- Shaifur Ra, M., Islam, R., Asaduzzama, S.M., & Shahedur R, M. (2015). Properties and Therapeutic Potential of Human Amniotic Membrane. Asian Journal of Dermatology, 7(1), 1-12. doi: 10.3923/ajd.2015.1.12
- Fairbairn, N. G., Randolph, M. A., & Redmond, R. W. (2014). The clinical applications of human amnion in plastic surgery. Journal of Plastic, Reconstructive & Aesthetic Surgery, 67(5), 662-675.
- K193552 510(k) Summary
- 7. Data on file -RDR-002
- Cardinal, L. J. (2015). Central tendency and variability in biological systems. J Community Hosp Intern Med Perspect, 5(3), 27930. doi:10.3402/jchimp.v5.27930
- Collier, A. C., Tingle, M. D., Paxton, J. W., Mitchell, M. D., & Keelan, J. A. (2002). Metabolizing enzyme localization and activities in the first trimester human placenta: the effect of maternal and gestational age, smoking and alcohol consumption. Hum Reprod, 17(10), 2564-2572. doi:10.1093/humrep/17.10.2564
- DuBois, B. N., O’Tierney-Ginn, P., Pearson, J., Friedman, J. E., Thornburg, K., & Cherala, G. (2012). Maternal obesity alters feto-placental cytochrome P4501A1 activity. Placenta, 33(12), 1045-1051. doi:10.1016/j.placenta.2012.09.008
- Huuskonen, P., Amezaga, M. R., Bellingham, M., Jones, L. H., Storvik, M., Hakkinen, M., . . . Pasanen, M. (2016). The human placental proteome is affected by maternal smoking. Reprod Toxicol, 63, 22-31. doi:10.1016/j.reprotox.2016.05.009
- McRobie, D. J., Glover, D. D., & Tracy, T. S. (1998). Effects of gestational and overt diabetes on human placental cytochromes P450 and glutathione S-transferase. Drug Metab Dispos, 26(4), 367-371. Retrieved from https://www.ncbi.nlm. nih.gov/pubmed/9531526
- O’Huallachain, M., Karczewski, K. J., Weissman, S. M., Urban, A. E., & Snyder, M. P. (2012). Extensive genetic variation in somatic human tissues. Proc Natl Acad Sci U S A, 109(44), 18018-18023. doi:10.1073/pnas.1213736109
- Paakki, P., Stockmann, H., Kantola, M., Wagner, P., Lauper, U., Huch, R., . . . Pasanen, M. (2000). Maternal drug abuse and human term placental xenobiotic and steroid metabolizing enzymes in vitro. Environ Health Perspect, 108(2), 141-145. doi:10.1289/ehp.00108141
- Strolin-Benedetti, M., Brogin, G., Bani, M., Oesch, F., & Hengstler, J. G. (1999). Association of cytochrome P450 induction with oxidative stress in vivo as evidenced by 3-hydroxylation of salicylate. Xenobiotica, 29(11), 1171-1180. doi:10.1080/004982599238038
- Gilpin A, Yang Y. Decellularization Strategies for Regenerative Medicine: From Processing Techniques to Applications. Biomed Res Int. 2017;2017:9831534. doi: 10.1155/2017/9831534. Epub 2017 Apr 30. PMID: 28540307; PMCID: PMC5429943
- Keane, T. J., Londono, R., Turner, N. J., & Badylak, S. F. (2012). Consequences of ineffective decellularization of biologic scaffolds on the host response. Biomaterials, 33(6), 1771- 1781. doi:10.1016/j.biomaterials.2011.10.054
- Sicari, B. M., Dziki, J. L., Siu, B. F., Medberry, C. J., Dearth, C. L., & Badylak, S. F. (2014). The promotion of a constructive macrophage phenotype by solubilized extracellular matrix. Biomaterials, 35(30), 8605-8612. doi:10.1016/j. biomaterials.2014.06.060
ADVERTISEMENT
InnovaMatrix PD
InnovaMatrix® PD is the first and only particulate placental ECM medical device cleared by the FDA for wound management.
The introduction of InnovaMatrix® PD is an important and innovative advancement in the management of wounds. As a next-generation technology, InnovaMatrix® PD offers the inherent benefits of the placenta1,2 plus the quality control, reliability, and safety profile of a medical device3,4. Manufactured with our proprietary TriCleanse™ Placental Extracellular Matrix (ECM) Process, InnovaMatrix® PD is the next-generation particulate placental device designed for the management of complex surgical wounds, hard-to-heal wounds, and burns.
While the benefits of placental-derived allografts are well documented1,2, human-derived grafts can be variable due to the unique medical histories and social behaviors of each donor5-12. Knowing this challenge, a porcine source was selected because it can be controlled for age, diet, health, and activity level, thereby reducing the variability of the raw material used to manufacture InnovaMatrix® PD.
Click here for more info.
References
Triad Life Sciences
Triad Life Sciences
Triad Life Sciences, Inc., an emerging regenerative medicine company, was founded in 2017 to address unmet clinical needs in complex surgical wounds, chronic or hard-to-heal wounds, and burns. Since then, our groundbreaking, proprietary, patent-pending, FDA-cleared technology platform has developed an array of innovative wound management solutions.
In 2022, Triad Life Sciences, Inc. was acquired by Convatec to support its strategy, securing access to a complementary and innovative technology platform that enhances advanced wound management and patient outcomes.
Founded to disrupt the extracellular matrix (ECM) market with a platform technology that introduces the first-ever placental-derived medical device, our company addresses the inherent challenges and related restrictions of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Our leadership team has a collective 100+ years of medical device experience at biologics companies and more than 30 years of combined experience specifically in ECM technologies.
Our leaders identified three key challenges with placental allografts manufactured from HCT/Ps: graft variability and inconsistency, minimal manipulation requirements, and the economics of care. The InnovaMatrix Platform offers a unique, unparalleled solution to these challenges1-8 while also providing the reliability, reproducibility, and safety profile of a medical device9,10.
(901) 333-6000
IMP-0100-01: 100 mg, 50cm2 (coverage varies)
Indicated for the Management of Wounds Including:*
*See package insert for full list of indications.
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Chronic vascular ulcers
- Tunneled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post- laser surgery, podiatric, wound dehiscence)
- Trauma wounds (abrasions, lacerations, and skin tears)
- Partial-thickness second degree burns
- Draining wounds
The device is intended for one-time use.
This device is derived from porcine collagen and should not be used on patients with sensitivity or allergy to porcine materials; sensitivity or allergy to collagen; or active or latent infection in or around the application site.
This device is not indicated for use in third degree burns.
