Obesity treatment devices, companies

The clinical management of obesity is, in its simplest terms, broken down by those treatments that use products or not. Behavioral modification and surgery (e.g., gastric bypass or roux en-y) comprise the "not" category.

In the area of products, the choices are pharmaceuticals or devices.  The obesity pharma field has had plenty of attention lately, given the burgeoning demand for obesity treatment being met by a shifting set of standards by the FDA on obesity drug approvals. Several big, prospective drugs — Lorcaserin, Qnexa, Contrave — appeared to have hit the "safety" wall at the FDA, but actions by the agency in the past year have considerably backtracked toward a stance (at least suggested by panel recommendation) favoring approval.

Simultaneously, the obesity device market has been quietly getting the job done by aggressively gaining approvals and, to a fault, heavily marketing themselves as solutions.

Obesity devices (and drugs for that fact) accomplish treatment objectives by serving one (or more) of a number of functions: 

• Restriction — limiting stomach capacity to reduce caloric intake
• Appetite suppression — limiting the driver behind caloric intake
• Satiety or "artificial fullness" — limiting caloric intake by signalling fullness earlier
• Malabsorption — limiting the impact of caloric intake by reducing its absorption in the GI tract
• Gastric emptying — slowing the rate of digestion, which leads to an earlier feeling of fulliness

The predominant mechanism of obesity devices is in restriction, for a variety of reasons. For one, it is in some ways the least challenging mechanism to accomplish (and emulates gastric bypass without being as invasive/traumatic).

Below is illustrated graphically the number of companies active by obesity device type.

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

Investment in medical technologies, May 2012

Total medical technology investment for May 2012 stands at $315 million, represented at the top by several big investments:

• Mitralign, Inc., has raised $35 million in a Series D financing according to press reports
• Neotract, Inc., has raised $32.4 million of a planned $40.32 million round of funding according to a regulatory filing
• Flowonix Medical, Inc., has raised $25 million in funding according to the company
• Zyga Technologies, Inc., has raised $25 million in a Series C funding according to press reports
• Sonitus Medical, Inc., has raised $25 million in a Series D funding according to a regulatory filing

The complete list of financings we have compiled is shown at link.

Investment in new medical technologies in 2012 is off the pace set in the first five months of 2011.  Year-to-date medtech fundings in 2012 are at $1.65 billion through May, while the comparable figure for 2011 was $2.11 billion, reflecting a 21% drop to 2012.  In May 2011, there were two particularly large individual fundings — Cameron Health raised $107 million and CardioDx raised $60 million — and even excluding these reflects a significant drop in funding (-15%) from 2011 to 2012.

As illustrated in the historical, month-by-month fundings shown from 2009 to 2012 at link, investment in medical technology remains fairly volatile and it is expected to remain so.

Medtech startups

More new technologies identified at medtech startups:

• Products to eliminate preventable contamination during invasive medical procedures.
• Arrhythmia mapping catheters.
• Electrophysiology (EP) recording systems for the treatment of atrial fibrillation.
• Reusable surgical trays.
• Biodegradable implant for treatment of stress urinary incontinence.
• Foam device to stabilize and position patients for surgical procedures.
• Disposable devices for the microsurgical treatment of ophthalmic diseases.
• Surgical simulation technology for spine surgery.
• Intraoperative nerve monitoring.
• Preventive surgical technology to treat the risk of hip fracture.

Companies developing these products were added to the Medtech Startups Database this month.

Ablation technologies global growth (electrical, radiation, light, RF, ultrasound, cryo, thermal, microwave, hydro)

The global market for ablation is in steady growth, but also is shifting in the balance of technologies employed.

The global market for energy-based ablation Devices in 2011 was estimated at almost $11.5 billion. For purposes of definition, ablation is considered to be a therapeutic destruction and sealing of tissue. The technologies that fall into this segment to nine different types based on the energy modality employed:

• Electrical
• Radiation
• Light
• Radiofrequency
• Ultrasound
• Cryotherapy
• Thermal (other than cryotherapy)
• Microwave
• Hydromechanical

Below is illustrated, first, the 2009 and 2019 revenues ($millions) for ablation by energy type and, second, the 2009 and 2019 revenues by energy type as a percent of total.

