Medtech manufacturers interested in “growth” markets need to consider the relative versus absolute. Nascent markets can growth from $1 million sales in year 1 to $2 million in year 2, obviously a 100% increase. But in multi-billion markets, a $1 million increase will elicit a yawn from all but the smallest manufacturers.
Just as an exercise, I ranked the growth rates for sales of wound closure products detailed in our Report #S192 by both the absolute sales growth from 2014 to 2018 and the compound annual growth rate over this period. To reveal the differences even further, I did this ranking by the all combinations of geographic area and wound closure product type. Partial results (just the top growth rankings, since the list is too long to show all) are shown side by side below.
Wound Closure Sales Growth, Absolute and Relative, 2014-2018
Source: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, Report #S192.
Even though tapes, sutures and staples have very modest growth rates in many geographic markets, their current dollar volume sales make such growth much more significant in absolute terms.
The simple practice of closing wounds is not so simple, driven as it is by the fact that wounds can be the conduit for blood, infectious agents and every other liquid, gas or solid that should not enter or exit the wound. The closure has to be readily accomplished, regardless of where the wound exists. The closure should not only prevent blood from being lost but ideally should actively stop the bleeding. The wound must stay closed despite the pressures exerted upon it. The closure should also have a minimal “footprint”, with the closure components being easily removed, absorbed or otherwise leaving the least possible trace of the closure, including scar tissue.
Hence, tapes, staples, sutures, clips, hemostatic agents, sealants, glues and other devices have been developed to get the job done. The market for this range of closure options now reflects biologics, absorbable materials, devices and other products. Fundamentally, the market remains largely dominated by sutures and staples/clips, which have satisfied the demands of internal/external closure, easy of use, low cost, strength of closure and other considerations, not least of which is the evolving nature of surgical practice from the “open” to endo/laparoscopic. Nonetheless, tighter wound sealing, less bleeding and better outcomes in general have driven manufacturers to develop improvements.
Below is illustrated the 2014 market for the range of wound closure products along with their associated growth rates. The prospects for medical/surgical tapes are the exception to the rule, demonstrating a steady decline while better alternatives demonstrate steady growth.
Source: MedMarket Diligence, LLC; Report #S192
Fundings for medical technologies in May 2015 thus far stand at $775 million, led by the (planned) $115 million IPO of EndoChoice, Inc.
Below are the top fundings for the month thus far.
|EndoChoice, Inc., has filed for a $115 million initial public offering according to the company
||Endoscopy imaging and instruments
|Glaukos Corp. has filed for an $86 million initial public offering according to a regulatory filing
||Device-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 filing
|Shockwave Medical, Inc., has raised $40 million in a round of funding according to the company
||Balloon 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 company
||Devices for minimally invasive peripheral vascular procedures
|Autonomic Technologies, Inc., has raised $38 million in a Series D round of funding according to the company
||Microstimulator for treatment of autonomic disorders, including severe headache
|AirXpanders, Inc., has filed for a $36.5 million initial public offering according to the company
||Breast tissue expander
|AEGEA Medical, Inc., has raised $36 million in a Series C round of funding according to the company
||Connective water vapor treatment for menorrhagia (abnormal uterine bleeding)
|Ceterix Orthopedics, Inc., has secured $35 million in debt funding according to the company
||Surgical 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 filing
||Extra-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.
This is an excerpt from Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, published by MedMarket Diligence, LLC.
Compared to biologically active sealants containing fibrin and other human- or animal-derived products, synthetic sealants represent a much larger segment of the sealant market in terms of the number of competitors, variety of products, and next-generation products in development. Non-active synthetic sealants do not contain ingredients such as fibrin that actively mediate the blood clotting cascade, rather they act as mechanical hemostats, binding with or adhering to the tissues to help stop or prevent active bleeding during surgery.
Synthetic sealants represent an active category for R&D investment in large part because they offer several advantages over fibrin-based and other biologically active sealants. First and foremost, they are not derived from animal or human donor sources and thus eliminate the risks of disease transmission. Moreover, they are typically easier to use than biological products, often requiring no mixing or special storage, and many of these products have demonstrated improved sealing strength versus their biological counterparts. Synthetic products also have the potential to be more cost-effective than their biologically active counterparts.
