Forecasts for neurointerventions in acute stroke

Over the past two decades, one could witness the advent and significant expansion of the neurointerventional armamentarium targeting management of acute stroke. In mid-1990s, endovascular coiling embolization tools and techniques for treatment of cerebral aneurysms and AVMs (arterio-venous malformations) were introduced as a less invasive alternative to craniotomy-based surgery in primary prevention of hemorrhagic stroke. Several years later, these techniques were supplemented with coil-containing stents, which enabled treatment of large, giant, and wide-neck aneurysms. The latter was followed by the launch of stent-based flow diversion systems, which allowed clinicians to hemoisolate such aneurysms without tedious and risky coil packing of the rupture-prone aneurysmal sac.

In primary ischemic stroke prevention, development of embolically-protected carotid stenting and left atrial appendage closure techniques provided clinicians with an option of using non-inferior transcatheter tools instead of customary surgical interventions.

Finally, a recent launch of the novel stent-based cerebral thrombectomy systems manifested a qualitative breakthrough in emergent treatment of acute cerebral ischemia, where marginally effective and severely caseloads restrictive intravenous tPA therapy represented the only available therapeutic option.

Presently, endovascular techniques are increasingly seen and used by practicing clinicians as preferred therapeutic modalities in prophylaxis and treatment of acute stroke and are likely to expand their role in the years to come.

Based on the industry reporting and other estimates, in 2014, approximately 227.3 thousand cerebral endovascular therapeutic procedures were performed worldwide. Prophylaxis of ischemic stroke via carotid artery stenting and left atrial appendage (LAA) closure with contributed 91.2 thousand and 11.9 thousand interventions (or 40.1% and 5.2%, accordingly), followed by transcatheter embolization of intracranial aneurysm and AVM for hemorrhagic stroke prevention with 90.5 thousand interventions (or 39.8%), and cerebral thrombectomy-based emergent treatment of acute cerebral ischemia with 33.7 procedures (or 14.8% of the total).

Geographically, Western Europe and the U.S. accounted for the largest shares of corresponding cerebrovascular interventions in 2014, with 35.7% and 35.0%, accordingly, followed by major APAC states with 19% and rest-of-the-world with the remaining 10.3% of the total procedures performed.

Source: MedMarket Diligence, LLC; Report #C310.

 

Acute Stroke Therapeutics and a $1.7+ Billion Neurointerventional Worldwide Market; MMD Report

Stroke is a costly condition with a growing patient population targeted neurointerventional treatments that will account for hundreds of millions in sales over the next five years, according to a recent MedMarket Diligence report.

Acute stroke therapeutics are focused almost exclusively on patients’ cardiopulmonary and hemodynamic support and ad hoc containment of dangerous complications and corresponding brain damage associated with stroke. Among the life-threatening complications that commonly accompany acute cerebral hemorrhage or ischemia are cerebral edema; hydrocephalus; brain stem compression; vasospasm and pulmonary embolism. These therapeutic technologies will account for $323 million in new revenue from 2015 to 2019, according to the recently published MedMarket Diligence report, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, details

“Stroke is associated with costly long-term care, especially for a patient population that is typically older and more susceptible to its complications, but neurointerventional treatment have succeeded in both making a positive clinical impact and securing respectable revenue streams for manufacturers,” says Patrick Driscoll of MedMarket Diligence. These technologies will continue to develop and improve over the next five years, but much growth will also come from the penetration by these technologies in non-U.S. markets, where relative use is lower and shows untapped potential.

Stroke is a life-threatening medical condition characterized by a sudden catastrophic breakdown in the brain-supporting cerebrovascular system and blood supply, which, in many instances, is followed by an irreversible injury to the brain cells and severe neurological impairment or death.

Notwithstanding the remarkable progress in medical science and technology and associated improvements in clinical practices, stroke continues to constitute the major public health problem in the U.S. and overseas.

