New technologies at medtech startups, October 2014

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

  • Prosthetic disc nucleus in spine surgery.
  • Device and non-device technologies based on dynamics of blood flow.
  • Magnetic and fluorescent technology point-of-care device to detect heart attack.
  • Technologies for tissue reconstruction.
  • Adult stem cell therapy in orthopedics, aesthetics, and chronic diseases (diabetes, COPD, heart disease, multiple sclerosis, stroke/cerebrovascular disease).
  • Vagus nerve stimulation for neuromodulation treatment of various inflammatory autoimmune diseases.
  • Surgical devices including for endoscopic access closure.
  • Device to measure sympathetic nerve activity and produce ECG.
  • Simultaneously track electrical measures that indicate brain, heart, optical and musculoskeletal activity.
  • Needle-free pediatric withdrawal of blood.
  • Ventilation systems for improved delivery of gas, moisture and nebulized medication.
  • Broadly focused medical technology company active in osteoarthritis, cardiovascular, stroke, diabetes, infection control and spine surgery.

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

Medtech fundings for June 2014

Fundings in medical technology for the month of June totaled $445 million, led by fundings of Benvenue Medical ($64 million) and InSightec ($50 million).

Below are the top fundings in the month.

Company fundingProduct/technology
Benvenue Medical, Inc., has raised $64 million in a round of funding according to the companyMinimally invasive implants for spine surgery
InSightec, Inc., has raised $50 million in a Series D round of funding according to the companyMR-guided focused ultrasound
Pixium Vision has raised $46.7 million in an initial public offering according to press reportsImplants to treat blindness
OrthoPediatrics Corp. has raised $39 million in a round of funding according to a regulatory filingOrthopedic implant technologies designed for pediatric use
Cheetah Medical, Inc., has raised $33.85 million in a round of funding according to a regulatory filingNon-invasive hemodynamic monitoring
Spinal Kinetics, Inc., has raised $33.85 million of a planned $34.77 million round of funding according to a regulatory filingMotion preservation systems, including artificial discs, for degenerative disc disease

For a complete list of medtech fundings in June 2014, see link.

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

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence has added three previously published, comprehensive analyses of  medtech markets to its Reference Reports listings. The markets covered in the three reports are:

  • Ophthalmology Diagnostics, Devices and Drugs (see link)
  • Coronary Stents: Drug-Eluting, Bare, Bioresorbable and Others (see link)
  • Tissue Engineering, Cell Therapy and Transplantation (see link)

Termed “Reference Reports”, these detailed studies were initially completed typically within the past five years. They now serve as exceptional references to those markets, since fundamental data about each of these markets has remained largely unchanged. Such data includes:

  • Disease prevalence, incidence and trends (including credible forecasts to the present)
  • Clinical practices and trends in the management of the disease(s)
  • Industry structure including competitors (most still active today)
  • Detailed appendices on procedure data, company directories, etc.

Arguably, a least one quarter of every NEW medtech report contains background data encompassing the data listed above.  Therefore, the MedMarket Diligence reports have been priced in the single user editions at $950 each, which is roughly one quarter the price of a full report.

See links above for detailed report descriptions, tables of contents, lists of exhibits and ordering. If you have further questions, feel free to contact Patrick Driscoll at (949) 859-3401 or (toll free US) 1-866-820-1357.

See the comprehensive list of MedMarket Diligence reports at link.

 

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.

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

2013 Medtech Outlook

The 2013 Medtech Industry — Some General Predictions

In 2012, much has been made of the Affordable Care Act or, more precisely, the 2.3% excise tax on medical devices used to fund the addition of 30 million new patients to the U.S. healthcare system. Despite a chorus of voices for a repeal of the tax, with repeal arguments that range from credible to absurd, the tax is likely to stay in place.  With the influx of new patients in 2013 and beyond, the cost versus benefit will become clear, but we forecast that the debate on the excise tax will linger well into the new year.

The U.S. and global economy have been recovering with growing momentum following several stagnant years.  Just as a rising tide floats all boats, the stronger economy in 2013 will help drive medtech though more available capital leading to increased spending by healthcare systems for increased inventories and investment in new technologies.

