New medical technologies at recently identified startups

Below is a list of companies recently identified and included in the Medtech Startups Database from MedMarket Diligence.

  • 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.
  • Technology to stabilize and position patients for surgical procedures.
  • Disposable devices for the microsurgical treatment of ophthalmic diseases.
  • Surgical simulation technology for spine surgery.

Further information about the Medtech Startups Database is found at link. A detailed list of technologies at companies is shown at link.

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.

Balloon-kyphoplasty-2011-2020
Source: "Worldwide Spine Surgery:  Products, Technologies, Markets and Opportunities 2010-2020"; Report #M520, MedMarket Diligence.

 

Medtech investment on tepid pace in May 2012

Medical technology investment in May 2012 is off to a sluggish start, reaching only $89 million by mid-month, putting it at pace for a monthly total under $200 million.

See the list of financings in medtech so far at:
https://docs.google.com/spreadsheet/lv?key=0AvLXRCi9OOphdDJQc3lSdXZoNHh1aExpM...

Obesity 2019: More Slices of Pie

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

Obesity-pie-2019

 

Source: MedMarket Diligence, LLC; Report #S835.

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.

Spine-share-cagr
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 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.

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.

Artificial-pancreas
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.

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:

Obesity-drugs-devices-2015
Source: MedMarket Diligence, LLC; Report #S835.

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.

Japan-row-sealants

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.

Us-kyphoplasty-decline-share

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

 

 

 

Underestimating obesity

Obesity Co-Morbidities

  • Cardiometabolic syndrome
  • Type 2 diabetes
  • Hypertension
  • Dyslipidemia
  • Coronary heart disease
  • Osteoarthritis
  • Stroke
  • Gall bladder disease
  • Obstructive sleep apnea
  • Gastroesophageal reflux disease (GERD)
  • Some cancers (endometrial, breast, and colon)

The great majority of attention on obesity over the past couple years has been centered on its high prevalence and the high costs (direct and indirect in comorbidities, as shown at left) of managing the condition. Therefore, it only adds fuel to the fire for proponents of more aggressive measures when data is released indicating that current numbers of the obese and overweight are actually understatements.

Current estimates of obesity prevalence in the U.S. are based on body mass index (BMI) and account for  20% obesity rate in the 50 states, with 12 states having rates of over 30%, according to the CDC.  However, recent research carried out by researchers at New York University School of Medicine and other institutions have indicated the imprecision of BMI is resulting in a high number of false negatives for obesity.  In the research studying a sampling of men and women and comparing BMI to an alternative method for determining obesity by employing specific biomarkers and duel-energy x-ray absorptiometry (DXA), the BMI measurement concluded that 26% of the subjects were obese, while DXA concluded that 64% of the patients were obese.

Body mass index has previously been challenged as a measure of obesity due to its inability to effectively differentiate between body types regarding obesity. Whether the DXA ultimately becomes a more reliable standard measure for obesity remains to be seen, but what is clear is that any measure that results in higher counts of the obese will be met by healthcare (and the medical product industry) as justification for increased spending in the treatment of obesity. Further research, of course, will be necessary to evaluate the relationship between the increased sensitivity to detection of obesity and the identification of associated morbidity or, as is often the case with obesity, the co-morbidities of diabetes, heart disease and other expensive healthcare challenges.


For further information on obesity drugs and devices, see the 2011 MedMarket Diligence report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019".

Development of high strength medical and surgical adhesives

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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