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

Vascular closure devices

[Vascular closure devices are among the products and technologies addressed in the MedMarket Diligence report, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018” (details), published October 2014.]

From relatively humble beginnings in the late 1990s, and some failed product designs involving in-dwelling collagen plug materials that were eventually abandoned due to the potential risk of embolization, the vascular closure market – primarily serving the fields of interventional radiology and interventional cardiology – has mushroomed over the past several years with the introduction of a number of new, safer, and more effective products. Effectively sealing the puncture left behind after a catheter-based procedure performed through the femoral artery helps achieve faster hemostasis, enabling the patient to walk and resume activities sooner than with manual compression and thus it provides much greater post-procedure comfort for the patient.

Growth in this market is also being driven by a desire to increase efficiency and throughput in the cath lab and by the growing number of complex, large-bore procedures (18-French and greater) being performed percutaneously through the femoral artery (e.g., endovascular abdominal aortic aneurysm repair and transvascular aortic heart valve replacement), which, due to the large size of the puncture, routinely employ a closure device to achieve hemostasis following the procedure.

However, usage of vascular closure devices varies widely by location and facility and they are still not considered routine for simple cardiac catheterizations, such as cardiac stenting procedures, in large part due to the added cost they convey to the procedure – a cost that in the US, often must be absorbed by the hospital. In fact, in about 40% of interventional coronary and peripheral vascular procedures, physicians still employ manual compression alone. Additional clinical data proving their benefits versus standard manual compression in a variety of clinical settings, but particularly for high-complexity procedures or high-risk patients, will be essential to improving payor coverage and reimbursement and increasing penetration of these devices.

The active vascular closure device (VCD) market will be negatively impacted going forward by the rapid rise in the number of interventional procedures (particularly simple cardiac interventions) performed via the radial artery in the wrist, which leaves behind a much smaller arteriotomy that is easier to close using manual compression alone or with an assisted-compression device. The percentage of procedures performed via the radial artery route varies widely by country/region as well as by physician/facility preference; however, this newer method of performing interventional procedures, which offers a lower vascular complication rate, is trending upward overall. To address this growing opportunity, several manufacturers have developed compression-assist devices designed specifically to facilitate hemostasis after radial procedures.

When the VCD market began some twenty years ago, there were just two active closure device products available: Abbott Vascular’s Perclose and St. Jude Medical’s AngioSeal. Now, however, there are more than a dozen different products available or in development in the active, mechanical closure space alone (not including passive devices such as hemostats and compression devices), and the list of competitors continues to grow.

Selected Small- and Large-Bore Vascular Closure Devices

Abbott Vascular/Abbott LaboratoriesPerclose ProGlideSuture-mediated closure device for 5-21F femoral artery access sites.
ProStar XLSuture-mediated closure device for 8.5-10F sheaths (8.5-24 F OUS).
StarClose SEClosure device delivers nitinol clips for 5-6F access sites.
Perclose A-TSuture-mediated closure device for 5-8F femoral artery access sites. Sold in US only.
AccessClosure Inc. (acquired by Cardinal Health in May 2014 for $320M cash.)MynxGripMynx sealant with Grip Technology added to distal end to seal the arteriotomy while expanding to fill tissue tract.
Mynx AceExtravascular PEG sealant that actively adheres to the artery for secure mechanical closure. Dissolves within 30 days.
ArstasisAxera 2 Access DeviceThis device creates a long, shallow-angle arteriotomy (5-6F) through the femoral artery wall. Resulting arteriotomy has self-sealing capability that requires only minimal compression for rapid hemostasis and eliminates the need to leave behind foreign material to close the puncture site.
Cardiva MedicalVascade Vascular Closure SystemUtilizes existing procedural sheath to obtain temporary hemostasis using a collapsible disc while delivering a thrombogenic, resorbable collagen patch extravascular to the arteriotomy. For closure of 5-7F femoral arteriotomies.
Cardiva Catalyst II and III manual assisted closure devicesManual closure assist device with a deployable nitinol disc that provides temporary hemostasis at the puncture site while puncture recoils to size of an 18-gauge needle. Wire has hemostatic coating to accelerate clotting. Catalyst III adds protamine sulfate coating for patients receiving heparin.
Cordis/J&JExoseal Vascular Closure DeviceUses existing procedural sheath to deliver resorbable PGA plug to the outside of the artery wall at the site of the arteriotomy. For closure of 5-7F femoral arteriotomies. FDA approved May 2011.
Innovasa Corp.Stat*Seal

Available in over the wire (for deeper insertion in the puncture tract) and topical versions
Button-like device with attached medicated foam-tip bandage. Tip is inserted into the femoral puncture tract and remainder of device rests on skin around puncture site. Facilitates hemostasis via targeted focal pressure combined with the hydrophilic drying and pro-coagulant effect of the foam tip, which is medicated with chitosan. After hemostasis is achieved, the device is completely removed from the patient.

