It’s Personal. We fail in organ donation. Help one person.

I grew up around medicine, with a surgeon father and a pediatric uncle. I studied toward a profession in medicine as well, but I was also enormously intrigued with the science, business, and future of medicine, especially the potential emerging from biotech, with genetics and molecular biology at the top of the list. It led me to research many genetic diseases, among them cystic fibrosis (I knew someone who survived this very late, into college), and polycystic kidney disease (PKD).

Sadly, I also know someone with polycystic kidney disease, and her name is M. Christina Mayo. Tina is now in urgent need of both a kidney and liver to save her life.

I do not editorialize much here (I show restraint), but the state of organ donation in this country and worldwide is rather pathetic. We fail. And we cannot afford to fail at so simple a thing.

Last week, an old college friend of Tina’s, who also happens to be a very good friend of mine, opted to be evaluated as a “live liver” donor. (The liver is a “vital” organ, like heart and kidneys, that we can’t do without — we can donate one kidney, but techniques exist now to allow a donor to donate a lobe of the liver, rather than the whole, with the donate lobe eventually growing back.)
So, Tina’s and my friend was evaluated rigorously at UC San Francisco, where the donation would be. Unfortunately, despite so many indicators looking good, there was no match.

Tina is now making an urgent appeal (see below). And in the spirit my brother (a long time blood donor who passed away, but was an organ donor), I hope you read this and pass it along to ANYONE who might be able to help her.

I have nothing to gain from this except comfort in knowing that I bothered to take a few minutes out of my life to save someone else.

If you can donate, then I am asking you to consider this.

If you cannot donate, then please post to pass it along to anyone who might be able to.

Contact me if you have any questions: patrick@mediligence.com.
Online link to kidney donation questionnaire: https://www.ucsf-kidneytransplant.org/approach/?service=recipient.kidney:recipient.prereq.1#
Tina Mayo

Top Caseload, Growth through 2020 in Peripheral Stenting

Peripheral stenting technologies encompass all vasculature but coronary. We have assessed the volume of all such peripheral stenting procedures through 2020 worldwide.

Peripheral stenting procedures include lower extremity bare metal and drug-eluting stents for treatment of symptomatic periperal artery disease (PAD) and critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in chronic venous insufficiency.

In 2015, these peripheral stenting systems were employed in approximately 1.565 million revascularization procedures worldwide, of which the lower extremity arterial stenting accounted for over 80%, followed by abdominal aortic aneurysm (AAA) and thoracic aortic aneurysm (TAA) endovascular repairs and peripheral venous stenting.

Below is illustrated the top geographic areas by caseload for individual peripheral stenting technologies.

Screen Shot 2016-04-14 at 8.32.04 AM

Source: MedMarket Diligence, LLC, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, Report #V201.

Below is illustrated, in order, the top growth areas geographically in peripheral stenting for the period 2015 to 2020. Note that the subtotal of all peripheral stenting products for Asia-Pacific falls within this listing of the top areas of growth in peripheral stenting.

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Source: Report #V201.

Surgical Sealants, Glues, and Hemostats: Bioactive, Nonactive, Matrices/Scaffolds

Drawn from: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

Sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, where leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures 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 forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

Surgical sealants, glues, and hemostats can be divided into several different categories based on their primary components and/or their intended use:

  • Products containing biologically active agents (e.g., Baxter Tisseel, Bristol-Myers Squibb Recothrom)
  • Products made from natural and synthetic (nonactive) components (e.g., Baxter CoSeal, Cohera Sylys)
  • Nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats (e.g., Beekin Biomedical NuStat, Equimedical Equitamp)
RevMedX XStat

Drawn from: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

Wound management regional growth (“rest of north america”)

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From Report S251 (see global analysis and the above detail for Americas (with detail for U.S., Rest of North America and Latin America), Europe (United Kingdom, Germany, France, Spain, Italy, and Rest of Europe), Asia/Pacific (Japan, Korea, and Rest of Asia/Pacific) and Rest of World.

Do you wish to see excerpts from “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets”?

