New Global Cardiovascular Procedures Report Reveals Medtech Outlook

MedMarket Diligence has published, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

See link for report description, sources, table of contents, and list of exhibits. The report may be purchased for download.

The report details the therapeutic procedures that address acute and chronic conditions affecting myocardium and vascular system, with relevant prevalences, incidence rates, separate procedure counts for surgical versus interventional and other key splits of the procedure volume.

Screen Shot 2016-08-12 at 9.48.46 AMThe report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.

Each set of forecasts is accompanied by discussion per condition of the changing clinical practice and technology adoption rates, procedural limitations or drivers competitively, the surgical-interventional balance, and the resulting market outlook for cardio manufacturers.

Excerpts available on request.

Six Key Trends in Sealants, Glues, Hemostats Markets to 2022

From July 2016 published Report #S290.

Here are six key trends we see in the global market for surgical sealants, glues, and hemostats:

  1. Aggressive development of products (including by universities, startups, established competitors), regulatory approvals, and new product introductions continues in the U.S., Europe, and Asia/Pacific (mostly Japan, Korea) to satisfy the growing volume of surgical procedures globally.
  2. Rapid adoption of sealants, glues, hemostats in China will drive much of the global market for these products, but other nations in the region are also big consumers, with more of the potential caseload already tapped than the rising economic China giant. Japan is a big developer and user of wound product consumer. Per capital demand is also higher in some countries like Japan.
  3. Flattening markets in the U.S. and Europe (where home-based manufacturers are looking more at emerging markets), with Europe in particular focused intently on lowering healthcare costs.
  4. The M&A, and deal-making that has taken place over the past few years (Bristol-Myers Squibb, The Medicines Company, Cohera Medical, Medafor, CR Bard, Tenaxis, Mallinckrodt, Xcede Technologies, etc.) will continue as market penetration turns to consolidation.
  5. Growing development on two fronts: (1) clinical specialty and/or application specific product formulation, and (2) all purpose products that provide faster sealing, hemostasis, or closure for general wound applications for internal and external use.
  6. Bioglues already hold the lead in global medical glue sales, and more are being developed, but there are also numerous biologically-inspired, though not -derived, glues in the starting blocks that will displace bioglue shares. Nanotech also has its tiny fingers in this pie, as well.

See Report #S290, “Worldwide Sealants, Glues, and Hemostats Markets, 2015-2022”.

The Demand for Sealants, Glues, and Hemostats in 2016

The following is drawn from “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” Report #S290.

The need for surgical sealants, glues and hemostats is directly related to the clinical caseload and procedure volumes, as well as to the adoption of these products for multiple uses, such as the use of one product for sealing, hemostasis and anti-adhesion. It is fair to say that use of these products has become routine in the surgical suite and in other clinical locations. Procedure volumes are in turn driven by demographic forces, including global aging populations, while regulatory changes will continue to influence uptake of these products.

wound-prevalance

Source: MedMarket Diligence, LLC; Report #S290.

Medical Sealants

Fibrin sealants are made of a combination of thrombin and fibrinogen. These sealants may be sprayed on the bleeding surface, or applied using a patch. Surgical sealants might be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates.

Sealants are most often used to stop bleeding over a large area. If the surgeon wishes to fasten down a flap without using sutures, or in addition to using sutures, then the product used is usually a medical glue.

Hemostatic Products

The surgeon and the perioperative nurse have a variety of hemostats from which to choose, as they are not all alike in their applications and efficacy. Selection of the most appropriate hemostat requires training and experience, and can affect the clinical outcome, as well as decrease treatment costs. Some of the factors that enter into the decision-making process include the size of the wound, the amount of hemorrhaging, potential adverse effects, whether the procedure is MIS or open surgery, and others.

Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a flowable putty that may be applied to the bleeding area.

Medical Glues

Sealants and glues are terms which are often used interchangeably, which can be confusing. In this report, a medical glue is defined as a product used to bond two surfaces together securely. Surgeons are increasingly reaching for medical glues to either help secure a suture line, or to replace sutures entirely in the repair of soft tissues. Medical glues are also utilized in repairing bone fractures, especially for highly comminuted fractures that often involve many small fragments. This helps to spread out the force-bearing surface, rather than focusing weight-bearing on spots where a pin has been inserted.

Thus, the surgeon has a fairly wide array of products from which to choose. The choice of which surgical hemostat or sealant to use depends on several factors, including the procedure being conducted, the type of bleeding, severity of the hemorrhage, the surgeon’s experience with the products, the surgeon’s preference, the price of the product and availability at the time of surgery. For example, a product which has a long shelf life and does not require refrigeration or other special storage, and which requires no special preparation, usually holds advantages over a product which must be mixed before use, or held in a refrigerator during storage, then allowed to warm up to room temperature before use.

 

Where is the medtech growth?

Medical technology is, for many of its markets, being forced to look for growth from more sources, including emerging markets. Manufacturers are able to gain better margins through innovation, but their success varies by clinical application.

Cardiology. A demanding patient base (it’s life or death). Be that as it may, there are few new or untapped markets, only the opportunity for new technologies to displace existing markets. Interventional technologies are progressively enabling treatment of larger patient populations, but much growth will still be from emerging markets.

Wound management. Even the most well-established markets will see growth from innovation. The wound market just needs less growth to be happy, since small percentage growth becomes very large by volume. And yet, some of the most significant growth in the long run will be for more advanced

Surgery. Every aspect of surgery seems to be subject to attempts to improve upon it. Robotics, endoscopy, transcatheter, single-port, incisionless, natural orifice. Interventional options are increasing the treatable patient population, and it seems likely that continued development (e.g., materials, including biodegradables, use of drug or other coatings, including cells) will yield more routine procedures for more and different types of conditions, many of which have been inadequately served, if it all.

