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

Harsh questions for complex medtech

robotic_or_scalpelOn the one hand, as I track medical device technology development, I see the increasing trend toward a reduction in the complexity of approaches to accomplish therapeutic ends. The underlying force seems to be, “healthcare technology is expensive, so let’s minimize the technological complexity, minimize the invasiveness, reduce collateral damage, make treatments more specific to the resolution of symptoms and/or disease…” The result is that, for example, endoscopic surgery leads to laparoscopic surgery, which leads to single port laparoscopic surgery, which leads to natural orifice transluminal endoscopic surgery, potentially competing in its minimally invasiveness against alternatives like transcatheter interventional procedures — even for procedures like cardiac valve repair or replacement or coronary artery bypass grafting.

Then, on the other hand, I see technological development moving in the entirely opposite direction of increasing complexity with developments like robotic surgical systems, intraoperative imaging and others, all of which raise the question as to whether we are simply developing technologies for technology’s sake. Do these increasingly complex technologies provide a clinical endpoint not achievable with alternative technologies, or more importantly, procedural approaches? Certainly, I think that technologies that enable a surgeon to perform a procedure that he otherwise simply could not perform, such as those involving the use of intraoperative imaging technologies that enable the surgeon to see healthy versus pathological tissues and differentiate his actions accordingly can arguably result in a better clinical outcome. And as part of this process, one must consider the cost of the accompanying technology such as imaging systems.

Accordingly, when one considers the range of different complex robotic surgical technologies on the market or under development, one has to ask whether these systems truly allow the performance of procedures that the average, well-trained surgeon could not perform without that technology. Certainly, there are complex surgical procedures, such as delicate neuro procedures that, if not performed with extremely precise accuracy, might result in serious collateral damage. But hernia repair? Appendectomy? Colon resection? Hysterectomy? Some of these fairly high-volume procedures have indeed been presented as justification for the enormous expenditure needed to acquire robotic surgical systems.

Forgive me for stating the obvious, but it seems incumbent upon healthcare systems to critically evaluate the cost/benefit of new technology, given the limited resources in healthcare.

For this reason, it does not surprise me in the least that recent reports of complications or, in the least, device problems associated with the use of Intuitive Surgical’s robotic systems have promptly led to a precipitous decline in that company’s stock value. If a technology can’t enable the performance of a procedure that otherwise could not be performed, then its value is in question. Further, if the technology cannot perform a procedure flawlessly, and without complication or error that can arguably be performed without that technology, then its value is seriously in question.

Wound management markets globally in modest to aggressive growth

The global markets for wound management range from basic to advanced products, from gauze to bioengineered skin. By product type, traditional bandages remain the largest volume of sales, and this will persist through 2020.  The fastest growing segments, however, vary by region, with the highest growth alternately coming from sales of alginate dressings or bioengineered skin.

Geographically, sales in North America, in particular the USA, will remain the dominant share of wound management products.  However, the greatest growth will come from markets in Asia/Pacific as economic strength in the region (including China) contributes to deeper penetration of the large potential caseload.

Below is illustrated the worldwide wound management market by product type and geographic region for 2012, and, presented on the same scale for comparative purposes, the market for these products in 2020.

Wound2012

Source: MedMarket Diligence, LLC; Report #S249, “Wound Management, Worldwide Market and Forecast to 2020: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

Wound2020

 Source: MedMarket Diligence, LLC; Report #S249.

Spine surgery worldwide market, sales growth rates of products

Demonstrating a very wide range of clinical approaches and technologies, products used in spine surgery range from the very well established to products demonstrating considerably more potential than actual, current sales.

The products in spine surgery include:

  • Posterior Pedicle Screw Fusion Systems
  • Anterior Cervical Plate Systems Anterior Thoracolumbar Systems
  • Anterior Lumbar Interbody Fusion
  • Thoracolumbar Interbody Fusion
  • Posterior Lumbar Interbody Fusion
  • Axial Lumbar Interbody Fusion
  • Interspinous Process Spacers
  • Cervical Artificial Discs
  • Lumbar Artificial Discs
  • Vertebroplasty
  • Balloon Kyphoplasty
  • Allografts
  • Demineralized Bone Matrices
  • Bone Morphogenic Proteins

Spine fusion systems represent the most well established products in spine surgery.  Novel and/or emerging technologies include artificial discs, vertebroplasty and kyphoplasty.  The more novel use of allografts, demineralized bone matrices and bone morphogenic proteins offer considerable promise, but clinical challenges have limited their more rapid growth.

Below are illustrated the relative growth rates (comparing CAGR from 2012 to 2020) of spine surgery products. (We are providing the growth rates represented graphically with the absolute values of the growth rates not shown on the x-axis to simply illustrate the relative growth rates.)

