GOSSELIES, Belgium–(BUSINESS WIRE)–Regulatory News:
TheraVet (ISIN: BE0974387194 – ticker: ALVET) (Paris:ALVET) (Brussels:ALVET), a pioneering company in the management of osteoarticular diseases in companion animals, announces today the first two dog patients treated with BIOCERA-VET® Bone Surgery in United Stated of America.
These first patients mark the start of TheraVet clinical cases study on BIOCERA-VET® Bone Surgery in the USA, the objective of which is to collect additional safety and efficacy data in surgical procedures such as arthrodesis, osteotomy, fracture and Tibial Tuberosity Advancement (TTA). In this study, a minimum of thirty (30) patients will be treated with BIOCERA-VET® Bone Surgery. BIOCERA-VET® Bone Surgery commercialization in the USA is expected for 2022 first in the States of Texas, Florida and the Carolinas (north and south) – areas with high veterinary coverage -, before expanding to the whole of the United States.
The two first patients included in this study were treated for a bilateral TTA and for a tarsal arthrodesis with BIOCERA-VET® Bone Surgery. Cases were performed by Dr. Hirshenson (DVM, DACVS-SA) and Dr. Morgan Hackett (DVM) from Triangle Veterinary Referral Hospital (North Carolina) based in the Research Triangle park known as one of the largest US research parks housing hundreds of companies and in a state ranked in the top 10 states with the highest number of vets and private practices.
A pilot study performed in Europe earlier this year has been assessing the efficacy and safety of BIOCERA-VET® in arthrodeses (i.e., bone fusion) in a total of 29 dogs (7 tarsus and 22 carpus) among which 16 were treated with autografts and 13 with BIOCERA-VET®. A blinded radiological analysis was performed by an independent surgeon at 4 and 8 weeks after surgery: radiographs were scored from 0 (no visible sign of fusion) to 3 (total fusion). Bone fusion induced by BIOCERA-VET® was as good as the one induced by bone autograft (respective mean scores of 1.70 vs 1.41 (p>.05) at 4 weeks and of 2.08 vs 1.88 (p>.05) at 8 weeks). However, the safety evaluation showed a lower rate of complications with BIOCERA-VET® as compared to autograft. Together, this translates into an excellent efficacy-safety profile for TheraVet’s bone substitute.
This US TheraVet clinical cases study is still recruiting investigators.
Enrico Bastianelli, Chief Executive Officer of TheraVet, says: “We are very pleased with the first patients treated in this US-dedicated and specific clinical cohort. This formally marks the entry of BIOCERA-VET® in the United States. TheraVet’s goals with this study are to build a network of prescribers and ambassadors, and to create the visibility of BIOCERA-VET® prior to the commercial launch planned in 2022.”
About TheraVet SA
TheraVet is a veterinary biotechnology company specialising in osteoarticular treatments for animals. The Company develops targeted, safe and effective treatments to improve the quality of life of pets suffering from osteoarticular diseases. For pet owners, the health of their pets is a major concern and TheraVet’s mission is to address the need for innovative and curative treatments. TheraVet works closely with international opinion leaders in order to provide a more effective response to ever-growing needs in the field of veterinary medicine. TheraVet is listed on Euronext Growth® Paris et Brussels, its head office is in Gosselies, Belgium, and it has a subsidiary in the US.
For more information, visit www.thera.vet