Orthopedics. Aging populations demanding more agility and mobility will drive orthopedic procedures and device use. Innovation still represents some upside, but more from 3D printing than other new technologies being introduced to practice.

Tissue/Cell Therapy. This is a technology opportunity (and represents radical innovation for most clinical areas), but it is also a set of target clinical applications, since tissues/cells are being engineered to address tissue or cell trauma or disease. Growth is displacing existing markets with new technology, such as bioengineered skin, tendons, bladders, bone, cardiac tissue, etc. These are fundamentally radical technologies for the target applications.

Below is my conceptual opinion on the balance of growth by clinical area coming from routine innovation (tweaks, improvements), radical innovation (whole new “paradigms” like cell therapy in cardiology), and emerging market growth (e.g., China, S. America).

Screen Shot 2016-06-22 at 1.56.13 PM

Source: MedMarket Diligence, LLC.

Medtech Fundings in May 2015

Fundings for medical technologies in May 2015 came in at $757 million, led by the $96 million IPO of EndoChoice, Inc.

Below are the top fundings for May.

Company, fundingProduct/technology
EndoChoice, Inc., raised $96 million from a planned $115 million initial public offering according to the companyEndoscopy imaging and instruments
Glaukos Corp. has set terms for a $75 million (previously filed for $86 million) initial public offering according to a regulatory filingDevice-based treatment for glaucoma
Outset Medical, Inc., has raised $59.59 million of a planned $65.59 million round of funding according to a regulatory filingDialysis technology
Shockwave Medical, Inc., has raised $40 million in a round of funding according to the companyBalloon dilatation catheters integrated with lithotripsy for treatment of vascular and valvular lesions
Intact Vascular, Inc., has raised $38.9 million in a Series B round of funding according to the companyDevices for minimally invasive peripheral vascular procedures
Autonomic Technologies, Inc., has raised $38 million in a Series D round of funding according to the companyMicrostimulator for treatment of autonomic disorders, including severe headache
AirXpanders, Inc., has filed for a $36.5 million initial public offering according to the companyBreast tissue expander
AEGEA Medical, Inc., has raised $36 million in a Series C round of funding according to the companyConnective water vapor treatment for menorrhagia (abnormal uterine bleeding)
Ceterix Orthopedics, Inc., has secured $35 million in debt funding according to the companySurgical instruments and other products for treatment of soft tissue injuries
Moximed, Inc., has raised $33 million of a planned $37.64 million round of funding according to a regulatory filingExtra-capsular and extra-articular knee implant for treatment of osteoarthritis

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

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

Medical technologies at startups, July 2014

Below is a list of technologies under development at medical technology startups identified in July 2014 and included in the Medtech Startups Database.

  • thrombectomyInstrumentation for electrophysiology diagnosis and treatment.
  • Products for the treatment of hypertension and other chronic disease by interventional cardiologists
  • Surgical stapling device for use during natural orifice transluminal endoscopic surgery.
  • Low cost medical technologies to improve patient management in emerging markets.
  • Heart valve for the treatment of mitral valve regurgitation
  • Thrombectomy catheter
  • Microstaple bandage for wound closure.
  • Whole-body cryotherapy chambers as well as devices for local cryotherapy and cryosurgery.
  • Minimally invasive surgical device for the treatment of glaucoma
  • Electrical muscle stimulation.

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

Percutaneous accomplishes even more

Melody TranscatheterWith the FDA's approval of Medtronic's Melody Transcatheter Pulmonary Valve and Ensemble Delivery System (see link), another step has been made toward eliminating traditional surgery — at least that's the idea. The ability to implant a valve via a percutaneous procedure advances the art of less invasive intervention in ways akin to laparoscopic surgery, albeit at lower volume.

Percutaneous, NOTES (natural orifice transluminal endoscopic surgery) and laparoscopic surgery are progressively removing the need for invasive traditional surgery. 

It is precisely due to percutaneous procedures that coronary stents have been able to present such a clinical challenge to coronary artery bypass. Although minimally invasive approaches to CABG are an attempt to pull back some surgical caseload, they are technically complex, expensive and, therefore, are not likely to stem the tide toward the dominance of percutaneous procedures. Ironically, the one procedure that may save bypass is the transcatheter route.  With the approval of the Melody approach, it is clear that that is not impossible.

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See Worldwide Coronary Stents Market.

Technologies at new medtech companies (startups)

New medical technologies represented in specific companies recently added (September 2008) to the Medtech Startups Database:

  • Recombinant proteins and cells for intervertebral disc cell regeneration
  • Non-hydrogel polymer used to stimulate tissue growth in dental/orthopedic applications
  • Biomaterials and biologics for repair of bone and cartilage
  • Portable endoscopic imaging
  • Device treatments for restless leg syndrome (RLS)
  • Disposable steerable surgical instrumentation for arthroscopy
  • Technologies to restore spinal disc function
  • Embolic protection system 

For details on the Medtech Startups Database, see link.  


Also from MedMarket Diligence: 

  • New!  Ablation Technologies 2008:  “Worldwide Ablation Technologies, 2008-2017.”  See link.
  • Spine Surgery 2008: Spine Surgery: Products, Technologies, Markets & Opportunities, Worldwide, 2008-2017.  See link. 
  • Wound Management 2007-2016: Wound Management: Established and Emerging Products, Technologies and Markets in the US, Europe, Japan and Rest of World.  See link. 

For additional details on Reports or the Medtech Startups Database, contact Patrick Driscoll at +1-949-859-3401 or patrick(at)mediligence(dot)com.