The future (of medicine) is biology

It was once quite convenient for manufacturers of deluxe medical widgets to worry only about other manufacturers of deluxe medical widgets. Manufacturers must now widen their perspective to consider current and future competition (and opportunity) from whatever direction it may come. –> Just thought I might chime in and suggest that, if you do make such widgets, it might be a good idea to maybe throw at least an occasional sidelong glance at biotech. (Most of you are, great, but some of you think biotech is too far away to compete…)

Organ Bioengineering is years away and poses little challenge to medical devices …FALSE.  Urinary bladders have been engineered for pediatric applications. Bioengineered skin (the “integumentary” organ) is now routinely bioengineered for burns, chronic wounds, and other wound types. Across a wide range of tissue types (bone, cardiac, smooth muscle, dermal, etc.) scientists — clinicians — have rapidly developed technologies to direct the construction and reconstruction of these tissues and restore their structure and function.

Cell Biology. Of course cells are engineered into tissues as part of the science of tissue engineering, but combine this with advances in engineering not just between cells but between cells AND within cells and (…sound of my head exploding). With the sum of the understanding and capacity to control we have gained over cellular processes over the past few decades now rapidly accelerating, medical science is fast approaching the point at which it can dictate outcomes for cell, tissues, organs, organ systems, and humans (I am not frightened, but excited, with caution).  Our understanding and proficiency gained in manipulating processes from cell division to pluripotency to differentiation to senescence to death OR NOT has profound consequences for fatal, debilitating, incurable, devastating, costly, and nearly every other negative superlative you can conceive.

CRISPR*: This is a new, relatively simple, but extraordinary tool allowing researchers or, more importantly, physicians to potentially swap out defective genes with healthy ones. See Nature.
(* clustered regularly interspersed short palindromic repeats)

Biotech has, over its history, often succeeded in getting attention, but has had less success justifying it, leaving investors rudely awakened to its complexities.  It has continued, however, to achieve legitimately exciting medical therapeutic advances, if only as stepping stones in the right direction, like mapping the human genome, the development of polymerase chain reaction (“PCR”), and biotech-driven advances in molecular biology, immunology, gene therapy, and others, with applications ripe for exploitation in many clinical specialties, Sadly, the agonizing delay between advanced and “available now” has typically disappointed manufacturers, investors, clinicians and patients alike. CRISPR and other tools already available (see Genetic Engineering News and others) are poised to increase the expectations – and the pace toward commercialization – in biotechnology.

Vaccines and Infectious Disease: Anyone reading this who has been under a rock for lo these many years, blissfully ignorant of SARS, Ebola, Marburg, MRSA, and many other frightening acronyms besides HIV/AIDS (more than enough for us already) should emerge and witness the plethora of risks we face (and self-inflict through neglect), any one of which might ultimately overwhelm us if not medically then economically in their impacts. But capitalists (many altruistic) and others have come to the rescue with vaccines such as for malaria and dengue-fever and, even, one for HIV that is in clinicals.

Critical Mass, Synergies, and Info Tech. Biotechnology is succeeding in raising great gobs of capital (if someone has a recommended index/database on biotech funding, let me know?).  Investors appear to be forgetful increasingly confident (in the 1990s, I saw big layoffs in biotech because of ill-advised investments, but that was then…) that their money will result in approved products with protected intellectual property and adequate reimbursement and manageable costs in order to result in attractive financials. The advances in biological and medical science alone are not enough to account for this, but such advances are almost literally being catalyzed by information technologies that make important connections faster, yielding understanding and new opportunities. The net effect of individual medically-related disciplines (commercial or academic) advancing research more efficiently as a result of info tech and info sharing/synergies between disciplines is the expected burst of medical benefits ensuing from biotech. (Take a look also at Internet of DNA.)

Stents: From Peripheral Arterial to Peripheral Venous

Interventional technologies are expanding in all directions and vasculatures. Peripheral stenting as part of endovascular aortic repair or treatment of other symptomatic peripheral artery disease also include bare metal and drug-eluting stents for critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in CVI.

Despite similarities in market dynamics (a notable difference here is the higher growth rate of venous stents)…

Screen Shot 2016-03-21 at 9.36.37 AM

Source: MedMarket Diligence, LLC; Report #V201.

…venous markets have not yet reach the same scale as arterial stents (now shown on the same scale):

Screen Shot 2016-03-21 at 9.35.13 AM

Source: MedMarket Diligence, LLC; Report #V201.