FDA cleared.
InSeal Medical Ltd. (Israel; a fully owned subsidiary of E-Pacing Inc.)InSeal Intravascular Closure DeviceSelf-expanding nitinol frame covered with biodegradable membrane for closure of 14-21F punctures in vessels 6-10mm diameter. Device is delivered using procedure sheath (no sheath exchange required); membrane covers puncture and uses blood pressure to seal against vessel wall. Delivery and deployment take less than 2 minutes.

In clinical development for use following large-bore procedures such as TAVR (transcatheter aortic valve replacement) and EVAR (endovascular aortic aneurysm repair).
Morris Innovative Inc.CombiClose/ControlClose Vascular Closure Devices (formerly FISH)Devices deliver a plug of ExtraCellular Matrix, made of porcine small intestine submucosa (SIS), to the inside of the vessel wall, which seals the arteriotomy and promotes remodeling of the host tissue within 30 days. For 5-8F punctures.
St. Jude MedicalAngioSealIntra-arterial anchor, suture, and collagen components form ÒsandwichÓ to close arteriotomy. FDA labeled for immediate restick and for 20-min ambulation/60-min discharge for diagnostic cases. Components resorb within 90 days.
AngioSeal EvolutionNext-generation AngioSeal with automated collagen compaction and enhanced ease of use.
Transluminal Technologies LLCVelox CD Vascular Closure DeviceConsists of delivery device and metal closure implant made of a proprietary magnesium alloy. Intended for closure of femoral arteriotomies. Implant comprises an intraluminal footplate that absorbs in about 24 hours and an extraluminal plug that absorbs in two weeks.

CE marked July 2014.
Vascular Closure Systems Inc.FastSeal Bioabsorbable Vascular Access Closure SystemSystem deploys a non-collagen, double-disc polymer sealing element that is positioned with components resting on both the inner and outer side of the artery, sandwiching the puncture site and enabling hemostasis within 60 seconds. FIH trial completed for 6-8F puncture closure system. OUS commercialization is expected to begin in 2014. A large-bore (18-F) system is also in early-stage development.

Source: MedMarket Diligence, LLC: Report #S192.


Medtech Fundings, September 2015

Medtech fundings for September 2015 have just hit $996 million (a new single month high, since we’ve been tracking), led by the $300 million IPO of NovoCore, followed by the $150 million funding of Auris Surgical Robotics, and the $100 million Series C for CeQur.

Below are the top fundings for the month thus far. Please revisit this post and refresh your browser to see additional fundings during the month.

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

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

The Future (Ours) is in China for Medtech

The importance of China in the global economy became apparent this week, with the ups and downs of its economic state tripping the hair trigger that financial markets have for the huge nation’s growth market.

But in hard terms, what does that mean? As an example, look at spine surgery technology and compare the forecasted growth in sales in China not against the much lower U.S. market but against other high-growth Asia-Pacific markets such as India and Japan. Below is the balance of spine surgery technology sales (encompassing cervical fusion, thoracolumbar implants, minimally invasive spinal fusion, interbody fusion, and orthobiologics) for 2014 and forecasted for 2021 for China, India, and Japan.

Spine Surgery Sales by Country, 2014 & 2021

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Source: MedMarket Diligence, LLC; Report #M540

The relative growth of the market in China is apparent in the change of pie slice sizes, but in hard numbers, Japan’s annual sales in 2021 will be $243 million higher than they were in 2014, but by comparison, China’s 2021 spine surgery sales will be $536 million higher than in 2014.

It is evident that China has made great advances in the quality and quantity of research work and in the development of its medical industry and the provision of healthcare in China. According to the International Monetary Fund, the gross domestic product of China was over $8,230 billion in 2012, making China’s economy the second largest economy in the world. China’s life sciences markets have shown particularly aggressive growth in absolute terms, with sales of the country’s reagents and analytical laboratory instruments showing annual growth in the 15% to 20% range. The Chinese pharmaceutical market is growing at 13.1% through 2020 (Source: McKinsey) and projected growth in the in vitro diagnostics market in China is at 10%.

The overall size and growth in China’s medtech market, including spine surgery, demands a business strategy to gain sales there, since no other market worldwide is expected to drive so much new revenue.



Medical technologies under development at startups, August 2015

Below is a list of the technologies under development at medical technology startups identified in August 2015 and added to the Medtech Startup Database.

