Peripheral Stenting Procedures and Markets

First introduced about two decades ago as a bailout technique for suboptimal or failed iliac angioplasty, peripheral vascular stenting gradually emerged as a valuable and versatile tool for a variety of primary and adjuvant applications outside the domain of coronary and cerebral vasculature.  Today, peripheral vascular stenting techniques are commonly employed 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.

Notwithstanding a relative maturity of the core technology platforms and somewhat problematic opportunities for conversion to value-adding peripheral drug-eluting systems, peripheral vascular stenting appears to have a significant room for qualitative and quantitative growth both in established and emerging peripheral indications.

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

 

New medical technologies at startups, January 2017

Below is a list of the technologies under development at medtech startups identified in January 2017 (thus far) and included in the Medtech Startups Database.

  • Devices and accessories for minimally invasive surgery.
  • Undisclosed surgical technology
  • Technologies for treatment of spinal and orthopedic deformities.
  • 3D visualization and printing for prototyping, surgical planning.
  • Point of care, portable breast cancer screening test.
  • Devices to enable delivery of autologous tissue at point-of-care.
  • Navigation and other technologies to facilitate laparoscopic surgery.
  • Tissue-to-bone reattachment systems
  • Products for bone, joint, and soft tissue conditions of the foot and ankle.
  • Soft tissue marker for ultrasound at surgical sites
  • System to locate breast abnormalities during surgical incision.

For a comprehensive listing of the technologies at medtech startups 2016 and earlier, see link.

The best medtech investment opportunities

In reviewing patents, fundings, technology development trends, market development, and other hard data sources, we feel these are some of the strongest areas for investment in not only the medical device side of medtech, but also the broader biomedical technology arena:

  • Materials technologies
    • graphene
    • bioresorbables
    • biosensors
    • polymers
    • bioadhesives
  • Cell therapy and tissue engineering
    • cell-based treatments (diabetes, spinal cord injury, traumatic brain injury)
    • extracellular matrices in soft tissue repair and regeneration
  • Nanotechnology (subject of forthcoming report)
    • nano coatings
    • nano- and micromedical technologies for localized drug delivery
    • nanoparticles
  • 3D printing
    • prototype development
    • patient-specific implants
  • Minimally- and non-invasive technologies
    • transcatheter alternatives to surgery
    • NOTES (natural orifice transluminal endoscopic surgery)
  • Diabetes non-invasive glucose testing
  • Intraoperative surgical guidance
    • Cancer probes (e.g., fluorescent or optical coherence tomography, frozen section, cytologic imprint analysis, ultrasound, micro-computed tomography, near-infrared imaging, and spectroscopy)
  • neurostimulation and neuromodulation
  • point-of-care diagnostics
  • point-of-care imaging
  • AI-enhanced devices

In addition, there are many areas in healthcare in which there is much untapped demand with problems that, so far, seem to have eluded medtech solutions. These include infection control (Zika, MRSA, TB, nosocomial infections, etc.), chronic wound treatment (including decubitus/stasis/diabetic ulcers), type 2 diabetes and obesity.

 

Market fragmentation and growth, decline in wound management

The market for wound management products — as varied as negative pressure wound therapy, skin grafts, hydrogel dressings, and growth factors — is a sort of free-for-all of offerings designed to accelerate healing, reduce treatment costs, yield better outcomes, or all of these and more. With so many sectors, and with well-established ones tending toward commodity, there can be many competitors, with few having significant market shares. Yet in several areas, quite remarkable growth is still available.  Excluding traditional bandage and dressings, three companies — S&N, Acelity and Mölnlycke — control over half the worldwide market.

Global Advanced Wound Market Market Shares

Source: MedMarket Diligence, LLC; Report #S251. Order online.

Growth is coming in the advanced areas of bioengineered skin, the ever-needed antimicrobials, and the great demand for foam dressings.


Source: MedMarket Diligence, LLC; Report #S251. Order online.

 

Viewed another way, with size and growth mapped relative to each other…

 

Source: MedMarket Diligence, LLC; Report #S251. Order online.

The U.S. remains the biggest consumer of wound management products, and this is not expected to materially change. Europe is seeing relative decline, however, as Asia Pacific demand ramps up:

Source: MedMarket Diligence, LLC; Report #S251. Order online.


The MedMarket Diligence report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World,” is detailed at link and is available for purchase and download online

Asia Giving Western Markets Run for the Money in Sealants

Numerous variants of fibrin sealant exist, including autologous products. Other sealants include those containing thrombin, collagen & gelatin-based ingredients.

Fibrin sealants are used in the U.S. in a wide array of applications; they are used the most in orthopedic surgeries, where the penetration rate is stands at 25-30% of such procedures. Fibrin sealants can, however, be ineffective under wet surgical conditions. The penetration rate in other surgeries is estimated to be about 10-15%.