Investment in medtech will likely show modest increase as money that has been previously stored in the “safe harbor” of medtech investment will shift back to non-medtech investment targets that have now been made more attractive by the stronger economy. In the recessionary economy of post 2008, medtech investment has favored later stage (i.e., “less risky”) technologies — those already in or about to enter the market.  Now, with hunger for larger returns in the stronger economy, the money that will flow into medtech in 2013 will be more inclined to fund earlier stage products and companies.

Physicians and companies will not part ways, but in 2013 they will not be so cozy, given the Sunshine Act’s intention to reveal how cozy they actually are in order to eliminate financial bias in physician endorsement of new technology. Even before the Sunshine Act, the writing has been on the wall that the links between physicians and companies have been too close. Greater scrutiny of these links will create challenges for medtech to ensure that clinical validation of new technologies will be unbiased.

Trends associated with the FDA include steady progress in reducing review times, closer scrutiny of off-label uses, more stringent attention to false or misleading claims and, in general, an uptick in enforcement. We forecast that the regulation of medical devices will become increasingly complex as the FDA seeks to address deficiencies in the 510(k) process and, in general, complete reviews more efficiently to satisfy the needs of industry and needy patients without compromising device safety.

The regulatory process will also become further challenged as it faces new definitions (or lack thereof) for “medical devices”, since the marriage of drugs and devices (i.e., hybrids), the growth of resorbable implants and other innovation trends blur the previously distinct boundaries between drug, device, biotech and other products.

2013 will also see the emergence and/or expansion of multiple medtech markets.

  • Expect a growing number of developments in neurology-focused therapeutics such as neuromodulation, the expanded use of hybrid devices in cardiology (including bioresorbable stents).
  • The press for minimal invasiveness and the capacity of medtech to respond through innovation will drive development and adoption of new technologies paradigms such as NOTES (natural orifice transluminal endoscopic surgery) technologies; transcatheter technologies and other medical/surgical technologies that dramatically reduce the need for surgical incisions or other invasiveness; non-invasive diagnostics such as glucose meters in diabetes
  • Surgical and interventional procedures are increasingly being integrated with more sophisticated pre-operative and intraoperative (“real time”) imaging systems that enhance the physician’s ability to direct therapy more effectively at pathologies with less collateral damage, reducing complications, accelerating recovery and otherwise improving patient outcomes.  Some of these systems, such as intraoperative MRI, are very sophisticated and accordingly expensive, so benefit/cost may limit adoption but for the most at risk caseload.
  • The blessing in disguise that was the Bush administration’s ban on federal funding of embryonic stem cell research led to a burst of research in adult stem cells that bypassed the embryonic stem-cell ethical dilemma. With the Obama administration’s subsequent lifting of the federal ban, both embryonic and adult stem cell research is proceeding at breakneck pace.  2013 is therefore likely to see an equally powerful burst of advances leading to practical therapies based on stem (or pluripotent) cell technology.
  • Driven by research indicating important, patient-specific differences in physiology that impact the effectiveness of medical devices and other medtech, 2013 will show an increase in customized or personalized medicine.  The diagnostic component will include genetics-driven predictors of disease while the therapeutic will include a wide range of product types, from the development of autologously cultured tissues or stem cell-derived tissues, and custom-fitted implants in cardiology, orthopedics, general surgery and other specialties.
  • 3D printing is being applied to medtech in both prototype development and in such seemingly far-fetched ideas as organ printing, which is actually in active development.
  • Biomaterials, or materials technology in general, increasingly expand the number of possibilities of what can be achieved with medical devices and other medtech products. Drug-coated devices, drug-delivery devices, extracellular matrices, bioresorbable implants, nanotechnology-based and other coatings and a wide range of other materials technologies are enabling medtech products to be more disease-specific, less toxic, less prone to biocompatibility issues, less likely to be associated with procedure-specific collateral damage and otherwise more effective in achieving high quality outcomes at lower overall cost.