CAGRs-relative

 

Source: MedMarket Diligence, LLC, Report #M520, “Worldwide Spine Surgery: Products, Technologies, Markets & Opportunities, 2010-2020.”  This data is also represented in the Data Forecast, #M520X, “Worldwide Spine Surgery Data Forecast 2010-2020.”

Medtech Funding Average Deal Size Trend

Tracking medtech fundings by month, we have compiled several years of data and here present the trending in the average deal size by month, which indicates a relatively volatile pattern but does nonetheless also indicate a modest but still upward trend.

deal-size-trend

 

Source: Compiled by MedMarket Diligence, LLC.  Data shown at link.

The burst this month is a bit overstated due to several large fundings in a month that is only one week old.

Clinical utility of advanced wound closure and securement products

Products for the advanced securement of wounds — stopping bleeding, sealing the wound, tightly closing the wound and preventing post-surgical adhesions — will be accepted by clinicians (and paid for by healthcare systems) to the extent that the provide very specific clinical utility compared to traditional alternatives, many of which (like sutures and tapes) are simple to use, cost little and otherwise are readily accepted in the business of wound management.

Clinicians (and healthcare systems) will accept and adopt for routine use those new products for hemostasis, closure, sealing and anti-adhesion of wounds, whether chronic or acute, based on the level of clinical utility they provide compared to those traditional products, and the extent to which those new products provide utility is based on the types of utility provided (from “critical” to “perceived”), a metric that varies by clinical specialty.  For example, a new product that prevents bleeding and dramatically reduces morbidity is much more likely to be adopted than a product that yields merely aesthetic (e.g., reduced scarring) or perceived benefits that have no impact on morbidity.

Advanced products offer different degrees of utility from, on the high end, the value of enabling procedures otherwise not possible or highly impractical to, on the low end, perceived benefits with no significant positive impact on morbidity.  Further, the impact of advanced products varies by clinical specialty, with some expected differences between, for example, cardiology procedures and cosmetic procedures. The four main categories of benefit from advanced products include:

  • Important and Enabling: Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
  • Improved Clinical Outcome: Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
  • Cost-Effective and Time-Saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • Aesthetic and Perceived Benefits: Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

Below is illustrated the distribution — by clinical category — of the kind of utility provided by advanced wound securement products (fibrin and other sealants, high strength adhesives, hemostatic products and anti-adhesion products):

cardio

 Total: 51.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

cosmetic

Total: 12.7 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 digestive

Total: 20.9 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

general

Total: 27.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

neuro

Total: 16 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

ortho

Total: 10.8 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

 

Medtech Financings for March 2013

Medtech financings for March 2013 came in at a total of $561 million, contributing to the trend of increased monthly fundings as well as average deal size.

Top financings for the month include:

  • $150 million for Mesoblast Ltd (stem cells for regenerative medicine)
  • $48 million for Nevro Corp. (spinal cord stimulation for treatment of pain)
  • $43 million for Avedro, Inc. (vision correction technologies)
  • $42 million for Alere, Inc. (device-based and other near-patient diagnostics)
  • $35 million for OvaScience, Inc. (egg precursor cells for treatment of infertility)
  • $33 million for Cardiovascular Systems, Inc., (atherectomy for treatment of peripheral artery disease)
  • $25 million for Topera Medical (3D mapping for arrhythmia)
  • $22.4 million for Saladax Biomedical (tests to aid in cancer drug dosage)
  • $19 million for SynCardia Systems, Inc. (total artificial heart)
  • $17.2 million for TranS1, Inc. (devices for treatment of conditions of the lumbar spine)

The complete list of medtech financings for March 2013 is shown at link.

Medtech technologies that are gaining traction (funding, other commitment)

Developments in medical technology span a stunningly diverse set of applications enabled by an equally diverse range of technologies.  To hone in on the developments that “matter”, it is worth considering those that have garnered, at a minimum, a level of financial or other commitment to move them toward commercialization.  Here, we highlight technologies under development at companies that have recently (Feb. 2013) received fundings as well as technologies under development at startups recently identified.