Leaders in the synthetic surgical sealants space include Baxter International Inc., CryoLife, CR Bard, and Ethicon/J&J; however, there are many up-and-coming competitors operating in this segment of the market with some interesting next-generation technologies that could gain significant traction in the years ahead. Moreover, unlike the fibrin sealants segment, where most products have more general indications for surgical hemostasis, a good number of competitors in the synthetic sealant field are focused on specific clinical applications for their products, such as cardiovascular surgery, plastic surgery, or ophthalmic surgery.
Selected Nonactive Synthetic Surgical Sealants and Glues
|Baxter||CoSeal||Synthetic, translucent gel for cardiovascular and peripheral vascular surgery applications. Consists of two polyethylene glycol (PEG) polymers that rapidly crosslink with proteins in the tissues, forming a covalent bond. Also mechanically adheres to synthetic graft materials. Intended for adjunctive use to seal areas of leakage.
|Cohera Medical||TissuGlu Surgical Adhesive||Synthetic, resorbable adhesive based on companyÕs proprietary lysine-derived urethane polymer technology. Used for surgeries involving large flap tissue approximation, such as mastectomy and abdominoplasty, to reduce wound drainage and reduce or eliminate the need for wound drains and lower the risk of seroma formation.
|Cohera Medical||Sylys Surgical Sealant||Synthetic sealant designed specifically to help reduce leaks at the anastomosis in gastrointestinal surgery procedures. Used in conjunction with standard closure techniques to protect suture or staple line during first few days of healing.
|CR Bard/Davol||Progel (obtained via BardÕs 2012 acquisition of Neomend)||Hydrogel sealant made of human serum albumin and PEG.
|CryoLife||BioGlue||Bovine serum albumin (BSA)-based surgical adhesive delivered in dual-chamber system.
|CryoLife||BioFoam Surgical Matrix||Dual-action sealant and hemostat. Delivered as liquid and sets into soft foam for difficult to access spaces.
|Endomedix||N/A||In early-stage development with a surgical sealant designed to help control bleeding during brain surgery procedures. Product is a hydrogel comprised of two biocompatible polysaccharides that are simultaneously mixed and sprayed onto the surgical site.
|Gecko Biomedical (France)||N/A||Biodegradable, biocompatible hydrophobic light-activated adhesive made by combining glycerol and sebacic acid. Applied in liquid form and solidifies into leak-proof, flexible seal after a few seconds exposure to UV light.
|Hyperbranch Medical Technology||Adherus Dural Sealant||Hydrogel comprised of two synthetic components: activated PEG and polyethyleneimine. Designed for adjunctive use with standard methods of dural repair during neurosurgery and spinal surgery.
|Integra LifeSciences*||DuraSeal||Absorbable hydrogel dural sealant comprised of synthetic PEG ester solution and trilysine amine solution. Delivered via double barrel system.
|Integra LifeSciences*||VascuSeal||Similar in composition to DuraSeal but intended for use in arterial and venous reconstruction procedures to seal suture lines.
|J&J/Ethicon||Omnex Surgical Sealant||Cyanoacrylate sealant for prevention of leakage along suture lines in vascular reconstruction procedures.
|LifeBond (Israel)||LifeSeal/LifePatch Surgical Sealants||Crosslinked gelatin sealants applied as an adhesive hydrogel matrix. In development for internal wounds and staple-line reinforcement.
|Medical Adhesive Revolution GmbH (Aachen, Germany)||N/A||In development with a high-strength, biodegradable surgical adhesive that can be used instantaneously to stop bleeding within seconds..
|Ocular Therapeutix (formerly I-Therapeutix)||ReSure||Hydrogel sealant designed specifically for use during ophthalmic surgery (such as cataract surgery) as an alternative to sutures.
