TheraVet: Patient Recruitment Phase Successfully Completed in BIOCERA-VET Fracture Revision Surgery Study in Toy Dogs
27 September 2023 - 7:30AM
Business Wire
- Multicentric (4 sites in 3 countries) prospective study
assessing BIOCERA-VET in revision surgery of distal radioulnar
fracture in toy and miniature dogs
- A niche market with important unmet medical needs
- Unique BIOCERA-VET positioning among bone grafts, by
providing the necessary biomechanical support thanks to its
unrivaled mechanical resistance
Regulatory News:
TheraVet (ISIN: BE0974387194 - ticker: ALVET), a pioneering
company in the management of osteoarticular diseases in pets,
announces the completion of recruitment in a multicentric
prospective study assessing BIOCERA-VET in revision surgery of
distal radioulnar fracture (DRUF) in toy and miniature dog
breeds.
As announced, the Company continues its focus on developing the
market by enlarging the use of BIOCERA-VET in clinical indications
with unmet medical needs: revision surgery of distal radioulnar
fracture in toy and miniature dogs is a complex procedure in a
challenging anatomical and biomechanical environment. Applications
within other clinical indications and targeting other breeds of dog
could emerge once the benefits provided by BIOCERA-VET have been
validated in this indication.
DRUF is the third more common fracture in dogs1. In
toy and miniature breeds, these fractures representing 120.000
cases/year2 can occur after minor trauma, probably due to the small
size of the bones. A high complication rate up to 75%3 is
associated to DRUF repair, depending on the surgical procedure.
The predisposition of these breeds to major complications has been
attributed to anatomical reasons as spare soft tissue coverage and
decreased vascular density at the level of the distal radius. Also,
biomechanics plays a role, whereas minimal bone surface contact
after reduction is found when there is a small size cross-section
area of the distal radius and a short oblique or transverse
orientation of the fracture. If DRUF osteosynthesis is technically
and biomechanically difficult for the reasons stated above,
revision surgery becomes an even bigger challenge. In the worst
scenario, amputation may be eventually required4,5.
So far, only few records evaluated revision surgery in DRUF with
major complications. In this context, a prospective study assessing
BIOCERA-VET used as bone graft during revision surgical procedure
in DRUF after the occurrence of a major complication (e.g., delayed
union, non-union, mal-union, osteopenia (refracture) and implant
failure) in toy and miniature dogs, was conducted in 4 centers in
Italy (2), Ireland (1) and Belgium (1). BIOCERA-VET was used
instead of autograft, which is considered as the gold standard, in
order to overcome the limitation of its availability, especially in
toy and miniature dogs and also to provide strong biomechanical
support thanks to its unique mechanical resistance.
The recruitment was completed in September 2023 with 6 patients
included in a 6-month period (very low rate of patients recruitment
has been previously described in literature6), stressing the strong
interest of vet surgeons for this approach overcoming the
shortcomings of the reference procedure. Follow-up of patients is
still ongoing, and the results will be available by the end of the
year for scientific publication and conference communication.
About TheraVet SA TheraVet is a veterinary biotechnology
company specializing in osteoarticular treatments for companion
animals. The Company develops targeted, safe and effective
treatments to improve the quality of life of pets suffering from
joint and bone 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 and Brussels, has its
head office in Belgium (Gosselies) with a US subsidiary. For more
information, visit the TheraVet website or follow us on LinkedIn /
Facebook / Twitter
About BIOCERA-VET In close collaboration with an
international scientific board, THERAVET® has developed a new line
of calcium-phosphate and biological bone substitutes, BIOCERA-VET®.
BIOCERA-VET® is a full range of innovative, easy-to-use, efficient
& cost-effective bone substitutes indicated in bone surgeries
where a bone graft is required and as a palliative alternative in
the management of canine osteosarcoma. Based on extremely promising
clinical results, this line offers the possibility of a better,
more convenient and more efficient orthopedic surgery. BIOCERA-VET®
is declined in different lines:
- BIOCERA-VET® BONE SURGERY RTU, a ready-to-use highly injectable
self-hardening calcium-phosphate cement
- BIOCERA-VET® SMARTGRAFT, a naturally osteoconductive bone
graft
- BIOCERA-VET® GRANULES, an affordable biocompatible
calcium-phosphate bone substitute
- BIOCERA-VET® OSTEOSARCOMA RTU, a ready-to-use highly injectable
calcium-phosphate bone substitute for cementoplasty
For more information, visit BIOCERA-VET website.
1 Harasen G. Common long bone fractures in small animal
practice: part 2. Can Vet J 2003;44:503–504. 2 Based on 89.7
Mio dogs in USA and 92 Mio dogs in Europe 3 Welch JA,
Boudrieau RJ, Dejardin LM, Spodnick GJ. The intraosseous blood
supply of the canine radius: implications for healing of distal
fractures in small dogs. Vet Surg 1997;26:57–61. 4Lappin MR,
Aron DN, Herron HL. Fractures of the radius and ulna in the dog. J
Am Anim Hosp Assoc 1983; 19: 643–650. 5 Kraus KH, Bayer BJ.
Delayed Unions, Nonunions, and Malunions. In: Tobias KM, Johnston
SA, eds. Veterinary Surgery: Small Animal. vol. 1. St. Louis:
Elsevier/Saunders, 2012;46:647-658. 6 Aikawa, Takeshi et al.
(2019). Clinical outcomes of 119 miniature‐ and toy‐breed dogs with
140 distal radial and ulnar fractures repaired with free‐form
multiplanar type II external skeletal fixation. Veterinary Surgery,
vsu.13245
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TheraVet Chief Operating Officer Sabrina Ena
investors@thera.vet Tel: +32 (0) 71 96 00 43
NewCap Investor Relations and Financial Communications
Théo Martin / Nicolas Fossiez theravet@newcap.eu Tel: +33 (0)1 44
71 94 94
Press Relations Arthur Rouillé theravet@newcap.eu Tel: +33 (0)1
44 71 00 15
NewCap Belgique Press Relations Laure-Eve Monfort
lemonfort@thera.vet Tel: + 32 (0) 489 57 76 52
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