Excerpt from Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure 2013-2018″.
Biologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly.
Selected Biologically Active Sealants, Glues, and Hemostats
|Asahi Kasei Medical||CryoSeal FS System||Fibrin sealant system comprising an automated device and sterile blood processing disposables that enable autologous fibrin sealant to be prepared from a patient's own blood plasma in about an hour.
|Baxter||Artiss||Fibrin sealant spray
|Baxter||Tisseel||Biodegradable fibrin sealant made of human fibrinogen and human thrombin. For oozing and diffuse bleeding.
|Baxter||FloSeal||Hemostatic bioresorbable sealant/glue containing human thrombin and bovine-derived, glutaraldehyde-crosslinked proprietary gelatin matrix. For moderate to severe bleeding.
|Baxter||GelFoam Plus||Hemostatic sponge comprising Pfizer's Gelfoam hemostatic sponge, made of porcine skin and gelatin, packaged with human plasma-derived thrombin powder.
|Behring/Nycomed||TachoComb||Fleece-type collagen hemostat coated with fibrin glue components.
|Bristol-Myers Squibb/ZymoGenetics (Sold by The Medicines Company in the US and Canada)||Recothrom||First recombinant, plasma-free thrombin hemostat.
|CSL Behring||Beriplast P/Beriplast P Combi-Set||Freeze dried fibrin sealant. Comprised of human fibrinogen-factor XIII and thrombin in aprotinin and calcium chloride solution.
|CSL Behring||Haemocomplettan P, RiaSTAP||Freeze-dried human fibrinogen concentrate. Haemocomplettan (US) and RiaSTAP (Europe).
|J&J/Ethicon||Evicel||Evicel is a new formulation of the previously available fibrin sealant Quixil (EU)/Crosseal (US). Does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, nor does it contain synthetic or bovine aprotinin, which reduces potential for hypersensitivity reactions.
|J&J/Ethicon||Evarrest||Absorbable fibrin sealant patch comprised of flexible matrix of oxidized, regenerated cellulose backing under a layer of polyglactin 910 non-woven fibers and coated on one side with human fibrinogen and thrombin.
|J&J/Ethicon||BIOSEAL Fibrin Sealant||Low-cost porcine-derived surgical sealant manufactured in China by J&J company Bioseal Biotechnology and targeted to emerging markets.
|J&J/Ethicon||Evithrom||Human thrombin for topical use as hemostat. Made of pooled human blood.
|Pfizer/King Pharmaceuticals||Thrombin JMI||Bovine-derived topical thrombin hemostat.
|Stryker/Orthovita||Vitagel Surgical||Bovine collagen and thrombin hemostat.
|Takeda/Nycomed||TachoSil||Absorbable surgical patch made of collagen sponge matrix combined with human fibrinogen and thrombin.
|Teijin Pharma Ltd/Teijin Group (Tokyo, Japan)||KTF-374||Company is working with Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) to develop a sheet-type surgical fibrin sealant. Product combines KAKETSUKEN's recombinant thrombin and fibrinogen technology with Teijin's high-performance fiber technology to create the world's first recombinant fibrin sealant on a bioabsorbable, flexible, nonwoven electrospun fiber sheet.
|The Medicines Company (TMC)||Raplixa (formerly Fibrocaps)||Sprayable dry-powder formulation of fibrinogen and thrombin to aid in hemostasis during surgery to control mild or moderate bleeding.
|The Medicines Company (TMC)||In development: Fibropad patch||FDA accepted company's BLA application for Fibrocaps in April 2014 and set an action date (PDUFA) in 2015. In November 2013, the European Medicines Agency agreed to review the firm's EU marketing authorization application. Status update in report #S192.
|Vascular Solutions||D-Stat Flowable||Thick, but flowable, thrombin-based mixture to prevent bleeding in the subcutaneous pectoral pockets created during pacemaker and ICD implantations.
Note: Status of products detailed in Report #S192.
Source: MedMarket Diligence, LLC
Below is a list of the technologies under development at startups identified in March 2015 and included in the Medtech Startups Database.
- Implanted neuromodulation device for the control of blood pressure.
- Less invasive, catheter-based treatment of congestive heart failure caused by ischemic cardiomyopathy.
- Electrophysiology recording systems for the treatment of atrial fibrillation.
- Transcatheter mitral valve repair.
- Orthopedic surgical instruments.
- Smartphone-enabled stethoscope.
- Bioresorbable device for the non-surgical treatment of aneurysms in patients with Kawasaki Disease.
- Cold-based dilatation catheter system for the treatment of various peripheral lesion types.
- Intraoperative surgical image guidance system.
- Surgical device for bone alignment.
- Bone-fixation for orthopedics and tissue allografts for post-surgery wound care.