The $1.5 billion global market for acute stroke management is revealed in detail in the MedMarket Diligence report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, (see http://mediligence.com/rpt/rpt-c310.htm). The report is a detailed market and technology assessment and forecast of the products and technologies in the management of acute stroke. The report describes the epidemiology, etiology and management of hemorrhagic stroke, ischemic stroke, subarachnoid hemorrhage, and transient ischemic attack, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in the treatment of acute stroke. The report provides a current and forecast to 2019 by region /country for the U.S., Western Europe, the major Asia-Pacific states (China, India, and Japan), and the rest of world. The report profiles the most top companies in this industry, providing status and forecast data on their current products, current market position, and products under development.

The report is described in detail at http://mediligence.com/rpt/rpt-c310.htm and may be ordered for immediate download from https://www.mediligence.com/store/page54.html.

 

Technologies in Development at Medtech Startups, October 2015

In our flurry of activity in October, we overlooked summarizing the new medical technologies identified at startups and added to the Medtech Startups Database:

  • Neodymium vaginal dilator for treatment of pelvic pain.
  • Large bore, power injection vascular access
  • Surgical instruments for use in bariatrics.
  • Surgical oncology.
  • Spine surgical technology including expandable intervertebral cage.
  • Technologies to treat hearing loss.
  • Device to determine blood vessel size.
  • Cerebrospinal fluid shunt.
  • Focused ultrasonic surgical devices for hemostasis, cauterization, and ablation.
  • Collagen polymers to create 3D tissue systems for drug discovery, engineered tissue/organ, wound management, and 3D bioprinting.
  • Regenerative medicine to treat brain injury or damage.
  • Neuro-monitoring and neuro-critical care.
  • Orthomusculoskeletal implants.
  • Devices and methods for hip replacement
  • Intraoperative image system.
  • Exocentric medical device
  • Electro-hydraulic generated shockwave for cosmetic, medical applications.

For a historical listing of technologies at medtech startups, see link.

Technologies in Development at Medtech Startups, November 2015

Below is a list of the technologies under development at new medtech companies and recently added to the Medtech Startups Database.

  • Devices to assist pulmonary function.
  • Technologies to improve performance of orthopedic implantation.
  • Treatments for conditions associated with spinal cord injury and disease.
  • Technologies for the preservation and transport of organs and biologicals.
  • Interventional technologies for the treatment of neurovascular technologies.
  • Spinal fusion technologies
  • Orthopedic implants, including a prosthetic meniscus for placement in the knee joint.
  • Women’s health products including low risk device to measure cervical dilation.
  • Medical device to rapidly and accurately diagnose otitis media.
  • Bioabsorbable heart valve.
  • Electro-hydraulic generated shockwave for cosmetic, medical applications.

For a historical listing of technologies at medtech startups, see link.

 

Growth in Treatment of Acute Stroke

Drawn from Report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, published by MedMarket Diligence, LLC.

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.

The commonly accepted, current 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.

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.

Among the life-threatening complications that commonly accompany acute cerebral hemorrhage or ischemia are cerebral edema; hydrocephalus; brain stem compression; vasospasm and pulmonary embolism.

Management of the aforementioned acute complications relies on a few proven treatment regimens, including (but not limited to):

  • medical therapy and catheter-based ventricular drainage of cerebrospinal fluid to control intracerebral pressure in patients at risk of edema, hydrocephalus or brain stem compression;
  • hypertensive hypervolemic hemodilution (or “triple-H” therapy) to treat ischemic neurological deficit from vasospasm following subarachnoid hemorrhage;
  • subcutaneous anticoagulation (with heparins or heparinoids) for prophylaxis of pulmonary embolism (which accounts for approximately 10% of deaths following stroke); and
  • elective hypothermia for temporary salvaging brain cells from necrosis due to hemorrhagic trauma or acute ischemia (although the latter technique has not been proven efficacious in clinical trials and was not endorsed in the latest, 2007 versions of the AHA hemorrhagic and ischemic stroke guidelines).

The currently available curative treatment options for acute stroke are limited to intravenous t-PA therapy (which has about 30% efficacy and is indicated for a very narrow cohort of eligible ischemic stroke patients only), investigational intra-arterial thrombolytic therapy, transcatheter cerebral thrombectomy (in patients who did not qualify for or failed t-PA therapy), and emergency craniotomy-based or endoscopic removal of stroke-related hematoma (which carries a 50% to 80% risk of mortality and is reserved for rapidly deteriorating young patients with large lobar hemorrhages).