Several common themes underly the companies gaining funding, stemming from advances with versatile applications (cell/tissue, info tech), technologies that succeed in providing clinical advantage (minimal invasiveness) or otherwise increase the efficacy of existing treatments (imaging, diagnostics):

  • Tissue/cell-based technologies
  • Minimally invasive or less-invasive approaches to treatments
  • Neural based treatments (e.g., neurological stimulation, denervation)
  • Wireless technology and information technology embedded in device function
  • Imaging, diagnostic or other procedural enhancement to surgery or other treatment

Technologies at companies funding in February 2013:

  • Ocular surface interferometry and thermal pulsation system for diagnosis and treatment of evaporative dry eye
  • Sinus treatment implants
  • Regenerative medicine therapies for orthopedics and wound care
  • Satiety device for the treatment of obesity
  • Microstent for treatment of glaucoma
  • Catheter-based treatment of heart failure
  • Minimally invasive treatment for uterine fibroids
  • Wireless vital signs monitoring
  • Neuroscience-based device company focusing on obesity and metabolic disease
  • Wireless, transdermal continuous glucose monitoring system
  • Magnetic resonance imaging guidance of surgical and interventional procedures
  • Nonsurgical interstitial laser therapy for treatment of breast cancer
  • Ophthalmic drug delivery
  • Lung denervation
  • Deep brain stimulation.
  • Intra-ocular implants (glaucoma, severe infection) and intra-articular implant osteoarthritis)
  • Technology providing real-time, high resolution imaging of cancer cells
  • Targeted drug delivery in ophthalmology
  • Surgical adhesives
  • Device technology for treatment of respiratory disease
  • Neurological cooling to reduce the impact of trauma
  • Minimally invasive treatment for mitral valve regurgitation
  • Devices for use in cardiac and vascular markets
  • Supersaturated oxygen therapy to reduce myocardial necrosis following heart attack
  • Left ventricular access and closure devices
  • Intravascular continuous glucose monitoring
  • Amniotic membrane-based biomaterial technology
  • Needleless intramuscular drug injection device
  • Binocular device for ophthalmology diagnostics
  • Stem cells for use in regenerative medicine
  • Intraoperative ophthalmology diagnostics using wavefront aberrometry
  • Devices for the diagnosis and treatment of arrhythmias
  • Neurostimulation for treatment of chronic pain
  • Collagen-based implants
  • Needleless drug injection technology
  • Endoscopic vein harvesting
  • Undisclosed technology in ophthalmology
  • Nanotechnology-based, injectable wound healing scaffold for treatment of diabetic foot ulcers
  • Surgical robotic technologies integrated to digital 3D imaging for applications in spine, brain, and musculoskeletal procedures

Technologies at recently identified startups (recent additions to startups database):

  • Tissue regeneration technologies for non-invasive skin care.
  • Biomaterials supplied to medical device and pharma manufacturers
  • Trans-reflective fetal EKG.
  • Surgical instrumentation.
  • Undisclosed medical technology.
  • Technologies for autologous tissue collection.
  • Stem cell therapy.
  • Novel, implantable ring to prevent parastomal hernia in abdominal surgery.
  • Transcatheter repair of mitral valve regurgitation.
  • Synthetic cartilage implant for treatment of osteoarthritis or cartilage damage.
  • Device-based treatment of congestive heart failure.
  • Clamping device to control bleeding in trauma.
  • Tissue matrix composition for tissue regeneration and wound care.
  • Spinal pain relief devices.
  • Wireless remote arrhythmia monitoring and diagnosis.
  • Undisclosed medical technology.
  • Surgical tools for arthroscopic procedures.
  • Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
  • Technology to ensure accurate intraoperative placement of hip and knee implants.
  • Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
  • Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
  • Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
  • Ophthalmology diagnostics; binocular device for eye exams.
  • Device-based treatment for respiratory disease.
 Companies represented by these technologies are:
AFcell Medical, ArthroCAD, BAROnova, BeneChill, Bioject Medical Technologies, BioSig Technologies, Blaze Bioscience, CardioKinetix, Cartiva, Ceterix Orthopaedics, Clearside Biomedical, Cohera Biomedical, Cotera, Cytomedix, Diagnostic Biochips, Echo Therapeutics, Enteourage Medical Technologies, EnteroMedics, Envision DIagnostics, Evolus, Excelsius Surgical, First Pulse Medical, GluMetrics, Guided Interventions, Gynesonics, H & M Innovations, Handsome Ltd., HighLife SAS, Holaira, InfoBionic, Innocoll, Innovative Trauma Care, Insight Surgical Instruments, Intersect ENT, IsoStem, Ivantis, Kala Pharmaceuticals, Koring GmbH, Magenta Medical, Mardil, MRI Interventions, MxBiodevices, Neuros Medical, Novian Health, Parios Regenerative Sciences, PharmaJet, PLC Systems, PolyActiva, Rest Devices, Saphena Medial, Sapiens BV, Sotera Wireless, StemBioSys, TearScience, TELA BIO, TherOx, Uro Lasers, Ventec Life Systems, Vornia, Wavetech Vision Systems