that the clotting process has evolved, over many millennia of evolutionary development, to be very efficient at stopping bleeding rapidly, preventing infection, and stimulating repair, albeit at some cost in terms of the resultant cosmetic appearance of the healed skin.

The evolved ability of the human body to stop bleeding has limits when the size and/or nature of the wound overwhelms the clotting process. Additionally, patients with compromised abilities in their clotting process can be at extreme risk from relatively minor wounds. As a result, hemostasis products have seen, and will continue to see, strong growth in the overall wound closure and management market.

Given the opportunity and the relatively low barrier to market entry, there are many active companies in the hemostasis market. Such opportunity is responsible for the U.S. market (often near 50% share of the worldwide market for medtech) representing a scant 32% of the global market.

Source: MedMarket Diligence, LLC; "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017." Report #S190.

Growth in the global hemostasis market is near 10% with some of the highest growth seen in the U.S. and Asia/Pacific markets, although driven by different dynamics.

Medtech Financings in April 2012

P. Driscoll — Wed, 18 Apr 2012 17:22:07 +0000

Below is a list of medtech financings in April 2012. You may bookmark this page, or visit link, to check on the status of investments during the month.

Source: MedMarket Diligence, LLC