Rehabilitation phase of stroke management relies on general physiotherapeutic techniques commonly used in patients with various physical and neurological disabilities. Prophylactics of recurrent cerebrovascular events in stroke survivors employs medical and interventional regimens referred to in the overview of primary and secondary stroke prevention.


Drawn from Report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, published by MedMarket Diligence, LLC.

 

Growth in Neurointevention Procedure Volumes for Acute Stroke Treatment

The largest (39.8%) share of 2015 global therapeutic neurointerventional device revenues was generated in the U.S. market, followed by Western European marketplace with 32.3%, APAC markets with 18.5%, and the rest-of-the-world market segment with the remaining 9.4% of the global stroke-related neurointerventional system business.

During the forecast period, the overall worldwide volume of novel peripheral interventional and neurointerventional procedures and corresponding product sales are projected to experience a healthy growth expanding an average of 6.3% and 5.3% accordingly to over 308 thousand total interventions and $1,773.2 million in cumulative device revenues in the year 2019.

The largest absolute gains in the market can be expected in the biggest and most mature endovascular embolization system segment which is forecast to expand by $165 million to approximately $1,017 million in the year 2019.

The fastest relative advances are likely to occur in the smallest LAA closure and cerebral thrombectomy device segments which are expected to grow 16.3% and 10.1% to $121 million and $268.4 million in device revenues, respectively, in 2019.

Geography wise, underpenetrated APAC (particularly Chinese) marketplace is projected to register the fastest growth in stroke-related neuro-interventional market dollar volume, followed by the ROW market segment (albeit from a relatively low base), and highly mature U.S. and West European markets.

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

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.

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.

Growth in endovascular thrombectomy accelerating globally

First generation thrombectomy systems, despite their allure, have not fared well against standard medical (and tPA) therapy, since the endovascular retrieval of clots did not result in improved patient outcomes.

However, clinical trials of second generation systems and interviews with clinicians and industry support the common perception that the cumulative worldwide volume of cerebral thrombectomy procedures is projected to experience accelerated growth through 2019, resulting in an 10.8% overall average annual expansion of corresponding interventions in the to an estimated 56.2 thousand total procedures worldwide in 2019.

The fastest cerebral thrombectomy procedural gains (11.4% and 11.7% annually) are likely to be registered in major Asian state and the U.S., followed by largest Western European countries and rest of the world (9.9% and 7.8% annually).

See incidence of ischemic stroke and compound growth in thrombectomy in the major global markets.
Screen Shot 2015-10-19 at 9.06.29 AM

Source: MedMarket Diligence, LLC; Report #C310.

Screen Shot 2015-10-19 at 9.06.43 AM

Source: MedMarket Diligence, LLC; Report #C310.

Cerebral Aneurysm and AVM Embolization System Suppliers

In recent years, transcatheter embolization techniques have emerged as a mainstay treatment modality in repair of rupture-prone cerebral aneurysms and indispensable pre-surgical adjunct in treatment of intracranial AVMs.

Aside from the ongoing (but gradually moderating in the U.S. Europe and Japan) migration of patients from open surgical to minimally invasive neurovascular embolization techniques, consistent and robust growth in this market was driven by the introduction of improved and premium-priced embolic coil designs, launch of coil containing stents and flow diversion devices for wide neck aneurysms, and increasing utilization of user-friendly liquid embolics in AVM (and selected wide neck aneurysm) applications. In the forthcoming years, the cited growth factors are likely to stay in place supporting further expansion of cerebral aneurysm and AVM transcatheter embolization business.

In 2014, endovascular embolization techniques were employed in approximately 90.5 thousand cerebral aneurysm and AVM repair procedures worldwide, of which aneurysm targeting interventions accounted for about 89.2%, with the rest contributed by AVMs hemoisolation.

Screen Shot 2015-10-12 at 4.07.21 PM

Source: MedMarket Diligence, LLC; Report #C310.