There will also be secondary forces impacting medical technologies. By this, we mean forces in the innovation of non-medical technologies or other forces that are changing the use and/or implementation of medical devices. First among these is forces for the integration of information technologies in medical devices encompassing infusion pumps and other “smart” devices, radiofrequency identification systems, wireless telemetry and others.

While we are more focused on medical technologies than on technologies like information systems that affect more of the logistics than the clinical delivery of healthcare, it should not be overlooked that healthcare in 2013 will also be characterized by steady growth in the application of information technology.  At its simplest level, information technology in healthcare is the management of healthcare information — electronic medical records, healthcare information systems, picture archiving and retrieval, etc. But to a much greater degree, information technology is impacting healthcare through several key areas:

  • Computer aided design and prototype development. Conventional use of computer aided design in the development of medical devices is already common, but increasingly sophisticated programs and systems are being developed to optimize device design to reflect a more comprehensive understanding of the forces, dynamics and anatomy of patients, as well as the more thorough understanding of pathology. With the use of CAD and 3D printing, prototypes can be quickly produced that, if not functional, can facilitate the development of ideas toward functional prototypes. In cardiology, flow dynamics have been recognized as a critical aspect effectively applied through computer aided design of vascular stents, catheters, embolic protection, aneurysm repair and many others. In orthopedics, the use of CAD is facilitating customized implants.
  • Systems biology and the demand for multivariate analysis. One of the most significant long term objectives of medical device (or medtech) development is the innovation of products that more comprehensively address disease states (or wellness) by integrating understanding of anatomy, physiology, chemistry, genetics, physics and all other possible disciplines having potential impact on the long term efficacy of a medical product.  While there is fundamental science to be learned to achieve such a multivariate understanding/solution, and this is a long-term goal well beyond 2013, the increasing recognition of diverse factors impacting product efficacy is incrementally improving each new product embodiment — and such work is a part of product development already.  The concurrent interplay of alternative device (or other medtech product) configurations with myriad biological, physical and other forces demands information technologies that are able to predict downstream effects of each possible innovation.

[Please note we are continuing to review new medtech development efforts and analyze their potential impacts so that we may update our 2013 forecast here.]

 

Spine Surgery Map

Spine surgery is a broad area of clinical practice encompassing treatments for many different conditions encompassing degenerative disc and other spinal diseases, congenital and adult spinal deformities, autoimmune diseases of the spine, and the many different conditions of spinal trauma.

Therefore, the range of approaches to addressing spine disease and trauma is equally broad.

Below is a rough outline of spine surgery treatments, drawn from our 2011 Worldwide Spine Surgery report:

Source: MedMarket Diligence Report #M520.

Recent global medtech market reports

Most recent published reports from MedMarket Diligence:

Selected new medical technologies with big potential impact

One of our readers at nursingschools.net sent along an interesting set of medical technologies that are good examples of new and evolving technologies impacting patient care.  

For the full review of these advances at nursingschools.net see link.

Recent medical technology startups

Recent medical technology startups (2009-2010):

  • Alacer Biomedical, Inc. — Silk-based biomaterial platforms for tissue repair and orthopedic applications.
  • Caymus Medical, Inc. — Undisclosed medical technology from previous founder of Opus Medical, Inc.
  • Cecuris Surgical, LLC — Tendon, ligament and soft tissue repair.
  • Corhythm, Inc. — Implantable device to detect onset of atrial fibrillation and chronic heart failure.
  • Crocker Spinal Technologies, Inc. – Spinal implant technologies
  • Domain Surgical, Inc. – Development stage medical device company.
  • ECW Therapeutics, Inc. — Systems for concentration of autologous adult stem cells applied in surgical approaches to orthopedics.
  • EndoRetics, Inc. — Incisionless bariatric surgery device.
  • InCyte Innovations, LLC — undisclosed
  • Innovative Pulmonary Solutions, Inc. — Novel devices for treating lung diseases.
  • OsteoSping Medical, Inc. – Orthopedic implants
  • SonoCiné, Inc. — Automated breast ultrasound system to complement mammography.
  • Vesatek, LLC c/o Incuvate, LLC — Surgical guidewire apparatus.

Companies drawn from the Medtech Startups Database.