Category Archives: medtech

topic is about medical technology of different types, describing specific products under development, the market for them or their impact on healthcare

Fundings in Medtech, November 2015

Fundings in medical technology now stand at $537.9 million, led by the $75 million IPOs filed by both SurgiQuest and Ellipse Technologies,, the $57 million funding of Fractyl Labs, $39.2 million debt funding of SI-BONE, the $36.5 million funding of BAROnova, the$35 million funding of Signostics, and the $32 million funding of Avedro.

Below are the top fundings for the month of November 2015 thus far. (Revisit this post and refresh your browser to see updates during the month.)

See link for the complete list of medtech fundings in November 2015.

To see a historical listing of fundings since 2009, see link.


Coronary Stent takes largest total market share to 59.6%

The global trend is for a continued decrease in the number of CABG procedures and an increase in the number of percutaneous coronary intervention procedures. Typically about 90% of all percutaneous coronary intervention procedures use a coronary stent in the developed economies with approximately 75% of all procedures that use stents do so with drug-eluting stents (DES) and this percentage continues to increase.

For the vast majority of cases of coronary artery disease, the treatment options are typically limited to angioplasty alone or with stents or coronary artery bypass grafting. Aside from the advent of new device and equipment technologies to perform coronary artery bypass via catheter or otherwise in minimally invasive formats (such as minimally invasive direct coronary artery bypass, or MIDCAB), the market for the treatment of coronary artery bypass is largely represented by interventional cardiology, comprised of the following products:

  • Global sales of coronary guide wires, balloon dilatation catheters, guiding catheters and accessories
  • Stents
  • Vascular closure devices

See the White Paper on Coronary Stents (see the “DOWNLOAD” button) and the associated report, “The Future of Coronary Artery Disease Medical Devices to 2021“, published by Smithers Apex.

Bioactive and Synthetic Sealants in Wound Closure

The following is excerpted from sections of Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, published by MedMarket Diligence, LLC.

Sealants and glues in wound closure may be comprised of naturally-occurring (bioactive) ingredients (including from human or animal) or may be synthetic in origin. Many bioactives are comprised primarily of fibrin sealant, give its evolutionary design in stopping bleeding and sealing wounds. Bioactive sealants offer the benefit of well documented performance with lack of toxicity, but with the existing sealants on the market, the strength of the closure provided falls somewhat short of what is needed for sealants to be used autonomously in all but the least challenging closure conditions. For this reason, a wide range of other biologically active agents with higher sealant strength are in various phases of evaluation (See “Gecko feet, mussel shells and other sticky things” at link).

Bioactive sealants that on the market and in development are detailed at link.

Compared to biologically active sealants containing fibrin and other human- or animal-derived products, synthetic sealants represent a much larger segment of the sealant market in terms of the number of competitors, variety of products, and next-generation products in development. Non-active synthetic sealants do not contain ingredients such as fibrin that actively mediate the blood clotting cascade, rather they act as mechanical hemostats, binding with or adhering to the tissues to help stop or prevent active bleeding during surgery.

Synthetic sealants that are on the market and in development are detailed at link.

Below is the global surgical wound closure products market.

Surgical Wound Closure Products Market, by Device Segment


Source: MedMarket Diligence, LLC; Report #S192.

Acute Stroke Treatment, Trends to 2019

See also “Guidelines Urge New Approach to Treating Worst Strokes” (American Heart Association). 

Therapeutic management of stroke encompasses a broad scope of prophylactic, palliative and curative treatment modalities that are typically employed in some combinations during the preventive, acute and rehabilitation phases of stroke-related care delivery.

Historically, prevention has been universally regarded as the best form of medicine for dealing with any disease. This old wisdom is especially true in management of acute stroke, which represents a catastrophic event with a largely predetermined clinical progression and outcome that stem from the patient’s preexisting pathologies and can be only marginally altered with available emergent therapies.

Presently, the commonly accepted strategy of primary and secondary stroke prevention is focused on elimination or remedying of the modifiable risk factors that have been shown to create a general predisposition or directly contribute to the onset of acute cerebral ischemia or/and hemorrhage.

Within the context of general population, this strategy is targeting alleviation of certain lifestyle risk factors (such as smoking, obesity, physical inactivity, excessive alcohol consumption, drug abuse, high-fat diet etc.), which could contribute to the development of cardiovascular and other pathologies associated with increased propensity to stroke.

In patient caseloads with preexisting medical conditions (AFib, mechanical prosthetic valves, recent AMI, stoke or TIA, hypertension, diabetes, etc.) which are characterized by a high risk of adverse vascular events potentially leading to stroke, preventive strategy is focused on reducing such risks via a strict control and monitoring of corresponding hemostatic and hemodynamic parameters.