|Sapheon Inc. (being acquired by Covidien)||VenaSeal Sapheon Closure System||Proprietary catheter-based system that delivers a specially formulated cyanoacrylate medical adhesive to embolize and close the saphenous vein in patients with venous reflux disease. Eliminates the need for surgery, thermal ablation, sedatives, tumescent anesthesia, post-procedure compression stockings, and chemical sclerosants.
|Sealantis Ltd||Seal-V||Protein-free, biodegradable vascular surgery sealant made with Alga-Mimetic Adhesive Technology: mimics algae underwater adherence mechanism.
|Tenaxis Medical (being acquired by The Medicines Company)||ArterX Vascular Sealant||Bioresorbable, gluteraldehyde-based prophylactic synthetic sealant with unique, noninflammatory crosslinking agent that mechanically seals human tissue and artificial grafts in wet or dry field.
|Xcede Technologies Inc. (subsidiary of Dynasil Biomedical Corp.)||Xcede Patch||First product based on platform of ready-to-use, high-strength, fast-acting combination of hemostat/sealant technology initially invented by Dr. Daniel Ericson and acquired by Dynasil in 2011.
Source: MedMarket Diligence, LLC
Below is a list of the technologies under development at medical technology startups identified in April 2015 and added to the Medtech Startup Database.
- Therapeutic drug monitoring device.
- Artificial pancreas for diabetes.
- Automated, 3D ultrasound for breast cancer diagnosis.
- Products for the treatment of facet joint syndrome.
- Fractional laser with applications in aesthetics and gynecology.
- Undisclosed surgical technology.
- Antimicrobial implants and other devices in orthopedics to reduce surgical-site and hospital-acquired infection.
- Developing a portable artificial lung.
- Technologies to reduce infections and improve efficiency of patient ventilation.
- Small molecule drugs for treatment and prevention of atrial fibrillation.
- Vascular access device.
- Stem cell technology.
- Development, marketing, and distribution of medical technology equipment in urology, aesthetics.
- Technology for securing a medical device combined with a hemostasis valve.
- Embolic protection devices.
- Head-mounted neurostimulation system for the treatment of migraine.
For a historical listing of medical technologies at startups since 2008, see link.
Fundings for medical technologies in April 2015 reached $615 million, led by the huge $225 million funding of Intarcia Therapeutics.
Below are the top fundings for the month.
|Intarcia Therapeutics has raised $225 million in a round of funding according to the company
||Subcutaneous, osmotic pump for drug delivery in type 2 diabetes
|Mesoblast has raised $58.5 million in a round of funding by Celgene Corp.
||Precursor and stem cells for cell therapy
|MyoKardia, Inc., has raised $46 million in a round of funding according to a regulatory filing
||Genetically based treatments for cardiomyopathies
|Scanadu has raised $35 million in a Series B round of funding according to press reports
||Device that enables patients to scan and upload diagnostic information
|Neuronetics, Inc., has completed a $34.3 million Series F funding round, according to the company
||Transcranial magnetic stimulation for the treatment of depression
|Lombard Medical, Inc., has raised $26 million in financing from Oxford Finance, LLC
||Stent grafts for treatment of abdominal aortic aneurysm
|EBR Systems, Inc., has raised $20 million in a round of funding according to the company
||Wireless cardiac pacing
For the complete list of medtech fundings in April 2015, see link.
For a historical list of the individual fundings in medtech, by month, since 2009, see link.
Products in wound closure include sutures/staples, tapes, vascular closure devices, surgical hemostats, and surgical sealants/glues.
Wound types have not changed over history, with a slight exception being the emergence (several decades ago) of femoral punctures associated with catheterization procedures. But what has changed, and what continues to evolve, is the practice of closing those wounds. Sutures, staples and tapes are a mainstay of medical practice, representing uncomplicated methods to secure wounds. And while innovators continue to change the form and function of these products to improve performance, the more recently introduced surgical hemostats, vascular closure, and surgical sealants/glues have seized significant shares of wound closure caseload and are growing marginally faster than sutures/staples and tapes. The result is and will be an erosion of traditional wound closure technology shares.
Below is illustrated the size/growth of segments in the global wound closure market.
Source: MedMarket Diligence, LLC; “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, Report #S192.