Filling the Gap: Tissue Adhesives & Surgical Sealants

Acute wounds have long represented a major focus for healthcare professionals and clinicians. While traditional wound care strategies have revolved around the use of sutures, staples, and tack-type devices, significant development has focused on the expansion of topical tissue adhesives and surgical sealants.
Overall, the global market for wound care has reached over $10.8 billion (2014) with forecasted growth of ~$14 billion in 2018.1

Current product offerings within the tissue adhesive and surgical sealant field strive to meet:

    • long-lasting microbial protection
    • integration into wound-site
    • sufficient tensile strength
    • flexibility and compliance on curved surfaces (i.e. elbows, knees, etc.)

These materials are typically synthetic or naturally-derived and are meant to restore compromised tissue boundaries limiting infection while allowing healing to occur. Based on the demonstrated efficacy of adhesives and sealants, their use independent of other traditional closure technologies (i.e. sutures) has been rapidly increasing with exceptional growth (CAGR +15%)1.

Poly-Med, a world leader and innovator in bioresorbable polymers, is active in the tissue adhesive and surgical sealant space and has been for more than twenty (20) years. Within this time, the Poly-Med team has worked to address common problems present in topical wound care products including limited viscosity, low compliance (i.e. brittleness), and poor integration at the wound site. To overcome these limitations, Poly-Med has developed a range of bioresorbable modifiers that can be incorporated directly into a variety of wound closure systems.

Poly-Med’s patented chemistry can be directly added into well-known adhesive systems (i.e. cyanoacrylates) currently on the market. From our extensive polymer catalogue, Caproprene™ and Strataprene® polymer families provide a full range of potential additives that can offer customizable viscosity with enhanced compliance.

Strataprene® is a fully traceable, medical grade polymer and offers customizable molecular weight while also exhibiting elastic-like properties (able to undergo 1000% strain prior to breaking2). In addition to being used as a modifier for tissue adhesive systems, Strataprene® 3534 can be used as a spray bandage or film that can be directly applied to the patient’s skin in the clinical setting. Strataprene®’s enhanced solubility allows use with a host of benign solvents, making it readily dissolvable and able to integrate with a patient’s skin. Strataprene® can also readily combined with a host of active pharmaceutical ingredient’s and can provide a variety of release profiles for extended wound protection and healing.2

If you are working on an advanced formulation for a tissue adhesive or surgical sealant,
Contact us to learn how your project can benefit from Poly-Med’s innovative wound care technologies.

Seth McCullen, Ph.D.

Manager, Business Development, Poly-Med, Inc.

1 L. MedMarket Diligence, Report #S190, Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion Markets, 2010–2017.

2 Internal data on file at Poly-Med, Inc.

3D Printing Bioresorbable Polymers for Medical Devices

“If we can expand the number of biomaterials used in additive manufacturing, we can tackle a tremendous number of problems in all fields of reconstructive surgery and make enormous strides for the benefit of patients.”
– Dr. Scott Hollister, University of Michigan1

3D-Printing. Additive manufacturing. Rapid prototyping. These buzz-phrases are always sure to attract attention at talks, conferences, on posters; you name it. Up until recently, the world of additive manufacturing was considered more niche, and some speculated the field would never realize the potential many industry leaders were suggesting. In fact, additive manufacturing has grown to become a $5.2 billion industry as of 2015, and some say total revenue could reach upwards of $20 billion by 2020 and beyond.2 Undoubtedly, 3D-printing is a disruptive technology that is still growing at an exponential rate, as more companies are beginning to adopt and reap its benefits.

While the medical field only accounts for a small fraction of the overall additive manufacturing industry, it too is finding new uses for the technology at an ever-increasing rate. Already, patients are receiving customized, 3D-printed implants and prosthetics. 3D-printing has saved the lives of numerous infants born with rare tracheal defects. Joint replacements and bone reconstruction therapies are becoming more effective due to a level of customization that simply did not exist before additive manufacturing methods. These are only a few of many medical applications developed to date.