  • Non-hormonal, non-invasive treatment for vaginal dryness and atrophy.
  • Vascular access technology for hemodialysis and oncology.
  • Stents for peripheral vascular disease.
  • Combined ultrasound guidance and interventional access probe.
  • Transendoscopic and laparoscopic instrumentation.
  • Device for real-time monitoring of blood loss.
  • Hand-held blood velocity, blood oxygen and heart rate monitor
  • Endovascular navigation.

For a historical listing of medical technologies at startups since 2008, see link.

Medtech: Numbers and Size of Fundings, Jan-Aug 2015

Fundings in medtech in 2015 follow a common pattern in that most fundings are between $1 million and $5 million — in 2015 thus far, we have identified 111 separate fundings in the $1M-$5M range — with the aggregate value of all fundings in this range being $286 million. However, the size category with the highest cumulative fundings is fundings at $25 million to $50 million, of which there were 41 separate fundings, reflecting an aggregate of $1.36 billion.

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Source: MedMarket Diligence, LLC; see specifics in August 2015 fundings and historical fundings.

By comparison, below is the graph of numbers and totals of fundings for the same period in 2014.

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Source: MedMarket Diligence, LLC

Global Growth in Spine Surgery

Spine surgery is a relatively mature market — all segments of the spine can be treated, significant share has been garnered by a few major companies, and there are no radically new technologies disrupting current market positions. Yet, trends in the patient population, the active innovation by all companies (see further, below, on market shares per region), the fact that it remains an invasive procedure (even the best minimally invasive approaches have room for improvement), and the accelerating migration of advanced spine technologies to developing non-U.S. markets are all reasons why this “mature” market is anything but stagnant.

Success in applying minimally invasive approaches to spine fusion has opened up procedure volumes for more patients, resulting in the fastest growing area of spine fusion sales. Fusion devices are strong worldwide, with the non-U.S. markets lagging in volumes, but growing at markedly faster rates.

Below is illustrated the segment growth rates for major geographic regions.

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Source: MedMarket Diligence, LLC; Report #M540

The result of the faster non-U.S. growth is that the dominance of U.S. spine surgery markets will decline over the next decade. Below is the change in the share of the global spine surgery market represented by each reach from 2014. For example,  the U.S. market will lose 6% of the global market between 2014 and 2021, while Asia-Pacific will gain roughly 5%.

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Source: MedMarket Diligence, LLC; Report #M540

A two-tier market

The big players (Medtronic, DePuy, Stryker, Zimmer-Biomet) cumulatively control a large swath of the spine surgery market, yet many millions of dollars streams to hungry and innovative smaller spine companies. For example, below is the distribution of market shares for cervical fusion globally.

cervical fusion mkt shares by region

Source: MedMarket Diligence, LLC; Report #M540




Global Spine Surgery Finding Double Digit Growth from Innovation, Economics, and Clinical Trends According to MedMarket Diligence Report

[August 21, 2015 — Mission Viejo  CA — MedMarket Diligence has published its 2015 global report on spine surgery. For details, see link.]

Decades of clinical research and medtech innovation have combined to offer solutions for every segment of the spine.  Economics and innovation have also made spine surgery one of the strongest growth of all medtech markets. MedMarket Diligence’s new global report on spine surgery device markets reveals opportunities for established, emerging, and potential medtech players.

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Screen Shot 2015-08-24 at 2.10.34 PMThe $9.17 billion global market for cervical fusion, thoracolumbar Implants, MIS spine fusion, interbody fusion, and orthobiologics has evolved dramatically over the last several decades as a result of significant advances in the understanding of spinal biomechanics, the proliferation of sophisticated spinal instrumentation devices, surgical advances in bone fusion techniques, refinement of anterior approaches to the spine and the emergence and development of microsurgical, minimally invasive methods and robotics. As a result of these advances it is now possible to stabilize every segment of the spine successfully, regardless of the offending pathology. The global market for spine surgery devices is detailed in the MedMarket Diligence report, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021.” See Report #M540.

“While this market may be dominated by the bigs — Medtronic, DePuy, Stryker, Zimmer-Biomet, et al. – there remains more than enough business in spine technology to attract a remarkably large number of mid-tier and smaller market participants,” says Patrick Driscoll of MedMarket Diligence. “And there are ample participants who do not accept the status quo, by aggressively innovating and introducing clinical and economic improvement in spine surgery.”

Spine fusion is the fastest growing technology in spine surgery and with growth in spine surgery being fastest in the Asia-Pacific and Central/Latin America, the growth of spine fusion in those areas is double-digit. The improvements in spine surgery and technology development have produced steady growth in volumes of surgeries, supported by reimbursement and clinical outcomes (and the increasingly active aging population). Spine surgery, with its exponential growth, has been the answer to an orthopaedic industry seeking to optimize earnings and add value for shareholders.