Finally, in persons with diagnosed cerebrovascular pathologies (high grade carotid stenosis, intracranial aneurysms and AVMs) the first line preventive therapy involves their repair or eradication, when technically possible.

The scope of FDA-approved medical and interventional modalities commonly employed in preventive management of stroke includes oral anticoagulation, antiplatelet, and lipid-lowering drug therapies, cerebral aneurysm and AVM repair surgery, carotid endarterectomy, stereotactic radiosurgery, as well as endovascular embolization of intracranial aneurysms and AVMs, carotid artery stenting with embolic protection, left atrial appendage closure, along with  rarely used and likely to be abandoned intracranial stenting.

Global Projected Dynamics of Cerebral Endovascular Embolization Procedures 2013-2019 (#000)

Source: MedMarket Diligence, LLC; Report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019.”

In contrast to causes-oriented therapies used in stroke prevention, therapeutic modalities employed in the emergent management of acute stroke are focused almost exclusively on patients’ cardiopulmonary and hemodynamic support and ad hoc containment of dangerous complications and corresponding brain damage associated with stroke.

Global trends in spine surgery, 2015 to 2021

The global spine surgery market, which is largely stable in terms of technologies and the dominance of the U.S. market, will demonstrate the most significant change through 2021 through an increasing share of spine surgeries done minimally invasively and a noticeable shift of sales to OUS, especially to China, Japan, and India.

See the relative growth from 2015 to 2021 in the charts below (the proprietary data in axes values omitted, but the sales for North America and Asia-Pacific are presented on the same vertical scale for comparison purposes).

Source: MedMarket Diligence, LLC; Report #M540.


Technologies Gaining Nearly $600M Fundings in Medtech for October 2015

Fundings for medical technology reached $594 million for the month of October 2015. These are the technologies gaining funding In October 2015:

  • Tissue engineering in blood vessels, including for acellular vessels use for vascular access in ESRD
  • Magnetically adjustable spinal bracing system
  • Technologies to reduce the risk of stroke in transcarotid artery revascularization
  • Technologies to treat hearing loss
  • Surgical adhesives and sealants
  • Drug-device for novel treatment of urologic diseases
  • Drug delivery device technology
  • Minimally invasive device for the treatment of acute decompensated heart failure
  • Diagnostics for acute kidney injury
  • Catheter-based, minimally invasive treatment of endovascular arteriovenous fistula
  • Minimally invasive, non-surgical technology for circulatory support
  • Endovascular aortic aneurysm repair
  • Non-invasive intracranial pressure measurement
  • Implantable pump technology for fluid management
  • Intraoperative imaging and navigation
  • Devices for dry eye, glaucoma, others.
  • Nonsurgical device for the treatment of chronic nasal obstruction
  • Focused ultrasonic surgical devices for hemostasis, cauterization, and ablation
  • Technology for drug delivery to brain
  • Technologies for robotically-assisted minimally invasive surgery
  • Catheter based therapeutic devices for the treatment of cerebral aneurysms
  • Neuromodulation technologies
  • Renal denervation
  • Device to provide rapid allergy relief and device to monitor neonatal end-tidal carbon monoxide

For details on these, including the companies and their funding amounts, see link.

Spinal fusion migrating overseas

Spine fusion (of all types) has long been a fixture primarily of the United States, but a recent MedMarket Diligence report (#M540) reveals that the flat growth in the U.S. is being more than matched by uptake of spine fusion outside the U.S., with particularly strong growth in China, Japan, and India.

Below is illustrated the current and forecast regional distribution of the spine fusion market through 2021.

Global Market: Revenue Forecasts: Medical Device Technologies Used For Spinal Fusion
by Region, 2011-2021

Source: MedMarket Diligence, LLC; Report #M540.

The future of medtech demands more and better imagination

I frequently see conclusions about the the future of medtech derived by analysts who are walking backward looking at their feet — living by the tenet of “past is prologue”. This type of “foresight” presumes an unchanging set of forces, leading (at best) to a conclusion that the future will hold more of the same.