Fibrin-based sealants were originally made with bovine components. These components were judged to increase the risk of developing bovine spongiform encephalopathy (BSE), so second-generation commercial fibrin sealants (CSF) avoided bovine-derived materials. The antifibrinolytic tranexamic acid (TXA) was used instead of bovine aprotinin. Later, the TXA was removed, again due to safety issues. Today, Ethicon’s (JNJ) Evicel is an example of this product, which Ethicon says is the only all human, aprotinin free, fibrin sealant indicated for general hemostasis. Market growth in the Sealants sector is driven by the need for improved biocompatibility and stronger sealing ability—in other words, meeting the still-unsatisfied needs of physician end-users.

Source: MedMarket Diligence, LLC; Report #S290. Order online.

Tracking Medtech Fundings in January 2017

Fundings for medtech in January 2017 stand at over $700 million, led thus far by the $55 million funding of Intuity Medical, the $54 million for Apollo Endosurgery, $50 million debt funding of ConforMIS, and the $50 million funding of Neuropace. Below are the top fundings for the month. For a complete list of fundings (to be updated during the month), see link.



Source: Compiled by MedMarket Diligence, LLC

For a historical list of fundings since 2009, see link.

 

Wound Hemostasis, Closure, and Sealing in the U.S. versus Asia/Pacific, 2015-2022

Sales of sealants, glues, and hemostats projected to 2022 for the U.S. and Asia/Pacific. While these products have had tremendous success in Japan, their sales in the rest of Asia/Pacific have not yet caught up to Japan, let alone to the U.S.

But that is expected to change as the most significant growth in these markets will indeed be coming from China, Korea, Australia, India, and elsewhere in these emerging markets.

Sales of Sealants, Glues, and Hemostats in the
U.S. and Asia/Pacific Markets, 2015-2022

Note: For direct comparative purposes, sales in these markets are shown on the same vertical scale.

Source: MedMarket Diligence, LLC; Report #S290. Available for purchase/download online.

Coronary revascularization options evolve

The number of options that are in use or development for coronary revascularization or other treatment for ischemic heart disease is extraordinary. Given the mortality associated with coronary artery disease, it is unsurprising that it has been the focus of so much development.

Below are the options that have evolved for treatment of ischemic heart disease, inclusive of surgical, interventional, and other medical approaches.

Coronary Revascularization and Other
Ischemic Heart Treatment Options

Source: MedMarket Diligence, LLC

See also “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, report #C500. Order online.

Peripheral Stenting Worldwide: Arterial, Venous, BMS, DES, AAA, TAA

First introduced about two decades ago as a bailout technique for suboptimal or failed iliac angioplasty, peripheral vascular stenting gradually emerged as a valuable and versatile tool for a variety of primary and adjuvant applications outside the domain of coronary and cerebral vasculature.  Today, peripheral vascular stenting techniques are commonly employed 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.

Notwithstanding a relative maturity of the core technology platforms and somewhat problematic opportunities for conversion to value-adding peripheral drug-eluting systems, peripheral vascular stenting appears to have a significant room for qualitative and quantitative growth both in established and emerging peripheral indications.

A panoply of stenting systems are available for the management of occlusive disorders and other pathologies affecting peripheral arterial and venous vasculature. Systems include lower extremity bare metal and drug-eluting stents for treatment of symptomatic 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 CVI.

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 almost 1.252 million interventions (or 80.9%), followed by AAA and TAA endovascular repairs with 162.4 thousand interventions (or 10.5%) and peripheral venous stenting used in an estimated 132.6 thousand patients (or 8.6% of the total).

The U.S. clinical practices performed almost 528 thousand covered peripheral arterial and venous procedures (or 34.1% of the worldwide total), followed by the largest Western European states with over 511 thousand interventions (or 33.1%), major Asian-Pacific states with close to 377 thousand interventions (or 24.4%), and the rest-of-the-world with about 131 thousand peripheral stent-based interventions (or 8.4%).

Below is illustrated the global market for peripheral stenting by region in 2016 and by segment from 2014 to 2020.

Source: MedMarket Diligence, LLC; Report #V201. Available online.

 

Source: MedMarket Diligence, LLC; Report #V201. Available online.

Technologies at Medtech Startups, December 2016

Below is a list of technologies under development at startups identified thus far in December 2016 and included in the Medtech Startups Database:

  • Nanoparticle-based imaging for the treatment of epilepsy.
  • Implantable device for continuous relief of congestive heart failure.
  • Nanofiber technology for soft tissue repair.
  • Technology to facilitate intubation.
  • Medical device to manage skin complications suffered by ileostomy patients.
  • An implant for arthritis sufferers that mimics the natural motions of the joint.
  • Embolic protection device used during TAVR procedures.
  • Glucose monitor for diabetes using low-power RF/Microwave detection in fingertips.
  • Novel disinfection and sterilization solutions.
  • Drug delivery.
  • Dental and orthopedic applications of nanomaterials.
  • Catheter and guidewire technologies.

For a comprehensive list of the technologies at medtech startups identified by month, see link.