Bringing Chemistry to Life: The future of surgical sealants.

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Presentation transcript:

Bringing Chemistry to Life: The future of surgical sealants

Tissuemed Ltd Tissuemed is an R&D based medical device company based in Leeds, UK Founded by surgeons as a University spin-out (mid-1970s) Initially focused on tissue heart valves and grafts Tissuemed possesses world-class expertise in developing adhesive polymers for surgical applications.

The Product –TissuePatch3

TissuePatch3 Description Thin film (40µm), flexible, integrated tissue sealant, barrier and adhesive Developed from absorbable synthetic materials commonly used in surgery Easy to handle and conformable Self-adhesive/tissue-bonding Dry and ready-to-use Barrier Adhesive terpolymer Cross section: fused multi-laminate structure, preformed in manufacture

Upper Surface is Demonstrably Hydrophobic

Indications TissuePatch3 is CE marked and indicated for use to seal and reinforce against: air leakage in thoracic surgery, e.g. lung resection leakage of low pressure or oozing bleeding in general surgery TissuePatch3 is intended for use as an adjunct in Thoracic and General surgery. It is not intended to replace sutures or staples. TissuePatch3 can be applied to a wound to seal the area effectively within 30 seconds.

Product Advantages Easy to Use: Open and Apply. No guns, no cartridges, no preparation required, Bonds to surgical site in <30 seconds. Strong: Strong adhesion with cross linking in situ. Flexible/Elastic:Can be applied to non-uniform surfaces. Synthetic: Constructed from synthetic polymers. No human or animal material. Gamma-sterilized. Absorption in about 50 days. Cost-Effective:Potential to reduce OR time, tissue support during wound healing, and reduce hospital stay.

Polyvinylpyrrolidone (PVP) Acrylic Acid (AAc) Acrylic Acid/N-Hydroxysuccinamide (AAc-NHS)

Mechanism of action Tissuemeds patented polymer technology enables TissuePatch3 to bond to a range of tissue surfaces in a two-stage process. This is why it works…..

This is how it works…..

Pre-Clinical and Clinical Summary

Pre-clinical efficacy Efficacy was demonstrated using two surgical models: Thoracic General Both showed TissuePatch3 to be an effective treatment for the sealing of air and blood leaks.

Pre-Clinical Thoracic surgery model Porcine lung (n=6) Punch biopsy to create pleural defect Acute air leak grading 14 and 28 day recovery

Pre-Clinical Thoracic surgery model t 30 minutes t =14 days

Clinical performance – TissuePatch3 A Post-Market Surveillance Study of the Safety and Performance of TissuePatch3 in the Prevention of Air Leaks Following Lung Surgery Target population: Patients undergoing lung surgery Two centre study with 2 Clinical Investigators Patients treated – 20 Follow-up - 6 weeks and 3 months Study was independent with monitoring and control performed by Medvance Ltd

Apply with lung ¾ inflated

Air Leak reduction at chest closure Twelve of the 15 treated subjects (5 were outside the inclusion criteria) had no air leaks remaining at chest closure (80%). Of the patients who had residual air leaks, the maximum time to the last air leak being present was 120 hours and the minimum 0. In comparison, of the 20 control patients, all (100%) displayed air leaks at chest closure. The maximum time to the last air leak present was 120 hours and the minimum 0 hours

Time to last air leak recorded At both centres, time to the last air leak recorded was shorter for the 15 patients treated with TissuePatch3. This was statistically significant at Norfolk and Norwich (p=0.05). For the patients treated at Leeds, whilst the average time to the last air leak recorded was lower (49.8 c.f 59.3 hours) there was no statistically significant difference between control and TissuePatch3 treated patients.

Time to chest drain removal For patients treated with TissuePatch3 at the Norfolk and Norwich hospital, despite the significant reduction in the time to the last air leak recorded, this was not reflected in the time to chest drain removal, with the mean time to drain removal for treated or control patients being 5 to 6 days. The median time to drain removal of TissuePatch3 treated patients was lower than the control group, 3 c.f 5 days. In Leeds, both the mean and median times for chest drain removal of TissuePatch3 treated cases were shorter than the control subjects.

Time to discharge For TissuePatch3 patients treated at the Norfolk and Norwich hospital, despite the significant reduction in the time to the last air leak recorded, this was not reflected in the time to hospital discharge. In Leeds, both the mean and median times for hospital discharge of TissuePatch3 treated cases were shorter (each by 2 days) than the control subjects. Once again, due to the low patient numbers and the range of data presented, analysis by Mann-Whitney (considering each centre in isolation) revealed no statistical difference (p=0.05) between control and TissuePatch3 treated cases.

Adverse events There were no reports of any device-related adverse events during this study. Clinician satisfaction During the course of this post market study, both clinicians were consistently extremely satisfied with TissuePatch3 application. Overall surgical procedure satisfaction level showed 87% of the procedures being scored as extremely satisfactory and the remainder moderately satisfactory.

Conclusions Easy to handle and apply Immediate reduction in air leaks Normal fluid discharge and patient recovery Early chest drain removal and hospital patient discharge No device related adverse events Strong surgeon endorsement Further study is required to generate statistically significant clinical results to support use of TissuePatch3 for routine sealing of air leaks.

finally…..a few soundbites Because of its construction and contact surface chemistry TissuePatch3 is a very effective product for prevention of air leakage in lung surgery with the highest energy of adhesion of all products in current use. TissuePatch3 requires no advance preparation, mixing, soaking or extended contact apposition…..it requires the least amount of preparation and application time of all available products, being truly open and apply TissuePatch3 is the easiest product to handle and apply to the target tissue.