MALVERN, PA — TELA Bio, Inc. (Nasdaq: TELA), a commercial stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, announced data from a non-human primate study demonstrating favorable response to reinforced biologic material used in a hernia repair compared to seven clinically used biologic and synthetic products.
The data are published online in the journal, Hernia, the world journal of hernia and abdominal wall surgery, in an article entitled “In-vivo evaluation of a reinforced ovine biologic: a comparative study to available hernia mesh repair materials.” Hernia is published in cooperation with the American Hernia Society, the European Hernia Society, the Americas Hernia Society, and the Asia Pacific Hernia Society.
The study is the first of its kind to compare a wide variety of commercially used biologic, reinforced biologic and synthetic hernia repair materials in an animal model to predict clinical performance. The study used adult non-human primates, a species that shares greater than 98% of its DNA with humans and thus provides the best possible model to predict the response of the human immune system and healing kinetics.
In the study, two innovative reinforced biologics, OviTex 1S® Resorbable and OviTex 1S® Permanent, were studied in a non-human primate hernia repair model and were evaluated for their biologic performance as measured by inflammatory response, healing kinetics, integration, and remodeling into functional host tissue. For comparison, seven clinically used biologic and synthetic meshes were also studied. Seventy-three non-human primates were implanted with test articles in surgically created full thickness midline abdominal wall defects. Clinical observations were recorded daily. Implants were recovered at 4, 12, and 24 weeks and evaluated for signs of herniation, inflammation, adhesions, contraction, or other abnormalities as well as evidence of healing and integration.
The results showed that both the reinforced biologics (OviTex 1S®) and biologics remodeled into naturally appearing tissue and were associated with low levels of inflammation. However, reinforced biologics showed earlier cellular and blood vessel infiltration than biologics. This resulted in earlier remodeling and better maintenance of the geometry of the repair. In contrast, a foreign body response persisted with the synthetic mesh products which manifested itself as a layer of reactive tissue often above and separate from the contracted mesh structure.
“The data generated from this animal study were a critical tool for us to evaluate and confirm our design concepts prior to human implantation,” said Maarten Persenaire, M.D., co-founder, Chief Medical Officer of TELA Bio. “In the clinic, chronic inflammation associated with synthetic mesh can lead to serious complications including mesh erosion, contraction, chronic pain and infection. While biologic implants avoid the issue of chronic inflammation, they are prone to stretching over time. Based on the observed performance of the different products, we believe OviTex will address many of the concerns associated with the continuous foreign body response of synthetics and the stretching of biologics. In addition, the earlier host cell infiltration and remodeling may help explain the resilience of reinforced biologics against post-operative infections as has been reported by several surgeons.”
Source: TELA Bio, Inc., 1 Great Valley Pkwy Ste 24, Malvern, PA 19355
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