The increasing problem of chronic wounds, and their medtech solutions

Wounds have many different sources, etiologies and forms and, therefore, demand a range of approaches. By virtue of these differences, they have considerably different costs. At the top of the list of wound culprits driving up cost is the category of chronic wounds. Simply put, these wounds are very slow to heal due to poor circulation at the site (e.g., decubitus stasis, or pressure, ulcers), concomitant health issues (diabetes) and the difficulty in changing the local environment toward one with conditions more conducive to the healing process.

Chronic wounds are not the most common — that is a category represented by surgical wounds, in which the wound has been created medically or surgically in order to excise or otherwise manage diseased tissue. But surgical wounds, traumatic wounds and lacerations are by their nature acute and, especially for surgical wounds, can be surgically managed to create clean wound edges, good vascularization and other conditions that accelerate healing. Therefore, while the volume of surgical and traumatic wounds and lacerations is significant, their costs are manageable and their growth is unremarkable.

But the costs of chronic wounds are higher due to both the types of different products required and the length of time required for those products to be used. Moreover, given the association of chronic wounds with conditions that are growing in prevalence due to increasing incidence of obesity, diabetes and other conditions, combined with an aging population that is increasingly sedentary, the prevalence of chronic wounds is shifting the balance among wound types. Below is the balance of wound types by prevalence worldwide in 2011, followed by the projected balance of wound types in 2025.

Worldwide Share of Wound Prevalence By Type, 2011

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Source: MedMarket Diligence, LLC; Report #S190 and Report #S249.

 

Worldwide Share of Wound Prevalence By Type, 2025

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Source: MedMarket Diligence, LLC; Report #S190 and Report #S249.

Surgical wounds offer the potential for use of devices which can ensure hemostasis, prevent internal adhesions and anastomoses, secure soft tissue, and close the skin. Traumatic wounds also offer potential for skin closure products and for hemostats, and adhesion prevention during post-trauma surgery. New wound-covering sealant products may also offer potential for treatment of cuts, grazes, and burns.

Chronic wounds are generally not amenable to treatment by adhesives, sealants and hemostats unless the wound has either been debrided to a sterile bleeding surface (in which case it becomes like a surgical wound), or the product offers some stimulant activity. Many hemostats exhibit some inflammatory and cytokinetic activity, which has been associated with accelerated healing. However, this inflammatory activity has also been known to burn the patient’s skin. Chronic wounds are instead dealt with often by a combination of debridement, frequent dressing changes, products to address local vascular circulation and pressure (negative and positive) and others. Progress is being made in reducing the associated healing times, but a large opportunity remains.

Clinical and Technology Focus of New Medtech Startups

Since January 2011, a total of 245 new medtech companies have been founded and added to the Medtech Startups Database from MedMarket Diligence. These are companies that are either device-based or based on other technologies that are directly competitive with, or complementary to, medical devices, inclusive of medical device implants, med/surg instruments or equipment, drug/device or biotech/device hybrids, bioresorable implants/devices and other similar technologies. The companies excluded from this are those that are developign pure pharmaceutical products with no direct competitive/complementary role with medical devices or hybrids of info technology (e.g., smart-phone) piggybacked on existing medical devices.

The companies represented here cover a surprising range of innovations and clinical applications. They have been identified based on recently issued patents, patent applications, corporate filings and a litany of press releases, social media sources, and other data sources. As we identify the companies during this process, we categorize them into a number of clinical/technology categories, with multiple categories possible (e.g., minimally invasive plus cardio therapeutics, or diagnostic plus oncology, and others). Below is illustrated, in descending order, the clinical/technology categories of the companies founded since January 2011:

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Source: Medtech Startups Database; MedMarket Diligence, LLC

[Note, please, that we have little focus on pharmaceutical or drug discovery or dental/oral surgery, so these terms low tally in the graphic reflects our lower focus than prevalence of startups in these areas.]

Clearly, the great majority of medical technology startup companies is focused on surgical and/or cardio therapeutics and/or minimally invasive and/or ortho/musculoskeletal applications, areas that have historically and persistently represented the dominant thrust of medtech innovation.