- Single-use surgical retractors for use during minimally invasive surgery.
- Developing a cell therapy for Type 1 diabetes.
- Optical targeting and visualization of trajectories in surgical procedures.
- Contract medical technology development.
- Device for the treatment of obstructive sleep apnea.
For a historical listing of technologies at medtech startups, see link.
Advanced technologies are frequently developed in well developed economies, then migrate to other economies over time. Consequently, relatively new technologies tend to be more dominant in the well developed economies while relatively old technologies tend to be more dominant in the developing economies.
Case in point, surgical sealants for wound management versus surgical tapes, the former relatively new (and advanced) and the latter relatively old.
Source: MedMarket Diligence, LLC; Report #S192
Tissue Engineering. Tissue engineering is a young, emerging, very promising area of medicine that combines engineering principles and processes to human tissues, resulting in the modification and ideally the regeneration of tissues which are able to fully function like the original tissues. The resulting engineered, living tissues may be delivered to the body at places of injury, trauma or disease, thus stimulating the body’s natural healing processes. It does this by activating the body’s innate ability to regrow and regenerate. At this time, scientists still have a great deal to learn about the body’s ability to regenerate tissues, but there are already innovative therapies that are intended to heal or reconstruct diseased tissues, and to support further regeneration and repair. Such therapies are helping to speed up healing and to help heal tissues that cannot heal on their own. Researchers feel that, in the future, tissue engineering will likely help to heal fractures, severe burns, chronic wounds, heart and nerve damage and likely many other diseases as well. While it is true that most of the industry and its benefits lie in the future, the promise of tissue engineering is materializing virtually on a daily basis.
Cell Therapy. Patient-specific cell therapies are either autologous or allogeneic. Off-the-shelf cell therapies involve donor cells which are expanded in tissue cultures, allowing the growth of large banks of cells. These cells, which originally came from a single individual, can then be frozen or otherwise preserved for use as treatments for potentially thousands of patients. By definition, off-the-shelf cell therapies are always allogeneic. Formally speaking, cell therapy covers a wide area, touching as it does on gene therapy, cancer vaccines, and even on delivery of drugs to tumour bodies. Cells might be delivered by injection directly to the site of disease, or by using a medical device. Some areas of cell therapy have shown distinct promise in early clinical trials, but only Phase 2 and 3 clinical trials will show whether the therapies will work in the clinic. Safety is of leading importance whenever cell therapies are involved. The areas of greatest interest for cell therapy at this time are cancer, cardiovascular and neurological, as well as for treatment of diabetes.
Source: Smithers Apex
Tissue engineering and cell therapy markets are the subject of a pending global study by Smithers Apex.
The global market for products used in wound closure encompasses sutures/staples, tapes, specialized vascular closure devices, hemostats, and surgical sealants. Some well known companies dominate some segments, but the market remains open to innovations by others. As a result, the balance of control of each segment has continued to shift. Below is illustrated the overall market shares of companies in this market.
B: Abbott Vascular
C: Access Closure
F: C.R. Bard
I: CSL Behring
J: Equimedical BV
M: St. Jude Medical
Source: MedMarket Diligence, LLC; Report #S192.
Fundings for medical technologies in March 2015 totaled $542 million, led by the $57 million funding of EndoChoice, Inc.
Below are the top fundings for the month.
|EndoChoice, Inc., has raised $57 million in a round of funding, according to the company
||Endoscopes and other instrumentation in gastroenterology
|Apollo Endosurgery, Inc., has closed a $50 million secured term loan according to the company
||Minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures
|Semma Therapeutics has raised $44 million in a Series A round of funding according to the company
||Cell therapy for type I diabetes
|Svelte Medical Systems, Inc., has raised $38.01 million of a planned $48.74 million round of funding according to a regulatory filing
||Drug eluting and other coronary stents
|Auxogyn, Inc., has raised $34.32 million of a planned $40 million round of funding according to a regulatory filing
||Diagnostic and other technologies focused on women’s reproductive health
|SteadyMed Therapeutics, Inc., has raised $39.95 million in its IPO according to press reports
||Patch-pump drug delivery technology
|Hansen Medical, Inc., has raised $35 million in a round of funding according to a regulatory filing
For the complete list of medtech fundings in March 2015, see link.
For a historical list of the individual fundings in medtech, by month, since 2009, see link.
In 2013, energy-based tissue ablation tools and techniques were used in hundreds of millions of procedures required, generating an estimated $12.4 billion in cumulative global sales. These total sales are projected to register a healthy growth over the forecast to the year 2020, reaching $16.8 billion by that time.
A new report published by Smithers Apex covers the global market for energy-based tissue ablation products. See link.