TheraVet: First Patients Treated With BIOCERA-VET® Bone Surgery in the United States of America
26 Octobre 2021 - 7:30AM
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
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version on businesswire.com: https://www.businesswire.com/news/home/20211025005359/en/
TheraVet Sabrina Ena Chief Operating Officer
sabrina.ena@thera.vet
Julie Winand Chief Corporate Officer julie.winand@thera.vet
NewCap Investor Relations and Financial Communications
Théo Martin / Louis Tilquin theravet@newcap.eu Tel: +33 (0)1 44 71
94 94
Press Relations Arthur Rouillé / Ambre Delval theravet@newcap.eu
Tel: +33 (0)1 44 71 00 15
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