Another way to view these companies is a “word cloud” compiled from each company’s product/technology descriptions, with the most frequently occurring words in the descriptions being represented in larger type face in the graphic. Admittedly, this is little more than a curiosity, but in reflecting the words used to reflect the focus of these companies (whether the words are theirs, mine or a third party source), it lends a sense to the common/primary thinking is in conveying what these companies are about:
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Source: Medtech Startups Database; MedMarket Diligence, LLC

 

Aesthetic and Reconstructive Products Accelerating to Double Digit Growth Worldwide

Global medical aesthetic and reconstructive products, which include medical/surgical implants, materials, injectable products, energy-based devices (e.g., laser, RF), “cosmeceuticals” and other products used in aesthetic and/or reconstructive procedures, achieved sales of more than $6.5 billion in 2013. By 2018, the worldwide market for aesthetic/reconstructive products will reach $10.7 billion. The U.S. and the Latin America markets will have a CAGR close to 10%. The U.S. and Latin America will experience growth, respectively, of 9.2% and 10% in line with global trends. Of course, the global trend is largely represented by the U.S. market, which holds 45% of the total. Europe has been witnessing relatively a slower growth of 6.6% per year. Declining purchasing power, particularly in southern Europe affects the European market and this geographical segment is estimated at $1.84 billion in 2013 to reach $1.94 billion in 2018.

The Asia/Pacific region will have an overall CAGR of more than 14.1% driven by increasing demand and, accordingly, by the expanded access to technologies and products in China and by the continued high growth in the strong economies of Japan and South Korea. Overall, Asia will experience the strongest growth in aesthetic/reconstructive product sales, eventually eclipsing the total for the European market in 2018, reaching $2.24 billion. Globally, the growth of the market from 2013 and 2018 be a 10%+ compound annual growth rate.

Global Segmentation of All Surgical and Non-Surgical
Aesthetic/Reconstructive Procedures, 2013

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Source: MedMarket Diligence, LLC; Report #S710, “Global Markets for Products and Technologies in Aesthetic and Reconstructive Surgery, 2013-2018”.

 

Top Locations for New Medtech Companies

Medical technology thrives in geographic locations where economics, access to intellectual property, tax incentives and other synergies and infrastructure support it. Reflecting this is the locations where entrepreneurs decide to locate their medical technology startups. As an exercise, we compressed roughly 10+ years of data collected for our Medtech Startups Database to reveal the geographic locations in which there was the most concentration.

From a country standpoint, it should not be surprised that, by virtue of its population, economic strength and many other determinants, the United States is the most common country in which medtechs get started. Below is the list of the top countries in our Medtech Startups Database, ranked in descending order by the number of startup companies:

  1. USA
  2. Israel
  3. Switzerland
  4. United Kingdom
  5. France
  6. Germany
  7. Ireland
  8. Canada
  9. Australia
  10. Sweden
  11. Denmark
  12. Finland
  13. India
  14. Belgium
  15. Hungary
  16. Japan
  17. Korea
  18. Netherlands
  19. New Zealand
  20. Singapore

Since the U.S. is the most common country for new medtechs, it follows that the top cities in which all startups would be founded are in the U.S. The exception to this is Israel’s M.P. Misgav, a very concentrated area of investment and development in that country. The rest of the top cities are indeed U.S., with cities in California the most prevalent in the list (in descending order):

  1. Palo Alto, CA
  2. Menlo Park, CA
  3. San Diego, CA
  4. San Francisco, CA
  5. Cleveland, OH
  6. Cambridge, CA
  7. Mountain View, CA
  8. Irvine, CA
  9. New York, NY
  10. Austin, TX
  11. Redwood City, CA
  12. Boulder, CO
  13. Fremont, CA
  14. Minneapolis, MN
  15. Sunnyvale, CA
  16. Houston, TX
  17. Chicago, IL
  18. M.P. Misgav (Israel)
  19. Salt Lake City, UT
  20. Lexington, KY

It is noteworthy that, from our periodic review of startups, the locations that have been progressively moving up the chart are Austin, Boulder and Mountain View, while locations that have seen fewer startups than were newly located there in the past are Minneapolis and Chicago (we will leave it to others to speculate the reasons behind these ups/downs).