The MedMarket Diligence report, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World,” (report #M540) is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes the diseases and disorders of the spine, 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 spine surgery. The report provides a current and forecast assessment by region/country of procedures and manufacturer revenues for, specifically, Americas (United States, Rest of North America, Latin America), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Rest of Asia/Pacific) and Rest of World. The forecast addresses the product- and country-specific impacts in the market of new technologies through the coming decade.

The report profiles 38 of the most notable current and emerging companies in this industry, providing data on their current products, current market position and products under development. The products and activities of numerous additional startup and emerging companies are also detailed in the report.

The report is described in detail at and may be ordered for immediate download from

Until August 28, 2015, Report #M540 is available for $500 off the list price. See Spine Surgery 2015 (M540) $500 off early release

Global Markets for Medical Devices in Spine Surgery, Forecast to 2021

The market for spinal implants and associated spinal fusion products has evolved dramatically over the last several decades as a result of significant advances in the understanding of spinal biomechanics, the proliferation of sophisticated spinal instrumentation devices, surgical advances in bone fusion techniques, refinement of anterior approaches to the spine and the emergence and development of microsurgical, minimally invasive methods and robotics. As a result of these advances it is now possible to stabilize every segment of the spine successfully, regardless of the offending pathology.

Prior to these developments, the orthopedic industry had traditionally regarded spinal surgery as a “Cinderella” segment that — far from being a major market segment — was almost regarded as a service area supporting a relatively small number of highly specialized surgeons focusing on the clinical issues associated with the vertebral column. In contrast, by the beginning of the new millennia it became clear that an orthopaedic industry seeking to provide optimized earnings and value to share holders had identified this area as a major unmet need in which the demand to resolve an increasingly wide range of spinal conditions was growing exponentially.

In response to these developments, and in recognition that the market for spinal implants and associated spinal fusion products was and is growing, orthopedic companies have realigned their strategic approach by:

  • Providing greater resources to further product development.
  • Expanding of sales and marketing resources
  • Growing new and emerging geographic regions

It is anticipated that, collectively, these elements will further open the door to the development of implantable devices that can identically reproduce the elements of the spine that need to be reinforced or replaced by artificial. Accordingly, use of spinal fusion and instrumentation is anticipated to increase in the foreseeable future and continue to represent a better than average growth area in medtech.



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Source: MedMarket Diligence, LLC; Report #M540

MedMarket Diligence, LLC, has completed an analysis entitled, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2020”. The report (#M540) will be published August 21, 2015, and will be downloadable in PDF and available in print for single, site, and global licenses. The report is described in detail, with a complete table of contents and list of exhibits, at link.

Medtech fundings in August 2015

Medtech fundings for August 2015 totaled $754 million, led by the $115 million IPO of Penumbra.

Below are the top fundings for the month.

Penumbra, Inc., has filed for a $115 million initial public offering Micro-catheter based multi-modality device for the revascularization of an occluded vessel in the brain
LDR Holding has raised $86.5 million in a round of funding according to press reports Cervical discs in spine surgery
Mevion Medical Systems, Inc., has raised $58.84 million in a round of funding according to a regulatory filing Proton radiation therapy for cancer
InVivo Therapeutics Corp. has raised $50 million in equity funding from Cowan and Company according to the company Biomaterial scaffold for treatment of spinal cord injury
ReShape Medical, Inc., has raised $38 million in a Series D round of funding according to the company Dual balloons implanted in stomach endoscopically to create satiety in treatment for obesity
Advanced Inhalation Therapies has filed an IPO valued up to $36 million Drug delivery

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

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

Medical technologies at startups July 2015

Below is a list of the technologies under development at medical technology startups identified in July 2015 and added to the Medtech Startup Database.

  • Wound drainage devices.
  • Robotic technology.
  • Neuromodulation devices.
  • Device to detect ischemic and hemorrhagic stroke in the pre-hospital environment.
  • RF ablation device for treatment of overactive bladder.
  • Infusion pump and sensing technologies for pain management during labor.
  • Arthroplasty devices.
  • Bone regeneration biomaterial.
  • Pedicle screws and interbody cages for spine surgery.
  • Developing a non-hormonal device to treat vaginal dryness and atrophy, particularly in breast cancer survivors and post-menopausal women.
  • Catheter technology for tissue resection in vascular and gastrointestinal endoluminal application

For a historical listing of medical technologies at startups since 2008, see link.