Yet, the future of medtech is dictated far more significantly not by what has already happened, or as a result of past trends continuing as future trends, but by what has not happened yet. The major thrust of any significant growth (and isn’t growth most interests us?) comes primarily from events that do not as clearly follow from past events:

  • Surgical device sales forecasts are uprooted by introduction of laparoscopy
  • Tissue engineering preempts conventional treatments in wound, orthopedics, cardiology…
  • Success in type 1 diabetes treatment will be determined by device advances as well as cell therapy advances
  • Systems biology reveals risks and opportunities previously unseen

If you view your markets myopically, then you consider your competitors to be limited to those whose products most resemble your own. If you have a long view, you consider what might be possible based on available/emerging technology to tap into untapped demand or simply create latent demand that no company has yet been sufficiently visionary or innovative to seize. What patient populations, clinical practice patterns and their trends are the pulse that you monitor (or are you even monitoring these)?  There is a gap between what is available and a whole set of patients virtually untreated, physicians unsatisfied, and third party payers struggling.  Are you an angioplasty catheter manufacturer — or a coronary artery disease solution?  Do you make devices — or outcomes?

Source: Yann Girard

Look at staid “device” companies like Baxter International and see that they have “biosurgery” divisions.  Look at Medtronic and appreciate that they are as sensitive to developments in glucose monitoring and insulin pump technologies as they are to the litany of cell therapy approaches under pursuit. (These companies are fundamentally aware of technology “S-curves” — see graphic at right.)

Virtually every area of current clinical practice is subject to change when considering drug/device hybrids, biomaterials, nanotechnology/MEMs devices and coatings, biotechnology, pharmaceutical (and its growing sophistication in drug development), western medicine and eastern medicine, healthcare reform, cost containment, RFIDs, 3D printing, information technology  — it is imperative to see the upside and downside of these.

These are some of the forces that less characteristic of the past that are leading to startling new success in medtech developments:

  • Materials technologies are redefining the nature and functional limits of medical devices
  • Technologies more closely aligned with cure than symptomatic treatment gain rapid acceptance
  • The practice of considering outcomes measures of highly diverse technology solutions to disease has ascended to prominence in the mindsets of healthcare systems and payers
  • The use of information technologies and cross-medical discipline initiatives enables rapid determination of likely success and failures in whole new ways

Aside from the demands for operational efficiency and managing cash flows, the success or failure of medical technology companies has become a reflection of how well these companies position themselves now and in the future with an imaginative long view. Companies must consider the revenue streams in Year 1, Year 5 and Year 10.


Stroke: Etiology and Features

Below is an excerpt from, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019.” Published Sept. 2015. Report #C310.

The adult brain weighs approximately 3 pounds and contains billions of nerve cells (neurons) and trillions of support cells (glia). It is composed of three parts: the cerebrum, the cerebellum, and the brain stem.

The cerebrum, the largest part of the human brain, is divided into left and right hemispheres that communicate with each other through a bundle of nerve fibers called the corpus callosum. The hemispheres are covered by a 2mm- to 6mm-thick layer of gray matter (composed of neurons) known as the cerebral cortex, which is responsible for the higher functions of language, perception, reasoning, thought, and voluntary movement. The inner portion of the cerebrum is white matter, which is composed of neural “processors” that carry information between neurons in the brain and spinal cord. The cerebral cortex consists of many folds that allow a large surface area to fit into a small volume. These folds divide the cerebral cortex into four lobes, which perform various specific functions, although no region of the brain functions alone.

The cerebellum is also divided into hemispheres and has a cortex; this portion of the brain plays an important role in balance, fine motor coordination, posture, and voluntary movement.

The brain stem, the smallest part of the brain, connects the cerebral hemispheres with the spinal cord. It contains the medulla oblongata, the pons, and the reticular activating system, structures that are responsible for basic life functions such as initiating and maintaining wakefulness; regulating blood pressure, breathing, and heart rate; and reflex actions such as coughing, sneezing, swallowing, and vomiting.

Other structures located in the brain include the basal ganglia, which consists of a number of components including two that are important in coordinating movement, called the globus pallidus and the substantia nigra; the hypothalamus, which is important in controlling body temperature, circadian rhythm, metabolism of fats and sugar, and water balance; the limbic system, a group of structures important for learning and memory as well as for controlling emotional behavior; the pituitary gland, which secretes many hormones that travel to, and regulate the function of, other organs and glands; and the thalamus, which contains nuclei that receive sensory input from spinal and brainstem circuits and process information from auditory, pain, somatic sensory, taste, thermal, and visual modalities.

Although the brain makes up only approximately 2% of body weight in humans, it receives between 15% and 20% of the body’s blood supply. The blood vessels, which enter the brain through holes in the skull called foramina, bring oxygen, nutrients, and hormones into the brain and carry away carbon dioxide and other waste products.

Häggström, Mikael. “Medical gallery of Mikael Häggström 2014”. Wikiversity Journal of Medicine 1 (2). DOI:10.15347/wjm/2014.008. ISSN 20018762.