Despite all of the medical advances employing the use of 3D-printing, medical grade materials suitable for 3D-printing are very difficult to procure. Stock polylactic acid (PLA), polycaprolactone (PCL), and acrylonitrile butadiene styrene (ABS) have been around for many years, though companies looking for medical grade 3D-printing filaments are generally out of luck. Additionally, if the goal is to develop a bioresorbable 3D-printed medical device submitted for FDA review, device manufactures have a difficult time identifying reliable, ISO-certified suppliers to pursue.

Poly-Med, a world leader in bioresorbable polymers, has taken note of the lack of materials available and will be providing medical-grade material options to the 3D-printing filament market. Our extensive polymer catalogue translates easily into the additive manufacturing materials space. And, Poly-Med’s materials are supported by an ISO 13485 certified quality system.

Poly-Med is launching its new line of 3D-printing filaments later this year. This innovative product line is set to include Lactoprene® 100M, Dioxaprene® 100M, and Maxprene® 955 as the flagship filaments, with many additional polymers set to follow in late 2017 and into 2018. These three initial filament offerings provide unique features.

Lactoprene® 100M is analogous to many standard 100% PLA filament offerings widely available, except that Lactoprene® 100M is medical grade and fully traceable. It is tailor made for 3D-printing applications involving orthopedics or for any device that requires a long-lasting, high strength material. Where faster resorption times are a design criteria, Maxprene® 955 is a good option. Maxprene® 955 is a custom 95/5 poly(glycolide-co-lactide) copolymer, boasting a high tensile modulus coupled with a shorter timeframe for strength and mass loss. Dioxaprene® 100M is a 100% polydioxanone material that has extended strength retention and also carries a degree of softness and flexibility. Dioxaprene® 100M may be appropriate when moderate degradation time is required.

Beyond these three initial offerings, Poly-Med is also evaluating translation of other bioresorbable polymers in its catalogue to 3D-printing filaments. Lactoprene® 7415, Strataprene® 3534, Caproprene® 100M, and Glycoprene® 7027 are just a few of the polymers in the 3D-printing filaments pipeline. Poly-Med is excited to be on the forefront of additive manufacturing materials and is poised to be the industry leader for bioresorbable, medical grade 3D-printing filaments. Please contact us with any questions about our 3D-printing materials or additive manufacturing developmental capabilities.

1EOS. University of Michigan reference

2Keeney, Tasha. ”3D Printing: A Disruptive Innovation Still In Its Infancy”. Ark Invest. October 2016

Bioresorbable Medical Devices: State of Art

October is always a busy and fun time of year. Football is mid-season, Halloween is close at hand, and we start planning for the next year at Poly-Med. It’s also the perfect time to step back from the daily task list and think about progress over the last year at Poly-Med and also among medical device innovation overall. And, through this process, I am always honored to be a part of this amazing industry.

We’ve seen some of the largest developments in our field in 2016, such as FDA approval of the Abbott ABSORB® stent which is the highest profile bioresorbable product in recent memory. As in many cases, the use of bioresorbable materials to replace permanent implants is used as a technique to reduce long term complications. Dr. Gregg Stone, chair of the ABSORB® clinical program, reflected on the potential upside of bioresorbable stents compared to permanent metal versions including no residual implant which may reduce future blockages and non-interference for future procedures. When considering potential impact of the product and associated clinical trials, Dr. Stone said “if those trials are positive, then I think bioresorbable technology will ultimately be used in the majority of patients..” ¹

Additive manufacturing is also a trending topic, with big investments from a variety of companies. While the use of bioresorbable polymers in 3D printing is limited, it has already saved lives. Polycaprolactone scaffolds have been printed into tracheal splints, custom bone scaffolds have been prepared for reconstruction after significant orthopedic injury, and creating scaffolding with patient-specific structures is an exciting reality. Advanced bioresorbable materials, like those developed at Poly-Med which are specifically tailored to these applications, is supporting continued development of improved techniques for better patient care in this area.