Venous and Arterial Stents in Peripheral Vascular Applications

In the February 2016 report #V201, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, we detail the markets for peripheral stents in the management of the most prevalent occlusive circulatory disorders and other pathologies affecting the abdominal and thoracic aortic tree and lower extremity arterial bed.

Stents are also increasingly used in the management of the debilitating conditions like venous outflow obstruction associated with deep venous thrombosis and chronic venous insufficiency.

Globally, peripheral stenting procedures for arterial indications, as in abdominal and thoracic aortic aneurysm, are growing around 6% annually, while venous procedures are a little higher. More noteworthy is the actual shifts of the market as the slowing, but still relentless, growth in China and elsewhere in Asia-Pacific region is actually changing the balance of markets, and in fact will become the dominant market for peripheral arterial stents by 2020

Periph stent px arterial

Note: Proprietary data obscured.
Source: MedMarket Diligence, LLC; Report #V201.

In the less well developed venous stenting arena, the U.S. and Europe still represent the largest share of the market, and will do so through 2020.

Screen Shot 2016-03-18 at 2.40.34 PM

Note: Proprietary data obscured.
Source: MedMarket Diligence, LLC; Report #V201.

Bioengineered Skin & Skin Substitutes in Wound Care

Bioengineered skin was developed because of the need to cover extensive burn injuries in patients who no longer had enough skin for grafting. Not so long ago, a patient with third degree burns over 50% of his body surface usually died from his injuries. That is no longer the case. Today, even someone with 90% TBSA has a good chance of surviving. With the array of bioengineered skin and skin substitutes available today, such products are also finding use for chronic wounds, in order to prevent infection, speed healing and provide improved cosmetic results.

apligraf
Apligraf, Organogenesis

Skin used in wound care may be autograft (from the patient’s own body, as is often the case with burn patients), allograft (cadaver skin), xenogeneic (from animals such as pigs or cows), or a combination of these. Bioengineered skin substitutes are synthetic, although they, too, may be combined with other products. It consists of an outer epidermal layer and (depending on the product) a dermal layer, which are embedded into an acellular support matrix. This product may be autogenic, or from other sources. Currently most commercial bioengineered skin is sheets of cells derived from neonatal allogenic foreskin. This source is chosen for several reasons: because the cells come from healthy newborns undergoing circumcision, and therefore the tissue would have been discarded anyway; foreskin tissue is high in epidermal keratinocyte stem cells, which grow vigorously; and because allergic reactions to this tissue is uncommon.

Selected Bioengineered Skin & Skin Substitutes

bio-skin

Source: Exhibit 3-16 in MedMarket Diligence, LLC, Report #S251. To get excerpts, Click Here

Bioengineered skin displacing traditional wound management products

Very decided shifts are taking place in the wound management market as advanced wound technologies take up caseload from traditional technologies like gauze and others. It becomes evident that traditional products once representing above average sales are now projected to be below average (gauze) as are even a moderately new technology, “negative pressure wound therapy devices” (NPWD), while bioengineered skin and skin substitutes will represent “above average”.

Global Wound Management Market,
Above/Below Average Sectors, 2015 & 2024

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Source: Report #S251.

Global Wound Management Market, Sales, 2015 & 2024

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Source: Report #S251.

Despite the tepid growth of traditional wound management products, they remain very large markets that even the most aggressively growing segments will require time to match that volume. Bioengineered skin and skin substitutes are moving fast in that direction.

Global CAGR 2016-2024 for Wound Management Segments

Screen-Shot-2016-03-16-at-8.09.10-AM

Source: Report #S251.

If you would like excerpts from this report, Click Here!

Wound Markets East and West: A Comparison?

Placed on the same scale, U.S. markets for wound management technologies do not seem starkly different from those in the Asia/Pacific region, with insignificant differences, now and in the future, in the balance of different technologies used.

Screen Shot 2016-03-07 at 8.50.43 AMScreen Shot 2016-03-07 at 8.50.55 AM

Source: MedMarket Diligence, LLC; Report #S251.

However, one cannot really compare the U.S. and Asia/Pacific on the “same scale” without seeing the obvious differences:

Screen Shot 2016-03-07 at 8.49.54 AMScreen Shot 2016-03-07 at 8.50.28 AM

Source: MedMarket Diligence, LLC; Report #S251. If you would like excerpts from this report, Click Here.