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

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

Spinal trauma assessment, classification and treatment

From "Worldwide Spine Surgery:  Products, Technologies, Markets and Opportunities, 2010-2020", Report #M520.

Trauma to the spine can involve one of more of the bony elements, soft tissues, and neurological structures. Surgeons are most concerned about instability of the vertebral column and sustained, or potential, neurological damage. Many cases of spinal trauma involve both dislocations and fractures, and they can occur in any region of the spine.

Causes of Trauma to Spinal Regions

Source: MedMarket Diligence, LLC

Spinal fracture classification is a critical first step in determining treatment. In order to describe and diagnose spinal fractures, spine surgeons use a system that involves segmenting the spine into three sections. These sections are comprised of:  the anterior column, which includes the anterior longitudinal ligament and the anterior one-half of the vertebral body, disc, and annulus; the middle column, which covers the posterior half of the vertebral body, disc, and annulus, and the posterior longitudinal ligament; and the posterior column, comprised of the facet joints, ligamentum flavum, the posterior elements and the interconnecting ligaments. 

Upside challenge to further adoption of surgical sealants and glues

Surgical sealants are wax or gel-like substances used alone or with sutures to completely seal internal and external incisions after surgery. They are particularly important following lung or spinal operations, where air and cerebrospinal fluid can leak through the suture holes, causing numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Several formulations of fibrinogen and thrombin have been developed. The most common formulation is the liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components and delivery to the wound. Because of the laborious preparation, these liquid products are not easy to use.

Over two dozen companies are active in the development and/or marketing of surgical sealants. Product formulations include the following

• fibrin
• thrombin
• polyethylene glycol (PEG), oxydized alginate, gelatin and other hydrogels
• cyanoacrylate-based
• diisocyanated prepolymer
• proprietary cross-linking formulations
• synthetic matrices
• naturally-derived bioglues

The market potential of surgical sealants is dictated in one part on the penetration of (limited) sealant-only procedures and adjunctive use of sealants with sutures, staples and clips.  Predictable hurdles already the focus of development include challenges to create sealants that:

• provide high-tensile strength adhesion
• enable tight-sealing that will prevent air/fluid leaks
• are free from direct or byproduct toxicity or other negative side effects
• are biodegradable
• allow ease of use
• provide hemostatic as well as sealant benefits
• are cost effective

For this reason, sutures, staples and clips — however low-tech they  may be — have staying power in clinical practice and the market and are therefore expected to represent a stubborn potential market for sealants to penetrate:

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

Developed versus emerging markets in advanced wound management

Continuing a vein of discussion posted previously, Trickle Down Technologies in Medtech, it is worth looking at the advanced wound management products represented by hemostats (i.e., hemostatic agents, like ZMedica's QuikClot), fibrin and other sealants, high-strength medical adhesives and products for prevention of post-surgical adhesion and look at their relative size in a set of  well-developed economies like that of the Americas versus the same for emerging markets, such as represented by Asia/Pacific excluding Japan and Korea.

The point of this comparison is to illustrate that markets for advanced technologies grow first and fastest in advanced economies.  In the case of advanced wound management products, least "advanced" product is hemostats, while the most advanced is high-strength medical adhesives (even moreso than anti-adhesion products).  See below in graphics comparing in absolute terms the market segmentation (stacked column chart) and the relative size of segments (two pie charts) for the Americas and Emerging Asia/Pacific.

Source: MedMarket Diligence Report #S190.

Hemostats represent a relatively low hurdle to market entry, since the important functions of the product are simply to stop bleeding without being toxic.  On the other end of the spectrum is high-strength medical adhesives, which must create strong tissue adhesion without toxicity and, as has been demonstrated by toxic cyanoacrylates, this is indeed a challenge.

Having said this, despite the technical challenge, which exists independently of geographic market differences, the real challenge (beyond gaining U.S. or EU regulatory approval) is bringing the price of these advanced products down to levels can accelerate their more rapid introduction into growth markets like the emerging Asia/Pacific (see CHINA).

New medical technologies at recently identified startups

Balloon kyphoplasty in spine surgery standing out in growth markets

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

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 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 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

Spine surgery segments distinguished by size and growth

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

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.

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

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Obesity Drugs and Devices Both Driven by Rapid Growth

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

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

Making or Buying Growth in the Medical Device Arena

New technologies at medtech startups

The undeniable hemostasis opportunity

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