Category Archives: biomaterials

Use of Surgical Sealants for Cranial and Spinal Dura

Surgical sealants have an enormous range of applications in the treatment of acute and chronic wounds, but while the majority of sealant revenues derives from their use in the hemostasis, closure and sealant of tissues to prevent blood loss…

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Source: MedMarket Diligence, LLC; Report #S190

… a different niche use of sealants is stopping cerebrospinal fluid leaks and other dural wound treatments associated with cranial and spinal procedures. These include their use in:

  • Cranial and spinal dural plastic surgery to prevent CSF fistulas.
  • Dural plastic surgery in residual cavities following tumor removal.
  • Dural lacerations in hemilaminectomy operations

Of this, most of the use is currently in cranial applications, but use in spinal applications is growing considerably faster:

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Source: MedMarket Diligence, LLC; Report #S190

 

 

 

Fundings in Medtech 2009-2014: A Contrarian View

Since 2008, medtech has taken a lot of hits. Indeed, when the capital crunch hit, medtech was not viewed as the safest place for investment by a suddenly very risk averse world. Blue chip stock, high volume, low growth, STABLE markets became the norm for a lot of money. But, after a short while, it became apparent that medtech was hardly junk bonds or penny stock, especially considering the battle-hardened innovators of medtech who continued to seize on innovations that provided treatment where there once wasn’t, that accelerated healing, that measurably improved outcomes, that resulted in real cost savings to health systems and insurers, that, in other words, met DEMAND.

So, money came back to medtech. I tracked it then, and I track it now, month by month, funding by funding, company by company. Was it coming back in the pollyanna-esque windfalls of biotech and pharma? No, and I don’t think it ever has or ever will — nor should it. Biotech seems to perennially able to tap the “hope springs eternal” deep pockets of venture capital that can regularly draw individual fundings of $50 million, $75 million or $100 million. Pharmaceuticals don’t seem to go to the VC well as often, but when they do, their funding rounds are no less spectacular.

Medtech excels at crafting plain and simple solutions to disease, suffering, high healthcare costs and clinical need. Not every solution is a blockbuster — in fact, there are more than a few 510(k) products that should probably just be called “me, too”, since they do not distinguish themselves independently, at least not from a clinical or technology standpoint. But medtech has proven its ability to keep pushing the treatment envelope by innovating a little further to gain a bit more edge on outcome or cost or both.

So, medtech regularly pulls in $5 million, $10 million, $25 million at at time — frequently less, but not infrequently more.

My Contrarian View. But let me highlight again that medtech is a moving target and not everyone is thinking apples to your oranges.  What I consider medtech is, at its root, technologies that were traditionally represented as medical device treatments for disease and trauma. (And, yes, so I don’t have to answer this later on, by “medical device” I mean implants, instruments, instrumentation, even capital equipment.)  But medtech is not only medical device, for it is also (at least by my authoritarian definition, since this is my blog, but it is read by many in this field), anything and everything (within reason) that is either adjunctive to medical devices like drug delivery, like biomaterial-based implants/grafts, drug/device hybrids, tissue engineering and cell therapy (this latter is perhaps at the fringe of medtech, bordering on pure biotech).

Where’s the boundary of medtech? In my mind, it is anything and everything that competes with markets that have in the past and are to some extent still served by medical devices, equipment and supplies. For the sake of repetition, this is the definition I have posted on the medtech fundings I report on month by month in this blog (and in the online spreadsheets linked here):

What is “medtech”?: We view medical technology (medtech) as principally medical devices and equipment, but also all technologies that are directly competitive with or complementary to technologies represented by therapeutic or diagnostic medical devices/equipment.

Note: Historic coverage of “medtech” has been limited to medical devices, supplies and equipment. We feel that such a limited definition poorly reflects the true nature of the markets that once were limited to such products. In reality, assessing the markets and competition for medical devices by ONLY considering other medical devices would result in gross underestimations of both competition and market potential. Moreover, this is reflected in both the nature of medical devices (which may be hybrid device/bio/pharm products or products that may not be “devices” at all (especially in the typical definitions defined by material type and function) but that compete head-on with devices.

So, on this more liberal definition of medtech (which some still feel is too restrictive), I can point to a steady stream of investments that has been on an upward trend for the last five years. If you disagree, feel free to come up with your own definition(s), but here is the five year trend of medtech investment:

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Source: MedMarket Diligence, LLC

Looked at from a seasonal standpoint, this data is shown below:

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Source: MedMarket Diligence, LLC

The monthly data underlying both of these charts is at link. If that is not enough data for you, then you can look at a comprehensive listing of the individual fundings behind this at link.

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″.

 

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:

Company Product/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, LLC Embolectomy 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, LLC Ocular stent for treating age-based vision changes.
Reveal Optical, LLC Ophthalmic device company focusing on age-related macular degeneration (AMD), diabetic retinopathy, retinitis pigmentosa, hemianopia, and glaucoma.
Mimedis AG Custom surgical implants including using 3D printing.
Socrates Health Solutions, Inc. Noninvasive blood glucose monitor.
Gecko Biomedical Biodegradable 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. 

Sales of Sealants, Hemostasis, Other Closure a Large, Shifting Market Worldwide

Products that provide hemostasis, closure, sealing and anti-adhesion of wounds comprised long established products (e.g., tapes, sutures, etc.) as well as a variety of advanced products such as fibrin and other surgical sealants, surgical glues, hemostats and products to prevent post-surgical adhesion.  While traditional products are being innovated to keep pace with advanced products (for example, through the development of absorbable sutures), the shift of caseload and product sales away from traditional products appears unrelenting.

As a result, the balance of the competitive landscape is forecast to shift over the next few years toward advanced sealing, hemostasis, closure and anti-adhesion products.  Below is illustrated, in a combined “donut” chart, this shift from 2012 to 2017 in the share of the global market for these products.

sealants_donut_2012-2017

Source: MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017.”

These percentage shifts may not seem significant unless one considers that the global market for these products is over $5 billion.

 

Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide

The MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017″, details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples/mechanical closure, hemostats, fibrin sealants/glues and medical adhesives 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 from 2011. The report provides a worldwide 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 description, table of contents and list of exhibits at http://www.mediligence.com/rpt/rpt-s190.htm.

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 funding Product/technology
Golden Meditech Holdings Ltd has raised $101 million in a round of funding according to press reports Autologous blood recovery products as well as healthcare services
Lumenis Ltd has raised $75 million in an initial public offering according to the company RF and light-based ablation devices in ophthalmology, surgery and aesthetics
Unilife Corporation has secured $60 million in debt funding, according to the company Drug delivery devices
Alphatec’s Spine, Inc., has raised $50 million in a round of funding, according to the company Devices 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 filing In vivo, high resolution imaging via optical coherence tomography
Invuity, Inc., has raised $36 million in a Series E round of funding according to the company Technologies 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 reports Infrared-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.