The brain is supplied with blood by two pairs of major arteries called the internal carotid and vertebral arteries. The vertebral arteries meet at the base of the brain to form the basilar artery, which joins the internal carotid arteries to form the Circle of Willis; this ring structure is a safety mechanism that helps ensure blood flow to the brain if one of the arteries leading into it becomes blocked. Every minute, 600mL to 700mL of blood flows through the carotid arteries and their branches, while 100mL to 200mL flows through the vertebral-basilar system.

The internal carotid arteries and their branches, which are an integral part of the carotid system, supply the anterior two-thirds of the cerebral hemispheres, including the deep white matter and the basal ganglia. The vertebral arteries and basilar artery and their branches supply the remaining posterior and medial regions of the hemispheres, the brain stem, the cerebellum, and cervical spinal cord, and most of the diencephalon.

The carotid and vertebral-basilar systems are connected through the Circle of Willis; however, these connections may not be functionally significant if the connecting vessels are of small diameter, or if pressure gradients are too small to drive adequate blood flow.

The right common carotid artery originates from the bifurcation of the brachiocephalic trunk; the left common carotid artery originates directly from the aortic arch. Each common carotid artery then branches to form the internal and external carotid arteries. After the internal carotid artery ascends through the neck, traverses the temporal bone, and passes through the cavernous sinus, it reaches the subarachnoid space at the base of the brain. As the internal carotid artery leaves the cavernous sinus, it forms its first intracranial branch, the ophthalmic artery, which travels along the optic nerve into the orbit. There, its branches supply the retina and other structures of the eyeball, as well as other structures in and around the orbit. The internal carotid artery continues in a superior direction and usually branches into the posterior communicating and anterior choroidal arteries.

The posterior communicating arteries range from large to threadlike, and link the internal carotid vessel to the posterior cerebral arteries; however, in some individuals, one or both of the posterior cerebral arteries retain their embryological state as direct branches of the internal carotid artery itself. The anterior choroidal artery also varies greatly in size and importance in different individuals, and may branch from the middle cerebral arteries rather than the internal carotid artery.

The internal carotid artery also divides to produce the anterior and middle cerebral arteries. Atheromatous plaque tends to form at the branches and curves of the cerebral arteries. In carotid circulation, the most frequent sites for plaque formation are in the internal carotid artery at its origin from the common carotid artery, in the stem of the middle cerebral artery or its bifurcation into superior and inferior divisions, and in the anterior cerebral artery as it curves over the corpus callosum.

The vertebral arteries typically arise from the subclavian arteries and course through the cervical transverse foramina, run medially, and ascend into the foramen magnum, where they pierce the dura mater and enter the cranial cavity. The vertebral arteries run alongside the medulla oblongata and give rise to vessels that participate in supplying the spinal cord as well as the brain stem.

Cardiogenic emboli tend to enter the vertebral circulation far less frequently than they enter the carotid circulation. Several aspects of vascular anatomy may account for this tendency. Each vertebral artery arises from the subclavian at a sharp angle and has a much smaller diameter. By contrast, the internal carotid artery is approximately the same diameter as the common carotid artery, and makes only a slight bend at its origin. In addition, the vertebral-basilar system handles a much smaller percentage of the total cerebral blood flow than the carotid system.

Acute stroke – also known as “cerebrovascular accident” – represents a catastrophic manifestation of accumulated circulatory disorders that affect the vasculature of the brain described above. The two major subdivision of stroke are ischemia or lack of blood and oxygen supply typically resulting from occlusion of cerebral arteries, and hemorrhage or leakage of blood outside the normal cerebral vessel conduit. Both types of stroke cause necrosis of certain groups of brain cells, which leads to irreversible impairment of various neurological functions in about 22% to 25% of patients and death within one year in another 35% of stroke caseloads.

According to available clinical data, ischemic stroke accounts for approximately 87% of all stroke cases in the U.S., 85% in largest European states and up to 80% in major Asian-Pacific states and the rest of the world, with the remaining 13%, 15%, and 20% represented by episodes of hemorrhagic stroke. These two major groups or categories of stroke are further differentiated by the location of the brain hemorrhage and ischemia.

Clinical Features and Characteristics of Ischemic Stroke


Clinical Features and Characteristics of Hemorrhagic Stroke

“Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019.”
Report #C310. 194 Pages. 34 Exhibits. Published September 2015

Medtech Fundings for October 2015

Medtech fundings for October 2015 totaled $618 million, led by the $150 million Series B funding of Humacyte, followed by the $75 million IPO filed by Eclipse Technologies, the $57 million funding of Silk Road Medical, and the  $52 million Series A funding of Decibel Therapeutics.

Below (with the full list at link) are the top fundings for the month.

Source: MedMarket Diligence, LLC

For the complete list of medtech fundings in October 2015, see link.

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