TheraVet: Patient Recruitment Phase Successfully Completed in BIOCERA-VET Fracture Revision Surgery Study in Toy Dogs

27 Sep 2023 07:30 CEST

• 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 dogs ¹ . 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 required^4,5.

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 o r 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.
⁴ Lappin 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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