Electrospinning as a process has been known for more than 80 years, though only recently has it advanced to manufacturing feasibility. Significant products, such as the Xeltis bioabsorbable valve² and the Acera Surgical bioabsorbable dura substitute³, both of which are significant because they create a scaffold for native tissue regrowth and highlight the potential impact of electrospinning technology. Over the last year, Poly-Med was able to support several medical device development opportunities utilizing electrospinning, and has made significant advancement in scale and support for new and developing products.

The transition of bioresorbables into mainstream device development confirms the need for enhanced materials, specialty processing, and design support. So as I reflect about the last year within Poly-Med, it has been filled with foundational growth to support this type of development. We completed manufacturing transfer for a bioresorbable electrospun product which recently received market clearance, implemented scaled solutions to support growth in polymer and textile products, and are preparing new material offerings for advanced product design. As it has been throughout my 15 years at Poly-Med, it is fun and exciting to be a part of these innovative, impactful products that can improve patient care and reduce long term risk.

Scott Taylor, Ph.D.
Chief Technology Officer
Poly-Med, Inc.

¹ Reference
² Reference
³ Reference

Poly-Med Welcomes Industry Leader to team

This month we welcome David Gravett to Poly-Med as Vice President of Strategy. He brings over 20 years of experience working with small to mid-sized companies in the medical device, combination product and drug delivery fields. An inventor on 18 issued US patents and over 130 US patent applications, he’s developed numerous drug and combination devices that utilize a range of biomaterials and pharmaceuticals.

Before joining Poly-Med, David was Vice President, Research and Development at Carbylan Therapeutics located in the Bay area in California. Carbylan was focused on developing a novel injectable hyaluronic acid based product for the treatment of pain associated with osteoarthritis. During this time David led the development of the product, the preclinical safety studies and the development of the clinical manufacturing process, taking the product from concept through to the completion of a Phase III clinical study. David first partnered with Poly-Med in 1998 when he was developing drug-device combination products at Angiotech Pharmaceuticals as the Vice President, Formulations and Polymer Chemistry.

A native of South Africa, David completed his undergraduate degree and MSc at the University of Natal in South Africa. He received his PhD in physical chemistry at the University of Toronto under Prof. Guillet. His thesis involved the investigation of controlling the selectivity of photochemical reactions with the use of polymers that were capable of transferring light energy to a spatially defined cavity. It was during this time that he was introduced to the field of biomaterials and drug delivery. David then completed a NSERC industrial Post-doc at Pasteur-Merieux-Connaught (Toronto, Canada) where he investigated the targeted delivery of DNA vaccines via liposomes as well as the use of PLGA microspheres as delivery vehicles for vaccines.

Poly-Med is pleased to welcome someone of David’s caliber join to the ranks here at Poly-Med.

Biomedical Textiles: Poly-Med Research Published in Current Issue of In Vivo Journal

Development of Critical-size Abdominal Defects in a Rabbit Model to Mimic Mature Ventral Hernias

Abstract: Background/Aim: Mesh hernioplasty is one of the most frequently performed procedures in the United States. Abdominal rigidity and chronic inflammation, among other factors, contribute to long-term complications including chronic pain, abdominal wall stiffness and fibrosis.

Acute models do not replicate the chronic environment associated with most hernias, limiting the ability to improve products. The present study details development of a critical-size defect in rabbit abdominal wall for maturation into a chronic hernia to enable analysis of hernia repair devices in a realistic environment.

Materials and Methods: New Zealand White Rabbits were used to assess defect creation and mature hernia development through a period of 21-35 days.

Results and Conclusion: Through this study, a critical-size defect was developed based on 3-cm full-thickness incision through musculature and peritoneum followed by simple skin closure and wound maturation, which was identified as a reliable procedure for creating defects presenting typical aspects of mature hernias including hernia ring and adhesions.

Authors: Georgios Hilas, Michael Scott Taylor and Joel Corbett

For the complete article, visit http://iv.iiarjournals.org/