Newest Medtech Startups, and I do mean MEDTECH

Since you’re reading this, I am going to assume you have some interest in medical technology, and just to make it bluntly obvious, I’m going to hammer a definition of it so you know exactly what I mean and what I don’t mean. Why I do this will become clear, but simply put, it’s to keep me from going insane.

In the most liberal definition of “medical technology” (which can still be restrictive, as I’ll mention below), I mean “the adaptation of scientific knowledge to the practical application of medicine”.  In your travels, I am certain you have come across uses of the term “medtech” that seem expansively broad, such as those that are simply the application of virtually any kind of technology to medicine.

If you call your doctor, does that make your phone a medtech device? What about surgical gloves, since they’re really just gloves? Ah, but what about surgical gloves coated with a material that prevents formation of post-surgical adhesions? Then, too, what about devices for wireless transmission of BP, pulse, pCO2 and other vital signs — are they just glorified telephones?

The point is that there is a wide range of perspectives that may variously be brought to bear when considering medtech and, since not everyone has the same perspective, it’s important to understand which perspective is in play.

Today, I saw a post about “medtech” companies at this year’s SXSW conference. Intrigued, I read on, only to find that most of these are technologies that have been applied to medical applications (and some not even that), but are for the most part not “medical technologies”:

  • a medication compliance device that chimes when doses are missed
  • a thermometer that connects to your iPhone or Android device
  • a smart diaper that monitors select analytes to potentially reveal UTIs, type 1 diabetes, dehydration, etc.
  • motion sensor-enabled underwear with micro-airbags to reduce injuries from falls in elderly
  • shoes to reduce the risk of plantar fasciitis, complications from diabetic neuropathy, etc.
  • wearable baby monitor to detect ambient temperature, posture and movement
  • mobile device to connect patients with mental health professionals
  • cloud-based service to connect individuals to the health/wellness resources of their employers

(Of course, the bottom line for many is whether the FDA or any other relevant governing body would consider a device a “medical device” or would otherwise conclude that its function, design or application is such that it must be regulated as a medical device, but even under that sort of all encompassing consideration, many of the above technologies would not likely be called “medical devices”. However, it’s not my definition that matters in those cases; it’s the FDA’s.)

I’m not placing a judgment that these devices are somehow inferior — not my point at all.  I have no doubt that there are countless non-medical technologies that can be applied to medical applications to create huge demand and/or solve big problems.  I just have to draw the line somewhere as I seek to describe, characterize and analyze an already large universe of innovations — I’ll leave the analysis of iPhone-enabled or otherwise information technology-centered devices to those who are better suited to the task. (If, in addition to the implants, surgical devices and range of other technologies requiring a physician to actually use, I had to also analyze any of those iPhone-enabled widgets, I would go mad.) My focus is instead on innovations that are intrinsically medical applications of knowledge that have been developed to improve outcomes, tap unmet patient demand, reduce healthcare costs or otherwise improve healthcare delivery. 

Fundamentally, these are technologies that have been developed to reduce symptoms, hasten recovery from disease or trauma (surgically-induced or otherwise), facilitate the removal of malignant tissue, restore normal organ or system function, facilitate the ongoing management of chronic disease, provide differential diagnostic information to facilitate courses of treatment, and many, many similar. By now, you should have a sense of what technology I would consider “medical” and what technology may have a medical application but which is not itself “medical”.

So what? Well, to be very specific, these are the most recent additions of startup companies to our Medtech Startups Database:

CompanyProduct/technology
Medallion Therapeutics, Inc.Targeted, localized drug delivery
PB&B S.A.Use of biomaterials in aesthetics for non-surgical temporary & permanent breast and buttock enhancement, facial rejuvination solutions and adipose tissue engineering related therapies.
TS3 Medical, Inc.Vascular drill to cross chronic total obstructions (CTOs) and facilitate balloon angioplasty and stenting.
SynerZ Medical, Inc.Developing a device that mimics the actions of gastric bypass surgery for the treatment of obesity and Type 2 diabetes.
Biotrace Medical, Inc.Temporary cardiac pacing as treatment for reversible symptomatic bradycardia.
Rbpark, LLCEmbolectomy devices
NeuroTek Medical, Inc.Non-invasive, migraine therapy device worn on the back of the head at the onset of or during a migraine to relieve pain.
RegenEye, LLCOcular stent for treating age-based vision changes.
Reveal Optical, LLCOphthalmic device company focusing on age-related macular degeneration (AMD), diabetic retinopathy, retinitis pigmentosa, hemianopia, and glaucoma.
Mimedis AGCustom surgical implants including using 3D printing.
Socrates Health Solutions, Inc.Noninvasive blood glucose monitor.
Gecko BiomedicalBiodegradable sealants and adhesives in surgery.

Source: MedMarket Diligence, LLC

Entrepreneurs have for years been relentlessly conceiving and implementing innovations for therapeutics and diagnostics that leverage the advances in materials sciences and the individual and combined gains in understanding the onset, development and intervention to palliate, cure or otherwise eliminate disease.  Developments such as these have had a profound impact on patients’ lives and the costs (of all kinds) in the end result. 

Combine these medtech developments with other non-medtech developments in additional innovative ways and an even bigger impact can be made. 

New fundings in medical technology, March 2014

Fundings for medical technology in March 2014 stand at $593 million, led by the $101 million raised by Golden Meditech Holdings Ltd and the $75 million IPO funding of Lumenis. Below is a list of the month’s top fundings to date:

Company fundingProduct/technology
Golden Meditech Holdings Ltd has raised $101 million in a round of funding according to press reportsAutologous blood recovery products as well as healthcare services
Lumenis Ltd has raised $75 million in an initial public offering according to the companyRF and light-based ablation devices in ophthalmology, surgery and aesthetics
Unilife Corporation has secured $60 million in debt funding, according to the companyDrug delivery devices
Alphatec’s Spine, Inc., has raised $50 million in a round of funding, according to the companyDevices for the treatment of spine disease and trauma
NinePoint Medical, Inc., has raised $38.56 million of a planned $50 million round of funding according to a regulatory filingIn vivo, high resolution imaging via optical coherence tomography
Invuity, Inc., has raised $36 million in a Series E round of funding according to the companyTechnologies to improve access and visualization in minimally invasive surgeries
EarLens Corp. has raised $36 million of a planned $38 million round of funding according to press reportsInfrared-based hearing aid

For the complete list of medtech fundings during March 2014, see link.

For a full list of the fundings in medtech, by month, since 2009, see link.

Technologies at medtech startups in February-January 2014

Below is a list of the technologies under development at startups recently identified and included in the Medtech Startups Database:

  • Ophthalmology prescreening technology for detection of diabetic retinopathy, cataract, glaucoma, cornea problems and refractive errors.
  • Tissue engineered scaffolds to generate synthetic tracheas.
  • Embolectomy devices
  • Resorbable embolization material for use in interventional radiology and drug delivery.
  • Tissue attachment technology
  • Devices and procedures to improve nasal breathing.
  • Devices for minimally invasive, augmentative or reconstructive mastopexy.
  • Ocular stent for treating age-based vision changes.
  • Ophthalmic device company focusing on age-related macular degeneration (AMD), diabetic retinopathy, retinitis pigmentosa, hemianopia, and glaucoma.
  • Neuroscience-based technology (neuromodulation) for enhancing performance on cognitive tasks, for the healthy and impaired.
  • Portable, ultrasound-based device non-invasive, transcranial diagnosis of stroke.
  • Temporary cardiac pacing as treatment for reversible symptomatic bradycardia.
  • Product to improve treatment of kidney stones and product to reduce pneumonia in intubated patient and ventilated patients in the ICU.
  • Biometric medical device for orthopedic and other diagnostic applications.
  • Technologies for treating urological conditions and disorders.
  • Use of biomaterials in aesthetics for non-surgical temporary & permanent breast and buttock enhancement, facial rejuvination solutions and adipose tissue engineering related therapies.

For a historical listing of medtech startup technologies, see link.